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WO2025191478A1 - Valves cardiaques prothétiques - Google Patents

Valves cardiaques prothétiques

Info

Publication number
WO2025191478A1
WO2025191478A1 PCT/IB2025/052604 IB2025052604W WO2025191478A1 WO 2025191478 A1 WO2025191478 A1 WO 2025191478A1 IB 2025052604 W IB2025052604 W IB 2025052604W WO 2025191478 A1 WO2025191478 A1 WO 2025191478A1
Authority
WO
WIPO (PCT)
Prior art keywords
tab
prosthetic
struts
frame
extending
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/IB2025/052604
Other languages
English (en)
Inventor
Meni IAMBERGER
Bar GOLDFARB
Anna KECELMAN
Lidia SALIKOV
Nataly TEVIS
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.)
Global Heart Valve Innovation Center Israel Ltd
Original Assignee
Global Heart Valve Innovation Center Israel Ltd
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 Global Heart Valve Innovation Center Israel Ltd filed Critical Global Heart Valve Innovation Center Israel Ltd
Publication of WO2025191478A1 publication Critical patent/WO2025191478A1/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
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Definitions

  • Aortic regurgitation also known as aortic insufficiency (Al)
  • AR aortic insufficiency
  • TAVR Transcatheter aortic valve replacement
  • commissure portions that are radially offset and/or are radially flexible relative to the rest of the frame.
  • the commissure portions can extend radially outwardly from the rest of the frame such that they are positioned at a greater radius than the adjacent struts of the frame.
  • the commissure portions can be cantilevered from the frame, such that only one axial end of the commissure portion is attached to the rest of the frame, allowing the commissure portions to flex radially inwardly and outwardly relative to the rest of the frame.
  • Lateral arms can also couple upper ends of the commissure portions to adjacent apices to pull them in at larger diameters. The radial position of the commissure portions relative to the rest of the frame can affect the positioning of the leaflets and the effectiveness of the valve.
  • US Patent Application Publication 2022/0031454 to Straubinger et al. describes a method of placing an implant including a stent at a native heart valve site including orienting an expandable body of the stent such that a first open end of the stent is upstream a second open end of the stent relative to a direction of blood flow through a native heart valve.
  • the native heart valve includes native leaflets and an annulus.
  • the method also includes radially expanding a plurality of positioning arches positioned around an outer perimeter of the expandable body.
  • the method additionally includes inserting the plurality of positioning arches respectively within a plurality of pockets defined by leaflets of the native heart valve and a heart structure from which the native leaflets extend.
  • the method further includes radially expanding the first open end of the stent into a position upstream of the annulus and out of contact with nerve bundles.
  • US Patent Application Publication 2019/0224008 to Bressloff et al. describes a frame for an implantable medical device, comprising: a first member, comprising a plurality of struts defining a plurality of cells, wherein the first member is annular and defines a longitudinal direction which is parallel to the axis of the first member, a radial direction, and a circumferential direction; a second member, comprising a plurality of struts and coupled to the first member at circumferentially distributed locations; wherein the second member overlaps a first end portion of the first member and extends beyond the first end portion of the first member.
  • PCT Publication WO 2019/030753 to Hariton et al. describes a unitary flexible sheet is folded to define (i) a panel; (ii) a first tab, having a first-tab outer layer and a first-tab inner layer, and protruding away from the panel; and (iii) a second tab, having a second-tab outer layer and a second-tab inner layer, and protruding away from the panel.
  • a commissural portion of a first prosthetic leaflet, and a commissural portion of a second prosthetic leaflet are disposed between the first-tab inner layer and the second- tab inner layer.
  • a first stitching is stitched through the inner layer of each tab, and the commissural portion of each leaflet.
  • a second stitching is stitched through the outer and inner layers of each tab, and the commissural portion of each leaflet.
  • the first-tab outer layer and the second-tab outer layer cover the first stitching.
  • Other embodiments are also described.
  • a prosthetic heart valve having a prosthetic valve frame assembly comprising an inner frame and an outer frame.
  • the prosthetic heart valve is percutaneously deliverable to a native heart valve in a compressed state, and is expandable at the native valve to facilitate one-way inflow-to-outflow, upstream- to-downstream, fluid flow through the lumen in a proximal-to-distal direction.
  • the prosthetic heart valve is typically designated for implantation at a native aortic valve of a patient. It is to be noted that the scope of the present invention includes implantation of the prosthetic heart valve at other native cardiac valves of the patient, e.g., a pulmonary valve, a mitral valve, or a tricuspid valve.
  • the outer frame of the prosthetic heart valve comprises at least four pairs, e.g., six pairs, of outer-frame struts and at least four, e.g., six, outer-frame junctions. These junctions function as tissue locators which locate and identify tissue at the downstream surface of the native valve (e.g., tissue at the downstream surface of the native cusp of the native leaflet).
  • the pairs of outer-frame struts function as tissue anchors which anchor the native leaflet between the respective pair of outer-frame struts and the inner frame thereby securing the prosthetic heart valve at the native valve by sandwiching tissue of the native valve between the inner frame and the outer frame.
  • the pairs of outer-frame struts prevent migration of the prosthetic heart valve in the proximal direction toward the left ventricle. Because the anchoring relies primarily on this sandwiching, the prosthetic heart valve substantially does not use outwardly- applied radial force to assist with the anchoring, i.e., does not require oversizing for anchoring.
  • the sandwiching-based anchoring of the prosthetic heart valve may reduce the risk of requiring permanent pacemaker implantation, by reducing the mechanical pressure applied by the prosthetic heart valve on the conduction system adjacent to the aortic valve annulus.
  • the prosthetic heart valve comprises an upstream sealing cuff, which may help prevent paravalvular leak (PVL).
  • PVL paravalvular leak
  • an upstream portion of the frame of the prosthetic may apply an outwardly-directed radial force to the surrounding aortic tissue, this radial force primarily provides sealing between the upstream sealing cuff and the surrounding aortic tissue, rather than materially assisting with anchoring.
  • the distance between the upstream end of the first stitching and the first-tab fold line is 30-60% of the distance between the upstream end of the first stitching and the panel.
  • the distance between the upstream end of the first stitching and the first-tab fold line is 35-55% of the distance between the upstream end of the first stitching and the panel.
  • a prosthetic valve including:
  • the first and second lines are disposed at an angle of 4-8 degrees with respect to each other.
  • a length of the second stitching is 1-1.5 mm greater than a length of the first stitching.
  • the point of intersection of the first and second lines is disposed 1-5 mm upstream of the second stitching.
  • the point of intersection of the first and second lines is disposed upstream of the sheet.
  • the point of intersection of the first and second lines is disposed 2-4 mm upstream of the sheet.
  • a number of holes in the first-tab outer layer through which the first stitching passes is lower than a number of holes in the first-tab outer layer through which the second stitching passes.
  • one plus the number of holes in the first-tab outer layer through which the first stitching passes is equal to the number of holes in the first-tab outer layer through which the second stitching passes.
  • the first stitching passes through exactly three holes in the first-tab outer layer and the second stitching passes through exactly four holes in the first-tab outer layer.
  • a prosthetic valve including:
  • a prosthetic heart valve configured for transcatheter implantation, the prosthetic heart valve including: a prosthetic valve frame, which (a) surrounds a central longitudinal axis of the prosthetic heart valve to define a lumen along the axis when the prosthetic heart valve is in an expanded state, (b) has a proximal end at an inflow end of the prosthetic valve frame, (c) has a distal end at an outflow end of the prosthetic valve frame, and (d) includes a plurality of struts; a plurality of prosthetic leaflets, disposed within the lumen, and arranged to facilitate one-way inflow-to-outflow fluid flow through the lumen in a proximal-to- distal direction when the prosthetic heart valve is in the expanded state; and a leaflet connector, wherein the prosthetic valve frame is shaped so as to define: a plurality of distal end nodes 32 that are at the distal end of the frame, and
  • an average width of the vertical struts 60 equals at least 125% of an average width of the distal-end-node-proximally-extending struts 62.
  • the average width of the vertical struts 60 equals at least 150% of an average width of the distal-end-node-proximally-extending struts 62.
  • the average width of the vertical struts 60 equals at least 200% of an average width of the distal-end-node-proximally-extending struts 62.
  • the one of the vertical struts 60 is monolithic.
  • the one of the vertical struts 60 terminates at the one of the distal junctions 45.
  • the leaflet connector is directly coupled to the prosthetic valve frame by stitching to the one of the vertical struts 60 using at least two stitches.
  • the leaflet connector is directly coupled to the prosthetic valve frame by stitching to the one of the vertical struts 60 using at least five stitches.
  • the pairs of the distal-end-node-proximally-extending struts 62 are first pairs of the distal-end-node-proximally-extending struts 62, each distal end node 32 has, in addition to the pair of distal-end-node- proximally-extending struts 62 extending from the distal end node 32, a second pair of distal-end-node-proximally-extending struts 66 extending from the distal end node 32, and the leaflet connector is directly coupled to the prosthetic valve frame by stitching to: the respective portions of the one of the first pairs of the distal-end-node- proximally-extending struts 62, and respective portions of one of the second pairs of the distal-end-node-proximally-extending struts 66, the respective portions of the one of the pairs of the distally-extending struts 44, and the one of the vertical struts 60
  • the pairs of the distally-extending struts 44 are first pairs of the distally- extending struts 44
  • each intermediate node 230 has at least a second pair of distally-extending struts 247 extending from the intermediate node 230, wherein, for each pair of circumferentially adjacent intermediate nodes 230, (i) a third distally-extending strut 247a that extends from the one of the intermediate nodes 230a of the pair of the intermediate nodes 230 converges at the distal junction 45 with (ii) a fourth distally-extending strut 247b that extends from the other of the intermediate nodes 230b of the pair of the intermediate nodes 230, and the third distally-extending strut 247a is distal to the first distally-extending strut 44a, and the fourth distally- extending strut 247b is distal to the second distally -extending strut 44b
  • the leaflet connector is directly coupled to the
  • the prosthetic valve frame is an inner frame that surrounds the central longitudinal axis of the prosthetic heart valve to define the lumen along the axis when the prosthetic heart valve is in the expanded state
  • the prosthetic heart valve includes a prosthetic valve frame assembly including the inner frame and an outer frame that is coupled to and surrounds the inner frame, and the leaflet connector is directly coupled to the inner frame by the stitching.
  • the leaflet connector is additionally directly coupled to the outer frame.
  • the leaflet connector is directly coupled to the outer frame by stitching.
  • the outer frame 80 is shaped so as to define: a plurality of distal end nodes 88 that are at a distal end of the outer frame 80, and for the distal end nodes 88, respective pairs of distally-extending struts 87 that converge at the distal end node 88, and the leaflet connector is directly coupled to the outer frame 80 by stitching to respective portions of one of the pairs of distally-extending struts 87.
  • FIGs. 1A-D are schematic illustrations of a prosthetic heart valve, and an inner frame of a frame assembly of the prosthetic heart valve, in accordance with some applications of the invention
  • FIGs. 2A-C are schematic illustrations of the prosthetic heart valve, and an outer frame of the frame assembly of the prosthetic heart valve, in accordance with some applications of the invention
  • FIGs. 3A-F are schematic illustrations of the frame assembly of the prosthetic heart valve, in accordance with some applications of the invention.
  • FIGs. 4A-B are schematic illustrations of the inner frame in a compressed state, in accordance with some applications of the invention.
  • FIGs. 5A-B are schematic illustrations of the outer frame in a compressed state, in accordance with some applications of the invention.
  • Figs. 6A-B are schematic illustrations of frame assembly in a compressed state, in accordance with some applications of the invention.
  • Figs. 7A-F are schematic illustrations of implantation of the prosthetic heart valve at a native aortic valve of a patient, in accordance with some applications of the invention.
  • Fig. 8 is a schematic illustration of an inner frame of another prosthetic heart valve, in accordance with an application of the present invention.
  • Fig. 9 is a schematic illustration of an outer frame of the prosthetic heart valve of Fig. 8, in accordance with an application of the present invention.
  • Fig. 10 is a schematic illustrations of a prosthetic heart valve frame assembly of the prosthetic heart valve of Figs. 8 and 9, in accordance with some applications of the invention.
  • Figs. 12A-H are schematic illustrations of additional configurations of the inner frame of Fig. 8, in accordance with respective applications of the present invention.
  • Figs. 13A-B are schematic illustrations of additional configurations of the outer frame of Figs. 2A-C, in accordance with respective applications of the present invention.
  • Fig. 17 is a schematic illustration of a sheet in an unfolded state, in accordance with some applications of the present invention.
  • Figs. 19A-C are photographs of a method of suturing one of a plurality of leaflet connectors to struts of the prosthetic heart valve of Figs. 10 and 11A-C, and a portion of the resulting assembled prosthetic heart valve, in accordance with an application of the present invention.
  • Prosthetic heart valve 22 comprises prosthetic valve frame assembly 21, a skirt 300 comprising flexible sheeting (such as such as described hereinbelow with reference to Figs. 11 A-C for prosthetic heart valve 222), and a valve member comprising prosthetic leaflets 140.
  • FIG. 2B shows a flat rollout view of outer frame 80.
  • Fig. 2C shows a top, outflow view of outer frame 80.
  • the enlarged portion of Fig. 2A shows a circumferential half of outer frame 80, and the entireties of Figs. 3C and 3D show a circumferential half of enlarged portion of prosthetic heart valve 22.
  • Figs. 1A-3D omit prosthetic leaflets 140, although prosthetic heart valve 22 comprises prosthetic leaflets 140.
  • prosthetic heart valve 22 further comprises skirt 300 and/or upstream sealing cuff 310, such as described hereinbelow with reference to Figs. 11 A-C for prosthetic heart valve 222.
  • Prosthetic heart valve 22, and each of inner frame 24 and outer frame 80, has an upstream, proximal end 26, a downstream, distal end 28, and defines a central longitudinal axis axl therebetween.
  • Frame assembly 21 comprises a prosthetic valve frame that comprises a valve body (which is a generally tubular portion), and is shaped to define a lumen through the valve body from its upstream end to its downstream end.
  • the valve body circumscribes axis axl, and thereby defines the lumen along the axis.
  • upstream and downstream are defined with respect to the longitudinal axis of valve 22, by the orientation and functioning of the prosthetic leaflets, which facilitate one-way upstream-to-downstream fluid flow through the lumen in a proximal-to-distal direction.
  • the struts of inner frame 24 have an average wall thickness of at least 0.35 mm, no more than 0.55 mm, and/or 0.35 - 0.55 mm, e.g., 0.48 mm.
  • the struts are electropolished, in which case the struts may have the above-mentioned wall thickness after electropolishing.
  • Figs. 2A-C show outer frame 80.
  • Outer frame 80 comprises appendages 81 configured to reversibly couple prosthetic heart valve 22 to a delivery tool.
  • Frame assembly 21 has an overall height Hl that is 20-26 mm, e.g., 22.0-24.83 mm.
  • Hl does not include appendages 81.
  • Hl also typically represents the height of inner frame 24.
  • the present invention provides a shorter overall height Hl of prosthetic heart valve 22 as compared to conventional transcatheter prosthetic aortic valves. This shortened overall height Hl is hypothesized by the inventors to minimize or even eliminate interference with openings 124 and 126 of coronary arteries 123 and 125, respectively, and to shorten the supra-annular portion 92 of prosthetic heart valve 22.
  • Figs. 1 A-D show inner frame 24. It is to be noted that inner frame 24 is typically used in combination with outer frame 80 as shown in Figs. 2A-C and, in general, herein. It is to be noted however, that the scope of the present invention includes the use of inner frame 24 (1) on its own itself, i.e., without an outer frame or (2) in combination with any other suitable valve frame, e.g., a suitable additional outer frame or a suitable additional inner frame.
  • Prosthetic valve inner frame 24 comprises a plurality of struts, comprising a biocompatible material, e.g., Nitinol.
  • Inner frame 24 is shaped so as to define a plurality of intermediate nodes 30 that are intermediate the proximal and distal ends 26 and 28 of inner frame 24.
  • Prosthetic valve inner frame 24 is also shaped so as to define a plurality of distal end nodes 32 that are at distal end 28 of inner frame 24.
  • first outflow junctions 64a are not at distal end 28 of inner frame 24, but instead are proximally offset from distal end 28.
  • Intermediate nodes 30 are circumferentially offset with respect to distal end nodes 32, i.e., angularly offset with respect to central longitudinal axis axl .
  • circumferentially means “angularly with respect to central longitudinal axis axl,” and thus refers to the position of the described element around central longitudinal axis axl, i.e., the "o'clock" of the element around the axis.
  • a first portion of the plurality of struts of inner frame 24 are intermediate struts 40.
  • Each intermediate node 30 has at least four struts extending therefrom, e.g., at least six struts (e.g., exactly six struts), such as shown in Figs. 1A-D and 3A-D, or at least eight struts (e.g., exactly eight struts), such as shown in Figs. 8, 10, 11A-C, and 12, described hereinbelow.
  • each intermediate node 30 includes (a) a distally-extending pair of two struts 44 of the at least four struts, and (b) a proximally-extending pair of two struts 46 of the at least four struts.
  • each of intermediate nodes 30 is shaped so as to define a waist axially separating the ends of the distally-extending pair of two struts 44 from the ends of the proximally-extending pair of two struts 46; for example, the waist may have a length of 0.1 - 0.3 mm, such as 0.12 - 0.2 mm, e.g., 0.15 mm.
  • a smaller rhombus 10 (or similar shape) of the prosthetic valve inner frame 24 is bounded by (1) distal portions of the first and second distally-extending struts 44a and 44b, and (2) the first and second intermediate struts 40a and 40b,
  • a larger rhombus 12 (or similar shape) of prosthetic valve inner frame 24 is bounded by (1) the first and second distally-extending struts 44a and 44b, and (2) the first and second proximally-extending struts 46a and 46b, and
  • inner frame 24 is not shaped so as to define first intermediate strut 40a and second intermediate strut 40b.
  • each intermediate node 30 has at least six struts extending therefrom (as shown):
  • the proximally-extending pair of two struts 46 is a first proximally-extending pair of two struts 46 of the at least six struts
  • the proximal junction defines a first proximal junction 48a.
  • the third proximally-extending strut 50a is proximal to the first proximally- extending strut 46a
  • the second proximal junction 48b is proximal to the first proximal junction 48a
  • the second proximal junction 48b and the first proximal junction 48a are circumferentially aligned, i.e., angularly aligned with respect to central longitudinal axis axl, and typically spaced apart in the proximal-to-distal direction.
  • each of first proximal junction 48a, its corresponding second proximal junction 48b, its corresponding intermediate junction 42, its corresponding distal end node 32, and its corresponding distal junction 45 are circumferentially aligned, i.e., angularly aligned with respect to central longitudinal axis axl.
  • (1) third and fourth proximally-extending struts 50a and 50b are connected to (2) first and second proximally-extending struts 46a and 46b at a connector 55.
  • connector comprises a vertical metal element. It is to be noted that (1) struts 50a and 50b and (2) struts 46a and 46b may be connected using any suitable connector.
  • a smaller rhombus 10 of the prosthetic inner valve inner frame 24 is bounded by (1) distal portions of the first and second distally- extending struts 44a and 44b, and (2) the first and second intermediate struts 40a and 40b,
  • a larger rhombus 12 of the prosthetic inner valve inner frame 24 is bounded by (1) the first and second distally- extending struts 44a and 44b, and (2) the first and second proximally-extending struts 46a and 46b, and
  • a largest rhombus 14 (or similar shape) of the prosthetic inner valve inner frame 24 is bounded by (1) the first and second distally-extending struts 44a and 44b, and (2) the third and fourth proximally-extending struts 50a and 50b.
  • the smaller rhombus 10 is within the larger rhombus 12, and the larger rhombus 12 is within the largest rhombus 14.
  • inner frame 24 defines a rhombus-within- rhombus section.
  • proximal struts 52 are disposed at the inflow, proximal end 26 of prosthetic valve inner frame 24 and provide increased strength and rigidity to a subannular portion 70 of the native aortic valve. This increased strength and rigidity provided by proximal struts in helpful in minimizing or eliminating paravalvular leaks. Additionally, proximal struts 52, in combination with the first and second proximal junctions 48a and 48b, which are longitudinally close together (as is described hereinbelow with reference to Fig. 3C), and provide additional increased strength and rigidity to subannular portion 70 of the native aortic valve.
  • subannular portion 70 is covered by a covering, e.g., a fabric, a polyester such a Dacron(TM), velour cloth, an inflatable cuff that is inflatable either with blood or fluid, and/or any other suitable material.
  • a covering e.g., a fabric, a polyester such a Dacron(TM).
  • This covering 150 is described hereinbelow with reference to Fig. 7F.
  • subannular portion 70 has a height H3 of 5.4-6.5 mm e.g., 5.4 mm.
  • a first proximal strut 52a extends proximally from an intermediate location 53a along a first strut 50’ of the second proximally-extending pair of two struts 50 of the at least six struts that extend from intermediate node 30, and (ii) a second proximal strut 52b extends proximally from an intermediate location 53b along a second strut 50” of the second proximally-extending pair of two struts 50 of the at least six struts that extend from intermediate node 30.
  • Each intermediate location 53a and 53b along respective first and second struts 50’ and 50” of the second pair of two struts 50 of proximally-extending struts is between the intermediate node 30 and respective proximal ends of each of the first and second struts 50’ and 50” of the second pair of two struts 50 of proximally-extending struts.
  • the first and second proximal struts 52a and 52b converge at a proximally- pointing junction 54 of the first and second proximal struts 52a and 52b.
  • the proximally-pointing junction 54 of the first and the second proximal struts 52a and 52b and the intermediate node 30 are circumferentially aligned, i.e., angularly aligned with respect to central longitudinal axis axl, and typically spaced apart in the proximal-to-distal direction.
  • Each proximally-pointing junction 54 is circumferentially offset with respect to its neighboring second proximal junction 48b i.e., angularly aligned with respect to central longitudinal axis axl.
  • the proximally-pointing junctions 54 are typically but not necessarily longitudinally aligned with the second proximal junctions 48b at a same height along central longitudinal axis axl, at proximal end 26 of the prosthetic valve inner frame 24.
  • each intermediate node 30 has at least four struts extending therefrom: (a) a distally-extending pair of two struts 44 of the at least four struts, and (b) a proximally- extending pair of two struts 46 of the at least four struts.
  • a first reinforcing strut 56a extends proximally from an intermediate location 57a along a first strut 44’ of the pair of distally-extending struts 44
  • a second reinforcing strut 56b extends proximally from an intermediate location 57b along a second strut 44” of the pair of distally-extending struts 44.
  • Each intermediate location 57a and 57b along respective first and second struts 44’ and 44” of the pair of distally-extending struts 44 is between the intermediate node 30 and respective distal ends of each of the first and second struts 44’ and 44” of the pair of distally-extending struts 44.
  • First and second reinforcing struts 56a and 56b converge at a proximally-pointing junction 58 of the first and second reinforcing struts 56a and 56b.
  • the proximally-pointing junction 58 of the first and second reinforcing struts 56a and 56b, and (2) its corresponding intermediate node 30 are circumferentially aligned i.e., angularly aligned with respect to central longitudinal axis axl.
  • proximally-pointing junction 58 of the first and second reinforcing struts 56a and 56b, (2) its corresponding intermediate node 30, and (3) its corresponding proximally-pointing junction 54 are circumferentially aligned i.e., angularly aligned with respect to central longitudinal axis axl .
  • reinforcing struts 56a and 56b are at a position of the inner frame 24 at which adjacent to the commissures of the prosthetic leaflets 140 of prosthetic heart valve 22. As shown, each of reinforcing struts 56a and 56b is coupled to a respective distally -extending struts 44. As described hereinbelow with reference to Figs. 3C, 18A-B, 19A-C, and 20, leaflet connectors 102 connect prosthetic leaflets 140 of prosthetic heart valve 22 to inner frame 24 by being sutured (i.e., stitched) to respective distally-extending struts 44 and to other struts.
  • Leaflet connector 102 form the commissures of prosthetic leaflets 140 of prosthetic heart valve 22. Since reinforcing struts 56a and 56b are coupled to respective distally- extending struts 44, reinforcing struts 56a and 56b reinforce that position and thereby reinforce the adjacent prosthetic commissures of the prosthetic heart valve 22. Additionally, reinforcing struts 56a and 56b additionally strengthen, stiffen, and provide additional rigidity to each of distally-extending struts 44. As such, each pair of reinforcing struts 56a and 56b create a respective reinforced zone 100 of prosthetic heart valve 22. As shown, in zone 100 prosthetic heart valve 22 defines a semi-double- strutted region of prosthetic heart valve 22.
  • the semi-double- strutted region is particularly appropriate in such an area of increased density due to the presence of leaflet connectors 102 of prosthetic heart valve 22.
  • the smaller reinforcing struts 56 as compared to other struts of valve 22 are used in zone 100.
  • each reinforcing strut 56 is 20-80%, such as 30-60%, a length of each intermediate strut 40.
  • the relatively smaller lengths of each reinforcing strut 56 provides increased rigidity to the strut as compared to a longer strut. It is hypothesized by the inventors that reinforcing struts 56 are particularly suited to accommodate radial forces at the left ventricular outflow tract.
  • Each distal end node 32 has at least two struts extending therefrom which comprise a distal-end-node-proximally-extending pair of two struts 62.
  • struts extending therefrom which comprise a distal-end-node-proximally-extending pair of two struts 62.
  • a first distal-end-node-proximally-extending strut 62a that extends from one distal end node 32a of the pair of distal end nodes 32 converges at a first outflow junction 64a with (ii) a second distal-end-node -proximally-extending strut 62b that extends from the other distal end node 32b of the pair of distal end nodes 32, and
  • first outflow junction 64a (2) the proximally-pointing junction 58 of the first and second reinforcing struts 56a and 56b, and (3) the corresponding intermediate node 30 are circumferentially aligned i.e., angularly aligned with respect to central longitudinal axis axl .
  • Each distal end node 32 has at least four struts extending therefrom.
  • the distal- end-node-proximally-extending pair of two struts 62 defines a first distal-end-node- proximally-extending pair of two struts 62, and the at least four struts of the distal end node 32 comprise a second distal-end-node-proximally-extending pair of two struts 66.
  • first and second outflow junctions 64a and 64b are circumferentially aligned i.e., angularly aligned with respect to central longitudinal axis axl.
  • proximally-pointing junction 58 of the first and second reinforcing struts 56a and 56b, (2) its corresponding intermediate node 30, (3) its corresponding proximally-pointing junction 54 are circumferentially aligned, i.e., angularly aligned with respect to central longitudinal axis axl, and its corresponding first and second outflow junctions 64a and 64b are circumferentially aligned i.e., angularly aligned with respect to central longitudinal axis axl.
  • each distal end node 32 has at least five struts extending therefrom.
  • the at least five struts comprise a vertical strut 60 which extends proximally from the distal end node 32 and to distal junction 45 and is disposed between (1) the first and third distal-end-node-proximally-extending struts 62a and 66a and (2) the second and fourth distal-end-node-proximally-extending struts 62b and 66b.
  • vertical strut 60 terminates at distal junction 45, i.e., does not extend proximally beyond distal junction 45.
  • the struts of the distal, outflow portion of inner frame 24 can be described as arranged in a double-strut formation in which pairs of two inner-frame distal struts (i.e., distal-end-node-proximally-extending pair of two struts 62 and second distal-end-node- proximally-extending pair of two struts 66) are arranged alongside each other.
  • the double-strut formation at the outflow, distal end 28 of inner frame 24 define the distal perimeter of inner frame 24 and are arranged in an undulating or zigzag pattern as a series of ascending and descending struts between circumferentially-adjacent distal end nodes 32.
  • the double-strut formation provides radial strength and rigidity to the distal, outflow portion of inner frame 24, and of prosthetic heart valve 22. Additionally, the double-strut formation of inner frame 24 enhances the strength of inner frame 24 such that it does not deform in response to hydrodynamic forces and other forces acted upon prosthetic heart valve 22 by the native tissue.
  • second proximal junctions 48b extend further radially away from axis axl than do distal end nodes 32 from axis axl such that the proximal end 26 of inner frame 24 is wider than the distal end 28 of inner frame 24.
  • the diameter of inner frame 24 gradually decreases from proximal end 26 to distal end 28 in a tapering manner.
  • first and second intermediate struts 40a and 40b have respective sequential longitudinal portions.
  • the respective sequential longitudinal portions when the prosthetic heart valve is in the expanded state, the respective sequential longitudinal portions:
  • first and second intermediate struts 40a and 40b of each pair of circumferentially adjacent intermediate nodes 30 has the shape described immediately above.
  • first curved longitudinal portion 41 and a beginning of second curved longitudinal portion 43 are defined by a point of inflection between first curved longitudinal portion 41 and second curved longitudinal portion 43.
  • an end of second curved longitudinal portion 43 is defined by either (a) a point of inflection along the intermediate strut or (b) a point at which the intermediate strut becomes straight.
  • each first curved longitudinal portion 41 may have a length of at least 0.2 mm (e.g., at least 0.25 mm), no more than 0.75 mm (e.g., no more than 0.6 mm), and/or 0.2 - 0.75 mm (e.g., 0.25 - 0.6 mm).
  • each second curved longitudinal portion 43 may have a length of at least 1 mm (e.g., at least 1.1 mm), no more than 1.75 mm (e.g., no more than 1.5 mm), and/or 1 - 1.75 mm (e.g., 1.1 - 1.5 mm). These lengths are measured along respective curved central longitudinal axes of the curved longitudinal portions.
  • a ratio of the length of each second curved longitudinal portion 43 to the length of each first curved longitudinal portion 41 may be 1.5 - 10, e.g., 2 - 8, such as 2 - 6.
  • each first curved longitudinal portion 41 may have a first inner radius of curvature RQI of at least 0.05 mm (e.g., at least 0.06 mm), no more than 0.2 mm (e.g., no more than 0.16 mm), and/or 0.05 - 0.2 mm (e.g., 0.06 - 0.16 mm).
  • each second curved longitudinal portion 43 may have a second inner radius of curvature R 2 of at least 0.4 mm (e.g., at least 0.5 mm), no more than 0.8 mm (e.g., no more than 0.7 mm), and/or 0.4 - 0.8 mm (e.g., 0.5 - 0.7 mm).
  • a ratio of the second inner radius of curvature R 2 to the first inner radius of curvature R ] may be 2 - 10, e.g., 3 - 9.
  • first and second intermediate struts 40a and 40b may help (a) provide a low crimping profile and/or (b) create an optimal curvature for these struts such that when these struts meet at intermediate junction 42, these struts can be stitched to the upstream part of the scallop of the prosthetic heart valve without having to apply tension to or fold the scallop (this stitching is shown in Figs. 11A-C for prosthetic heart valve 222).
  • Figs. 2A-C show prosthetic valve outer frame 80 of prosthetic heart valve 22.
  • outer frame 80 comprises appendages 81 configured to reversibly couple prosthetic heart valve 22 to a delivery tool.
  • Outer frame 80 Frame has a height H2 that is 12-17 mm, e.g., 13.3-15.9 mm. Height H2 does not include appendages 81.
  • outer frame 80 has a wall thickness that is smaller than the wall thickness of inner frame 24, which decreases the crimping profile of prosthetic heart valve 22 when inside the delivery tube.
  • the wall thickness of outer frame 80 may equal 36% - 99%, e.g., 45% - 65%, of the wall thickness of inner frame 24.
  • outer frame 80 has a wall thickness that is greater than the wall thickness of inner frame 24.
  • the wall thickness of outer frame 80 may equal 101% - 115% of the wall thickness of inner frame 24.
  • inner frame 24 comprises appendages 81, either instead of outer frame 80, or in addition to outer frame 80 (configurations not shown). Whether inner frame 24 or outer frame 80 comprises appendages 81, the appendages extend distally downstream beyond distal end 28 of the respective frame, i.e., are not considered part of the respective frame, and thus are not included in the respective height of the respective frame.
  • Prosthetic valve outer frame 80 comprises a plurality of struts, comprising a biocompatible material, e.g., Nitinol.
  • Outer frame 80 is shaped so as to define a plurality of intermediate nodes 86 that are intermediate the proximal and distal ends 26 and 28 of outer frame 80.
  • Prosthetic valve outer frame 80 is also shaped so as to define a plurality of distal end nodes 88 that are at distal end 28 of outer frame 80.
  • Intermediate nodes 86 are circumferentially offset with respect to distal end nodes 88, i.e., angularly offset with respect to central longitudinal axis axl .
  • Each intermediate node 86 has at least four struts extending therefrom, e.g., at least eight struts (e.g., exactly eight struts), such as shown in Figs. 2A-B and 3A-D (and Figs. 14, 21, 22, and 23, described hereinbelow), or at least 12 struts (e.g., exactly 12 struts), such as shown in Figs. 9 and 10, described hereinbelow.
  • the struts extending from each intermediate node 86 include (a) a distally-extending pair of two struts 87 (87a and 87b) of the at least four struts, and (b) a proximally-extending pair of two struts 85 (85a and 85b) of the at least four struts.
  • each intermediate node 86 has at least eight struts extending therefrom, such as shown
  • the struts extending from each intermediate node include (a) a first distally-extending pair of the two struts 87 (87a and 87b) of the at least eight struts, (b) a second distally-extending pair of the two struts 89 (89a and 89b) of the at least eight struts, (c) a first proximally-extending pair of two struts 85 (85a and 85b) of the at least eight struts, and (d) a second proximally- extending pair of two struts 83 (83a and 83b) of the at least eight struts.
  • the struts of outer frame 80 are arranged in a multiple- strut formation, such as a double- strut formation.
  • a multiple- strut formation such as a double- strut formation.
  • pairs of two outer- frame distal struts i.e., two struts 87 and two struts 89
  • the double-strut formation at the outflow, distal end 28 of outer frame 80 define the distal perimeter of outer frame 80 and are arranged in an undulating or zigzag pattern as a series of ascending and descending struts between circumferentially-adjacent distal end nodes 88. It is hypothesized by the inventors that the double-strut formation provides radial strength and rigidity to the distal, outflow portion of outer frame 80, and of prosthetic heart valve 22, and
  • pairs of two outer- frame proximal struts are arranged alongside each other.
  • the double-strut formation at the inflow, proximal end 26 of outer frame 80 define the proximal perimeter of outer frame 80 and are arranged in an undulating or zigzag pattern as a series of ascending and descending struts between circumferentially-adjacent outer-frame proximal junctions 84. It is hypothesized by the inventors that the double- strut formation provides radial strength and rigidity to the inflow, proximal portion of outer frame 80, and of prosthetic heart valve 22.
  • the entire outer frame 80 is arranged in a multiple- strut formation, such as a double- strut formation.
  • the multiple- strut formation is a triple- strut formation, such as described hereinbelow with reference to Fig. 9.
  • the multiple- strut formation, such as the double- strut formation, of outer frame 80 enhances the strength of outer frame 80 such that it does not deform in response to hydrodynamic forces and other forces acted upon prosthetic heart valve 22 by the native tissue.
  • the pairs of two outer-frame proximal struts i.e., two struts 83 and two struts 85
  • outer-frame proximal junctions 84 and 94 are disposed in an anchoring region 90 of outer frame 80 and of prosthetic heart valve 22 and provide increased radial strength and stiffness to valve 22 at anchoring region 90.
  • outer-frame proximal struts 83 and 85 and outer-frame proximal junctions 84 and 94 are covered in foam, e.g., polyurethane.
  • Outer- frame proximal junctions 84 extend further radially away from axis axl than do distal end nodes 88 from axis axl such that the proximal end 26 of outer frame 80 is wider than the distal end 28 of outer frame 80.
  • Each outer- frame proximal junction 84 is circumferentially aligned with a corresponding distal end node 88, i.e., angularly aligned with respect to central longitudinal axis axl .
  • Outer- frame proximal junctions 84 are longitudinally aligned.
  • outer frame 80 comprises at least four outerframe proximal junctions 84a, 84b, 84c, and 84d.
  • outer frame 80 comprises at least six outer- frame proximal junctions 84a, 84b, 84c, 84d, 84e, and 84f. outer-frame proximal junctions 84.
  • Each outer- frame proximal junction 84 (and for some applications, together with junctions 94) defines a tissue position locator 93 which is configured to abut against and locate tissue at the outflow surface of the native cusp of the native leaflet of the native aortic valve.
  • Each locator 93 is formed by respective pairs 82 of outer-frame struts which converge at respective outer-frame junctions (i.e., 84 and/or 94) that point in the proximal direction.
  • the plurality of pairs 82 of outer-frame struts are circumferentially disposed (i.e., angularly disposed with respect to central longitudinal axis axl) so as to engage an outflow surface of the native aortic valve.
  • locators 93 are typically not specifically aligned with cusps or commissures of the native aortic valve, although they may become aligned by chance during deployment.
  • prosthetic heart valve 22 is rotated during delivery such that exactly two locators 93 are disposed within each cusp of the native aortic valve.
  • each pair 82 of outer-frame struts comprises at least two proximally-extending proximal struts 83 from respective circumferentially- adjacent intermediate nodes 86.
  • each pair 82 of outer-frame struts comprises at least two proximally-extending proximal struts 83 from respective circumferentially- adjacent intermediate nodes 86.
  • outer- frame struts comprises at least (1) two proximally-extending proximal struts
  • outer frame 80 comprises at least four pairs 82 of outer- frame struts.
  • outer frame 80 comprises at least six pairs 82 of outer-frame struts, as can be seen in the isometric view of Fig. 2A, and in Figs. 2B-C; in the enlarged portion of Fig. 2A, which shows a circumferential half of outer frame 80, three of the six pairs can be seen and are labeled 82a, 82b, and 82c.
  • Prosthetic heart valve 22 thus defines at least four, e.g., six as shown in Figs. 2A-C, outer- frame tissue anchors 98 which each comprise (1) a pair 82 of outer- frame struts 83 (and for some applications a double-strut pair of outer-frame struts 83 and 85), and (2) an outer-frame proximal junction 84 (and for some applications, together with junctions 94) that defines a tissue position locator 93.
  • outer- frame tissue anchors 98 which each comprise (1) a pair 82 of outer- frame struts 83 (and for some applications a double-strut pair of outer-frame struts 83 and 85), and (2) an outer-frame proximal junction 84 (and for some applications, together with junctions 94) that defines a tissue position locator 93.
  • prosthetic heart valve 22 of the present invention comprises at least four, e.g., six, locators 93 and anchors 98 so as to increase the imaging visibility and to increase the likelihood of proper alignment, anchoring, and sealing of prosthetic heart valve 22 with respect to the native aortic valve.
  • the pairs 82 of outer-frame struts and outer-frame proximal junctions 84 and 94 defining locators 93 are disposed in a tissue-locating region 91 of outer frame 80 and of prosthetic heart valve 22 and provide increased radial strength and stiffness to valve 22 at tissue-locating region 91.
  • Each distal end node 88 has at least two struts extending therefrom which comprise first and second distal-end-node-proximally-extending distal struts 89. As shown, each distal end node 88 has at least four struts extending therefrom which comprise first and second distal-end-node-proximally-extending distal struts 89 and third and fourth distal-end-node-proximally-extending distal struts 87.
  • the struts of outer frame 80 have an average wall thickness of at least 0.2 mm, no more than 0.4 mm, and/or 0.2 - 0.4 mm, e.g., 0.31 mm.
  • the struts are electropolished, in which case the struts may have the above- mentioned wall thickness after electropolishing.
  • Fig. 3 A is an isometric view of frame assembly 21 from an inflow -outflow direction.
  • Fig. 3B is an isometric view of frame assembly 21 from an outflow-inflow direction.
  • Figs. 3C-D are side views of frame assembly 21 at different rotations.
  • Fig. 3E is a bottom, inflow view of frame assembly 21.
  • Fig. 3F is a top, outflow view of frame assembly 21.
  • Fig. 3C shows the relative distances between respective junctions of inner frame 24 and outer frame 80 of prosthetic heart valve 22.
  • junctions of both inner frame 24 and outer frame 80 decreases overall gap space between metal components of prosthetic heart valve 22 and increases overall radial forces of prosthetic heart valve 22 against tissue of the native aortic valve.
  • This particular configuration of multiple circumferentially- aligned and longitudinally disposed junctions helps prosthetic heart valve 22 withstand the high pressures associated with the left ventricular outflow tract and the aortic valve.
  • Prosthetic heart valve 22 defines a height H4 between (a) the proximal end of second proximal junction 48b, and (b) the proximal end of first proximal junction 48a of between 4.5-8.0 mm, e.g., 5.2-6.4 mm.
  • Prosthetic heart valve 22 defines a height H5 between (a) the proximal end of first proximal junction 48a, and (b) the proximal end of second outerframe proximal junction 84 of between 2.2-3.0 mm, e.g., 2.5-2.6 mm.
  • Prosthetic heart valve 22 defines a height H6 between (a) the proximal end of second outer-frame proximal junction 84, and (b) the proximal end of intermediate junction 42 of inner frame 24 of between 1.2-2.2 mm, e.g., 1.6-1.9 mm.
  • prosthetic heart valve 22 is configured in a manner in which:
  • the inner frame 24 is shaped so as to define a plurality of pairs of inner-frame struts which converge at respective inner-frame junctions 42, 48a, and 48b that point in the proximal direction, the plurality of pairs of inner-frame struts being circumferentially disposed (i.e., angularly disposed with respect to central longitudinal axis axl) so as to engage an inflow surface of the native aortic valve of the patient,
  • the outer frame 80 is shaped so as to define a plurality of pairs 82 of outer-frame struts which converge at respective outer-frame junctions 84 that point in the proximal direction, the plurality of pairs 82 of outer-frame struts being circumferentially disposed (i.e., angularly disposed with respect to central longitudinal axis axl) so as to engage an outflow surface of the native aortic valve,
  • each one of the outer-frame proximal junctions 84 is circumferentially aligned with a corresponding inner frame junctions 42, 48a, and 48b, i.e., angularly aligned with respect to central longitudinal axis axl,
  • the plurality of pairs of inner-frame struts and the plurality of pairs 82 of outerframe struts are configured to engage leaflets of the native valve between corresponding pairs of inner-frame struts and pairs 82 of outer-frame struts, and
  • the outer frame 80 is shaped so as to define at least four pairs 82 of outer-frame struts and at least four outer- frame junctions 84.
  • Fig. 3C additionally shows the relationship between intermediate node 86 of outer frame 80 and intermediate node 30 of inner frame 24, and in particular with reinforcing struts 56 and proximally-pointing junction 58.
  • each pair of reinforcing struts 56a and 56b, in combination with junction 58 and nodes 30 and 86 create a respective reinforced zone 100 of prosthetic heart valve 22.
  • reinforced zone 100 reinforces the adjacent prosthetic commissures of the prosthetic heart valve 22 are coupled to frame assembly 21 of prosthetic heart valve 22.
  • Fig. 3D shows prosthetic heart valve 22 having an outer diameter DI at inflow, proximal end 26 of 26-36 mm, e.g., 28.6-35.2 mm.
  • Prosthetic heart valve 22 has an outer diameter D2 at outflow, distal end 28 of 23-32 mm, e.g., 24.82-30.82 mm.
  • Prosthetic heart valve 22 defines a distance Dil between the outer-frame proximal junctions 84 of circumferentially-adjacent outer-frame tissue anchors 98 of 12-19 mm, e.g., 14.3-17.3 mm.
  • Outer frame 80 is directly coupled to inner frame 24 at outflow, distal end 28, specifically, distal end nodes 88 of outer frame 80 are directly coupled to distal end nodes 32 of inner frame 24.
  • outer frame 80 is sutured (i.e., stitched) to inner frame 24.
  • outer frame 80 is mechanically coupled to inner frame 24 in any suitable manner, e.g., welding or by coupling pins or other apparatus. As shown in Fig. 3D, the coupling of outer frame 80 to inner frame 24 is at the outflow, distal end 28 so as to enable increased radial flexibility of outer frame 80 as it progresses proximally from distal end 28.
  • outer frame 80 is at the outflow, distal end 28 so as to enable increased radial expansion of out-frame tissue anchors 98 and locators 93, as shown hereinbelow with reference to Fig. 7C.
  • the struts of outer frame 80 at anchoring region 90 and tissue-locating region 91 are not directly connected to inner frame 24 and thereby, these struts are capable of (1) flexing radially outwardly enough to accommodate leaflet tissue, while (2) maintaining sufficient rigidity in order to compress the native leaflets between (1) the outer-frame struts 83 and 85 at anchoring region 90 of outer frame 80 (2) and the inner frame struts at anchoring region 90.
  • prosthetic heart valve 22 defines a distance Di3 between (1) outerframe proximal junction 84 and tissue position locator 93, and (2) an outer surface of inner frame 24 of 0.8-2.2 mm, e.g., 1.1-1.5 mm.
  • annular plane AP is drawn in phantom so as to show the relative position of prosthetic heart valve 22 in the native aorta.
  • Anchoring region 90, tissue-locating region 91, and supra-annular portion 92 are typically disposed distal to annular plane AP and subannular portion 70 is typically disposed proximal to annular plane AP.
  • Figs. 3E-F show prosthetic heart valve 22 in respective blood inflow and blood outflow views.
  • prosthetic heart valve 22 comprises three prosthetic leaflets 140 which arranged to facilitate one-way inflow -to-outflow fluid flow through the lumen of prosthetic heart valve 22 in a proximal-to-distal direction.
  • Figs. 3E-F are shown without a covering of prosthetic heart valve 22.
  • prosthetic leaflets 140 may comprise pericardium, such as bovine or porcine pericardium, or a synthetic polymer, as is known in the prosthetic valve art.
  • FIGs. 4A-B are schematic illustrations of inner frame 24 of prosthetic heart valve 22 in a crimped configuration for delivery through a delivery tube, in accordance with some applications of the invention.
  • inner frame 24 has a crimped, outer diameter D3 of 4.5-6.5 mm, e.g., 5.5-6.0 mm.
  • FIGs. 5A-B are schematic illustrations of outer frame 80 of prosthetic heart valve 22 in a crimped configuration for delivery through a delivery tube, in accordance with some applications of the invention.
  • outer frame 80 In the crimped configuration, outer frame 80 has a crimped, outer diameter D4 of 5.0-7.5 mm.
  • FIGs. 6A-B are schematic illustrations of prosthetic valve frame assembly 21 comprising inner frame 24 and outer frame 80 of prosthetic heart valve 22 in a crimped configuration for delivery through a delivery tube, in accordance with some applications of the invention.
  • Outer frame 80 surrounds inner frame 24.
  • one or more capsules surround all or a portion of outer frame 80. Additionally, one or more capsules (not shown) surround all or at least a proximal portion of inner frame 24 to allow for controlled release of prosthetic heart valve 22 in the native aortic valve. Each capsule is independently controllable for sequential expanding of respective portions of valve frame assembly
  • Figs. 7A-F are schematic illustrations of a method for transcatheter implantation of prosthetic heart valve 22 at a native aortic valve 120 of a patient, in accordance with some applications of the invention.
  • a system 20 which comprises prosthetic heart valve 22 and a delivery system 131 comprising a delivery tube 132, housing prosthetic heart valve 22 in its crimped (compressed) configuration, is used to advance prosthetic heart valve 22 to aortic valve 120 using a transaortic approach, as shown.
  • tube 132 may be inserted through a blood vessel in the leg (transfemoral), through a large blood vessel in the heart (transaortic) or through the bottom tip of the heart (transapical).
  • proximal end 26 of prosthetic heart valve 22 is exposed from within tube 132.
  • proximal end 26 is exposed in the ascending aorta upstream of the aortic sinuses and upstream of openings 124 and 126 of coronary arteries 123 and 125, respectively, and upstream of downstream surfaces of the native cusps of native leaflets 122 of native aortic valve 120.
  • prosthetic heart valve 22 is advanced proximally and out of tube 132 and is moved axially proximally and distally to properly position prosthetic heart valve
  • prosthetic heart valve 22 within native aortic valve 120. It is to be noted that one or more delivery capsules (not shown) surrounds prosthetic heart valve 22 such that it remains in the crimped configuration. As shown, prosthetic heart valve 22 is reversibly coupled to delivery tube 132 using appendages 81.
  • a proximal portion of outer frame 80 of prosthetic heart valve 22 is exposed from within the one or more delivery capsules (not shown) such that outerframe tissue anchors 98 radially expand.
  • outer-frame tissue anchors form a downstream flange.
  • prosthetic heart valve 22 is moved such that outer-frame tissue anchors 98 and tissue position locators 93 are positioned at a downstream surface of cusps of native leaflets 122 of the native aortic valve 120.
  • prosthetic heart valve 22 is delivered to native aortic valve 120 in a manner in which native leaflets 122 are disposed between outer-frame tissue anchors 98 and the outer surface of inner frame 24.
  • Locating region 91 of outer frame 80 is thus appropriately positioned at the downstream surface of the native aortic valve 120.
  • inner frame 24 remains disposed within the one or more capsules (not shown) such that inner frame 24 remains in the crimped configuration. Additionally, at this stage, distal end 28 remains crimped due to the appendages 81 being surrounded by the end of delivery tube 132.
  • outer-frame tissue anchors 98 and locators 93 radially expand from within a delivery capsule by retracting the delivery capsule distally.
  • outer-frame tissue anchors 98 and locators 93 are allowed to radially expand at a site downstream of native aortic valve 120.
  • prosthetic heart valve 22 is then pushed in the upstream direction so as to position outerframe tissue anchors 98 and locators 93 at the downstream surface of native aortic valve 120, as described hereinbelow with reference to Fig. 7D.
  • delivery tube 132 is advanced upstream such that its distal end is within the left ventricle, and outer-frame tissue anchors 98 and locators 93 are allowed to radially expand at a site upstream of native aortic valve 120, e.g., within the left ventricle.
  • prosthetic heart valve 22 is then (1) retracted in the downstream direction so as to draw the outer-frame tissue anchors 98 and locators 93 downstream through the native aortic valve 120, and subsequently, (2) prosthetic heart valve 22 is pushed in the upstream direction so as to position outer-frame tissue anchors 98 and locators 93 at the downstream surface of native aortic valve 120, as described hereinbelow with reference to Fig. 7D.
  • prosthetic heart valve 22 is pushed by delivery tube 132 in the upstream, proximal direction with respect to the native aortic valve such that outerframe tissue anchors 98 and tissue position locators 93 are appropriately positioned at the downstream surface of cusps of native leaflets 122 of the native aortic valve 120. Additionally, position locators 93 and proximal junctions 84 are pushed in the upstream, proximal direction until they abut the surface and align with the downstream surfaces of cusps 127 of native aortic valve 120. That is, junctions 84 touch the base of leaflet 122 at the junction between the atrial wall and the leaflet 122.
  • junctions 84 touch the base of leaflet 122 in the middle of cusp 127.
  • locators 93 typically, but not necessarily comprise radiopaque markers.
  • a first portion of locators 93 and/or of first outer-frame proximal junction 94 comprise radiopaque markers, while a second portion of locators 93 and/or of first outer-frame proximal junction 94 do not comprise radiopaque markers, and thus function as tissue anchors.
  • the first portion of locators 93 and/or of first outer-frame proximal junction 94 are locators 93 and/or of first outer-frame proximal junction 94 which are present at the commissures of prosthetic heart valve 22. These first portion of locators 93 and/or of first outer-frame proximal junction 94 comprise the radiopaque markers which help align the commissures of prosthetic heart valve 22 with the native commissures of the native aortic valve 120. In addition to aiding the positioning of prosthetic heart valve 22 valve by facilitating imaging, the first portion of locators 93 and/or of first outerframe proximal junction 94 also provide tactile feedback during the positioning of the valve. The second portion of locators 93 and/or of first outer- frame proximal junction 94 is for providing tactile feedback during positioning and for providing and anchoring.
  • Outer-frame tissue anchors 98 and locators 93 provide mechanical anchoring and prevent migration of prosthetic heart valve 22 in the upstream direction away from native aortic valve 120 and toward the left ventricle.
  • inner frame 24 remains disposed within the one or more capsules (not shown) such that inner frame 24 remains in the crimped configuration. Additionally, at this stage, distal end 28 remains crimped due to the appendages 81 being surrounded by the end of delivery tube 132.
  • a proximal portion of inner frame 24 is expanded.
  • the proximal portion of inner frame 24 defines an upstream flange.
  • the capsule surrounding inner frame 24 is pushed from around inner frame 24 typically in the proximal direction and then retracted distally through prosthetic heart valve 22 and finally through aorta 121 and out of the body of the patient.
  • the proximal portion of inner frame 24 exerts radial forces against native tissue of the native aortic valve 120 thereby preventing and eliminating migration of prosthetic heart valve 22 in both the upstream and downstream directions.
  • the native leaflets 122 are sandwiched between (1) tissue anchors 98 of prosthetic heart valve 22 and (2) the proximal portion of inner frame 24 at anchoring region 90.
  • Fig. 7F shows prosthetic heart valve 22 fully implanted at native aortic valve 120.
  • the distal end 28 of prosthetic heart valve 22 is allowed to expand by fully retracting delivery tube 132 (not shown) such that tube 132 is disposed distally to and downstream of appendages 81. Once tube 132 does not surround appendages 81, distal end 28 of valve 22 is allowed to expand.
  • Fig. 7F shows the appropriate alignment and sealing of prosthetic heart valve 22 with native aortic valve 120. As shown, due to the overall height Hl of prosthetic heart valve 22, distal end 28 of prosthetic heart valve 22 does not extend downstream toward the aortic sinuses or to the openings 124 and 126 of coronary arteries 123 and 125.
  • prosthetic heart valve 22 does not occlude any of the openings 124 or 126 of coronary arteries 123 and 125.
  • height Hl of prosthetic heart valve 22 is 20-26 mm, e.g., 22.0-24.83 mm. Hl typically does not include appendages 81.
  • Prosthetic heart valve 22 is covered by a covering 130 comprising one or more sheets, e.g., fabric, a polyester such a Dacron(TM), or any other suitable material. It is to be noted that prosthetic heart valve 22 is shown only partially covered by covering 130 for clarity of illustration.
  • Supra-annular portion 92 is disposed downstream annular plane AP and subannular portion 70 is disposed upstream of annular plane AP.
  • subannular portion 70 is covered by a covering 150, e.g., a fabric, a polyester such a Dacron(TM), velour cloth, an inflatable cuff that is inflatable either with blood or fluid, and/or any other suitable material.
  • a covering 150 e.g., a fabric, a polyester such a Dacron(TM), velour cloth, an inflatable cuff that is inflatable either with blood or fluid, and/or any other suitable material.
  • Anchoring region 90 provides mechanical anchoring and prevents migration of prosthetic heart valve 22 upstream into the left ventricle, and subannular portion 70 exerts sufficient radial forces against tissue of aortic valve 120 in order to ensure that prosthetic heart valve 22 remains securely implanted and doesn’t migrate in either the upstream or downstream direction.
  • the overall configuration of frame assembly 21 of prosthetic heart valve 22 ensures that prosthetic heart valve 22 withstands and endures the high-pressure environment at the native aortic valve 120.
  • prosthetic heart valve 22 is robust in metal struts at anchoring region 90 so as to provide reinforcement of prosthetic heart valve 22.
  • (1) reinforcing struts 56a and 56b at reinforced zones 100 of prosthetic heart valve 22 that defines a semi-double- strutted region of prosthetic heart valve 22, (2) intermediate struts 40, (3) intermediate nodes 30, (4) junctions 58, (5) intermediate junctions 42, and (6) junctions 84 and 94 of outer frame 80 provide increased structural support to anchoring region 90.
  • inner frame 24 enhances the strength of inner frame 24 such that it does not deform in response to hydrodynamic forces and other forces acted upon prosthetic heart valve 22 by the native tissue.
  • prosthetic heart valve 22 is robust in metal struts at subannular portion 70 so as to provide reinforcement of prosthetic heart valve 22.
  • (1) struts 52, (2) junctions 54, (3) junctions 48a, and (6) junctions 48b provide increased structural support to subannular portion 70.
  • FIG. 8 is a schematic illustration of an inner frame 224, in accordance with an application of the present invention.
  • Fig. 8 shows a circumferential half of inner frame 224.
  • Inner frame 224 may be assembled with any of the outer frames described herein to form a prosthetic valve frame assembly.
  • inner frame 224 is shown assembled with an outer frame 280 to form a prosthetic valve frame assembly 221.
  • inner frame 224 may be identical to inner frame 24, described hereinabove with reference to Figs. 1A- 7F, and may implement any of the features thereof, mutatis mutandis; like reference numeral refer to like parts.
  • Inner frame 224 is shaped so as to define a plurality of intermediate nodes 230 that are intermediate the proximal and distal ends 26 and 28 of inner frame 224.
  • each intermediate node 230 has at least eight struts extending therefrom, e.g., exactly eight struts, as shown.
  • the struts extending from each intermediate node 230 include:
  • first intermediate strut 40a extends proximally from intermediate location 39a along first distally-extending strut 44a
  • second intermediate strut 40b extends proximally from intermediate location 39b of second distally-extending strut 44b
  • intermediate location 39a along first distally-extending strut 44a is between the one intermediate node 230a and distal junction 45
  • intermediate location 39b along second distally-extending strut 44b is between the other intermediate node 230b and the distal junction 45.
  • the first intermediate strut 40a and second intermediate strut 40b have some or all of the characteristics described hereinabove with reference to Figs. 1A-D.
  • the first distally-extending pair of two struts 44 and the second distally- extending pair of two struts 247 can be described as arranged in a double- strut formation in which the first and the second pairs are arranged alongside each other.
  • the struts of this double-strut formation are arranged in an undulating or zigzag pattern as a series of ascending and descending struts between circumferentially-adjacent distal junctions 45. It is hypothesized by the inventors that the double- strut formation provides radial strength and rigidity to prosthetic heart valve 22. Additionally, this double- strut formation of inner frame 224 enhances the strength of inner frame 224 such that it does not deform in response to hydrodynamic forces and other forces acted upon prosthetic heart valve 22 by the native tissue.
  • first and second intermediate struts 40a and 40b extend from respective upstream sides of first and second distally-extending struts 44a and 44b and curve with the angle and directions of curvature described hereinabove with reference to Figs. 1 A-B.
  • this shape of first and second intermediate struts 40a and 40b may help maintain the correct distance between the double struts (i.e., first intermediate struts 40 and second distally- extending pair of two struts 247).
  • the struts of the distal, outflow portion of inner frame 224 can be described as arranged in a double- strut formation in which pairs of two inner-frame distal struts (distal-end-node-proximally-extending pair of two struts 62 and second distal-end-node-proximally-extending pair of two struts 66) are arranged alongside each other. Also as described hereinabove with reference to Figs. 1A-D, 2A-C, and 3A-F regarding inner frame 24:
  • first distal-end-node-proximally-extending strut 62a that extends from one distal end node 32a of the pair of distal end nodes 32 converges at first outflow junction 64a with (ii) second distal-end-node -proximally-extending strut 62b that extends from the other distal end node 32b of the pair of distal end nodes 32,
  • third distal-end-node-proximally-extending strut 66a that extends from the one distal end node 32a of the pair of distal end nodes 32 converges at second outflow junction 64b with (ii) third distal-end-node-proximally-extending strut 66b that extends from the other distal end node 32b of the pair of distal end nodes, and
  • first and second outflow junctions 64a and 64b are circumferentially aligned, i.e., angularly aligned with respect to central longitudinal axis axl .
  • first and second outflow junctions 64a and 64b are joined at an outflow node 264.
  • inner frame 24, described hereinabove with reference to Figs. 1A-D, 2A-C, and 3A-F, may implement this feature.
  • inner frame 224 is also shaped so as to define the plurality of distal end nodes 32 that are at distal end 28 of inner frame 224.
  • each of distal end nodes 32 is shaped so as to define two notches 229 to facilitate stitching of inner frame 224 to outer frame 280.
  • FIG. 9 is a schematic illustration of outer frame 280, in accordance with an application of the present invention.
  • Fig. 9 shows a circumferential half of outer frame 280.
  • Outer frame 280 may be assembled with any of the inner frames described herein to form a prosthetic valve frame assembly.
  • outer frame 280 is shown assembled with inner frame 224 to form prosthetic valve frame assembly 221.
  • outer frame 280 may be identical to outer frame 80, described hereinabove with reference to Figs. 1A- 7F, and may implement any of the features thereof, mutatis mutandis; like reference numeral refer to like parts.
  • Outer frame 280 is shaped so as to define a plurality of intermediate nodes 286 that are intermediate the proximal and distal ends 26 and 28 of outer frame 280.
  • each intermediate node 286 has at least 12 struts extending therefrom, e.g., exactly 12 struts, as shown.
  • the struts extending from each intermediate node include:
  • first distally-extending distal strut 87a that extends from one intermediate node 286a of the pair of intermediate nodes 286 converges at distal end node 88 with (ii) second distally-extending distal strut 87b that extends from the other intermediate node 286b of the pair of intermediate nodes 286,
  • distal intermediate node 296 and proximal intermediate node 299 are circumferentially aligned, i.e., angularly aligned with respect to central longitudinal axis axl, such as shown.
  • the first distally-extending pair of two struts 87, the second distally-extending pair of two struts 89, and the third distally- extending pair of two struts 295 can be described as arranged in multiple- strut formation, such as a triple- strut formation, in which the first, the second, and the third pairs are arranged alongside each other.
  • an average distance between the second distally- extending pair of two struts 89 and the third distally-extending pair of two struts 295 is greater than (ii) an average distance between the first distally-extending pair of two struts 87 and the second distally-extending pair of two struts 89, such as shown in Figs. 9 and 10.
  • intermediate nodes 286 are shaped to as to define respective narrow waists, which may serve as stitching point between the inner and the outer frames, such as shown.
  • outer frame 280 is also shaped so as to define the plurality of distal end nodes 88 that are at distal end 28 of outer frame 280.
  • each of distal end nodes 88 is shaped so as to define two notches 233 to facilitate stitching of outer frame 280 to inner frame 224.
  • FIG. 10 is a schematic illustrations of a prosthetic heart valve 222 comprising a prosthetic valve frame assembly 221 comprising inner frame 224 and outer frame 280, in accordance with some applications of the invention.
  • Fig. 10 shows a circumferential half of prosthetic heart valve 222.
  • Fig. 10 omits prosthetic leaflets 140, although prosthetic heart valve 222 comprises prosthetic leaflets 140.
  • prosthetic heart valve 222 further comprises skirt 300, such as described hereinbelow with reference to Figs. 11A-C.
  • FIGs. 11A-B are schematic illustrations of inner frame 224 of prosthetic heart valve 222, including skirt 300 and prosthetic leaflets 140, in accordance with respective applications of the present invention.
  • FIG. 11C is a schematic illustration of prosthetic valve frame assembly 221 of prosthetic heart valve 222, including skirt 300 and prosthetic leaflets 140, in accordance with an application of the present invention.
  • Figs. 11A-B and/or 11C may be incorporated into any of the other prosthetic heart valves described herein.
  • prosthetic leaflets 140 are partially visible and partially concealed by skirt 300.
  • Prosthetic leaflets 140 can perhaps better be seen in Figs. 3E- F, which show frame assembly 21 of prosthetic heart valve 222.
  • the stitching that couples prosthetic leaflets 140 to skirt 300 can be seen in Figs. 11A-C, as described below.
  • outer frame 280 is shown partially in phantom so as not obscure inner frame 224.
  • prosthetic heart valve 222 comprises skirt 300, which covers a portion of inner frame 224 of prosthetic heart valve 222, such as shown.
  • Skirt 300 may help prevent paravalvular leak (PVL).
  • Skirt 300 may be attached to an inner surface of inner frame 224 (such as shown) and/or to an external surface of the inner frame (configuration not shown).
  • skirt 300 may be provided covering a portion of outer frame 280 (configuration not shown).
  • skirt 300 may comprise polyethylene terephthalate (PET), polyurethane (PU), or pericardium, such as bovine or porcine pericardium.
  • PET polyethylene terephthalate
  • PU polyurethane
  • pericardium such as bovine or porcine pericardium.
  • skirts 300 may be shaped so as to define openings 304, which may provide coronary access, such as for future percutaneous coronary intervention (PCI).
  • PCI percutaneous coronary intervention
  • prosthetic leaflets 140 are coupled to skirt 300, such as by stitching 302, which may, for example, comprise polyester, e.g., braided polyester.
  • prosthetic heart valve 222 comprises an upstream sealing cuff 310, in addition to or instead of skirt 300, such as shown in Fig. 11B.
  • Upstream sealing cuff 310 may help prevent paravalvular leak (PVL).
  • Upstream sealing cuff 310 may optionally be folded over upstream proximal end 26 of prosthetic heart valve 222, such as shown.
  • Upstream sealing cuff 310 may be coupled to an upstream end of portion of skirt 300, such as by stitching, or may be integral with skirt 300, i.e., fabricated from the same piece(s) of material as the skirt.
  • Upstream sealing cuff 310 may be attached to inner frame 224 (such as shown) and/or to outer frame 280 (configuration not shown).
  • upstream sealing cuff 310 may comprise polyethylene terephthalate (PET), polyurethane (PU), or pericardium, such as bovine or porcine pericardium.
  • prosthetic heart valve 222 does not comprise upstream sealing cuff 310, such as shown in Figs. 11A and 11C.
  • Figs. 12A-H are schematic illustrations of additional configurations of inner frame 224, in accordance with respective applications of the present invention. For clarity of illustration, Figs. 12A-H show circumferential halves of inner frame 224. These configurations may be implemented in combination with, or instead of, any of the configurations of the inner frame described herein.
  • inner frame 224 shown in Fig. 12A is identical to the configuration of inner frame 224 shown in Fig. 8, except that first and second outflow junctions 64a and 64b are not joined at outflow node 264.
  • the configuration of inner frame 224 shown in Fig. 12A is similar to the configuration of inner frame 24 shown in Figs. 1A-C.
  • inner frame 224 is shaped so as to define:
  • these struts can be described as arranged in a partial triple- strut formation and partial a double-strut formation.
  • Figs. 12C-H show additional alternative configurations of inner frame 224.
  • FIGs. 13A-C are schematic illustrations of additional configurations of outer frame 80, in accordance with respective applications of the present invention.
  • Figs. 13A-C show circumferential halves of outer frame 80.
  • outer frame 80 shown in Figs. 13B-C are generally similar to the configuration shown in Fig. 2 A, except that each of distal end nodes 88 is shaped so as to define two notches 233 to facilitate stitching of the outer frame to the inner frame, such as described hereinabove with reference to Fig. 9 for outer frame 280.
  • the shape of the struts is somewhat different in the configuration shown in Fig. 13B from the configuration shown in Fig. 13C. Either of these shapes may be implemented in any of the configurations of outer frames described herein, mutatis mutandis.
  • FIG. 14 is a schematic illustration of an outer frame 380, in accordance with an application of the present invention.
  • Fig. 14 shows a circumferential half of outer frame 380.
  • the features of this configuration may be implemented in combination with, or instead of, any of the other outer frames described herein.
  • this configuration is generally similar to the configuration of outer frame 80 described hereinabove with reference to Figs. 2A-C.
  • each intermediate node 86 has at least eight struts extending therefrom, such as shown, and the struts extending from each intermediate node 86 include (a) a first distally-extending pair of two struts 387 (387a and 387b) of the at least eight struts, (b) second distally- extending pair of two struts 89 of the at least eight struts, (c) a first proximally-extending pair of two struts 385 of the at least eight struts, and (d) second proximally-extending pair of two struts 83 of the at least eight struts.
  • These four pairs of struts together define a stent cell 390.
  • First proximally-extending pair of two struts 385 includes (i) a first proximally- extending proximal strut 385a that extends from the one intermediate node 86a of the pair of intermediate nodes 86 and converges at first outer-frame proximal junction 94 with (ii) a second proximally-extending proximal strut 385b that extends from the other intermediate node 86b of the pair of intermediate nodes 86
  • First distally-extending pair of two struts 387 includes (i) a first distally- extending distal strut 387a that extends from one intermediate node 86a of the pair of intermediate nodes 86 and converges at distal end node 88 with (ii) a second distally- extending distal strut 387b that extends from the other intermediate node 86b of the pair of intermediate nodes 86.
  • Outer frame 380 is further shaped so as to define, for each stent cell 390 defined as described above, four struts arranged in a generally X-shaped arrangement within stent cell 390 as follows: • first and second distal struts 392a and 392b extend from first distally- extending distal strut 387a and second distally-extending distal strut 387b, respectively, and converge at a central junction 396, and
  • first and second proximal struts 394a and 394b extend from first proximally- extending proximal strut 385a and second proximally- extending proximal strut 385b, respectively, and converge at central junction 396.
  • Figs. 15A-B are schematic illustrations of a prosthetic valve 400, in accordance with some applications of the present invention.
  • Prosthetic valve 400 comprises a tubular frame 402 that typically comprises an inner frame and an outer frame (as shown in Fig. 15A).
  • tubular frame 402 comprises a single frame.
  • prosthetic valve 400 may be similar or identical to any of the prosthetic valves described herein, including, but not limited to prosthetic valve 222, described with reference to Figs. 10 and 11A-C.
  • Fig. 15A shows tubular frame 402 and Fig. 15B does not show the tubular frame.
  • Prosthetic valve 400 is generally described herein as being a prosthetic aortic valve, but may alternatively be implemented as a prosthetic mitral valve, tricuspid valve, or pulmonary valve, mutatis mutandis.
  • First, second and third prosthetic leaflets 404, 406, and 408 of prosthetic valve 400 are disposed within a lumen 412 of tubular frame 402.
  • the leaflets When the leaflets are open they facilitate upstream-to-downstream fluid flow (e.g., blood flow) through lumen 412, and when they are closed they inhibit downstream-to-upstream fluid flow through lumen 412.
  • the leaflets are coupled to tubular frame 402 via a leaflet connector 401, which may be one implementation of leaflet connector 102, described herein with reference to Figs. 3C, 18A-B, 19A-C, and 20.
  • the number of leaflet connectors 401 is typically the same as the number of leaflets (i.e., three, as shown in Figs. 15A-B).
  • Figs. 16A-F are schematic illustrations of leaflet connector 401, showing the leaflet connector from different perspectives, in accordance with some applications of the present invention.
  • Leaflet connector 401 is typically embodied as a flexible sheet 410 (e.g., a unitary flexible sheet) that is connected to tubular frame 402 and is folded to define a panel 420, first and second tabs 430 and 440 between which two leaflets are secured (Fig. 15A), and one or more connection portions 418 for connecting leaflet connector 401 to struts of tubular frame 402 (Figs. 15A, 16B).
  • each connection portion 418 wraps around a respective strut of tubular frame 402.
  • each connection portion 418 typically but not necessarily wraps around one strut of the inner frame and one strut of the outer frame.
  • leaflet connector 401 comprises exactly two such connection portions 418 for wrapping around struts of tubular frame 402. Experiments performed by the inventors have shown that two such connection portions 418 are sufficient. Alternatively, four connection portions 418 connect leaflet connector 401 to tubular frame 402 (configuration not shown).
  • Panel 420 has a first side 422 facing in a first direction, and a second side 424 that is opposite first side 422.
  • First tab 430 is disposed on first side 422 of panel 420 and has a first-tab outer layer 432 and a first-tab inner layer 434 (Fig. 16C). First tab 430 protrudes in the first direction away from panel 420.
  • second tab 440 is disposed on first side 422 of panel 420, and has a second-tab outer layer 442 and a second-tab inner layer 444. Second tab 440 also protrudes in the first direction away from panel 420.
  • a first-leaflet commissural portion 450 of first prosthetic leaflet 404 and a second-leaflet commissural portion 452 of second prosthetic leaflet 406 are secured between first-tab inner layer 434 and second-tab inner layer 444, as shown in the exploded view in Fig. 15A.
  • a first stitching 460 and a second stitching 462 (Figs. 15 A, 16F) are stitched through first-tab outer layer 432, first-tab inner layer 434, first- leaflet commissural portion 450, second-leaflet commissural portion 452, second-tab inner layer 444, and second-tab outer layer 442.
  • stitchings 460 and 462 are shown in Fig. 15A, but only the holes through which the stitchings pass are shown in Figs. 16A-F.
  • all stitchings that pass through inner layers 434 and 444 also pass through outer layers 432 and 442.
  • sheet 410 is folded along a first-tab fold line 470 to define first-tab outer layer 432 and first-tab inner layer 434 (Fig. 16C), and is folded along a second-tab fold line 472 to define second-tab outer layer 442 and second-tab inner layer 444.
  • second stitching 462 is between first stitching 460 and panel 420.
  • the distance DI between the upstream end 474 of first stitching 460 and first-tab fold line 470 is less than the distance D2 between the upstream end of first stitching 460 and panel 420.
  • distance DI between the upstream end 474 of first stitching 460 and second-tab fold line 472 is less than distance D2 between the upstream end of first stitching 460 and panel 420.
  • the upstream direction in Fig. 15A (and in Fig. 16F) is toward the bottom of the page.
  • the inventors have found that implementing leaflet connector 401 using a smaller DI than D2 reduces the restriction on the movement of the leaflets by leaflet connector 401. Based on experiments, the inventors have found that particularly good results may be obtained by setting DI to be 30-60% (e.g., 35-55%) of distance D2.
  • first stitching 460 is disposed along a first line
  • second stitching 462 is disposed along a second line (Fig. 16F)
  • a point of intersection 480 of the first and second lines is upstream of first stitching 460 and upstream of second stitching 462.
  • the first and second lines are typically disposed at an angle theta that is at least 4 degrees and/or less than 8 degrees (e.g., 6-7 degrees) with respect to each other.
  • the length D3 of second stitching 462 is typically at least 1 mm and/or less than 1.5 mm (e.g., 1.2 mm) greater than the length D4 of first stitching 460.
  • the point of intersection of the first and second lines is typically a distance D5 that is at least 1 mm and/or less than 5 mm (e.g., 3-4 mm) upstream of second stitching 462.
  • the point of intersection of the first and second lines is disposed upstream of sheet 410, e.g., a distance D6 that is at least 2 mm and/or less than 4 mm (e.g., 2.7 mm) upstream of sheet 410.
  • the inventors have determined in experiments that constructing prosthetic valve 400 such that the point of intersection is as described herein may enhance the stability of prosthetic valve 400, in particular by increasing the stabilized contact area of the leaflets.
  • first stitching 460 may pass through exactly three holes 478 in first-tab outer layer 432 and second stitching 462 may pass through exactly four holes 476 in first-tab outer layer 432 (Fig 15A).
  • the inventors have determined in experiments that the direction of folding of tabs 430 and 440 at respective first-tab and second-tab fold lines 470 and 472 contributes to the strength of the support provided by leaflet connector 401.
  • sheet 410 is folded along a first-tab fold line 470 to define first-tab outer layer 432 and first-tab inner layer 434 (Figs. 16A, 16F).
  • first-tab inner layer 434 it is useful for first-tab inner layer 434 to be both contiguous with panel 420 along sheet 410 and to face first-leaflet commissural portion 450.
  • the contiguity of first-tab inner layer 434 with panel 420 can be more easily appreciated by considering Fig. 17 (described hereinbelow), which shows fold-line B separating what in the folded configuration of sheet 410 are first-tab inner layer 434 and one of two layers of panel 420. (As seen for example in Figs.
  • FIG. 16A-B panel 420 is a bi-layered panel.
  • Figs. 16C- F also show the contiguity of first-tab inner layer 434 with panel 420.
  • First-tab inner layer 434 extends away from the bi-layered panel toward first-tab fold line 470, whereupon sheet 410 bends at first-tab fold line 470 away from first-leaflet commissural portion 450, and first-tab outer layer 432 continues from the first-tab fold line, extending from first-tab fold line 470 toward the bi-layered panel.
  • sheet 410 is folded along second-tab fold line 472 to define second-tab outer layer 442 and second-tab inner layer 444.
  • Second-tab inner layer 444 faces second-leaflet commissural portion 452, is contiguous with the bi-layered panel along sheet 410, and extends from the bi-layered panel toward second-tab fold line 472.
  • sheet 410 bends at second-tab fold line 472 away from second-leaflet commissural portion 452, whereupon second-tab outer layer 442 extends from second- tab fold line 472 toward the bi-layered panel.
  • Fig. 17 is a schematic illustration of sheet 410 in an unfolded state, in accordance with some applications of the present invention.
  • sheet 410 is folded to produce leaflet connector 401.
  • Suitable fold lines in sheet 410 are shown in Fig. 17, and the order of folding may be A, B, C, D, E, F, G, and then H, based on the fold lines shown in the figure. (The scope of the present invention includes other sequences; for example, a fold may be made along fold-line B before fold-line A.)
  • the folding operations to produce leaflet connector 401 from sheet 410 shown in Fig. 17 are clear based on the multiple perspectives shown in Figs. 16A-F, it is noted that the fold lines shown in Fig.
  • FIG. 17 are of two kinds, a dashed line (fold lines A-D) and a dash-dot line (fold lines E-H), which indicate by way of illustration and not limitation whether a fold is to be made toward or away from the person making leaflet connector 401.
  • FIGs. 18A-B are photographs of a configuration of prosthetic heart valve 222 viewed from two different directions, in accordance with an application of the present invention.
  • FIGs. 19A-C are photographs of a method of suturing (i.e., stitching) one of leaflet connectors 102 to struts of prosthetic heart valve 222, and a portion of the resulting assembled prosthetic heart valve 222, in accordance with an application of the present invention.
  • Fig. 19A, Fig. 19B, and the lower left view of Fig. 19C show only inner frame 224 of prosthetic heart valve 222, while the other views in Fig. 19C show both inner frame 224 and outer frame 280 of prosthetic heart valve 222.
  • Fig. 3C also shows in phantom a leaflet connector 102 which is typically directly coupled to inner frame 24, e.g., typically by suturing, i.e., stitching.
  • Leaflet connector 102 is typically sutured (i.e., stitched) to (1) respective portions of pairs of distal-end-node-proximally-extending struts 66 and/or to respective portions of pairs of distal-end-node-proximally-extending struts 62, and (2) to respective portions of pairs of distally-extending struts 44.
  • leaflet connector 102 is sutured (i.e., stitched) to vertical strut 60. It is to be noted that the scope of the present invention includes coupling of the leaflet connectors 102 to the outer frame 80 in addition to the inner frame 24.
  • leaflet connector 102 is directly coupled to the prosthetic valve frame by stitching (using one or more sutures 104) to:
  • leaflet connector 102 may also be implemented in the other prosthetic heart valves described herein.
  • leaflet connector 102 is implemented in prosthetic heart valve 222 in Figs. 18A-B and 19A-C.
  • leaflet connector 102 may be implemented in other prosthetic heart valves known in the art.
  • leaflet connector 102 is directly coupled to inner frame 24 by the stitching.
  • leaflet connector 102 is shaped so as to define a flap 418, such as described hereinabove with reference to Figs. 15A-17. Flap 418 is wrapped around and sutured to the respective portions of the one of the pairs of distal-end-node- proximally-extending struts 62 of the inner frame, and, optionally, if provided, the respective portions of the one of the second pairs of distal-end-node-proximally- extending struts 66 of the inner frame.
  • leaflet connector 102 is additionally directly coupled to outer frame 80, such as by stitching, such as shown in Figs. 18A-B and 19C (except the lower left view) for outer frame 280.
  • leaflet connector 102 is directly coupled to outer frame 80 by stitching to respective portions of one of the first pairs of distally-extending struts 87 of outer frame 80 and/or one of the second pairs of distally-extending struts 89 of outer frame 80.
  • leaflet connector 102 is shaped so as to define flap 418, such as described hereinabove with reference to Figs. 15A-17. Flap 418 is wrapped around and sutured to:
  • leaflet connector 102 is directly coupled to the prosthetic valve frame by stitching to: • the respective portions of the one of the first pairs of distal-end-node- proximally-extending struts 62, and respective portions of one of the second pairs of distal-end-node-proximally-extending struts 66,
  • leaflet connector 102 is directly coupled to the prosthetic valve frame by stitching to:
  • an average width of vertical struts 60 equals at least 125%, such as at least 150%, e.g., at least 200%, of an average width of distal-end- node-proximally-extending struts 62.
  • an average width of vertical struts 60 is at least 0.4 mm, no more than 0.6 mm, and/or 0.4 - 0.6 mm, e.g., 0.5 mm.
  • an average width of distal-end-node-proximally- extending struts 62 is at least 0.18 mm, no more than 0.3 mm, and/or 0.18 - 0.3 mm, e.g., 0.24 mm.
  • the other struts of the inner frame may optionally also have these widths.
  • the one of vertical struts 60 is monolithic.
  • the monolithic vertical strut 60 typically does not define an elongate slit, and/or is not defined by two parallel struts running alongside each other.
  • leaflet connector 102 is directly coupled to the prosthetic valve frame by stitching to the one of vertical struts 60 using at least two stitches, such as using at least five stitches.
  • Leaflet connector 102 may optionally implement any of the techniques of leaflet connector 401, described hereinabove with reference to Figs. 15A-17.
  • FIG. 19A shows additional views of the assembly of the prosthetic heart valve, in accordance with an application of the present invention.
  • the sewing (stitching, i.e., suturing) sequence starts with an initial suture 25, which functions as a means of approximating a leaflet skirt assembly 20 to inner frame 24 (leaflet skirt assembly 20 comprises skirt 300 and leaflets 140, both described hereinabove).
  • This allows the sewing of an alignment suture 23 directly to vertical strut 60, as shown in View 2 of Fig. 19A.
  • This ensures that commissure 19 of leaflets 140 will be aligned with the inner frame.
  • a fixation suture 26 which ends in a knot 27, as shown in Fig. 19B.
  • This alignment suture is important as it ensures that all the load-bearing struts carry the load equally, which helps prevent fatigue -induced fractures, which otherwise might occur if a strut were to carry more load than it should, or if a load were to be applied in an unexpected manner, which might be caused by a misaligned commissure. Fixation suture 26 ensures the proper alignment is maintained throughout the lifetime of the prosthetic valve.
  • This use of vertical strut 60 during sewing assembly may help facilitate symmetrical assembly.
  • Figs. 1A-19C Reference is now made to Figs. 1A-19C. It is to be noted that although the prosthetic heart valves described in are described as being configured for implantation at a native aortic valve of the patient, the prosthetic heart valves may also be configured, mutatis mutandis, to be implanted at other cardiac valves of the patient, e.g., the pulmonary valve, the mitral valve and the tricuspid valve.

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  • 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)
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  • Prostheses (AREA)

Abstract

Une valve comprend une armature tubulaire dotée d'une lumière, et une feuille souple reliée à l'armature, pliée pour former un panneau, des première et des seconde pattes. Les pattes comportent des couches externe et interne, avec des parties commissurales de feuillets prothétiques positionnées entre les couches internes des pattes. La valve comprend de multiples lignes de couture qui permettent de fixer les feuillets à l'armature. La structure de l'armature, qui comprend des entretoises verticales et des paires d'entretoises allongées, assure une résistance et une rigidité radiales accrues, améliorant l'ancrage et la durabilité à l'intérieur du cœur. Le dispositif de fermeture incorpore un support de positionnement de suture qui passe de la position de mise en place à la positions déployée, aidant au processus de suture à l'intérieur de structures anatomiques creuses.
PCT/IB2025/052604 2024-03-13 2025-03-12 Valves cardiaques prothétiques Pending WO2025191478A1 (fr)

Applications Claiming Priority (2)

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US202463564747P 2024-03-13 2024-03-13
US63/564,747 2024-03-13

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WO2025191478A1 true WO2025191478A1 (fr) 2025-09-18

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120123529A1 (en) * 2010-10-05 2012-05-17 Edwards Lifesciences Corporation Prosthetic heart valve
US20200163760A1 (en) * 2016-08-10 2020-05-28 Cardiovalve Ltd. Prosthetic valve with leaflet connectors
US20210393398A1 (en) * 2019-03-04 2021-12-23 Edwards Lifesciences Corporation Commissure attachment for prosthetic heart valve

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120123529A1 (en) * 2010-10-05 2012-05-17 Edwards Lifesciences Corporation Prosthetic heart valve
US20200163760A1 (en) * 2016-08-10 2020-05-28 Cardiovalve Ltd. Prosthetic valve with leaflet connectors
US20210393398A1 (en) * 2019-03-04 2021-12-23 Edwards Lifesciences Corporation Commissure attachment for prosthetic heart valve

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