• 专利附录
  • 专利说明
  • 权利要求
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  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    An intra-aneurysmal device (1) for the treatment of an aneurysm, this device comprising: a stent (3) of substantially circular cross-section of diameter (D1), the stent (3) being adapted and intended to anchor the device (1 ) in an artery, - a head (5) intended to be inserted into the aneurysm, the head (5) being able to significantly reduce a blood flow in the aneurysm, - an intermediate portion (4) located between the head ( 5) and the stent (3), and connecting the head (5) to the stent (3), wherein the intermediate portion (4) is ellipsoid-shaped, a distal end (11) of which is connected to the head (5). ) and a proximal end (12) is connected to the stent (3), and a transverse diameter (18) of the intermediate portion (4) is greater than the diameter (D1) of the stent (3), the transverse diameter (18) being substantially perpendicular to a longitudinal axis (19) of the device (1).
    公开号:FR3061647A1
    申请号:FR1750227
    申请日:2017-01-11
    公开日:2018-07-13
    发明作者:Vincent Costalat
    申请人:Universite de Montpellier I；Centre Hospitalier Universitaire de Montpellier CHUM；Universite de Montpellier；
    IPC主号:
    专利说明:

    © Publication number: 3,061,647 (to be used only for reproduction orders) © National registration number: 17 50227 ® FRENCH REPUBLIC
    NATIONAL INSTITUTE OF INDUSTRIAL PROPERTY
    COURBEVOIE © Int Cl 8 : A 61 B 17/12 (2017.01), A 61 F2 / 90
    A1 PATENT APPLICATION
    ©) Date of filing: 11.01.17. © Applicant (s): UNIVERSITE DE MONTPELLIER - FR and UNIVERSITY HOSPITAL CENTER OF (3U) Priority: MONTPELLIER— FR. @ Inventor (s): COSTALAT VINCENT. (43) Date of public availability of the request: 13.07.18 Bulletin 18/28. ©) List of documents cited in the report preliminary research: Refer to end of present booklet (© References to other national documents ® Holder (s): UNIVERSITE DE MONTPELLIER, related: UNIVERSITY HOSPITAL CENTER OF MONT- PELLIER. ©) Extension request (s): (© Agent (s): GEVERS & ORES Société anonyme.
    FR 3 061 647 - A1 (o4) intra-aneurysmal device.
    (© Device (1) intra-aneurysm for the treatment of an aneurysm, this device comprising:
    a stent (3) of substantially circular cross section of diameter (D 1), the stent (3) being suitable and intended to anchor the device (1) in an artery,
    - a head (5) intended to be inserted into the aneurysm, the head (5) being capable of significantly reducing a blood flow in the aneurysm,
    - an intermediate portion (4) located between the head (5) and the stent (3), and connecting the head (5) to the stent (3), in which the intermediate portion (4) is in the form of an ellipsoid, one of which distal end (11) is connected to the head (5) and a proximal end (12) is connected to the stent (3), and a transverse diameter (18) of the intermediate portion (4) is greater than the diameter (D1) of the stent (3), the transverse diameter (18) being substantially perpendicular to a longitudinal axis (19) of the device (1).

    INTRA-ANEVRISMAL DEVICE
    The invention relates to the field of intra-aneurysmal medical devices. More specifically, the invention relates to intra-aneurysmal devices with flow diversion.
    An aneurysm is a dilation of the wall of an artery. The dilation causes an aneurysmal pocket which communicates with the artery through a narrowed area known to practitioners as the "collar".
    The rupture of an aneurysm, or more precisely of the aneurysmal pocket, can have serious consequences, including death. Several factors are responsible for aneurysms. It should be noted that the elderly have a higher prevalence. In these people, the risk of rupture is also greater, in particular due to related pathologies such as high blood pressure which manifests itself in the form of an increase in blood pressure.
    It is therefore a public health problem that needs to be addressed. Several treatment techniques exist.
    One of the techniques is called "endovascular", which includes a step of treating the aneurysm using an intra-aneurysmal device. In this case, the aneurysm is approached by following the route of the arteries. A carrying catheter (from an intra-aneurysmal device) is introduced through the arteries and directed under fluoroscopic control. The device is then placed in the aneurysm. This isolates the aneurysm from the arterial blood flow to prevent the aneurysmal pocket from rupturing under the effect of blood pressure.
    Intra-aneurysmal devices are known in the medical field. The international application published under the number WO 2006/052322 describes an intraaneurysmal device which aims to secure the implantation of "coils". The term "coils" is an English term for a small metal coil used to seal a vessel. Indeed, many intra-aneurysmal devices use coils to fill the aneurysmal pocket of the aneurysm to be treated in order to limit the flow of blood to the aneurysm. These coils can however constitute a danger since they can inadvertently be positioned in the source artery (obstructing the blood circulation thereby), they can also move over time from the aneurysm to the source artery ( also impeding blood circulation). Despite the fact that this document WO 2006/052322 describes a device for securing the insertion of coils, this device still has many drawbacks, in particular due to the use of coils, both for patients and for patients. practitioners.
    In this document, the device includes a stent for anchoring the device in a source artery carrying the aneurysm. The stent is an English term commonly used in the medical field to designate a tube of substantially circular section. Anchoring is done by endothelialization of the stent on the internal wall of the artery. The device comprises a head, generally in the form of a dome intended to be housed inside the aneurysmal pocket. Between the dome and the stent, the device comprises a thinned intermediate portion through which the blood flow passes.
    One drawback is that this device cannot treat any type of aneurysm. Indeed, among the aneurysms some are said to have "wide necks". A wide neck aneurysm is a difficult anatomical situation that corresponds to a particularly open entrance. With this type of aneurysm, the stability of endovascular treatments is often lacking. The dome is not stable and may move in the aneurysmal pocket over time and even worse come out of it, which in the best case would make the device useless and in the worst case could cause complications in the patient. Indeed, a wide collar does not provide the dome with the support (or contact) area necessary for the dome to be able to remain in the aneurysmal pocket in the long term. Thus, this device cannot effectively treat a large neck aneurysm because it would not be stable and could be ineffective or even dangerous for the patient, particularly in the long term.
    Another drawback of this device is that it may require the use of coils. It is therefore necessary to use an additional tool to position the coils in the aneurysm once the device is installed on the patient. This can extend the exposure time and involves more operations for the practitioner at the expense of patient safety.
    Another drawback is that this device has long-term failures for any type of aneurysm combined. Indeed its architecture does not allow it a stable anchoring in the long term.
    A first objective is to propose an intra-aneurysmal device which can be adapted to any type of aneurysm and particularly to aneurysms whose neck is wide.
    A second objective is to propose an intra-aneurysmal device which does not require the addition of additional material within the aneurysm (coils).
    A third objective is to provide an intra-aneurysmal device with great stability whatever the form of the aneurysm.
    A fourth objective is to propose a device which is stable when it is used to treat an aneurysm located in the vicinity of an arterial bifurcation.
    A fifth objective is to propose a device having a long-term stable anchoring compared to existing devices.
    To this end, an intra-aneurysmal device is firstly proposed for the treatment of an aneurysm, this device comprising:
    a stent of substantially circular cross section of diameter, the stent being suitable and intended to anchor the device in an artery, a head intended to be inserted into the aneurysm, the head being capable of significantly reducing a blood flow in the aneurysm, a intermediate portion located between the head and the stent, and connecting the head to the stent, in which the intermediate portion is in the shape of an ellipsoid of which a distal end is connected to the head and a proximal end is connected to the stent, and in which a transverse diameter of the intermediate portion is greater than the diameter of the stent, the transverse diameter being substantially perpendicular to a longitudinal axis of the device.
    This device easily adapts to any type of aneurysm. It is particularly suitable for treating wide-necked aneurysms thanks to its ellipsoid-shaped intermediate portion and its diameter greater than that of the stent. This geometry also advantageously makes it possible to improve the stability of the intra-aneurysmal device whatever the form of the aneurysm and more particularly of an aneurysm located in the vicinity of an arterial bifurcation. In addition, the intermediate part together with the stent allow stable anchoring in the long term.
    Various additional features can be provided alone or in combination:
    the intermediate portion and the head are connected by a knot so that the head is movable relative to the intermediate portion;
    the head is dome-shaped;
    the head comprises around its center, a concavity facing the intermediate portion;
    the intermediate portion extends the stent continuously;
    the head is made by means of a plurality of threads arranged to form together a suitable mesh and intended to divert a large part of the blood flow;
    the head comprises between thirty-two and two hundred sons;
    the stent and / or the intermediate portion are produced by means of a plurality of wires arranged to form together a mesh capable of allowing the passage of a blood flow through them;
    the stent and / or the intermediate portion comprises between four and thirty-two wires;
    the shape of an outer wall of the head located opposite the intermediate portion is substantially the counter-impression of an upper wall of the intermediate portion;
    the wires are made of nitinol.
    Other features and advantages of the invention will become apparent in the description below in relation to the appended drawings, given by way of non-limiting examples:
    - Figure 1 is a two-dimensional view of a processing device according to the invention;
    - Figure 2 is a two-dimensional view of the device of Figure 1, when the device is installed in an aneurysm located in the vicinity of an arterial bifurcation.
    In what follows, a wide neck aneurysm is an aneurysm whose ratio of the height thereof to the width of the neck is greater than 1.5. The height of the aneurysm corresponds to the distance H which separates a point PI located at the top thereof and a point P2 located at the entrance to the aneurysm. The width of the collar corresponds to the distance L which separates the lateral edges of the entrance to the aneurysm.
    In Figure 1 is shown an intra-aneurysmal device 1. The intraaneurysmal device 1 is intended for the treatment of an aneurysm 2. This device 1 is intended for endovascular treatment. It can be used for all types of aneurysms 2, whether wide neck or not. This device 1 can also be used to treat aneurysms 2 regardless of the part of the body affected.
    In the embodiment shown in Figure 1, the device 1 comprises a stent 3, an intermediate portion 4 and a head 5 in the form of a dome. The intermediate portion 4 is located between the stent 3 and the head 5.
    The stent 3, the intermediate portion 4 and the head 5 are advantageously manufactured using a plurality of wires 6, preferably made of nitinol. Nitinol has interesting mechanical properties, namely: shape memory and elasticity.
    The wires 6 are arranged relative to each other to form a mesh. The stent 3 is in the form of a flexible mesh tube.
    The section of the stent 3 is advantageously substantially circular. Note, however, that the characteristics of the stent 3 make it flexible. Thus the shape of the section can vary depending on whether or not a force is applied around the stent 3.
    At rest, that is to say when no pressure is applied around the device 1, the section of the stent 3 is therefore advantageously circular and has a diameter
    Dl.
    The intermediate portion 4 extends from an upper end 7 of the stent 3. The intermediate portion 4 advantageously has a mesh identical to that of the stent
    3. For example, the stent 3 and the intermediate portion 4 can each be formed by means of four to thirty-two wires 6 of nitinol depending on the size of the implant. This number of threads makes it possible to obtain a wide mesh which does not block the blood flow in the source artery, the blood can thus flow freely through the intermediate portion 4 and through the stent 3. The risk consequently, the formation of a blood clot caused by a foreign body (device 1) is reduced.
    The head 5 extends from the intermediate portion 4. It has a form of concave dome, the concavity 9a of which faces outward. Once the device 1 is installed on a patient, the concavity 9a faces the aneurysmal pocket 8 as illustrated in FIG. 2.
    Like the stent 3 and the intermediate portion 4, the mesh of the head 5 is produced with wires 6 preferably made of nitinol. However, unlike the stent 3 and the intermediate portion 4, a larger number of wires 6 is used. Between thirty-two and two hundred wires are used in the mesh of the head 5. Thus the head 5 is meshed in a fine mesh, finer than that of the stent 3 and of the intermediate portion 4, which makes it possible to greatly reduce the flow of blood to the aneurysmal pocket 8 without completely isolating it in a sealed manner from the artery. In this way, the aneurysmal pocket 8 sees its blood circulation slow down and the blood gradually stagnates in said aneurysmal pocket 8 to induce rapid thrombosis. This advantageously makes it possible to avoid the use of coils.
    The head 5 comprises a concavity 9 located around a center 10 of the dome, the concavity 9 being turned towards the intermediate portion 4. This concavity 9 is of very particular interest which gives the head 5 a domed shape towards the inside of the aneurysmal pocket 8 so that it does not extend or little in an artery. Indeed, by its characteristics (fine mesh), the head 5 can interfere with blood flow in the artery. The concavity 9 located around the center 10 of the head 5 makes it possible to prevent the latter from obstructing the blood circulation in the artery by reducing the intra luminal bulge. In other words, it is a question of limiting or avoiding the presence of the head 5 in the artery to avoid reducing the section of the latter. Indeed, a 5 head that extends into the artery could cause rapid platelet aggregation as well as potentially the formation of a blood clot in the source artery or in the arterial bifurcation.
    The intermediate portion 4 is in the shape of an ellipsoid. In the present application, the expression "ellipsoid" is not identical to the universally known mathematical definition. The term "ellipsoid" refers to a three-dimensional shape of an ellipse. An ellipse as defined mathematically has a closed contour. However, the intermediate portion 4, even if it visually recalls an ellipsoidal shape, does not have a closed contour in particular in the vicinity of a proximal end 12. Indeed, in the vicinity of the proximal end 12 of the intermediate portion 4, the latter is open on the stent 3 so that the interior volume that the intermediate portion defines communicates with the interior volume that the stent defines
    3. In other words, the intermediate portion 4 is a continuation of the stent 3, by extending the latter. In an alternative embodiment not shown in the figures, the intermediate portion 4 and the stent 3 are connected by a node. In the latter case, the intermediate portion 4 has a substantially closed contour.
    A distal end 11 of the intermediate portion 4 is connected to the head 5 by means of a node 14 in the vicinity of a junction 13 between said head 5 and said intermediate portion 4. In what follows, the connection between the intermediate portion 4 and the head 5 will be called "nodal connection".
    The nodal connection advantageously allows the head 5 to be movable relative to the intermediate portion 4 and generally relative to the rest of the stent 3. This allows the device 1 to adapt to all anatomies because thus, the head 5 can be in an axis different from a longitudinal axis 19 of the device 1. An aneurysm 2 which is not in the axis of an artery through which the device 1 passes can therefore be treated thanks to the mobility of the head 5 made possible by the previously described nodal link.
    In a preferred embodiment shown in the figures, the intermediate portion 4 has an ellipsoidal shape which approaches a spheroid. Note that a sphere is a special case of an ellipsoid.
    As previously explained, in the case of a wide neck aneurysm 2, there is no support zone for correctly stabilizing the head 5 in the aneurysm pocket 8. The intermediate portion 4 whose shape is ellipsoidal advantageously makes it possible to solve jointly with the stent 3 this problem of stability.
    Advantageously, an outer wall 15 of the head 5 located opposite the intermediate portion 4, corresponds substantially to the counterprint of an upper wall 16 of said intermediate portion 4. This allows harmonious contact between the head 5 and the intermediate portion 4, when there is possible contact between these two elements. The expression "harmonious" designates the fact that the outer wall 15 has a shape allowing the head 5 to rest on the intermediate portion 4, the latter can thus possibly serve as a seat for the head 5.
    Referring to Figure 2, the device 1 is inserted into an aneurysm 2 with a wide neck. More specifically, the head 5 is inserted into the aneurysmal pocket 8. When the head 5 is deployed, its walls are supported on the walls of the aneurysmal pocket 8 which gives the device 1 its initial stability conditions. Achieving long-term stability of the device 1 will be described later.
    As can be seen in Figure 2, the intermediate portion 4 is at a bifurcation between a main artery A and two secondary arteries B. The intermediate portion 4 is supported at two points 17 supports. As for the stent 3, the intermediate portion 4 will be subjected to the endothelialization phenomenon which may fix it on the wall of the arteries. The intermediate portion 4 and the stent 3 thus jointly provide increased long-term stability compared to existing devices.
    Advantageously, a transverse diameter 18 of the intermediate portion 4 is greater than a diameter D1 of the stent 3. The transverse diameter 18 of the intermediate portion 4 targets the width of the latter in a direction transverse to a longitudinal axis 19 of the device 1, in other words substantially perpendicular to said longitudinal axis 19. This allows the intermediate portion 4 to have better stability.
    In an embodiment conducive to the treatment of a cerebral aneurysm, the head 5 has a form of dome, the largest diameter of which is substantially between 4 and 13 mm. The diameter Dl of the stent 3 is for example between 2.5 and 4 mm and its length 21 between 15 and 25 mm. The intermediate portion 4 comprises a transverse diameter 18 of approximately 4-5 mm. However, these values are variable and depend mainly on the location of the aneurysm to be treated. Indeed, an aneurysm located in the brain will not have the same dimensions as an aneurysm located in another part of the body.
    The device 1 includes an electrolytic detachment system which makes it possible to detach the device 1 once it has been placed in the aneurysm. In the embodiment shown in the figures, the detachment system is located at one end 22 of the stent 3.
    The device 1 described above has several advantages. Thus a first advantage of this device is that it can adapt to any type of aneurysm and particularly to aneurysms with a large neck. A second advantage is that it can treat aneurysms without adding additional material (coils). A third advantage is that the device is stable whatever the shape of the aneurysm and more particularly when the collar of the aneurysm is wide. A fourth advantage is that the device is also particularly stable when used to treat an aneurysm in the vicinity of an arterial bifurcation. A fifth advantage of the device is its stable and effective anchoring in the long term.
    Naturally, to meet specific needs, a person competent in the field of the invention may apply modifications to the preceding description.
    权利要求:
    Claims (9)
    [1" id="c-fr-0001]
    1. Intra-aneurysm device (1) for the treatment of an aneurysm (2), this device (1) comprising:
    a stent (3) of substantially circular section of diameter (Dl), the stent (3) being suitable and intended to anchor the device (1) in an artery, a head (5) intended to be inserted into the aneurysm (2 ), the head (5) being able to significantly reduce a blood flow in the aneurysm (2), an intermediate portion (4) located between the head (5) and the stent (3), and connecting the head (5) to the stent (3), characterized in that the intermediate portion (4) is in the form of an ellipsoid, one distal end (11) of which is connected to the head (5) and one proximal end (12) of which is connected to the stent (3 ), and in that a transverse diameter (18) of the intermediate portion (4) is greater than the diameter (Dl) of the stent (3), the transverse diameter (18) being substantially perpendicular to a longitudinal axis (19) of the device (1).
    [2" id="c-fr-0002]
    2. Device (1) according to claim 1 wherein the intermediate portion (4) and the head (5) are connected by a knot (14) so that the head (5) is movable relative to the portion (4) intermediate.
    [3" id="c-fr-0003]
    3. Device (1) according to any one of the preceding claims wherein the head (5) is in the form of a dome.
    [4" id="c-fr-0004]
    4. Device (1) according to claim 3 wherein the head (5) comprises around its center (10), a concavity (9) facing the intermediate portion (4).
    [5" id="c-fr-0005]
    5. Device (1) according to one of the preceding claims wherein the intermediate portion (4) extends the stent (3) continuously.
    [6" id="c-fr-0006]
    6. Device according to one of the preceding claims, in which the head (5) is produced by means of a plurality of wires (6) arranged to form together a suitable mesh and intended for largely deviating the blood flow.
    [7" id="c-fr-0007]
    7. Device (1) according to claim 6 wherein the head (5) comprises between thirty-two and two hundred son.
    5. Device (1) according to one of the preceding claims, in which the stent (3) and / or the intermediate portion (4) are produced by means of a plurality of wires (6) arranged to form a mesh together. able to allow the passage of a blood flow through them.
    [8" id="c-fr-0008]
    9. Device (1) according to claim 8 wherein the stent and / or the intermediate portion comprises between four and thirty-two wires.
    10. Device (1) according to one of the preceding claims in which the shape of an outer wall (15) of the head located opposite the intermediate portion (4) is
    15 substantially the counter-impression of an upper wall (16) of the intermediate portion (4).
    [9" id="c-fr-0009]
    11. Device (1) according to any one of claims 6 to 9 in which, the wires
    20 (6) are made of nitinol.
    3 ° 6 l6 47
    I 3 ° βΐ6 4 7 3 0 e
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    法律状态:
    2018-01-29| PLFP| Fee payment|Year of fee payment: 2 |
    2018-07-13| PLSC| Publication of the preliminary search report|Effective date: 20180713 |
    2018-10-30| PLFP| Fee payment|Year of fee payment: 3 |
    2019-11-21| PLFP| Fee payment|Year of fee payment: 4 |
    2020-12-15| PLFP| Fee payment|Year of fee payment: 5 |
    2021-12-01| PLFP| Fee payment|Year of fee payment: 6 |
    优先权:
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    FR1750227|2017-01-11|
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    EP18700881.8A| EP3568088B1|2017-01-11|2018-01-11|Intra-aneurysm device|
    US16/477,173| US20190343533A1|2017-01-11|2018-01-11|Intra-aneurysmal device|
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