• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    Device for the treatment of aortic aneurysm. The invention describes a device (1) for the treatment of the aortic aneurysm, comprising: an external stent (2) made of a reticular mesh; an interior stent (3) comprising a central section (31) of a diameter less than a pair of end sections (32), where a central portion of the central section (31) comprises a mesh mesh, and where the walls of the ends of the central section (31) and of the end sections (32) of the inner stent (3) comprise a waterproof material; and an essentially cylindrical thrombogenic material dispenser (4) having a diameter similar to the diameter of the inner leg central section (31) and having a network of multi-perforated tubes (41) for injecting a thrombogenic material into a cavity present between the central section (31) of the inner stent (3) and the outer stent (2). (Machine-translation by Google Translate, not legally binding)
    公开号:ES2755223A2
    申请号:ES201830640
    申请日:2018-06-26
    公开日:2020-04-21
    发明作者:Garcia Jesús Alvarez
    申请人:Servicio Andaluz de Salud；
    IPC主号:
    专利说明:

    [0001]
    [0002] Device for treating aortic aneurysm
    [0003]
    [0004] OBJECT OF THE INVENTION
    [0005]
    [0006] The present invention belongs generally to the field of medicine, and more particularly to solutions for the aortic aneurysm.
    [0007]
    [0008] The object of the present invention is a new improved device designed for the treatment of aortic aneurysm.
    [0009]
    [0010] BACKGROUND OF THE INVENTION
    [0011]
    [0012] An aortic aneurysm is a localized dilation that causes weakness in the artery wall. In the absence of treatment, the aneurysm tends to grow progressively, increasing the risk of rupture and massive internal bleeding. Fig. 1 generally shows the position of the aortic artery (A) in a person's body. There are different types of aneurysms depending on the portion of the aorta where dilation occurs. The infrarenal aortic aneurysm is the most frequent and corresponds to a widening of the aorta (A) in an area located approximately between the iliac arteries (I) and the renal arteries (R), as shown in Fig. 2. However, visceral or thoracoabdominal aortic aneurysms are generally those in which the outflows of the visceral arteries (renal, mesenteric, and celiac trunk) are involved, requiring different treatments than those known for the infrarenal aorta.
    [0013]
    [0014] Currently, a possible treatment for the infrarenal aortic aneurysm is the introduction of a stent that channels blood flow to decrease the internal pressure to which the walls of the aneurysm are subjected. Fig. 3 schematically shows an inverted Y-shaped stent that channels blood flow from the main body of the aorta to the iliac arteries. To further minimize pressure on the walls of the aneurysm cavity, some devices are known which further include injecting a thrombogenic material into the cavity between the aneurysm walls and the outer surface of the stent. This material thrombogenic can include polyurethane foam, polymeric foam, or others. By way of example of this type of systems, reference can be made to document WO 2014/004160, the system of which is shown schematically in Fig. 4.
    [0015]
    [0016] However, these types of systems are not useful in visceral aortic aneurysms, since they do not preserve the light to the visceral arteries (renal, mesenteric, and celiac trunk), and therefore require different techniques. They can be treated with custom-made stents with the drawback that each device is unique to a patient and requires a very long production time. There are also some flow modulating stents (stents that theoretically have multiple overlapping layers of uncoated stents that produce enough turbulence for the sac to thrombose, while the visceral branches remain permeable), although so far they have not produced the desired results . There are also recourse techniques such as the chimney technique (placement of one or more stents that revascularize visceral arteries placed parallel to the stent) or hybrid surgery with extra-anatomic bypass (performing a bypass that revascularizes the visceral arteries, occluded in its origin from an aortic endoprosthesis that covers the visceral aorta). Neither of these solutions has satisfactorily resolved the problem.
    [0017]
    [0018] DESCRIPTION OF THE INVENTION
    [0019]
    [0020] The present invention solves the above drawbacks thanks to a new device consisting essentially of two stents that are installed one inside the other inside the aneurysm and a dispenser that allows the injection of a thrombogenic substance in the intermediate space between both stents. The irrigation of the organs through the visceral arteries (renal, mesenteric and celiac trunk) is carried out by means of coated stents placed perpendicular to the stents of the invention. This configuration is advantageous because it could be used in all anatomies, it has a lower learning curve, it does not require the manufacture of a custom stent for each patient, and therefore it reduces the waiting time for surgery, and Furthermore, the implantation procedure could be performed under local anesthesia and by arterial puncture.
    [0021]
    [0022] The present invention is directed to a device for the treatment of the aortic aneurysm, which basically comprises three elements: an outer stent, an inner stent, and a dispenser of thrombogenic material to fill a space between the inner stent and the outer stent. Each of these elements is described below with more detail.
    [0023]
    [0024] a) Exterior stent
    [0025]
    [0026] It is an essentially cylindrical stent configured for insertion into an aneurysm cavity. In this context, this means that the dimensions of the stent, mainly length and diameter, are suitable for accommodating it inside the aortic aneurysm in a similar way to currently known stents. As an example, the diameter of the outer stent can range from 28mm to 36mm, and its length can be from 70mm to 120mm.
    [0027]
    [0028] The walls of the outer stent of the invention are formed by a mesh mesh made of any suitable biocompatible material, preferably self-expanding nitinol. The lumen of the mesh is sufficient to allow the passage of lateral branches emanating from the aorta in the area of the aneurysm through the holes in the mesh, such as the renal, mesenteric and celiac trunk vessels. For example, the mesh size of the outer stent mesh can be essentially 0.5 cm.
    [0029]
    [0030] b) Interior shelf
    [0031]
    [0032] The inner stent comprises an essentially cylindrical central section having a first diameter and a pair of essentially cylindrical end sections having a second diameter greater than the first diameter. That is to say, the inner stent is essentially cylindrical dumbbell shaped with a thin central span and thicker end spans.
    [0033]
    [0034] In principle, the transition surface between the central section and the end sections can be designed in any way as long as it allows the passage of the blood stream without seriously affecting the main flow direction, for example due to the presence of obstacles such as cavities or very sharp edges. For example, the transition surface between the central section and the end sections of the inner stent may be essentially conical in shape. In addition, the edges can be rounded to avoid the detachment of the boundary layer of the blood flow.
    [0035]
    [0036] The walls of the central portion of the central section of the inner stent are formed by a lattice mesh, for example a lattice mesh similar to that which forms the outer stent. It is, therefore, a mesh made of any suitable biocompatible material, preferably self-expanding nitinol, with a mesh span of approximately 0.5 cm. For its part, the walls of the ends of the central section and of the end sections comprise a waterproof material. Therefore, unlike the outer stent, the inner stent only allows the passage of fluids through its central portion, being impervious to fluids at the ends of the central section and in the end sections.
    [0037]
    [0038] In principle, the walls of the ends of the central section and of the end sections of the inner stent can be configured in any way and using any material as long as they are waterproof, although in a particularly preferred embodiment of the invention they comprise a mesh mesh covered by a waterproof membrane. Therefore, in this preferred embodiment, the entire interior stent is made of a mesh mesh with the ends of the central section and the end sections covered by a waterproof membrane.
    [0039]
    [0040] Furthermore, the inner stent is configured to be housed within the outer stent so that the second diameter of the end spans essentially matches the diameter of the outer stent. That is, the length of the inner stent is similar to the length of the outer stent, so that the inner stent is housed within the outer stent spanning its entire length from end to end. Furthermore, the second diameter of the end sections is equal to, or in any case very slightly greater than, the diameter of the outer stent, such that said end sections are anchored internally to the ends of the outer stent. By way of example, suitable diameters for the inner leg of the inner stent are between 15mm and 25mm, and suitable diameters for the inner leg of the inner stent are between 28mm and 36mm. Moreover, the length of the inner stent can be between 70mm and 120mm
    [0041]
    [0042] c) Thrombogenic material dispenser
    [0043]
    [0044] It is an essentially cylindrical dispenser that has approximately the first diameter, so that it fits snugly within the central portion of the central section. The outer surface of the dispenser comprises a network of multi-perforated tubes for the injection of a thrombogenic material into a cavity between the central section of the inner stent and the outer stent. The thrombogenic material can comprise, for example, polyurethane, which can be stored in a tank that is in communication with the tube network or can be introduced through a conduit intended for this purpose.
    [0045]
    [0046] In a preferred embodiment of the invention, the thrombogenic material dispenser is an inflatable balloon. In this way, the inflation of the balloon causes it to be adjusted to the shape and dimensions of the central portion of the inner stent for the subsequent expulsion of the thrombogenic material through the holes in the tube network.
    [0047]
    [0048] In another preferred embodiment of the invention, the dispenser further comprises radiopaque markings to identify the position of the exit perforations of the thrombogenic material. This allows thrombogenic material to be injected into the lumen of lateral vessels emanating from the aneurysm, as will be seen in greater detail later in this document.
    [0049]
    [0050] Thanks to this configuration, the device of the invention is used as follows. First, the outer stent is inserted endoluminally into the aneurysm cavity. The inner stent is then also inserted endoluminally into the outer stent. Since both are of similar lengths and the diameter of the end spans of the inner stent is approximately the same as the diameter of the outer stent, the inner stent fits within the outer stent parallel to it. Conventional coated stents are then placed connecting the central portion of the inner stent to the lateral branches emanating from the aorta in the area of the aneurysm. These lateral stents are passed through the holes in the mesh of the outer stent and anchored to the mesh of the central portion of the inner stent. Two conventional stents arranged inside the iliac arteries are also connected to the lower end of the inner stent, leaving an inverted Y configuration. Next, the thrombogenic material dispenser is inserted endoluminally until it is housed inside the central portion of the central section of the inner stent and it is manipulated until ensuring, with the aid of radiopaque markings, that none of the material exit holes Thrombogenic is aligned with a lateral vessel of the aneurysm. When the dispenser takes the form of an inflatable balloon, the balloon is then inflated. Finally, the thrombogenic material is introduced through the channels of the balloon for its emission through the respective holes. Thrombogenic material passes through the mesh of the central portion of the central section of the inner stent and fills the space between said central section of the inner stent and the outer stent. The outer stent serves as a barrier for most of the material, which is thus mainly confined in the space between the inner and outer stent, waterproofing the central portion of the inner stent so that there are leaks in the blood flow that passes through it. .
    [0051]
    [0052] BRIEF DESCRIPTION OF THE FIGURES
    [0053]
    [0054] Fig. 1 shows a view of the position of the aortic artery in a person.
    [0055]
    [0056] Fig. 2 shows an example of a visceral aortic aneurysm.
    [0057]
    [0058] Fig. 3 shows a first example of a device for treating the infrarenal aorta aneurysm.
    [0059]
    [0060] Fig. 4 shows a second example of a device for treating the infrarenal aorta aneurysm.
    [0061]
    [0062] Fig. 5 shows a schematic view of the outer stent of the device of the invention.
    [0063]
    [0064] Fig. 6 shows a schematic view of the interior stent of the device of the invention.
    [0065]
    [0066] Fig. 7 shows a schematic view of a thrombogenic material dispensing balloon of the device of the invention.
    [0067]
    [0068] Fig. 8 shows a schematic view of the inner stent housed inside the outer stent.
    [0069]
    [0070] Figs. 9a-9f show various steps in an installation operation of the device of the invention.
    [0071]
    [0072] PREFERRED EMBODIMENT OF THE INVENTION
    [0073]
    [0074] An example of the present invention is described below with reference to the attached figures.
    [0075] Fig. 5 shows an outer stent (2) according to the invention having a cylindrical shape with a diameter of about 30 mm. This outer stent (2) is made of a self-expanding nitinol mesh screen with a mesh size of 0.5 cm. The length of the outer stent (2) is 120 cm.
    [0076]
    [0077] Fig. 6 shows an interior stent (3) according to the invention that has a central section (31) and end sections (32). All of them have an essentially cylindrical shape, although the central section (31) has a diameter of 20 mm and the end sections (32) have a diameter of approximately 32 mm. The transition surface between the central section (31) and the end sections (32) is conical. In a generic way, the angle that forms the longitudinal direction of the inner stent (3) and the conical transition surface will be 45 ° or less, thus avoiding the appearance of a zone of turbulence that affects the blood flow.
    [0078]
    [0079] The inner stent (3) is entirely made of a self-expanding nitinol reticular mesh with a 0.5 mm mesh span, although the ends of the central section (31) and the end sections (32) are covered with a waterproof membrane that prevents the passage of fluids. Therefore, only the central portion of the central section (31) of this inner stent (3) has the uncoated mesh grid and, therefore, allows the passage of fluids. The total length of the inner stent (3) is 120 mm, the central section (31) being 80 mm long and the end sections (32) 20 mm long. The central reticular mesh portion seen has a length of about 70 mm.
    [0080]
    [0081] Fig. 7 shows a schematic view of a balloon-dispenser (4) of thrombogenic material according to the present invention. The balloon-dispenser (4) comprises a conduit in communication with a network of tubes (41) arranged on the outer surface of the balloon-dispenser (4) and provided with a plurality of perforations through which the thrombogenic material exits when introduced from the outside through said conduit. (4).
    [0082]
    [0083] The balloon-dispenser (4) has a cylindrical shape whose diameter is about 20 mm, essentially the same as the diameter of the central section (31) of the inner stent (3). The length of the balloon-dispenser (4) is approximately the same as the length of the central portion of the inner stent (3), that is, 80 mm. Thus, when the thrombogenic material balloon-dispenser (4) is housed inside the inner stent (3), it covers just the length of the central portion of the central section (31) to allow the injected thrombogenic material to pass through. through the holes in the mesh.
    [0084] Fig. 8 schematically shows the inner stent (3) housed within the outer stent (2). As can be seen, the lateral stents (L) that connect with the lateral vessels of the aorta, such as the renal, mesenteric and celiac trunk vessels, pass through the mesh of the external stent (2) and are fixed to the mesh of the central portion of the inner stent (3). In this figure, the space between the inner stent (3) and the inner stent (2) has been filled by means of the balloon-dispenser (4) with a thrombogenic material (10). In this situation, blood flow passes through the interior of the interior stent (3), and the "walls" of thrombogenic material separate it from the aneurysm cavity.
    [0085]
    [0086] The procedure for installing device (1) according to the invention is described below with reference to Figs. 9a-9b. Fig. 9a shows the aortic aneurysm to be treated. First, as shown in Fig. 9b, the outer stent (2) is inserted into the aneurysm cavity, controlling its position radiologically at all times. Next, Fig. 9c shows the insertion of the inner stent (3) also controlling its position until it fits inside the outer stent (2). Once this is done, Fig. 9d shows the catheterization of the lateral branches and placement of conventional coated stents, which pass through the mesh of the outer stent (2) and are fixed to the mesh of the central portion of the inner stent ( 3). Next, insertion of the balloon-dispenser (4) of thrombogenic material into the central section (31) of the interior stent (3). The radiopaque markings of the balloon-dispenser (4) are used to position it so that when the thrombogenic material exit holes are inflated, they are not oriented towards the lumen of the lateral branches. Next, the balloon-dispenser (4) is inflated and the thrombogenic material, in this case polyurethane, is introduced through the multi-perforated ducts into the space between the inner stent (3) and the outer stent (2). Fig. 9e shows the beginning of the insertion of the thrombogenic material, which begins to fill the space between the inner stent (3) and the outer stent (2). Fig. 9f shows the final state of the process in which the thrombogenic material has completely filled this space and its expansion has stopped near the surface of the outer stent (2). The blood flow can now pass through the inner stent (3) in a watertight manner.
    权利要求:
    Claims (8)
    [1]
    1. Device (1) for the treatment of aortic aneurysm, characterized in that it comprises:
    an essentially cylindrical outer stent (2) configured for insertion into an aneurysm cavity, the walls of the outer stent (2) being formed by a lattice mesh;
    an inner stent (3) comprising an essentially cylindrical central section (31) having a first diameter and a pair of essentially cylindrical end sections (32) having a second diameter greater than the first diameter, the walls of one central portion of the central section (31) of the inner stent (3) by a mesh mesh, and the end walls of the central section (31) and of the end sections (32) of the inner stent (3) comprising a waterproof material , where the inner stent (3) is configured to be housed within the outer stent (2) such that the second diameter of the end sections (32) essentially coincides with the diameter of the outer stent (2); and
    a dispenser (4) of essentially cylindrical thrombogenic material having approximately the first diameter so as to fit snugly within the central portion of the central section (31) of the inner stent (3), comprising the surface of the dispenser (4) a network of multi-perforated tubes (41) for the injection of a thrombogenic material in a cavity between the central section (31) of the inner stent (3) and the outer stent (2).
    [2]
    2. Device (1) according to claim 1, wherein a transition surface between the central section (31) and the end sections (32) of the inner stent (3) is essentially conical in shape.
    [3]
    Device (1) according to any of the preceding claims, where the end walls of the central section (31) and of the end sections (32) of the inner stent (3) comprise a mesh mesh covered by a membrane waterproof.
    [4]
    4. Device (1) according to any of the preceding claims, wherein the thrombogenic material dispenser (4) is an inflatable balloon.
    [5]
    5. Device (1) according to any of the preceding claims, wherein the thrombogenic material dispenser (4) comprises radiopaque markings to identify the position of the exit perforations of the thrombogenic material.
    [6]
    6. Device (1) according to any of the preceding claims, wherein the mesh of the outer (2) and inner (3) stents is made of self-expanding nitinol.
    [7]
    7. Device (1) according to any of the preceding claims, wherein the mesh of the outer (2) and inner (3) stents has a mesh span of essentially 0.5 cm.
    [8]
    8. Device (1) according to any of the preceding claims, wherein the thrombogenic material comprises polyurethane.
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    同族专利:
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    ES2755223R2|2020-06-17|
    WO2020002734A1|2020-01-02|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US5282823A|1992-03-19|1994-02-01|Medtronic, Inc.|Intravascular radially expandable stent|
    US7267685B2|2000-11-16|2007-09-11|Cordis Corporation|Bilateral extension prosthesis and method of delivery|
    AU2008201081B8|1999-12-31|2011-03-10|Abps Venture One, Ltd|Valvular prostheses having metal or pseudometallic construction and methods of manufacture|
    ES2347770T3|2001-10-04|2010-11-04|Neovasc Medical Ltd.|IMPLANT FLOW REDUCER.|
    KR101231197B1|2012-09-20|2013-02-07|썬텍 주식회사|Polymeric stent|
    法律状态:
    2020-04-21| BA2A| Patent application published|Ref document number: 2755223 Country of ref document: ES Kind code of ref document: A2 Effective date: 20200421 |
    2020-06-17| EC2A| Search report published|Ref document number: 2755223 Country of ref document: ES Kind code of ref document: R2 Effective date: 20200610 |
    2020-10-08| FA2A| Application withdrawn|Effective date: 20201002 |
    优先权:
    申请号 | 申请日 | 专利标题
    ES201830640A|ES2755223R2|2018-06-26|2018-06-26|Device for the treatment of aortic aneurysm|ES201830640A| ES2755223R2|2018-06-26|2018-06-26|Device for the treatment of aortic aneurysm|
    PCT/ES2019/070442| WO2020002734A1|2018-06-26|2019-06-25|Device for treating aortic aneurysm|
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