• 专利附录
  • 专利说明
  • 权利要求
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    • 专利摘要:
    improvements regarding stent valves for transcatheter. a stent valve for transcatheter implant to replace a heart valve, the stent valve being compressible to a compressed state for delivery, and expandable to an operational state for implant, the stent valve comprising a stent, a plurality of leaflets to define a prosthetic valve, an inner skirt, an outer skirt, and a valve seal to seal against the surrounding tissue. in some embodiments, the valve seal comprises material that swells in response to contact with blood. in some embodiments, the seal comprises a flap or pocket that is distensible in response to the return pressure and / or return flow to the blood valve.
    公开号:BR112015022526B1
    申请号:R112015022526-8
    申请日:2013-03-25
    公开日:2020-12-15
    发明作者:Fabien Lombardi；Luc Mantanus；Stéphane Delaloye；Jacques Essinger；Jean-Luc Hefti；Youssef Biadillah
    申请人:Symetis Sa；
    IPC主号:
    专利说明:

    FIELD OF THE INVENTION
    [001] The present invention relates to the field of tipostent transcatheter valves. In some non-limiting aspects, the stent valve can be a heart valve, for example, an aortic valve. BACKGROUND OF THE INVENTION
    [002] Transcatheter valve implantation (for example, transcatheter aortic valve implantation (TAVI)) is an evolving technology for valve replacement therapy that (i) avoids the trauma of conventional open breast surgery, and (ii) avoids the need for cardiac and pulmonary bypass. In such a technique, a stent valve is compressed and loaded into a delivery catheter. The delivery catheter is introduced into the desired implant site (for example, in the heart) via a percutaneous route or through minimally invasive surgery. The stent valve is deployed into the implant position from or by the delivery catheter, and the delivery catheter is then removed.
    [003] Despite the successes of transcatheter stent-type valves, technological challenges remain. One of these challenges is the prevention of blood leakage around the stent valve (called a para-valve leak). The stents above form a friction fit with the native anatomy to anchor the stent valve in position, and are round in cross section. However, the native anatomy in which the stent is implanted is often not round and is different for each person. In addition, heavy calcification of the native anatomy can obstruct the full unfolding of any stent and make the native anatomy even more irregular. It can sometimes be difficult to provide a perfectly sealed fit between the stent valve and the surrounding anatomy.
    [004] In order to solve the para-valve leak, it is known to incorporate a skirt or external cover as part of the stent valve. For example, the skirt is made of compressible biocompatible material, such as fabric for cardiac or PET. The thicker the skirt material, the more capacity the skirt has to obstruct the spaces and seal. However, a disadvantage is that such skirts add volume to the stent valve. A thick skirt makes the stent valve problematic to compress to a desirably small size for implant.
    [005] It would be desirable to provide a technique to mitigate para-valve leakage without substantially impairing the compression capacity of a stent valve. SUMMARY OF THE INVENTION
    [006] Aspects of the invention are defined in the claims.
    [007] In addition or alternatively, an aspect of the present invention provides a stent valve for transcatheter delivery, the stent valve comprising a stent that supports a plurality of valve leaflets.
    [008] Several modalities feature a seal to mitigate para-valve leakage (which can also be referred to here as a (or) valve seal or a (-) valve seal). The seal can be made of flexible and / or resilient material. For example, the flexible and / or resilient material can comprise natural tissue (for example, pericardium, such as porcine pericardium, or bovine pericardium), and / or synthetic material (for example, silicone, PTE or PEEK, any of which can be in the form of film, or form of woven fabric, or non-woven fabric / interlacing).
    [009] In some embodiments, the valve seal can be configured to be a substantially supra-annular seal (for example, above the level of a native native valve ring), and / or a substantially annular seal (for example, in the level of a native native valve ring), and / or a substantially infra-annular seal (for example, below the level of a native native valve ring).
    [0010] In some embodiments, a seal is carried by at least one seal support. In addition, or alternatively, a sealing support (for example, folding) is provided to unfold a seal.
    [0011] In any case, in some embodiments, the sealing support is dismountable for a stored condition in which the sealing is relatively simplified or compressed with respect to the stent, or for at least an additional part of the stent, when the stent is compressed . (For example, in the stored condition, the sealing support can generally be coplanar with a part, such as a body part, of the stent, or it can be compressed against the stent or part of the stent). The sealing support can be foldable in an unfolded condition in which the support maintains or guides the seal to an unfolded state, for example, with respect to the stent or at least the additional part of the stent referred to previously. The sealing support can be automatically unfolded from the saved condition to the unfolded condition. For example, the sealing support should be restricted to the condition kept by protecting the stent in a compressed state for distribution. The sealing support can automatically unfold from the stored condition when the effect of the restriction sheath is removed. The sealing support can be of memory effect material, for example, memory effect metal alloy, for example, nitinol.
    [0012] Various shapes and sealing support structures are envisioned. In some embodiments, the sealing support may be integral with the stent (for example, formed integrally as part of the stent). In other forms, the sealing support may be distinct from the stent. Such a sealing support can optionally be coupled to or captive in the stent.
    [0013] The sealing support can be configured to rest against the sealing material without penetrating the sealing material. For example, the sealing support may be shaped to distribute contact force. A function of the seal holder may be to push the seal out without the seal holder penetrating through the seal material or a fabric surface against which the seal is desirable.
    [0014] In some embodiments, the sealing support comprises a guiding element that guides the seal, for example, to an unfolded condition. The sealing support (e.g., guiding element) can comprise, for example, a supporting element (or a plurality of supporting elements). Each support member may comprise a single stringer, or several struts (for example, first and second struts coupled together at a glance or a tip of the support element). The support elements can flex independently of each other in order to provide a high degree of local sealing compliance against an irregular lumen of the fabric surface. In some embodiments, each support element is associated with a respective opening of a truss-like structure of the stent. The support elements can, for example, have one end coupled (or integral) to the body of the stent, and one end opposite the remote one that is free to unfold outward. The remote end may have a rounded or enlarged tip to avoid having a sharp end that can otherwise penetrate the sealing material. Support elements can generally extend in the same direction as the other (for example, with the remote end directed to one end (such as the outflow end) of the stent valve), or the support elements can be arranged in two opposite directions (for example, at least one pointing towards the outgoing flow end, and at least one pointing towards the incoming flow end), or the support elements may be arranged in a variety of different directions .
    [0015] In some embodiments, the sealing support comprises an annular shape, or tubular shape, or annular element. The element may have an annular spiral shape.
    [0016] In some embodiments, the sealing support comprises an element that can be stored in a generally elongated or helical shape, and which unfolds into a radially expanded handle shape.
    [0017] In some embodiments, the sealing support comprises a part of the stent that leaves a stored condition for an unfolded condition. This movement of the stent can provide radial expansion upon unfolding without significantly increasing the diameter of the stent when compressed (de-everted). For example, an inlet end or part of the stent may everter towards the outflow end.
    [0018] In some embodiments, the stent carries a sealing skirt (or mesh). The sealing support can orient the skirt (or parts of it) radially outwardly to extend away from the stent body.
    [0019] In addition or alternatively to the aspect above the provision of a sealing support, a stent valve seal can be configured to respond to the direction of blood flow beyond the seal, with respect to the inlet and outflow ends stent valve outlet. The seal can be configured so that blood flow in a reverse direction (from outflow to inlet flow) directs the seal to an unfolded state to obstruct such flow.
    [0020] For example, the fence may comprise at least one screen defining one or more pockets. The one or more pockets can be configured to fill with blood in response to blood flow in the reverse direction, so that the pockets stretch outward. The distention of the pocket can fill a space between the stent valve and the surrounding anatomy, to obstruct the reverse flow of blood beyond the pocket.
    [0021] In some modalities, the pocket can be defined or carried in a respective opening of a stent truss structure. The pocket can be defined at least partially by an external skirt carried on an exterior of the stent. Additionally or alternatively, the pocket can be defined at least partially by an inner skirt carried within an interior of the stent.
    [0022] In addition or alternatively to the above aspects, a seal may comprise a skirt at least a part of which is captive with respect to the stent, and at least an additional part of which is free to unfold or float with respect to the stent.
    [0023] In some embodiments, the additional part may come into contact with a surrounding tissue or lumen wall before the stent body is fully deployed. As part of the deployment procedure, the stent can be moved or oriented in a first axial direction to rest against native leaflets. Frictional contact of the skirt against the fabric can cause the additional part of the skirt to wrinkle in the axial direction during the displacement action. Such a wrinkle can provide additional material to fill the voids between the stent and the surrounding tissue.
    [0024] Additionally or alternatively, in some modalities, the additional part of the skirt may respond to the direction or flow of blood to the valve or to the pressure of blood acting on the skirt (for example, on the additional part of the skirt). The additional part can, for example, unfold outwards to come into contact with a lumen wall of surrounding tissue. The additional part may form a flap, or generally annular pocket or channel in response and, and / or that responds to blood pressure or blood flow in the reverse direction. The flap / channel / pocket shape can orient an outer part of the skirt to rest against the surrounding fabric or lumen surface.
    [0025] In addition or alternatively to the above aspects, a seal of the stent valve can be engraved to present a non-smooth surface. For example, the recording can be defined by one or more sutures. The one or more sutures can define a zigzag pattern. The suture can define a generally continuous recording to obstruct blood flow beyond it.
    [0026] In addition or alternatively to the above aspects, a stent valve seal can generally be oversized compared to the diameter of the stent. The seal can be grouped or folded by connections (for example, suture) to the stent that cause grouping or folding between connections. Grouping / folding can create an additional volume of sealing material capable of filling the voids between the stent-type valve and the surrounding tissue or lumen surface. The positions of the connections can define the grouping or folding in directions in a pattern that blocks blood leakage beyond.
    [0027] In addition or alternatively to the above aspects, a stent valve seal can be configured to have automatic expansion or automatic filling due to a physical property of the seal.
    [0028] For example, in some embodiments, the seal may be made of or comprise an expandable material, foam, sponge or fibrous material. Such material can automatically expand resiliently when the stent unfolds. In addition or alternatively, such material can absorb blood (and / or a blood component) into its pores or interstices in order to physically expand the material or add volume.
    [0029] In some embodiments, the seal may be generally flat and / or tubular in a stored state and / or it may wrap in an annular crimp or donut shape when in the unfolded state. The seal can be self-orientated to the unfolded state, but resiliently deformable to the stored state during compression of the stent for loading into a delivery device. After removing a restrictive effect from a sheath from the delivery device, the seal can be configured to readjust to the unfolded state in order to provide a radially enlarged seal around the stent.
    [0030] In some embodiments, at least part of the stent comprises a truss structure, and the stent valve further comprises one or more foldable seals from or through the truss openings. In one form, the seals comprise parts of material mesh that define pockets associated with the respective openings of the lattice. The parts of fabric can be configured to extend outward from the respective openings. For example, in some embodiments, the fabric parts define open pockets on or to one side so that a respective pocket is filled with blood to stretch out from the opening of the truss. In addition or alternatively, the truss structure of the stent may comprise guiding elements for orienting the fabric parts (e.g., pockets) of material radially outwardly from the truss structure.
    [0031] In some embodiments, the stent carries a sealing skirt (or mesh). The stent may comprise guiding elements to orient the skirt (or parts of it) radially outwardly to extend away from the body of the stent. The sealing skirt can optionally be transported outside the stent. An internal skirt (or mesh) can optionally be transported inside the stent (and optionally attached directly to the leaflets). At least one of the skirts can be made of fabric (for example, PET). Additionally or alternatively, at least one of the skirts can be made of biological tissue, for example, pericardium.
    [0032] In some embodiments, an orientation element distinct from the stent may orient an outward seal. For example, the guiding element can be an annular element (e.g., closed ring or divided ring) within an annular seal. The guiding member can be compressible with the stent for a radially compressed condition. The guidance element can expand (for example, expand automatically) towards a radially expanded state when the stent is deployed. The guiding element may be of memory effect material, for example, nitinol.
    [0033] Certain characteristics, ideas and advantages of aspects of the invention are identified above and / or in the appended claims, but do not limit the invention. Protection is claimed by any new idea or feature described here and / or illustrated in the drawings whether or not emphasis has been given. BRIEF DESCRIPTION OF THE DRAWINGS
    [0034] Non-limiting modalities of the invention are illustrated in the attached drawings, in which:
    [0035] Figure 1 is a schematic drawing illustrating a stent valve 10 with which the present invention is to be used;
    [0036] Figure 2a is a front view of a display arrangement with support sealing brackets, and Figure 2b is a side view of Figure 2a in an unfolded configuration;
    [0037] Figure 3 is a schematic view of a sealing arrangement with an annular wire sealing support;
    [0038] Figure 4a is a schematic perspective view of an elongated seal support around the stent in a compressed state, and Figure 4b is a schematic top view of the seal when in an unfolded state;
    [0039] Figure 5a is a schematic view of a sealing arrangement in a non-everted and protected state, Figure 5b illustrates the initial sheath removal of the sealing arrangement of Figure 5a to allow eversion, and Figure 5c illustrates the sealing arrangement of figure 5a when not protected;
    [0040] Figure 6 is a schematic side view of an additional example of the sealing arrangement with flexible support arms;
    [0041] Figure 7a is a schematic side view of a sealing arrangement comprising a handle that can be rolled up when in an unfolded state, and Figure 7b is a schematic view of the sealing arrangement when in an unguarded state;
    [0042] Figure 8 is a schematic side view of a sealing arrangement comprising a porous material;
    [0043] Figure 9a is a schematic side view of a sealing arrangement comprising a floating skirt, and figure 9b is a schematic side view of the effect of the sealing arrangement of figure 9a when implemented;
    [0044] Figure 10 is a schematic illustration of an alternative arrangement of a floating skirt seal;
    [0045] Figure 11 is a schematic illustration of an alternative sealing arrangement using a folded skirt;
    [0046] Figure 12 is a schematic illustration of an alternative sealing arrangement using a folded skirt;
    [0047] Figure 13 is a schematic illustration of an alternative sealing arrangement using distensible pockets;
    [0048] Figure 14 is a schematic drawing of an alternative sealing arrangement using expandable material;
    [0049] Figure 15 is a schematic drawing illustrating the administration of a seal around the stent valve;
    [0050] Figure 16 is a schematic view of an alternative sealing arrangement using coagulation material
    [0051] Figure 17 is a schematic view of an alternative sealing arrangement using material that dissolves calcium locally;
    [0052] Figure 18 is a partial schematic view of optional details of a stent valve in figure 1;
    [0053] Figure 19 is a schematic section of the valve seal of Figure 18;
    [0054] Figure 20 is a partial schematic side view (with partial cut to the left) of an additional alternative sealing arrangement using a skirt defining an annular flap;
    [0055] Figures 21 to 23 are partial schematic sections of a detail of figure 20, illustrating alternative height of the skirt in relation to the upper crown of the stent, in other modalities;
    [0056] Figure 24 is a partial schematic side view (with partial cut to the left) of an additional alternative sealing arrangement using a skirt that defines an annular pocket;
    [0057] Figure 25 is a partial schematic section showing a detail of figure 24, with an alternative height of skirt in relation to the upper crown of the stent, in an alternative mode; and
    [0058] Figure 26 is a partial schematic view of the arrangement of figure 25 in a compressed condition for loading into an implant delivery device. DETAILED DESCRIPTION OF THE MODALITIES OF THE INVENTION
    [0059] With reference to figure 1 (and figure 18), a stent valve 10 is illustrated for transcatheter implantation. The stent valve 10 can be a cardiac stent valve, for example, an aortic stent valve, a mitral stent valve, a pulmonary stent valve, or a tricuspid stent valve, for implantation in the respective valve position in a human heart.
    [0060] Stent valve 10 may optionally comprise biological tissue (for example, pericardium, such as porcine pericardium and / or bovine pericardium) and / or natural heart valve leaflets (e.g., natural swine heart valve leaflets, optionally attached to a part of the natural cardiac wall tissue). The biological tissue can be fixed, for example, using glutaraldehyde. Biological tissue can have anti-calcification properties, for example, having been treated or processed to inhibit or decrease calcification (for example, by treatment in alcohol or a process using detergent).
    [0061] The stent valve 10 can be compressible to a radially compressed condition (not shown) for delivery using a delivery catheter, and be expandable to an expanded condition (as shown) in the implant. The stent valve 10 can comprise a stent 12 carrying a plurality of leaflets defining a valve 14. Various geometries of the stent 12 can be used. In some embodiments, stent 12 may include one or more of: a lower tubular part or crown 16; an upper crown part 18; a plurality of straight commissural supports 20; and a plurality of stabilizing arcs 22. In use, the bottom part 16 of the stent 12 can be configured to be deployed after other regions of the stent 12 have been at least partially deployed first. For example, the arches 22, the supports 20 and the upper crown 18 can be unfolded at least partially before the lower part 16 (in that order, or in the reverse order, or in a different order). At least once the upper crown 18 has been at least partially unfolded, stent 12 can be pushed and / or moved in the direction of arrow 24 to seat the upper crown 18 against native leaflets at the implant site. The unfolding of the lower part 16 finally fixes the stent 12 in its final position.
    [0062] In some embodiments, at least the lower part 16, and, optionally, a part of the upper crown 18, can be formed by a truss-like structure of the stent. The lattice-like structure can define openings, for example, generally diamond-shaped openings.
    [0063] In some embodiments, the upper crown 18 can be considered (for example, being or comprising) a sealing support, when a seal is attached to the upper crown 18. The sealing support defined by the upper crown can be considered to unfold the seal at least a little outward with respect to part or remainder of the stent just below the upper crown.
    [0064] Native leaflets can usually overlap with part 26 of the stent. The native valve ring can overlap with part 28 of the stent.
    [0065] Optionally, the stent valve 10 may additionally comprise an inner skirt 30 communicating with the leaflets 14 and carried within an interior of the stent 12. Additionally or alternatively, the stent valve 10 may additionally comprise an outer skirt 32 carried in one exterior of the stent 12. When both skirts are provided, the skirts may partially overlap. The skirts can be deflected so that one skirt (for example, the outer skirt 32) extends more towards one lower end of stent 12 than the other (for example, inner skirt 30). Additionally or alternatively, a skirt (for example, the inner skirt 30) extends more towards one upper end of the stent 12 than the other (for example, outer skirt 32). The skirts can be of any suitable flexible and / or resilient material, for example, fabric (for example, PET), or plastic film (for example, PET), or biological fabric (for example, pericardium).
    [0066] Optionally, at least the outer skirt 32 is positioned to leave (for example, at least a part of) the upper crown 18 substantially free by the outer skirt 32. Such an arrangement can assist the good blood flow to the coronary arteries ( for example, in the case of a stent valve for the aortic valve).
    [0067] In some embodiments, the lower part 16 has an end formed with a substantially zigzag shape. The zigzag shape can comprise smaller apexes 16a and higher apexes 16b. The upper apexes 16b can be masked in figure 1 by the superimposed presentation of both the front and rear cells of the lattice-like structure. The zigzag shape can be substantially continuous around the circumference of the stent 12. The outer skirt 32 can have a peripheral edge having a zigzag shape that substantially matches the zigzag shape of the bottom end 16. Such an arrangement can avoid material excessive at the end and thus facilitate tightening of the stent valve 10. At the same time, the outer skirt 32 covers (for example, completely) the open cells of the truss-like structure to the end of the stent to reduce the risk of leakage of blood through the cell openings. The outer skirt 32 can also provide a layer of material over the stent stringers, to thereby pad the engagement between the ostent and the sensitive native cardiac tissue.
    [0068] Valve 14 may comprise biological tissue, for example, pericardium (such as porcine or bovine pericardium) or natural heart valve leaflets (e.g., natural swine heart valve leaflets, optionally attached to a part of the wall tissue cardiac). Another biological material or not can also be used for valve 14, as desired.
    [0069] Stent 12 may optionally be of an automatic expansion type that is compressible to the compressed state for loading into a delivery catheter having a sheath to restrict stent 12 in the compressed state for delivery to the implant site. In use, by removing the sheath restriction effect, stent 12 automatically expands to or (for example, at least partially) in the direction of the expanded state. An auto-expanding stent may, for example, be of a memory effect material, for example, memory-effect metal alloy, for example, nitinol. In addition or alternatively, stent 12 can be configured to be expanded by applying an expansion force to the delivery catheter, such as using an expansion balloon.
    [0070] Now follows a description of the various delivery configurations that can be used with the stent valve described above 10. The sealing configurations can also be used with different formats and stent configurations. Whether or not described in detail, the The following descriptions of the seals may use any single or multiple combination of the stent and / or stent valve characteristics mentioned above.
    [0071] Suitable materials for a seal may include biological tissue (for example, pericardium, such as porcine or bovine pericardium). The biological tissue can be fixed tissue, for example, processed using glutaraldehyde. The pericardium is useful due to its very good flexibility, allowing the seal to conform to fit against and around the irregular shape of hard calcifications. In addition or alternatively, the material suitable for a seal may include plastics (for example, PET or PEEK). Plastics can be used in the form of woven fabric or not, and / or in the form of foil and / or in the form of film, as desired. Plastics can combine robustness with adequate flexibility and resilience. Plastics can be of a biocompatible type.
    [0072] Figure 2 illustrates a first example of sealing support in the form of a plurality of support elements 40 mounted on or integral with stent 12. Each support element 40 can be associated with a respective opening 42 of the type structure lattice.Each support element 40 can generally be folded independently from others. Each support element 40 can be moved between a stored condition, in which the support element is generally coplanar with the part of the stent 12 around the opening 42 (or at least it is compressed to meet directly or indirectly against it), and an unfolded condition in which the support element 40 is oriented radially outwardly from the body (e.g., bottom 16) of the stent 12 (figure 2b). The sealing support pushes a seal (e.g., outer skirt 32) outwardly to fill the spaces between the stent valve 10 and the surrounding lumen / tissue. The ability for the support elements 40 to flex independently can provide a high degree of local compliance. Each support element 40 may have a remote end 40a in the form of a rounded, pad-like shape, or other non-harmful shape that it can support against the sealing material to orient the seal radially outwardly, without penetrating through or piercing the sealing material. In the illustrated example, each support element 40 may comprise a single stringer.
    [0073] The support elements 40 can generally be arranged in the same orientation (for example, with remote ends 40a directed to one end, for example, the exit end of stent 12), or distributed to be oriented in two directions opposite, or be distributed to be oriented in a variety of different directions.
    [0074] The seal pushed by the support elements 40 can be generally continuous, or it can be discontinuous in the form of screens or pockets. The pockets can be arranged so that the return blood pressure, or blood flow to the valve in the reverse direction from the outlet to the entry of the stent 12, fill the pockets to cause the pockets to stretch later, thus improving the sealing effect to obstruct such valve flow. Additional details of such pockets are also described with reference to figure 13, and any of these features can also be used with the present example. The seal can optionally be attached to the support elements 40, or the seal can be detached so that the support elements 40 interact with the seal by pushing out.
    [0075] With reference to figure 3, a seal holder 46 is illustrated in the form of an annular wire or ring which is oversized compared to stent 12. The annular wire is compressible to a stored state when the stent is compressed, and expands to an unfolded state when not restricted, to push seal 48 to a radially expanded state to form a seal against the surrounding tissue / lumen.
    [0076] With reference to figure 4, a sealing support 50 is illustrated in the form of an elongated element carrying a seal 52. The sealing support is compressible to a guarded shape (figure 4a), for example, a helical shape in around the stent 12 when in its compressed state. The seal holder is expandable to an unfolded state (figure 4b), for example, a radially expanded or semi-closed closed loop shape in which the seal holder has the seal 52 in the expanded shape around the stent 12.
    [0077] With reference to figure 5, a sealing support 54 is shown in the form of a portion of the lower region 16 of the stent 12. Sealing support 54 is movable between a guarded non-everted configuration and an unfolded everted configuration . In a compressed form restricted by a sheath 56 (figure 5a), the lower part of the stent including the sealing support 54 is generally tubular (not everted). As the sheath 56 is progressively removed axially (figure 5b), the seal 56 is not protected. The unrestricted seal support 56 everts to its unfolded state in which the seal is presented and / or oriented radially outwardly from the stent body. Additional removal of the sheath from stent 12 or bottom 16 (figure 5c) allows stent 12 to expand to its expanded state. The everted seal holder 54 pushes the seal to a close seal contact with the surrounding fabric / lumen. The seal can be carried on the internal surface of the stent when compressed and presented in an external direction when ever removed.
    [0078] Figure 6 illustrates a sealing support that is similar to both figures 2 and 5. Sealing support 58 comprises flexible support elements at the bottom 16 of stent 12, similar to those in figure 2. The sealing support 58 also recalls the everted state of the sealing support 56 in figure 5. In the example in figure 6, the support elements do not move between an everted and non-everted state. In the stored state, the support elements are generally flat against or within the structure of stent 12 (similar to figure 2).
    [0079] Figure 7 illustrates a seal in the form of a frieze or handle that can be rolled up 60. The handle that can be rolled up can be automatically oriented or can be supported by a sealing support structure that tends to roll up the handle 60 In a stored state (figure 7b), the handle is unrolled to define a generally flat tubular shape. The handle can be restrained in the state held by a restraint sheath 62 of a dispensing device. When not protected, the handle 60 is free to move to its unfolded state (figure 7a) where the handle 60 curls to define a shape of handle or rib. Such a seal provides a conforming rib of material to fill any space between the stent 12 and the surrounding tissue / lumen.
    [0080] Figure 8 illustrates a seal 74 in the form of foam or sponge material or porous fibrous material. Such material is compressible when dry, since air is easily expelled from the pores and / or interstices of the material when compressed. Seal 74 can therefore adopt a compressed state without significantly increasing the volume of stent valve 10. Once implanted, blood can penetrate and fill the pores and / or interstices, thus creating a protection for blood flow through the material. Blood can also cause the sealing material to distend to further expand the seal outward and fill any empty spaces around the stent valve 10.
    [0081] Figure 9 illustrates a seal in the form of a flexible skirt 80. The skirt 80 depends, for example, on the junction between the upper crown 18 and the lower part 16 of the stent 12, to at least partially overlap to the bottom 16. A first (for example, top) part 82 of the skirt 80 is attached to the stent 12, to hold the skirt 80 captive. For example, the first part 82 can be sutured to the stent 12. A second part (for example, dependent) 84 of skirt 80 is generally unrestricted, and is free to float with respect to stent 12.
    [0082] As illustrated in figure 9b (and explained above with reference to figure 1), the implantation procedure for stent valve 10 may involve moving the stent valve in the direction of arrow 24 to seat the upper crown 18 against the native valve leaflets. The friction between the second floating part 84 of the skirt 80, and the surrounding fabric / lumen can cause the second part 84 to wrinkle axially, thus creating an excess of material that can seal any space between the stent valve 10 and the surrounding tissue / lumen.
    [0083] Figure 10 illustrates an alternative seal in the form of a flexible skirt 90. In contrast to the skirt of figure 9, skirt 90 projects from the upper crown 18 towards the upper end of stent 12. As indicated by dashed lines, under the blood return pressure, or inverse blood flow around the stent valve 10, the flexible skirt is supported externally to seal against the surrounding tissue / lumen. The flexible skirt can form a channel-shaped section so that the return blood pressure increases the sealing pressure against the surrounding tissue / lumen.
    [0084] Figure 11 illustrates an alternative seal in the form of an oversized flexible skirt 100 that is connected to stent 12 in one or more positions to define folding or bundling. The connections can be by suture. Folding or bundling creates an additional resilient material capable of filling the voids between stent 12 and the surrounding tissue / lumen.
    [0085] Figure 12 illustrates an alternative seal in the form of a skirt that is folded to define a handle 102. The skirt material is flexible, but the fold creates a radiused fold providing a natural volume. The volume guides the sealing material outward to fill the voids between stent 12 and the surrounding tissue / lumen.
    [0086] Figure 13 illustrates an alternative seal comprising a plurality of flexible pockets 110. Each pocket can be associated with a respective opening 112 of a stent lattice structure, for example, the lower part 16 and / or the upper crown 18 Pocket 110 can be defined by a flexible material screen. A pocket wall can be defined by a part of the outer skirt. Another pocket wall can be defined by a part of the inner skirt. The pocket can be opened on one side facing the outlet end of the stent, and closed in the opposite direction. In a stored state, the pocket can disassemble or fold substantially flat so as not to increase the volume of the stent valve. Once unfolded, the pocket may open under the influence of natural resilience, or under the influence of the rush to return blood that enters the pocket mouth. The return pressure causes the pocket to extend outwardly against the surrounding tissue / lumen, and thus additionally obstruct the leakage of blood around the outside of the stent valve 10.
    [0087] Figure 14 illustrates an alternative sealing arrangement comprising material 120 that swells in response to contact with blood. Expansion characteristics increase the volume of the seal, allowing the seal to stretch to fill any spaces between the stent valve 10 and the surrounding tissue / lumen. Illustrative expandable materials include a hydrogel and / or a polymer that swells in contact with liquid and / or a so-called superabsorbent material. The material may, for example, be transported by, or impregnated or otherwise embodied within, the outer skirt. For example, the skirt may be of fabric comprising fibers of expandable material. The material can be captive within a containment chamber, for example, a flexible and / or extensible bag or handle. The combination of internal and external skirts, with one comprising expandable material, can provide an especially effective sealing arrangement. Additional background information on the use of, for example, a hydrogel for stent-type valves can be found in US 2005/137688.
    [0088] The seal of figure 14 is also illustrated in other modalities of figures 18 and 19. The expandable material is denoted by the number 44, the containment chamber 42, together defining the seal for valve 40 carried by, or understood within, the external skirt 32.
    [0089] Figure 15 illustrates an alternative sealing arrangement in which a seal 122 is delivered from delivery catheter 124 (or from an additional delivery catheter inserted after implant) in order to seal around the periphery of the stent valve 10. For example, the seal is distributed on the flow outlet side of the stent valve to seal any spaces between the upper crown and the native leaflets. Figure 16 illustrates an alternative sealing arrangement comprising material 124 that provides hemostatic and / or coagulant effects in response to contact with blood. Material 124 may, for example, be carried by, or impregnated or otherwise embodied within, the outer skirt. The material can be captive within a containment chamber, for example, a flexible and / or expandable bag or handle. The combination of internal and external skirts, with one comprising such material, can provide an especially effective sealing arrangement.
    [0090] Figure 17 illustrates an alternative sealing arrangement comprising material 126 that dissolves calcium locally. Calcium can deposit directly or indirectly against the surrounding tissue / lumen so that any spaces can be blocked. Material 126 may, for example, be carried by, or impregnated or otherwise embodied within, the outer skirt. The material can be captive within a containment chamber, for example, a flexible and / or extensible bag or handle. The combination of the inner and outer skirts, with one comprising such material, can provide an especially effective sealing arrangement.
    [0091] Figures 20 to 23 illustrate an alternative seal in the form of a flexible skirt 150. The skirt 150 can be the outer skirt 32 previously described. The skirt 150 can be attached to the stent 12 and / or inner skirt 30 at least in one or more fixation positions 152a, 152b with an end 154 of the skirt 150 closest to the outlet end 156 of the stent valve 10. One or further fixation positions 152a, 152b can define a first captive skirt part 160 with respect to stent 12, and a second skirt part 162 free to unfold or float with respect to stent 12. One or more fixation positions 152a, 152b can , for example, correspond to an inlet end 164 of the stent valve 10 and / or an intermediate position between the ends of the upper crown 18 and the lower part 16. At least one clamping position 152a, 152b can overlap, at least partially to the inner skirt 30.Optionally, at least one fixation position 152a, 152b forms a direct fixation between the sealing skirt (for example, outer) 150 and the inner skirt 30.Such fixation can block blood leakage between the skirts 30 and 150.
    [0092] As already explained with reference to figure 18, optionally, the lower part 16 has an end formed with a substantially zigzag shape. The zigzag shape can comprise lower apexes 16a and upper apexes 16b. The upper apexes 16b can be masked in figure 20 by the superimposed presentation of both the front and rear cells of the truss structure. The zigzag shape can be substantially continuous around the circumference of stent 12. The sealing skirt (e.g., outer) 150 can have a peripheral edge having a zigzag shape that substantially matches the zigzag shape of the bottom end 16. Such an arrangement can avoid excessive material at the end, and thus facilitates tightening of the stent valve 10. At the same time, the sealing skirt (for example, external) 150 covers (for example, completely) open cells of the trellis-like structure to the end of the stent to reduce the risk of blood leakage through the cell openings. The sealing skirt (e.g. external) 150 can also provide a layer of material on the stent stringers, to thereby cushion the engagement between the stent and the sensitive native cardiac tissue.
    [0093] The second part 162 of the skirt 150 can define a pocket or flap which is capable of stretching out under return pressure or return blood flow. The flap or pocket can extend continuously through an angle of at least about 180 degrees, optionally, at least about 270 degrees, optionally about 260 (for example, correspond to the entire circumferential periphery). The flap or pocket may be substantially annular and / or may be channel-shaped.
    [0094] In use, when the stent valve is in its implanted position, the second part 162 of the skirt may distend against the surrounding tissue, for example, under blood return pressure acting on the stent valve 10 when the valve 14 closed, or leakage of blood to the valve flowing back around the stent valve 10. The distension of the second outlet part 162 can define a pocket, so that the return pressure of blood inside the pocket makes a seal against the surrounding tissue. In some respects, the second skirt part 162 may function similarly to skirt 90 of figure 10, but positioned closer to the entry end of the stent than in figure 10.
    [0095] The skirt 150 can be dimensioned so that the end 154 closest to the outlet can be positioned axially in a desired position. For example, in figure 20, end 154 can be positioned to be substantially on a stent waist 12 between the ends of the upper crown 18 and the bottom 16. In figure 21, end 154 can be partially positioned on the upper crown 18 (for example between the waist and the end of the upper crown 18). In figure 22, end 154 can be positioned substantially flush with the end of the upper crown 18. In figure 23, end 154 can be positioned beyond the end of the upper crown 18 (for example, extending at least partially beyond the upper crown 18 towards the outlet end of the stent valve 10).
    [0096] At least in the examples of figures 21 to 23, the upper crown 18 can act as a sealing support. When the upper crown 18 is unfolded, the upper crown 18 can at least partially orient the second skirt part 162 outwardly, for example, with respect to the waist between the upper crown 18 and the lower part 16. Such an orientation can push the second skirt part 162 (i) for engagement with the surrounding tissue and / or (ii) for a stretched shape defining a flap or pocket in response to blood return pressure and / or blood return flow around the outside of the stent valve 10. The upper crown 18 (and the sealing support) can comprise support elements. The support elements can be flexible independently of each other. Each support element can have a U or V shape. Each support element can comprise a pair of stringers found at the apex of the support element.
    [0097] In all examples, the end 154 may have a substantially straight edge, or it may have a non-straight edge, for example, a wavy shape, or a brownish shape, or a notched shape. Variations in a non-straight edge can optionally align with the apexes of the upper crown 18. The provision of a non-straight edge can, in some embodiments, allow a reduction in the volume of the skirt material 150 to be compressed for loading into or within a dispensing apparatus, which can be significant when the skirt 150 overlaps a region of the stent valve 10 that is "filled" in terms of the stent material and / or leaflet material and / or skirt material to be compressed.
    [0098] In some embodiments, the second skirt 162 may be fully detached from stent 12. Alternatively, in some embodiments, one or more control fixings 166 may be formed between the second skirt 162 and stent 12 ( for example, the upper crown 18). The control fasteners 166 can be configured to allow the second skirt part 162 to extend substantially free, while preventing unwanted eversion of the second skirt part 162 (for example, during compression and loading of the stent valve by a inexperienced user).
    [0099] Figures 24 to 26 illustrate a further modification of the sealing arrangement of figures 20 to 23. In figures 24 to 26, the end 154 of the seal is attached to the upper crown 18 in various positions 168 around the circumferential edges from the end 154, to define an annular pocket or an annular channel shape of the second skirt part 162. In use, the second skirt part 162 can stretch or curl out from the stent, like a stretch wrist, in response to return pressure and / or return blood flow. The second skirt part 162 can optionally have a space, and / or an opening and / or a notch between adjacent positions 170, to define a communication port to allow blood to enter the annular pocket. For example, end 154 may have a cast and / or notched and / or cut and / or wavy edge to define such communication ports.
    [00100] The upper crown 18 can act as a sealing support. For example, the fixing positions 168 can directly support the second skirt part 162. Additionally or alternatively, when the upper crown 18 is unfolded, the upper crown 18 can at least partially orient the second skirt part 162 outwardly, for example , with respect to the waist between the upper crown 18 and the lower part 16. Such an orientation can push the second skirt part 162 (i) to engage with the surrounding fabric and / or (ii) to a stretched shape defining a flap or pocket that responds to blood return pressure and / or blood return flow around the outside of the stent valve 10. The upper crown 18 (and the sealing support) can comprise support elements. The support elements can be flexible independently of each other. Each support element can have a U or V shape. Each support element can comprise a pair of stringers that correspond to the apex of the support element.
    [00101] Fixing the end 154 to the upper crown can provide additional control over the second skirt part, otherwise free 162. Such an arrangement can facilitate, for example, the compression and loading of the stent valve 10 for implantation, and to avoid the risk that the second skirt part 162 is accidentally spilled.
    [00102] The fixing positions 168 between the end 154 of the skirt 150 and the upper crown 18 can be chosen and / or varied as desired. In the embodiment of figure 25, the fixing positions 168 can correspond to the end of the upper crown 18. In figure 24, the fixing positions 168 can correspond to an intermediate position path in the upper crown 18 (for example, between the end of the crown. upper 18, and the waist between the upper crown 18 and the lower 16).
    [00103] Figure 26 illustrates how the upper crown 18, and the skirt 150 of figure 25, can be compressed to a saved configuration when the stent valve 10 is compressed using a loading device (for example, a clamping element or a compression funnel) to load the stent valve into or into a delivery device (for example, a delivery catheter, not shown). The upper crown 18 and the second skirt part 162 can be substantially flat with the rest of the stent 12. After unfolding, the upper crown 18 and the second skirt part 162 can unfold radially outward (to the shape shown in the figure 25).
    [00104] Skirt 150 may have any desired profile shape. For example, in some embodiments, skirt 150 may have a substantially cylindrical shape. The diameter of the cylindrical shape can correspond to the maximum diameter of the lower part 16 and / or the diameter of the stent 12 (for example, upper crown 18) at the point reached by the end 154 of the skirt 150, and / or the maximum diameter of the upper crown 18 , and / or a dimension larger than the upper crown. The defined waist between the upper crown 18 and the lower part 16 and / or the oversizing of a stent 12 with respect to the size of the native valve to be replaced (typically about 1, 2 or 3 mm of oversizing), can provide an excess of skirt material capable of stretching or growing outward for sealing purposes. Additionally or alternatively, the skirt 150 can be sculpted with a non-cylindrical shape, for example, a bulb shape or a funnel shape, also to provide the excess material capable of distending or growing outward to achieve the sealing effect.
    [00105] As already described, the seals and / or skirts of any of the above modalities can be made of any suitable material. Suitable material can include biological tissue, for example, pericardium (for example, swine pericardium or bovine pericardium). or alternatively, the suitable material may include plastics (for example, PET or PEEK). Plastics can be used in the form of woven or non-woven fabric, and / or in the form of foil and / or in the form of film.
    [00106] Although the sealing arrangements have been described as alternatives, it is envisaged that any two or more of the sealing arrangements can be combined to have a synergistic effect. It will also be appreciated that the above description is merely illustrative of the illustrative forms of the invention and that many modifications and alternatives can be used within the scope of the invention.
    [00107] Any and all references to publications or other documents, including but not limited to patents, patent applications, articles, web pages, books, etc., presented in this application, are hereby incorporated by reference in their entirety.
    [00108] Illustrative modalities of devices, systems and methods have been described here. As noted elsewhere, these modalities have been described for illustrative purposes only and are not limiting. Other modalities are possible and are covered by the description, which will be apparent from the teachings contained here. Thus, the scope and scope of the description should not be limited by any of the modalities described above, but should be defined only in accordance with the claims supported by the description presented and their equivalences. In addition, the modalities of the present description may include methods, systems and devices which may additionally include any and all elements from any other methods, systems and devices described including any and all elements corresponding to the stent type valves and / or seals for type valves stent. In other words, the elements of one or other of the described modalities can be interchangeable with elements of other described modalities. In addition, one or more characteristics of the described modalities can be removed and still result in patentable matter (and this, resulting in more modalities of this description).
    权利要求:
    Claims (16)
    [0001]
    1. Stent valve for transcatheter implant to replace a heart valve, the stent valve being compressible to a compressed state for delivery, and expandable to an operational state for implantation, the stent valve comprising a stent (12), a plurality of leaflets (14) to define a prosthetic valve and a paravalvular seal (40) to seal against the surrounding tissue, wherein the seal comprises a skirt (150) at least a first skirt part (160) which is secured in relation to to the stent and at least a second skirt part (162) which is free to settle or float in relation to the stent, where the skirt is an external skirt (150) outside the stent and where the stent valve has an inlet end (164) and an outlet end (156), characterized by the fact that the stent-type valve still comprises an internal skirt (30) that communicates with the leaflets and can be transported inside the stent, being that: the outer skirt (150) is directly coupled to the inner skirt (30) in one or more coupling positions (152) spaced from one end (154) of the outer skirt closest to the outlet end (156) of the stent valve, to block blood leakage between the inner skirt (30) and outer skirt (150); the first part (160) of the outer skirt (150) extends from the single or several coupling positions (152) to the inlet end (164) of the stent valve; and the second part (162) of the outer skirt (150) extends from the single or several coupling positions (152) to the end (154) of the outer skirt closest to the outlet end (156) of the stent valve, so that the use of the second skirt part can expand outwardly to seal against the surrounding tissue under reverse pressure or reverse blood flow.
    [0002]
    2.Stent valve, according to claim 1, characterized by the fact that the inner and outer skirts partially overlap, with the outer skirt (150) extending beyond the inner skirt (30) towards end of the stent at the inlet end (164) of the stent valve.
    [0003]
    3. Stent valve according to claim 1 or 2, characterized in that the inner skirt (30) extends beyond the outer skirt (150) towards the end of the stent at the outlet end (156) of the stent valve.
    [0004]
    4.Stent valve, according to any of the vindications 1 to 3, characterized by the fact that the second part of the external skirt is coupled to the stent by one or more coupling controls (166) that prevent the eversion of the second part with skirt.
    [0005]
    5. Stent valve, according to any of the vindications 1 to 4, characterized by the fact that the second skirt part (162) of the external skirt defines a pocket or flap capable of extending outwards under reverse pressure or reverse blood flow.
    [0006]
    6. Stent valve, according to any of the vindications 1 to 5, characterized by the fact that the inner and outer skirt (30, 150) are made of biological material.
    [0007]
    7. Stent valve, according to any of the vindications 1 to 6, characterized by the fact that the inner and outer skirt (30, 150) are made of fabric.
    [0008]
    8. Stent valve, according to any of the vindications 1 to 7, characterized by the fact that the stent comprises: a lower tubular part (16), an upper crown part (18), a plurality of straight commissural supports (20) and a plurality of stabilizing arcs (22).
    [0009]
    9. Stent valve according to claim 8, characterized by the fact that the lower tubular part (16) communicates with the upper crown (18) and the commissural supports (20), where the commissural supports (20 ) are straight with respect to the upper crown part (18), and where the stabilizing arches (22) communicate with the commissural supports (20).
    [0010]
    10. Stent valve according to claim 8 or 9, characterized in that the end (154) of the outer skirt closest to the outlet end (156) of the stent is positioned on the stent waist between the ends of the part upper crown (18) and the lower tubular part (16).
    [0011]
    11. The stent valve according to claim 10, characterized by the fact that the external skirt (150) depends on the junction between the upper crown part (18) and the lower tubular part (16).
    [0012]
    12. Stent valve, according to any of the claims 7 to 10, characterized by the fact that the upper crown part presses out at least partially the second skirt part.
    [0013]
    13. The stent valve according to claim 12, characterized by the fact that the upper crown part presses out the second part at least partially, in relation to the waist between the upper crown part and the lower part.
    [0014]
    14. The stent valve according to claim 12 or 13, characterized in that the upper crown part comprises a guiding element, each guiding element comprising a pair of supporting guiding elements that are at the apex of the guidance element.
    [0015]
    15. Stent valve, according to any of the claims 7 to 11, characterized by the fact that the outer skirt (150) is positioned to leave at least a part of the upper crown (18) substantially unobstructed by the outer skirt.
    [0016]
    16. Stent valve according to claim 15, characterized by the fact that the outer skirt (150) is positioned to leave the upper crown part (18) substantially unobstructed by the outer skirt.
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    同族专利:
    公开号 | 公开日
    BR112015022526A2|2017-07-18|
    JP6272915B2|2018-01-31|
    EP3616652A1|2020-03-04|
    CA2905544A1|2014-09-18|
    AU2013382378B2|2018-03-15|
    CN105188609B|2017-11-10|
    EP2967845B1|2018-08-29|
    CN107714240A|2018-02-23|
    AU2018203018B2|2019-03-28|
    EP3357456A1|2018-08-08|
    EP2967845A1|2016-01-20|
    EP3616652B1|2020-07-29|
    CN107714240B|2021-04-02|
    AU2013382378A1|2015-10-08|
    AU2018203018A1|2018-05-17|
    CN105188609A|2015-12-23|
    CA2905544C|2020-08-18|
    JP2016509891A|2016-04-04|
    EP3777770A1|2021-02-17|
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-10-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-09-01| B09A| Decision: intention to grant|
    2020-12-15| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 25/03/2013, OBSERVADAS AS CONDICOES LEGAIS. |
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