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WO2025015252A2 - Joint dynamique basé sur une mémoire de forme pour empêcher une fuite dans des valvules cardiaques - Google Patents

Joint dynamique basé sur une mémoire de forme pour empêcher une fuite dans des valvules cardiaques Download PDF

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Publication number
WO2025015252A2
WO2025015252A2 PCT/US2024/037743 US2024037743W WO2025015252A2 WO 2025015252 A2 WO2025015252 A2 WO 2025015252A2 US 2024037743 W US2024037743 W US 2024037743W WO 2025015252 A2 WO2025015252 A2 WO 2025015252A2
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WO
WIPO (PCT)
Prior art keywords
shape
dynamic seal
memory
layer
memory layer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/037743
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English (en)
Other versions
WO2025015252A3 (fr
Inventor
Srujana JOSHI
Lakshmi Prasad Dasi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Georgia Tech Research Institute
Georgia Tech Research Corp
Original Assignee
Georgia Tech Research Institute
Georgia Tech Research Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Georgia Tech Research Institute, Georgia Tech Research Corp filed Critical Georgia Tech Research Institute
Publication of WO2025015252A2 publication Critical patent/WO2025015252A2/fr
Publication of WO2025015252A3 publication Critical patent/WO2025015252A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means

Definitions

  • the various embodiments of the present disclosure relate generally to biological vessel valves, including heart valves.
  • 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).
  • SAVR surgical aortic valve replacement
  • TAVR transcatheter aortic valve replacement
  • PVL Paravalvular Leakage
  • 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.
  • 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 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 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.
  • the shape-memory layer can comprise a plurality of shape-memory members.
  • each shape-memory member of the plurality of shape-memory members can be a spring.
  • the plurality of shape-memory members can have shapes that are spherical, cylindrical, helical, or combinations thereof.
  • 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.
  • the plurality of shape-memory members can be disposed radially around the outer surface of the inner frame.
  • 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.
  • the shape-memory layer can comprise a pseudoelastic material.
  • the pseudoelastic material can comprise nitinol.
  • the pseudoelastic material can be biocompatible.
  • the shape-memory layer can be manufactured via laser-cutting.
  • the transition from the compressed state to the expanded state can occur when the shape-memory layer reaches a threshold temperature.
  • 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.
  • 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.
  • the valve can further comprise a first fabric layer disposed around the shape-memory layer.
  • the first fabric layer can be a texturized porous fabric.
  • the texturized porous fabric can comprise polyethylene, polyethylene terephthalate, or a combination thereof.
  • the first fabric layer can be attached to the inner frame via crimping.
  • first fabric layer can be attached to the inner frame via suturing.
  • the first fabric layer can be attached to the shape-memory layer.
  • At least a portion of the shape-memory layer can be embedded into the first fabric layer.
  • valve can further comprise a second fabric layer attached to an inner surface of the inner frame.
  • the second fabric layer can be a stable non-porous fabric.
  • the stable non-porous fabric can comprise PET, Dacron, or combinations thereof.
  • the second fabric layer can be attached to the inner frame via crimping.
  • the second fabric layer can be attached to the inner frame via suturing.
  • the second fabric layer can be attached to the shape-memory layer.
  • the shape-memory layer can be embedded into the second fabric layer.
  • the shape-memory layer can be attached to the inner frame.
  • the shape-memory layer can be attached to the inner frame via crimping.
  • the shape-memory layer can be intertwined with the inner frame.
  • the shape-memory layer can comprise an absorbent material.
  • the absorbent material can comprise one or more of sponges, cotton analogues, or any combination thereof.
  • 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.
  • 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.
  • the inner wall can have an elliptical shape.
  • 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.
  • 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.
  • the dynamic seal can be a transcatheter prosthetic heart valve.
  • the vessel can be an aortic valve, mitral valve, pulmonary valve, or tricuspid valve.
  • the inner wall can be a native annulus of an aortic valve, mitral valve, pulmonary valve, or tricuspid valve.
  • Another embodiment of the present disclosure provides a method of dynamically sealing a biological vessel valve, comprising: providing any of the dynamic seals disclosed herein 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.
  • FIG. 1A illustrates a conventional biological vessel valve
  • FIG. IB illustrates a cross-sectional view of the valve looking at the valve in the direction of flow through the vessel.
  • FIG. 2A provides a dynamic seal for a biological vessel
  • 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.
  • FIG. 3A provides a dynamic seal for a biological vessel
  • 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.
  • FIGS. 4A-B illustrate exemplary sphere and spring shape memory elements, respectively, in accordance with some embodiments of the present disclosure.
  • 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.
  • 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.
  • substantially free of something can include both being “at least substantially free” of something, or “at least substantially pure”, and being “completely free” of something, or “completely pure”.
  • “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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the inner wall 105 of the vessel 100 can define an elliptical shape (as shown in FIG. 2B).
  • 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.
  • the shape-memory layer 126 can comprise many different shape-memory materials known in the art.
  • the shape-memory layer can comprise a pseudoelastic material, such as nitinol, which can be biocompatible.
  • the shape memory layer 126 can be many different sizes and/or shapes, in accordance with various embodiments of the present disclosure.
  • the shape-memory layer 126 can be manufactured via a number of techniques, e.g., laser-cutting, to achieve the various sizes and shapes.
  • the shape-memory layer can comprise an absorbent material, including, but not limited to, sponges, cotton, the like, or combinations thereof.
  • the shape-memory layer 126 can comprise one or more shape-memory sublayers.
  • the sublayers can be formed of different materials/components.
  • the shape memory layer 126 can comprise a first contiguous sublayer and a second sublayer comprising a plurality of shape-memory members 125.
  • the sublayers can be coaxial with one another.
  • 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.
  • the shape-memory layer 126 can be intertwined with the inner frame 110.
  • 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.
  • 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.
  • 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.
  • the plurality of shape-memory members 125 can be disposed radially around the outer surface 111 of the inner frame 110.
  • 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.
  • 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.
  • 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.
  • 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.
  • the gap sizes and gap quantity can vary over time, i.e., can be temporally dynamic.
  • 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.
  • 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.
  • the shape memory layer 126 can be in the compressed state at a first temperature prior to be inserted into the vessel 100 of a subject.
  • 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.
  • heat from the blood can cause the shape-memory layer 126 to transition from the compressed state to the expanded state.
  • 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.
  • the dynamic seal can further comprise one or more layers of fabric 130 135.
  • 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.
  • 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.
  • a portion of the first fabric layer 135 can wrap around portions of the shape memory layer 126 and connect to the frame 110.
  • the first fabric layer 135 can be attached to the shape-memory layer 126.
  • at least a portion of the shape-memory layer 126 can be embedded into the first fabric layer 135.
  • 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.
  • 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.
  • 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.
  • 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.
  • the valve can be utilized as a surgical or a transcatheter prosthetic heart valve.
  • the seal can be utilized to treat aneurisms.
  • the biological vessel can be many different vessels, including, but not limited to an aortic valve, mitral valve, pulmonary valve, or tricuspid valve.
  • 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.
  • 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.
  • Embodiment 2 The dynamic seal of Embodiment 1, wherein the shape-memory layer comprises a plurality of shape-memory members.
  • Embodiment 3 The dynamic seal of Embodiment 2, wherein each shape-memory member of the plurality of shape-memory members is a spring.
  • 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.
  • 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.
  • 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.
  • 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.
  • Embodiment 8 The dynamic seal of any of Embodiments 1-7, wherein the shapememory layer comprises a pseudoelastic material.
  • Embodiment 9 The dynamic seal of Embodiment 8, wherein the pseudoelastic material comprises nitinol.
  • Embodiment 10 The dynamic seal of any of Embodiments 8-9, wherein the pseudoelastic material is biocompatible.
  • Embodiment 11 The dynamic seal of any of Embodiments 1-10, wherein the shapememory layer is manufactured via laser-cutting.
  • 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.
  • 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.
  • 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.
  • Embodiment 15 The dynamic seal of any of Embodiments 1-14, further comprising a first fabric layer disposed around the shape-memory layer.
  • Embodiment 16 The dynamic seal of Embodiment 15, wherein the first fabric layer is a texturized porous fabric.
  • Embodiment 17 The dynamic seal of Embodiment 16, wherein the texturized porous fabric comprises polyethylene, polyethylene terephthalate, or a combination thereof.
  • Embodiment 18 The dynamic seal of any of Embodiments 15-17, wherein the first fabric layer is attached to the inner frame via crimping.
  • Embodiment 19 The dynamic seal of any of Embodiments 15-17, wherein the first fabric layer is attached to the inner frame via suturing.
  • Embodiment 20 The dynamic seal of any of Embodiments 15-19, wherein the first fabric layer is attached to the shape-memory layer.
  • 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.
  • 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.
  • Embodiment 23 The dynamic seal of Embodiment 22, wherein the second fabric layer is a stable non-porous fabric.
  • Embodiment 24 The dynamic seal of Embodiment 23, wherein the stable non-porous fabric comprises PET, Dacron, or combinations thereof.
  • Embodiment 25 The dynamic seal of any of Embodiments 22-24, wherein the second fabric layer is attached to the inner frame via crimping.
  • Embodiment 26 The dynamic seal of any of Embodiments 22-24, wherein the second fabric layer is attached to the inner frame via suturing.
  • Embodiment 27 The dynamic seal of any of Embodiments 22-26, wherein the second fabric layer is attached to the shape-memory layer.
  • 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.
  • Embodiment 29 The dynamic seal of any of Embodiments 1-28, wherein the shapememory layer is attached to the inner frame.
  • Embodiment 30 The dynamic seal of any of Embodiments 1-28, wherein the shapememory layer is attached to the inner frame via crimping.
  • Embodiment 31 The dynamic seal of any of Embodiments 1-29, wherein the shapememory layer is intertwined with the inner frame.
  • Embodiment 32 The dynamic seal of any of Embodiments 1-31, wherein the shapememory layer comprises an absorbent material.
  • Embodiment 33 The dynamic seal of Embodiment 32, wherein the absorbent material comprises one or more of sponges, cotton analogues, or any combination thereof.
  • 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.
  • 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.
  • Embodiment 36 The dynamic seal of any of Embodiments 1-35, wherein the inner wall has an elliptical shape.
  • 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.
  • 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.
  • Embodiment 39 The dynamic seal of any of Embodiments 1-38, wherein the dynamic seal is a transcatheter prosthetic heart valve.
  • 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.
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Joint dynamique pour un vaisseau biologique comprenant un cadre interne et une couche à mémoire de forme. Le cadre interne peut présenter une forme annulaire et comprendre une surface externe. La couche à mémoire de forme peut être disposée autour d'une surface externe du cadre interne. La couche à mémoire de forme peut être configurée pour passer d'un état compressé à un état étendu. Le joint dynamique peut être configuré pour être inséré dans un récipient, de telle sorte que lorsque la couche à mémoire de forme est dans l'état comprimé, au moins un espace est présent entre la couche à mémoire de forme et une paroi interne du récipient, et la couche à mémoire de forme est configurée pour passer à l'état déployé afin de remplir l'au moins un espace.
PCT/US2024/037743 2023-07-12 2024-07-12 Joint dynamique basé sur une mémoire de forme pour empêcher une fuite dans des valvules cardiaques Pending WO2025015252A2 (fr)

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US202363513199P 2023-07-12 2023-07-12
US63/513,199 2023-07-12

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WO2025015252A2 true WO2025015252A2 (fr) 2025-01-16
WO2025015252A3 WO2025015252A3 (fr) 2025-06-12

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