WO2025224700A1 - Implant de prothèse cardiaque valvulaire - Google Patents

Implant de prothèse cardiaque valvulaire

Info

Publication number
WO2025224700A1
WO2025224700A1 PCT/IB2025/054339 IB2025054339W WO2025224700A1 WO 2025224700 A1 WO2025224700 A1 WO 2025224700A1 IB 2025054339 W IB2025054339 W IB 2025054339W WO 2025224700 A1 WO2025224700 A1 WO 2025224700A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve prosthesis
heart valve
radially
protrusion arm
valve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2025/054339
Other languages
English (en)
Inventor
Erik C. GRISWOLD
Veronica L. Woen
Elizabeth A. HEYDE
Jonathan Primeaux
Jorge D. ZINGRE SANCHEZ
Xiaoyin LING
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.)
Medtronic Inc
Original Assignee
Medtronic Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Inc filed Critical Medtronic Inc
Publication of WO2025224700A1 publication Critical patent/WO2025224700A1/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
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • 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
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the present disclosure relates generally to a prosthetic heart valve assembly and, more particularly, to a heart valve prosthesis configured to be positioned within an index valve prosthesis.
  • a prosthetic heart valve assembly for implanting a heart valve prosthesis within a target site of the vasculature of a patient.
  • the heart valve prosthesis can be moved from a radially-contracted position to a radially- expanded position.
  • positioning the heart valve prosthesis while avoiding obstruction of the coronary arteries can be difficult.
  • a heart valve prosthesis is configured to be positioned within an index valve prosthesis.
  • the heart valve prosthesis comprises an annular frame extending along a valve axis between a first valve end of the heart valve prosthesis and a second valve end of the heart valve prosthesis.
  • the annular frame comprises a plurality of frame members and is configured to be adjustable between a radially- collapsed configuration and a radially-expanded configuration.
  • the annular frame comprises an engagement region extending circumferentially around the valve axis.
  • the annular frame comprises at least one protrusion arm extending radially outwardly from the annular frame.
  • the annular frame comprises at least one anchor attached to the at least one protrusion arm and configured to contact at least one lacerated leaflet of the index valve prosthesis and move the at least one lacerated leaflet to a position that does not obstruct a coronary artery.
  • the at least one protrusion arm comprises a self-expanding material that is biased to radially expand.
  • the at least one protrusion arm comprises nitinol.
  • the at least one protrusion arm is balloon-expandable.
  • the engagement region is located at a central region of the heart valve prosthesis axially between the first valve end and the second valve end such that the engagement region is located an axial distance from the first valve end and the second valve end.
  • a first radial distance between the at least one protrusion arm and the valve axis is greater than a second radial distance between a frame member of the plurality of frame members and the valve axis.
  • the at least one anchor projects radially outwardly from the at least one protrusion arm, the at least one anchor comprising an anchor end that is oriented toward the first valve end.
  • the at least one protrusion arm is attached to the first valve end and is configured to move between a first position, in which the at least one protrusion arm extends longitudinally along the valve axis in an end-to-end configuration with the first valve end such that the at least one protrusion arm does not circumferentially surround the annular frame, and a second position, in which the at least one protrusion arm extends longitudinally along the valve axis and circumferentially surrounds the annular frame.
  • the at least one anchor is attached to an arm end of the at least one protrusion arm, such that when the at least one protrusion arm is in the second position, the at least one anchor comprises an anchor end that is oriented toward the first valve end.
  • the at least one protrusion arm comprises a self-expanding material that is biased to move from the first position to the second position.
  • the at least one protrusion arm comprises nitinol.
  • At least one attachment member is attached to the first valve end and extends longitudinally from the first valve end parallel to the valve axis.
  • the at least one attachment member is configured to be received within a portion of a valve delivery assembly.
  • the first valve end comprises an inflow end.
  • a heart valve prosthesis is configured to be positioned within an index valve prosthesis.
  • the heart valve prosthesis comprises an annular frame extending along a valve axis between a first valve end of the heart valve prosthesis and a second valve end of the heart valve prosthesis.
  • the annular frame comprises a plurality of frame members and is configured to be adjustable between a radially- collapsed configuration and a radially-expanded configuration.
  • the annular frame comprises an engagement region extending circumferentially around the valve axis.
  • the annular frame comprises at least one protrusion arm extending radially outwardly from the annular frame.
  • the at least one protrusion arm is configured to radially- expand such that a first radial distance between the at least one protrusion arm and the valve axis is greater than a second radial distance between a frame member of the plurality of frame members and the valve axis.
  • the annular frame comprises at least one anchor attached to the at least one protrusion arm and projecting radially outwardly from the at least one protrusion arm.
  • the at least one anchor is configured to contact at least one lacerated leaflet of the index valve prosthesis and move the at least one lacerated leaflet to a position that does not obstruct a coronary artery.
  • At least one attachment member is attached to the first valve end and extends longitudinally from the first valve end parallel to the valve axis.
  • the at least one attachment member is configured to be received within a portion of a valve delivery assembly.
  • the first valve end comprises an inflow end.
  • the at least one protrusion arm comprises a self-expanding material that is biased to radially-expand.
  • methods of implanting a heart valve prosthesis comprise lacerating index leaflets of an index valve prosthesis that is positioned in a native aortic annulus.
  • Methods comprise delivering the heart valve prosthesis to an interior index lumen of the index valve prosthesis.
  • Methods comprise deploying the heart valve prosthesis within the interior index lumen such that the heart valve prosthesis moves from a radially-compressed configuration to a radially-expanded configuration.
  • the heart valve prosthesis comprises at least one protrusion arm extends radially outwardly from an annular frame.
  • At least one anchor is attached to the at least one protrusion arm.
  • Methods comprise contacting the lacerated index leaflets of the index valve with the at least one anchor such that the lacerated index leaflets are moved to a position that does not obstruct a coronary artery.
  • the at least one protrusion arm is configured to radially- expand as the heart valve prosthesis moves from the radially-compressed configuration to the radially-expanded configuration.
  • the at least one protrusion arm comprises a self-expanding material that is biased to radially-expand.
  • methods comprise engaging the heart valve prosthesis with a radially-expanding balloon to radially-expand the at least one protrusion arm.
  • the at least one protrusion arm is attached to the first valve end and as the heart valve prosthesis moves from the radially-compressed configuration to the radially-expanded configuration, the at least one protrusion arm moves from a first position, in which the at least one protrusion arm extends longitudinally along a valve axis of the heart valve prosthesis in an end-to-end configuration with the heart valve prosthesis, and a second position, in which the at least one protrusion arm extends longitudinally along the valve axis and circumferentially surrounds the annular frame.
  • FIG. 1 schematically illustrates example aspects of a transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 2 illustrates a top-down view of the transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 3 illustrates a side view of a delivery assembly for delivering the transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 4 illustrates a side view of the delivery assembly for delivering the transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 5 illustrates an introducer sheath in accordance with aspects of the disclosure
  • FIG. 6 illustrates an introducer sheath in accordance with aspects of the disclosure
  • FIG. 7 schematically illustrates a side view of an index transcatheter heart valve prosthesis positioned at a treatment site in accordance with aspects of the disclosure
  • FIG. 8 illustrates an example of transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 9 illustrates an example of transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 10 illustrates an example of a lacerated leaflet in accordance with aspects of the disclosure
  • FIG. 11 illustrates an example of engaging the lacerated leaflet with one or more anchors of the transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 12 illustrates an example of deploying the transcatheter heart valve prosthesis within the index transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 13 illustrates an example of deploying the transcatheter heart valve prosthesis within the index transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 14 illustrates an example of deploying the transcatheter heart valve prosthesis within the index transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 15 illustrates another example of transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 16 illustrates the transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 17 illustrates the transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 18 illustrates an example of deploying the transcatheter heart valve prosthesis within the index transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 19 illustrates an example of deploying the transcatheter heart valve prosthesis within the index transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 20 illustrates an example of deploying the transcatheter heart valve prosthesis within the index transcatheter heart valve prosthesis in accordance with aspects of the disclosure
  • FIG. 21 illustrates a transcatheter heart valve prosthesis that is balloonexpandable in accordance with aspects of the disclosure.
  • FIG. 22 illustrates a transcatheter heart valve prosthesis that is balloonexpandable in accordance with aspects of the disclosure.
  • the term “about” means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not, and need not be, exact, but may be approximate and/or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art.
  • Ranges can be expressed herein as from “about” one value, and/or to “about” another value. When such a range is expressed, aspects include from the one value to the other value. Similarly, when values are expressed as approximations by use of the antecedent “about,” it will be understood that the value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.
  • substantially is intended to represent that a described feature is equal or approximately equal to a value or description.
  • a “substantially planar” surface is intended to denote a surface that is planar or approximately planar.
  • substantially is intended to denote that two values are equal or approximately equal.
  • the term “substantially” may denote values within about 10% of each other, for example, within about 5% of each other, or within about 2% of each other.
  • first,” “second,” or the like are not intended to imply a temporal aspect, a spatial aspect, an ordering, etc. Rather, such terms are merely used as identifiers, names, etc. for features, elements, items, etc.
  • a first end and a second end generally correspond to end A and end B or two different ends.
  • distal and proximal are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician.
  • self-expanding may be used in the following description with reference to one or more valve or stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration or vice versa.
  • Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal.
  • Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol.
  • polymers that can be made to have shape memory characteristics may also be suitable for use in aspects hereof to include polymers such as polynorborene, transpolyisoprene, styrene-butadiene, and polyurethane.
  • polymers such as polynorborene, transpolyisoprene, styrene-butadiene, and polyurethane.
  • poly L-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers.
  • Diseases associated with heart valves can include stenosis and valvular insufficiency or regurgitation.
  • valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve.
  • Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient.
  • a diseased or damaged valve which can be congenital, age-related, drug- induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency.
  • Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and/or life threatening.
  • Heart valve prostheses have been developed for repair and replacement of diseased and/or damaged heart valves.
  • Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems.
  • Such heart valve prostheses generally include a frame or stent and a prosthetic valve mounted within the frame.
  • Such heart valve prostheses are delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.
  • FIGS. 1 and 2 illustrate an example transcatheter heart valve prosthesis 10.
  • the delivery assemblies described herein may be used with the transcatheter heart valve prosthesis 10 and/or other transcatheter heart valve prostheses.
  • the transcatheter heart valve prosthesis 10 is illustrated to facilitate description of the disclosure.
  • the following description of the transcatheter heart valve prosthesis 10 is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention.
  • FIGS. 1 and 2 illustrate a side view and a top/end view, respectively, of the transcatheter heart valve prosthesis 10.
  • the transcatheter heart valve prosthesis 10 includes a radially-expandable frame or stent 15 and a prosthetic valve 20.
  • the frame 15 of the transcatheter heart valve prosthesis 10 supports the prosthetic valve 20 within an interior of the frame 15.
  • the frame 15 is self-expandable.
  • the frame 15 can be balloon-expandable or mechanically expandable in other embodiments.
  • the transcatheter heart valve prosthesis 10 may be delivered to and implanted at a treatment site within a patient to replace any of an aortic valve, a pulmonic valve, a mitral valve, and or a tricuspid valve.
  • the valve to be replaced may be a native valve or a previously-implanted prosthetic valve, such as a failed surgical replacement valve or a failed transcatheter valve.
  • the prosthetic valve 20 includes at least one leaflet 21 disposed within and secured to the frame 15.
  • the prosthetic valve 20 includes exactly three leaflets 21, as shown in FIG. 2.
  • this is not meant to be limiting, as the prosthetic valve 20 may include more or fewer leaflets 21.
  • the valve leaflets 21 open and close to regulate flow through the transcatheter heart valve prosthesis 10.
  • the transcatheter heart valve prosthesis 10 includes an inflow end 11 and an outflow end 12.
  • the prosthetic leaflets 21 are attached to the frame 15 at commissures 25 such that when pressure at the inflow end 11 exceeds pressure at the outflow end 12, the prosthetic leaflets 21 open to allow blood flow through the heart valve prosthesis 10 from the inflow end 11 to the outflow end 12.
  • the prosthetic leaflets 21 close to prevent blood flow from the outflow end 12 to the inflow end 11.
  • the at least one leaflet can be attached to the plurality of struts 16, for example, by being directly attached to the plurality of struts 16 at the commissures 25, or by being indirectly attached to the plurality of struts 16, for example, by being attached to a skirt, a commissure bracket, or other structure (e.g., mechanical actuator) that is attached to the plurality of struts 16.
  • the heart valve prosthesis 10 can comprise one or more attachment members 24 (e.g., paddles) positioned at an end, for example, the inflow end 11 or the outflow end 12.
  • the attachment members 24 can be received within pockets of a spindle 38 (e.g., illustrated in FIG.
  • the spindle 38 and the attachment members 24 can interact to facilitate loading of the transcatheter heart valve prosthesis 10 and, in aspects, allow for possible recapture of the transcatheter heart valve prosthesis 10 during the deployment process.
  • the attachment members 24 can be attached to either of the inflow end 11 or the outflow end 12.
  • the spindle 38 is configured to be positioned to receive the attachment members 24 either (1) adjacent to the inflow end 11 when the attachment members 24 are attached to the inflow end 11, or (2) adjacent to the outflow end 12 when the attachment members 24 are attached to the outflow end 12. Accordingly, the position of the attachment members 24 illustrated in FIG. 1 is merely exemplary.
  • the frame 15 of the transcatheter heart valve prosthesis 10 further includes a plurality of struts 16 that are arranged to form a plurality of openings or cells 18 arranged circumferentially around a longitudinal axis LA of the transcatheter heart valve prosthesis 10 and longitudinally to form a tubular structure defining a central lumen of the transcatheter heart valve prosthesis 10.
  • the frame 15 can extend along the longitudinal axis LA between the inflow end 11 and the outflow end 12.
  • the frame 15 is configured to secure the prosthetic valve 20 within the central lumen of the frame 15 and to secure the transcatheter heart valve prosthesis 10 in place in the vasculature of the patient.
  • the struts 16 are defined herein as the elongated wire segments of the frame 15. Struts 16 come together to form crowns 17 or nodes 19, as can be seen in FIG. 1.
  • the frame 15 of the heart valve prosthesis 10 includes a plurality of cells 18 defined as the spaces between the plurality of crowns 17, the plurality of nodes 19, and the plurality of struts 16.
  • the frame 15, and, thus, the plurality of struts 16, can be adjustable between a radially-collapsed position and a radially-expanded position.
  • the plurality of cells 18 may be diamond-shaped.
  • the plurality of cells includes a plurality of first cells 18 and, in aspects, access cells (e.g., an access cell 23).
  • the access cells may be larger than the first cells 18 and can provide access to one or more coronary arteries when the transcatheter heart valve prosthesis 10 is implanted in the patient.
  • FIG. 1 illustrates an example of an access cell 23, with the stmts 16 at the access cell 23 illustrated with dashed lines to show that the stmts 16 may not be present at the access cell 23, thus allowing for the access cell 23 to be larger than the first cells 18.
  • the access cells can have an enlarged area relative or compared to the first cells 18.
  • the transcatheter heart valve prosthesis 10 may include an outer skirt extending circumferentially around an outer circumference of the stent 15 at or near the inflow end 11 to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis 10 once implanted in the patient.
  • FIGS. 3 and 4 show schematically side views of a transcatheter heart valve delivery assembly 30 (e.g., “delivery assembly”) for delivering and deploying a transcatheter heart valve prosthesis (e.g., transcatheter heart valve prosthesis 10) according to embodiments hereof.
  • a transcatheter heart valve delivery assembly 30 e.g., “delivery assembly”
  • the delivery assembly 30 includes a distal end 31, a proximal end 32, and a handle 33.
  • the handle 33 enables a physician to manipulate a distal portion of the delivery assembly 30 and includes actuators for moving parts of the delivery assembly 30 relative to other parts.
  • an outer shaft 34 is coupled to an actuator 39 of the handle 33 for moving the outer shaft 34 relative to an inner shaft 36.
  • a distal portion of the outer shaft 34 is configured to surround a transcatheter heart valve prosthesis (e.g., transcatheter heart valve prosthesis 10) during delivery to the treatment site (e.g., a native heart valve) and is retracted from the transcatheter heart valve prosthesis to expose the transcatheter heart valve prosthesis such that it self-expands (in self-expanding embodiments).
  • the capsule 35 is in frictional engagement with the heart valve prosthesis 10.
  • the inner shaft 36 can be coupled to the handle 33 (e.g., by being directly connected and in contact with the handle 33, or by being indirectly connected to the handle 33 with intermediate structures between the inner shaft 36 and the handle 33) and movement of the handle 33 can translate to movement of the inner shaft 36 and a distal tip or nosecone 37 coupled to a distal end of the inner shaft 36.
  • the inner shaft 36 and distal tip or nosecone 37 may also be translated relative to the outer shaft 34 and the handle 33 via a tip retractor.
  • the inner shaft 36 includes a retainer or spindle 38 for receiving the paddles (e.g., attachment members 24) of the transcatheter heart valve prosthesis 10.
  • the actuator 39 is actuated (e.g., rotated) to move the capsule
  • Minimally invasive percutaneous interventional procedures require access to the venous or arterial system.
  • Small incisions and short tissue contact time generally lead to improved patient outcomes, less complications, and less trauma to the vessels or organs being accessed, as well as less trauma to the skin and tissue through which the access point is created.
  • Access is required for various medical procedures that deliver or implant structural elements (such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.) percutaneously.
  • Some procedures employ relatively large devices that require relatively large sheaths to deliver the devices to the intended site within the body.
  • Expandable sheath designs may be regionally or locally expansive to selectively and temporarily expand when the device is passing through a region of the sheath and to retract or recover when the device is not passing or has already passed through the sheath.
  • Embodiments disclosed herein may be employed with an expandable introducer sheath that may solve these and other issues that contribute to vascular trauma.
  • the expandable introducer sheath is described with respect to percutaneous access for transcatheter heart valve repair or replacement, and it should be understood that one or more features of the expandable introducer sheath may be employed alone or in combination for other medical procedures requiring percutaneous access, including but not limited to placement of stents, angioplasty, removal of arterial or venous calcification, and pre -dilatation or post-dilatation.
  • Various embodiments disclosed herein may include an introducer sheath that has a selectively expandable diameter to allow for the passage of a relatively larger device therethrough and further is configured to return to its original diameter upon passage of the device.
  • the various embodiments may reduce damage to surrounding tissues by reducing contact with those tissues and by eliminating the need to exchange sheaths of different sizes. As a result, these embodiments can reduce procedure time, vascular trauma, bleeding, and the resulting risk of infection and other complications.
  • FIGS. 5 and 6 depict one embodiment of an introducer sheath 50 positioned through an incision 60 in the skin 65 of a patient and into a vessel 40 of a patient.
  • the sheath 50 has a tubular shaft 55 and a proximal hub 56 with a hemostatic seal and a luer lock 57.
  • FIG. 5 shows the sheath 50 positioned in the vessel 40 in its normal, unexpanded state
  • FIG. 6 shows the sheath 50 positioned in the vessel 40 with a delivery device 75 delivering another device 70 that is being advanced through the sheath 50 such that the tubular shaft 55 expands or deforms at the location where the device 70 is passing through.
  • the shaft 55 expands at expanded region 58 when the device 70 passes through and then retracts or recovers to its original diameter after the device 70 moves past or is removed from the shaft 55.
  • the tubular shaft 55 is configured to be expandable and retractable.
  • the expandability of the shaft 55 is achieved via the elasticity of the shaft 55, which can result in the shaft 55 being either self-expandable or selfexpanding or mechanically expandable or mechanically expanding.
  • self-expandable means that the shaft 55 is configured to expand to a predetermined or nominal diameter automatically (without any type of actuation, mechanical or otherwise).
  • mechanically expandable means that the shaft 55 is configured to expand when a positionable medical device is positioned through the shaft 55. That is, the device itself that is being passed through the shaft 55 causes the expansion of the shaft 55, as depicted in FIG. 6.
  • the expandable characteristics of the shaft 55 can be caused by something other than elasticity.
  • the shaft 55 is configured to be contractable, retractable, or recoverable to its original, unexpanded state as depicted in FIG. 5.
  • the retractability can be, in certain embodiments, achieved by the elasticity of the shaft 55, which can result in the shaft 55 being either self-retractable or self-retracting, self- recoverable, or self-contractable, or mechanically retractable or mechanically retracting, mechanically recoverable, or mechanically contractable.
  • self-retractable means that the shaft 55 is configured to retract to a predetermined or nominal diameter automatically (without any type of actuation, mechanical or otherwise).
  • mechanically retractable means that the shaft 55 is configured to retract when a device or component is used to cause the shaft 55 to retract or recover.
  • the retractable characteristics of the shaft 55 can be caused by something other than elasticity.
  • any device that can be positioned through an introducer sheath can be referred to as a positionable medical device or insertable medical device.
  • Such devices include guidewires, dilators, delivery devices (for delivery and/or placement of structural elements such as heart valves, heart valve repair devices, occluders, grafts, electrical stimulators, leads, etc.), guide catheters, guiding sheaths, diagnostic catheters, stent delivery systems, balloon catheters, and other known vascular devices.
  • Other devices can include non-vascular devices such as scopes and other common surgical instruments.
  • the introducer sheath is configured to receive tissues or organs.
  • the introducer sheath 50 is described as being an expandable introducer sheath 50 for introduction of a delivery assembly 30 including a transcatheter heart valve prosthesis 10.
  • FIG. 7 illustrates the heart valve prosthesis 10 at a treatment site 701 within a patient’s vasculature.
  • the treatment site 701 can comprise a location of a native aortic annulus (hereinafter “annulus”) 703 of a native heart valve, for example, the annulus of a patient’s left ventricle.
  • the treatment site 701 can comprise one or more native valve leaflets 705 and corresponding native sinuses 707.
  • paravalvular leakage can occur when blood travels through a gap 709 around the outside of the transcatheter heart valve prosthesis 10, with the gap 709 formed between the transcatheter heart valve prosthesis 10 and the annulus 703.
  • the heart valve prosthesis 10 can be radially expanded such that an outer radial surface of the heart valve prosthesis 10 can contact the annulus 703 and/or the native valve leaflets 705, thus reducing or eliminating the gap 709 and causing the blood to flow through the central lumen of the heart valve prosthesis 10.
  • the heart valve prosthesis 10 can comprise the frame 15, which can comprise an asymmetric hourglass shape with a first section 713 at the inflow end 11, a second section 715 at the outflow end 12, and a waist section 717 positioned between the first section 713 and the second section 715.
  • the first section 713 can comprise a first diameter 721 and the second section 715 can comprise a second diameter 723, with the second diameter 723 greater than the first diameter 721.
  • the transcatheter heart valve prosthesis 10 may include an outer skirt extending circumferentially around an outer circumference of the frame 15 at or near the inflow end 11 to prevent paravalvular leakage of blood around the outside of the transcatheter heart valve prosthesis 10 once implanted in the patient.
  • the heart valve prosthesis 10 can function as an index valve prosthesis (e.g., a previously-implanted heart valve prosthesis), such that another heart valve prosthesis can be delivered and deployed within the heart valve prosthesis 10.
  • the delivery assembly 30 can deliver a heart valve prosthesis 751 to an interior of the heart valve prosthesis 10.
  • the delivery assembly 30 can comprise the capsule 35 and the distal tip 37, with the heart valve prosthesis 751 in a radially- compressed position and loaded within the capsule 35.
  • the heart valve prosthesis 751 can have some similarities in structure to the heart valve prosthesis 10 described herein, though the heart valve prosthesis 751 can function as a new or redo heart valve prosthesis that is deployed within the index, or previously-implanted, heart valve prosthesis 10.
  • FIG. 8 illustrates a side view of an example of the heart valve prosthesis 751 that can be delivered to the interior of the index heart valve prosthesis 10.
  • the heart valve prosthesis 751 can comprise an annular frame 801 comprising a plurality of frame members or struts 803, with the annular frame 801 configured to be adjustable between a radially-collapsed configuration (e.g., illustrated in FIG. 7) and a radially-expanded configuration (e.g., illustrated in FIG. 8).
  • the frame 801 can be similar to the frame 15 described herein, with the frame 801 supporting a prosthetic valve (e.g., substantially identical to the prosthetic valve 20 comprising at least one leaflet 21 disposed within and secured to the frame 801) within an interior of the frame 801.
  • the frame 801 can comprise a nitinol material.
  • the frame 801 can be self-expandable, balloon-expandable, or mechanically expandable in other embodiments.
  • the frame 801 can extend along a valve axis 809 between a first valve end 811 and a second valve end 813. The first valve end 811 forms the inflow end and the second valve end 813 forms the outflow end.
  • first valve end 811 and the second valve end 813 may comprise some differences from the index valve prosthesis 10.
  • first valve end 811 comprises attachment members 24 and retention anchors.
  • second valve end 813 comprises fewer coronary access crowns that are wider and do not flare as much as the crowns at the inflow end 11 of the index valve prosthesis 10.
  • the frame 801 can comprise a reduced thickness, for example, as compared to a thickness of the index valve prosthesis 10.
  • the thickness e.g., diameter, cross-sectional size, etc.
  • the reduced thickness of the frame 801 can provide several benefits, for example, by minimizing pressure gradients after the heart valve prosthesis 751 has been deployed and/or reducing the system crossing profile and annular narrowing to yield improved hemodynamic performance.
  • the frame 801 can comprise fewer crowns as compared to the number of crowns of the index heart valve prosthesis 10. The benefit of comprising fewer crowns is a further reduction in thickness of the frame 801.
  • the heart valve prosthesis 751 can comprise at least one attachment member 24 attached to the first valve end 811 and extending longitudinally from the first valve end 811 parallel to the valve axis 809.
  • the at least one attachment member 24 can comprise, for example, paddles that can be received within a portion of the valve delivery assembly 30, for example, the spindle 38.
  • the spindle 38 can be positioned adjacent to the first valve end 811, and the spindle 38 can comprise one or more spindle pockets (e.g., openings, recesses, cavities, etc.), wherein the at least one atachment member 24 can be received within the spindle pockets. In this way, the at least one atachment member 24 and the spindle can function to maintain the first valve end 811 in the radially-compressed configuration, at least until the at least one atachment member 24 has been removed from the spindle pockets.
  • the heart valve prosthesis 751 can comprise an engagement region 817 extending circumferentially around the valve axis 809 and located axially between the first valve end 811 and the second valve end 813.
  • the engagement region 817 can be located at a central region of the heart valve prosthesis 751 axially between the first valve end 811 and the second valve end 813 such that the engagement region is located an axial distance from the first valve end 811 and the second valve end 813. That is, as illustrated in FIG. 8, the engagement region 817 can be located a first axial distance from the first valve end 811, and the engagement region 817 can be located a second axial distance from the second valve end 813. Though not required, the engagement region 817 can be located at a similar axial location as the waist section 717 of the heart valve prosthesis 10.
  • the engagement region 817 can comprise at least one protrusion arm 821 and at least one anchor 823.
  • the at least one protrusion arm 821 can extend radially outwardly from the annular frame 801.
  • the at least one protrusion arm 821 can comprise a first protrusion arm 901, a second protrusion arm 903, and a third protrusion arm 905 that are located radially exterior of the frame 801.
  • a first radial distance 909 is between the first protrusion arm 901 of the at least one protrusion arm(s) 821 and the valve axis 809.
  • a second radial distance 911 is between a frame member of the plurality of frame members 803 and the valve axis 809.
  • the first radial distance 909 is greater than the second radial distance 911.
  • the second protrusion arm 903 and the third protrusion arm 905 may be similar or identical in structure to the first protrusion arm 901.
  • the protrusion arms 821, 901, 903, 905 can comprise a selfexpanding material that is biased to radially-expand, such as, for example, nitinol.
  • the self-expanding material can be heat-set such that the self-expanding material is biased to move to a radially-expanded position.
  • the first protrusion arm 901 can extend non- linearly between a first arm end 827 and a second arm end 829.
  • the first arm end 827 can be atached to one of the frame members 803, and the second arm end 829 can also be attached to one of the frame members 803.
  • the first arm end 827 and the second arm end 829 can be located at the same longitudinal location along the valve axis 809 but at different circumferential locations about the valve axis 809.
  • the first arm end 827 can be separately connected to, or alternatively, formed together (e.g., one-piece formed as a single unitary structure) with the frame members 803.
  • the second arm end 829 can be separately connected to, or alternatively, formed together (e.g., one-piece formed as a single unitary structure) with the frame members 803.
  • the first protrusion arm 901 can project radially outwardly from the frame 801 (e.g., as illustrated in FIG. 9, which is a top-down view of the heart valve prosthesis 751 along lines 9-9 of FIG. 8).
  • the first protrusion arm 901 can comprise a rounded or curved shape that projects toward the first valve end 811. In this way, the first protrusion arm 901 may be located a non-constant distance from the first valve end 811.
  • first arm end 827 and the second arm end 829 can represent a maximum separating distance 833 between the first protrusion arm 901 and the first valve end 811 along the valve axis 809, while a midpoint or center of the first protrusion arm 901 may represent a minimum separating distance 835 between the first protrusion arm 901 and the first valve end 811 along the valve axis 809. Likewise, the midpoint or center of the first protrusion arm 901 can represent a maximum radial distance at which the first protrusion arm 901 is separated from the valve axis 809.
  • the midpoint or center of the first protrusion arm 901 forms a curved shape that projects radially- outwardly from the valve axis 809 and longitudinally toward the first valve end 811.
  • the frame 801 can comprise a stabilizing arm 822 that extends between one of the frame members 803 and the first protrusion arm 901.
  • the stabilizing arm 822 can be attached at one end to the frame 801 (e.g., one of the frame members 803) and can be attached at an opposing end to the first protrusion arm 901 , for example, a center or midpoint of the protrusion arm 901.
  • the stabilizing arm 822 can extend radially-outwardly from the valve axis 809 and can function to stabilize or secure the first protrusion arm 901 relative to the frame 801.
  • the other protrusion arms 903, 905 can similarly be atached to stabilizing arms that are substantially identical in function, shape, and position to the stabilizing arm 822.
  • the second protrusion arm 903 and the third protrusion arm 905 may be substantially identical in size, shape, structure, and function to the first protrusion arm 901.
  • the second protrusion arm 903 can be circumferentially offset from the first protrusion arm 901 about the valve axis 809, for example, within a range from about 100 degrees to about 140 degrees, or about 120 degrees.
  • the second protrusion arm 903 can be circumferentially offset from the third protrusion arm 905 about the valve axis 809, for example, within a range from about 100 degrees to about 140 degrees, or about 120 degrees.
  • the first protrusion arm 901 can be circumferentially offset from the third protrusion arm 905 about the valve axis 809, for example, within a range from about 100 degrees to about 140 degrees, or about 120 degrees.
  • the at least one anchor 823 can be attached to the at least one protrusion arm 821 and can contact at least one lacerated leaflet of the index valve prosthesis 10 and move the at least one lacerated leaflet to a position that does not obstruct a coronary artery.
  • the at least one anchor 823 can comprise one or more anchors attached to each of the first protrusion arm 901, the second protrusion arm 903, and the third protrusion arm 905. As illustrated in FIGS.
  • the at least one anchor 823 can comprise three anchors attached to the first protrusion arm 901, three anchors attached to the second protrusion arm 903, and three anchors attached to the third protrusion arm 905, however any number of anchors can be attached to the protrusion arms 901, 903, 905.
  • the at least one anchor 823 can comprise a first anchor 915, a second anchor 917, and a third anchor 919 attached to the first protrusion arm 901.
  • the first anchor 915 (e.g., and the other anchors 823, 917, 919) can project radially outwardly (e.g., away from the valve axis 809), with the first anchor 915 comprising an anchor end 837 that is oriented toward the first valve end 811.
  • the first anchor 915 can comprise a wire or other structure that is stiff and has an elongated shape.
  • the first anchor 915 may extend non-linearly, with one end of the first anchor 915 attached to the first protrusion arm 901, and the opposing end of the first anchor 915 terminating at the anchor end 837.
  • the first anchor 915 can comprise a rounded, curved, or bent shape that projects from the first protrusion arm 901 toward the first valve end 811.
  • the first anchor 915 can, in aspects, simultaneously extend toward the first valve end 811 while extending radially- outwardly away from the valve axis 809. In this way, by extending radially-outwardly while being oriented (e.g., facing toward) the first valve end 811, the first anchor 915 is configured to contact and engage one or more of the leaflets 21 of the index valve prosthesis 10.
  • first anchor 915 can be attached at any location of the first protrusion arm 901
  • first anchor 915 can be attached to the center of the first protrusion arm 901 (e.g., wherein the center of the first protrusion arm 901 defines the minimum separating distance 835) at a midpoint of the length of the first protrusion arm 901 between the first arm end 827 and the second arm end 829.
  • the second anchor 917 can be attached to the first protrusion arm 901 at a location between the first arm end 827 and the first anchor 915 (e.g., the location at which the first anchor 915 is attached to the first protrusion arm 901).
  • the second anchor 917 may be located at a midpoint between the first arm end 827 and the location at which the first anchor 915 is attached to the first protrusion arm 901.
  • the third anchor 919 can be attached to the first protrusion arm 901 at a location between the second arm end 829 and the first anchor 915 (e.g., the location at which the first anchor 915 is attached to the first protrusion arm 901).
  • the third anchor 919 may be located at a midpoint between the second arm end 829 and the location at which the first anchor 915 is attached to the first protrusion arm 901.
  • the other anchors 823 may be substantially identical in structure and function to the first anchor 915, such that the description of the first anchor 915 is applicable to the other anchors.
  • distal markers e.g., radiopaque markers
  • the heart valve prosthesis 751 can comprise wide coronary access crowns to allow for improved coronary access and easier positional accuracy.
  • FIG. 10 illustrates a side view of at least one lacerated leaflet 1001 of the leaflets 21 of the index valve prosthesis 10 after the leaflet 1001 has been lacerated but prior to the anchors 823, 915, 917, 919 engaging the leaflet 1001.
  • the other portions of the index valve prosthesis 10 are omitted from view in FIG. 10.
  • two anchors 915, 919 are illustrated in FIG. 10, the other portions of the heart valve prosthesis 751 are omitted from view.
  • the leaflet 1001 can be lacerated (e.g., laceration 1003 illustrated schematically with dashed lines) prior to being engaged by the anchors 915, 917, 919.
  • the laceration 1003 of the leaflet 1001 can form a first leaflet portion 1005 and a second leaflet portion 1007.
  • one or more of the anchors for example, the first anchor 915 and the third anchor 919, can be moved into position in a movement direction 1009 (e.g., toward the lacerated leaflet 1001) to engage the first leaflet portion 1005 and the second leaflet portion 1007.
  • an ultrasound technology e.g., shockwave, etc.
  • FIG. 11 illustrates the first anchor 915 and the third anchor 919 engaging the lacerated leaflet 1001.
  • the heart valve prosthesis 751 can be radially- expanded and moved in the movement direction 1009 toward the lacerated leaflet 1001.
  • the anchors for example, the first anchor 915 and the third anchor 919 can contact and engage the lacerated leaflet 1001.
  • the first anchor 915 can contact and engage the first leaflet portion 1005 while the second anchor 917 can contact and engage the second leaflet portion 1007.
  • This engagement can allow for the anchors 915, 919 to grip the leaflet portions 1005, 1007 (e.g., with anchor ends 837 of the anchors 915, 919) and, in aspects, penetrate or extend through the leaflet portions 1005, 1007.
  • the anchors 915, 919 can cause the leaflet portions 1005, 1007 to spread apart (e.g., splay) in a separation direction 1011 (e.g., illustrated in FIG. 10), for example, with the first leaflet portion 1005 being pushed away from the second leaflet portion 1007, and the second leaflet portion 1007 being pushed away from the first leaflet portion 1005. Accordingly, as illustrated in FIG.
  • a gap 1101 can be formed between the first leaflet portion 1005 and the second leaflet portion 1007.
  • the anchors 915, 919 can remain in engagement with the leaflet portions 1005, 1007 and may prevent the leaflet portions 1005, 1007 from moving to a position that obstructs the coronary arteries.
  • methods can comprise contacting the lacerated index leaflet(s) 1001 of the index valve 10 with the at least one anchor 823 such that the lacerated index leaflet(s) 1001 (e.g., the leaflet portions 1005, 1007) can be moved to a position that does not obstruct a coronary artery.
  • Any of the anchors disclosed herein can serve the benefit of improving migration resistance of the valve prosthesis while reducing reliance on radial force.
  • the stabilizing arms 822 may help to splay the lacerated leaflets portions as the heart valve prosthesis 751 is moved in the distal direction (e.g., in direction of arrow 1009).
  • FIGS. 12-14 illustrate example aspects of deploying the heart valve prosthesis 751 within the interior index lumen of the index heart valve prosthesis 10.
  • methods can comprise lacerating index leaflets 21 of the index valve prosthesis 10 that is positioned in the native aortic annulus 703. The leaflets 21 are lacerated prior to the deployment of the heart valve prosthesis 751.
  • methods can comprise delivering the heart valve prosthesis 751 to the interior index lumen of the heart valve prosthesis 10.
  • the heart valve prosthesis 751 can be delivered in a similar manner as described relative to FIGS. 3-7. For example, and as illustrated in FIGS.
  • the heart valve prosthesis 751 can be radially-compressed and loaded into the capsule 35. That is, the heart valve prosthesis 751 is in the radially-compressed configuration in FIGS. 7 and 12.
  • the engagement region 817 may likewise be radially-compressed and received within the capsule 35.
  • the capsule 35 can be moved through a patient’s vasculature to the native aortic annulus 703.
  • delivering the heart valve prosthesis 751 can comprise holding the heart valve prosthesis 751 in the radially-compressed configuration within the capsule 35 as the heart valve prosthesis 751 is moved to the interior index lumen of the index heart valve prosthesis 10.
  • the engagement region 817 when the engagement region 817 is radially-compressed, the engagement region 817 comprises a diameter that is less than the diameter of the engagement region 817 when the engagement region 817 is expanded and released from the capsule 35 (e.g., illustrated in FIG. 8).
  • the capsule 35 can be separated.
  • the capsule 35 can comprise a first sheath 1301 and a second sheath 1303 that, together, circumferentially surround the heart valve prosthesis 751 and maintain the heart valve prosthesis 751 in the radially-compressed configuration.
  • the first valve end 811 can be positioned within the first sheath 1301.
  • the first sheath 1301 can be moved in a movement direction 1305 away from the second sheath 1303. This movement of the first sheath 1301 can cause the second valve end 813 to be released from the capsule 35, whereupon the second valve end 813 may begin to radially expand.
  • the first sheath 1301 can be advanced independently of the second sheath 1303 to uncover (e.g., unsheathe, release, etc.) the heart valve prosthesis 751.
  • the first valve end 811 may comprise the attachment members 24 (e.g., illustrated in FIG. 8), with the attachment members 24 attached to a spindle 38 that is adjacent to the first valve end 811.
  • the proximal end (e.g., second valve end 813) of the heart valve prosthesis 751 can be exposed first prior to releasing and exposing the distal end (e.g., first valve end 811).
  • FIG. 14 further illustrates methods of deploying the heart valve prosthesis 751 within the interior index lumen (e.g., of the index heart valve prosthesis 10) such that the heart valve prosthesis 751 can move from the radially-compressed configuration to the radially-expanded configuration.
  • the first sheath 1301 can continue to move in the movement direction 1305, such that the engagement region 817 may be released from the capsule 35, with the engagement region 817 (e.g., the at least one protrusion arm 821, anchors, etc.) moving to the radially-expanded position.
  • the engagement region 817 can contact and engage the lacerated leaflets 1001 (e.g., illustrated schematically in FIG.
  • the engagement region 817 upon being released from the first sheath 1301, can radially-expand.
  • the heart valve prosthesis 751 can be moved, for example, due to movement by the capsule 35, axially in the movement direction 1305 that is toward the lacerated leaflets 1001.
  • the engagement region 817 upon being released from the first sheath 1301, can both radially-expand and move axially in the movement direction 1305, which allows the engagement region 817 to engage the lacerated leaflets 1001 and move the lacerated leaflets 1001 to a position that does not block the coronary arteries.
  • the at least one protrusion arm 821 can radially-expand as the heart valve prosthesis 751 moves from the radially- compressed configuration to the radially-expanded configuration.
  • the first sheath 1301 can continue to move in the movement direction 1305, which allows the remainder of the heart valve prosthesis 751 to be removed from the first sheath 1301, whereupon the heart valve prosthesis 751 can move to the radially-expanded position.
  • the heart valve prosthesis 751 is capable of being recaptured prior to full deployment of the heart valve prosthesis 751.
  • the heart valve prosthesis 751 can be recaptured in the event that the heart valve prosthesis 751 is positioned at a less-than-optimal location.
  • the first sheath 1301 can be moved in a direction opposite the movement direction 1305, whereupon the heart valve prosthesis 751 can be recaptured.
  • FIGS. 15-17 illustrate another example of a heart valve prosthesis 1501.
  • the heart valve prosthesis 1501 can be delivered to the interior of the heart valve prosthesis 10 in a substantially identical manner as the heart valve prosthesis 751.
  • the heart valve prosthesis 751 can comprise the annular frame 801 comprising the plurality of frame members or struts 803, with the annular frame 801 configured to be adjustable between a radially-collapsed configuration (e.g., illustrated in FIG. 7) and a radially- expanded configuration (e.g., illustrated in FIG. 8).
  • the frame 801 can extend between the first valve end 811 and the second valve end 813 along the valve axis 809.
  • the heart valve prosthesis 1501 can comprise an engagement region 1503 that is attached to the frame 803.
  • FIG. 15 illustrates the heart valve prosthesis 1501 in the radially-collapsed configuration and positioned within the capsule 35, such that the capsule 35 can deliver the heart valve prosthesis 1501 to the interior index lumen of the index valve prosthesis 10, whereupon the heart valve prosthesis 1501 can be deployed.
  • FIG. 16 illustrates the heart valve prosthesis 1501 after being removed from the capsule 35 and moving to the radially-expanded configuration.
  • the engagement region 1503 can comprise at least one protrusion arm 1601 and can be attached to the first valve end 811 in an end-to-end configuration.
  • FIG. 15 illustrates the heart valve prosthesis 1501 in the radially-collapsed configuration and positioned within the capsule 35, such that the capsule 35 can deliver the heart valve prosthesis 1501 to the interior index lumen of the index valve prosthesis 10, whereupon the heart valve prosthesis 1501 can be deployed.
  • FIG. 16 illustrates the heart valve prosthesis 150
  • FIG. 16 illustrates the at least one protrusion arm 1601 in a first position, in which the at least one protrusion arm 1601 extends longitudinally along the valve axis 809 in an end-to-end configuration with the first valve end 811 such that the at least one protrusion arm 1601 does not circumferentially surround the annular frame 801. That is, in the illustrated first position, a radial axis can intersect the valve axis 809 and the at least one protrusion arm 1601 without intersecting or passing through any of the frame members 803. Likewise, another radial axis can intersect the valve axis 809 and the frame members 803 without intersecting or passing through any of the at least one protrusion arms 1601.
  • the at least one protrusion arms 1601 can comprise any number of protrusion arms, such as, for example, a first protrusion arm 1603, a second protrusion arm 1605, and a third protrusion arm 1607.
  • the protrusion arms 1603, 1605, 1607 can extend parallel to one another and parallel to the valve axis 809.
  • the protrusion arms 1603, 1605, 1607 can be arranged around the valve axis 809, such as, for example, with a spacing of about 120 degrees between each of the protrusion arms 1603, 1605, 1607.
  • the second protrusion arm 1605 can be circumferentially offset from the first protrusion arm 1603 about the valve axis 809, for example, within a range from about 100 degrees to about 140 degrees, or about 120 degrees.
  • the second protrusion arm 1605 can be circumferentially offset from the third protrusion arm 1607 about the valve axis 809, for example, within a range from about 100 degrees to about 140 degrees, or about 120 degrees.
  • the first protrusion arm 1603 can be circumferentially offset from the third protrusion arm 1607 about the valve axis 809, for example, within a range from about 100 degrees to about 140 degrees, or about 120 degrees.
  • the second protrusion arm 1605 and the third protrusion arm 1607 may be substantially identical in size, shape, structure, and function to the first protrusion arm 1603.
  • the first protrusion arm 1603 can extend between a first arm end 1611 and a second arm end 1613, with the first arm end 1611 attached to the first valve end 811.
  • the first protrusion arm 1603 can extend linearly between the first arm end 1611 and the second arm end 1613, or, alternatively and as illustrated in FIG. 16, the first protrusion arm 1603 can comprise a non-linear and curved shape between the first arm end 1611 and the second arm end 1613.
  • the protrusion arms 1603, 1605, 1607 can comprise a self-expanding material (e.g., nitinol, for example) that is biased to move from the first position illustrated in FIG. 16 to the second position illustrated in FIG. 17.
  • a self-expanding material e.g., nitinol, for example
  • the at least one protrusion arm 1601 can move from the first position (e.g., illustrated in FIG. 16) to a second position (e.g., illustrated in FIG. 17), in which the at least one protrusion arm 1601 can extend longitudinally along the valve axis 809 while circumferentially surrounding the annular frame 803.
  • the protrusion arms 1603, 1605, 1607 can be biased to move to the second position after the heart valve prosthesis 1501 has been removed from the capsule 35.
  • the engagement region 1503 can comprise at least one anchor 1701 attached to the arm ends of the at least one protrusion arm 1601.
  • the at least one anchor when the at least one protrusion arm 1601 is in the second position, the at least one anchor comprises an anchor end 1703 that is oriented toward the first valve end 811.
  • the at least one anchor 1701 can comprise a first anchor 1705 attached to the second arm end 1613 of the first protrusion arm 1603, a second anchor 1707 attached to a second arm end of the second protrusion arm 1605, and a third anchor 1709 attached to a second arm end of the third protrusion arm 1607.
  • the anchors 1705, 1707, 1709 may be substantially identical in structure and function to the 823, 915, 917, 919 described above. That is, the at least one anchor 1701 can contact at least one lacerated leaflet of the index valve prosthesis 10 and move the at least one lacerated leaflet to a position that does not obstruct a coronary artery.
  • the anchors 1705, 1707, 1709 can project radially outwardly (e.g., away from the valve axis 809), with the anchors 1705, 1707, 1709 configured to extend linearly or non- linearly.
  • the anchors 1705, 1707, 1709 can comprise a rounded, curved, or bent shape that projects form the protrusion arms 1603, 1605, 1607 toward the first valve end 811.
  • the anchors 1705, 1707, 1709 can, in aspects, simultaneously extend toward the first valve end 811 while extending radially- outwardly away from the valve axis 809. In this way, by extending radially-outwardly while being oriented (e.g., facing toward) the first valve end 811, the anchors 1705, 1707, 1709 are configured to contact and engage one or more of the leaflets 21 of the index valve prosthesis 10.
  • the anchors 1705, 1707, 1709 can contact and engage the at least one lacerated leaflet 1001 (e.g., illustrated in FIGS. 10-11) in a substantially identical manner as described above relative to FIGS. 10-11. That is, after the leaflet 1001 has been lacerated to form the leaflet portions 1005, 1007, one or more of the anchors 1705, 1707, 1709 can contact and engage one or more of the leaflet portions 1005, 1007, etc. to separate the leaflet portions 1005, 1007 and form the gap 1101.
  • the anchors 1705, 1707, 1709 can remain in engagement with the lacerated leaflet portions 1005, 1007, etc. to prevent the leaflet portions 1005, 1007, etc. from moving to a position that obstructs the coronary arteries.
  • methods can comprise contacting the lacerated index leaflet(s) 1001 of the index valve 10 with the at least one anchor 1701 such that the lacerated index leaflet(s) 1001 (e.g., the leaflet portions 1005, 1007) can be moved to a position that does not obstruct a coronary artery.
  • the lacerated index leaflet(s) 1001 e.g., the leaflet portions 1005, 1007
  • the anchors 1705, 1707, 1709 are on an inner-radial side of the protrusion arms 1603, 1605, 1607
  • the anchors 1705, 1707, 1709 are on an outer-radial side of the protrusion arms 1603, 1605, 1607.
  • the radial position of the anchors 1705, 1707, 1709 can change upon being the heart valve prosthesis 1501 being released from capsule 35.
  • the engagement region 1503 is in the first position (e.g., illustrated in FIG.
  • a length of the heart valve prosthesis 1501 (e.g., along the valve axis 809 from the second valve end 813 to the arm ends 1613 of the protrusion arms 1603, 1605, 1607) is greater than a length of the heart valve prosthesis 1501 when the engagement region 1503 is in the second position.
  • FIGS. 18-20 illustrate example aspects of deploying the heart valve prosthesis 1501 within the interior index lumen of the index heart valve prosthesis 10.
  • methods can comprise lacerating index leaflets 21 of the index valve prosthesis 10 that is positioned in the native aortic annulus 703. The leaflets 21 are lacerated prior to the deployment of the heart valve prosthesis 1501.
  • methods can comprise delivering the heart valve prosthesis 1501 to the interior index lumen of the heart valve prosthesis 10.
  • the heart valve prosthesis 1501 can be delivered in a similar manner as described relative to FIGS. 3-7. For example, and as illustrated in FIGS.
  • the heart valve prosthesis 1501 can be radially-compressed and loaded into the capsule 35.
  • the engagement region 1503 may likewise be radially-compressed and received within the capsule 35.
  • the capsule 35 can be moved through a patient’s vasculature to the native aortic annulus 703.
  • delivering the heart valve prosthesis 1501 can comprise holding the heart valve prosthesis 1501 in the radially-compressed configuration within the capsule 35 as the heart valve prosthesis 751 is moved to the interior index lumen of the index heart valve prosthesis 10.
  • the capsule 35 can be separated from the distal tip 37 to partially expose the heart valve prosthesis 1501.
  • the capsule 35 can be moved in a direction away from the distal tip 37, which can allow for the first valve end 811 of the heart valve prosthesis 1501 to be removed from the capsule 35.
  • the engagement region 1503 and, in aspects, the first valve end 811 can begin to radially-expand upon being removed from the capsule 35, while a remaining portion of the heart valve prosthesis 1501 may remain in the capsule 35 in the radially-compressed configuration.
  • the heart valve prosthesis 1501 can be positioned above the index valve prosthesis 10.
  • the engagement region 1503 can begin to move from the first position (e.g., illustrated in FIG. 16) to the second position (e.g., illustrated in FIG. 17).
  • the engagement region 1503 in particular, the anchors 1701, 1705, 1707, 1709 (e.g., illustrated in FIG. 17), can contact and engage the lacerated index leaflet(s) 1001 (e.g., in a substantially identical manner as the anchors engaging the leaflets 1001 in FIGS. 10-11).
  • the capsule 35 can be moved in a movement direction 1901 toward the index valve prosthesis 10 and the distal tip 37, thus causing the partially-deployed heart valve prosthesis 1501 to move toward the index valve prosthesis 10 and further into the interior index lumen.
  • the anchors 1701, 1705, 1707, 1709 can remain in engagement and contact with the lacerated index leaflet(s) 1001, thus limiting inadvertent movement of the lacerated index leaflet(s) 1001.
  • the capsule 35 can then be fully retracted, thus allowing for the remaining portion of the heart valve prosthesis 1501 to be removed from the capsule 35.
  • the heart valve prosthesis 1501 can radially-expand and move to the radially-expanded configuration, with the anchors 1701, 1705, 1707, 1709 contacting the lacerated index leaflets and maintaining the lacerated index leaflets in a position that does not obstruct the coronary arteries.
  • the anchors 1701, 1705, 1707, 1709 have engaged the lacerated index leaflet(s) 1001
  • the remaining portion of the heart valve prosthesis 1501 can be removed from the capsule 35 and deployed within the index valve prosthesis 10.
  • FIGS. 21-22 illustrate another example of the heart valve prosthesis 751, wherein the heart valve prosthesis 751 is balloon-expandable with a balloon 2101.
  • FIGS. 21-22 illustrate only a portion of the heart valve prosthesis 751, namely, portions of the engagement region 817.
  • the heart valve prosthesis 751 in FIGS. 21-22 can be substantially in shape and function to the heart valve prosthesis 751 illustrated and described relative to FIGS. 8-9.
  • the heart valve prosthesis 751 in FIGS. 21-22 can comprise a material that is not self-expandable, such that the heart valve prosthesis 751 is balloon-expandable.
  • the heart valve prosthesis 751 in FIGS. 21-22 can comprise a material such as cobalt chromium, or a hybrid of nitinol and cobalt chrome.
  • the balloon 2101 is configured to be inflated in a proximal -to-distal direction to extend the engagement region 817 to engage the leaflets 1001, while allowing a distal end of the heart valve prosthesis 751 to have a retention force against the balloon 2101. After the leaflets 1001 have been engaged by the engagement region 817, full expansion of the balloon 2101 and the heart valve prosthesis 751 can be performed.
  • the balloon 2101 can comprise a non-constant shape along a length of the balloon 2101.
  • the balloon 2101 can be attached to and/or in fluid communication with a conduit 2103.
  • the conduit 2103 is substantially hollow such that a fluid (e.g., gas, air, etc.) can be delivered through the conduit 2103 to the balloon 2101.
  • a fluid e.g., gas, air, etc.
  • the balloon 2101 illustrated in FIG. 21 is in the inflated state.
  • the balloon 2101 can comprise an engagement section 2105 that comprises a larger cross-sectional size than other regions/areas of the balloon 2101.
  • the engagement section 2105 is configured to contact/engage the engagement region 817 of the heart valve prosthesis 751.
  • the heart valve prosthesis 751 may be in the radially-compressed configuration and the balloon 2101 may be in a deflated state.
  • the balloon 2101 can be positioned within the heart valve prosthesis 751 and pressurized from the deflated state to the inflated state.
  • the engagement section 2105 of the balloon 2101 can contact the engagement region 817 of the heart valve prosthesis 751.
  • FIG. 22 illustrates a top-down view of the balloon 2101 along lines 22-22 of FIG. 21.
  • the engagement section 2105 of the balloon 2101 can comprise three regions 2201, 2203, 2205 that are spaced circumferentially apart.
  • a first region 2201 can contact/engage the first protrusion arm 901
  • a second region 2203 can contact/engage the second protrusion arm 903, and a third region 2205 can contact/engage the third protrusion arm 905.
  • the engagement section 2105 can cause the protrusion arms 901, 903, 905 to radially expand.
  • the balloon 2101 can contact/engage other portions of the heart valve prosthesis 751 to cause the heart valve prosthesis 751 to radially-expand.
  • the heart valve prosthesis 751 can comprise either a self-expanding material (e.g., as illustrated in FIGS. 8-14), or a material that is not self-expanding, such that the heart valve prosthesis 751 can be balloon-expandable, for example, via the balloon 2101 illustrated in FIGS. 21-22.
  • Example 1 A heart valve prosthesis configured to be positioned within an index valve prosthesis, the heart valve prosthesis comprising: an annular frame extending along a valve axis between a first valve end of the heart valve prosthesis and a second valve end of the heart valve prosthesis, the annular frame comprising a plurality of frame members and configured to be adjustable between a radially-collapsed configuration and a radially-expanded configuration, the annular frame comprising: an engagement region extending circumferentially around the valve axis and comprising: at least one protrusion arm extending radially outwardly from the annular frame; and at least one anchor attached to the at least one protrusion arm and configured to contact at least one lacerated leaflet of the index valve prosthesis and move the at least one lacerated leaflet to a position that does not obstruct a coronary artery.
  • Example 2 The heart valve prosthesis of Example 1, wherein the at least one protrusion arm comprises a self-expanding material that is biased to radially expand.
  • Example 3 The heart valve prosthesis of Example 2, wherein the at least one protrusion arm comprises nitinol.
  • Example 4 The heart valve prosthesis of Example 1, wherein the at least one protrusion arm is balloon-expandable.
  • Example 5 The heart valve prosthesis of Example 1, wherein the engagement region is located at a central region of the heart valve prosthesis axially between the first valve end and the second valve end such that the engagement region is located an axial distance from the first valve end and the second valve end.
  • Example 6 The heart valve prosthesis of Example 1, wherein a first radial distance between the at least one protrusion arm and the valve axis is greater than a second radial distance between a frame member of the plurality of frame members and the valve axis.
  • Example 7 The heart valve prosthesis of Example 1, wherein the at least one anchor projects radially outwardly from the at least one protrusion arm, the at least one anchor comprising an anchor end that is oriented toward the first valve end.
  • Example 8 The heart valve prosthesis of Example 1, wherein the at least one protrusion arm is attached to the first valve end and is configured to move between: a first position, in which the at least one protrusion arm extends longitudinally along the valve axis in an end-to-end configuration with the first valve end such that the at least one protrusion arm does not circumferentially surround the annular frame; and a second position, in which the at least one protrusion arm extends longitudinally along the valve axis and circumferentially surrounds the annular frame.
  • Example 9 The heart valve prosthesis of Example 8, wherein the at least one anchor is attached to an arm end of the at least one protrusion arm, such that when the at least one protrusion arm is in the second position, the at least one anchor comprises an anchor end that is oriented toward the first valve end.
  • Example 10 The heart valve prosthesis of Example 8, wherein the at least one protrusion arm comprises a self-expanding material that is biased to move from the first position to the second position.
  • Example 11 The heart valve prosthesis of Example 10, wherein the at least one protrusion arm comprises nitinol.
  • Example 12 The heart valve prosthesis of Example 1, further comprising at least one attachment member attached to the first valve end and extending longitudinally from the first valve end parallel to the valve axis, the at least one attachment member configured to be received within a portion of a valve delivery assembly, the first valve end comprising an inflow end.
  • Example 13 A heart valve prosthesis configured to be positioned within an index valve prosthesis, the heart valve prosthesis comprising: an annular frame extending along a valve axis between a first valve end of the heart valve prosthesis and a second valve end of the heart valve prosthesis, the annular frame comprising a plurality of frame members and configured to be adjustable between a radially-collapsed configuration and a radially-expanded configuration, the annular frame comprising: an engagement region extending circumferentially around the valve axis and comprising: at least one protrusion arm extending radially outwardly from the annular frame, the at least one protrusion arm configured to radially-expand such that a first radial distance between the at least one protrusion arm and the valve axis is greater than a second radial distance between a frame member of the plurality of frame members and the valve axis; and at least one anchor attached to the at least one protrusion arm and projecting radially outwardly from the at
  • Example 14 The heart valve prosthesis of Example 13, wherein the at least one protrusion arm comprises a self-expanding material that is biased to radially- expand.
  • Example 15 A method of implanting a heart valve prosthesis comprising: lacerating index leaflets of an index valve prosthesis that is positioned in a native aortic annulus; delivering the heart valve prosthesis to an interior index lumen of the index valve prosthesis; deploying the heart valve prosthesis within the interior index lumen such that the heart valve prosthesis moves from a radially-compressed configuration to a radially-expanded configuration, the heart valve prosthesis comprising at least one protrusion arm extending radially outwardly from an annular frame, and at least one anchor attached to the at least one protrusion arm; and contacting the lacerated index leaflets of the index valve with the at least one anchor such that the lacerated index leaflets are moved to a position that does not obstruct a coronary artery.
  • Example 16 The method of Example 15, wherein the at least one protrusion arm is configured to radially-expand as the heart valve prosthesis moves from the radially-compressed configuration to the radi
  • Example 17 The method of Example 16, wherein the at least one protrusion arm comprises a self-expanding material that is biased to radially-expand.
  • Example 18 The method of Example 16, further comprising engaging the heart valve prosthesis with a radially-expanding balloon to radially-expand the at least one protrusion arm.
  • Example 19 The method of Example 15, wherein the at least one protrusion arm is attached to the first valve end and as the heart valve prosthesis moves from the radially-compressed configuration to the radially-expanded configuration, the at least one protrusion arm moves from: a first position, in which the at least one protrusion arm extends longitudinally along a valve axis of the heart valve prosthesis in an end-to-end configuration with the heart valve prosthesis; and a second position, in which the at least one protrusion arm extends longitudinally along the valve axis and circumferentially surrounds the annular frame.

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

Abstract

Prothèse cardiaque valvulaire positionnée à l'intérieur d'une prothèse valvulaire d'indice. La prothèse cardiaque valvulaire comprend un cadre annulaire s'étendant le long d'un axe de valve entre une première extrémité de valve et une seconde extrémité de valve. Le cadre annulaire comprend une pluralité d'éléments de cadre et peut être ajusté entre une position repliée radialement et une position déployée radialement. Le cadre annulaire comprend une région de mise en prise s'étendant de manière circonférentielle autour de l'axe de valve et comprend au moins un bras en saillie s'étendant radialement vers l'extérieur. Au moins un ancrage est fixé audit bras en saillie, entre en contact avec au moins un feuillet lacéré de la prothèse valvulaire d'indice, et déplace ledit feuillet lacéré vers une position qui n'obstrue pas une artère coronaire. L'invention concerne également des procédés d'implantation d'une prothèse cardiaque valvulaire.
PCT/IB2025/054339 2024-04-26 2025-04-25 Implant de prothèse cardiaque valvulaire Pending WO2025224700A1 (fr)

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US202463639382P 2024-04-26 2024-04-26
US63/639,382 2024-04-26

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200000579A1 (en) * 2018-06-27 2020-01-02 Edwards Lifesciences Corporation Frame for prosthetic heart valve
WO2024020181A1 (fr) * 2022-07-22 2024-01-25 Edwards Lifesciences Corporation Valvules cardiaques prothétiques et ensembles de pose de valvules cardiaques prothétiques
WO2024084481A1 (fr) * 2022-10-20 2024-04-25 Sheba Impact Ltd. Valvule cardiaque transcathéter valve-dans-valve dédiée

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200000579A1 (en) * 2018-06-27 2020-01-02 Edwards Lifesciences Corporation Frame for prosthetic heart valve
WO2024020181A1 (fr) * 2022-07-22 2024-01-25 Edwards Lifesciences Corporation Valvules cardiaques prothétiques et ensembles de pose de valvules cardiaques prothétiques
WO2024084481A1 (fr) * 2022-10-20 2024-04-25 Sheba Impact Ltd. Valvule cardiaque transcathéter valve-dans-valve dédiée

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