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WO2025024391A2 - Dispositif, systèmes et procédés pour prothèses de valvules cardiaques - Google Patents

Dispositif, systèmes et procédés pour prothèses de valvules cardiaques Download PDF

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Publication number
WO2025024391A2
WO2025024391A2 PCT/US2024/039042 US2024039042W WO2025024391A2 WO 2025024391 A2 WO2025024391 A2 WO 2025024391A2 US 2024039042 W US2024039042 W US 2024039042W WO 2025024391 A2 WO2025024391 A2 WO 2025024391A2
Authority
WO
WIPO (PCT)
Prior art keywords
frame structure
leaflets
inflow
region
valve
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/US2024/039042
Other languages
English (en)
Other versions
WO2025024391A3 (fr
Inventor
Mitchell Young
Ali Salahieh
Savina Brachthauser Balcells
Jonathan Hwan OAKDEN
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.)
Shifamed Holdings LLC
Original Assignee
Shifamed Holdings LLC
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 Shifamed Holdings LLC filed Critical Shifamed Holdings LLC
Publication of WO2025024391A2 publication Critical patent/WO2025024391A2/fr
Publication of WO2025024391A3 publication Critical patent/WO2025024391A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • 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
    • 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

  • Blood flow between heart chambers is regulated by native valves - the mitral valve, the aortic valve, the pulmonary valve, and the tricuspid valve.
  • Each of these valves is a passive one-way valve that opens and closes in response to differential pressures.
  • Patients with valvular disease have abnormal anatomy and/or function of at least one valve.
  • a valve may suffer from insufficiency, also referred to as regurgitation, when the valve does not fully close, thereby allowing blood to flow retrograde.
  • Valve stenosis can cause a valve to fail to open properly.
  • Other diseases may also lead to dysfunction of the valves.
  • the valve frame 102 can include or be attached to an internal skirt 1 16 and one or more external skirts 118.
  • the skirts can be made, for example, of a polymer, such as polyethylene terephthalate (PET). Further, the skirts described herein can be woven and/or knitted, or both, (e.g., with a denier of 15-25, such as approximately 20).
  • the internal skirt 116 can include tabs 120 or other features configured to attach the leaflets of the valve prosthesis to the valve frame, as will be described below.
  • the external skirt 118 can be configured to provide fluid impermeability, promote tissue growth in selected portions, and/or prevent tissue damage or erosion.
  • FIG. 1A shows external skirt 118 folded or wrapped over the inflow edge of the frame and secured upon itself and the valve frame via suture line 130. as will also be described in more detail below.
  • the leaflet tabs 220 and commissure tabs 222 of the internal skirt can be attached to the valve frame 202 and/or the external skirt, e g., with one or more stitches. Additionally, both the leaflet tabs and commissure tabs can be sewn or attached to the external skirt, as shown in FIG. 2D.
  • the one or more stitches shown in FIG. 2C are temporary for placement of the internal skirt on the frame, and are removed w hen the internal skirt is sewn or atached to the external skirt as shown in FIG. 2D.
  • FIG. 2A shows stitch line 227 for ataching the leaflet tabs 220 to the external skirt.
  • the leaflets can extend above or beyond the valve frame 202 in the inflow' or atrial portion of the device.
  • the leaflets extend beyond the atrial portion of the frame by a distance 228. Since the leaflet tabs of the internal skirt are atached to the nadirs of the leaflets, this distance 228 can create a gap betw een the internal skirt and the frame.
  • the leaflet tabs of the internal skirt advantageously provide support to the inflow end of the leaflets and provide a buffer between the leaflets and the frame, to prevent the leaflets from directly contacting the frame.
  • the leaflet tabs further allow for the overall height of the valve prosthesis to be reduced, since there is no need for a rigid or frame support of the leaflet nadirs on the inflow end of the device. Supporting the leaflets with the internal skirt further provides increased packing performance in crimping, easier delivery', and may allow' for reduced diameter of the device in a delivery' configuration. Furthermore, the leaflet tabs can provide for improved leaflet motion since the leaflets are not constrained by full circumferential support, but instead are only constrained along a portion of the nadir of each leaflet where the leaflet tabs extend from the leaflets and are atached to the frame.
  • FIG. 2C further shows the tabs 224 on the ventricular side of the device which are paterned so as to keep the last row of the valve frame open and un-obstructed by the internal skirt.
  • FIG. 3A shows another view of a valve prosthesis 300 having an inflow or atrial portion 306, a central w aist portion 310, and an outflow or ventricular portion 306.
  • FIG. 3 A also shows an external skirt 318 covering all or a portion of the exterior of the valve prosthesis.
  • the external skirt 318 can comprise two portions 318a and 318b.
  • the portions 318a and 318b of the external skirt can have different fabrics, materials, or properties.
  • the portions 318a and 318b can be separate portions of material that are separately stitched or atached to the valve prosthesis.
  • the two portions can have a different material or material properties, but can be a uniform or integral section of skirt (e.g., the material can transition from a weave to a knit).
  • the portion 318a of the external skirt e.g., in the atrial portion of the valve prosthesis
  • the portion 318b of the external skirt can comprise a PET warp knit (e.g.. 15-25 denier, 30 denier, etc.). A PET warp knit is less abrasive than the PET w eave.
  • the portion 318b disposed over the central/ventricular portions of the valve prosthesis can include the PET warp knit to prevent chordal erosion.
  • Portions of the device, such as the leaflets can comprise a coating configured to prevent tissue ingrowth (e.g., chronosil coating). Such a coating can help to prevent pannus formation on the leaflets.
  • FIG. 3 A also shows stitching or suturing used to attach the external skirt 318 to the valve prosthesis 300.
  • suture line 330 is shown near the inflow end of the valve frame can secure the external skirt 318 to itself and/or to the frame.
  • the external skirt such as portion 318a, can be w rapped or folded over the inflow edge of the valve frame and secured with suture line 330.
  • Portion 318b of the external skirt can be placed over portion 318a and secured to the valve frame via suture lines 332a and 332b. While two suture lines are shown, it should be understood that any number of suture lines can secure portion 318b of the external skirt to the frame and/or the portion 318a.
  • portion 318a extends axially along a portion of the frame underneath portion 318b. In other embodiments, portion 318a ends where portion 318b starts.
  • FIG. 3 A also shows suture line 327, which corresponds to sutures 227 in FIG. 2D and is used to attach tabs 220 of the internal skirt to the valve frame and/or external skirt. As is described above, these tabs provide a non-rigid attachment between the leaflets and the valve frame.
  • FIG. 3B is an interior view of the atrial portion 306, including the suture line 330 where the portion 318a of the external skirt is wrapped or folded over the inflow edge of the valve prosthesis and secured to the frame and to itself.
  • FIG. 3B also shows suture line 332a securing the portion 318b to portion 318a of the external skirt.
  • FIGS. 3C and 3D show interior views of the ventricular or outflow portion 308 of the valve prosthesis, including attachment of the internal skirt and external skirt to valve frame.
  • tabs 324 of the interior skirt 316 are sutured or stitched to the valve frame with one or more suture lines 334.
  • the suture lines form a diamond or oval shaped pattern to fully secure the tabs 324 to the entirety of a diamond or oval shaped cell of the frame.
  • the suture lines 334 may not fully encircle or encapsulate a row of frame cells, but instead secure the interior skirt to only a portion of the frame cells (e.g., a single suture line 334 of the two suture lines shown in FIGS. 3C-3D).
  • Leaflets 304 are also shown attached to the interior skirt.
  • exterior skirt 318 is folded upon itself and secured to the frame with suture line 336.
  • the suture line 336 deliberately avoids struts or portions of the frame that are immediately connected to the interior commissure attachment mechanisms of the frame. While the exterior skirt 318 is folded upon itself, it is not folded over the outflow 7 end of the frame, but instead the entirety 7 of the exterior skirt is disposed on the exterior of the valve frame. This is in contrast to the inflow edge of the frame, where the exterior skirt is folded over the frame.
  • the coverings/skirts described herein can be attached using sutures.
  • a polymer suture such as polyethylene can be used.
  • the suture comprises ultra-high molecular weight (UHMW) polyethylene.
  • UHMW ultra-high molecular weight
  • running stiches are used.
  • whip stiches are used.
  • a combination of stitching types is used, such as whip stitching on the ventricular portion of the frame and running stiches everywhere else.
  • a feature or element When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, w hen a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present.
  • the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
  • first and second may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/ element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
  • any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and/or steps may alternatively be exclusive, and may be expressed as “consisting of’ or alternatively “consisting essentially of’ the various components, steps, sub-components or sub-steps.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic 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

L'invention concerne un dispositif de traitement d'une valvule native pathologique chez un patient, qui peut comprendre une structure de cadre comprenant une région d'entrée ayant une extrémité d'entrée, une région de sortie ayant une extrémité de sortie, et une partie de taille centrale positionnée entre la région d'entrée et la région de sortie, un segment de valvule positionné radialement à l'intérieur de la structure de cadre, le segment de valvule comprenant une pluralité de feuillets valvulaires, et une jupe interne accouplée à un intérieur de la structure de cadre et au segment de valvule et s'étendant de la région d'entrée à la région de sortie, la jupe interne comprenant une pluralité de languettes de feuillets valvulaires accouplées à la pluralité de feuillets valvulaires, un bord d'entrée de chacun de la pluralité de feuillets valvulaires étant supporté uniquement par une languette de feuillet valvulaire correspondant. Le dispositif peut également comprendre une jupe externe accouplée à un extérieur de la structure de cadre.
PCT/US2024/039042 2023-07-21 2024-07-22 Dispositif, systèmes et procédés pour prothèses de valvules cardiaques Pending WO2025024391A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363515070P 2023-07-21 2023-07-21
US63/515,070 2023-07-21

Publications (2)

Publication Number Publication Date
WO2025024391A2 true WO2025024391A2 (fr) 2025-01-30
WO2025024391A3 WO2025024391A3 (fr) 2025-04-17

Family

ID=94375432

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/039042 Pending WO2025024391A2 (fr) 2023-07-21 2024-07-22 Dispositif, systèmes et procédés pour prothèses de valvules cardiaques

Country Status (1)

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WO (1) WO2025024391A2 (fr)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7914569B2 (en) * 2005-05-13 2011-03-29 Medtronics Corevalve Llc Heart valve prosthesis and methods of manufacture and use
DE202011111125U1 (de) * 2010-10-05 2020-05-20 Edwards Lifesciences Corporation Prothetische Herzklappe
US10195025B2 (en) * 2014-05-12 2019-02-05 Edwards Lifesciences Corporation Prosthetic heart valve
JP2023552745A (ja) * 2020-12-04 2023-12-19 シファメド・ホールディングス・エルエルシー 張り出し人工心弁送達デバイスおよびシステム
AU2022242802A1 (en) * 2021-03-23 2023-09-14 Edwards Lifesciences Corporation Prosthetic heart valve having elongated sealing member

Also Published As

Publication number Publication date
WO2025024391A3 (fr) 2025-04-17

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