• 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:
    Device (1) for suturing a cardiac valve prosthesis (2), characterized in that it comprises an assembly adapted to cooperate with a handle that is subject to control means for actuating the assembly for suturing the prosthesis (2) on a heart valve (5), said assembly is arranged at the free end of a handling rod (3) and comprises: - a set of needles (6) arranged parallel to each other by pointing in a direction opposite to the free end of the shaft (3), and being connected in pairs by suture threads (7) extending up and down the shaft (3), the assembly of needles (6) is held in a cylindrical configuration between, on the one hand, a plurality of guides (8) through which the pairs of needles (6) slide freely and, on the other hand, a plurality of push elements (9) supporting the pairs of needles (6) on the side of the free end of the rod (3), the guides (8) and the pushing elements (9) are displaceable along the rod (3) and are pivotally connected to the rod (3) so as to pass, under the action of the control means, a folded position along the rod (3) at an extended position spaced apart from the rod (3) to increase the diameter of the cylindrical configuration of the needle assembly (6); - Two clamping rings (12) for passing through the needles (6) to maintain them in the cylindrical configuration, the rings (12) comprising locking means (12b) in position around the needles (6).
    公开号:FR3072013A1
    申请号:FR1759440
    申请日:2017-10-09
    公开日:2019-04-12
    发明作者:Marco Vola；Bernard Pain
    申请人:Cminov；
    IPC主号:
    专利说明:

    Device for suturing a heart valve prosthesis
    TECHNICAL AREA
    The invention relates to the technical field of cardiac surgery, and more particularly relates to a device for suturing a cardiac valve prosthesis, for example for repairing or replacing an aortic valve or a mitral valve of a heart. .
    PRIOR STATE OF THE ART
    In the field of cardiac surgery, it is known to carry out interventions to replace an aortic or mitral valve, with an open heart, that is to say in extracorporeal circulation. The valve implant is fixed by means of a plurality of sutures placed after having ablated the calcified valve. To do this, it is necessary to make, using needles and suture threads, a bundle of threads, up to 40 threads, allowing the positioning and fixing of the valve prosthesis on the valve native ring. In practice, these wires are placed one by one, and are evenly spaced around the circumference of the native ring.
    The disadvantage of this technique results in the fact that the surgeon must handle a large quantity of wires leaving the patient's open heart, without having to mix or tangle them. In practice, the wires are spread all around the opening made in the thorax, in order to tie them later in pairs to fix the valve prosthesis. This operation is long and tedious, and involves risks in particular during the delicate handling of the sutures.
    STATEMENT OF THE INVENTION
    The object of the invention is to remedy the drawbacks of the state of the art, by proposing a device for suturing a cardiac valve prosthesis, which allows a surgeon to be able to handle the sutures, without risk of mix, lose, or tangle.
    Another objective of the invention and therefore to provide such a device which makes it possible to considerably shorten the time associated with the surgical operation.
    To this end, a device for suturing a cardiac valve prosthesis has been developed, remarkable in that it comprises an assembly capable of cooperating with a handle subject to control means for actuating the assembly. for suturing the prosthesis on a heart valve. The assembly is arranged at the free end of a handling rod and includes:
    - a set of needles arranged parallel to each other, pointing in a direction opposite to the free end of the rod, and being connected in pairs by suture threads running up and inside the rod; the set of needles is held in a cylindrical configuration between, on the one hand, a plurality of guides through which the pairs of needles slide freely and, on the other hand, a plurality of pushing elements supporting the pairs of needles on the side of the free end of the rod, the guides and the pushing elements are movable along the rod and are pivotally connected to the rod so as to pass, under the action of the control means, d a folded position along the rod to a deployed position spaced from the rod to increase the diameter of the cylindrical configuration of the needle assembly;
    - two clamping rings intended to be crossed by the set of needles to keep it in the cylindrical configuration, the rings comprising means for locking in position around the needles.
    In this way, the device according to the invention allows a surgeon to position the free end of the manipulation rod through the heart valve to be repaired, and to position the set of needles in the cylindrical configuration. support under the native ring.
    When the needles are in support under the native ring, one of the clamping rings is positioned in abutment on the other side of the native ring to allow the pushing elements to push the needles until they these cross the native ring and are inserted into the clamping ring. The ring locking means make it possible to maintain the set of needles in a cylindrical configuration so as to allow the pusher elements, the guides, and more generally the manipulation rod to be removed from the heart.
    In this configuration, the surgeon can withdraw from the heart and simultaneously all the needles held by the clamping ring to form a bundle of suture threads attached, on the one hand, to the native ring of the valve and, on the other hand connected to the different needles.
    This bundle of threads is under control, the risks of losing, mixing or tangling the sutures are eliminated.
    The surgeon can then position the valve prosthesis, for example a textile ring, directly on the clamping ring, being pierced by all of the needles, and locked against the support by the second clamping ring which is inserted around the needles against support.
    In this configuration, the surgeon can remove the lower clamping ring, that is to say the one positioned on the side of the heart valve, allowing him to slide the valve prosthesis up to the native ring of the heart valve and in support against the latter. At this stage, the surgeon only has to remove the needles two by two and tie the sutures to permanently fix the valve prosthesis. The operation is simple and quick.
    According to a particular embodiment, each guide is in the form of a sheath comprising an eight-shaped cross section, and in particular making it possible to optimally guide a pair of needles, while allowing the passage of the son suture when the guide is removed.
    In the same way, each pusher element is, for example, in the form of a sheath comprising an eight-shaped cross section, with in particular a bottom wall in order to be able to push the pair of needles in the direction of the valve, said bottom wall also having an opening for the passage of the suture when the pusher element is removed.
    According to a particular embodiment, each clamping ring comprises:
    an external ring pierced with a plurality of orifices regularly distributed in pairs around the circumference of the external ring, each orifice being open and opening onto the edge of the external ring, in particular to allow the passage of the sutures when the ring is removed, or when the hands are removed;
    an internal ring mounted coaxially in the external ring, and with a capacity for rotation relative to the external ring, the rotation of the internal ring allows the portion walls of said internal ring to at least partially close the orifices , and to be housed in complementary notches formed in the needles for blocking the ring and maintaining the cylindrical configuration of the set of needles.
    Preferably, the internal ring includes a crenellated internal periphery to cooperate with means allowing it to be rotated.
    According to a particular embodiment, the guides and the pusher elements are each connected to the handling rod by at least one arm articulated relative to the rod.
    Advantageously, the arms of the guides and of the pushing elements are pivotally connected to the rod so as to pass, under the action of the control means, simultaneously or selectively, and independently of each other, from the folded position to the deployed position. .
    Furthermore, the device advantageously comprises a protective cover mounted to slide around the manipulation rod so as to cover the pointed end of the set of needles.
    BRIEF DESCRIPTION OF THE DRAWINGS
    Other characteristics and advantages of the invention will emerge clearly from the description which is produced below, by way of indication and in no way limiting, with reference to the appended schematic figures in which:
    - Figure 1 illustrates in perspective, the device according to the invention, with the protective cover removed and a clamping ring;
    - Figure 2 illustrates the clamping ring in perspective, the internal ring not being in the locking position;
    - Figure 3 is similar to Figure 2, with the inner ring in the locked position;
    - Figure 4 illustrates the device according to the invention in longitudinal section, after insertion through the heart valve;
    - Figure 5 is similar to Figure 4, the protective cover being removed, and the guides and pushers being moved towards the heart valve;
    - Figure 6 is similar to Figure 5, the arm of the guides and push elements being pivoted to move away from the rod so as to be able to position the needles bearing under the native ring of the heart valve;
    - Figure 7 is similar to Figure 6, one of the clamping rings having been positioned against the support on the other side of the native ring of the heart valve;
    - Figure 8 is similar to Figure 7, the pusher elements having been moved in the direction of the guides so that the needles pass through the native ring of the mitral valve and the clamping ring;
    - Figure 9 is similar to Figure 8, the inner ring of the clamping ring having been pivoted to lock the set of needles in its cylindrical configuration;
    - Figure 10 is similar to Figure 9, the pusher elements are moved to move away from the guides for their removal;
    - Figure 11 is similar to Figure 10, the guides being moved towards the pusher elements for their removal;
    - Figure 12 is similar to Figure 11, the handling rod having been removed to leave only the set of needles maintained in a cylindrical configuration by the clamping ring;
    - Figure 13 is similar to Figure 12, the set of needles being removed to form a bundle of suture threads attached to the native ring of the heart valve;
    - Figure 14 is similar to Figure 13, before anchoring a heart valve prosthesis;
    FIG. 15 is similar to FIG. 14, the valve prosthesis coming to anchor on the set of needles until it comes to bear against the clamping ring;
    - Figure 16 is similar to Figure 15, a second clamping ring coming into abutment of the first to grip the heart valve prosthesis, said second clamping ring being in the locked position to hold the set of needles in a cylindrical configuration;
    - Figure 17 is similar to Figure 16, the first clamping ring having been removed;
    - Figure 18 is similar to Figure 17, the heart valve prosthesis being slid towards the native ring of the heart valve;
    - Figure 19 is similar to Figure 18, the heart valve prosthesis being positioned in abutment against the native ring of the heart valve, waiting to be fixed by knotting the plurality of sutures.
    DETAILED PRESENTATION OF THE INVENTION
    Referring to Figure 1, the present invention relates to a device (1) for securing a heart valve prosthesis (2) by sutures, for example on an aortic valve or else a mitral valve. The device (1) according to the invention is intended to penetrate, with a rib cage and open heart, through the heart valve (5) to be repaired.
    To this end, the device (1) comprises a rod (3) for manipulation, at the end of which is arranged an assembly (4) for suturing the prosthesis (2) on the native ring of the valve (5 ). The valve prosthesis (2) can be of any type such as a reinforcing ring, for example made of textile. The other end of the rod (3) is intended to cooperate with a handle, not shown, subject to control means, not shown, for example in the form of a trigger, for actuating the assembly ( 4).
    The device (1) allows a plurality of simultaneous sutures to be produced, around the circumference of the native ring of the valve (5) in order to be able to fix the prosthesis (2). The device (1) comprises a set of needles (6) held in a cylindrical configuration and linked in pairs by suture threads (7). More specifically, the needles (6) are arranged parallel to each other, at the end of the manipulation rod (3), pointing in a direction opposite to the free end of the rod (3). The sutures (7) connecting the needles (6) in pairs go up along and inside the rod (3). The needle assembly (6) is held in the cylindrical configuration, on the one hand by a plurality of guides (8) and, on the other hand, by a plurality of pusher elements (9).
    The guides (8) are arranged so as to surround and enclose the pointed end of each pair of needles (6). In other words, two needles (6) are arranged inside the same guide (8). The guides (8) and needles (6) slide freely with respect to each other. Each guide (8) is for example in the form of a sheath comprising an eight-shaped cross section so as to optimally hold the needles (6) while allowing them to slide along the latter. Each guide (8) is open at both ends so that the suture (7) can escape when the guide (8) is removed.
    On the other side, the needles (6) are held in pairs by a plurality of pushing elements (9), for example in the form of sleeves comprising, in the same way, an eight-shaped cross section, in particular with a bottom wall for pushing each pair of needles (6). The bottom wall has an opening for the passage of the suture (7) when the pusher element (9) is removed. Each pusher element (9) acts as a base adapted to maintain the non-pointed end of the needles (6), and to be able to ensure an axial pushing force of said needles (6).
    The guides (8) and the pushing elements (9) are subject to the manipulation rod (3) by means of arms (10) articulated and pivotally mounted relative to the rod (3), under the action of the means control. By means of said arms (10), the guides (8) and pusher elements (9) can be moved along the rod (3), always under the action of the control means, and can adopt a folded position along of the rod (3) or a deployed position spaced from the rod (3), in particular to increase the diameter of the cylindrical configuration of the set of needles (6). Preferably, the guides (8) and pusher elements (9) are pivotally connected to the rod (3) so as to pass, under the action of the control means, simultaneously or selectively, and independently of each other from the folded position to the deployed position.
    Referring to Figures 1 and 4, the device (1) also comprises a protective cover (11) slidably mounted around the rod (3) to cover the pointed end of the set of needles (6) and the plurality guides (8).
    Thus, during the surgical operation, the free end of the manipulation rod (3) is engaged through the heart valve (5), then the protective cover (11) is slid to be removed.
    Referring to Figure 5, the plurality of guides (8) and pusher elements (9) are moved along the rod (3), under the action of the control means, and in particular in a direction opposite to the 'free end of the rod (3) so that the pointed ends of the needles (6) come close to and under the native ring of the valve (5) to be repaired.
    Referring to Figure 6, the control means are actuated to separate the guides (8) and the pusher elements (9) in the deployed position by means of the pivoting arms (10). This makes it possible to adjust the diameter of the cylindrical configuration of the set of needles (6) to the diameter of the native ring of the valve (5) to be repaired.
    With reference to FIG. 7, when the device (1), and in particular all of the guides (8) are supported under the valve (5), a first clamping ring (12) is slid along the rod ( 3) to come into abutment with the plurality of guides (8), on the other side of the valve (5).
    In this configuration, and with reference to FIG. 8, the surgeon is able to actuate the control means to move the pusher elements (9) in the direction of the guides (8). In this way, the set of needles (6) is pushed towards the native ring until it pierces the valve (5) and is inserted through the first clamping ring (12).
    To this end, and with reference to Figures 2 and 3, the clamping ring (12) comprises an outer ring (12a) pierced with a plurality of orifices (13) regularly distributed in pairs around its circumference. These orifices (13) make it possible in particular to receive each pair of needles (6) for insertion. Each orifice (13) is open and opens onto the edge of the external ring (12a), in order to subsequently allow the withdrawal of the clamping ring (12) and the suture threads (7). The first ring (12) also comprises blocking means in the form of an internal ring (12b), mounted coaxially in the external ring (12a), with the ability to rotate relative to the external ring (12a). The rotation of the internal ring (12b) in particular allows wall portions of said internal ring (12b) to close off, at least in part, the orifices (13) of the external ring (12a).
    In this way, and with reference to FIG. 11, when the internal ring (12b) is pivoted, the wall portions close off the orifices (13) and are housed in first complementary notches (14) that each needle includes ( 6). This allows the ring (12) to be locked and the set of needles (6) to be kept in a cylindrical configuration.
    At this stage, the surgeon can actuate the control means to move the guides (8) and the pusher elements (9) along the rod (3) and in the direction of its free end. In this way, the arms (10) which connect the guides (8) and the pusher elements (9) to the rod (3) can be pivoted in a folded position along the rod (3), for removal of the manipulation rod (3).
    With reference to FIG. 12, when the manipulation rod (3) has been removed, it releases the suture threads (7) which went up and inside said rod (3), to leave the beam son (7) attached in pairs to the set of needles (6) held in a cylindrical configuration through the valve (5) by the clamping ring (12).
    Referring to Figure 13, the surgeon can now remove the set of needles (6) forming a rigid assembly extended by a bundle of suture threads (7) attached to the heart valve (5). In this way, the sutures (7), in the form of the bundle, can neither be lost, nor be mixed or tangled. The suturing is rapid and is carried out simultaneously by the set of needles (6), and not one by one as in the prior art.
    Referring to Figure 14, the surgeon can then position the valve prosthesis (2) against the clamping ring (12), being pierced by all of the needles (6) for subsequent fixation.
    With reference to FIG. 15, a second clamping ring (12) is positioned in abutment against the valve implant, and in particular in abutment against the first clamping ring (12). This second clamping ring (12) is identical to the first ring and also comprises blocking means in the form of an internal ring (12b) adapted to be pivoted so as to become blocked in second complementary notches (15) which include the needles (6).
    With reference to FIGS. 2 and 3, the internal periphery of the internal ring (12b) of the clamping rings is crenellated so as to be able to insert a specific complementary tool making it possible to rotate said internal ring (12b). The specific tool is of any suitable type.
    Referring to Figure 16, when the second clamping ring (12) has been locked, it keeps all the needles (6) in the cylindrical configuration. In this way, the first clamping ring (12), disposed on the side of the heart valve (5), can be released by the rotation of its internal ring (12b), and removed, allowing the wires to escape. suturing (7) through the orifices (13) opening onto the edge of the outer ring (12a).
    With reference to FIGS. 17, 18 and 19, the valve prosthesis (2) is then slid along the needles (6) and the sutures (7) until it comes to bear against the native ring of the heart valve. (5) to be repaired. In this configuration, the sutures (7) can be recovered and tied two by two to permanently fix the prosthesis (2) on the heart valve (5).
    It follows from the above that the invention does indeed provide an advantageous device (1) in that it allows simultaneous sutures to be made through the heart valve (5), then to be able to simultaneously remove all the sutures ( 7) in the form of a bundle, which avoids mixing, losing or tangling said threads (7), with a view to knotting them two by two. The resulting surgical operation is greatly improved in terms of efficiency and speed.
    权利要求:
    Claims (8)
    [1" id="c-fr-0001]
    1. Device (1) for suturing a cardiac valve prosthesis (2), characterized in that it comprises an assembly (4) capable of cooperating with a handle subject to control means for actuating the assembly (4) for suturing the prosthesis (2) on a heart valve (5), said assembly (4) is arranged at the free end of a manipulation rod (3) and comprises:
    - a set of needles (6) arranged parallel to each other pointing in a direction opposite to the free end of the rod (3), and being connected in pairs by suture threads (7) going up along and inside the rod (3); the set of needles (6) is maintained in a cylindrical configuration between, on the one hand, a plurality of guides (8) through which the pairs of needles (6) slide freely and, on the other hand, a plurality of push elements (9) supporting the pairs of needles (6) on the side of the free end of the rod (3), the guides (8) and the push elements (9) are movable along the rod (3) and are pivotally connected to the rod (3) so as to pass, under the action of the control means, from a folded position along the rod (3) to a deployed position spaced from the rod (3) to increase the diameter of the cylindrical configuration of the needle assembly (6);
    - two clamping rings (12) intended to be crossed by the set of needles (6) to keep it in the cylindrical configuration, the rings (12) comprising locking means (12b) in position around the needles (6 ).
    [2" id="c-fr-0002]
    2. Device (1) according to claim 1, characterized in that each guide (8) is in the form of a sheath comprising a cross section in the shape of an eight.
    [3" id="c-fr-0003]
    3. Device (1) according to claim 1, characterized in that each pusher element (9) is in the form of a sheath comprising an eight-shaped cross section, with a bottom wall for pushing the pair of needles (6), said bottom wall having an opening for the passage of the suture (7).
    [4" id="c-fr-0004]
    4. Device (1) according to claim 1, characterized in that each clamping ring (12) comprises:
    - an external ring (12a) pierced with a plurality of orifices (13) regularly distributed in pairs around the circumference of the external ring (12a), each orifice being open and opening onto the edge of the external ring ( 12a);
    - an internal ring (12b) mounted coaxially in the external ring (12a) with rotation capacity relative to the external ring (12a), the rotation of the internal ring (12b) allows portions of the wall to come at least partially close the orifices (13), and come to be housed in complementary notches (14, 15) formed in the needles (6) for blocking the ring (12) and maintaining the cylindrical configuration of the set of needles (6).
    [5" id="c-fr-0005]
    5. Device (1) according to claim 4, characterized in that the internal ring (12b) comprises a crenellated internal periphery to cooperate with means making it possible to drive it in rotation.
    [6" id="c-fr-0006]
    6. Device (1) according to claim 1, characterized in that the guides (8) and the pusher elements (9) are each connected to the rod (3) by at least one arm (10) articulated relative to the rod (3).
    [7" id="c-fr-0007]
    7. Device (1) according to claim 6, characterized in that the arms (10) of the guides (8) and pusher elements (9) are pivotally connected to the rod (3) so as to pass under the action of the control means, simultaneously or selectively, and independently of each other, from the folded position to the deployed position.
    [8" id="c-fr-0008]
    8. Device (1) according to claim 1, characterized in that it comprises a protective cover (11) slidably mounted around the rod (3) to cover the pointed end of the set of needles (6 ).
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    同族专利:
    公开号 | 公开日
    EP3691547A1|2020-08-12|
    WO2019073131A1|2019-04-18|
    US20200268374A1|2020-08-27|
    FR3072013B1|2019-09-27|
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    法律状态:
    2018-10-27| PLFP| Fee payment|Year of fee payment: 2 |
    2019-04-12| PLSC| Publication of the preliminary search report|Effective date: 20190412 |
    2019-10-25| PLFP| Fee payment|Year of fee payment: 3 |
    2020-10-29| PLFP| Fee payment|Year of fee payment: 4 |
    2021-10-26| PLFP| Fee payment|Year of fee payment: 5 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1759440|2017-10-09|
    FR1759440A|FR3072013B1|2017-10-09|2017-10-09|DEVICE FOR SUTURING A CARDIAC VALVULAR PROSTHESIS|FR1759440A| FR3072013B1|2017-10-09|2017-10-09|DEVICE FOR SUTURING A CARDIAC VALVULAR PROSTHESIS|
    EP18766316.6A| EP3691547A1|2017-10-09|2018-08-10|Device for suturing a heart valve prosthesis|
    US16/648,790| US20200268374A1|2017-10-09|2018-08-10|Device for suturing a heart valve prosthesis|
    PCT/FR2018/052054| WO2019073131A1|2017-10-09|2018-08-10|Device for suturing a heart valve prosthesis|
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