• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
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  • 优先权
    • 专利摘要:
    thrombectomy device the invention relates to a thrombectomy device with a stent structure (1) in essence, cylindrical, which has a plurality of meshes (3, 4), as well as two connectors (5, 5 '), which are arranged in several meshes (3) at the proximal end of the stent structure (1) and the device also has a guide wire (2), comprising a coupling element (11), to which the connectors (5) are attached , 5 '), as well as a slot (7), which extends helically through the lining surface (8) of the stent structure (1), and a clamping arch (9), which covers the slot (7) ), at the proximal end.
    公开号:BR112013012388B1
    申请号:R112013012388-5
    申请日:2011-11-18
    公开日:2020-05-26
    发明作者:Hermann Monstadt；Ralf Hannes；Jörg Ascherfeld
    申请人:Phenox Gmbh；
    IPC主号:
    专利说明:

    Descriptive Report of the Invention Patent for THROMBECTOMY DEVICE.
    [0001] The invention relates to a thrombectomy device with a stent structure, in essence, cylindrical, which has a plurality of meshes, as well as two connectors, which are arranged in several meshes at the proximal end of the stent structure and, a guide wire, which has a coupling element, to which the connectors are attached. The thrombectomy device is determined, in particular, to carefully and reliably remove thrombi in the brain area, such as those frequently found in strokes.
    [0002] Thromboembolic diseases such as cardiac infarction, pulmonary embolism, peripheral thrombosis, organ embolisms, etc. are typically triggered by a thromboembolus (hereinafter abbreviated: thrombi), therefore, a cluster of viscoelastic blood from blood platelets, fibrinogens, clotting factors, etc., which is fixed in a blood vessel, and closed it completely or partially. Occlusion of organ arteries, in this case, leads to an interruption of oxygen and nutrient-dependent tissue feeding. The interruption of functional metabolism with functional loss, within a short time, is followed by the collapse of the metabolism of the structure with the decline of the affected tissue (infarction). The organs most affected in humans are the heart and the brain. Such changes, however, also refer to extremity and pulmonary arteries. Venous thrombosis and thromboembolic clasps also frequently occur in the leg veins and pelvic veins. The pathological picture of a thrombotic occlusion of an intracranial sinus can lead to severe cerebral hemorrhages due to the interruption of venous drainage of brain tissue.
    [0003] In view of the severity of pathological conditions,
    Petition 870190094844, of 9/23/2019, p. 7/25
    2/12 due to thromboembolisms, and the frequency of these diseases, several techniques for the removal or removal of thrombi are known.
    [0004] Thus, it is known to treat patients of this type with thrombolytic means such as streptokinase or uruchinase or with anticoagulants, which is used for thrombolysis or to contain the growth of thrombi. Since these treatment processes are often time-consuming, they are often combined with processes, which serve for medical shredding or removal of the thrombus or embolism.
    [0005] Along with open surgical interventions, in the state of the art, forms of interventional therapy guided by a transluminar or endovascular catheter are increasingly used, since these forms are less invasive. Thus, it is known to remove the thrombus from the patient's body by means of suction catheters that produce vacuum, or mechanically with catheters, which are equipped with capture baskets, spirals, hooks or the like, see US patents 6,245,089 B1; US 5,171,233 A1, Thomas E. Meier et al., Stroke 2002 (9) 2232.
    [0006] The disadvantage of thrombolytic treatment processes lies in the fact that, after the expiration of the time window, they still only rarely succeed. Also, transluminary devices often cannot completely exclude a thrombus, and there is also a danger that the thrombus or fragments of it may be released and sent to smaller luminary vessels in the bloodstream, where they are more difficult to reach and treat. . In addition, devices known in the prior art are appropriate, due to their dimensions and / or small flexibilities, only insufficiently for the removal of thrombi from particularly small or very sinuous luminary vessels, such as those
    Petition 870190094844, of 9/23/2019, p. 8/25
    3/12 of the brain.
    [0007] From WO 2004/008991 A1 a medical implant in the form of an open stent is known, which is determined for the treatment of aneurysms and other vascular malformations. This implant is conducted with the aid of a guide wire to the place of employment, and is released there. It has been suggested to employ this combination of implant and guide wire for the extraction of thrombi, and, naturally, the release of the implant part is not carried out by the guide wire. The disadvantage of this implant and guide wire construction is undoubtedly a relatively small clamping or spring force. The construction develops a shear effect that is not always sufficient for the thrombus seated on the vessel wall, in such a way that remains remain in the vessel. The connection to the guide wire through a reduced structure (bulb) leads, in particular, to a thinning of the proximal area of the structure under tension, which is opposed to the construction efficiency.
    [0008] In view of the disadvantages linked to the state of the art, the task of the invention is to provide a device for the removal of foreign bodies and thrombi from blood vessels, which allows, in particular, the removal of thrombi from luminary vessels small and, in this case, have a good maneuverability in very sinuous vessels, and a large active surface.
    [0009] This task is solved according to the invention with a device of the type mentioned at the beginning, which has a slit, which extends helically through the covering surface of the stent structure, to which at the proximal end of the stent structure is covered by a tightening arch.
    [00010] The device according to the invention is constituted by a cylindrical structure, like the one that the stents present, with a plurality of meshes. These meshes are connected with a guide wire
    Petition 870190094844, of 23/09/2019, p. 9/25
    4/12 via two connectors, which allow precise location. The connectors are arranged in a mesh structure at the proximal end, and terminate in a coupling element, which in turn represents the distal end of the guide wire.
    [00011] The term proximal used here designates the side to be treated facing the doctor, distal on the contrary, designates the side away from the doctor, for example, from the stent structure or the guide wire.
    [00012] The mesh structure of the stent may be a braided structure, that is, it may consist of individual wires, but preferably it is a cut structure, in which a tube of the appropriate diameter, with the aid of a laser beam, is the mesh structure is cut. The material, in general, is a metal, but it can also be a synthetic material. It needs to have sufficient elasticity, which allows for a contraction to the diameter of a usual catheter and, on the other hand, during the release of the catheter, allows for expansion to the desired and specified diameter.
    [00013] As stent materials, alongside iron alloys (stainless steel, spring steel) and cobalt and chromium alloys, in particular shape memory alloys, for example, binary nickel alloys and titanium (nitinol) and nickel, titanium and chromium ternary alloys (chromium alloys). For use in self-expanding stent structures in the neurovascular area, nitinol is known in particular.
    [00014] The device according to the invention is, in principle, a flat structure, which is rolled up to form a tubular structure, and has a slit, which extends helically or helically through the coating surface of the structure stent. This slot, in this case, can have a complete 360 ° spiral, but also a partial spiral of, for example, approximately 180 ° or 120 °. The lining surface of the stent structure opens in the area of this crack, and the width of the crack in the
    Petition 870190094844, of 9/23/2019, p. 10/25
    5/12 place of use is also determined respectively, by the vessel lumen, since, after the catheter is released, the stent structure can only be deployed as far as the vessel lumen allows. [00015] In order to fix the stent structure spatially, on the one hand, and to provide a certain tension, on the other hand, on the other hand, at the proximal end of the stent structure, a clamping arch extends through a slot . The clamping arc increases the radial force of the self-expanding structure, but it also serves the purpose of securing the corners of the stent structure in relation to each other, which are opposite each other in their position along the slot.
    [00016] In addition to the proximal clamping arch, the thrombectomy device according to the invention may have other clamping arches in the central and distal area. In the case of the use of materials with shape memory with sufficient pre-tension, however, any tightening arc can also be abolished.
    [00017] The thrombectomy device according to the invention is employed in such a way that, it is taken to the place of use by means of a catheter, and there it is released either in the thrombus itself or it is released distally from the thrombus. The device expands in the vessel, and adapts to the vessel's lumen. During the squeeze or during the retraction, the material of the thrombus is captured in the mesh structure, and during the retraction of the device it is taken into the catheter. The parts of the thrombus adhered to the vessel wall are dragged by the shear effect of the meshes and corners along the crack. The thrombus is inserted into the catheter and is removed from the body with the catheter.
    [00018] During the extraction of the thrombus, the helical path of the slit through the lining surface has the particular advantage that the corners of the stent structure wander along the slit with tangential traction along the circumference of the vessel wall. This improves the shear effect. At the same time improves (reduces) the rigi
    Petition 870190094844, of 9/23/2019, p. 11/25
    6/12 Dec to flexion due to the helical path, in such a way that a better adaptation to the curvilinear vessel is possible. This facilitates both the localization and the extraction of thrombi from complex vessel structures.
    [00019] The proximal arch improves the radial force path of the stent structure in the proximal area. In particular, the arch reduces a thinning of the stent structure and traction load, as occurs during insertion into the catheter. At the same time, an additional peeling effect is obtained, such as that which is also exercised by the meshes and corners of the stent structure.
    [00020] Of significance, however, is the improvement, in particular, of the clamping force in the proximal area, which enables an ideal adaptation of the stent structure to the vessel lumen. At the same time, areas of the stent separated from each other by the slit are prevented from moving against each other.
    [00021] In order to enable a smooth insertion of the stent structure with the arch into the catheter, the clamping arch faces the distal end of the stent structure. This means that the arc of the arc is closed to the distal, on the contrary, to the proximal, together with the connectors, it forms a loop, which joins in the coupling element, similar to the opening of a capture basket.
    [00022] According to a variant, at the distal end, the stent structure according to the invention can be closed by a mesh structure, such that the thrombotic material joins it as in a capture basket.
    [00023] As already mentioned, the stent structure according to the invention is preferably cut from a cylindrical tube, with the aid of a laser beam. This allows the individual meshes to be given a special cross section, for example, square, rectangular or trapezoidal. In the case of rectangular and trapezoidal forms of execution, on the
    Petition 870190094844, of 9/23/2019, p. 12/25
    7/12 side, the narrow side of the cross section can be on the outer surface, on the other hand, the long side. It is preferred that the narrow side of both the rectangle and, in particular, the trapezoid faces the vessel wall, which allows the thrombus to penetrate the mesh structure more easily, and allows a good displacement of the mass of the thrombus during expansion of the stent structure. [00024] The connectors arranged at the proximal end of the stent structure lead from the proximal combs adjacent to the slot to a coupling element, in which they are brought together. They are part of the stent structure and therefore are made of the same material. [00025] The guide wire of the thrombectomy device according to the invention is a usual guide wire, such as that used for endovascular and, in particular, neuroradiological purposes. It ends distally at the coupling element, which in turn receives the proximal ends of the connectors.
    [00026] The coupling element itself can be a simple solder point, in which the guide wire and the connectors are brought together. In addition, however, it can also be a usual coupling element, which allows the release of the cylindrical stent structure, which is necessary, in particular, so when a recovery is not indicated for medical reasons, for example, because it would take damage to the patient. In this case, the stent structure can remain in the body as a stent, and develop its effect, due to the fact that it forms a channel in the thrombus; the thrombus is compressed by the mesh structure on the vessel wall.
    [00027] For the latter case, the coupling element is, for example, a mechanical coupling element, which is suitable for releasing the connectors at the catheter outlet. Numerous systems of this type are described in the specialized literature. Likewise, hydraulic transfer systems are described. Particularly
    Petition 870190094844, of 9/23/2019, p. 13/25
    8/12 suitable are electrolytic separation systems, in which a part that can be corroded electrolytically is separated by means of the current effect, and the connection between the stent structure and the guide wire is broken. According to a first variant, the coupling element as such can be configured as a part that can be electrolytically separated, according to a second variant, the connectors are equipped with such a transfer point, or with a transfer element separate, which separates with current effect. Stainless steel elements, magnesium elements or cobalt and chromium alloys are suitable as transfer elements. Such systems are described in the literature.
    [00028] In the case of configuration of the proximal area of the cylindrical stent structure, a short execution of the connectors is preferred. The path between the proximal end of the mesh structure and the coupling element must be kept short. This shortens, on the one hand, the unused length of the device, and increases, on the other hand, the tension in the capture loop formed with the clamping arc at the proximal end of the structure.
    [00029] According to a special form of execution, the distal area of the cylindrical stent structure can be enlarged conically or in the form of a trumpet, in order to allow a good adaptation to the vessel lumen in this area. During the extraction of thrombi from a vessel, an active area is reached as possible, that is, the contact of the lining surface with the vessel wall. The greater the contact surface, the greater the chance of completely removing the thrombus.
    [00030] In the usual way, the guide wire and / or the stent structure can be equipped with markers, which are X-ray proof, for example, in the form of spirals or gloves.
    [00031] The invention will be clarified in more detail, by means of
    Petition 870190094844, of 9/23/2019, p. 14/25
    9/12 of the attached figures. They are shown:
    In Figure 1, in plan view, a first variant of the stent structure according to the invention;
    In Figure 2, a spatial representation of the stent structure of Figure 1;
    In Figure 3, a plan view of a second variant of a stent structure according to the invention;
    In Figure 4, a spatial representation of the stent structure of Figure 3, with a guide wire attached;
    In Figure 5, a perspective representation of a stent structure according to the invention with two connectors;
    In Figure 6, a representation of the core cross sections of the stent structure and
    In Figure 7, a schematic representation of the thrombectomy device according to the invention.
    [00032] Figures 1 to 3 show two variants of a cylindrical stent structure 1, with individual 3 and 4 meshes, and with connectors 5 and 5 '. Meshes 3 and 4 are of two different types, which have one (3) a wave shape, the other (4) a concave shape with two ends. When working together, these two forms give the total structure both stability and flexibility.
    [00033] In the flat representation of figures 1 to 3, a slit or channel 7 passes through the stent structure, which is covered at the proximal end of the structure by the clamping arch 9. Slit 7 is limited by the lateral surfaces 10 and 10 ' mesh structure. Slot 7 passes not parallel to the longitudinal axis of the structure, but inclined in relation to the longitudinal axis, which in the spatial representation is represented as a helical path along the covering surface (see figures 2/4).
    [00034] The representation in figures 1 and 3 is a representation
    Petition 870190094844, of 9/23/2019, p. 15/25
    10/12 plane of the cut-out stent 1 structure; the spatial representations are reproduced in figure 2 and figure 4. In the flat representation, meshes 3 are directly limited to meshes 3 ', in such a way that a tubular structure results in all with a groove or channel 7 surrounding approximately half in around the coating surface 8.
    [00035] The variants of figures 1 and 3 differ in the shape of connectors 5 and 5 ', which in the case of figure 3 are longer, and are joined in a coupling element 11 (see figure
    4). The coupling element 11 can be, for example, an electrolytically corrosive system, which allows to separate the stent structure 1 from the guide wire 12 (see figure 4). In the variant according to figure 2, two separation elements 6, 6 'may be provided for the electrolytic separation.
    [00036] It is common to both forms of execution that the gap 7 is covered by the arch 9. The arch 9 itself is seated on the edges 10, 10 'of the combs that are in the construction of meshes, and is facing with its arc to the distal side of the stent structure. This allows for the smooth introduction of the stent structure into a catheter. With the connectors 5 and 5 'adjacent, the clamping arc 9 forms a capture loop or opening of a capture basket that converges on the coupling element 11 (figure 4). For this, the distal end of the stent structure, likewise, can be closed with a mesh structure.
    [00037] In the representations of figures 2 and 4, which are the spatial reproduction of the stent structures of figures 1 and 3, the souls of the stent structure that are on the rear side are clearly represented. Slit 7 passing through the proximal end of the structure can be recognized under the clamping arch 9, which wraps in the direction of the right side around the covering surface 8 of the structure
    Petition 870190094844, of 9/23/2019, p. 16/25
    11/12 stent. Slit 7 ends distally on the underside of the stent structure 1 and thereby describes a rotation of approximately 180 °.
    [00038] Figure 5 shows the spatial representation of a stent structure according to the invention, and the connectors 5 and 5 'are equipped with hooks directed inwards, which engage in a corresponding reception of a coupling element 11 of a guide wire 12. While the coupling element 11 with the proximal end of the connectors 5 and 5 'is in a catheter, the stent structure 1 is coupled to the guide wire. When pushing out of the catheter, the connection between connectors 5 and 5 'and the coupling element 11 is canceled and the structure is released as a stent to remain in the vessel system. Decoupling, however, will only occur in special (emergency) cases, for example, when the device cannot be retracted without problems again in the catheter.
    [00039] The loop structure formed by arc 9 and connectors 5 and 5 'can be clearly recognized in figure 5, and the path of the souls 12 of the stent structure along the lining surface 8, which with its corners serves to have effect on the thrombus material to be removed, and to cut that material from the vessel wall.
    [00040] Figure 6 shows the two preferred forms of execution of the souls 12 with a rectangular and trapezoidal cross section, with the narrow side facing, respectively, the covering surface 8 of the stent structure 1 or the wall of the vessel 13. These execution variants guarantee the necessary stability of the mesh network, on the one hand, and a good shear and displacement effect on the thrombus, on the other hand.
    [00041] Figure 7 shows schematically the construction of a thrombectomy device according to the invention, with the
    Petition 870190094844, of 23/09/2019, p. 17/25
    12/12 guide 12, with the coupling element 11, the area of the proximal connection with the connectors 5 and 5 ', the active area with the covering surface 8 and the distal area 13 with a trumpet-shaped widening.
    [00042] In the illustrations the same reference numbers represent equal conditions.
    权利要求:
    Claims (13)
    [1]
    1. Thrombectomy device with an essentially cylindrical stent structure (1) that presents a plurality of meshes (3, 4), as well as two connectors (5, 5 '), which are arranged in different meshes (3) at the proximal end of the stent structure (1) and a guide wire (2), which has a coupling element (11), to which the connectors (5, 5 ') are attached, characterized by a slot (7), which extends helically through the covering surface (8) of the stent structure (1) and through a clamping arch (9) covering the slit (7) at the proximal end of the stent structure (1).
    [2]
    2. Device according to claim 1, characterized by the fact that it consists of a material with a memory shape, preferably of nitinol or of an alloy of nickel, titanium and chromium.
    [3]
    Device according to claim 1 or 2, characterized in that the clamping arch (9) with its arch faces the distal end of the stent structure (1).
    [4]
    Device according to claim 3, characterized in that the clamping arc (9) and the connectors (5, 5 ') form a loop, which converges on the coupling element (11).
    [5]
    5. Device according to any one of the preceding claims, characterized by the fact that it has one or more other arches (9), in the central and / or distal part of the stent structure (1).
    [6]
    6. Device according to any one of the preceding claims, characterized by the fact that the stent structure (1) is cut from a tube and has rectangular or trapezoidal web cross sections.
    Petition 870190094844, of 9/23/2019, p. 19/25
    2/2
    [7]
    Device according to claim 6, characterized in that the web cross sections, with their narrow side, form the lining surface (8) of the stent structure (1).
    [8]
    8. Device according to any one of the preceding claims, characterized by the fact that the stent structure (1) can be removed mechanically, hydraulically or electrochemically from the guide wire (2).
    [9]
    Device according to claim 8, characterized in that the coupling element (11) is made as a removable element.
    [10]
    Device according to claim 8, characterized by two removal points, preferably with electrochemical removal.
    [11]
    11. Device according to any one of the preceding claims, characterized in that the coupling element (11) is arranged peripherally.
    [12]
    Device according to any one of the preceding claims, characterized in that the distal end of the stent structure (1) is extended conically or in the form of a trumpet.
    [13]
    13. Device according to any one of the preceding claims, characterized by marker elements.
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    法律状态:
    2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-08-13| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-03-31| B09A| Decision: intention to grant|
    2020-05-26| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 18/11/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    DE102010051740A|DE102010051740A1|2010-11-19|2010-11-19|thrombectomy|
    DE102010051740.2|2010-11-19|
    PCT/EP2011/005817|WO2012065748A1|2010-11-19|2011-11-18|Thrombectomy device|
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