WO2021207695A1 - Hemi-valvule cardiaque prothétique - Google Patents

Hemi-valvule cardiaque prothétique Download PDF

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Publication number
WO2021207695A1
WO2021207695A1 PCT/US2021/026710 US2021026710W WO2021207695A1 WO 2021207695 A1 WO2021207695 A1 WO 2021207695A1 US 2021026710 W US2021026710 W US 2021026710W WO 2021207695 A1 WO2021207695 A1 WO 2021207695A1
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WO
WIPO (PCT)
Prior art keywords
prosthetic
valve
leaflet
stent frame
hemi
Prior art date
Application number
PCT/US2021/026710
Other languages
English (en)
Inventor
Thuy Pham
Caitlin MARTIN
Nur HAMIDEH
Original Assignee
Sutra Medical, Inc.
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 Sutra Medical, Inc. filed Critical Sutra Medical, Inc.
Priority to CN202180036654.8A priority Critical patent/CN115867230A/zh
Priority to EP21784839.9A priority patent/EP4132427A4/fr
Priority to JP2022560890A priority patent/JP2023521684A/ja
Publication of WO2021207695A1 publication Critical patent/WO2021207695A1/fr

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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
    • 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
    • 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

Definitions

  • the application relates generally to replacement heart valves, e.g., for replacing diseased mitral and/or tricuspid valves. More particularly, embodiments of the subject matter relate to tissue-based, collapsible and expandable replacement heart valves.
  • the mitral valve has two distinct large leaflet cusps, or leaflets. As shown in Figure 1 A, the MV is on the left side of the heart and located between the left atrium and the left ventricle.
  • the mitral valve apparatus consists of a mitral annulus, two leaflets, chordae tendineae (“chords”), two papillary muscles and the left ventricular myocardium.
  • Chords chordae tendineae
  • the mitral annulus is subdivided into an anterior portion and a posterior portion. Normally, the anterior mitral leaflet (AML) is connected to the aortic valve via the aortic-mitral curtain, and the posterior mitral leaflet (PML) is hinged on the posterior mitral annulus.
  • chords originate from either the two major papillary muscles or from multiple small muscle bundles attaching to the ventricular wall and connect to the free edge of the mitral leaflets. Chords are composed mainly of collagen bundles, which give the chords high stiffness and maintain minimal extension to prevent the leaflets from billowing into the left atrium during systole.
  • mitral valve regurgitation MR
  • Mitral regurgitation is dysfunction of the mitral valve that causes an abnormal leakage of blood from the left ventricle back into the left atrium during systole (i.e., the expulsion phase of the heart cycle in which blood moves from the left ventricle into the aorta). While trivial mitral regurgitation can be present in healthy patients, moderate to severe mitral regurgitation is one of the most prevalent forms of heart valve disease. The most common causes of mitral regurgitation include ischemic heart diseases, non-ischemic heart diseases, and valve degeneration.
  • ischemic mainly due to coronary artery diseases
  • non-ischemic idiopathic dilated cardiomyopathy for example
  • mitral regurgitation the mitral valve apparatus remains normal. Incomplete coaptation of the leaflets is due to enlargement of the mitral annulus secondary to left ventricle dilation and possibly left atrium enlargement.
  • patients with functional mitral regurgitation can exhibit papillary muscle displacement due to the left ventricle enlargement, which results in excessive tethering of the leaflets.
  • degenerative (or organic) mitral regurgitation is caused by structural abnormalities of the mitral leaflets and/or the subvalvular apparatus, which can include stretching or rupture of tendinous chords.
  • mitral valve repair benefiting from improved understanding of mitral valve mechanics and function, may be now preferred to complete mitral valve replacement.
  • complex physiology and three-dimensional anatomy of the mitral valve and its surrounding structure present substantial challenges when performing these repair procedures.
  • Endovalve-Herrmann (Micro Interventional Devices, Inc.), developed a mitral prosthesis that had a foldable Nitinol-based valve with a sealing skirt.
  • Tendyne Holdings, Inc. produces a prosthetic mitral valve replacement device comprising a pericardial valve with a self-expandable Nitinol stent. The device is designed for transapical delivery and has a ventricular fixing anchor.
  • CardiAQ uses a pericardial valve with a Nitinol self- expandable stent in their mitral valve replacement device.
  • Tiara (Neovasc, Inc.) uses a mitral valve replacement system that is deliverable trans-apically with a 30 Fr catheter that has anchor structures, and a pericardial valve on a self-expandable stent with a D-shaped atrial portion and a ventricular portion that has an outer coating.
  • the noted challenges to an efficacious mitral valve replacement device generally include operative delivery challenges; positioning and fixation challenges; seal and paravalvular leakage challenges; and hemodynamic function challenges such as left ventricular outflow tract (LVOT) obstruction.
  • operative delivery challenges since a conventional mitral prosthesis is larger than a conventional aortic prosthesis, it is more difficult to fold and compress the larger mitral prosthesis into a catheter for deployment as well as retrieval through either conventional trans-apical or trans-femoral delivery techniques.
  • a good fit between the native annulus and the prosthesis that minimizes paravalvular leak is desirable.
  • a prosthetic mitral valve may have a large overhanging atrial portion or flare which can prevent leakage, but, problematically, it also requires a large valve size at the ventricular level so that the prosthesis can be tightly fitted in the native mitral valve.
  • a prosthetic mitral valve is smaller than the diseased native valve and additional material is added around the prosthetic valve to compensate for the large native mitral annulus. Undesirably, adding more material to a prosthetic valve increases the size of the delivery system.
  • the prosthetic hemi-valve comprises a plurality of dual guiding and fixation (DGF) members, described elsewhere herein, which can be configured to secure the prosthetic hemi- valve to the native mitral annulus.
  • DGF dual guiding and fixation
  • the associated methods can be configured to implant the replacement valve prosthesis and to help prevent further dilation of the native mitral annulus.
  • heart valve leaflet replacement system and the associated methods can be used or otherwise configured to be used to treat other valve disease conditions such as degenerative mitral regurgitation and replace other valves (e.g., tricuspid valve) of the human heart, or could be used or otherwise configured to be used in other mammals suffering from valve deficiencies as well.
  • valve disease conditions such as degenerative mitral regurgitation and replace other valves (e.g., tricuspid valve) of the human heart, or could be used or otherwise configured to be used in other mammals suffering from valve deficiencies as well.
  • the prosthetic hemi-valve is configurable or otherwise sizable to be crimped down to fit within a delivery sheath and to subsequently be selectively re-expanded to an operative size and position once removed from the delivery sheath within the heart.
  • at least a portion of the prosthetic hemi-valve can have a stent shape, which can comprise an upper atrial portion and a lower ventricular portion.
  • the atrial portion can be configured to facilitate anchoring of the stent, which can help prevent paravalvular leakage and dislodgement of the stent.
  • the ventricular portion can displace a diseased native leaflet out of the blood flow tract and house at least one prosthetic leaflet.
  • the prosthetic hemi-valve can comprise a lining skirt that can be coupled to at least a portion of the inner and/or outer surfaces of the stent.
  • at least one prosthetic leaflet can be mounted on the inner lumen of the stent and/or on at least a portion of the outer side of the stent, which can function in place of at least one native leaflet to restore normal valve function, i.e., to prevent mitral regurgitation.
  • At least one prosthetic leaflet of the prosthetic hemi-valve can be configured with at least one leg structure which prevents the valve leaflet from billowing into the atrium and prolapsing.
  • the at least one leg structure also acts to distribute prosthetic leaflet stress and facilitate the coaptation with at least one of the native mitral valve leaflets, in order to recreate the competent closure anatomy of a native mitral valve with sufficient leaflet coaptation length and height and proper leaflet angles during systole.
  • the delivery of the prosthetic hemi-valve can be conducted using several desired delivery access approaches, such as, for example and not meant to be limiting, a surgical approach, a trans-septal approach, a trans-atrial, or a trans-apical approach, similar to the methods disclosed in the applications incorporated by reference herein.
  • the trans-septal approach can comprise creating an opening in the internal jugular or femoral vein for the subsequent minimally invasive delivery of portions of the prosthetic hemi-valve through the superior vena cava, which flows into the right atrium of the heart.
  • the access path of the trans-septal approach crosses the atrial septum of the heart, and once achieved, the components of the prosthetic hemi-valve can operatively be positioned in the left atrium, the native mitral valve, and the left ventricle.
  • a main delivery catheter can be placed along the access path to allow desired components of the prosthetic hemi-valve to be operatively positioned in the left atrium without complications.
  • the prosthetic hemi-valve has a unique crescent-shape, forming a half- or hemi-valve.
  • the prosthetic hemi-valve is configured to have a ventricular portion that lies in the left ventricle and displaces at least one diseased native mitral leaflet.
  • An atrial portion of the hemi-valve is configured to prevent paravalvular leak and engage with DGF members to fix the entirety of the prosthetic hemi-valve on the mitral annulus.
  • An angled neck region forms a transition between the ventricular and atrial portions of the hemi-valve.
  • the stent is configured to span at least a portion, or the entirety, of the circumference of the native posterior mitral valve via a network of compressible and self-expanding diamond-shaped cells occupying a non-uniform, semi-elliptical shape with varying lengths as to avoid interfering with surrounding native valve structures.
  • the stent can assume an asymmetric, semi- conical or semi-circular cross-sectional profile.
  • the atrial portion of the stent includes a plurality of cells that assume a shape designed to conform to the native mitral annulus.
  • the atrial portion of the stent includes curved atrial stent tips so as to not interfere with the atrial wall, and a plurality of through-holes. It connects to the neck region that curves downward along the native mitral annulus and transitions to the ventricular portion of the stent.
  • the through-holes on the atrial portion of the stent are configured to accept DGF locking members to fix the prosthetic hemi-valve in place on the mitral annulus.
  • the neck region transitions from the atrial portion to the ventricular portion of the stent.
  • the ventricular portion of the stent is configured with at least one prosthetic leaflet coupled to the inner surface, which is configured to form a C-shape which can extend to a D-shape in systole in the operative position.
  • the ventricular portion of the stent can be configured with a plurality of through-holes to facilitate attachment of at least a portion of the prosthetic leaflet.
  • a plurality of tabs extends from the ventricular portion of the stent, e.g., making the stent a shape similar to a stingray.
  • the tabs can be directly extended from the tips of the stent, or coupled via an extended strut.
  • the tabs are configured to be a safety mechanism for the prosthetic valve throughout the housing, positioning, and locking process.
  • a component of the prosthetic hemi-valve is at least one dome-shaped prosthetic leaflet.
  • At least one prosthetic leaflet can be mounted to the inner surface of the ventricular portion of the stent frame, and displace at least one diseased native posterior mitral leaflet.
  • the prosthetic valve includes a plurality of dome shaped leaflets, which are configured to be flexible and mobile throughout the cardiac cycle.
  • the at least one prosthetic leaflet extends radially to form a D-shape to coapt with healthy native anterior leaflets by extending radially outwards from the stent, thus preventing transvalvular leakage and mitral regurgitation.
  • the at least one prosthetic leaflet is configured to move towards the stent in a C-shape to allow for ventricular filling.
  • the half-valve can also be crimped to a smaller profile, compared to a full-valve, allowing a greater portion of the at-risk population to undergo a transcatheter mitral valve replacement operation.
  • the at least one prosthetic leaflet can mimic the configuration of the native mitral posterior leaflets with three adjoined semilunar cusps extended from the neck portion of the stent into the ventricle, with the central cusp extending further downwards and radially inwards than the two smaller lateral cusps.
  • each prosthetic leaflet can comprise a parabolic attachment line, two commissures, a belly region, a coaptation region and optionally, at least one leg.
  • the central leaflet attachment line is configured to be symmetrical about the axial midline, with the central prosthetic leaflet spanning one- third to two-thirds of the ventricular portion of the stent.
  • the two lateral leaflets are configured to mirror each other on either side of the central leaflet, spanning one-sixth to one-third of the ventricular portion of the stent, and are asymmetric about their respective axial midlines.
  • the prosthetic valve includes a plurality of prosthetic leaflets, which are configured to have arm structures extending from the commissures that stabilize the commissure region of the prosthetic leaflets by restricting backwards motion of the prosthetic leaflet towards the stent frame during the diastolic phase of the cardiac cycle.
  • the arm structures can be configured to fold-over portions of the at least one prosthetic leaflet to increase the leaflet thickness at the commissure region. It is contemplated that, in exemplary embodiments, the arm structures can be triangular, rectangular, or irregularly shaped.
  • At least one dog-bone, rectangular, cylindrical-, or conical shaped leg structure may be provided on the prosthetic leaflet, which can be configured to attach to, and extend radially away from, the stent frame.
  • the leg structures mimic the native chordae tendineae, in that they can prevent over-extension and prolapse of the prosthetic leaflet, which is especially necessary with larger prosthetic leaflets.
  • the leg structures also serve to distribute force throughout the prosthetic leaflet and frame.
  • the prosthetic hemi-valve is configured to occupy about one-half of the mitral orifice in the D-shape configuration when coapting with the native anterior mitral leaflets.
  • the prosthetic leaflets are designed to extend radially inwards, up to the lateral edges of the stent, and not beyond.
  • a skirt is coupled to at least a portion of the inner and outer surface of the stent.
  • the skirt serves dual purposes: acting as a means to mount the prosthetic leaflets onto the ventricular portion of the stent, and also creating a paravalvular seal along the atrial portion of the stent.
  • the skirt material can be made of polymers, fabric, biological tissue, and the like.
  • An important characteristic of the skirt is that it is biaxially oriented, allowing it to stretch in both the axial and transverse direction during crimping and expansion of the prosthetic hemi-valve.
  • the skirt can be a single piece of material, or alternatively, the skirt can be configured from multiple separate pieces of material, coupled to the stent via one or more non-absorbable sutures or strings.
  • a sealing ring can be coupled to the circumference of the prosthetic hemi-valve to promote tissue ingrowth, and to protect the native mitral valve surrounding structures from abrasion by the prosthetic valve.
  • a plurality of DGF members can be operatively positioned and implanted at desired locations in the native annulus prior to the delivery of the replacement prosthetic hemi-valve.
  • the DGF members can improve the subsequent positioning and anchoring of the replacement prosthetic hemi-valve.
  • the plurality of DGF members can help prevent leakage of blood between the operatively positioned prosthesis and the native mitral valve.
  • the DGF members can comprise a permanent head and body portion with a removable flexible tail portion.
  • the DGF head member can comprise a coil shape that can be operatively embedded in the annular tissue.
  • the DGF body member can be coupled to a plurality of DGF locking members to fix the prosthetic hemi-valve device onto the native mitral annulus.
  • the DGF tail member can be configured as a tether component that extends from the proximal portion of the DGF body, and links the DGF member to the crimped prosthetic hemi-valve within the prosthetic hemi-valve delivery and implantation system.
  • the DGF member body is coupled to a plurality of DGF locking members.
  • the DGF locking members comprise a plurality of radially compressible legs, e.g., forming a cone shape.
  • the tip of the cone is configured to have a smaller diameter than the legs of the cone, and also a diameter smaller than the holes on the atrial portion of the stent, while the legs of the cone have a larger diameter than the holes on the atrial portion of the stent.
  • the DGF tails can be tensioned to pull the DGF locking members through the holes on the atrial portion of the stent, thereby compressing the legs of the DGF locking members inward to allow for the passage of the DGF locking member through the hole of the atrial portion if the stent.
  • the legs of the DGF locking members After passing through the holes in the atrial portion of the stent, the legs of the DGF locking members re-expand to their operative position, and prevent backward motion of the DGF locking member through the holes in the atrial flare portion of the stent, effectively locking the prosthetic hemi-valve in the operative position.
  • Figure 1 A is a prospective posterior cross-sectional view of the healthy native mitral valve during systole.
  • Figure 1 A shows that the mitral leaflets coapt to form a “fish-mouth” coaptation line.
  • Figure IB is a prospective view of the native mitral valve after the left ventricle has been splayed open to reveal the anatomy of the mitral leaflets: the mitral valve leaflets are divided into two portions: the anterior and posterior portions, and each portion is subdivided into three sections.
  • the posterior leaflet comprises three adjoined semi-lunar shapes, namely the PI, P2, and P3 cusps.
  • the P2 cusp is the largest and extends the furthest into the ventricle, while the PI and P3 cusps are smaller and shorter.
  • the anterior mitral leaflet similarly has regions which coapt with PI, P2, and P3, respectively, in systole.
  • Figure 2A illustrates the native mitral valve from an atrial view. It is clear that the native anterior leaflet is larger than the native posterior leaflet. The native posterior leaflet forms a C-shape along the posterior annulus.
  • FIG. 2B is a schematic view of an exemplary aspect of a prosthetic hemi- valve device including three prosthetic leaflets mounted on the inner surface of the frame in operation at a pressurized, systolic state.
  • the prosthetic PI, prosthetic P2, and prosthetic P3 are shown coapting with the native anterior mitral leaflet.
  • Figure 3 A is a schematic front view of an exemplary embodiment of a prosthetic hemi-valve frame including a plurality of cells, which may be included in a prosthetic hemi-valve, such as that shown in Figure 2B.
  • the frame comprises an upper atrial portion and a lower ventricular portion which are separated by a neck region.
  • the atrial portion of the frame has a plurality of through-holes and curved stent-tips.
  • the lower ventricular portion is configured with a plurality of through-holes for attachment of a prosthetic leaflet, and a variable stent height along its circumference.
  • Figure 3B shows an alternative embodiment of the stent frame, wherein a central extended member with a tab extends from the tip of the center cell of the ventricular portion of the stent.
  • Figure 3C shows an alternative embodiment of the stent frame, wherein a central and at least one peripheral extended member with a tab extends downward from the ventricular portion of the stent.
  • Figure 4 is a schematic view of an exemplary embodiment of a prosthetic hemi-valve in the crimped configuration.
  • the lateral free edges of the stent are configured with binding sites to engage each other during the crimping process to keep the valve in a cylindrical configuration throughout crimping.
  • the elongated member is the longest part of the crimped device, such that a portion of the delivery system can be configured to engage the tab on the tip of the elongated member without affecting the rest of the valve.
  • Figure 5 is a schematic view of an atrial skirt creating a paravalvular seal around the atrial portion of a valve, such as that the prosthetic hemi-valve of Figure 2B.
  • Figure 6 is a schematic view of a frame covered with atrial and ventricular sealing skirts and a sealing ring on both lateral edges.
  • Figure 7 is a schematic view of one embodiment of a prosthetic hemi-valve with three dome-shaped prosthetic leaflets mounted on the inner surface of a frame.
  • the assembly of prosthetic leaflets include one larger central leaflet and two smaller lateral leaflets.
  • Figure 8 shows an exemplary embodiment of a large central prosthetic leaflet which comprises a dome-shaped body, two legs, and two arms.
  • Figures 9A and 9B show examples of smaller lateral prosthetic leaflets, each including a dome-shaped body and two arms.
  • Figure 10 is a schematic ventricular view of an exemplary aspect of a prosthetic hemi-valve device showing the prosthetic leaflets at a pressurized, systolic state, overlaid with the prosthetic leaflets at an unpressurized, resting state. The prosthetic leaflets extend radially away from the frame under systolic pressure.
  • FIG 11 is a schematic view of an exemplary embodiment of a DGF member locking unit.
  • the locking unit comprises a through-hole for attachment to a tether and a plurality of legs.
  • heart valve leaflet replacement system and the associated methods can be used or otherwise configured to be used to treat other types of mitral regurgitation or to replace other diseased valves of the human heart, such as tricuspid valve, or could be used or otherwise configured to be used in other mammals suffering from valve deficiencies as well.
  • prosthetic valve and “prosthesis” and “valve stent” and “heart valve leaflet replacement device” and “valve device” are used interchangeably and is contemplated as a heart valve replacement device described herein.
  • the mitral valve leaflets consist of anterior 6 and posterior 10 leaflets, originating from the annulus and extending into the left ventricle 3.
  • anterior mitral leaflet 6 and the posterior mitral leaflet 10 come together and coapt during systole to prevent backward flow through the mitral valve 4.
  • the posterior mitral leaflet 10 forms a “C-shape” extending from the posterior annulus, as shown in Figure 2A.
  • the posterior leaflet 10 may not fully coapt with the anterior leaflet 6 due to posterior leaflet 10 tethering and/or dilation of the mitral annulus leading to mitral regurgitation.
  • FIG. 1 an exemplary embodiment of a prosthetic hemi- valve device 1 is shown that is designed to treat mitral regurgitation in patients with regurgitation and normal anterior mitral leaflet 6 motion by replacing the posterior mitral leaflet 10, e.g., as shown in Figure 2B.
  • the prosthetic hemi-valve device 1 comprises a crescent-shaped frame or stent 100 which is secured to the posterior mitral annulus and positions at least one prosthetic leaflet 200 over the native posterior leaflet 10 such that it forms a coaptation region 204 with the native anterior mitral leaflet 6 during systole in operation.
  • the prosthetic leaflet(s) 200 extend from the stent 100 to form a C-shape similar to the native posterior leaflet 10, but notably, they can extend further radially so as to coapt with the native anterior mitral valve 10 in dilated hearts.
  • the prosthetic hemi-valve device 1 can include a crescent-shaped stent 100, at least one dome-shaped prosthetic leaflet 200, and at least one sealing skirt 300 to facilitate sealing and mounting of the prosthetic leaflet 200 onto the stent 100.
  • the prosthetic hemi-valve device 1 is configured such that at least one prosthetic leaflet 200 will coapt with at least one native anterior leaflet 6 during the systolic phase of the cardiac cycle in operation, e.g., as shown in Figure 2B.
  • the stent in the expanded configuration, the stent
  • the stent 100 can define a substantially semi-circular cross-sectional profile. It is further contemplated that the stent 100 can be configured such that the surface of the stent 100 defines a non-circular cross-sectional profile, including but not limited to, a semi-elliptical cross-sectional profile or an asymmetric cross-sectional profile, e.g., to at least partially conform to the shape of the natural valve annulus. As used herein, the term “asymmetric cross-sectional profile” includes any non-circular cross-sectional shape.
  • the stent 100 is configured with a crescent shape to form a half- or hemi -valve.
  • the stent 100 can have a hemi- conical shape.
  • the hemi-conical stent 100 includes an upper atrial portion 104, a lower ventricular portion 110, and a neck region 109 between the upper atrial 104 and the lower ventricular 110 portions, thereby defining a longitudinal axis therebetween, i.e., aligned along the length of the stent 100.
  • the stent 100 of the hemi-valve can be made from a self-expanding or balloon-expandable material formed into a network of cells or a mesh.
  • the stent frame 100 can be laser cut or woven from deformable, biocompatible materials, such as stainless steel or cobalt chromium for balloon-expandable devices, or Nitinol for self-expandable devices with memory-shape properties.
  • the stent 100 can be configured to be collapsible, crimped and expanded into the desired loading and operative positions, respectively.
  • the atrial portion 104 of the stent can be configured to be positioned on or above the native mitral annulus to facilitate anchoring and sealing of the prosthetic hemi-valve 1.
  • the atrial portion 104 of the stent may be configured to span at least some or all of the native mitral annulus.
  • the atrial portion 104 of the stent is configured to flare out radially over some or all of the posterior annulus of the native mitral annulus.
  • the upper atrial portion 104 can be configured with at least one row of cells.
  • the cells include struts that are oriented in a collapsible diamond-shaped structure that extend outward radially from the neck portion 109 of the stent.
  • the diameter of the upper atrial portion 104 is smallest near the neck portion 109 and increases moving outward towards the atrial crowns 117 and the left atrial wall.
  • the atrial portion 104 of the stent is configured with compressible cells.
  • the atrial portion 104 of the stent comprises at least one row of cells.
  • the cells include a collapsible network of struts that are oriented in a diamond-shaped configuration that extend outward radially from the neck portion 109 of the stent.
  • the height of the cells can be between approximately six and twelve millimeters (6-12 mm) in height.
  • each cell is formed with four struts, two upper and two lower struts.
  • the dimensions of the upper and lower struts can be the same or different.
  • the upper and lower struts are joined together by a cell bridge, referred to as a junction 103.
  • the junctions 103 can be designed to be either compressible or non- compressible with the entire stent 100.
  • some of the junctions 103 of the atrial portion of the stent can be configured with a through-hole or hole 108.
  • the through-holes 108 are used for anchoring and fixing the stent 100 onto the mitral annulus.
  • the holes 108 can be configured with an inner diameter of approximately 0.5 to three millimeters (0.5-3 mm), and approximately five to fifteen (5-15) holes can be configured along the atrial portion 104 of the stent.
  • the holes 108 in the atrial portion 104 of the stent are configured to allow for passage of the locking members 131 in one direction only.
  • fixation of the stent 100 to the mitral annulus can be also achieved by other methods such as one or more of using adhesives, tissue grabbing, capturing, and suturing methods.
  • the holes 108 can have circular, rectangular, square or oval shapes.
  • lateral edge 107 of the lateral cells 106 of the atrial portion 104 of the stent do not share a junction 103 with adjacent cells.
  • the junction 103 of the lateral cells 106 can be configured with binding sites on the lateral edges 107.
  • the binding sites of the lateral edges 107 of the stent can be configured with matching corresponding shapes such that they fit together snugly and keep the stent in a cylindrical configuration throughout crimping.
  • the shape of one junction 103 on one side can be configured to match and fit to the shape of the other junction on the opposite side.
  • the binding sites can be straight, zigzagged, wavy, semi-circular, semi-oval, rectangular or irregular shaped struts.
  • the atrial portion 104 of the stent is configured to conform to the annulus in operation.
  • the upper struts of the cells on the atrial portion 104 of the stent also referred to as crowns or free stent tips, can be configured with curved tips 117, e.g., as shown in Figure 3 A, so as not to interfere with the left atrial wall 2 in operation.
  • the curved angle of the tips 117 can be approximately 90°-145° with respect to the rest of the upper flare portion 104.
  • Such a curvature allows the atrial portion 104 of the stent to conform to the wall of the left atrium 2.
  • the bottom struts of the cells of the atrial portion 104 of the stent curve downward to connect to the neck region 109, which transitions at an angle range of 65° - 120° to the ventricular portion 110 of the stent.
  • the stent tips 117 on the atrial portion 104 of the stent can be configured with a curvature such that they lie substantially parallel to the mitral annulus in operation.
  • the atrial portion 104 of the stent can be configured with two rows of cells.
  • the row of cells near the neck region 109 have smaller dimensions than the other row of cells towards the stent tip 117.
  • the further row of cells can be configured with bend struts with angle between 90° - 145°.
  • the cells in two rows of the atrial portion 104 of the stent can be of the same dimensions.
  • a neck region 109 joins the atrial 104 and ventricular 110 portions of the stent.
  • the neck region 109 is continuous with the upper atrial 104 and lower ventricular 110 portions of the stent.
  • the neck region 109 can be configured with at least one row of cells, e.g., with a height of approximately one to seven millimeters (1.0-7.0 mm).
  • the top portion of the neck 109 can be curved or angled to ease the transition between the atrial 104 and neck 109 portions of the stent.
  • the bottom portion of the neck 109 can be curved or angled to ease the transition between the neck 109 and ventricular 110 portions of the stent.
  • the neck region 109 includes a single row of cells.
  • the cells in the neck regions 109 are formed by the struts on the atrial portion 104 and struts on the ventricular portion 110: the lower struts of the atrial portion 104, form a collapsible half-cell, connect to an elongated, thickened straight strut, and the top struts on the ventricular portion 110 form the other half of the collapsible cell.
  • the neck region 109 is configured to bend so that the angle between the atrial portion 104 and the ventricular portion 110 ranges from about 65° to 120°.
  • the atrial portion 104 of the stent is nearly parallel to the annulus.
  • the ventricular portion 110 of the stent can assume an asymmetric, semi-conical or semi-circular cross-sectional profile.
  • the ventricular portion 110 of the stent is configured to span at least some or all of the posterior leaflet 10 of the native mitral valve 4.
  • the lateral edges 112 of the stent can extend circumferentially to the native mitral commissures 14 (not shown, see, e.g., Figure IB) to ensure there is at least partial or full coaptation between the native anterior mitral leaflet 6 and at least one prosthetic leaflet 200 coupled to the inner surface of the ventricular portion 110 of the stent.
  • the stent 100 in the expanded configuration, is configured to have an anterior-posterior (AP) dimension.
  • the AP dimension at the ventricular level ranges from about ten to forty millimeters (10-40 mm) and/or the AP dimension at the atrial level ranges from about twenty to sixty millimeters (20-60 mm).
  • the anterior commissure to posterior commissure length namely the commissure-to-commissure (CC) length can range from about twenty to sixty millimeters (20-60 mm) and/or the CC length can range from about thirty to ninety millimeters (30-90 mm) at the atrial level.
  • the ventricular portion 110 of the stent is configured to form a “C- shape” in the operative position, thereby displacing the native posterior mitral leaflets 10 and allowing for at least one prosthetic leaflet 200 to extend radially up to the lateral edges of the stent 100 to coapt with the native anterior leaflet 6.
  • the ventricular portion 110 of the stent is configured with different heights along its circumference such that it does not interfere with the papillary muscles 14.
  • the stent height in the center of the valve can range between about ten and forty millimeters ) 10-40 mm) and the stent height at the lateral sides of the stent 112 can range between about five and fifteen millimeters (5-15 mm).
  • the ventricular portion 110 of the stent can comprise at least one row of cells.
  • a row of cells can span all or a portion of the circumference of the ventricular portion 110 of the stent.
  • the ventricular portion 110 of the stent is configured to have three rows of cells. Rows I, II, and III 134,135,136 are configured to be at the top, middle, and bottom of the ventricular portion 110 of the stent, respectively.
  • Each row is configured to have a plurality of conjoined struts that assume a collapsible diamond shaped cell with a height of 7- 8 mm and a width of 4 - 6 mm. Each row can include the same number of cells, or differ in their number of cells.
  • Row I cells 134 are attached to the neck region 109 at the top of the cell, and share Row II cells 135 at the lower struts 101.
  • one or more of the Row I cells 134 can be configured to be covered with the sealing skirt 300 to facilitate prosthetic leaflet 200 coupling and prevent leakage.
  • Row II cells 155 share Row I cells 154 to the top and
  • Row III cells 156 to the bottom.
  • a plurality of Row II cells 155 positioned behind the at least one prosthetic leaflet 200 can optionally be configured to be open cells, without being covered by the skirt 300. This configuration promotes radial extension of the at least one prosthetic leaflet 200 and prevents blood stagnation behind the leaflet(s) 200.
  • the cells which are covered by the skirt 300 include a leaflet attachment line, e.g., to couple a plurality of prosthetic leaflets 200 to the stent 100.
  • Row III cells 136 are shared with Row II cells 135 to the top and are free standing on the bottom.
  • the two lateral edges 112 are configured to be covered with at least one layer of fabric 300.
  • Portions of the Row III cells 136 corresponding to prosthetic leaflet 200 attachment regions can be configured to be covered with the sealing skirt 300, while other regions can optionally be left open without a skirt 300.
  • the height and width of the cells in each row can be the same.
  • the height and width of the cells in each row can be different.
  • the ventricular portion 110 of the stent can be configured with a hemi-conical shape where the diameter is smallest near the neck portion 109 and increases moving downward towards the ventricle 3 in operation.
  • the stent can include binding sites on the lateral edges 112 on the ventricular portion 110 of the stent to facilitate crimping.
  • the binding sites 112 can be configured to include at least one row of the ventricular cells and optionally, at least one row of the atrial cells.
  • the lateral edges 112 of the stent can be configured with corresponding shapes such that they fit together snugly and keep the stent in a cylindrical configuration throughout crimping.
  • the binding sitel 12 can be configured as straight, zigzag, semi circular, semi-oval, or rectangular shaped struts.
  • the binding junction 103 can be configured as a non-straight section on the lateral edges 112 wherein opposing lateral edges 112 are configured to engage each other during stent crimping 18.
  • one or more cell struts can be configured with through-holes
  • one or more struts in Row III 136 of the ventricular portion 110 of the stent can be configured with through-holes 113 for attachment of at least one prosthetic leaflet legs 205 directly to the strut.
  • the plurality of through-holes 113 can range from about 0.1mm- lmm in diameter.
  • the struts containing the through -holes 113 can be configured to be approximately 1.1 to 2.5 times wider than other struts to accommodate for the presence of the through-holes 113.
  • the ventricular portion 110 of the stent can be configured such that the at least one prosthetic leaflet commissures 201 attach to the frame 100 at one or more of the ventricular stent tips 118, such that the stent tips 118 can radially deflect when the leaflet 200 is loaded.
  • the ventricular portion 110 of the stent can be configured with a sting-ray shape, which extends furthest in the ventricle 3 in the center, and is shorter on the lateral sides 112 to prevent interference with the native papillary muscles 16 in operation.
  • At least one string-ray tail or extended member 114 can be configured to extend vertically downwards from the bottom strut junction 103 of the ventricular section 110 of the stent.
  • One or more extended members 114 can be extended from the cell at the center of the bottom portion of the ventricular section 110 of the stent, or optionally, from any other parts of the stent 100.
  • the extended member 114 can have a width of about 0.3 - 5.5 mm and a length of about 1.0 to 10.0 mm.
  • the distal end of the extended member 114 can be configured with a central tab 115.
  • the extended member 114 with the central tab 116 can extend from different cells along the circumference of the ventricular portion 110 of the stent.
  • the length of the extended member 114 can be about 1.0 to 5.0 mm so that it will not interfere with the native surrounding structures.
  • At least one peripheral tab 116 can be configured to attach to different cells along the circumference of the ventricular portion 110 of the stent, without the extended member 114.
  • At least a portion of the ventricular portion 110 is configured such that the lowest tips 118 bend inwards radially.
  • the bend angle can be configured to be between 10° - 50° with respect to the axial direction of the stent 100.
  • the tabs 115, 116 can comprise at least one hole.
  • the tabs 115,116 can be configured with various shapes for various delivery system engagement mechanisms, including but not limited to magnetic engagement mechanisms, male-female coupling engagement mechanisms, turning locks, etc., which can selectively engage at least a portion of the delivery system throughout the valve deployment process, thereby stabilizing the deployment process.
  • the tabs 115, 116 can be made of the same as or different materials to the stent 100, and can be permanently connected to the stent 110 via a variety of attachment means such as adhesives, magnetic engagement, etc.
  • the tabs 115,116 and their extension structures 114 can be connected to the delivery system in different directions.
  • the tabs 115,116 can be detached from the stent 100 after the stent deployment.
  • At least one prosthetic leaflet 200 is mounted to a skirt 300 that is coupled to the ventricular portion of the stent 110 via non-absorbable sutures.
  • the stent 100 can be configured to permit the natural dynamic motion of any remaining native leaflet(s) to coapt with the prosthetic leaflet(s) 200.
  • the ventricular portion 110 of the stent is configured to displace the native posterior mitral leaflet 10 in the left ventricular chamber 3 of the heart and position at least one prosthetic leaflet 200 in its place.
  • a sealing skirt 300 is coupled to at least a portion of the inner and outer surfaces of the stent 100 to prevent leakage between the prosthetic hemi valve frame 100 and at least one prosthetic leaflet 200, and to also provide a base for attachment of the at least one prosthetic leaflet 200.
  • the skirt 300 can be made of a synthetic or natural biocompatible non- permeable material including, but not limited to, polymers, fabric, biological materials, and the like.
  • the skirt 300 may be cut from a similar or different material as the leaflets 200 to ensure compatibility within the body.
  • the skirt 300 can be laser cut, die cut, or manually cut to optimize uniformity and accuracy of the desired dimensions.
  • the skirt 300 thickness can range between about 0.1mm and 0.15mm.
  • the skirt 300 can be configured to exhibit a biaxial orientation, with the fibers aligned circumferentially, thus allowing the skirt 300 to stretch axially during the crimping and release process such that the skirt 300 can conform to the elongated stent shape without tearing or damaging the prosthetic leaflets 200.
  • the non-permeable sealing skirt 300 further comprises atrial 302 and ventricular 301 portions.
  • the atrial 302 and ventricular 301 portions can be configured as one piece.
  • the atrial 302 and ventricular 301 portions can be configured as two separate pieces.
  • the skirt 300 is coupled to the stent 100 via one or more of sutures, adhesive, and/or other biocompatible materials.
  • a ventricular skirt 301 is used as a structure to attach the prosthetic leaflets 200 to the stent 100.
  • the ventricular skirt 301 can be configured to cover at least a portion of the ventricular portion 110 of the stent to facilitate attachment of the prosthetic leaflet 200.
  • the ventricular portion of the skirt 301 is configured with a plurality of tabs configured to wrap around stent struts at the commissural regions to prevent skirt translation during crimping.
  • the ventricular skirt 301 can be configured to conform to the inner surface of the ventricular portion 110 of the stent.
  • the upper edge of the ventricular skirt covers the neck region 109 of the stent and also provides a path for a connection line 303 to attach the ventricular skirt 301 to the atrial skirt 302.
  • the ventricular skirt 301 is configured to cover select cells on the ventricular portion 110 of the stent.
  • prosthetic leaflets 200 are configured to attach to the ventricular skirt 301 along an engineering-designed parabolic leaflet attachment line.
  • the ventricular skirt 301 is configured to cover the stent portions 110 where the leaflet attachment line should align to facilitate attachment of the at least one prosthetic leaflet 200 to the stent 100.
  • a plurality of enlarged tabs 312 of the atrial skirt 302 are folded to create a plurality of pockets for paravalvular sealing.
  • folding over the enlarged tabs 312 creates a uniform layer of skirt 302 on the back side of the valve 100 that comes into direct contact with the atrial tissue 2. This layer of folded over enlarged tabs 312 prevents paravalvular leakage.
  • an atrial skirt 302 is used to encourage paravalvular sealing in the atrium 2, and further anchoring the valve 1 to the annulus.
  • the atrial skirt 302 is configured to conform to the unique curvature of the atrial portion 104 of the stent.
  • the atrial skirt 302 can be configured with a material that can be penetrated by the DGF member head such that after the valve 1 is deployed and locked into place, additional DGF members can be implanted through the atrial skirt 302 to further fasten the valve 1.
  • FIG. 5 there are two side tabs 309 on the atrial skirt 302. These tabs 309 are configured to fold over the lateral edges 106 of the atrial portion of the stent to create a side skirt.
  • the lower portion of the side tab 306 on the atrial skirt 302 engages with a large tab on the ventricular skirt 301 by folding under the corresponding large tab.
  • the large tab on the ventricular skirt 301 and side tab 309 on the atrial skirt 302 fold over themselves.
  • This feature is notable, as this region comes into direct contact with the commissures 14 of the native mitral valve 4.
  • the side skirt thereby provides a dual function. First, the side skirt prevents the sharp edges of the stent 100 from cutting into the native mitral commissure 14. Second, the side skirt provides an attachment for a sealing ring 316 to create a paravalvular seal around the edges of the valve 1.
  • a sealing ring 316 can be affixed to the lateral edges 107,112 of the valve to create a paravalvular seal along the commissures 14 of the native mitral valve 4 and also provide cushioning between the lateral edges 107, 112 of the stent 100 and the surrounding tissues.
  • a sealing ring 316 can be affixed to at least a portion of the atrial portion 104 of the frame to create a paravalvular seal along the annulus.
  • the sealing ring 316 can be made of a flexible synthetic or natural biocompatible material including, but not limited to, polymers, fabric, biological material, and the like.
  • the sealing ring 316 can surround the lateral and top edges of the valve 1 that can come into contact with the native tissue, avoiding the bottom edge of the valve 1 as to not interfere with leaflet motion in operation.
  • the sealing ring 316 may be permanently fixed to the valve 1, e.g., with one or more sutures, adhesives, and/or other biocompatible materials.
  • At least one dome-shaped prosthetic leaflet 200 can be mounted on the inner surface of the frame. In one aspect, at least one prosthetic leaflet 200 can be mounted to the inner surface of the lower ventricular portion 110 of the frame. It is contemplated that at least one prosthetic leaflet 200 can comprise a plurality of leaflets wherein all of the prosthetic leaflets 200 can have the same shape and size or wherein one or more of the plurality of leaflets 200 have different shapes and/or sizes.
  • each dome-shaped prosthetic leaflet 207 can comprise two commissures 201, a curved attachment edge 202, a belly region 203, a coaptation region 204 and, optionally, at least one arm 215, and at least one leg 205.
  • the attachment edge 202 of the at least one leaflet 207 can be mounted to an inner lumen of the stent 100 or skirt 300, e.g., using non absorbable sutures.
  • the foot 214 i.e., the free end of the at least one leg 205, can be mounted to an inner lumen of the stent 100 or skirt 300, e.g., using non absorbable sutures.
  • the dome-shaped prosthetic leaflet(s) 207 can be configured to be mobile throughout the cardiac cycle such that the belly and coaptation regions extend radially inward from the frame 100 at systole to prevent transvalvular central or commissural leakage, and to move towards the frame 100 during diastole to allow ventricular filling.
  • the prosthetic leaflet commissures 201, attachment edge 202, and feet 214 of the legs 205 that are attached to the stent 100 are immobile with respect to the stent 100.
  • the at least one prosthetic leaflet 207 can be configured with at least one arm 215 extending from the leaflet commissure 201.
  • the dome-shaped leaflet(s) 207 can be configured such that they exhibit limited collapsibility and radial extension such that they do not hit the frame 100 during valve opening, and cannot extend beyond the frame 100 radius during valve closing, in operation.
  • the dome-shaped prosthetic leaflet(s) 207 can be configured to coapt with the native anterior mitral leaflet 6 during systole in operation. Referring to Figure 1 A of the healthy native mitral valve 4 during systole, the posterior mitral leaflet 10 extends radially to form a C-shape to coapt with the anterior mitral leaflet 6.
  • the native leaflets 6,10 would not be able to extend far enough towards each other in order to coapt fully. It is contemplated, as seen in Figure 2B, that the prosthetic leaflet 200 can be configured to form the C-shape of the native posterior leaflet 10 and extend beyond this line, to a D-shape, to coapt with the native anterior mitral leaflet 6 in patients with functional mitral regurgitation.
  • the prosthetic hemi-valve device 1 anchoring mechanism can be configured to resist separation from the posterior mitral annulus during systole and device migration in operation.
  • the prosthetic hemi-valve device 1 can be configured to cover about half or 2/3 of the mitral orifice during systole.
  • the prosthetic hemi-valve device 1 given the half valve nature of the prosthetic hemi-valve 1, only about half of the total force induced by the blood flow during systole will act on the prosthetic hemi-valve device 1, thus only half of the total force will act on the anchoring mechanism. The rest of the force induced by the blood flow will act on the native anterior mitral leaflet 6 and annulus.
  • a prosthetic hemi-valve 1 may be easier to secure to the mitral annulus compared to a full circumference prosthetic valve.
  • anchoring of full circumference prosthetic valve devices in the mitral position continues to be a challenge.
  • the plurality of dome-shaped prosthetic leaflets 200 can be formed from a flat piece of flexible material which is sewn or otherwise attached to the frame 100 such that they can be mobile throughout the cardiac cycle and resist separation from the frame 100.
  • the plurality of dome-shaped prosthetic leaflets 200 can be pre-shaped into a 3D dome geometry by casting, deforming, molding, braiding, heat or chemical treatment, 3D printing, electro-spinning, or other fabrication methods.
  • the plurality of prosthetic leaflets 200 can comprise pericardial tissue, or other biological or tissue engineered materials, polymeric, fabric, or flexible metallic material, and the like.
  • a moveable, flexible prosthetic leaflet 200 would exhibit give when interacting with a native anterior leaflet 6, and thus would induce minimal damage to a native valve leaflet 6 due to repeated contact.
  • the prosthetic leaflet 200 can be configured with a thicker leaflet material than other prosthetic mitral valves intended to be implanted via catheter, and still have a small crimped device profile which is desirable for procedure feasibility and patient safety.
  • a thicker prosthetic leaflet 200 is desirable for prosthetic valve 1 durability.
  • the native posterior mitral leaflet 10 comprises three adjoined semilunar shapes, namely the PI, P2, and P3 cusps 11,12,13.
  • the P2 12 cusp is the largest and extends the furthest into the ventricle 3, while the PI and P3 cusps 11,13 are smaller and shorter, particularly on the lateral sides.
  • the plurality of prosthetic leaflets 200 can comprise two smaller lateral leaflets 206, 208, and larger central leaflet 207 mimicking the native posterior leaflet 10 anatomy.
  • the prosthetic leaflets 200 can be configured as a plurality of dome-shaped structures extending inward radially away from the stent 100.
  • the prosthetic P2 (PP2) leaflet 207 can extend further down into the left ventricle 3 in operation than the lateral sides of the prosthetic PI (PP1) and prosthetic P3 (PP3) leaflets 206, 208, similar to the native posterior mitral leaflet 10
  • PP3 leaflets 206, 208 can be configured as mirror images of each other, with a shorter height on the lateral edges corresponding to a shorter frame height at the lateral edges, and a taller height on the medial edges to align the medial PP1 and PP3 commissures 210 with the PP2 commissures.
  • the crimped profile of the prosthetic hemi- valve device 1 can be desirably reduced, because the amount of leaflet material is greatest at the leaflet commissures 201, and by having the lateral commissures 209 at a different height than the medial commissures 210, the amount of material at the medial commissures 210 is reduced and thus can be crimped to a smaller diameter.
  • the prosthetic leaflets 200 can be configured to attach to the frame 100 starting just below the neck region 109 of the frame 100 and extending axially to the tips of the ventricular portion 118 of the frame and cover the circumference of the ventricular portion 110 of the frame.
  • the prosthetic leaflets 200 can be configured to wrap around the lateral edges of the frame 112 or only cover a portion of the frame 100 circumference.
  • the prosthetic leaflets 200 can be configured to extend axially from the upper flared 104 or neck portions 109 of the frame to the ventricular portion 110 of the frame.
  • the prosthetic leaflet 200 can be configured to cover only a portion of the ventricular portion 110 of the frame.
  • the prosthetic leaflets 200 are attached to the frame 100 along a leaflet attachment line 320 that comprises a plurality of parabolic shapes where each parabolic shape delineates a prosthetic leaflet 200.
  • the leaflet attachment line 320 can be configured to be symmetric about the center of the skirt 300. In an optional aspect, the leaflet attachment line 320 can be configured to be asymmetric.
  • the leaflet attachment line 320 is configured as three parabolic shapes next to each other for the attachment of three distinct prosthetic leaflets 200.
  • the leaflet attachment lines for PP1 are configured as three parabolic shapes next to each other for the attachment of three distinct prosthetic leaflets 200.
  • PP2, and PP3 206, 207, 208 can be configured with the same size and shape or differing size and shape, and can be either symmetric or asymmetric.
  • the PP2 leaflet attachment line 320 is configured to span about one third to two thirds of the stent 100 circumference and be symmetric about its axial midline.
  • the PP1 and PP3 leaflet attachment lines 320 can be configured as mirror images of each other, and to span about one sixth to one third of the stent circumference.
  • the PP1 and PP3 leaflet attachment lines 320 can be configured to be shorter on the lateral edges such that they are asymmetric about their respective axial midlines.
  • the plurality of leaflets 200 can be configured as separate individual pieces of flexible material that are affixed to the frame 100 along each of the parabolic leaflet attachment lines 320.
  • Each leaflet 206, 207, 208 can be made of the same or different material.
  • the plurality of leaflets 200 can be formed from one single piece of flexible material by affixing the material to the frame 100 along each of the parabolic leaflet attachment lines 320.
  • the parabolic shape of the leaflet attachment lines 320 can be configured to distribute blood flow induced forces throughout the prosthetic leaflets 200 and frame 100.
  • One skilled in the art can appreciate that by distributing forces throughout the device 1, localized high stress regions which can negatively impact device 1 durability, can be prevented.
  • the leaflet attachment line 320 can be configured to align with the stent struts, particularly at high stress regions such that blood flow forces acting on the leaflet 200 will be, in part, distributed directly to the stent 100.
  • the leaflet attachment line 320 can be configured such that the prosthetic leaflet commissures 201 align with the ventricular stent tips 118 such that the ventricular stent tips 118 can deflect radially inwards, e.g., about 5° to 15° when a pressure load is applied to the prosthetic leaflets 200.
  • the stent-tip 118 deflection can cushion the prosthetic leaflets 200 from forces acting on them which has been shown to be important for bioprosthetic valve 1 durability.
  • the leaflet attachment line 320 can be configured such that the prosthetic leaflet commissures 201 align with tabs 116 extending from the lower ventricular portion 110 of the frame, as seen in Figure 3C.
  • the tab 116 can be configured with at least one through-hole to facilitate attachment of the commissure 201 to the frame 100.
  • the tab 116 can be configured on the end of an extended member 115 configured such that the tab can deflect radially inwards, e.g., about 5° to 15° when a pressure load is applied to the prosthetic leaflets 200.
  • the prosthetic leaflets 200 can be mounted on the frame 100 such that the stent cells behind the belly region 203 of the prosthetic leaflets 200 are open with no skirt 300 material. It is contemplated that by leaving these cells open, blood flow can reach the belly region 203 of the prosthetic leaflet 200 more quickly such that the prosthetic leaflets 200 can extend quickly to cover the mitral valve orifice in systole and prevent regurgitation. Further in this aspect, it is contemplated that by increasing blood washout between the prosthetic leaflets 200 and the frame 100, the incidence of thrombosis formation due to flow stagnation can be reduced.
  • the leaflet legs 205 can be configured with a plurality of leg structures 205, the feet 214 of which attach to the ventricular portion of the frame 110.
  • the leaflet legs 205 are configured to limit radial extension of the leaflet belly 203 and coaptation regions 204 and prevent billowing and prolapse. Further, the leaflet legs 205 can help distribute force throughout the leaflet 200 and frame 100 which is particularly important for larger leaflets experiencing large blood flow induced forces.
  • dome shape proportions must be maintained for proper prosthetic leaflet 200 function, i.e., radial extension.
  • radial extension For simplicity, consider a two-dimensional dome height-to-width ratio, if the height-to-width ratio is small, the prosthetic leaflet 200 can extend a lot radially, but can also potentially prolapse in operation, and if the height-to-width ratio is large, the prosthetic leaflet 200 radial extension is limited and potentially cannot extend far enough to cover the regurgitant orifice area.
  • the PP2 leaflet 207 has a small height-to-width ratio of about 0.4-0.7 which allows a great degree of radial extension however also makes it vulnerable to prolapse. Therefore, the PP2 leaflet 207 is configured with two legs 205 which attach to the frame 100 to limit the PP2 leaflet 207 from extending radially beyond the leg 205 length which is about 70-100% of the anterior- posterior dimension of the frame.
  • the leg structure 205 is a design feature which prevents leaflet prolapse in a leaflet with a small height-to-width ratio and a large degree of radial extension.
  • the length-to-width ratio of the leg structure 205 is about 4 to 7.
  • the PP1 and PP3 leaflets 206, 208 have a large maximum height-to-width ratio of about 1-1.5 which allows a smaller degree of radial extension, thus the PP1 and PP3 leaflet 206, 208 in this embodiment do not require legs 205.
  • the height-to-width ratio determining leaflet prolapse will also depend on the angle of the ventricular portion 110 of the stent with respect to the atrial portion 104 of the stent, where an angle less than 90° will help prevent prolapse in leaflets with a low height-to-width ratio. Further, the height-to-width ratio will depend on the leaflet 200 opening angle, i.e., the angle made between the two commissures 201 and the center point of the frame 100, where a larger angle will help prevent prolapse in leaflets 200 with a low height-to-width ratio. Therefore, the leaflet 200 height-to-width ratios presented here are meant to be illustrative to demonstrate the effect of the leg structures 205, and are not meant to be limiting.
  • the prosthetic leaflets 200 may require one or more additional leg structures 205, including on the smaller lateral prosthetic leaflets 206,208. In some other aspects, the prosthetic leaflets 200 may require one or more additional leaflets to make it a four- or five-leaflet valve.
  • prosthetic hemi-valve device 1 it is beneficial for the prosthetic hemi-valve device 1 to have prosthetic leaflets 200 with limited radial extension by design, without the need for additional ventricular anchoring and independent of patient characteristics.
  • the prosthetic leaflet feet 214 at the end of the leaflet legs 205 can be directly attached to the stent 100 at the through-holes 113 for foot attachment 214 such that there is no need for additional skirt material 300 in this region.
  • the prosthetic leaflets 200 can be configured to form a C-shape at a resting, non-pressurized state similar to that formed by the native posterior mitral leaflet 10 in a healthy mitral valve 4, e.g., as shown in Figure 2A. Further, the prosthetic leaflets 200 can be configured to form a D-shape at a systolic pressurized state to cover approximately half of the mitral orifice area as shown in Figure 10
  • leg structures 205 on the PP2 leaflet 207 helps to create the C-shape such that the PP2207 extends radially to approximately the same distance across its width, similar to the native P2 leaflet 12. It can be appreciated that without the leg structures 205, the PP2207 would create a rounded or pointed shape which would extend furthest radially at the center and less on the sides.
  • FIG. 10 shows a ventricular view of the prosthetic hemi-valve 1 with the prosthetic leaflets 200 at the pressurized condition 211, 212, 213, i.e., systole, overlaid with the prosthetic leaflets at the resting 206,207,208, unpressurized condition. It can be seen that each of the prosthetic leaflets 200 extends radially away from the stent 100 under pressurization, where the degree of extension is greatest in the center of the prosthetic valve 1 at PP2207, and the smallest at the lateral edges of PP1 and PP3 206,207.
  • Figure 10 also shows that the legs 205 extending from the bottom of the PP2207 dome shape to the frame 100 are straight with no twisting at both conditions. It can be seen that at full extension, the prosthetic leaflets 200 together form a D-shape covering nearly the entire lumen of the hemi-valve stent 100. Thus, in operation, the prosthetic leaflets 200 could cover nearly half of the mitral orifice area.
  • this design can prevent mitral valve leakage in patients that have a native anterior mitral leaflet 6 that covers more than the half of the mitral orifice area during systole.
  • the native anterior mitral leaflet 6 covers nearly two thirds of the mitral orifice area during systole.
  • the prosthetic leaflets 200 in Figure 2B are not expected to have to extend much if at all beyond their resting state position to coapt with the native anterior mitral leaflet 6.
  • the extra prosthetic leaflet extension enabled by this exemplary design is a precautionary measure to provide a large coaptation zone 204 for the native anterior mitral leaflet 6 with ample coverage of the mitral orifice even in dilated hearts.
  • the leg structures 205 can be configured such that when the prosthetic leaflet 200 is loaded, the leg structures 205 extend radially away from the frame 100 in a straight manner, with no twisting of the legs 205.
  • leg structures 205 also act similarly to the native chordae tendineae 15, in that they can prevent over-extension and prolapse of the prosthetic leaflet 200.
  • the PP1 and PP3 leaflets 206, 208 can also be configured with leg structures 205, particularly for large size prostheses where the PP1 and PP3 leaflets 206,208 are large.
  • the PP1 and PP3 leaflets 206, 208 can be configured without leg structures 205, particularly for small size prostheses where the PP1 and PP3 leaflets 206,208 are small.
  • the foot 214 of the leg structure 205 can be configured at an angle to facilitate attachment to an angled strut of the stent with the through-holes 113.
  • the plurality of leg structures 205 can be configured with a dog-bone shape that is wider at the foot 214 where it attaches to the frame 113, and the base where it extends from the bottom of the dome-shape and relatively narrower in an intermediate region. In this aspect, the added width reduces stress in the leg structure 205 at the regions experiencing the highest forces.
  • the dog-bone shape design distributes mechanical stress throughout the leg 205 which is important for durability.
  • it is desirable for the plurality of leg structures 205 to be made of a single piece of the same material as the rest of the prosthetic leaflet 200.
  • the PP2 leaflet 207 can be configured with a tallest height in the center (belly 203 and coaptation regions 204) of the leaflet and a shorter height at each of the commissures 201, corresponding to the native posterior mitral leaflet 12 structure, e.g., as shown in Figure 2B.
  • the plurality of dome-shaped prosthetic leaflets 200 are configured as individual flat pieces of flexible material.
  • the prosthetic hemi-valve includes a stent 100 which is coupled to a skirt 300 on the inner surface of a stent 100 and a portion of the outer surface of the stent 100. Furthermore, a plurality of prosthetic leaflets 200 are coupled to the inner surface of the skirt 300. In a further aspect, one or more sutures are used to couple the skirt 300 to the stent 100, and the prosthetic leaflets 200 to the skirt 300.
  • the prosthetic hemi-valve device 1 is fixed to the posterior mitral annulus by a plurality of DGF members which can be operatively positioned and implanted at desired locations in the native annulus prior to the delivery of the prosthesis 1, e.g., similar to the systems and methods described in the applications incorporated by reference elsewhere herein.
  • the DGF members can guide the subsequent precise positioning and fixation of the prosthesis 1.
  • the plurality of DGF members can help prevent leakage of blood between the operatively positioned prosthesis 1 and the native mitral annulus.
  • each DGF member can be configured with removable and permanent components, where removable components can aid in guiding the prosthetic hemi-valve device 1 to the operable position, and then be removed from the patient’s body after fixing the prosthesis 1, and permanent components remain in the patient’s body to keep the prosthetic hemi-valve device 1 secured to the native annulus.
  • each DGF member can comprise head, body, and tail components.
  • each DGF head member can be configured with a coil shape such that it can be operatively inserted and embedded in the annular tissue.
  • each DGF body member can be configured with a DGF locking member 131 to fix the prosthetic hemi-valve device 1 to the native mitral annulus, such as that shown in Figure 11.
  • the DGF tail member can be configured as a flexible component that extends from the proximal portion of the DGF body, and links the DGF member to the crimped prosthetic hemi-valve 1 within the prosthetic hemi-valve delivery and implantation system.
  • the tail portion can be manipulated on the proximal end of the delivery system to guide and securely maneuver the prosthetic hemi-valve 1 to the native mitral annulus.
  • the DGF tail can be configured to be selectively removable, such that it can be removed from the body at the completion of the heart valve leaflet replacement system implantation procedure.
  • the prosthetic hemi-valve can be configured to engage the
  • each DGF tail member can be a tether that is configured so that one end of the tether is attached to the DGF body member and the other end of the tether can exit the body. Subsequently, the tether can be inserted through the hole 108 on the atrial flared portion 104 of the stent, such that the prosthetic hemi-valve device 1 can be delivered over the DGF tail members and the atrial flared portion 104 of the stent can be precisely delivered to the DGF body members embedded in the annulus.
  • the DGF locking member 131 can be configured to pass through the hole 108 on the atrial flared portion 104 of the stent in one direction only. [0184] In one aspect, the DGF locking member 131 can be configured such that it can selectively be compressed to a diameter smaller than the diameter of the hole 108 on the atrial flared portion 104 of the stent, such that it can pass through the hole 108, and subsequently be selectively re-expanded to its original size, larger than the diameter of the hole 108 on the flared portion 104 of the stent to prevent backward motion of the DGF locking member 131 through the hole 108.
  • the proximal tip of the cone shape has a smaller diameter than the hole 108 on the atrial portion 104 of the stent, and the distal base of the cone shape has a larger diameter than the hole 108 on the atrial portion 104 of the stent.
  • the DGF tails can be tensioned to pull the proximal tips of the DGF locking members 131 into the holes 108 on the atrial portion 104 of the stent, and as the locking member legs 132 come into contact with the edges of the holes 108, the legs will compress radially to allow the DGF locking member 131 to be pulled completely through the holes 108.
  • the DGF locking member legs 132 can re-expand to full size to prevent backward motion of the DGF locking member 131 through the holes 108 in the atrial portion 104 of the stent and effectively lock the prosthetic hemi-valve 1 in the operative position.
  • the locking members 131 are configured to be selectively compressible from a cross-sectional profile larger than the diameter of the holes 108 in the atrial portion 104 of the stent to a cross-sectional profile smaller than the diameter of the holes 108 in the atrial portion 104 of the stent such that they can pass through the holes 108 in the atrial portion 104 of the stent, and then can be re-expanded to its original size to prevent the locking member 131 from passing through the holes 108 in the opposite direction.
  • the locking member 131 can be configured with a conical, dome, arrow shaped or wedge structure with a plurality of slits using a rigid material, or optionally a deformable rubber-like cork or stopper structure with a cone, dome, wedge or spherical shape, or optionally clamp, clipping or snapping structure
  • the locking members 131 are configured to be selectively expandable from a cross-sectional profile smaller than the diameter of the holes 108 to a cross-sectional profile larger than the diameter of the holes 108 such that they can pass through the holes 108 in the atrial portion 104 of the stent and then can be selectively expanded such that they cannot pass through the holes 108 in the opposite direction.
  • the locking member 131 can be formed, for instance, with a shape memory material and a mechanism to selectively hold the locking member 131 in a crimped state which can be selectively released to re-expand the locking member 131.
  • the 131 include a conical shape with legs 132 that flare radially outwards.
  • the legs 132 of the locking members 131 compress radially when passing through the hole 108 on the atrial portion 104 of the stent, and re-expand once it has passed fully through the hole 108 and lies on the top of the atrial portion 104 of the stent.
  • the expanded legs 132 of the locking unit 131 prevent backward motion through the hole 108, thereby locking the prosthetic hemi-valve 1 into place.

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

Une hémi-valvule cardiaque prothétique pour le traitement d'une valvule cardiaque malade ayant des feuillets antérieurs natifs et postérieurs prothétiques comprend un stent en forme de rayon et de croissant ayant une languette étendue configurée pour être un mécanisme de sécurité. Au moins un feuillet prothétique monté sur une surface interne du stent comprend un bord libre, deux régions de fixation de commissure, un bord de fixation, une région de coaptation, une région ventrale et au moins une structure de jambe couplant une partie du ou des feuillets à une partie ventriculaire inférieure du stent. Une jupe d'étanchéité est couplée à la surface interne du stent pour monter le ou les feuillets et créer un joint paravalvulaire sur la partie atriale de l'hémi-valvule prothétique. L'hémi-valvule cardiaque prothétique comprend en outre une pluralité d'éléments doubles de guidage et de fixation pour ancrer la partie évasée atriale du stent à une partie postérieure de l'anneau de valvule native.
PCT/US2021/026710 2020-04-09 2021-04-09 Hemi-valvule cardiaque prothétique WO2021207695A1 (fr)

Priority Applications (3)

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CN202180036654.8A CN115867230A (zh) 2020-04-09 2021-04-09 假体半心脏瓣膜
EP21784839.9A EP4132427A4 (fr) 2020-04-09 2021-04-09 Hemi-valvule cardiaque prothétique
JP2022560890A JP2023521684A (ja) 2020-04-09 2021-04-09 人工半心臓弁

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US202063007418P 2020-04-09 2020-04-09
US63/007,418 2020-04-09

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CN115153969A (zh) * 2022-08-12 2022-10-11 清华大学 自稳定的三尖瓣支架

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WO2013040554A1 (fr) * 2011-09-16 2013-03-21 Kassab Ghassan S Dispositifs et procédés pour faciliter la fonction des valvules, remplacer des valvules veineuses et prédire la réussite du traitement des valvules
US8500798B2 (en) * 2005-05-24 2013-08-06 Edwards Lifesciences Corporation Rapid deployment prosthetic heart valve
US20140052237A1 (en) * 2011-04-28 2014-02-20 Neovasc, Inc. Methods and apparatus for engaging a valve prosthesis with tissue
US20170258589A1 (en) * 2016-03-08 2017-09-14 Dura Biotech Heart valve leaflet replacement system and method for same
WO2019241777A1 (fr) * 2018-06-15 2019-12-19 Dura Llc Dispositif de remplacement de feuillet de valvule cardiaque et système de pose de valvule cardiaque à plusieurs étages et à plusieurs lumières et procédé associé

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WO2015052570A1 (fr) * 2013-10-07 2015-04-16 Medizinische Universität Wien Implant et procédé pour améliorer la coaptation d'une valve atrioventriculaire

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US8500798B2 (en) * 2005-05-24 2013-08-06 Edwards Lifesciences Corporation Rapid deployment prosthetic heart valve
US20140052237A1 (en) * 2011-04-28 2014-02-20 Neovasc, Inc. Methods and apparatus for engaging a valve prosthesis with tissue
WO2013040554A1 (fr) * 2011-09-16 2013-03-21 Kassab Ghassan S Dispositifs et procédés pour faciliter la fonction des valvules, remplacer des valvules veineuses et prédire la réussite du traitement des valvules
US20170258589A1 (en) * 2016-03-08 2017-09-14 Dura Biotech Heart valve leaflet replacement system and method for same
WO2019241777A1 (fr) * 2018-06-15 2019-12-19 Dura Llc Dispositif de remplacement de feuillet de valvule cardiaque et système de pose de valvule cardiaque à plusieurs étages et à plusieurs lumières et procédé associé

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Publication number Priority date Publication date Assignee Title
CN115153969A (zh) * 2022-08-12 2022-10-11 清华大学 自稳定的三尖瓣支架

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CN115867230A (zh) 2023-03-28
JP2023521684A (ja) 2023-05-25
EP4132427A4 (fr) 2024-05-01

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