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    • 专利摘要:
    The invention relates to a stent (1), in particular a vascular or cardiac stent (1), which has a body (2) and also one or more thrombogenic elements (3) which are fixed to the endoprosthesis (1) and which are capable of extending a distance away from the body away from the latter. The endoprosthesis comprises means (33) to selectively retain thrombogenic elements close to the body (2). The release of one or more thrombogenic elements, after the stent graft has been snapped into place by a conventional method through a sheath, promotes thrombosis.
    公开号:BR112014030199B1
    申请号:R112014030199-9
    申请日:2013-06-05
    公开日:2021-07-06
    发明作者:Claude Angel；Dominique Fabre
    申请人:Kardiozis；
    IPC主号:
    专利说明:

    FIELD OF TECHNIQUE
    [001] The present invention relates to the field of endoprostheses such as stents and, more particularly, endoprostheses combined with thrombogenic elements. TECHNICAL BACKGROUND
    [002] Stent grafts composed of a sheath armed with one or more stent-like elements are commonly used for the treatment of arterial aneurysms to reestablish the artery geometry.
    [003] In a well-known procedure, an endoprosthesis is positioned in such a way that it isolates the aneurysm from the blood flow to prevent aneurysm growth.
    [004] However, in several considerable cases, it has been observed that the aneurysm continues to grow due to the fact that it is irrigated by blood vessels in addition to the artery in question. The risk of rupture, therefore, remains.
    [005] In an attempt to solve this problem, solutions have been proposed that involve the introduction of thrombogenic materials into the aneurysm after the stent is snapped into place or even at the same time as the stent graft is snapped into place to promote thrombosis of the aneurysm and thus avoid any risk of rupture.
    [006] However, the introduction of such thrombogenic materials is an inadequate procedure and greatly complicates interventions, specifically due to the fact that it is necessary to ensure that such thrombogenic materials do not obstruct the stent graft fit and that they remain exclusively on the outside of the endoprosthesis and do not run the risk of penetrating its inner conduit. DESCRIPTION OF THE INVENTION
    [007] The objective of the present invention is, therefore, to overcome the advantages of the prior art and, in particular, to provide an endoprosthesis, an application device and an application method that allow to prevent a continuous growth of aneurysms and that allow, in particular , use thrombogenic materials easily and without risk to the patient.
    [008] The invention thus refers to a stent, in particular, a vascular or cardiac stent that has at least one body and, in addition, one or more thrombogenic elements that are fixed to the stent and that can extend over a distance away from the body. The stent graft can be formed integrally as one body part or, preferably, it can be formed from more than one body part that are attachable to each other. According to a first aspect of the invention, at least an area of the outer surface of the at least one body part of the stent, preferably the entire outer surface of the at least one body part of the stent, is provided with thrombogenic elements which are substantially , evenly distributed over at least one area of the outer surface, preferably over the entire outer surface. In relation to the present application, it is understood that a substantially uniform distribution over the surface refers to a coverage of at least 50% of the surface by thrombogenic elements. By supplying thrombogenic elements substantially uniformly over the surface of the body, it is possible to ensure that the thrombogenic elements will be disposed in the area where the aneurysm is located. Due to the fact that thrombogenic elements are directly supplied in the stent graft body, there is no risk of elements migrating into the blood stream.
    [009] In some modalities, thrombogenic elements may only be arranged in an area of the outer surface. For example, in cardiac stents, thrombogenic elements are only disposed on the outer surface of an area upstream of the endoprosthesis. In an aortic valve, thrombogenic elements are therefore only disposed on the ventricle side of the stent. The thrombotic effect of the thrombogenic elements will allow a reduction in paravalvular leakage. Due to the fact that the aortic side is free of thrombogenic elements, there is no increased risk of thrombus migration with the bloodstream. In a mitral valve, the thrombogenic elements will therefore be arranged in the atrium area and not in the ventricle area of the external surface.
    [0010] An additional aspect relates to a stent, in particular, a vascular or cardiac stent that has a body and, in addition, one or more thrombogenic elements that are fixed to the stent so that the elements can extend over a distance away from the body.
    [0011] According to such aspect of the invention, the endoprosthesis comprises means to selectively retain thrombogenic elements close to the body.
    [0012] Preferably, the thrombogenic elements are formed by fibers.
    [0013] Fibers are highly thrombogenic. They automatically expand in the presence of blood. The flexibility of fibers also allows for an arrangement in any desired way, for example in certain directions along the stent graft.
    [0014] Thrombogenic elements can be elongated and can each be connected to the body through an anchorage point. They can be delivered from such an anchorage point. By fixing each thrombogenic element to an anchorage point, the position of the thrombogenic elements can be chosen easily and independently. Furthermore, a complete separation of thrombogenic elements from the body is avoided.
    [0015] According to another aspect of the invention, an endoprosthesis is provided which has thrombogenic elements. Thrombogenic elements are arranged at least partially on the external surface of the prosthesis. The stent is additionally provided with at least one selectively deactivatable retention element. The retaining element is used to retain thrombogenic elements close to the surface of the body part. Retaining the elements close to the surface of the body part is understood to keep the elements closer to the surface when the retaining means are not yet deactivated and to allow the thrombogenic elements to move away from the surface for a greater distance upon deactivation. With such selectively deactivatable retaining elements, obstructions during stent placement can be avoided.
    [0016] If the thrombogenic elements are connected to the body through an anchorage point, the thrombogenic elements can easily be delivered radially or axially in the opposite direction to the anchorage point.
    [0017] Thrombogenic elements can be formed as loops at least locally. In such a case, the retaining elements may comprise at least one elongated retaining element which passes through such loops and which can be removed from the loops. By removing the elongated retention element, for example by pulling it in one direction, the thrombogenic elements can be released and delivered. Preferably, such loops are located in the area of the free ends of the thrombogenic elements. This makes fabrication particularly easy.
    [0018] It is also possible to form loops along substantially the entire length of the thrombogenic elements with the use of filament-like thrombogenic elements fixed at both their free ends. A loop is automatically formed substantially along the entire length of such a filament. In such a case, an elongated retaining element preferably passes through a zone in which at least two loops of two separate thrombogenic elements cover each other, i.e. partially overlap. The retaining elements can preferably be of a length chosen so that it is possible to pull the retaining element through a sheath of an delivery device that is used for insertion of the stent, for example, which can be pulled through a catheter.
    [0019] If a retention means retains at least two or preferably all thrombogenic elements in position, more than one and preferably all thrombogenic elements can be delivered through the actuation of a retention means.
    [0020] Preferably, the retaining means can be deactivated by being torn towards a proximal end of a delivery system. The proximal end of the delivery system is the end that is directed towards the operator.
    [0021] According to an alternative embodiment, the selectively deactivatable retention means is formed from a resorbable material. Upon contact with bodily fluids after delivery, the retaining means are gradually resorbed and thus deactivated. Once the retention media are resorbed, the thrombogenic elements are released. Consequently, in accordance with the present application, selective activation or deactivation refers not only to elements that require actuation by the operator, but also includes elements that are automatically deactivated under certain conditions, for example, upon contact with certain materials or by changing the temperature.
    [0022] Still, according to alternative modality, the selectively deactivatable elements may comprise a tearable envelope. The elements can be deactivated by tearing such an envelope or pulling it in the opposite direction, for example in an axial direction, preferably proximally, but also distally.
    [0023] It is possible to provide the thrombogenic elements with at least one medical substance and design the elements so that they release the substance once the stent has been implanted.
    [0024] The body of the stent graft may be formed tubular and the thrombogenic elements may extend circumferentially around the body. It is also, alternatively, possible to use thrombogenic elements that extend axially throughout the body. Furthermore, combinations of such modalities are possible, i.e. the thrombogenic elements may be arranged helically or some of the elements may be arranged axially and others circumferentially.
    [0025] According to a preferred embodiment of the invention, the outer surface of the at least one body may have at least one edge area that is free of thrombogenic elements. If the edge areas are not provided with the thrombogenic elements, the fixation of the other structural elements in the edge area can be facilitated. Furthermore, the extension of thrombogenic elements over the edge area can be avoided.
    [0026] Areas without thrombogenic elements in the distal ends additionally prevent distal thrombosis.
    [0027] It is advantageous to fix the thrombogenic elements on the surface in one location and choose the size of the thrombogenic elements so that they do not extend over an axial edge of the body part. The extension of thrombogenic elements into the blood flow once the stent is implanted can thus be prevented.
    [0028] It is possible to design the stent graft as a bifurcated stent that comprises two body parts. In particular, such a bifurcated prosthesis comprises a main part and a leg which is fixed or attachable to the main part. It is also possible to design the stent graft with a trifurcated stent graft comprising three parts, such as a main part and two legs fixed or attachable to the main part. Such bifurcated and trifurcated stent grafts are known for the versed elements. For fixing the legs to the main part, the main part and legs can be provided with one or more fixing portion(s). Such an attachment portion can preferably be truncated. Preferably, the fixation portion of the leg and/or the main body has an edge area that is free from thrombogenic elements. Furthermore, the complete fixation portion can preferably be free of thrombogenic elements.
    [0029] When fixed to each other, an internal fixation portion is radially covered, on its external surface, by the other fixation portion. In particular, the internal fixation portion is free from thrombogenic elements. The absence of thrombogenic elements in such areas facilitates the fixation of the legs in the main part. Due to the fact that the fixation portion in the main body will be covered by the legs (or vice versa, the secondary portion will be covered by the legs), thrombogenic elements arranged in such area have no effect whatsoever.
    [0030] According to an additional preferred modality, the thrombogenic elements can be supplied in the main part and the legs, preferably, can be free of the thrombogenic elements.
    [0031] Although a preferred indication of the stent graft as disclosed above is the treatment of aneurysms, it will be evident to the person skilled in the art that the use of such a prosthesis as stent valves may also be advantageous. In particular, the stent graft can be placed in the area of a pre-existing heart valve and can allow restoration of valve function. Thrombosis generated by thrombogenic elements may allow a reduction in paravalvular leaks.
    [0032] According to a further aspect of the invention, there is provided a delivery device comprising an endoprosthesis as disclosed above. The delivery device preferably has at least one sheath configured to keep the stent compressed during delivery. The stent is arranged so that it is released through relative movement between the sheath or sheaths and the stent.
    [0033] In a preferred one, the device can additionally be provided with an activation mechanism to deactivate a retention element that retains the thrombogenic elements close to the stent. However, it is also possible to use retaining elements that are automatically deactivated upon implant.
    [0034] Yet another aspect of the invention relates to a method for implanting an endoprosthesis as described above. The stent is particularly implanted in a vascular site that has aneurysms or close to a native heart valve. In a first step, the endoprosthesis is positioned in such a way as to isolate the aneurysms from the blood flow or in the site neighboring the native valve.
    [0035] In a next step, the thrombogenic elements of the stent are released in such a way that they extend for a distance in the opposite direction to the stent and into the aneurysms or towards the wall neighboring a native valve.
    [0036] Thrombogenic elements can be formed as filaments fixed to the surface of the body, for example, filaments produced from natural materials such as cotton, silk or synthetic materials such as Dacron, polyesters or polyamides. Typically, individual filaments can be used. It is also possible to use bamboos from a plurality of filaments, for example 5:100 filaments. BRIEF DESCRIPTION OF THE FIGURES
    [0037] The other features, objectives and advantages of the invention will become clear from the following description, which is purely illustrative and not limiting and should be read with reference to the attached drawings, in which:
    [0038] Figure 1 is a side view of a first modality of a vascular endoprosthesis according to the invention,
    [0039] Figure 2 is a cross-sectional view of the endoprosthesis of Figure 1;
    [0040] Figure 3 illustrates a detail of Figure 2 in an enlarged view;
    [0041] Figure 4 illustrates the placement of such a stent;
    [0042] Figure 5 illustrates another example of an endoprosthesis according to the invention;
    [0043] Figure 6 shows yet another example of an endoprosthesis according to the invention;
    [0044] Figure 7 is a perspective and diagrammatic view illustrating the stent graft of Figures 1 to 4 in an insertion sheath;
    [0045] Figure 8 shows a cross-section of the stent graft of Figures 1 to 4 in an insertion sheath;
    [0046] Figures 9 to 12 illustrate an endoprosthesis according to an embodiment of the invention, and
    [0047] Figure 13 is a perspective and diagrammatic view of a stent graft according to another embodiment of the invention.
    [0048] Figure 14 is a schematic side view of a preferred embodiment of a vascular prosthesis according to the invention and
    [0049] Figure 15 is a side view of a leg attachable to a main body of a bifurcated or trifurcated stent graft,
    [0050] Figure 16 is an enlarged view of the proximal end of the modality shown in Figure 14.
    [0051] Figure 17 is a schematic side view of a slightly different prosthesis, which is similar to Figure 14.
    [0052] Figure 18 is a schematic top view of a prosthesis according to the invention.
    [0053] Figure 19 is a partial side view of a bifurcated or trifurcated prosthesis according to the invention.
    [0054] In all Figures, like elements are designated by common reference numbers. DETAILED DESCRIPTION
    [0055] Figure 1 shows an example of a vascular endoprosthesis 1 which is of the composite type, for example by a stent in one or more parts sutured to a tubular sheath, typically produced from polyester and which is typically used to treat an aneurysm in a blood vessel or an artery. It can also be a heart valve type stent, for example, and more generally any stent in which it is desirable to obtain a thrombotic effect on the outside of the stent after it has been snapped into place.
    [0056] Figure 2 shows the cross-sectional view of vascular endoprosthesis 1.
    [0057] The stent 1, as shown, is comprised of a tubular body 2 which extends between a proximal end 21 and a distal end 22 and which is formed from the combination of the stent and its sheath.
    [0058] The ends 21 and 22 of the stent 1 are typically provided with anchoring means 23 such as burrs or anchor hooks which are formed on the stent portion and which are designed to hook into tissues of the blood vessel walls at issue, thus ensuring that stent 1 is held in position in such a vessel.
    [0059] The endoprosthesis 1 is provided with thrombogenic elements 3, in this document, the filaments, which are fixed to the outside of it and extend close to the outer surface of the tubular body 2.
    [0060] In the embodiment shown, the thrombogenic filaments 3 are arranged such that they form rings around the body 2 of the stent 1 and are typically evenly distributed along its length. The filaments 3 can be arranged in such a way that they surround the body 2 one or more times.
    [0061] The thrombogenic filaments 3 are each connected to the body 2 of the stent graft through an anchorage point 31 (preferably on the stent part) of the body, with the filament between such anchorage point 31 and its free end 32 can be delivered at a distance away from body 2 of stent 1 starting from such an anchorage point 31. Alternatively, the same filament can be anchored in an intermediate region of its length, the filament then it forms two wires that can be positioned between the common anchor point 31 and their respective free ends.
    [0062] Advantageously, the thrombogenic filaments 3 are kept in contact with the body 2 through the temporary retention means 33.
    [0063] Such temporary retention means 33 are designed to selectively release said thrombogenic filaments 3 such that they are delivered around the body 2 of the stent 1, while at the same time ensuring that they are held against the body 2 of stent 1 prior to, and in particular during, placement of the stent.
    [0064] In the embodiment shown, the temporary retaining means comprise a cord 33 in engagement with the free ends 32 of the thrombogenic filaments 3, such free ends 32 in such a case having, for example, loops or loops 34 through the which cord 33 is passed.
    [0065] It will be understood that by pulling the cord 33 in the longitudinal direction of the stent 1, so that it detaches from the loops 34, the thrombogenic filaments 3 then become free to be delivered at a distance in the opposite direction from the body 2 of endoprosthesis 1, while, at the same time, they remain connected to it through their respective anchorage point 31.
    [0066] Figure 3 shows a detailed view of the free ends 32 of the thrombogenic filaments 3 comprising the loops 34 through which a strand 33 passes. Loops can be produced from the filament itself, with a knot or a solder point, or they can be formed by a fixed element such as a small ring.
    [0067] Figure 4 illustrates such a stent 1 in place, in a vessel such as an artery.
    [0068] In such Figure, vessel 4, eg an artery, is shown with an aneurysm 43 located between a proximal portion 41 and a distal portion 42 of the vessel.
    [0069] The endoprosthesis 1 is positioned in vessel 4 in such a way as to isolate the aneurysm 43 from the blood flow, that is, to connect the proximal portion 41 directly to the distal portion 42.
    The proximal end 21 and the distal end 22 of the stent 1 are connected, respectively, to the proximal portion 41 and the distal portion 42 of the vessel 4 through their anchoring arrangements 23.
    [0071] Blood in vessel 4 thus flows through stent 1 without passing through aneurysm 43.
    [0072] The implantation of endoprosthesis 1 into vessel 4 can be performed using any suitable set of procedures. It is evident to a person skilled in the art in particular of the set of implant procedures performed with the aid of an insertion sheath or through the means of a balloon, which are sets of commonly used procedures.
    [0073] Now, referring to Figure 7, in the case where the stent graft is introduced with the aid of an insertion sheath 5 which keeps the stent 1 compressed during the insertion phase, the cord 33 extends along the sheath 5 up to a handle 51 and through a passage 52 from which the cord emerges to the outside.
    [0074] Figure 8 illustrates an endoprosthesis 1 provided with filaments 3 and composed inside the sheath 5, into which the cord 33 also extends.
    [0075] Once the stent 1 has been positioned in vessel 4, the clinician applies traction to the cord 33 that projects from the opening 52 such that the loops 32 detach from the thrombogenic filaments 3, thus releasing them and these can then be delivered at a distance in the opposite direction to stent 1, specifically, within the volume of aneurysm 43.
    [0076] Such delivery of thrombogenic filaments 3 into aneurysm 43 will generate thrombosis within the volume of aneurysm 43 and thus prevent its continued development.
    [0077] The stent 1, as shown, thus allows the simple development of thrombogenic elements in the aneurysm after the stent has been positioned in the vessel, and does so without the filaments interfering with the positioning through the sheath 5 or without the filaments penetrating in the inner conduit of the stent 1.
    [0078] Figure 5 shows another embodiment of an endoprosthesis 1 according to the invention.
    [0079] In such a modality, the endoprosthesis is a bifurcated endoprosthesis with a body 2 composed of two parts, namely, a main part and a leg fixed, in a known way, to itself.
    [0080] The main part 24 has several portions of defined dimensions, namely, a common tubular portion 26 which then divides into secondary tubular portions 27 and 28 of smaller dimensions, one of such secondary portions 28 being truncated and projected to join the fixed leg 25 to form the bifurcated structure of the stent graft.
    [0081] As in the modality shown in the previous Figures, the body 2 of the stent 1 is provided with thrombogenic filaments 3 arranged in rings around different portions of the main part 24 and the fixed part 25. Such thrombogenic filaments 3 are connected to the body 2 at respective anchorage points 31 and thus form wires which have a free end 32 and which can be delivered at a distance in the opposite direction to the body 2 of the stent 1, starting from its respective anchorage point 31. free ends 32 in the form of a loop or eye are held in position by temporary retaining means 33, for example, in such a case, again by a cord 33 which can be pulled to release the free ends 32 of the filaments 3, as was described above.
    [0082] It will be observed, considering the specific structure of the stent 1 which, in this document, comprises a body 2 in two parts, that several temporary retention arrangements 33 are necessary, in this case, a retention arrangement 33 for the main part 24 and a retaining arrangement 33 for the fixed portion 25.
    [0083] Alternatively and depending on the area where the aneurysms are located, it is also possible to provide the thrombogenic filaments only in the main part 24 or only in the leg 25.
    [0084] Furthermore, it is possible to provide an area in the secondary tubular portion 28 without any thrombogenic elements or to provide an end area of the leg 25 without any thrombogenic elements. Such areas free from thrombogenic elements allow a better fixation of the leg 25 to the main part 24 without the risk of thrombogenic elements entering the endoprosthesis.
    [0085] The implantation of the stent 1 of Figure 5 is performed in the conventional manner, while the thrombogenic filaments are retained with the respective bodies of parts 24 and 25. Parts 24 and 25 are snapped into place one after the other and then united.
    [0086] Once they are thus joined to form the bifurcated structure of the stent, the clinician pulls on the temporary retention means 33 to allow the thrombogenic filaments 3 to be delivered at a distance in the opposite direction to the stent.
    [0087] It will be clearly evident in this document that an additional advantage of selective and controlled delivery of the thrombogenic filaments, which are only delivered once the body 2 of the stent graft is positioned and assembled, is that it is possible to prevent the thrombogenic filaments 3 from a part of the endoprosthesis penetrate into the inner conduit of the other part when they are joined.
    [0088] Figure 6 shows another example of the arrangement of thrombogenic filaments 3 on the outer surface of an endoprosthesis 1.
    [0089] In such a modality, the thrombogenic filaments 3 are attached to the body 2 of the stent 1 through a common anchor point 31 disposed at one end, in this case, the proximal end 21, and extend to the other end, in this case, the distal end 22, in such a way that they are distributed around the entire periphery of the stent 1.
    [0090] In this document, the temporary retention means are also composed of a cord 33 that forms a plurality of rings distributed along the body 2 of the stent 1, in such a way as to hold the thrombogenic filaments against the body 2 of the stent 1 while the retaining means 33 is present.
    [0091] When the filaments 3 are to be delivered, the retaining means 33 are removed, typically by pulling the cord 33 which will thus come loose from the body 2, for example, ring by ring, thereby releasing progressively the thrombogenic filaments 3 so that they are delivered at a distance in the opposite direction to the endoprosthesis 1.
    [0092] It will be evident that several variants are possible in relation to the configuration of the thrombogenic filaments 3 in the body 2 of the stent graft and in relation to the retention arrangements.
    [0093] With reference to the modality shown in Figure 6, it is thus possible to arrange several groups of thrombogenic filaments 3 in the stent 1, for example, two groups similar to that illustrated in Figure 6, each starting from one end of the stent 1 and each having a common anchor point 31.
    [0094] It is also possible, for example, to combine the modalities shown in Figures 1 and 5, in the case where the thrombogenic filaments 3 arranged in the rings, as shown in Figure 1, can keep the thrombogenic filaments arranged longitudinally, as shown in Figure 6.
    [0095] Now, with reference to Figures 9 to 12, an alternative modality has been shown in which each thrombogenic filament is formed by a loop that closes on itself. This can be achieved, for example, by clamping each free end of an individual filament to a common anchor point or two anchor points close together. In such a case, temporary retention is provided through a strand that passes through the loop formed by assembling the filament 3 close to where the filament changes direction to return to the anchoring region. As illustrated, the preferred configuration in this document is one in which two filaments in a loop shape extend through approximately 180° around the body 2 on each side thereof, the retaining cord 33 passing through the loops formed by the two filaments at an end region where such loops transpose one another.
    [0096] Figure 12 illustrates the stent graft in place after delivery of the loop-shaped filaments into aneurysm 43.
    [0097] Figure 13, finally, shows a diagrammatic view of another modality in which the thrombogenic filaments 3 extend in the general longitudinal direction of a main part of a bifurcated vascular stent, starting from two anchorage points situated at a proximal end of said main part and in the area of the bifurcation to the fixed leg.
    [0098] In such an embodiment, the means for retaining the filaments comprises an envelope 6 which completely surrounds the stent and the filaments and which can be torn and removed in situ after the stent has been snapped into place.
    [0099] Figure 14 schematically shows a main body 24 of a trifurcated stent graft 1. The main body 24 comprises a common tubular section 26 and two secondary tubular portions of equal length 27, 28. The tubular portions 27, 28 form a zone of overlay to receive a respective leg 25 (see also Figure 15) of the trifurcated prosthesis. The main part 24 is typically produced relatively short with a common tubular section 26 of typically 4 cm in the axial direction and with a length of the secondary tubular portions 27, 28 of about 3 cm.
    [00100] The axially superior edge, ie proximal edge of the common tubular section 26 has an area 29 which is not provided with thrombogenic elements. An adrenal stent 7 is disposed on the proximal edge of the common tubular section. Due to the fact that no thrombogenic elements are disposed in area 29, the extension of the thrombogenic elements into the stent graft is prevented even after the release of the thrombogenic elements. For this purpose, the length of the thrombogenic elements is chosen depending on the position in which they are arranged and depending on the axial length of the area 29. Typically, the length of the thrombogenic elements should be chosen shorter than the axial distance between the anchorage point of the respective element and the proximal edge of the common tubular section. Typically, the fibers can have a length of several mm up to 5 cm and the distance between the fibers is about 3 mm. Thrombogenic elements are very short, that is, several millimeters near the distal and proximal end of the prosthesis, and longer, that is, approximately 5 cm approximately in the center of the prosthesis. A possible length distribution of thrombogenic elements is shown and detailed in Figure 19.
    [00101] The common tubular section 26 and the secondary tubular portions 27, 28 are substantially uniformly provided with thrombogenic elements in the form of fibers.
    [00102] Figure 15 schematically shows a leg 25 that can be attached to one of the secondary tubular portions 27, 28 shown in Figure 14. The leg 25 is provided with thrombogenic elements in the form of fibers along its length. Distal end 45 and proximal end 46 of leg 25 are again provided with an area free of thrombogenic elements. The area at the proximal end 46 has a length substantially corresponding to the length of the secondary portion of the main portion 24 to which the leg 25 is to be attached. If, for example, a main part 24, as shown in Figure 14, with a secondary tubular portion 27, 28 having an axial length of 3 cm is chosen, the length of the overlap in the area near the end 46 will also be 3 cm. The distal end 45 of leg 25 is also provided with an area free of thrombogenic elements. The area without thrombogenic elements neighboring the proximal end 46 is advantageous over securing the leg 25 to the main part 24. In particular, such an area can prevent the thrombogenic elements from extending into the assembled stent graft. The legs are typically about 12 mm long.
    [00103] Alternatively, if the leg is fixed over the secondary portion, the proximal area end of the leg 25 may be provided with thrombogenic elements while the distal end of the secondary portion is free of such elements. The area without thrombogenic elements at the distal end 45 prevents the extension of thrombogenic elements over the axial end of the stent graft and, thus, prevents the extension of thrombogenic elements into the blood flow.
    [00104] In a more alternative embodiment, instead of the retaining means 33 in the form of a string extending out of an application device, the retaining means may simply be formed from a resorbable material. A cord that fixes the thrombogenic elements, as shown in Figures 2 and 3, can be produced from a resorbable material. Once the stent graft is implanted, the resorbable retention means are resorbed after a certain period of time and the thrombogenic elements are released. The time may be considerably short, ie a range of a few minutes or hours, or it may take a long time to resorb the material, ie a few months or any time in such an interval. A separate actuation by the operator is therefore not required.
    [00105] Thrombogenic elements are typically formed as filaments that have a length of several mm up to 5 cm and produced from natural fibers such as cotton or silk.
    [00106] The stent, for example, the main body 24, may additionally be provided with radiopaque markers, for example, along the circumference of the distal end or the proximal end.
    [00107] The adrenal stent 7 can be equipped with hooks for better fixation of the endoprosthesis at the implantation site. The main body itself can be supplied without any hooks. The axial length of the adrenal stent is chosen to be relatively short, for example typically about 2.3 cm. The stent graft is formed in a manner known to the skilled person, i.e., typically with a support structure produced from a nitinol stent that has a plurality of zigzag-shaped running limbs that are sutured to a produced tubular sleeve. from a polymeric material.
    [00108] Figure 16 schematically shows an enlarged view of the proximal end of the main part 24 as shown in Figure 14. The main part 24 has area 29 without thrombogenic elements which has a length 11 of typically about 1.4 cm . Thrombogenic elements in the form of filaments 3 are fixed to an anchorage point 31 with one end and have a free other end. Length 12 between anchor point 31 and free end is shorter than length 11.
    [00109] Obviously, the present invention is by no means limited to the embodiments that are described and illustrated and, instead, several variants are possible.
    [00110] Regarding the materials, the endoprosthesis can be produced from the usual materials for its sheath and the one or more stents that compose it, while thrombogenic filaments are produced from, for example, natural fibers, such as cotton or silk or polyester or another biocompatible polymer.
    [00111] The one or more strands 33 can be produced from polymer with a suitable cross-section and tensile strength if they are intended for manual actuation. In such a case, it is not essential that they are biocompatible due to the fact that they do not remain at the implantation site. In the embodiment in Figure 13, the envelope 6 can also be produced from a polymer, for example a low density polymer so that it can be broken open.
    [00112] In addition, the thrombogenic elements in the form of filaments can be replaced by any other generally elongated elements that may extend in the opposite direction to the body 2 of the stent, for example, ribbons, tubes, etc.
    [00113] Finally, it will be noted that thrombogenic elements can be treated in such a way that they release a drug at the site.
    [00114] As mentioned at the beginning of the description, the invention can also be applied in particular to the cardiac stent that comprises a stent and valves, which is applied to the area of a pre-existing heart valve, specifically, through a transapical percutaneous route , transfemoral, transseptal, subclavian or transaortic and which allows restoration of a valve function. The release of thrombogenic elements, in such a way that they are peripherally delivered from the prosthesis, in such a case, makes it possible to reduce paravalvular leaks.
    [00115] Figure 17 shows a schematic view of a slightly different trifurcated stent graft, similar to Figure 14. The main body 24 comprises a common tubular section 26 having a length of about 4 cm. The diameter d of the common tubular section 26 is between 2.2 and 3.8 cm. The legs each have a length b of about 3.0 cm. The adrenal stent 7 preferably has 8 or 10 "peaks" 40. The peaks 40 are all separated in a fixed 0.8 cm to 1.2 cm. The adrenal stent has a total length of about 2.3 cm, a proximal end of which is uncovered, i.e. it is not endowed with thrombogenic elements and has a length c of about 1.35 to 1.5 cm. A distal end is endowed with thrombogenic elements and has a length of about 0.5 to 0.6 cm.
    [00116] The common tubular section 26 has four stent tiers, each having a length of about 0.7 to 0.8 cm and a proximal area 29 that is not endowed with thrombogenic elements 3. Each leg 27, 28 has 3 stent floors that have a maximum length g of about 0.97 cm.
    [00117] Figure 18 shows a top view of a prosthesis according to the invention. Thrombogenic filaments 3 are attached to prosthesis 1 with two fibers 41. The two fibers are preferably produced from PTFE and can be arranged helically around the prosthesis (see Figure 19 for more details). Thus, all thrombogenic fibers 3 are fixed to the prosthesis with only two fibers 41. However, a different amount of fibers 41 for fixation may be possible, for example, 1, 3, 4 or 5.
    [00118] Figure 19 shows a partial schematic view of one half of a trifurcated stent graft 1 with a common tubular section 26 and two legs 27, 28 of which only one leg 28 is shown, however. At the proximal edge of the prosthesis is the adrenal stent. On the outer surface of the common tubular section 26, as well as on the outer surface of the legs 27, 28, are disposed the thrombogenic filaments 3. The length of the thrombogenic filaments is indicated with a dotted line in the form of approximately a semicircle. The length of thrombogenic filaments 3 is shorter near the proximal and distal edges compared to the center of the prosthesis.
    权利要求:
    Claims (24)
    [0001]
    1. Vascular stent or cardiac stent (1) comprising at least one body part (2, 24, 25), wherein the thrombogenic elements (3) are disposed at least partially on an outer surface of the at least one body part (2, 24, 25) of the vascular stent or cardiac stent and characterized by the fact that the vascular stent or cardiac stent is provided with at least one selectively deactivatable retention means (33) to retain the thrombogenic elements close to the surface of said part. of body.
    [0002]
    2. Stent according to claim 1, characterized in that the thrombogenic elements (3) are substantially uniformly distributed across at least one area of the outer surface, preferably the entire outer surface.
    [0003]
    3. Stent according to claim 1 or 2, characterized in that the thrombogenic elements (3) are elongated.
    [0004]
    4. Stent according to any one of claims 1 to 3, characterized in that each thrombogenic element (3) is fixed to the body part (2, 24, 25) in at least one anchor point (31) of the thrombogenic elements (3).
    [0005]
    5. Stent according to any one of claims 1 to 4, characterized in that the thrombogenic elements (3) have at least one loop (34), in particular, a loop substantially at a free end opposite a point of anchorage (31).
    [0006]
    6. Stent according to claim 5, characterized in that the loops substantially form the entire length of the thrombogenic elements and an elongated retention element (33) which preferably passes through a coverage zone of at least two two element loops.
    [0007]
    7. Stent according to claim 5 or 6, characterized in that the at least one selectively deactivatable retention means (33) retains the thrombogenic elements (3) being in operational connection with the at least one loop ( 34) of the thrombogenic elements.
    [0008]
    8. Stent according to claim 7, characterized in that a selectively deactivatable retention means (33) retains at least two thrombogenic elements, preferably all thrombogenic elements, being in operational connection with the at least a loop (34) of the thrombogenic elements.
    [0009]
    9. Stent according to any one of claims 4 to 8, characterized in that the at least one selectively deactivatable retention means can be deactivated by being pulled, in particular, towards a proximal end of a release system.
    [0010]
    10. Stent according to any one of claims 4 to 8, characterized in that the at least one selectively deactivatable retention means is formed of resorbable material and is deactivatable through resorption.
    [0011]
    11. Stent according to any one of claims 4 to 8, characterized in that the at least one selectively deactivatable element (33) comprises a tearable envelope and is deactivated by tearing the envelope.
    [0012]
    12. Stent according to any one of claims 1 to 11, characterized in that the thrombogenic elements are endowed with at least one medical substance and are designed to release said substance.
    [0013]
    13. Stent according to any one of claims 1 to 12, characterized in that the body is generally tubular and the thrombogenic elements (3) extend circumferentially around the body.
    [0014]
    14. Stent according to any one of claims 1 to 12, characterized in that the body is generally tubular and the thrombogenic elements (3) extend axially along the body.
    [0015]
    15. Stent according to any one of claims 1 to 14, characterized in that the outer surface of said at least one body part has at least one edge area (29, 45, 46) that is free of elements thrombogenics.
    [0016]
    16. Stent according to any one of claims 1 to 15, characterized in that the thrombogenic elements (3) are fixed to said surface in one place and have a size chosen so that the thrombogenic elements (3) do not become extend over an axial edge of said body part (2, 24, 25).
    [0017]
    17. Stent according to any one of claims 1 to 16, characterized in that the stent is constructed as a bifurcated stent comprising two body parts, consisting of a main part (24) and a fixed or fixable leg ( 25).
    [0018]
    18. Stent according to any one of claims 1 to 16, characterized in that the stent is constructed as a trifurcated stent comprising three body parts (24), in particular, a main part and two fixed or fixable legs (25).
    [0019]
    19. The stent according to claim 17 or 18, characterized in that the main body part and/or the leg or legs preferably have truncated attachment portion(s) (27, 28 , 46) for attaching the leg or legs (25) to the main body part (24).
    [0020]
    20. Stent according to claim 19, characterized in that the fixation portion(s) has an edge area that is free of thrombogenic elements.
    [0021]
    21. Stent according to any one of claims 17 to 20, characterized in that said thrombogenic elements are provided in said main part (24) and in that said legs (25) are preferably free of elements thrombogenics.
    [0022]
    22. Stent according to any one of claims 1 to 21, characterized in that it is of the valve type that comprises at least one stent and a valve and that is capable of being placed in the area of a preexisting heart valve and allows the restoration of a valve function, in which the thrombosis effect caused by the thrombogenic elements, preferably in the upstream part of the valve, allows a reduction in paravalvular leaks.
    [0023]
    23. Delivery device characterized in that it comprises a stent as defined in any one of claims 1 to 22, wherein the delivery device preferably comprises at least one sheath configured to keep the stent compressed during application and wherein the stent is arranged such that it is released through relative movement between the sheath and the stent.
    [0024]
    24. Delivery device according to claim 23, characterized in that the device is provided with an activation mechanism to deactivate a retention element to retain thrombogenic elements close to the stent.
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    同族专利:
    公开号 | 公开日
    KR20150035997A|2015-04-07|
    AU2013273526B2|2018-02-22|
    SG11201408092UA|2015-01-29|
    MX2014014926A|2015-05-15|
    CA2875444A1|2013-12-12|
    JP2015518761A|2015-07-06|
    ES2804583T3|2021-02-08|
    EP2854705B1|2020-04-15|
    CN104519831B|2016-06-22|
    ZA201408930B|2016-03-30|
    BR112014030199A2|2017-06-27|
    CA2875444C|2020-12-15|
    RU2014153551A|2016-07-27|
    US9848976B2|2017-12-26|
    RU2637106C2|2017-11-29|
    WO2013182614A1|2013-12-12|
    JP6669495B2|2020-03-18|
    MX359306B|2018-09-05|
    CN104519831A|2015-04-15|
    EP2854705A1|2015-04-08|
    UA115242C2|2017-10-10|
    AU2013273526A1|2015-01-15|
    KR102127539B1|2020-06-26|
    US20150148889A1|2015-05-28|
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-12-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-05-11| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-07-06| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 05/06/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1255207A|FR2991162B1|2012-06-05|2012-06-05|ENDOPROTHESIS, IN PARTICULAR VASCULAR OR CARDIAC, WITH THROMBOGENIC ELEMENTS|
    FR1255207|2012-06-05|
    PCT/EP2013/061620|WO2013182614A1|2012-06-05|2013-06-05|Endoprosthesis and delivery device for implanting such endoprosthesis|
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