• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    This prosthesis (1) comprises an expandable tubular frame (2) with a mesh structure and a prosthetic valve (3) mounted on this frame, said armature (2) comprising an atrial portion (2a), a ventricular portion (2v) and a portion ring (2i) located between these atrial and ventricular portions. According to the invention: - said atrial portion (2a) has a conical shape whose section increases from said annular portion (2i) towards the end of this atrial portion opposite this annular portion, and comprises, on the side of said annular portion (2i), over at least a portion of its circumference, anchoring points (5a) projecting from its outer face; and - said ventricular portion (2v) has a substantially spherical or ovoidal shape and comprises, on the side of said annular portion (2i), on at least a part of its circumference, anchoring points (5v) projecting from its face exterior.
    公开号:FR3021208A1
    申请号:FR1454678
    申请日:2014-05-23
    公开日:2015-11-27
    发明作者:Thomas Modine
    申请人:Thomas Modine；
    IPC主号:
    专利说明:

    [0001] The present invention relates to a mitral or tricuspid heart valve prosthesis. A well-known pathology of a heart valve, affecting mainly elderly patients, is the distension of the valve ring, this distension leading to poor coaptation of the valves and thus to the loss of sealing and efficiency of the valve. It is known to treat this pathology by annuloplasty, that is to say by the establishment of a total or partial prosthetic ring for the purpose of re-calibrating the native valve ring. This technique has some disadvantages, including not being very suitable for elderly patients. It is also known to implant, over the native valve, a prosthesis comprising an expandable tubular frame and a prosthetic valve mounted on this frame. Tubular reinforcement, frequently called "stent", has a mesh structure, and comprises an atrial portion, that is to say intended to take place at the level of the atrium of a heart, a ventricular portion, it that is to say, intended to take place at the level of the ventricle of a heart, and an annular portion, that is to say intended to take place at the level of the native valve ring, located between these atrial and ventricular portions . The armature may be self-expanding (being in particular a shape memory material) or an expandable material by means of a balloon. The prosthetic valve may, for its part, be in a synthetic or natural material. Such a prosthesis is deformable so that it can be placed in a catheter and is intended to be deployed from this catheter at the level of the native valve to be treated. It can be put in place by the apical first approach (that is to say by the inferior tip of the heart) or by a transeptal way (mitral valve) or jugular or femoral (tricuspid valve). The existing prostheses of this type do not give complete satisfaction, in particular presenting risks of migration and obstruction of the ventricular ejection channel, having an implementation which is not always very easy to operate, and which does not have a perfectly perfect shape. adapted to that of the implantation site. The main object of the present invention is to remedy these essential drawbacks. Another object of the invention is to provide a prosthesis to achieve this main objective without interfering with the operation of the aortic valve.
    [0002] The prosthesis concerned is of the aforementioned type, comprising an expandable tubular reinforcement with a mesh structure and a prosthetic valve mounted on this reinforcement, said reinforcement comprising an atrial portion, a ventricular portion and an annular portion located between these atrial and ventricular portions.
    [0003] According to the invention, - said atrial portion has a conical shape whose section increases from said annular portion towards the end of this atrial portion opposite this annular portion, and comprises, on the side of said annular portion, at least part of its circumference, anchoring points protruding from its outer face; and said ventricular portion has a substantially spherical or ovoid shape and comprises, on the side of said annular portion, on at least a part of its circumference, anchoring points protruding from its outer face. When the prosthesis is put in place by the apical approach, its atrial portion is first deployed and brought against the atrial portion of the valve ring; the conical shape of this atrial portion is well adapted to a large support against this atrial portion of the ring; once said atrial portion is deployed, the various anchoring points that comprise this atrial portion are oriented to fit into said atrial portion of the ring when the catheter is moved back to release the other portions of the frame. A good pre-positioning of the prosthesis vis-à-vis the implantation site is thus ensured. Further retraction of the catheter realizes the progressive deployment of the ventricular portion; given the spherical or ovoid shape of this ventricular portion, this deployment performs a radial expansion of the wall of this ventricular portion, which causes the various anchor points that comprise the ventricular portion to be inserted into the ventricular portion of the ventricular portion. valvular ring, from the beginning of deployment, thus achieving a perfect locking of the prosthesis on the native valve ring. This locking is all the more efficient that the spherical or ovoid shape of the ventricular portion allows a narrow application of the armature against said ventricular portion of the valve ring. This same spherical or ovoid shape allows a support of the armature which is well adapted to the shape of the ventricle near the valve ring and which does not conflict with the underlying anatomical structures.
    [0004] The prosthesis thus structured makes it possible to perfectly achieve the aforementioned objective of obtaining very low migration risks, of having a relatively easy implementation, and of having a shape adapted to that of the implantation site. It should be noted that the prosthesis according to the invention can be implanted by a transeptal approach (mitral valve) or jugular or femoral (tricuspid valve), in which case the ventricular portion is deployed first and the atrial portion is deployed in second, with insertions of the anchoring points of the ventricular portion and the atrial portion in the ring, which operate in a similar manner to that mentioned above.
    [0005] Preferably, said anchoring points are in the form of curved claws developing outwardly of the prosthesis from their bases to their pointed free ends. The anchoring points thus shaped provide effective anchoring. The anchoring points are preferably present over the entire circumference of the prosthesis; they are preferably regularly distributed over this circumference. Preferably, the anchoring points that comprise said atrial portion are located opposite the anchoring points that comprises said ventricular portion. The anchoring is thus achieved by a clamping effect operated by the various pairs of anchor points, which allows a very effective anchoring. The peculiarity of these tips is then to form a kind of "crab clamp" because the tips point symmetrically towards each other, allowing to bite the annular tissue and stabilize the valve frame . When deploying the prosthesis using the apical approach, the atrial anchor points deploy first, allowing the annular tissue to be hooked, and then, as the progression progresses Deployment, the ventricular anchoring points are deployed in turn and allow to perfect the anchoring of the prosthesis, with maintaining the anchor points in intra-annular position. Thus, the proposed structure allows implantation that is based on the peri-annular valve tissue at first (the anchor points), which is followed by additional support on the valve ring. Indeed, the gripper clamp system allows attachment of the valve tissue and is completed by the intra-annular support of the metal structure, and in the mitral and tricuspid position whatever the access used.
    [0006] The prosthesis may include six pairs of atrial anchoring points and ventricular anchoring points. Preferably, the mesh structure of the armature comprises, at the level of said atrial and annular portions, and at the portion of the ventricular portion comprising said anchoring points, diamond-shaped meshes connected to one another by their angles, and the anchoring points have their bases connected to the portions of the meshes which form the opposite angles of these meshes in the atrial-ventricular direction of the prosthesis, these anchoring points protruding from these portions of the meshes.
    [0007] This mesh structure allows the armature to take effective support against the corresponding parts of the valve ring and ensure proper insertion of said anchor points in this ring. Preferably, the mesh structure of the armature comprises, at the portion of the ventricular portion devoid of anchoring points, meshes in the form of drops of water, with two adjacent meshes arranged spades heads way. one compared to the other. This mesh structure allows the armature to have significant flexibility at said ventricular portion portion, which is adapted to support against the wall of the ventricle of a heart. Preferably, said ventricular portion has a broad indentation on one side, extending in length from its end opposite said annular portion to its portion with the anchor points, and extending over a sector of the order of 120 °. This indentation thus interrupts the mesh structure of the armature and thus gives an asymmetrical shape to the ventricular portion of the prosthesis. The notch is intended to be turned towards the wall of the ventricle located near the aortic valve, so-called mitro-aortic continuity zone. It allows an absence of mesh structure facing this wall and therefore the prosthesis does not present any risk of excessive support against the ventricle wall to the right of the aortic valve, likely to interfere with the operation of this aortic valve. The prosthesis or the catheter for introducing this prosthesis into a heart may then comprise radiopaque markers making it possible to visualize the angular orientation of this prosthesis or of this catheter so as to orient the prosthesis angularly before deployment of the prosthesis.
    [0008] The invention will be better understood, and other features and advantages thereof will become apparent, with reference to the attached schematic drawing, which represents, by way of non-limiting example, a preferred embodiment of the prosthesis concerned.
    [0009] Figure 1 is a side view, with the prosthetic valve that includes this prosthesis in the open position; Figure 2a is an enlarged view of a portion of the prosthesis as shown in Figure 1, including anchor claws; Figure 2b is a view of the same portion, in section, at an angle perpendicular to the view according to Figure 2a; Figure 3 is a view of the prosthesis by its ventricular end, slightly off-axis, with the prosthetic valve in the open position; Figure 4 is a view through its ventricular end, along the axis of this prosthesis, with the prosthetic valve in the open position; Figure 5 is a view similar to Figure 1, with the prosthetic valve in the closed position; and Figure 6 is a view through its atrial end, slightly off-axis, with the prosthetic valve in the closed position. The figures show a mitral or tricuspid heart valve prosthesis 1, comprising an expandable tubular frame 2 and a prosthetic valve 3 mounted on this frame. The frame 2 has a mesh structure formed of elastically deformable filaments, allowing it to take the expanded form shown in the figures and a contracted shape in which it can be contained in a catheter (not shown) for introduction into a heart. It may in particular be made, by a known technique, shape memory alloy, especially nickel alloy and titanium known under the name Nitinol. The armature 2 comprises an atrial portion 2a, that is to say intended to take place at the atrium of a heart, a ventricular portion 2v, that is to say 30 intended to take place at the ventricle level of a heart, and an intermediate annular portion 2i, located between these atrial portions 2a and ventricular 2v, intended to take place at the level of the native valve ring. In the state of deployment shown, the atrial portion 2a has a conical shape whose section increases from the annular portion 2i, and having an apex angle of the order of 120 °. It is formed by lozenge meshes connected to each other by their angles, and comprises six anchoring claws 5a regularly distributed over its circumference. As more particularly visible in FIGS. 2a and 2b, these claws 5a have their bases connected to the portions of the meshes which form the angles of the stitches situated on the atrial side of the prosthesis 1, and project from these portions of the stitches towards the side ventricular of the prosthesis. They are curved and develop towards the outside of the prosthesis 1 from these bases towards their sharp free ends. The intermediate annular portion 2i is formed of the same diamond meshes as the atrial portion 2a, in the continuity of these meshes.
    [0010] The ventricular portion 2v has a substantially ovoid shape. It comprises a marginal portion 2vm close to the intermediate annular portion 2i, connected thereto, having anchoring claws 5v, and a main portion 2vp connected to this marginal portion on the side opposite the portion 2i, having a wide notch 6 .
    [0011] The marginal portion 2vm is formed of the same diamond meshes as the atrial portion 2a and the intermediate portion 2i, in the continuity of these meshes. The claws 5v that it comprises are situated opposite the claws 5a and have a structure identical to that of these claws, having their bases connected to the portions of the meshes which form the angles of the meshes situated on the ventricular side of the prosthesis 1, making protruding from these portions of the meshes, being curved and developing outwardly of the prosthesis 1 from these bases to their sharp free ends. The main part 2vp is formed of meshes drops of water, arranged spades head of a mesh to an adjacent mesh.
    [0012] The notch 6 extends in length from the end of the ventricular portion 2v opposite the annular portion 2i to its marginal portion 2vm, and extends over a sector of the order of 120 °. It thus gives an asymmetrical shape to the ventricular portion 2v. The prosthetic valve 2, as for it is of known type, made from a synthetic or natural material (such as porcine pericardium). In the example shown, it comprises three valves. In practice, the prosthesis 1 is contracted and placed in an introductory catheter in a heart. This catheter comprises radiopaque markers for visualizing the angular orientation of this catheter, and therefore of the prosthesis 1, in order to orient the prosthesis angularly before the deployment of the latter. The catheter can be introduced into a heart by the apical first approach and is angularly oriented so as to orient the prosthesis 1 so that the notch 6 is turned towards the wall of the ventricle along the aortic valve, so-called continuity zone mitral and aortic. The atrial portion 2a of the prosthesis 1 is first deployed and brought against the atrial portion of the valve ring; the conical shape of this atrial portion 2a is well adapted to a wide support against this atrial portion of the ring; once said atrial portion is deployed, the various anchoring points 5a are oriented to fit into said atrial portion of the ring when the catheter is moved back to release the other portions of the frame 2. A good pre-positioning of the prosthesis 1 vis-à-vis the implantation site is thus ensured.
    [0013] Further retraction of the catheter realizes the progressive deployment of the ventricular portion 2v; given the ovoid shape of this ventricular portion, this deployment performs a radial expansion of the wall of this ventricular portion 2v, which causes the different anchoring points 5v to be inserted into the ventricular portion of the valve ring, as soon as the beginning of the deployment, thus achieving a perfect locking of the prosthesis 1 on the native valve ring. This locking is all the more efficient that the ovoid shape of the ventricular portion 2v allows close application of the armature 2 against said ventricular portion of the valve ring. This same ovoid shape allows a support of the frame 2 which is well adapted to the shape of the ventricle and does not conflict with the underlying anatomical structures. The notch 6 interrupts the mesh structure of the frame 2 and allows the prosthesis according to the invention does not present any risk of impeding the proper functioning of the aortic valve or obstructing the ventricular hunting chamber.
    [0014] It should be noted that the prosthesis according to the invention could be implanted by a transeptal (mitral valve) or jugular (tricuspid valve) approach, in which case the ventricular portion 2v is deployed first and the atrial portion 2a is deployed in second, with insertions anchor points 5v, 5a of the ventricular portion and the atrial portion in the ring which operate in a similar manner to that mentioned above.
    [0015] As can be seen from the foregoing, the invention provides a mitral or tricuspid heart valve prosthesis 1, having, compared to homologous prior art prostheses, the decisive advantages of having very low migration risks, a easy to operate and a form perfectly adapted to the implantation site. In addition, this prosthesis 1 does not interfere with the operation of the aortic valve. The invention has been described above with reference to an exemplary embodiment. It goes without saying that it is not limited to this embodiment but that it extends to all other embodiments covered by the appended claims.
    权利要求:
    Claims (9)
    [0001]
    CLAIMS1 - Prosthesis (1) of mitral or tricuspid heart valve, comprising an expandable tubular frame (2) with a mesh structure and a prosthetic valve (3) mounted on this frame, said armature (2) comprising an atrial portion (2a), a ventricular portion (2v) and an annular portion (2i) located between these atrial and ventricular portions; characterized in that: - said atrial portion (2a) has a conical shape whose section increases from said annular portion (2i) towards the end of this atrial portion opposite this annular portion, and comprises, on the side of said annular portion (2i), over at least a portion of its circumference, anchoring points (5a) projecting from its outer face; and - said ventricular portion (2v) has a substantially spherical or ovoidal shape and comprises, on the side of said annular portion (2i), on at least a part of its circumference, anchoring points (5v) projecting from its face exterior.
    [0002]
    2 - prosthesis (1) according to claim 1, characterized in that said anchoring points (5a, 5v) are in the form of curved claws developing towards the outside of the prosthesis from their bases to their sharp free ends 20 .
    [0003]
    3 - prosthesis (1) according to claim 1 or claim 2, characterized in that the anchoring points (5a, 5v) are present over its entire circumference.
    [0004]
    4 - Prosthesis (1) according to claim 3, characterized in that the anchoring points 25 (5a, 5v) are evenly distributed over its entire circumference.
    [0005]
    5 - Prosthesis according to one of claims 1 to 4, characterized in that the anchoring points (5a) that comprises said atrial portion (2a) are located opposite the anchor points (5v) that includes said ventricular portion (2v).
    [0006]
    6 - prosthesis (1) according to one of claims 1 to 5, characterized in that it comprises six pairs of atrial anchoring points (5a) and ventricular anchoring points (5v).
    [0007]
    7 - prosthesis (1) according to one of claims 1 to 6, characterized in that the mesh structure of the armature (2) comprises at said atrial (2a) and annular (2i) portions, and at the level of the portion (2vm) of the ventricular portion (2v) comprising said anchoring points (5v), diamond-shaped links connected to each other by their angles, the anchoring points (5a, 5v) having their bases connected to the portions of the meshes which form the opposite angles of these meshes in the atrial-ventricular direction of the prosthesis, these anchoring points (5a, 5v) projecting from these portions of the meshes.
    [0008]
    8 - Prosthesis (1) according to one of claims 1 to 7, characterized in that the mesh structure of the armature (2) comprises, at the portion (2vp) of the ventricular portion (2v) devoid of spikes anchor (5v), meshes in the form of drops of water, two adjacent meshes being arranged so heads spades relative to each other.
    [0009]
    9 - prosthesis (1) according to one of claims 1 to 8, characterized in that said ventricular portion (2v) has a wide notch (6) on one side, extending in length from its end opposite to said annular portion (2i) up to its portion (2vm) having the anchor points (5v), and extending over a sector of the order of 120 °.
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    US10925725B2|2021-02-23|
    FR3021208B1|2021-03-12|
    WO2015177655A1|2015-11-26|
    CA2949461A1|2015-11-26|
    JP2017526392A|2017-09-14|
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    引用文献:
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    法律状态:
    2015-05-21| PLFP| Fee payment|Year of fee payment: 2 |
    2015-11-27| PLSC| Search report ready|Effective date: 20151127 |
    2016-05-31| PLFP| Fee payment|Year of fee payment: 3 |
    2017-02-10| TP| Transmission of property|Owner name: VALMY HOLDING, FR Effective date: 20170110 |
    2017-04-27| PLFP| Fee payment|Year of fee payment: 4 |
    2018-05-29| PLFP| Fee payment|Year of fee payment: 5 |
    2019-05-27| PLFP| Fee payment|Year of fee payment: 6 |
    2020-05-28| PLFP| Fee payment|Year of fee payment: 7 |
    2021-05-28| PLFP| Fee payment|Year of fee payment: 8 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1454678A|FR3021208B1|2014-05-23|2014-05-23|MITRAL OR TRICUSPID HEART VALVE PROSTHESIS|FR1454678A| FR3021208B1|2014-05-23|2014-05-23|MITRAL OR TRICUSPID HEART VALVE PROSTHESIS|
    EP15708282.7A| EP3145448B1|2014-05-23|2015-01-22|Prosthetic mitral or tricuspid heart valve|
    US15/311,213| US10925725B2|2014-05-23|2015-01-22|Prosthetic mitral or tricuspid heart valve|
    PCT/IB2015/050498| WO2015177655A1|2014-05-23|2015-01-22|Prosthetic mitral or tricuspid heart valve|
    CN201580027245.6A| CN106456329B|2014-05-23|2015-01-22|Bicuspid valve or tricuspid valve heart valve prosthesis|
    CA2949461A| CA2949461A1|2014-05-23|2015-01-22|Prosthetic mitral or tricuspid heart valve|
    JP2016567259A| JP6551421B2|2014-05-23|2015-01-22|Artificial device for mitral valve or tricuspid valve|
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