PREVENTIVE AND / OR CURATIVE DEVICE FOR STROKE

Abstract

TITLE OF THE INVENTION: PREVENTIVE AND / OR CURATIVE DEVICE FOR VASCULAR ACCIDENT The preventive and / or curative device (100) for treating a thrombosis forming a clot in an artery or an aneurysm forming an aneurysmal sac on an artery comprises: - a cylindrical structure (105), deployable from a microcatheter to the walls of an artery, extending along an axis from an open proximal end (110) to a closed distal end (115), configured to lodge on the walls of an artery, - a cup-shaped head (125) with a bumpy base, defined by a distal ellipsoidal perimeter (130) and a proximal apex (135) with a concave profile, configured to lodge on the walls of the artery or the walls of the aneurysmal sac at the level of the neck, and - a junction (145) connecting the proximal apex (135) of the head (125) and the distal end (115) of the cylindrical structure (105). Figure for the abbreviation: Figure 1

Description

Title of the invention: PREVENTIVE AND / OR CURATIVE DEVICE FOR STROKE Technical field of the invention

[0001] The present invention relates to a device for the prevention and / or treatment of vascular accidents. It is particularly applicable to the medical field and more specifically to the field of aneurysmal devices and thrombectomy devices. State of the art

[0002] The approaches described in this section are approaches that could be pursued, but not necessarily approaches that have been previously conceived or pursued. Therefore, unless otherwise indicated, it should not be assumed that any of the approaches described in this section constitutes prior art simply because of its inclusion in this section.

[0003] Thrombosis is the formation of a blood clot in a blood vessel. This blood clot, called a thrombus, prevents blood flow in the vessel in which it formed.

[0004] When a blood vessel is blocked, the blood supply to the organ in which the thrombus has formed is impaired. This insufficient blood supply can lead to serious damage such as neurological disorders and, in the most severe cases, death. Such thrombosis falls under the category of ischemic strokes. In 80% of cases, strokes are caused by ischemia resulting from a lack of oxygen and blood in the brain.

[0005] An aneurysm is a dilation of the wall of a blood vessel. Such a dilation causes the appearance of an aneurysmal sac communicating with the vessel through a narrowing of the sac called the neck.

[0006] If the aneurysm is not treated in time, the aneurysmal sac can enlarge until, in some cases, it ruptures. Rupture of an aneurysm can have serious consequences, such as severe neurological sequelae in 30% of cases, and death in 50% of cases. Such an aneurysm falls into the category of hemorrhagic strokes. Strokes due to hemorrhage related to an aneurysm rupture represent 20% of cases. Aneurysmal devices and thrombectomy devices are known. In particular, there are so-called "endovascular" techniques that include a minimally invasive treatment step involving the insertion of a device inside an artery via a microcatheter.

[0007] For thrombosis, these techniques allow the removal of the thrombus that has formed in the blood vessel in order to restore blood circulation.

[0008] The "stent retriever" device is known. This English term, commonly used in the medical field, refers to a tube with a substantially circular cross-section. It is a very finely cut cylinder, giving it a lattice-like appearance, which is positioned within the clot to be removed. However, the stent retriever may not fully deploy on the walls of the artery surrounding the clot, resulting in residues remaining on these walls after the procedure. These residues, forming a local narrowing of the artery, can lead to the recurrence of a new thrombosis. Furthermore, during the deployment of the stent retriever within the clot, the clot may fragment. The fragments spread beyond the original obstruction and can, in turn, block smaller secondary arteries.

[0009] For an aneurysm, these techniques aim to block the aneurysm in order to stop the blood flow arriving in the aneurysmal sac, thus preventing the sac from rupturing under the effect of blood pressure.

[0010] The device known as "coils," which consists of platinum coils to be positioned within the aneurysm, is well known. Several coils are inserted during the procedure, and a stent retriever may be added to support the cluster of coils then arranged within the sac. However, this device requires significant material resources, resulting in a lengthy procedure on the patient. Furthermore, a recanalization phenomenon, in which blood flow enters the base of the aneurysm despite the presence of the device, can occur. A second procedure is then necessary.

[0011] A balloon-shaped device, notably known as "WEB®", is known. This device is a braid of Nitinol fibers with a very dense mesh and is inserted into the aneurysm. However, since the geometry of an aneurysm can sometimes be irregular, the spherical shape of the balloon makes its sizing difficult. If the balloon is undersized, there is a risk of displacement of the device, and conversely, if the balloon is oversized, there is a risk of perforation of the aneurysm or of covering the source artery. Furthermore, the final positioning of the device may be incorrect following its detachment within the aneurysm. Also, a compaction phenomenon can occur several months after the procedure. In 25% of cases, a residual aneurysm develops.

[0012] The device called "Contour®" is known; it takes the form of a hemisphere with a very dense double braid. It is positioned at the neck of the aneurysm. However, since this device lacks anchoring, a migration phenomenon can occur. The device no longer prevents blood flow into the aneurysmal sac, which can lead to rupture of the aneurysm under the effect of blood pressure or by the action of the device itself.

[0013] The "stent retriever" device, as previously described, is known. In the case of an aneurysm, the cylinder is positioned in the artery, at the entrance to the neck. However, this device requires a significant amount of metal. Furthermore, the patient must undergo antiplatelet therapy after the procedure. Also, this device is not compatible with the treatment of an aneurysm occurring at an arterial bifurcation.

[0014] The devices mentioned above fall into two categories. Some are made using a technique called "braiding," others using a technique called "laser cutting." The braiding technique consists of creating a braided structure from one or more wires forming a mesh. The laser cutting technique consists of using a laser to cut a tube, creating closed cells and giving it a lattice-like appearance. Summary of the invention

[0015] The general concept of the invention consists of an endovascular device capable of treating a thrombosis or aneurysm. The device of the invention has a head that is placed in the aneurysmal sac and a cylindrical structure, deployable from a microcatheter to the walls of an artery, that is positioned in a blood vessel. The head is capable of significantly reducing blood flow in the aneurysm, while the cylindrical structure is configured to adhere to the walls of the blood vessel, providing stable anchorage for the device of the invention. The head and the cylindrical structure are connected by a junction that does not impede blood flow in the blood vessel. The device can be adapted to different types of blood vessels. Preferably, the device is deployed in an artery.

[0016] The device of the invention is configured to be transported to the aneurysm or thrombus by means of a micro-catheter whose dimensions are much smaller than those of the device of the invention, without creating damage to the mesh of the head and / or the network of the cylindrical structure.

[0017] The head is made by braiding a plurality of wires forming a dense mesh improving the structural stability of the device and preventing the wires from moving away from each other which would occur during passage through the micro-catheter.

[0018] The cylindrical structure is produced by laser cutting and features an enhanced cell array. This array has, for example, within each cell, a second cut, finer than the first cuts constituting its outline. The outline of each cell is configured to ensure the opening of the device of the invention during its deployment and successful application to the artery walls. The second cut is configured for rapid integration of the device of the invention into the artery wall.

[0019] Once the device of the invention is correctly deployed in the aneurysm or around the clot, the device is functional. No waiting time. No additional material is required. Furthermore, the device of the invention provides stable long-term anchoring, regardless of the aneurysm's shape. More specifically, the device is stable in an aneurysm located near an arterial bifurcation. In particular, the head adapts to all shapes of aneurysmal sacs, including those with a wide neck. Presentation of the invention

[0020] The present invention aims to remedy all or part of the drawbacks of the prior art.

[0021] To this end, the present invention relates to a preventive device for vascular accidents, for the treatment of thrombosis forming a clot in an artery or of an aneurysm forming an aneurysmal sac on an artery which comprises: - a cylindrical structure, deployable from a microcatheter to the walls of an artery, extending along an axis from an open proximal end to a closed distal end, configured to fit onto the walls of an artery, - a cup-shaped head with a bumpy base, defined by a distal ellipsoidal perimeter and a proximal apex with a concave profile, configured to lodge on the walls of the artery or the walls of the aneurysmal sac at the neck, and - a junction linking the proximal apex of the head and the distal end of the cylindrical structure.

[0022] Thanks to these provisions, in the case of an aneurysm, the preventive and / or curative vascular accident device has a stable anchorage in the aneurysmal sac and the artery.

[0023] These features allow the device of the invention to treat aneurysms without the addition of extra material, such as coils. The device of the invention is stable regardless of the shape of the aneurysm, and particularly when the aneurysmal sac is large. The device of the invention is also particularly stable when used to treat an aneurysm near an arterial bifurcation. Its anchoring is stable and effective in the long term.

[0024] Furthermore, the concave profile of the apex of the head prevents obstruction of blood flow in the source artery, allowing blood to flow freely around the junction. The distal end of the cylindrical structure also prevents obstruction of blood circulation around the junction. Consequently, the risk of blood clot formation caused by a foreign body, the foreign body being the device of the invention, is reduced.

[0025] Thanks to these provisions, in the event of thrombosis, the preventive and / or curative stroke device can remove the entire clot. Since the head is deployed downstream of the clot, it protects other arteries during clot removal. The head prevents any fragments that might break off from the clot from moving into the arteries while the clot is removed. The device of the invention traps the clot and any fragments of the clot.

[0026] Finally, these provisions allow the device to be used in the case of an ischemic stroke and a hemorrhagic stroke. In other words, the device can be used for an aneurysm and / or a thrombosis.

[0027] In some embodiments, the cylindrical structure has a network made by laser cutting.

[0028] In some embodiments, the network of the cylindrical structure comprises at least one elementary cell including: - two initial laser cuts forming, between the point where they separate and the point where they rejoin, an outline of said elementary cell, and - a second laser cut passing through said elementary cell; the network being a staggered repetition of the elementary cell.

[0029] These embodiments allow for the creation of an assembly of elementary cells. The distinctive feature of this assembly lies in the presence, within each cell, of a second, central cutout, preferably thinner than the first cutouts constituting its outline. The outline of each cell ensures the opening of the device during its deployment within the blood vessel and successful application to the arterial walls. The central cutout is configured for the rapid integration of the device of the invention into the arterial wall. The central cutout also allows the network of the cylindrical structure to interlock with the clot mass. The staggered arrangement of the elementary cells improves the deployment capacity of the cylindrical structure against the walls. Furthermore, this staggered arrangement allows the cylindrical structure to have a better grip on the clot to be expelled.

[0030] The first cuts of the contour form a so-called "strong" network, which adhere to the arterial wall. The second cut allows preferential colonization by endothelial cells in order to be integrated into the arterial wall and ensure the anchoring of the device in the artery.

[0031] In embodiments, a first curvilinear abscissa of at least a first cut is equal to a second curvilinear abscissa of the second cut.

[0032] These embodiments allow the diameter of the cylindrical structure to be reduced so that it can fit inside a microcatheter. When the device is in the microcatheter, the curvilinear abscissas of the first and second cuts become substantially rectilinear. Indeed, the first and second curvilinear abscissas of the cuts of a cell, being of the same value, can all extend linearly. The cylindrical structure can therefore have small diameters when compressed.

[0033] In some embodiments, the second laser cut has a first width that is smaller than a second width of the first laser cuts.

[0034] In some embodiments, the width of at least a portion of the elements of the cylindrical structure's network is less than 0.3 mm. The elements may be the first cutouts 505 and / or the second cutouts 510.

[0035] In embodiments, the width of at least part of the network elements of the cylindrical structure is greater than 0.005 mm.

[0036] In embodiments, the head being a mesh made by braiding.

[0037] In some embodiments, the mesh of the head comprises a plurality of wires, each wire having a fold on the ellipsoidal perimeter of the cup with a bumpy bottom and the ends of the wires meeting at the top.

[0038] These embodiments make it possible to form a dense mesh which reduces blood flow in the aneurysm.

[0039] In some embodiments, the mesh of the head is denser than the network of the cylindrical structure.

[0040] In some embodiments, the head comprises a number of braided wires between 1 and 200.

[0041] These embodiments allow for a dense mesh of the head to significantly reduce blood flow to the aneurysmal sac, without completely isolating it from the artery. Thus, blood circulation within the aneurysmal sac is slowed, and blood gradually stagnates within it, inducing rapid thrombosis. This advantageously eliminates the need for additional materials such as coils.

[0042] In some embodiments, the junction is a crimped ring.

[0043] In some embodiments, the junction is a weld.

[0044] These embodiments make it possible to reduce the size of the device which is the subject of the invention, which facilitates its insertion into the area affected by the aneurysm.

[0045] These embodiments prevent the obstruction of blood flow in the source artery, allowing blood to flow freely around the junction, which is preferentially narrow. The risk of blood clot formation between the head and the cylindrical structure is therefore very low.

[0046] In some embodiments, the head and the cylindrical structure are made of nitinol.

[0047] These embodiments allow the device of the invention to have interesting mechanical properties such as shape memory and superelasticity. Brief description of the figures

[0048] Other advantages, purposes and particular features of the invention will become apparent from the following non-limiting description of at least one particular embodiment of the device of the present invention, with reference to the accompanying drawings, in which: [Fig. 1] schematically represents an embodiment of the device of the invention in its deployed configuration, [Fig. 2] schematically represents the device illustrated in [Fig. 1] during an initial phase of its deployment in an aneurysm, [Fig. 3] schematically represents the device illustrated in [Fig. 1] during an intermediate phase of its deployment in the aneurysm, [Fig. 4] schematically represents the device illustrated in [Fig. 1] at the end of its deployment in the aneurysm, [Fig. 5] schematically represents a particular embodiment of the network of the deployed cylindrical structure of the device of the invention, [Fig. 6] schematically represents the network of the [Fig. 7]5] of the contracted cylindrical structure of the device of the invention, [Fig.7] schematically and in perspective represents a particular embodiment of the head of the device of the invention, [Fig.8] schematically represents the device illustrated in [Fig.1] during an initial deployment phase in the case of thrombosis, [Fig.9] schematically represents the device illustrated in [Fig.1] during an intermediate deployment phase in the case of thrombosis, and [Fig.10] schematically represents the device illustrated in [Fig.1] at the end of deployment in the case of thrombosis. Description of the implementation methods

[0049] The present description is given by way of non-limiting grammar, each feature of an embodiment being able to be advantageously combined with any other feature of any other embodiment.

[0050] It should be noted from the outset that the figures are not to scale.

[0051] As will be understood from the present description, various inventive concepts can be implemented by one or more of the methods or devices described below, several examples of which are provided herein. The actions or steps carried out in the implementation of the method or device can be ordered in any appropriate manner. Consequently, it is possible to construct embodiments in which the actions or steps are performed in a different order than that illustrated, which may include the simultaneous execution of certain acts, even if they are presented as sequential acts in the illustrated embodiments.

[0052] The expression "and / or", as used in this document, shall be understood as meaning "either or both" of the elements thus joined, that is, elements that are present conjunctively in some cases and disjunctively in others. Multiple elements listed with "and / or" shall be interpreted in the same way, that is, "one or more" of the elements thus joined. Other elements may also be present, other than those specifically identified by the "and / or" clause, whether or not they are related to those specifically identified elements.Thus, by way of non-limiting example, a reference to "A and / or B", when used in conjunction with an open language such as "including", may refer, in one embodiment, to A only (possibly including elements other than B); in another embodiment, to B only (possibly including elements other than A); in yet another embodiment, to A and B (possibly including other elements); etc.

[0053] As used herein in the description, "or" is to be understood inclusively.

[0054] As used in this description, the expression "at least one," with reference to a list of one or more elements, is to be understood as meaning at least one element chosen from one or more elements in the list of elements, but not necessarily including at least one of each element specifically enumerated in the list of elements and not excluding any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than the elements specifically identified in the list of elements to which the expression "at least one" refers, whether or not they are related to those specifically identified elements.Thus, by way of non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B", or, equivalently, "at least one of A and / or B") may refer, in one embodiment, to at least one, possibly including more than one, A, without B present (and possibly including elements other than B); in another embodiment, to at least one, possibly including more than one, B, without A present (and possibly including elements other than A); in yet another embodiment, to at least one, possibly including more than one, A, and at least one, possibly including more than one, B (and possibly including other elements); etc.

[0055] In the description below, all transitive expressions such as "comprising", "including", "carrying", "having", "containing", "implying", "holding", "composed of", and others, should be understood as open, that is, as meaning including but not limited to. Only the transitive expressions "consisting of" and "consisting essentially of" should be understood as closed or semi-closed transitive expressions, respectively.

[0056] Throughout the description, the device that is the subject of the invention is said to be "at rest" when no pressure is applied around it.

[0057] Throughout the description, the device which is the subject of the invention is said to be "contracted" when it is positioned in a micro-catheter.

[0058] Throughout the description, the device that is the subject of the invention is said to be "deployed" when it is positioned in an artery or an aneurysmal sac.

[0059] Figure 1, which is not to scale, shows a schematic view of an embodiment of the device 100 that is the subject of the invention, in its deployed configuration.

[0060] In some embodiments, the device 100, which is preventive and / or curative for stroke, can be used to treat an aneurysm. Such an aneurysm can be of any type known to those skilled in the art, for example, a cranial aneurysm. An aneurysm forms an aneurysmal sac 250 on an artery 255, as shown in Figures 2, 3, and 4. This aneurysmal sac 255 is a dilation of the wall of an artery 255. Such an aneurysmal sac 255 can be of any shape and diameter known to those skilled in the art. The device 100 of the invention can be used for all types of aneurysms. Preferably, the device 100 of the invention is used for a cerebral aneurysm. The 100 device can be placed in all types of aneurysmal sacs and all types of arteries.Preferably, the device 100 of the invention is placed in an aneurysmal sac 255 located near an arterial bifurcation, as shown in Figures 2, 3 and 4.

[0061] In embodiments, the device 100 of the invention comprises a cylindrical structure deployable from a microcatheter to the walls of an artery 105 extending along an axis 155 from an open proximal end 110 to a closed distal end 115. The cylindrical structure 105 is preferably a hollow tube. The cylindrical structure 105 preferably has a thickness between 1 and 200 micrometers, and even more preferably, between 25 and 150 micrometers. The outer diameter of the hollow tube may be less than 20 mm. The inner diameter of the hollow tube may be greater than 0.2 mm. Preferably, the outer diameter of the hollow tube is 2.5 mm. Preferably, the lower diameter of the hollow tube is 2.4 mm.

[0062] The open proximal end 110 preferentially has an oval section, not perpendicular to the axis 155 of the cylindrical structure 105. An opening of the distal end 110 may have the same dimensions of diameters, lower and outer.

[0063] In variants (not shown), the open proximal end 110 may have a section perpendicular to the axis 155 of the cylindrical structure 105.

[0064] The closed distal end 115 may have a conical shape. A cone formed by the distal end 115 has, for example, an apex connected to the junction 145.

[0065] In some embodiments, the cylindrical structure 105 is configured to fit onto the walls of an artery 255, as shown in Figures 2, 3, and 4. The cylindrical structure 105 is preferably flexible. The cylindrical structure 105 can line the walls of an artery 255 having different radii of curvature. In other words, the cylindrical structure 105 can follow a slight curve.

[0066] In this embodiment, the device 100 further comprises a cup-shaped head 125 with a bumpy base, defined by a distal ellipsoidal perimeter 130 and a proximal apex 135 with a concave profile. The distal ellipsoidal perimeter 130 may be circular. The distal ellipsoidal perimeter 130 may have different diameter values ​​730, such as that shown in [Fig. 7]. For example, the diameter 730, such as that shown in [Fig. 7], of the distal ellipsoidal perimeter 130 is the same as the diameter of the cylindrical structure 105. Preferably, the diameter 730, such as that shown in [Fig. 7], of the distal ellipsoidal perimeter 130 is larger than the diameter of the cylindrical structure 105.

[0067] The proximal vertex 135 may have a concavity oriented towards the distal ellipsoidal perimeter 130. For example, the proximal vertex 135 may have a diameter 735 similar to the diameter 730, as shown in [Fig.7], of the distal ellipsoidal perimeter 130. The proximal vertex 135 has a diameter 735 preferentially smaller than the diameter 730, as shown in [Fig.7], of the distal ellipsoidal perimeter 130.

[0068] In embodiments, the head 125 is configured to fit onto the walls of the artery, as shown in Figures 8, 9 and 10. In other words, the diameter 730, such as that shown in [Fig.7], of the distal ellipsoidal perimeter 130 is adapted to a diameter of the artery.

[0069] In other embodiments, the head 125 is configured to fit onto the walls of the aneurysmal sac 250 at the neck 260, as shown in Figures 2, 3 and 4. In other words, the diameter 735, such as that shown in [Fig.7], of the ellipsoidal perimeter of the proximal apex 135 is adapted to a neck diameter 260.

[0070] In this embodiment, the device 100 also includes a junction 145 connecting the proximal apex 135 of the head 125 and the distal end 115 of the cylindrical structure 105. At rest, the junction 145 preferably has as its axis the axis 155 of the cylindrical structure 105. The junction 145 can be configured so that the head 125 is mobile relative to the cylindrical structure 105. In other words, the junction 145 can be configured so that the head 125 is mobile around the axis 155 of the cylindrical structure 105. The head 125 can, for example, be positioned on an axis different from the axis 155 of the cylindrical structure 105. Thus, the device can adapt to all anatomies. For example, in the case where an aneurysmal sac is not located in the axis of the artery through which the device 100, the object of the invention, passes, Since the head 125 is mobile thanks to the previously described junction, the aneurysm can be treated.

[0071] Such a junction 145 is, for example, very thin. Preferably, the junction 145 is thinner than the diameter of the cylindrical structure 105.

[0072] In some embodiments, the cylindrical structure 105 has a grating 120 formed by laser cutting. Such laser cutting is known to those skilled in the art. The grating 120 allows the cylindrical structure 105 to have a variable diameter. In other words, the inner and outer diameters of the cylindrical structure 105 can vary depending on the diameter of the walls of the artery 255 in which the device 100 is deployed.

[0073] Figures 2, 3 and 4, which are not to scale, show a schematic view of an embodiment of the device 100, the object of the invention, during different phases of its deployment in an aneurysm.

[0074] In the initial deployment phase, the device 100 of the invention can be compressed into a microcatheter 201 positioned in the artery 255 containing the aneurysm to be treated, as shown in [Fig. 2]. The microcatheter 201 is preferably adapted to the dimensions of the artery 255 into which it is inserted. The dimensions of the microcatheter 201 are preferably adapted to the dimensions of the device 100 of the invention. The cylindrical structure 105, the head 125, and the junction 145 are, for example, slid inside the microcatheter 201 to an end 202 positioned near the aneurysm. In other words, the mesh of the head 125 and the network 120 of the cylindrical structure 105 can be compressed when the device 100 is in the micro-catheter 201. The distal ellipsoidal perimeter 130 of the head is preferentially positioned near the end 202 of the micro-catheter 201.In other words, only the distal ellipsoidal perimeter 130 can be deployed during the initial deployment phase.

[0075] A deployment tool (not shown) can push the device 100 of the invention into the microcatheter 201 to the end 202. The deployment tool is, for example, a pusher or any other system known to those skilled in the art. The deployment tool preferentially pushes the device 100 of the invention by bearing against the distal end 115 of the cylindrical structure 105.

[0076] In an intermediate deployment phase, the device 100 of the invention can be partially compressed into the microcatheter 201, as shown in [Fig. 3]. In other words, the cylindrical structure 105 can be compressed into the microcatheter 201. The tip 202 of the microcatheter 201 is preferably positioned near the proximal tip 135. The junction 145 can be partially inside the microcatheter 201. In other words, a portion of the junction 145 and the head 125 are deployed in this configuration.

[0077] The head 125 can be fully extended from the microcatheter 201 and deployed within the aneurysmal sac 250. The distal ellipsoidal perimeter 130 can extend to the walls of the aneurysmal sac 250. The proximal ellipsoidal perimeter 135 can extend to the walls of the neck 260. The aneurysmal sac 250 can be more or less rounded and elongated. The aneurysmal sac 250 and the neck 206 can have varying dimensions and widths. Preferably, the distal ellipsoidal perimeter 130 takes the shape of the walls of the aneurysmal sac 250. In other words, the deployed head 125 can have a shape similar to the shape of the walls of the aneurysmal sac 250 with which said head 125 is in contact. The deployed shape of the 125 head is, for example, configured to fit the dimensions of the 250 aneurysmal sac.

[0078] The deployment tool (not shown) can push the head 125 into the aneurysmal sac 250.

[0079] In the final deployment phase, the device 100 of the invention can be completely outside the microcatheter, as shown in [Fig. 4]. The head 125 and the cylindrical structure 105 are fully deployed. In this configuration, the head 125, the junction 145, and the cylindrical structure 105 are fully deployed. The cylindrical structure 105 can extend to the walls of the artery 255. The artery 255 can have varying dimensions and shapes. Preferably, the cylindrical structure 105 takes the shape of the walls of the artery 255. For example, the cylindrical structure 105 may have slight variations in diameter along its deployed length. Preferably, the cylindrical structure 105 has a shape similar to the shape of the walls of the artery 255 with which said cylindrical structure 105 is in contact. The deployed form of the cylindrical structure 105 is, for example, configured to fit the dimensions of artery 255.

[0080] The deployment tool (not shown) can push the cylindrical structure 105 into the artery 255 positioned near the neck 260. The tool is then withdrawn into the microcatheter.

[0081] In embodiments (not shown), the device 100 of the invention includes a detachment system for detaching the device 100 of the invention once the head 125 is deployed in the aneurysmal sac 250 and the cylindrical structure 105 is deployed in the artery 255. Such a detachment system (not shown) is, for example, positioned near the proximal end 110 of the cylindrical structure 105. Such a system can detach by electrolytic activation or any other system known to a person skilled in the art.

[0082] In embodiments, the preventive and / or curative stroke device 100 can be used for the treatment of a thrombosis forming a clot 810, also called a thrombus, in an artery 805, as shown in Figures 8, 9 and 10. Such a thrombosis can be of any type known to a person skilled in the art, for example, venous or arterial. A thrombosis forms a blood clot. This clot creates an occlusion in a blood vessel. Such a clot can be of any type known to those skilled in the art, for example, an arterial or venous clot. The clot can be of any shape, length, and diameter known to those skilled in the art. The device of the invention is used for all types of thrombosis. Preferably, the device of the invention is used for cerebral thrombosis.

[0083] In embodiments, the cylindrical structure 105 is configured to fit onto the walls of an artery 805, as shown in Figures 8, 9 and 10.

[0084] In some embodiments, the head 125 is also configured to fit onto the walls of the artery 805. In other words, the diameter 730, such as that shown in [Fig.7], of the distal ellipsoidal perimeter 130 is at least equal to a diameter of the artery 805.

[0085] Thus, the device can adapt to all anatomies. For example, the diameter of the head varies depending on the diameter of the artery 805 in which the head 125 is deployed. In other words, the diameters, 730 and 735, such as those shown in [Fig. 7], of the distal ellipsoidal perimeter 130 and the proximal apex 135 vary depending on the diameter of the artery 805 in which the head 125 is deployed. The inner and outer diameters of the cylindrical structure 105 can vary depending on the diameter of the walls of the artery 805 in which the device 100 is deployed.

[0086] Figures 8, 9 and 10, which are not to scale, show a schematic view of an embodiment of the device 100 of the invention during different phases of its deployment in an artery 805 containing a clot 810.

[0087] In the initial phase of deployment, the device 100 of the invention can be compressed into a micro-catheter 201 positioned in the artery 805 containing the thrombosis to be treated, as shown in [Fig.8]. The microcatheter 201 passes through the clot 810 blocking the artery 805. The device 100 of the invention can be slid inside the microcatheter 201 to an end 202 positioned downstream of the clot 810. In other words, the head 125 and the cylindrical structure 105 can be compressed when the device 100 of the invention is inside the microcatheter 201. The distal ellipsoidal perimeter 130 of the head 125 is preferably positioned near the end 202 of the microcatheter 201, downstream of the clot 810. In other words, the distal ellipsoidal perimeter 130 is positioned downstream of the clot 810.

[0088] A deployment tool (not shown) can push the device 100, the object of the invention, into the micro-catheter 201 to the end 202.

[0089] In an intermediate phase of deployment, the device 100 which is the subject of the invention can be partially compressed in the micro-catheter 201, as shown in [Fig.9].

[0090] The head 125 can be fully extended from the microcatheter 201 and deployed in the artery 805. The distal ellipsoidal perimeter 130 can extend to the walls of the artery 805. The walls of the artery 805 can have varying dimensions and shapes. Preferably, the distal ellipsoidal perimeter 130 takes the shape of the walls of the artery 805. The mesh 140 of the head 125 lies flat, for example, against the walls of the artery 805 downstream of the clot 810. In other words, the head 125 can have a deployed shape similar to the shape of the walls of the artery 805 with which said head 125 is in contact. The mesh of the head 125 is, for example, configured to fit the dimensions of the artery 805.

[0091] The deployment tool (not shown) can push the head 125 into the artery 805.

[0092] The cylindrical structure 105 can be compressed into the micro-catheter 201. The end 202 of the microcatheter 201 is preferentially positioned near the proximal apex 135. The junction 145 may be partially within the microcatheter 201.

[0093] The cylindrical structure 105 can be partially compressed in the microcatheter 201. A portion of the cylindrical structure 105 is, for example, deployed in the artery 805 downstream of the clot 810. In other words, the deployed portion of the cylindrical structure 105 can be positioned between the head 125 and the clot 810. The deployed portion of the cylindrical structure 105 rests against the walls of the artery 805 downstream of the clot 810.

[0094] In the final deployment phase, the device 100 of the invention can be completely outside the microcatheter 201, as shown in [Fig. 10]. The head 125 and the cylindrical structure 105 are fully deployed. In this configuration, the head 125, the junction 145, and the cylindrical structure 105 are deployed. The cylindrical structure 105 deploys, for example, into the clot 810. The cylindrical structure 105 can extend to the walls of the artery 805. The artery 805 can have varying dimensions and shapes. Preferably, the cylindrical structure 105 takes the shape of the walls of the artery 805. For example, the cylindrical structure 105 can have different diameters along its deployed length. Preferably, the cylindrical structure 105 has a shape similar to the shape of the walls of the artery 805 with which said cylindrical structure 105 is in contact.The network 120 of the cylindrical structure 105 is, for example, configured to fit the dimensions of the artery 805. The network 120 of the cylindrical structure 105 can be configured to abut against the walls of the artery 805 positioned around, upstream and downstream of the clot 810. Preferably, the network 120 of the cylindrical structure 105 is . configured to trap the clot 810 within its mass. The portion of the cylindrical structure 105 in contact with the clot 810 can have a variable shape. The network of the cylindrical structure 105 is preferentially configured to adhere to the walls of the artery 805 and to interlock with the mass of the clot 810.

[0095] The deployment tool (not shown) can push the cylindrical structure 105 into the thrombosed artery 805. The tool is then withdrawn into the microcatheter 201.

[0096] In embodiments (not shown), the device 100 of the invention includes a detachment system for detaching the device 100 of the invention once the head 125 and the cylindrical structure 105 are deployed in the artery 805.

[0097] Figure 5 shows a schematic view of a particular embodiment of the network 500 of the deployed cylindrical structure of the device 100 which is the subject of the invention.

[0098] In this embodiment, the lattice 500 of the cylindrical structure 105, as shown in Figures 1 to 4 and 8 to 10, comprises at least one elementary cell 540. The lattice 500 may comprise a plurality of cells 540. Such a cell 540 may be a motif reproduced several times to form the lattice 500.

[0099] In some embodiments, the elementary cell 540 comprises first laser cuts 505 forming, between the point where they separate and the point where they rejoin, the contour of said elementary cell 540. The elementary cell 540 may comprise two first cuts 505, each following the shape of a sinusoidal waveform. In other words, the first two cuts 505 each follow a sinusoidal waveform. A first cut 505 is, for example, the reflection of another first cut 505 of the elementary cell 540 across an axis 515 of symmetry. The contour of the cell 540 may have a shape resulting from two waves in opposite phase. A first cut 505 is preferably positioned to have two points of intersection, 541 and 542, with another first cut 505 of the elementary cell 540.In other words, the first 505 cuts are preferentially positioned relative to each other to have two points of intersection, 541 and 542, respectively at the places where they separate and rejoin. In other words, the points of intersection, 541 and 542, can be positioned on the axis of symmetry 515. The outline of the elementary cell 540 can be defined by the two points of intersection, 541 and 542, of the first 505 cuts and the portions of the first 505 cuts located between the two points of intersection, 541 and 542.

[0100] In some embodiments, the network 500 further comprises a second laser cut 510 passing through the elementary cell 540. The second cut 510 is preferably positioned between the first two cuts 505 of the elementary cell 540. In other words, the second cut 510 can be positioned inside the contour of the elementary cell 540. The second cut 510 has, for example, two points of intersection with the contour of the elementary cell 540. The two points of intersection between the second cut 510 and the contour of the elementary cell 540 are preferably the two points of intersection, 541 and 542, of the first cuts 505. In other words, the first cut 510 crosses the cell 540 from the place where the first cuts 505 separate to the place where the first cuts 505 rejoin.

[0101] In some embodiments, the network 500 is a staggered repetition of the elementary cell 540. In other words, the network 500 can be a repetition of the first cuts 505 and the second cut 510. The intersection points, 541 and 542, of the elementary cell 540 coincide respectively with the points, 542 and 541, of the repeated elementary cell. Half of a first cut 505 of the elementary cell 540 can be half of another first cut 505 of the repeated elementary cell.

[0102] The cells 540 positioned near the distal end 115 preferentially have only the first cuts 505. In other words, the cells forming the distal end 115 may not have a second cut 510.

[0103] The oval section of the proximal end 110 is preferentially formed by portions of the first 505 cuts of the cells.

[0104] Figure 6, which is not to scale, shows a schematic view of the network of the contracted cylindrical structure 125 of the device 100 that is the subject of the invention.

[0105] In this embodiment, the lattice 500 of the cylindrical structure 105, as shown in Figures 1 to 4 and 8 to 10, comprises a first curvilinear abscissa of at least one first cut 505 which is equal to a second curvilinear abscissa of the second cut 510. Preferably, the first cuts 505 have the same curvilinear abscissa measure. The first curvilinear abscissa and the second curvilinear abscissa may be of the same measure. The first cuts 505 have lengths similar to the second cut 510. In other words, the sum of the segment lengths and the arc lengths of a first cut 505 is, for example, equal to the sum of the segment lengths and the arc lengths of the second cut. An arc can be a crest of the cuts, 505 and / or 510. In other words, the curve length of a first 505 cut can be equal to the curve length of the second 510 cut.

[0106] In its contracted form, the curvatures of the cutouts, 505 and 510, can be straightened. The first cutouts 505 and the first cutout 510 can be substantially linear. In other words, the first and second curved abscissas approach, for example, rectilinear abscissas. The cylindrical structure can to have a greater length when contracted. In other words, the length of the cylindrical structure 125 can increase when its diameter decreases. The length of cell 540 can increase when the cylindrical structure 125, as shown in Figures 1 to 4 and 8 to 10, contracts.

[0107] The cylindrical structure 125, as shown in Figures 1 to 4 and 8 to 10, can be deployed by applying an axial force to the lattice 500. The first cutouts 505 of a cell 540 can bend in opposite directions to each other. In other words, a first cutout 505 of a cell 540 bends, for example, symmetrically to another first cutout 505 of the cell 540 with respect to an axis (not shown) passing through the two points, 541 and 542, of intersection of the first cutouts 505. The curves of the first cutouts 505 can each have a vertex. The second cutout 510 of a cell 540 can also have a curve. The curvature of the second cut 510 is, for example, more curved than the curvature of the first cuts 505. The curvature of the second cut 510 preferably has two vertices. The radii of curvature of each vertex of the second cut 510 may be similar.The radius of curvature of a vertex of the second cut 510 is, for example, 2 times smaller than the radius of curvature of the vertex of a first cut 505. The length of the cell 540 can decrease when the cylindrical structure 125 unfolds, as shown in Figures 1 to 4 and 8 to 10. In other words, the length of the cylindrical structure 125 can decrease when its diameter increases.

[0108] In some embodiments, the cutouts, 505 and 510, may include undulations having spatial periods 520. Each first cutout 505 of the elementary cell 540 may follow the shape of a sinusoidal wave. The undulation of each first cutout 505 may have a spatial period 520. The first cutouts 505 preferably have the same spatial period 520. The undulation of a first cutout 505 is, for example, in opposite phase to the undulation of another first cutout 505 of the elementary cell 540. In other words, the undulation of a first cutout 505 is preferentially out of phase by 180° with respect to the undulation of another first cutout 505 of the elementary cell 540. The second cutout 510 may follow the shape of a sinusoidal wave. The waviness of the second 510 laser cut can have a period of 520. For example, the first 505 cuts and the second 510 cut have the same spatial period of 520.

[0109] In variants (not shown), the spatial period of the second cut is lower than the spatial period of the first cuts.

[0110] In variants (not shown), the spatial period of the first cuts is lower than the spatial period of the second cut.

[0111] In some embodiments, the undulations of the cutouts, 505 and 510, may include crests, 545, 550, 555 and / or 560. The first cutouts 505, for example, each have a crest, 545 and 550, respectively. In other words, each first cutout 505 may have a crest, 545 or 550. A crest 545 of a first cutout 505 may be symmetric to a crest 550 of another first cutout 505 of the same cell 540 with respect to an axis (not shown) passing through the two points of intersection of the first cutouts. Each crest, 545 and / or 550, of the first cutouts 505 of the elementary cell 540 is, for example, in contact with a point of intersection, 541 and / or 542, of a repeated elementary cell. Similarly, each ridge of the first 505 cuts of the repeated elementary cell is, for example, in contact with an intersection point, 541 and / or 542, of another repeated elementary cell.The second cut 510 has, for example, two ridges, 555 and 560. The ridges, 555 and 560, are preferentially positioned between the two points of intersection, 541 and 542. In other words, the second cut 510 can have two ridges, 555 and 560, positioned between the place where the first cuts 505 separate and the place where the first cuts 505 rejoin.

[0112] In some embodiments, a peak-to-peak distance 535 of the waviness of the first cut 510 can be half the maximum distance 530 between two peaks, 545 and 550, of the first two cuts 505, respectively. The maximum distance 530 can be the greater of the two peaks 545 of a first cut 505 and a peak 550 of another first cut 505. In other words, the maximum distance 530 is preferably the distance between peak 545 and peak 550. The distance 535 is, for example, the distance between a peak 555 and a peak 560 of the second cut 510. In other words, the peak-to-peak distance 535 can be a peak-to-peak amplitude of the second cut 510.

[0113] In some embodiments, the second laser cut 510 has a first width Wr that is smaller than the second width Wn of the first laser cuts 505. Preferably, the first width Wr is half the second width Wn of the first cuts 505.

[0114] In variants (not shown), the first width Wr is twice greater than the second width Wn of the first cuts 505.

[0115] In other variants (not shown), the first width Wr is similar to the second width Wn of the first 505 cutouts.

[0116] In some embodiments, the width, Wn and / or Wr, of at least a portion of the network elements 500 of the cylindrical structure 105 is less than 0.03 mm, preferably less than 0.2 mm, and even more preferably less than 0.0165 mm. Preferably, the first cutouts 505 have a width Wn between 0.100 mm and 0.180 mm, and even more preferably, between 0.080 mm and 0.160 mm.

[0117] In variants (not shown), the second cutout 510 has a width Wr between 0.100 mm and 0.180 mm, and even more preferably, between 0.080 mm and 0.160 mm.

[0118] In some embodiments, the width, Wn and / or Wr, of at least a portion of the network elements 500 of the cylindrical structure 105 is greater than 0.005 mm, preferably 0.010 mm, and even more preferably 0.015 mm. Preferably, the second cutout 510 has a width Wn between 0.040 mm and 0.100 mm, and even more preferably, between 0.020 mm and 0.080 mm.

[0119] In variants (not shown), the first cutouts 505 have a width Wr between 0.040 mm and 0.100 mm, and even more preferably, between 0.020 mm and 0.080 mm.

[0120] In some embodiments, the first cutouts 505 and the second cutout 510 may have a similar thickness. Preferably, the first cutouts 505 and the second cutout 510 have a thickness between 0.015 and 0.160 mm, and even more preferably, between 0.025 and 0.150 mm.

[0121] In variants (not shown), the first cutouts 505 have a greater thickness than the second cutout 510.

[0122] In other variants (not shown), the second cut 510 has a greater thickness than the first cuts 505.

[0123] The network 120 of the cylindrical structure 105, such as that shown in figures 1 to 4 and 8 to 10, having similar characteristics to the network 500, are not described again here.

[0124] Figure 7 shows a particular embodiment of the head 700 of the device 100 which is the subject of the invention, such as that shown in Figures 1 to 4 and 8 to 10.

[0125] In some embodiments, the head 125 is a mesh made by braiding 140. Such braiding is known to those skilled in the art.

[0126] In some embodiments, the mesh 715 of the head 700 comprises a plurality of wires. Preferably, the wires have a diameter less than 0.075 mm, even more preferably, less than 0.050 mm, and even more preferably, less than 0.025 mm. Preferably, the wires have the same diameter. In other variations, the wires have different diameters.

[0127] In embodiments, each wire has a fold 705 on the ellipsoidal perimeter 720 of the cup with a bumpy bottom, and the ends 725 of the wires meet at the apex 710. Such a fold 705 creates, for example, a mesh 715 comprising a double layer of wires. The folds 705 of the wires can form the ellipsoidal perimeter 720. The ends 725 of the wires are, for example, connected to the vertex 710. The junction 145, such as that shown in figures 1 to 4, connects the plurality of wires by their end below the vertex 710. The mesh 715 is preferentially denser at the vertex 710 than at the ellipsoidal perimeter 720.

[0128] The mesh 715 can be a grid in which portions of wires going in the same direction overlap portions of wires going in another direction. In other words, parallel wire portions intersect, for example, other parallel wire portions. In other words, wire portions positioned on one side of the fold 705 intersect, for example, wire portions positioned on the other side of the fold 705. Such a mesh 715 comprises, for example, between 1 and 200 wires. Such a mesh 715 preferably comprises 48 wires. The double layer created by the fold 705 is equivalent, for example, to a mesh comprising 96 wires.

[0129] In variants (not shown), the wires do not have folds and are, for example, mechanically linked in pairs along the ellipsoidal perimeter 720. The mesh can thus have a single layer of wires. Such a mesh comprises, for example, between 1 and 200 wires. Such a mesh preferably comprises 96 wires.

[0130] In embodiments, the mesh 715 of the head 700 is denser than the network 500 of the cylindrical structure 105, as shown in Figures 1 to 4 and 8 to 10.

[0131] In variants (not shown), the mesh 715 of the head 700 is as dense as the network 500 of the cylindrical structure 105.

[0132] In embodiments, the head 700 comprises a number of braided wires from 1 to 200 wires, and preferably from 4 to 96. For example, the head 700 comprises 48 wires.

[0133] The head 125 of the device 100 which is the subject of the invention, such as that shown in figures 1 to 4 and 8 to 10, having similar characteristics to the head 700, they are not described again here.

[0134] In some embodiments, the junction 145 is a crimped ring. The crimped ring connects, for example, the ends 725 of the wires, as shown in [Fig. 7], together.

[0135] In some embodiments, the junction 145 is a weld. The weld connects, for example, the ends 725 of the wires, as shown in [Fig. 7], to each other. In other words, the junction 145 can be formed by the ends 725 of the wires, as shown in [Fig. 7], welded together and welded to the distal end 115. The junction 145 is, for example, formed by the ends 725 of the wires, as shown in [Fig. 7], welded together and welded to the distal end 115. Such a weld can be made without the addition of material. The ends 725 of the wires of the head 125 are, for example, fused directly to the distal end 115 of the structure cylindrical 105 using as material for fusion, the material from the distal end 115.

[0136] In variants, the welding can be carried out with the addition of material. The welding is, for example, by adding molten metal to a point of contact between the ends 725 of the wires and the distal end 115.

[0137] In some embodiments, the head 125 and the cylindrical structure 105 are made of nitinol. Preferably, the head 125 and the cylindrical structure 105 are made of "DFT" (acronym for "Drawn Filled Tube") which is a nitinol wire with a platinum core.

[0138] In variants, the head 125 and the cylindrical structure 105 are a nickel-titanium alloy.

Claims

Demands

1. A device (100) for the prevention and / or treatment of vascular accidents, for the treatment of thrombosis forming a clot (810) in an artery (255, 805) or of an aneurysm forming an aneurysmal sac (250) on an artery (255, 805) characterized in that it comprises: - a cylindrical structure (105), deployable from a microcatheter to the walls of an artery, extending along an axis (155, 515) from an open proximal end (110) to a closed distal end (115), configured to lodge on the walls of an artery (255, 805), - a cup-shaped head (125) with a bumpy base defined by a distal ellipsoidal perimeter (130, 620) and a proximal apex (135, 710) with a concave profile, configured to fit onto the walls of the artery (255, 805) or the walls of the aneurysmal sac (250) at the neck (260), and - a junction (145) connecting the proximal apex (135, 710) of the head (125, 700) and the distal end (115) of the cylindrical structure (105).

2. Device (100) according to claim 1, wherein the cylindrical structure (105) comprises a grid made by laser cutting (120, 500).

3. Device (100) according to claim 2, wherein the network (120, 500) of the cylindrical structure (105) comprises at least one elementary cell (540) comprising: - two first laser cuts (505) forming, between the place where they separate and the place where they join, a contour of said elementary cell (540), and - a second laser cut (510) passing through said elementary cell (540); the network (120, 500) being a staggered repetition of the elementary cell (540).

4. Device (100) according to claim 3, wherein a first curvilinear abscissa of at least a first cut (505) is equal to a second curvilinear abscissa of the second cut (510).

5. Device (100) according to any one of claims 3 or 4, wherein the second laser cut (510) has a first width (Wr) weaker than a second width (Wn) of the first cuts (505) by laser.

6. Device (100) according to any one of claims 2 to 5, wherein the width (Wn, Wr) of at least a part of the network elements (120, 500) of the cylindrical structure (120) is less than 0.3 mm.

7. Device (100) according to any one of claims 2 to 5, wherein the width of at least a part of the network elements (120, 500) of the cylindrical structure (120) is greater than 0.005 mm.

8. Device (100) according to any one of claims 1 to 7, wherein the head (125, 700) comprises a mesh made by braiding (140, 715).

9. Device (100) according to claim 8, wherein the mesh (140, 715) of the head (125, 700) comprises a plurality of wires, each wire having a fold (705) on the ellipsoidal perimeter (130, 720) of the cup with a bumpy bottom and the ends (725) of the wires meeting at the top (135, 710).

10. Device (100) according to claim 8, when it depends on claim 2, or according to claim 9, wherein the mesh (140, 715) of the head (125, 700) is denser than the network (120, 500) of the cylindrical structure (120).

11. Device (100) according to any one of claims 1 to 10, wherein the head (125, 700) comprises a number of braided wires from 1 to 200.

12. Device (100) according to any one of claims 1 to 11, wherein the junction (145) is a crimped ring.

13. Device (100) according to any one of claims 1 to 11, wherein the junction (145) is a weld.

14. Device (100) according to any one of claims 1 to 13, wherein the head (125, 700) and the cylindrical structure (105) are made of nitinol.

Images