Shape memory based dynamic seal to prevent leakage in heart valves

Abstract

A dynamic seal for a biological vessel, comprising an inner frame and a shape memory layer. The inner frame can have an annular shape and can comprise an outer surface. The shape¬ memory layer can be disposed around an outer surface of the inner frame. The shape-memory layer can be configured to transition between a compressed state and an expanded state. The dynamic seal can be configured to be inserted into a vessel, such that when the shape-memory layer is in the compressed state, at least one gap is present between the shape-memory layer and an inner wall of the vessel, and the shape-memory layer is configured to transition to the expanded state to fill the at least one gap.

Description

SHAPE MEMORY BASED DYNAMIC SEAL TO PREVENT LEAKAGE IN HEART VALVESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 513,199, filed on 12 July 2023, which is incorporated herein by reference in its entirety as if fully set forth below.FIELD OF THE DISCLOSURE

[0002] The various embodiments of the present disclosure relate generally to biological vessel valves, including heart valves.BACKGROUND

[0003] Aortic stenosis - narrowing of the aortic valve opening - is one of the most common heart valve diseases, affecting around 1.5 million people in the United States and approximately 9 million people worldwide. The standard treatment for most patients with severe aortic stenosis is surgical aortic valve replacement (SAVR). In recent years, transcatheter aortic valve replacement (TAVR) has now overtaken open heart surgery as the preferred approach for the oldest and most frail patients at high risk of surgery. One of the highest reasons for all-cause mortality with TAVR implants is Paravalvular Leakage (PVL). This problem is shown in FIGS. 1 A-B. The valve comprises a frame 110 having an outer wall 111. When the valve is placed in a vessel 100 PVL occurs through the gaps 120 between the native valve annulus 105 of the vessel 100 and the outer wall of the frame 111 and can cause stroke and silent death post treatment. PVL, which constitutes an important factor in patient’s mortality can either be central or paravalvular and recently supraskirtal. Studies have shown that it occurs in 8-18% of the patients who undergo valve replacement surgery. The risk of the occurrence of paravalvular leakage increases in the presence of calcification of the native annulus and prosthesis malposition and the deployment of an undersized valve selection. Despite newer designs of the valves, PVLs continue to be a main concern.BRIEF SUMMARY

[0004] An exemplary embodiment of the present disclosure provides a dynamic seal for a biological vessel valve, comprising an inner frame and a shape memory layer. The inner framecan have an annular shape and can comprise an outer surface. The shape-memory layer can be disposed around an outer surface of the inner frame. The shape-memory layer can be configured to transition between a compressed state and an expanded state. The dynamic seal can be configured to be attached onto a prosthetic valve and inserted into a vessel, such that when the shape-memory layer is in the compressed state, at least one gap is present between the shape-memory layer and an inner wall of the vessel, and the shape-memory layer is configured to transition to the expanded state to fill the at least one gap.

[0005] In any of the embodiments disclosed herein, the shape-memory layer can comprise a plurality of shape-memory members.

[0006] In any of the embodiments disclosed herein, each shape-memory member of the plurality of shape-memory members can be a spring.

[0007] In any of the embodiments disclosed herein, the plurality of shape-memory members can have shapes that are spherical, cylindrical, helical, or combinations thereof.

[0008] In any of the embodiments disclosed herein, at least one shape-memory member of the plurality of shape-memory members can be configured to be intertwined with at least one other shape-memory member of the plurality of shape-memory members.

[0009] In any of the embodiments disclosed herein, the plurality of shape-memory members can be disposed radially around the outer surface of the inner frame.

[0010] In any of the embodiments disclosed herein, at least one shape-memory member of the plurality of shape-memory members can be configured to transition from the compressed state to the expanded state independent of other shape-memory members of the plurality of shape-memory members.

[0011] In any of the embodiments disclosed herein, the shape-memory layer can comprise a pseudoelastic material.

[0012] In any of the embodiments disclosed herein, the pseudoelastic material can comprise nitinol.

[0013] In any of the embodiments disclosed herein, the pseudoelastic material can be biocompatible.

[0014] In any of the embodiments disclosed herein, the shape-memory layer can be manufactured via laser-cutting.

[0015] In any of the embodiments disclosed herein, the transition from the compressed state to the expanded state can occur when the shape-memory layer reaches a threshold temperature.

[0016] In any of the embodiments disclosed herein, the at least one gap can be characterized by a gap size and a gap quantity, wherein the gap size and gap quantity are temporally dynamic.

[0017] In any of the embodiments disclosed herein, the shape-memory layer in the expanded state can be further configured to expand based at least in part on temporal changes to the gap size and the gap quantity.

[0018] In any of the embodiments disclosed herein, the valve can further comprise a first fabric layer disposed around the shape-memory layer.

[0019] In any of the embodiments disclosed herein, the first fabric layer can be a texturized porous fabric.

[0020] In any of the embodiments disclosed herein, the texturized porous fabric can comprise polyethylene, polyethylene terephthalate, or a combination thereof.

[0021] In any of the embodiments disclosed herein, the first fabric layer can be attached to the inner frame via crimping.

[0022] In any of the embodiments disclosed herein, wherein the first fabric layer can be attached to the inner frame via suturing.

[0023] In any of the embodiments disclosed herein, the first fabric layer can be attached to the shape-memory layer.

[0024] In any of the embodiments disclosed herein, at least a portion of the shape-memory layer can be embedded into the first fabric layer.

[0025] In any of the embodiments disclosed herein, the valve can further comprise a second fabric layer attached to an inner surface of the inner frame.

[0026] In any of the embodiments disclosed herein, the second fabric layer can be a stable non-porous fabric.

[0027] In any of the embodiments disclosed herein, the stable non-porous fabric can comprise PET, Dacron, or combinations thereof.

[0028] In any of the embodiments disclosed herein, the second fabric layer can be attached to the inner frame via crimping.

[0029] In any of the embodiments disclosed herein, the second fabric layer can be attached to the inner frame via suturing.

[0030] In any of the embodiments disclosed herein, the second fabric layer can be attached to the shape-memory layer.

[0031] In any of the embodiments disclosed herein, at least a portion of the shape-memory layer can be embedded into the second fabric layer.

[0032] In any of the embodiments disclosed herein, the shape-memory layer can be attached to the inner frame.

[0033] In any of the embodiments disclosed herein, the shape-memory layer can be attached to the inner frame via crimping.

[0034] In any of the embodiments disclosed herein, the shape-memory layer can be intertwined with the inner frame.

[0035] In any of the embodiments disclosed herein, the shape-memory layer can comprise an absorbent material.

[0036] In any of the embodiments disclosed herein, the absorbent material can comprise one or more of sponges, cotton analogues, or any combination thereof.

[0037] In any of the embodiments disclosed herein, the shape-memory layer can comprise one or more shape-memory sublayers, wherein the one or more shape-memory sublayers can be coaxial, wherein each of the one or more shape-memory sublayers can comprise a plurality of shape-memory members.

[0038] In any of the embodiments disclosed herein, the inner wall can be further characterized by the presence of calcific structures, wherein the quantity and size of the at least one gap can be based at least in part on the presence of calcific structures.

[0039] In any of the embodiments disclosed herein, the inner wall can have an elliptical shape.

[0040] In any of the embodiments disclosed herein, the shape-memory layer can be configured to transition from the compressed state to the expanded state based at least in part on contact with blood.

[0041] In any of the embodiments disclosed herein, the valve can further comprise a cover configured to cause the shape-memory layer to remain in the compressed state, wherein removal of the cover can cause the shape-memory layer to transition to the expanded state.

[0042] In any of the embodiments disclosed herein, the dynamic seal can be a transcatheter prosthetic heart valve.

[0043] In any of the embodiments disclosed herein, the vessel can be an aortic valve, mitral valve, pulmonary valve, or tricuspid valve.

[0044] In any of the embodiments disclosed herein, the inner wall can be a native annulus of an aortic valve, mitral valve, pulmonary valve, or tricuspid valve.

[0045] Another embodiment of the present disclosure provides a method of dynamically sealing a biological vessel valve, comprising: providing any of the dynamic seals disclosedherein in the compressed state; inserting the biological vessel valve into a vessel of a subject, such that the at least one gap is present between the shape-memory layer of the biological vessel valve and the inner wall of the vessel; and dynamically expanding the shape-memory layer to the expanded state to fill the at least one gap.

[0046] These and other aspects of the present disclosure are described in the Detailed Description below and the accompanying drawings. Other aspects and features of embodiments will become apparent to those of ordinary skill in the art upon reviewing the following description of specific, exemplary embodiments in concert with the drawings. While features of the present disclosure may be discussed relative to certain embodiments and figures, all embodiments of the present disclosure can include one or more of the features discussed herein. Further, while one or more embodiments may be discussed as having certain advantageous features, one or more of such features may also be used with the various embodiments discussed herein. In similar fashion, while exemplary embodiments may be discussed below as device, system, or method embodiments, it is to be understood that such exemplary embodiments can be implemented in various devices, systems, and methods of the present disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0047] The following detailed description of specific embodiments of the disclosure will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the disclosure, specific embodiments are shown in the drawings. It should be understood, however, that the disclosure is not limited to the precise arrangements and instrumentalities of the embodiments shown in the drawings.

[0048] FIG. 1A illustrates a conventional biological vessel valve, and FIG. IB illustrates a cross-sectional view of the valve looking at the valve in the direction of flow through the vessel.

[0049] FIG. 2A provides a dynamic seal for a biological vessel, and FIG. 2B provides a schematic cross-sectional view of a portion of the seal looking at the seal in the direction of flow through the vessel, in accordance with some embodiments of the present disclosure.

[0050] FIG. 3A provides a dynamic seal for a biological vessel, and FIG. 3B provides a cross-sectional view of the seal looking at the seal in the direction of flow through the vessel, in accordance with some embodiments of the present disclosure.

[0051] FIGS. 4A-B illustrate exemplary sphere and spring shape memory elements, respectively, in accordance with some embodiments of the present disclosure.

[0052] FIG. 5 provides a flow chart for a method of dynamically sealing a biological vessel valve, in accordance with some embodiments of the present disclosure.DETAILED DESCRIPTION

[0053] Although preferred exemplary embodiments of the disclosure are explained in detail, it is to be understood that other exemplary embodiments are contemplated. Accordingly, it is not intended that the disclosure is limited in its scope to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other exemplary embodiments and of being practiced or carried out in various ways. Also, in describing the preferred exemplary embodiments, specific terminology will be resorted to for the sake of clarity.

[0054] To facilitate an understanding of the principles and features of the present disclosure, various illustrative embodiments are explained below. The components, steps, and materials described hereinafter as making up various elements of the embodiments disclosed herein are intended to be illustrative and not restrictive. Many suitable components, steps, and materials that would perform the same or similar functions as the components, steps, and materials described herein are intended to be embraced within the scope of the disclosure. Such other components, steps, and materials not described herein can include, but are not limited to, similar components or steps that are developed after development of the embodiments disclosed herein.

[0055] As used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise.

[0056] Also, in describing the preferred exemplary embodiments, terminology will be resorted to for the sake of clarity. It is intended that each term contemplates its broadest meaning as understood by those skilled in the art and includes all technical equivalents which operate in a similar manner to accomplish a similar purpose.

[0057] Ranges can be expressed herein as from “about” or “approximately” one particular value and / or to “about” or “approximately” another particular value. When such a range is expressed, another exemplary embodiment includes from the one particular value and / or to the other particular value.

[0058] Similarly, as used herein, “substantially free” of something, or “substantially pure”, and like characterizations, can include both being “at least substantially free” of something, or “at least substantially pure”, and being “completely free” of something, or “completely pure”.

[0059] By “comprising” or “containing” or “including” is meant that at least the named compound, member, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if the other such compounds, material, particles, method steps have the same function as what is named.

[0060] Mention of one or more method steps does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. Similarly, it is also to be understood that the mention of one or more components in a device or system does not preclude the presence of additional components or intervening components between those components expressly identified.

[0061] The materials described as making up the various members of the invention are intended to be illustrative and not restrictive. Many suitable materials that would perform the same or a similar function as the materials described herein are intended to be embraced within the scope of the invention. Such other materials not described herein can include, but are not limited to, for example, materials that are developed after the time of the development of the invention.

[0062] Reference will now be made in detail to exemplary embodiments of the disclosed technology, examples of which are illustrated in the accompanying drawings and disclosed herein. Wherever convenient, the same references numbers will be used throughout the drawings to refer to the same or like parts.

[0063] As discussed above, a problem with conventional prosthetic valves, e.g., heart valves, is that that they routinely lead to PVL. To overcome this disadvantage, some embodiments of the present disclosure utilize shape memory based dynamic seal designed to sit around the prosthesis annulus and activate immediately upon deployment to provide for a complete and reliable annular seal, thus reducing PVL. In addition to aortic disease, the shape memory can be used for different transcatheter and surgical heart valve applications and for other valvular diseases affecting the aortic, mitral, pulmonary and tricuspid valves.

[0064] FIG. 1 illustrates a conventional heart valve disposed in a vessel 100. The vessel 100 has a native annulus 105 in which the valve is disposed. The valve can comprise a frame 110 having an annular shape. As shown in FIG. 1, one or more gaps 120 can be present between the outer wall 1 11 of the frame 110 and the inner wall 105 of the annulus of the vessel 100. These gaps can allow for PVL.

[0065] To overcome this problem, as shown in FIGS. 2A-B and 3A-B, some embodiments of the present disclosure further comprise a shape-memory layer 126 disposed around an outer surface 111 of the frame 110 (e.g., around a portion of the outer surface). The shape-memory layer 126 can be configured to transition between a compressed state and an expanded state. For example, the seal can be utilized with a prosthetic valve and inserted into a biological vessel 100 when the shape memory layer 126 is in the compressed state. After insertion, the shapememory layer 126 can transition to the expanded state to fill one or more gaps 120 between the outer wall 11 1 of the frame 110 and the inner wall 105 of the vessel 1 10.

[0066] The shape-memory layer 126 can be configured such that the seal can be used in many different vessels having many different shapes, thus creating varying numbers and sizes of gaps between the outer wall of the frame 111 and the inner wall 105 of the vessel 100. For example, in some embodiments, the inner wall 105 of the vessel 100 can define an elliptical shape (as shown in FIG. 2B). Further, the annulus of the vessel can define varying shapes due to the presence of calcific structures along the inner wall 105 of the vessel 110. These calcific structures can further define the quantity and size of the gaps 120.

[0067] The shape-memory layer 126 can comprise many different shape-memory materials known in the art. In some embodiments, the shape-memory layer can comprise a pseudoelastic material, such as nitinol, which can be biocompatible.

[0068] The shape memory layer 126 can be many different sizes and / or shapes, in accordance with various embodiments of the present disclosure. In some embodiments, the shape-memory layer 126 can be manufactured via a number of techniques, e.g., laser-cutting, to achieve the various sizes and shapes.

[0069] In some embodiments, the shape-memory layer can comprise an absorbent material, including, but not limited to, sponges, cotton, the like, or combinations thereof.

[0070] Further, in some embodiments, the shape-memory layer 126 can comprise one or more shape-memory sublayers. The sublayers can be formed of different materials / components. For example, the shape memory layer 126 can comprise a first contiguous sublayer and a second sublayer comprising a plurality of shape-memory members 125. In some embodiments, the sublayers can be coaxial with one another.

[0071] In some embodiments, the shape-memory layer 126 can be attached to the frame 110. The attachment of the shape-memory layer 126 to the frame 110 can occur via many means known in the art, including, but not limited to, crimping, suturing, and the like. In some embodiments, the shape-memory layer 126 can be intertwined with the inner frame 110.

[0072] The shape-memory layer 126 can comprise a plurality of shape-memory members 125 that together can form the shape-memory layer 126. The shape memory members 125 can be many different sizes and / or shapes, including, but not limited to, spherical, cylindrical, helical, or combinations thereof. In some embodiments, one or more of the shape-memory members 125 can be in the form of a spherical spring, as shown in FIG. 4A, or an elongated spring, as shown in FIG. 4B.

[0073] In some embodiments, one or more of the plurality of shape-memory members 125 can be intertwined with one or more other shape-memory members. The intertwining of the members 125 can create the shape-memory layer.

[0074] In some embodiments, as shown in FIG. 2, the plurality of shape-memory members 125 can be disposed radially around the outer surface 111 of the inner frame 110. In some embodiments, the shape-memory members 125 (or shape memory layer 126) can be disposed radially round the entirety of the outer surface 111 of the inner frame 110, and in some embodiments, the shape-memory members 125 (or shape-memory layer 126) can be disposed radially around only a portion of the outer surface 111 of the inner frame 110.

[0075] In some embodiments, at least one shape-memory member of the plurality of shapememory members 125 can be configured to transition from the compressed state to the expanded state independent of other shape-memory members of the plurality of shape-memory members 125. For example, a first portion of shape members can transition from the compressed state to the expanded state, while a second portion of shape members can remain in the compressed state. This can allow for expansion of only those shape members needed to fill any gaps 120, while other shape members can remain compressed. This can also be advantageous because the size and quantity of gaps 120 can be different for various vessels and persons. Thus, the shape-memory layer 126 (comprising the shape memory members 125) can expand based on the gap size and gap quantity for the particular application.

[0076] Additionally, in some applications, the gap sizes and gap quantity can vary over time, i.e., can be temporally dynamic. Thus, in some embodiments, the expansion of the shapememory layer 126 or shape memory members 125 can correspond with the temporal changes to the size and quantity of gaps 120. This can prevent leakage around the valve over time as the gap properties change.

[0077] In some embodiments, the transition of the shape-memory layer 126 (or shape memory members 125) from the compressed state to the expanded state can occur when the shape-memory layer 126 reaches a threshold temperature. For example, the shape memorylayer 126 can be in the compressed state at a first temperature prior to be inserted into the vessel 100 of a subject. When inserted into the vessel 100, the vessel 100 can increase the temperature of the shape-memory layer 126 (e.g., due to body heat of the subject) causing expansion of the shape-memory layer 126. For example, in some embodiments, when the valve is exposed to blood, heat from the blood can cause the shape-memory layer 126 to transition from the compressed state to the expanded state.

[0078] In some embodiments, the seal can further comprise a cover (not shown) surrounding at least a portion of the shape-memory layer 126. The cover can cause the shape-memory layer 126 to remain in the compressed state. After insertion into the vessel 100, the cover can be removed, allowing the shape-memory layer 126 to transition to the expanded state.

[0079] In any of the embodiments disclosed herein, the dynamic seal can further comprise one or more layers of fabric 130 135. In some embodiments, a first fabric layer 135 can be disposed around the shape-memory layer 126. The first fabric layer 135 can be many different fabrics, including, but not limited to, a texturized porous fabric. The texturized porous fabric can comprise polyethylene, polyethylene terephthalate, or a combination thereof. In some embodiments, the first fabric layer 135 can be attached to the frame, via many methods known in the art, including, but not limited to, crimping, suturing, and the like. For example, a portion of the first fabric layer 135 can wrap around portions of the shape memory layer 126 and connect to the frame 110. In some embodiments, the first fabric layer 135 can be attached to the shape-memory layer 126. In some embodiments, at least a portion of the shape-memory layer 126 can be embedded into the first fabric layer 135.

[0080] In some embodiments, the valve can further comprise a second fabric layer 130 attached to an inner surface of the inner frame 110. The second fabric layer 130 can be many fabrics known in the art, including, but not limited to, a stable non-porous fabric. In some embodiments, the stable non-porous fabric can comprise PET, Dacron, or combinations thereof. The second fabric layer 130 can be attached to the inner frame 110 many ways known in the art, including but not limited to crimping, suturing, and the like. In some embodiments, the second fabric layer 130 can be attached to the shape-memory layer 126. In some embodiments, at least a portion of the shape-memory layer 126 can be embedded into the second fabric layer 130.

[0081] The dynamic seals disclosed herein can be utilized in many different applications where it can be desirable to prevent / limit valve leakage in a biological vessel 100. For example, the valve can be utilized as a surgical or a transcatheter prosthetic heart valve. In someembodiment, the seal can be utilized to treat aneurisms. Accordingly, the biological vessel can be many different vessels, including, but not limited to an aortic valve, mitral valve, pulmonary valve, or tricuspid valve.

[0082] Another embodiment of the present disclosure provides a method 200 of dynamically sealing a biological vessel valve. The method 200 can comprise providing any of the dynamic seals disclosed herein in the compressed state 205. The method can further comprise inserting the dynamic seal into a vessel 100 of a subject, such that the at least one gap 120 is present between the shape-memory layer 126 of the dynamic seal and the inner wall 105 of the vessel 210. The method can further comprise dynamically expanding the shape-memory layer 126 to the expanded state to fill the at least one gap 215.

[0083] The disclosed technology can further be described according to the following embodiments:

[0084] Embodiment 1 : A dynamic seal for a biological vessel, comprising: an inner frame having an annular shape, the inner frame comprising an outer surface; and a shape-memory layer disposed around an outer surface of the inner frame, the shapememory layer configured to transition between a compressed state and an expanded state, wherein the dynamic seal is configured to be inserted into a vessel, such that when the shape-memory layer is in the compressed state, at least one gap is present between the shapememory layer and an inner wall of the vessel, and the shape-memory layer is configured to transition to the expanded state to fill the at least one gap.

[0085] Embodiment 2: The dynamic seal of Embodiment 1, wherein the shape-memory layer comprises a plurality of shape-memory members.

[0086] Embodiment 3 : The dynamic seal of Embodiment 2, wherein each shape-memory member of the plurality of shape-memory members is a spring.

[0087] Embodiment 4: The dynamic seal of any of Embodiments 2-3, wherein the plurality of shape-memory members have shapes that are spherical, cylindrical, helical, or combinations thereof.

[0088] Embodiment 5 : The dynamic seal of any of Embodiments 2-4, wherein at least one shape-memory member of the plurality of shape-memory members is configured to be intertwined with at least one other shape-memory member of the plurality of shape-memory members.

[0089] Embodiment 6: The dynamic seal of any of Embodiments 2-5, wherein the plurality of shape-memory members are disposed radially around the outer surface of the inner frame.

[0090] Embodiment 7 : The dynamic seal of any of Embodiments 2-6, wherein at least one shape-memory member of the plurality of shape-memory members is configured to transition from the compressed state to the expanded state independent of other shape-memory members of the plurality of shape-memory members.

[0091] Embodiment 8: The dynamic seal of any of Embodiments 1-7, wherein the shapememory layer comprises a pseudoelastic material.

[0092] Embodiment 9: The dynamic seal of Embodiment 8, wherein the pseudoelastic material comprises nitinol.

[0093] Embodiment 10: The dynamic seal of any of Embodiments 8-9, wherein the pseudoelastic material is biocompatible.

[0094] Embodiment 11 : The dynamic seal of any of Embodiments 1-10, wherein the shapememory layer is manufactured via laser-cutting.

[0095] Embodiment 12: The dynamic seal of any of Embodiments 1-11, wherein the transition from the compressed state to the expanded state occurs when the shape-memory layer reaches a threshold temperature.

[0096] Embodiment 13: The dynamic seal of any of Embodiments 1-12, wherein the at least one gap is characterized by a gap size and a gap quantity, wherein the gap size and gap quantity are temporally dynamic.

[0097] Embodiment 14: The dynamic seal of Embodiment 13, wherein the shape-memory layer in the expanded state is further configured to expand based at least in part on temporal changes to the gap size and the gap quantity.

[0098] Embodiment 15: The dynamic seal of any of Embodiments 1-14, further comprising a first fabric layer disposed around the shape-memory layer.

[0099] Embodiment 16: The dynamic seal of Embodiment 15, wherein the first fabric layer is a texturized porous fabric.

[0100] Embodiment 17: The dynamic seal of Embodiment 16, wherein the texturized porous fabric comprises polyethylene, polyethylene terephthalate, or a combination thereof.

[0101] Embodiment 18: The dynamic seal of any of Embodiments 15-17, wherein the first fabric layer is attached to the inner frame via crimping.

[0102] Embodiment 19: The dynamic seal of any of Embodiments 15-17, wherein the first fabric layer is attached to the inner frame via suturing.

[0103] Embodiment 20: The dynamic seal of any of Embodiments 15-19, wherein the first fabric layer is attached to the shape-memory layer.

[0104] Embodiment 21 : The dynamic seal of any of Embodiments 15-20, wherein at least a portion of the shape-memory layer is embedded into the first fabric layer.

[0105] Embodiment 22: The dynamic seal of any of Embodiments 15-21, further comprising a second fabric layer attached to an inner surface of the inner frame.

[0106] Embodiment 23: The dynamic seal of Embodiment 22, wherein the second fabric layer is a stable non-porous fabric.

[0107] Embodiment 24: The dynamic seal of Embodiment 23, wherein the stable non-porous fabric comprises PET, Dacron, or combinations thereof.

[0108] Embodiment 25 : The dynamic seal of any of Embodiments 22-24, wherein the second fabric layer is attached to the inner frame via crimping.

[0109] Embodiment 26: The dynamic seal of any of Embodiments 22-24, wherein the second fabric layer is attached to the inner frame via suturing.

[0110] Embodiment 27 : The dynamic seal of any of Embodiments 22-26, wherein the second fabric layer is attached to the shape-memory layer.

[0111] Embodiment 28: The dynamic seal of any of Embodiments 22-27, at least a portion of the shape-memory layer is embedded into the second fabric layer.

[0112] Embodiment 29: The dynamic seal of any of Embodiments 1-28, wherein the shapememory layer is attached to the inner frame.

[0113] Embodiment 30: The dynamic seal of any of Embodiments 1-28, wherein the shapememory layer is attached to the inner frame via crimping.

[0114] Embodiment 31 : The dynamic seal of any of Embodiments 1-29, wherein the shapememory layer is intertwined with the inner frame.

[0115] Embodiment 32: The dynamic seal of any of Embodiments 1-31, wherein the shapememory layer comprises an absorbent material.

[0116] Embodiment 33: The dynamic seal of Embodiment 32, wherein the absorbent material comprises one or more of sponges, cotton analogues, or any combination thereof.

[0117] Embodiment 34: The dynamic seal of any of Embodiments 1-33, wherein the shapememory layer comprises one or more shape-memory sublayers, wherein the one or more shapememory sublayers are coaxial, wherein each of the one or more shape-memory sublayers comprise a plurality of shape-memory members.

[0118] Embodiment 35: The dynamic seal of any of Embodiments 1-34, wherein the inner wall is further characterized by the presence of calcific structures, wherein the quantity and size of the at least one gap is based at least in part on the presence of calcific structures.

[0119] Embodiment 36: The dynamic seal of any of Embodiments 1-35, wherein the inner wall has an elliptical shape.

[0120] Embodiment 37: The dynamic seal of any of Embodiments 1-36, wherein the shapememory layer is configured to transition from the compressed state to the expanded state based at least in part on contact with blood.

[0121] Embodiment 38: The dynamic seal of any of Embodiments 1-37, further comprising a cover configured to cause the shape-memory layer to remain in the compressed state, wherein removal of the cover causes the shape-memory layer to transition to the expanded state.

[0122] Embodiment 39: The dynamic seal of any of Embodiments 1-38, wherein the dynamic seal is a transcatheter prosthetic heart valve.

[0123] Embodiment 40: The dynamic seal of any of Embodiments 1-39, wherein the vessel is an aortic valve, mitral valve, pulmonary valve, or tricuspid valve.

[0124] Embodiment 41 : The dynamic seal of any of Embodiments 1 -40, wherein the inner wall is a native annulus of an aortic valve, mitral valve, pulmonary valve, or tricuspid valve.

[0125] Embodiment 42: A method of dynamically sealing a biological vessel valve, comprising: providing the dynamic seal for a biological vessel of any of Embodiments 1-41 in the compressed state; inserting the biological vessel valve into a vessel of a subject, such that the at least one gap is present between the shape-memory layer of the biological vessel valve and the inner wall of the vessel; and dynamically expanding the shape-memory layer to the expanded state to fill the at least one gap.

[0126] It is to be understood that the embodiments and claims disclosed herein are not limited in their application to the details of construction and arrangement of the components set forth in the description and illustrated in the drawings. Rather, the description and the drawings provide examples of the embodiments envisioned. The embodiments and claims disclosed herein are further capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purposes of description and should not be regarded as limiting the claims.

[0127] Accordingly, those skilled in the art will appreciate that the conception upon which the application and claims are based may be readily utilized as a basis for the design of other structures, methods, and systems for carrying out the several purposes of the embodiments and claims presented in this application. It is important, therefore, that the claims be regarded as including such equivalent constructions.

[0128] Furthermore, the purpose of the foregoing Abstract is to enable the United States Patent and Trademark Office and the public generally, and especially including the practitioners in the art who are not familiar with patent and legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The Abstract is neither intended to define the claims of the application, nor is it intended to be limiting to the scope of the claims in any way.

Claims

What is claimed is:

1. A dynamic seal for a biological vessel, comprising: an inner frame having an annular shape, the inner frame comprising an outer surface; and a shape-memory layer disposed around an outer surface of the inner frame, the shapememory layer configured to transition between a compressed state and an expanded state, wherein the dynamic seal is configured to be inserted into a vessel, such that when the shape-memory layer is in the compressed state, at least one gap is present between the shapememory layer and an inner wall of the vessel, and the shape-memory layer is configured to transition to the expanded state to fill the at least one gap.

2. The dynamic seal of Claim 1, wherein the shape-memory layer comprises a plurality of shape-memory members.

3. The dynamic seal of Claim 2, wherein each shape-memory member of the plurality of shape-memory members is a spring.

4. The dynamic seal of Claim 2, wherein the plurality of shape-memory members have shapes that are spherical, cylindrical, helical, or combinations thereof.

5. The dynamic seal of Claim 2, wherein at least one shape-memory member of the plurality of shape-memory members is configured to be intertwined with at least one other shapememory member of the plurality of shape-memory members.

6. The dynamic seal of Claim 2, wherein the plurality of shape-memory members are disposed radially around the outer surface of the inner frame.

7. The dynamic seal of Claim 2, wherein at least one shape-memory member of the plurality of shape-memory members is configured to transition from the compressed state to the expanded state independent of other shape-memory members of the plurality of shapememory members.

8. The dynamic seal of Claim 1, wherein the shape-memory layer comprises a pseudoelastic material.

9. The dynamic seal of Claim 8, wherein the pseudoelastic material comprises nitinol.

10. The dynamic seal of Claim 8, wherein the pseudoelastic material is biocompatible.

11. The dynamic seal of Claim 1 , wherein the shape-memory layer is manufactured via laser-cutting.

12. The dynamic seal of Claim 1, wherein the transition from the compressed state to the expanded state occurs when the shape-memory layer reaches a threshold temperature.

13. The dynamic seal of Claim 1, wherein the at least one gap is characterized by a gap size and a gap quantity, wherein the gap size and gap quantity are temporally dynamic.

14. The dynamic seal of Claim 13, wherein the shape-memory layer in the expanded state is further configured to expand based at least in part on temporal changes to the gap size and the gap quantity.

15. The dynamic seal of Claim 1, further comprising a first fabric layer disposed around the shape-memory layer.

16. The dynamic seal of Claim 15, wherein the first fabric layer is a texturized porous fabric.

17. The dynamic seal of Claim 16, wherein the texturized porous fabric comprises polyethylene, polyethylene terephthalate, or a combination thereof.

18. The dynamic seal of Claim 15, wherein the first fabric layer is attached to the inner frame via crimping.

19. The dynamic seal of Claim 15, wherein the first fabric layer is attached to the inner frame via suturing.

20. The dynamic seal of Claim 15, wherein the first fabric layer is attached to the shapememory layer.

21. The dynamic seal of Claim 15, wherein at least a portion of the shape-memory layer is embedded into the first fabric layer.

22. The dynamic seal of Claim 15, further comprising a second fabric layer attached to an inner surface of the inner frame.

23. The dynamic seal of Claim 22, wherein the second fabric layer is a stable non-porous fabric.

24. The dynamic seal of Claim 23, wherein the stable non-porous fabric comprises PET, Dacron, or combinations thereof.

25. The dynamic seal of Claim 22, wherein the second fabric layer is attached to the inner frame via crimping.

26. The dynamic seal of Claim 22, wherein the second fabric layer is attached to the inner frame via suturing.

27. The dynamic seal of Claim 22, wherein the second fabric layer is attached to the shapememory layer.

28. The dynamic seal of Claim 22, at least a portion of the shape-memory layer is embedded into the second fabric layer.

29. The dynamic seal of Claim 1, wherein the shape-memory layer is attached to the inner frame.

30. The dynamic seal of Claim 1, wherein the shape-memory layer is attached to the inner frame via crimping.

31. The dynamic seal of Claim 1 , wherein the shape-memory layer is intertwined with the inner frame.

32. The dynamic seal of Claim 1, wherein the shape-memory layer comprises an absorbent material.

33. The dynamic seal of Claim 32, wherein the absorbent material comprises one or more of sponges, cotton analogues, or any combination thereof.

34. The dynamic seal of Claim 1, wherein the shape-memory layer comprises one or more shape-memory sublayers, wherein the one or more shape-memory sublayers are coaxial, wherein each of the one or more shape-memory sublayers comprise a plurality of shapememory members.

35. The dynamic seal of Claim 1, wherein the inner wall is further characterized by the presence of calcific structures, wherein the quantity and size of the at least one gap is based at least in part on the presence of calcific structures.

36. The dynamic seal of Claim 1, wherein the inner wall has an elliptical shape.

37. The dynamic seal of Claim 1, wherein the shape-memory layer is configured to transition from the compressed state to the expanded state based at least in part on contact with blood.

38. The dynamic seal of Claim 1, further comprising a cover configured to cause the shapememory layer to remain in the compressed state, wherein removal of the cover causes the shape-memory layer to transition to the expanded state.

39. The dynamic seal of Claim 1, wherein the dynamic seal is a transcatheter prosthetic heart valve.

40. The dynamic seal of Claim 1, wherein the vessel is an aortic valve, mitral valve, pulmonary valve, or tricuspid valve.

41. The dynamic seal of Claim 1 , wherein the inner wall is a native annulus of an aortic valve, mitral valve, pulmonary valve, or tricuspid valve.

42. A method of dynamically sealing a biological vessel valve, comprising:providing the dynamic seal of any of claims 1-41 in the compressed state; inserting the biological vessel valve into a vessel of a subject, such that the at least one gap is present between the shape-memory layer of the biological vessel valve and the inner wall of the vessel; and dynamically expanding the shape-memory layer to the expanded state to fill the at least one gap.

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