WO2014203106A1 - Valvule cardiaque prothétique aplatissable - Google Patents

Valvule cardiaque prothétique aplatissable Download PDF

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Publication number
WO2014203106A1
WO2014203106A1 PCT/IB2014/061969 IB2014061969W WO2014203106A1 WO 2014203106 A1 WO2014203106 A1 WO 2014203106A1 IB 2014061969 W IB2014061969 W IB 2014061969W WO 2014203106 A1 WO2014203106 A1 WO 2014203106A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
valve assembly
prosthetic heart
heart valve
valve
Prior art date
Application number
PCT/IB2014/061969
Other languages
English (en)
Inventor
Michael J. Girard
Randy Lane
Kathleen HUNG
Martin Schlun
Michael LITZENBURGER
Original Assignee
Jenavalve Technology Gmbh
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 Jenavalve Technology Gmbh filed Critical Jenavalve Technology Gmbh
Publication of WO2014203106A1 publication Critical patent/WO2014203106A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • 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

  • the present disclosure relates generally to heart valve replacement and, in
  • collapsible prosthetic heart valves having unique attachments of a stent to tissue material of a valve assembly.
  • aortic valve stenosis and/or aortic valve insufficiency generally refer to a congenital or acquired dysfunction of one or more cardiac valves. Such valvular disorders can affect any of the four cardiac valves, whereby the valves in the left ventricle or left chamber (aortic and mitral valve) are
  • the dysfunction typically more affected than those on the right side of the heart (pulmonary and tricuspid valve).
  • the dysfunction can be a constriction (stenosis), an incompetence (insufficiency) or a combination of the two (combined vitium).
  • Minimally invasive forms of treatment have recently been developed which are in particular characterized by allowing the procedure to be performed under local anesthesia.
  • One approach provides for using a catheter system to implant an expandable prosthetic heart valve into a human body, the prosthetic heart valve comprising a stent having a collapsed condition and an expanded condition, and a valve assembly.
  • Such an expandable prosthetic heart valve can be guided via a delivery or catheter system to the implantation site within the heart through an inguinal artery or vein.
  • the stent After reaching the implantation site, the stent can then be unfolded or expanded. After unfolding/expanding, the prosthetic heart valve can be anchored in the respective blood vessel at least in an area close to the heart, for example with the aid of anchoring hooks. The actual prosthetic heart valve is usually positioned in the inflow area of the stent.
  • document WO 2004/019825 Al describes a heart valve stent for a prosthetic heart valve having a stent a valve assembly affixed to the stent. This heart valve prosthesis can be introduced into the site of implantation in the patient's heart via a medical delivery system to treat an aortic valve stenosis and/or aortic valve insufficiency in a minimally invasive manner.
  • stent system transarterially / transfemorally or transapically into the body of the patient using a medical delivery system.
  • This type of stent system consists for example of an expandable anchoring support (hereinafter also referred to as "cardiac valve stent” or simply “stent”), to which the valve assembly is affixed or can be affixed, preferably at the end region nearest the heart (i nflow end).
  • medical delivery system generally refers to a medical system with which a prosthetic heart valve can be advanced in minimally invasive fashion to the site of implantation in the patient's heart, for example to treat an aortic valve stenosis and/or aortic valve insufficiency.
  • minimally invasive means a heart-lung machine is not needed when performing the procedure on the anaesthetized patient such that not only can the medical procedure be performed at reasonable cost, but there is also less physical and psychological strain on the patient.
  • a medical delivery system usually comprises a catheter system by means of which a prosthetic heart valve comprising a stent and a valve assembly affixed thereto can be introduced into the patient's body in its folded state.
  • the medical delivery system can exhibit a catheter tip having at least one
  • manipulatable receiving area at a distal end section of the catheter system i .e. closest to the heart. It is moreover conceivable for the medical delivery system to exhibit a handle at the proximal end section of the catheter system; i.e. at the end section of the catheter system farthest from the heart and the catheter tip, with which the at least one receiving area of the caterer tip can be appropriately manipulated such that the expandable prosthetic heart valve accommodated in the catheter tip can be incrementally released from the catheter tip according to a predefined or predefinable sequence of events.
  • catheter system means a system that can be inserted into a body cavity, duct or vessel .
  • a catheter system thereby allows access by surgical i nstruments.
  • the process of inserting a catheter system is catheterisation.
  • a catheter system is a thin, flexible tube: a "soft" catheter system; in some uses, it is a larger, solid tube: a “hard” catheter system.
  • a catheter system for a minimally invasive implantation and transvascular implantation of prosthetic heart valves is described, for example, in document WO 2006/076890 Al .
  • the stent together with the valve assembly affixed thereto is loaded into the tip of the medical delivery system's catheter.
  • the stent with the valve assembly affixed thereto needs to exhibit a first predefinable shape in which the stent and the valve assembly affixed thereto are in a compressed or folded state (collapsed condition).
  • the stent with the valve assembly affixed thereto exhibits a diameter which is essentially determined by the diameter of the catheter tip of the medical delivery system.
  • prosthetic heart valve for the majority of patients undergoing treatment, it is preferable for prosthetic heart valve (stent with valve assembly affixed thereto) to have an outer diameter of approximately 7.0 mm to approximately 5.0 mm in its first shape so that the prosthetic heart valve can be introduced with a 23F delivery system (given an external diameter of 7.0 mm) or with a 17F delivery system (given an external diameter of 5.0 mm). In some cases, however, a delivery system having a larger outside diameter (up to 32 French) is necessary for introducing a prosthetic heart valve.
  • the prosthetic heart valve After the prosthetic heart valve has been released from the catheter tip, in the implanted state respectively, the prosthetic heart valve exhibits a second predefined shape in which the stent and the valve assembly affixed thereto is in an expanded state (expanded condition). Depending on the patient being treated, it is preferable for the stent to exhibit a diameter of between 19.0 mm and 27.0 mm in its second shape and implanted state.
  • the first shape transitions to the second shape by a foreshortening and cross-sectional widening of the stent, wherein the longitudinal length of the stent is reduced while at the same time the stent stretches radially and presses against the vascular wall of a blood vessel near the heart and thus fixes the valve assembly affixed to the stent at the site of implantation.
  • the cross-sectional widening can be effected by a balloon system when the stent is implanted with the help of a so called "balloon catheter system".
  • the stent from a superelastic shape memory material which is designed such that the stent can transform from a temporary shape into a permanent shape under the influence of an external stimulus.
  • the temporary shape thereby corresponds to the stent's first shape when the stent with a valve assembly affixed thereto is in its folded state (collapsed condition).
  • the permanent shape corresponds to the stent's second shape when in its expanded state (expanded condition).
  • An example of a suitable shape memory material would be Nitinol, e.g ., an equiatomic alloy of nickel and titanium .
  • the stent with a valve assembly affixed thereto has to be compressed so that it will then be in its first shape and be able to be introduced into the tip of the catheter of a medical delivery system.
  • This subjects the stent to considerable compressive forces in order to overcome the self-expanding stent structure's expansion forces and achieve the desired reduction in cross-section.
  • the stent with a valve assembly attached thereto can often only be loaded into the tip of the catheter of a medical delivery system by an experienced perfusionist or by product specialists so as to avoid damaging, in particular, the valve assembly affixed to the stent.
  • the present disclosure relates to a prosthetic heart valve comprising a stent and a valve assembly coupled to the stent, wherein the prosthetic heart valve can be readily compressed to a desired diameter without the risk of the valve assembly being damaged.
  • the present invention may address one or more of these needs.
  • Embodiments of the present disclosure provide an improved fastening of a stent to tissue material of a valve assembly. With this improved fastening, a prosthetic heart valve can be manufactured which can be compressed to a desired diameter without the risk of the valve assembly coupled to the stent being damaged.
  • a prosthetic heart valve is provided, said prosthetic heart valve comprising a stent and a valve assembly.
  • the valve assembly is flexibly connected to the stent such that a relative movement between the stent and the valve assembly in the longitudinal direction of the stent is allowed. This may result in a reduction of stresses at different portions of the tissue material of the valve assembly, thereby avoiding valve failure.
  • the stent of the prosthetic heart valve During the compression of the prosthetic heart valve, i.e. when the stent of the prosthetic heart valve is transferred from its expanded condition into its collapsed condition, at least some sections of the stent have a tendency to prolong or lengthen in the longitudinal direction of the stent thereby increasing the total length of the prosthetic heart valve.
  • the stent may comprise sections which rarely change their length during crimping, and sections which tend to lengthen during crimping to a considerable degree.
  • the prosthetic heart valve can be compressed to a desired diameter without the risk of the valve assembly coupled to the stent being damaged.
  • the valve assembly of a prosthetic heart valve is secured to a stent in such a manner that, in at least a section of the prosthetic heart valve, a relative movement between the stent and the valve assembly in the longitudinal direction of the stent is allowed when transferring the stent from its expanded condition into its collapsed condition and vice versa. Accordingly, in at least some sections, the valve assembly is flexibly connected to the stent such that stent stretching can take place without
  • the valve assembly is secured to the stent by using a suture pattern comprising a plurality of stitches. At least one of the plurality of stitches is chosen such as to form a slideable connection point between a section of the valve assembly and a section of the stent.
  • the slideable connection point can be formed by a single turn stitch or a multi turns stitch, which provides a single fastening point with one or more turns.
  • the form of stitching and/or the tightening of the suture at the fastening point formed by the stitch is chosen such as a relative movement between the section of the valve assembly and the stent in the longitudinal direction of the stent is possible, at least when the stent is transferred from its expanded condition into its collapsed condition and vice versa.
  • the suture can slide on the struts somewhat to allow the axial deformation of the stent.
  • the stent of the collapsible prosthetic heart valve may have a plurality of cells, wherein each cell of the stent is formed by the plurality of struts.
  • the valve assembly is slideably connected to at least one of the struts which form the plurality of cells of the stent. At least one of the struts, to which the valve assembly is slideably connected, is preferably axially aligned with the longitudinal direction of the stent.
  • the prosthetic heart valve may comprise a plurality of commissure and leaflet features, in particular commissure and leaflet attachment regions, which are disposed on the stent or integrally formed with the stent.
  • the valve assembly is fixedly secured to the plurality of commissure and leaflet features, preferably by a plurality of stitches, for example single turn stitches or multi turns stitches.
  • the stent may comprise a structure having a plurality of cells, wherein each cell is formed by a plurality of struts.
  • the valve assembly may comprise a skirt portion and a plurality of leaflets which collectively function as a one-way valve and which are coupled to the skirt portion.
  • the skirt portion of the valve assembly is fixedly secured to the plurality of commissure and leaflet features and slideably connected to at least one of the struts which form the plurality of cells.
  • the stent may comprise a proximal inflow section and a distal outflow section. At least the inflow section of the stent includes a plurality of cells, each cell being formed by a plurality of struts. Commissure and leaflet features are connected with the top of at least some of the cells of the inflow section of the stent via connecting webs.
  • the valve assembly comprises a skirt portion and a plurality of leaflets, the skirt portion is designed such as to cover at least a part of and preferably all of the cells of the inflow section of the stent.
  • the prosthetic heart valve comprises a plurality of commissure and leaflet features, in particular commissure and leaflet attachment regions, which are disposed on the stent or integrally formed with the stent.
  • the commissure and leaflet features include a plurality of fastening means configured to anchor a suture used for coupling the valve assembly to the stent.
  • the fastening means may be in the form of fastening holes and/or fastening notches.
  • the valve assembly comprises a skirt portion and a plurality of leaflets, wherein the skirt portion is fixedly secured to the commissure leaflet features by means of suturing pattern comprising a plurality of stiches. At least one suture of the suturing pattern is guided through at least some of the fastening means thereby avoiding any relative movement between the commissure leaflet features of the stent and the skirt portion of the valve assembly fixedly secured to the commissure leaflet features.
  • the skirt portion of the valve assembly may further comprise a bendable transition area forming a junction to the plurality of leaflets, wherein the bendable transition area of the skirt portion is fixedly secured to the plurality of commissure and leaflet features.
  • the stent of the prosthetic heart valve comprises an annulus section, an aortic section, and an intermediate section disposed between the annulus and aortic sections.
  • at least one of the annulus section and the intermediate sections of the stent includes a plurality of cells connected to one another at least partly around the stent. Each cell is formed by a plurality of struts.
  • the valve assembly is slideably connected to at least one of the struts which form the plurality of cells.
  • at least one of the annulus section and the intermediate section of the stent includes one or more rows of cells connected to one another. More
  • the stent of the prosthetic heart valve comprises a structure having a plurality of first cells and a plurality of second cells.
  • the first cells are connected to one another at least partly around the circumference of the stent such as to form a first row of cells.
  • the second cells are connected to one another at least partly around the circumference of the stent such as to form a second row of cells.
  • the first and second rows of cells are connected to one another in the longitudinal direction of the stent.
  • the stent of the prosthetic heart valve comprises a structure having a plurality of cells, wherein each of the cells of stent structure is formed by a plurality of struts. Two adjacent struts of a single cell merge near the bottom of the cell before splitting off into two different struts. The meeting point, where the two adjacent struts merge, defines an ancon of the cell.
  • the valve assembly is preferably secured to the stent by a plurality of stitches. At least some of the stitches are located immediately adjacent to the ancones of the cells; these stitches are of a kind and chosen such as to allow for a relative movement between the stent and the valve assembly in the longitudinal direction of the stent.
  • the stent comprises a structure having at least two cells connected to one another in the longitudinal direction of the stent.
  • the valve assembly is secured to the stent preferably by means of a plurality of stitches. At least one of the plurality of stitches is located in or immediately adjacent to the area where the at least two cells are connected to one another; this at least one stitch is preferably of a kind and chosen such as to allow for a relative movement between the stent and the valve assembly in the longitudinal direction of the stent.
  • the valve assembly of the prosthetic heart valve disclosed herein is made of a xenograph tissue material, in particular bovine or porcine pericardial tissue.
  • the tissue material of the valve assembly preferably has a thickness of less than 300 pm, preferably a thickness from 240 pm to 280 pm.
  • the prosthetic heart valve comprises a plurality of commissure and leaflet features, in particular commissure and leaflet attachment regions, disposed on the stent, wherein the valve assembly is fixedly sutured to the plurality of commissure and leaflet features.
  • the stent comprises a structure having a plurality of cells, each cell being formed by a plurality of struts, wherein the valve assembly comprises a skirt portion and a plurality of leaflets which collectively function as a one-way valve and which are coupled to the skirt portion.
  • the skirt portion of the valve assembly is fixedly sutured to the commissure and leaflet features and slideably connected to at least one of the struts with a repeating suture pattern.
  • the valve assembly of the prosthetic heart valve comprises a plurality of leaflets. Each leaflet of the valve assembly meets an adjacent leaflet to form a commissure.
  • the prosthetic heart valve may further comprise attachment features in the stent for attaching the commissures of the valve assembly to the stent.
  • each leaflet is attached to the stent such that at least a portion of the first edge of each leaflet is attached to the attachment features.
  • FIG. la illustrates a plan view of the outflow end of an expanded
  • prosthetic heart valve comprising a heart valve stent and a valve assembly, where the valve assembly is in its closed state
  • FIG. lb illustrates a plan view of the outflow end of the prosthetic heart valve according to FIG. la, where the valve assembly is in its opened state;
  • FIG. 2a illustrates a first perspective side view of an exemplary
  • a prosthetic heart valve for treating a narrowed cardiac valve or a cardiac valve insufficiency, where the prosthetic heart valve is shown in its expanded state, the prosthetic heart valve comprising a cardiac valve stent and a valve assembly connected to the stent; illustrates a second perspective side view of the prosthetic heart valve according to FIG. 2a; illustrates a perspective side view of a first exemplary
  • FIG. 3a illustrates a first perspective side view of the cardiac valve stent according to FIG. 3a in its expanded state
  • FIG. 4a illustrates a cut-out view of a section of the cardiac valve stent according to FIG. 4a, where the cardiac valve stent is in its expanded state; illustrates the cut-out section of the cardiac valve stent shown in FIG. 5a, where the cardiac valve stent is in its collapsed state; illustrates an exemplary strain-load-diagram of an exemplary tissue material of a valve assembly suitable for a prosthetic heart valve; illustrates a flat pattern of a valve assembly material piece having an essentially T-shirt like shape for a valve assembly of a prosthetic heart valve according to an exemplary embodiment of the disclosure;
  • FIG. 8 illustrates an exemplary embodiment of a reinforcement element for reinforcing a connection between two essentially T-shirt shaped valve material pieces and the stent at the commissures;
  • FIG. 9a-e illustrates a process for connecting two separate valve assembly material pieces along their contiguous edges for manufacturing an exemplary embodiment of a valve assembly for a prosthetic heart valve
  • FIG. 10 is a perspective view of a prosthetic heart valve according to the present invention comprising a stent and a valve assembly attached to the stent;
  • FIG. 11 illustrates a separate tissue pieces used for forming the ⁇
  • proximal when used in connection with a prosthetic heart valve or a heart valve stent, refers to the end of the heart valve or the heart valve stent closest to the heart annulus when the heart valve is implanted in a patient
  • distal when used in connection with a prosthetic heart valve, refers to the end of the heart valve farthest from the heart annulus when the heart valve is implanted in a patient.
  • the proximal end of the valve is that portion that will be located in or adjacent the native valve annulus and the distal end will be located in the aorta or aortic sinus.
  • the present invention relates to collapsible prosthetic heart valves used in the treatment of a stenosis (narrowing) of a cardiac valve and/or a cardiac valve insufficiency.
  • the invention relates to prosthetic heart valves mounted on stents that are intended for catheter delivery.
  • the valve and stent require crimping to a small diameter to fit within a catheter for delivery through either small incisions (e.g. transapical) or the vascular system (e.g. percutaneous transfemoral).
  • the catheter delivers the prosthesis to the site of the diseased native valve where it is released, expanded and replaces the diseased valve.
  • the present invention relates to collapsible and expandable prosthetic heart valve incorporating a stent and a valve assembly.
  • the collapsible heart valves can be delivered to the implant site using a catheter for treatment of a stenosis (narrowing) of a cardiac valves and/or a cardiac valve insufficiency.
  • prosthetic heart valves disclosed herein can be used for replacing any of the four different heart valves, in particular the pulmonary valve and the aortic valve, the application of the invention for treatment of a diseased aortic valve is described in the following only for reasons of simplification.
  • a cardiac valve stent to which a valve assembly is appropriately affixed, is employed in accordance with at least certain embodiments of the invention to position and anchor the prosthetic heart valve.
  • a medical device for the treating of a narrowed cardiac valve or a cardiac valve insufficiency consisting of a cardiac valve stent and a valve assembly affixed to the stent will be referred to herein simply as "prosthetic heart valve”.
  • the prosthetic heart valve 1 includes a stent or frame 10, which may be wholly or partly formed of any biocompatible material, such as metals, synthetic polymers, or biopolymers capable of functioning as a stent.
  • Suitable biopolymers include, but are not limited to, elastin, and mixtures or composites thereof.
  • Suitable metals include, but are not limited to, cobalt, titanium, nickel, chromium, stainless steel, and alloys thereof, including nitinol.
  • Suitable synthetic polymers for use as a stent incl ude but are not limited to, thermoplastics, such as polyolefins, polyesters, polyamides,
  • polysulfones acrylics, polyacrylonitriles, polyetheretherketone (PEEK), and polyaramides.
  • the stent 10 may have an annulus section, an aortic section, and an intermediate section disposed between the annulus and aortic sections. At least one of the annulus section, the intermediate section, and the aortic section of the stent 10 includes a plurality of cells 60, 70 connected to one another at least partly around the stent 10.
  • the annulus section, the intermediate section, and/or the aortic section of the stent 10 may include one or more annular rows of cells 60, 70 connected to one another.
  • the annulus section may have one annular row of cells 60.
  • each cell 60 may be substantially diamond shaped.
  • each cell 60, 70 of the stent structure is formed by a plurality of struts 61, 71.
  • a cell 60, 70 may be formed by four struts 61, 71.
  • the prosthetic heart valve 1 according to the present invention also includes a valve assembly 100 preferably attached inside the stent 10.
  • the valve assembly 100 may be wholly or partly formed of any suitable biological material or polymer. Examples of biological materials suitable for the valve assembly 100 include, but are not limited to, porcine or bovine pericardial tissue. Examples of polymers suitable for the valve assembly 100 include, but are not limited to, polyurethane and polyester.
  • the valve assembly 100 may include a skirt portion 103 disposed on the lumenal surface of the annulus section of the stent 10, on the ablumenal surface of the annulus section of the stent 10, or at least partly on both surfaces.
  • the skirt portion 103 of the valve assembly 100 may cover all or part, of either or both of the lumenal and ablumenal surfaces of the annulus section of the stent 10.
  • the valve assembly 100 may further include a plurality of leaflets 102 which collectively function as a one-way valve.
  • the valve assembly 100 may be attached to the stent 10 by suturing, stapling or adhesives as described in more detail below.
  • a second or free edge 120 of each leaflet 102 may coapt with the corresponding free edges of the other leaflets, thereby enabl ing the leaflets 102 to function collectively as a one-way valve.
  • the skirt portion 103 of the valve assembly 100 may be attached to the stent 10 along at least some struts 61, 71 of the stent 10 to enhance the structural integrity of the valve assembly 100.
  • the stent 10 has a collapsed condition and an expanded condition. When transferring the stent 10 from its expanded condition into its collapsed condition for example by crimping, radial contracting forces are applied to the outer surface of the stent 10 such that the radial extend of the stent 10 is reduced . At the same time, longitudinal stretching of the stent 10 takes place. As it will be described in more detail with reference to FIGS.
  • the amount of stretching or lengthening during crimping is determined by the particular stent design and the degree of radial expansion of the respective stent sections.
  • the present invention provides for a specific attachment of the stent 10 to the tissue material of the valve assembly 100.
  • the valve assembly 100 is secured to the stent 10 in such a manner that, in at least one section of the prosthetic heart valve 1, a relative movement between the stent 10 and the valve assembly 100 in the longitudinal direction of the stent 10 is allowed when transferring the stent 10 from its expanded condition into its collapsed condition.
  • the at least one section of the prosthetic heart valve 1, in which a relative movement between the stent 10 and the valve assembly 100 is allowed, is preferably a section of the prosthetic heart valve 1 which exhibits a longitudinal stretching of more than 15% to 20% during crimping.
  • the valve assembly 100 is secured to the stent 10 by a plurality of stitches 75, 76, 77.
  • stitches 76 are used which provide a slideable connection point between the corresponding section of the valve assembly 100 and the corresponding stent section.
  • connection point means a connection point which allows for a relative movement between the corresponding section of the valve assembly 100 and the stent 10 in the longitudinal direction of the stent 10 when transferring the stent 10 from its expanded condition into its collapsed condition and vice versa (e.g . sliding of the connection along the strut). This definition also applies for the term “slideably connected”.
  • a slideable connection point may be formed, for example, by means of a single turn stitch or a multi turns stitch, wherein the thread, wire or suture used for generating the stitch 76 loops a strut section of the stent 10 which runs in the longitudinal direction of the stent and which provides for the stitch to be - at least for a certain distance - moveable relatively to the stent section.
  • Such a slideable connection point can be created, for example, by forming the stitch 76 at a vertically running strut section of the stent 10, wherein the strut section merges in an ancon and wherein a gap between the ancon and the stitch is provided which allows for the stitch to be moveable relatively to the stent section.
  • a continuous stitch is used to form the slideable connection points (stitches 76), the direction of the thread, wire or suture used for generating the corresponding stitches 76 should not travel across cells 70 in the axial direction of the stent 10.
  • a continuous stitching pattern if preferred comprising a plurality of slideable stitches 76 for slideably connecting the tissue material of the valve assembly 100 to corresponding strut sections of the structure of cells 70, and further comprising a plurality of transition stitches for connecting the plurality of slideable (discrete) connection points (stitches 76), which makes it possible that a single thread, wire or suture can be used for forming the continuous stitching pattern. In this way, the number of knots can be reduced .
  • Continuous suture means an uninterrupted series of stitches (slideable stitches 76 and transition stitches between two neighboring slideable stitches 76) using one suture, thread or wire. The stitching is fastened at each end by a knot.
  • a continuous suture is used for the stitching pattern, wherein the continuous is formed without or at least with a minimum of transition stitches mostly aligned in an axial (or vertical) direction of the stent.
  • the continuous suture used for connecting the valve assembly 100 to the stent 10 preferably does not comprise any constraining transition stitches; i .e. transition stitches which are aligned in an axial direction of the stent 10.
  • the stitching pattern is preferably formed by means of a continuous suture without any transition stitches that jump between stents of the stent structure in the vertical direction. Rather, the continuous suture comprises a plurality of horizontal transition stitches which allows the stent 10 to collapse easily during crimping .
  • vertical used herein refers to a direction aligned with the longitudinal axis of the stent.
  • horizontal refers to a direction
  • FIG. la is a plan view of the outflow end 3 of an expanded prosthetic heart valve 1 comprising a valve assembly 100.
  • the valve assembly 100 comprises at least two and preferably three leaflets 102. Each of the leaflets 102 is preferably made of a natural tissue and/or synthetic material .
  • the leaflets 102 are attached to a skirt portion 103 of the valve assembly 100. As will be discussed later on in detail, the skirt portion 103 is used for mounting the valve assembly 100 to a stent 10 (not explicitly shown in FIGS, la, b).
  • the leaflets 102 of the valve assembly 100 are adapted to be moveable from a first opened position for opening the heart chamber and a second closed position for closing the heart chamber.
  • the leaflets 102 may switch between their first and second position in response to the blood flow through the patient's heart.
  • ventricular systole pressure rises in the left ventricle of the patient's heart.
  • the leaflets 102 of valve assembly 100 opens, allowing blood to exit the left ventricle into the aorta.
  • pressure in the left ventricle rapidly drops.
  • the aortic pressure forces the leaflets 102 of the valve assembly 100 to close.
  • the leaflets 102 come together in the centre of the valve assembly 100 thereby creating a region of sealing .
  • the leaflets 102 pivot about a bendable transition area 104.
  • the bendable transition area 104 forms a junction between the leaflets 102 and the skirt portion 103 of the valve assembly 100 and progresses in a substantial U-shaped manner, similar to the cusp shape of a natural aortic or pulmonary heart valve.
  • the commissure region 105 and the leaflets 102 move radially outwards opening the valve in response to increased differential pressure allowing blood to flow through the prosthetic heart valve 1.
  • FIG. 2a and FIG. 2b respectively show first and second side views of an exemplary embodiment of a prosthetic heart valve 1 for treating a narrowed cardiac valve or a cardiac valve insufficiency, whereby the prosthetic heart valve 1 comprises a cardiac valve stent 10 and a valve assembly 100 affixed thereto.
  • the prosthetic heart valve 1 is shown in its expanded state. As illustrated, for example, in FIGS.
  • the cardiac valve stent 10 exhibits an expandable structure which is able to transform from a first predefinable shape in which the stent 10 is in a collapsed state into a second predefinable shape in which the stent 10 is in an expanded state.
  • the stent 10 For implanting and explanting the stent 10 together with a valve assembly 100 affixed thereto with a suitable catheter system, the stent 10 comprises catheter retaining means 23 at its outflow end 3.
  • the catheter retaining means 23 comprise oval-shaped heads which each comprise a corresponding oval-shaped eyelet 24.
  • the shape of the catheter retaining means 23 complements a crown on the tip of a catheter of a catheter system used to implant/explant the stent 10.
  • the crown on the catheter tip may have protruding elements that are configured as a negative of the catheter retaining means 23.
  • the stent 10 may also include radial arches 32a, 32b, 32c.
  • 2a, 2b has three radial arches 32a, 32b, 32c, with each arch 32a, 32b, 32c located between the two arms 15a, 15a', 15b, 15b', 15c, 15c' of each positioning arch 15a, 15b, 15c.
  • Each radial arch 32a, 32b, 32c has a shape that is roughly inverse to each positioning arch 15a, 15b, 15c and extends in the opposite direction to each one of the positioning arches 15a, 15b, 15c.
  • the stent 10 according to the exemplary embodiment of the prosthetic heart valve 1 depicted in FIGS. 2a, 2b is provided with corresponding retaining arches 16a, 16b, 16c.
  • Each one of the retaining arches 16a, 16b, 16c is allocated to one of the positioning arches 15a, 15b, 15c.
  • the stent 10 may be provided with a plurality of commissure attachment regions l ib with a plurality of additional fastening holes 12c configured at one end of each arm 16a', 16a", 16b', 16b", 16c', 16c" of the retaining arches 16a, 16b, 16c.
  • the stent 10 may also comprise leaflet attachment regions 11c for additional fastening of the tissue component(s) of a valve assembly 100.
  • the stent 10 has a configuration with a number of attachment regions l ib, 11c to attach the tissue material of a valve assembly 100.
  • the stent 10 may also be provided with leaflet guard arches, wherein one leaflet guard arch may be provided in between each positioning arch 15a, 15b, 15c.
  • the structure and function of the leaflet guard arches wi ll be described below with reference to FIGS. 3a to 3c.
  • one leaflet guard arch may be allocated to each positioning arch 15a, 15b, 15c.
  • the respective arms 16a', 16a", 16b', 16b", 16c', 16c" of the retaining arches 16a, 16b, 16c of the stent 10 shown in FIGS. 2a, 2b have a specific structure.
  • the respective arms 16a', 16a", 16b', 16b", 16c', 16c" of the retaining arches 16a, 16b, 16c have a shape similar to the shape of the inner leaflet edge of a valve assembly 100 affixed to the stent 10.
  • the respective arms 16a', 16a", 16b', 16b", 16c', 16c" of the retaining arches 16a, 16b, 16c serve as leaflet attachment regions 11c.
  • the leaflet attachment regions 11c may have a number of fastening holes or eyelets for fastening the tissue component(s) of a valve assembly 100. These fastening holes or eyelets may provide attachment points for the bendable transition area 104 of a valve assembly 100 attached to the stent 10. As it will be described in more detailed below, the prosthetic heart valve 1 shown in FIGS.
  • 2a, 2b is provided with a stent 10 having a plurality of retaining arches 16a, 16b, 16c, wherein the respective arms 16a', 16a", 16b', 16b", 16c', 16c" of the retaining arches 16a, 16b, 16c are provided with a number of fastening notches 33 which are used to fix the bendable transition area 104 of the valve assembly 100 to the stent 10.
  • the respective arms 16a', 16a", 16b', 16b", 16c', 16c" of the retaini ng arches 16a, 16b, 16c have a shape that substantially matches the transition area 104 of a valve assembly 100 attached to the stent 10 (see e.g. FIGS. 2a and 2b).
  • the respective arms 16a', 16a", 16b', 16b", 16c', 16c" of the retaining arches 16a, 16b, 16c follow the shape of the bendable transition area 104 of a valve assembly 100 affixed to the stent 10 in its expanded state.
  • the respective arms 16a', 16a", 16b', 16b", 16c', 16c" of the retaining arches 16a, 16b, 16c are designed to have a minimized unsupported gap from one arm to the other arm of a retaining arch 16a, 16b, 16c at the location behind the positioning arches 15a, 15b, 15c.
  • the respective arms 16a', 16a", 16b', 16b", 16c', 16c" of the retaining arches 16a, 16b, 16c are provided with a plurality of bending edges 33 which divide each arm 16a', 16a", 16b', 16b", 16c', 16c" into a plurality of arm segments.
  • the arm segments of a single arm 16a', 16a", 16b', 16b", 16c', 16c" of the retaining arches 16a, 16b, 16c are interconnected thereby constituting a retaining arch arm which describes an essentially straight line in the not-expanded state of the stent 10 (cf. FIG. 3a).
  • the respective arms 16a', 16a", 16b', 16b", 16c', 16c" of the retaining arches 16a, 16b, 16c of the stent 10, onto which the transition area 104 of a valve assembly 100 is coupled, in particular sewn, will change their shape when the stent 10 expands, wherein the retaini ng arches 16a, 16b, 16c are curved in the expanded state of the stent 10, but relatively straight when the stent 10 is collapsed .
  • the curvature of the respective arms 16a', 16a", 16b', 16b", 16c', 16c" of the retaining arches 16a, 16b, 16c is achieved by segmenting the arms 16a', 16a", 16b', 16b", 16c', 16c".
  • the arms 16a', 16a", 16b', 16b", 16c', 16c" are segmented by providing a plurality of bending edges 33.
  • two neighboring arm segments are angled relative to each other, wherein the bending point of these two neighboring arm segments is defined by the bending edge 33 which is provided in between the both neighboring arm segments.
  • the shape of the respective arms 16a', 16a", 16b', 16b", 16c', 16c" of the retaining arches 16a, 16b, 16c can be precisely adapted to the shape of transition area 104 of a valve assembly 100 to be affixed to the stent 10.
  • the stent embodiments depicted in FIGS. 3a to 3c and FIGS. 4a and 4b show a stent 10 for a prosthetic heart valve 1 with an even higher number of bending edges 33 providing a plurality of arm segments. Further to this, the bending edges 33 depicted in FIGS. 3a to 3c and FIGS. 4a and 4b are formed so as to provide a plurality of fastening notches along the retaining arches 16a, 16b, 16c, as will be described in more detail below.
  • the stent 10 of the prosthetic heart valve 1 may also be provided with an annular collar 40 arranged at the inflow end section 2 of the stent body.
  • the at least one annular collar 40 may serve as an additional anchoring measure for the prosthetic heart valve 1 in its implanted state.
  • the transition area 104 of the valve assembly 100 extends along the retaining arches 16a, 16b, 16c and, in particular, along the leaflet attachment region 11c and the commissure attachment region l ib of the retaining arches 16a, 16b, 16c of the stent 10.
  • the bendable transition area 104 of the valve assembly 100 is attached to retaini ng arches 16a, 16b, 16c of the stent 10 such as to enable the leaflets 102 of the valve assembly 100 to bend inwards in a controlled manner to the centre of the stent 10 forming the valvular leaflets 102.
  • the pattern of the flat-tissue material of the valve assembly 100 shall be cut so as to incorporate the leaflet structures, the annular skirt portion 103 and the transition area 104 in between them .
  • the valve exhibits a flared portion at the lower end .
  • This flared geometry fits the structure of the stent 10 and is constructed to optimally fit the vascular wall at the implantation site of the diseased heart valve.
  • the valve assembly 100 which is affixed to the stent 10, consists of a one piece flat pericardial tissue material extracted from an animal or human pericardial sack and cut into a pattern representing each of the three leaflets 102 and a skirt portion 103, wherein the pattern is sewn into a cylindrical shape before
  • the valve assembly 100 includes a transition area 104 which is connected to the retaining arches 16a, 16b, 16c and commissure attachment regions l ib of the stent 10.
  • the transition area 104 connects the leaflets 102 with the skirt portion 103.
  • the transition area 104 is essentially U-shaped, similar to the cusp shape of a natural aortic or pulmonary heart valve. For this reason, the transition area 104 allows for an opening and closing motion of the leaflets 102, causing minimal stresses within the biological valve assembly 100 tissue. Upon assembly of this tissue pattern to a stent 10, the regions of tissue between the retaining arches 16a, 16b, 16c of the stent 10 become the valve leaflets 102.
  • leaflets can be folded inwards so as to form three essentially closed leaflets.
  • the leaflets 102 are forced apart, in the direction of the stent 10, enabling blood to exit the heart chambers.
  • a pressure gradient in the opposite, upstream direction in response to a rising blood pressure in the heart chamber
  • the blood rushes into the leaflets 102, thereby pressing the leaflets 102 together in the centre of stent 10 and closing the prosthetic heart valve 11.
  • the skirt portion 103 of the valve assembly 100 may also be attached to the annular collar 40 of the stent 10 by means of sutures, threads or wires.
  • sutures threads or wires.
  • multi-filament sutures of a diameter up to 0.2 mm, preferably between 0.1 mm and 0.2 mm may be used.
  • a common running stitch pattern may be used to obtain said bonding.
  • the stitch pattern is preferably a locking stitch or a blanket stitch respectively.
  • any other suitable stitch pattern i .e.
  • the bendable transition area 104 of the valve assembly 100 may be attached to retaining arches 16a, 16b, 16c of the stent 10 by means of sutures, having a diameter larger than the diameter of the sutures used for attachment of the valve assembly 100 to an annular collar 40 of the stent 10. Due to this, the valve assembly 100 can be reliably attached to the stent 10 without adding too much bulk to the stent 10, in order to be able to collapse the prosthetic heart valve 1 to a small diameter.
  • the stent 10 of the exemplary prosthetic heart valve 1 is provided with a cell structure between two arms 16a', 16a", 16b', 16b", 16c', 16c" of two adjacent retaining arches 16a, 16b, 16c.
  • This cell structure is provided with a plurality of cells 70 for supporting the skirt portion 103 of the valve assembly 100 attached to the stent 10.
  • Each cel l 70 of the plurality of cells is formed by a plurality of struts 71.
  • Two adjacent struts 71 of a single cell 70 merge near the bottom of the cell 70 before splitting off into two different struts 71.
  • the meeting point, where the two adjacent struts 71 merge, defines an ancon of the cell 70.
  • the skirt portion 103 of the valve assembly 100 is supported by the plurality of cells 70 and connected to the struts 71 of the cells 70 by means of a plurality of stitches 75, 76.
  • the stitches 76 which are axially aligned with the longitudinal direction of the expanded stent 10 and which are located immediately adjacent to the ancones of the corresponding cells 71, provide for a slideable connection between the corresponding section of the valve assembly 100 and the stent 10.
  • This slideable connection provided by the stitches 76 al low for a relative movement between the section of the valve assembly 100 and the stent 10 in the longitudinal direction of the stent 10 when transferring the stent 10 together with the valve assembly 100 connected to the stent 10 from its expanded condition into its collapsed condition and vice versa.
  • the stitches 76 are orientated such as to loop a stent section which is vertically arranged, i.e. parallel to the longitudinal axis of the expanded stent 10. Accordingly, the stitches 76 are orientated in such a way that they can move along the corresponding strut during crimping because the forces acting on the stitches 76 during cri mping are parallel to the corresponding strut and the frictional force that resists the relative motion or tendency to such motion of the stitch 76 and stent section in contact can be overcome during crimping .
  • the other stitches 75 are not arranged immediately adjacent to the ancones of the cells 70 and are also not aligned with the longitudinal axis of the stent in its expended state. In other words, each of these stitches 75 loops a strut section of the stent 10 which is not vertically arranged, i.e. which is not parallel to the longitudinal axis of the stent.
  • the skirt portion 103 of the valve assembly 100 is also fixedly secured to the corresponding leaflet attachment regions 11c provided by the respective arms 16a', 16a", 16b', 16b", 16c', 16c" of the retaining arches 16a, 16b, 16c.
  • the annular collar 40 of the stent 100 has a flared shape. Accordingly, the lower part of skirt portion 103 of the valve assembly 100 affixed to the stent 10 also exhibits an extended diameter in order to accommodate the flared shape of the annular collar 40. It can further be seen from the FIG. 2a or FIG. 2b illustration how the valve assembly 100 can be affixed to the stent 10 by means of sutures.
  • a pericardial valve assembly 100 is used. Stitches 77 are used for fixedly sewing the pericardial valve assembly 100 to the retaini ng arches 16a, 16b, 16c, i.e.
  • the skirt portion 103 may be sewn to the annular collar 40 as well as other parts of the stent structure.
  • the valve assembly 100 may be tubular with a substantially circular cross-section.
  • the annular collar 40 comprises a plurality of cells 60, each cell 60 being formed by a plurality of struts 61.
  • the skirt portion 103 of the valve assembly 100 is secured to the struts 71 of the plurality of cells 70 by means of a plurality of stitches 75, 76.
  • the cells 60 of the annular collar 40 are arranged such as to form one single cell row.
  • the stitches 76 located immediately adjacent to the corresponding meeting points of two adjacent cells 60 provide for a slideable connection point.
  • the valve assembly 100 in the region at the meeting points of two adjacent cells 60 of the annular collar 40, the valve assembly 100 (skirt portion 103 of the valve assembly 100) is slideably connected to the corresponding struts 61 which form the plurality of cells 60.
  • the other stitches 75, which are used for connecting the skirt portion 103 of the valve assembly 100 to the annular collar 40 are chosen such as to form a fixed connection, i .e. a connection which does not allow for a relative movement between the corresponding section of the valve assembly 100 and the struts 61 of the annular collar 40.
  • the valve assembly 100 is fixedly connected to the leaflet attachment regions 11c and the commissure attachment regions l ib of the stent 10 by using a plurality of stitches 75 which does not allow a relative movement between the tissue material of the valve assembly 100 and the corresponding stent sections in the longitudinal direction of the stent 10 when transferring the stent 10 from its expanded condition into its collapsed condition. It is also conceivable to mount the valve assembly 100 to the outer surface of a support stent 10. That is, the skirt portion 102 could be in direct contact with the diseased native heart valve and could be attached to the stent 10 by means of sutures.
  • valve assembly 100 supports the load transfer from the leaflet 102 to the stent 10. This greatly reduces stresses on the leaflets 102 during closing and consequently improves the durability thereof. Also, it is possible to design the valve to obtain improved hemodynamics in the case of mounting the skirt portion and commissures to the outer surface of the stent 10. Additionally, the heart valve material which is in direct contact with the diseased native heart valve provides a good interface for sealing against leakage (i .e., paravalvular leakage), tissue in-growth and
  • the material for the valve assembly 100 and, in particular, the material for the leaflets 102 of the valve assembly 100 can be made from synthetics, animal valves or other animal tissues such as pericardium.
  • the animal tissues can be from a number of types of animals.
  • the leaflet material of the valve assembly 100 is from either bovine or porcine pericardium, but other animals can also be considered, for example equine, kangaroo, etc.
  • FIGS. 3a to 3c An exemplary embodiment of a stent 10 adapted to be used in a prosthetic heart valve 1 for holding a valve assembly 100 attached to the stent 10 is illustrated in FIGS. 3a to 3c.
  • FIG. 3a shows a side view of a collapsed stent 10 of a further
  • FIGS. 3b and 3c illustrate different side views of the stent 10 according to FIG. 3a, where the stent 10 is in its expanded state.
  • the design of the stent 10 illustrated in Figs 3a to 3c mostly corresponds to the design of the stent used in the prosthetic heart valve 1 shown in FIGS. 2a and 2b; however, contrary to the stent 10 of the prosthetic heart valve 1 shown in FIGS. 2a and 2b, the stent 10 illustrated in FIGS. 3a to 3c is provided with a plurality of leaflet guard arches 50a, 50b, 50c.
  • one leaflet guard arch 50a, 50b, 50c is provided in between each positioning arch 15a, 15b, 15c of the stent 10.
  • one leaflet guard arch 50a, 50b, 50c is allocated to each positioning arch 15a, 15b, 15c.
  • Each leaflet guard arch 50a, 50b, 50c has a substantially U-shaped or V-shaped structure which is closed to the inflow end 2 of the stent 10.
  • each leaflet guard arch 50a, 50b, 50c has a shape that is roughly similar to the shape of the positioning arch 15a, 15b, 15c and each leaflet guard arch 50a, 50b, 50c is arranged within the arms of the corresponding positioning arch 15a, 15b, 15c.
  • each of the leaflet guard arches 50a, 50b, 50c extends in the same direction as the positioning arch 15a, 15b, 15c.
  • the leaflet guard arches 50a, 50b, 50c are preferably programmed so that they extend in a radial direction outside the circumference of the stent 10 when the stent 10 is in its expanded state. In this way, an increased contact force can be applied to the leaflets of the native (diseased) cardiac valve when the stent 10 is in its expanded and implanted state. This, in turn, allows an increased security in the fixing of the stent 10 in situ.
  • the leaflet guard arches 50a, 50b, 50c actively keep the diseased leaflets, i .e. the leaflets of the native cardiac valve, from impinging the leaflets 102 of a valve assembly 100 attached to the stent 10, when the positioning arches 15a, 15b, 15c are placed outside the native leaflets.
  • the leaflet guard arches 50a, 50b, 50c may also provide additional anchoring and securing against migration.
  • the stent 10 according to the stent embodiment illustrated in FIGS. 3a to 3c may further include at least one auxiliary arch 18a, 18b, 18c interspaced between two adjacent retaining arches 16a, 16b, 16c, wherein the at least one auxiliary arch 18a, 18b, 18c includes a first arm 18a', 18b', 18c' connected at a first end thereof to a first retaining arch 16a, 16b, 16c and a second arm 18a", 18b", 18c" connected at a first end thereof to a second retaining arch 16a, 16b, 16c, and wherein the first and second arms 18a', 18a", 18b', 18b", 18c', 18c" of the at least one auxiliary arch 18a, 18b, 18c each include respective second ends connected to an annular collar 40 which is arranged at the lower end section of the stent 10 body.
  • first and second arms 18a', 18a", 18b', 18b", 18c', 18c" of the at least one auxiliary arch 18a, 18b, 18c are part of a strut or web structure which is provided between the first and second arms 18a', 18a", 18b', 18b", 18c', 18c" of two adjacent auxiliary arches 18a, 18b, 18c in order to support the valve assembly 100 to be affixed to the stent 10.
  • the strut or web structure may be composed by a plurality of struts 71 or strut-l ike members which are
  • Each strut 71 or strut- like element of the reinforcement structure serves as reinforcement member in order to increase the strength or resistance to deformation of the area between the first and second arms 18a', 18a", 18b', 18b", 18c', 18c" of two adjacent auxiliary arches 18a, 18b, 18c.
  • the reinforcement structure thereby provides mechanical reinforcement to the stent 10.
  • the reinforcement members of the reinforcement structure between the first and second arms 18a', 18a", 18b', 18b", 18c', 18c" of two adjacent auxiliary arches 18a, 18b, 18c provides for an additional support for the skirt portion 103 of a valve assembly 100 to be attached to the stent 10.
  • the terms “strength” or “resistance to deformation” as used herein may be used to denote any of a number of different properties associated with the reinforcement members.
  • the terms may be used to refer to properties of the material from which the reinforcement members are made, such as the yield strength, the modulus of elasticity, the modulus of rigidity, or the elongation percentage.
  • the terms may be used to refer to the hardness of the reinforcement members. Hardness may be characterized as the "durometer" of the material, in reference to the apparatus used to measure the hardness of the material.
  • the terms may also be used to denote geometric characteristics of the reinforcement members, such as the thickness of the reinforcement members.
  • the terms “strength” or “resistance to deformation” may also be used to characterize any combination of the above properties as well as additional properties and/or characteristics.
  • the strength or resistance to deformation of the area between the first and second arms 18a', 18a", 18b', 18b", 18c', 18c" of two adjacent auxiliary arches 18a, 18b, 18c can be increased in any number of ways.
  • the strength or resistance to deformation of the area between the first and second arms 18a', 18a", 18b', 18b", 18c', 18c" of two adjacent auxiliary arches 18a, 18b, 18c can be increased, for example, by providing a reinforcement structure formed by at least one, and preferably by a plurality of reinforcement elements (e.g . struts 71 or strut-like members) which are interconnected to each other.
  • a reinforcement web is provided in order to increase the strength or resistance to deformation of the area between the first and second arms 18a', 18a", 18b', 18b", 18c', 18c" of two adjacent auxiliary arches 18a, 18b, 18c.
  • This reinforcement web may also be composed by a plurality of reinforcement elements (e.g. struts 71 or strut-like members) which are interconnected to each other thereby forming a rhomboidal pattern.
  • the strength or resistance to deformation of the area between the first and second arms 18a', 18a", 18b', 18b", 18c', 18c" of two adjacent auxiliary arches 18a, 18b, 18c can be increased, for example, by increasing the thickness of the
  • the rei nforcement members can be made from a number of different materials, preferably shape memory materials, each having a different level of hardness. In this regard, it is conceivable to vary the stoichiometric composition of the material used for forming the stent 10 and the reinforcement members such as to adapt the material properties of the stent 10 and/or the reinforcement members to the specific needs of each stent 10 application.
  • the selection of the reinforcement members can be tailored to the specific needs of each stent application. For example, in regions where a high external force is expected, reinforcement members having a high hardness may be preferred .
  • the strength may also be increased by combining material properties with geometric changes.
  • the stent 10 is provided with a reinforcement structure which is constituted by a plurality of lattice cells 70 formed by a plurality of struts 71 in the area between the arms 16a', 16a", 16b', 16b", 16c', 16c" of two neighbouring (adjacent) retaining arches 16a, 16b, 16c, thereby providing for an additional support for the bendable transition area 104 of a valve assembly 100 to be attached to the stent 10.
  • a reinforcement structure which is constituted by a plurality of lattice cells 70 formed by a plurality of struts 71 in the area between the arms 16a', 16a", 16b', 16b", 16c', 16c" of two neighbouring (adjacent) retaining arches 16a, 16b, 16c, thereby providing for an additional support for the bendable transition area 104 of a valve assembly 100 to be attached to the stent 10.
  • this structure of the lattice cells 70 formed by a plurality of struts 71 in the area between the adjacent arms of two neighbouring retaining arches 16a, 16b, 16c may provide uniform stent structure which may minimize blood leakage in the implanted stage of the stent 10 having a heart valve prosthesis attached thereto.
  • the upper end sections of the respective struts 71 which are forming the structure of the lattice cells 70 are connected to the respective arms of the retaining arches 16a, 16b, 16c.
  • the upper end sections of the struts 71 comprise a widened diameter in order to strengthen the connection between the upper end sections of the struts 71 and the arms of the retaining arches 16a, 16b, 16c.
  • the annular collar 40 of the stent 10 which is provided at the lower end section of the stent body, is connected with the stent body via the retaining arches 16a, 16b, 16c on the one hand and the second ends of the respective arms 18a', 18a", 18b', 18b", 18c', 18c" of the at least one auxiliary arch 18a, 18b, 18c on the other hand, wherein these arms 18a', 18a", 18b', 18b", 18c', 18c" of the at least one auxiliary arch 18a, 18b, 18c are part of the structure of the lattice cells 60.
  • the stent 10 according to the stent embodiment depicted in FIGS.
  • the stent 10 according to this stent embodiment comprises a continuous design of its inflow end section 2. Due to this continuous design, in the implanted and expanded state of the stent 10, via the inflow end section 2 of the stent 10 an uniform radial force is applied to the wall of the blood vessel into which the stent 10 is deployed .
  • the implanted and expanded stent 10 together with a valve assembly 100 affixed thereto extend too far below the annulus of the heart, there may be the risk that the implanted prosthetic heart valve 1 consisting of the stent 10 on the one hand and the valve assembly 100 on the other hand contacts the nerve bundles and heart block.
  • the nerve bundles may enter at a location approximately 6 to 10 mm below the annulus of the heart.
  • the stent 10 pursuant to the stent embodiment of FIG. 3 is provided with an annular collar 40 which is shortened in its length by having only a single row of cells 60.
  • the total height of the stent 10 and thus the total height of the prosthetic heart valve 11 to be implanted into the body of the patient are reduced .
  • the stent 10 according to the stent embodiment of FIG. 3 comprises a number of notches 12e uniformly distributed around the lower end section of the annular collar 40. These notches 12e can be used for fixing a valve assembly (not shown in FIGS.
  • the means (threads or thin wires) used to fasten the tissue component(s) to the stent 10 are effectively prevented from being squeezed and thus degraded when the stent 10 with the valve assembly 100 affixed thereto, i .e. the prosthetic heart valve 11, is compressed and brought into its collapsed shape such as to be ready for being inserted into a catheter system which is used for implanting the prosthetic heart valve 11.
  • the risk of structural deterioration in the threads or thin wires used to fasten the tissue component(s) of the valve assembly 100 to the stent 10 is reduced .
  • the cross-sectional shape of the notches 12e may be adapted to the cross- sectional shape of the thread or thin wire used to fasten the tissue component(s) of the valve assembly 100. This allows fixing of the tissue component(s) of the valve assembly 100 to the stent 10 at a precise predefined position relative to the stent 10. Because the fastening notches 12e are adapted to the thickness and/or the cross-sectional shape of the thread or thin wire used to affix the valve assembly 100 to the stent 10, relative movement between the stent 10 and the tissue component(s) of the valve assembly 100 due to the peristaltic motion of the heart can be effectively prevented when the prosthetic heart valve 1 is implanted .
  • the tissue component(s) of the valve assembly 100 is/are thus fastened to the stent 10 with minimal play, based on which friction-induced wear of the thread or thin wire used to affix the valve assembly 100 is minimized.
  • the notches 12e may have a semi-circular cross-sectional shape.
  • the stent 10 may further comprise at least one radial arch 32a, 32b, 32c which enables a particularly secure anchoring of the stent 10 in the site of implantation in the heart and which is substantially circumferentially aligned with at least one of the plurality of positioning arches 15a, 15b, 15c.
  • the radial arches 32a, 32b, 32c of the stent 10 extend from the leaflet guard arches 50a, 50b, 50c towards the outflow end 3 of the stent 10.
  • the stent 10 has three radial arches 32a, 32b, 32c, with each arch 32a, 32b, 32c located between the two arms of each leaflet guard arch 50a, 50b, 50c.
  • Each radial arch 32a, 32b, 32c has a shape that is roughly inverse to each positioning arch 15a, 15b, 15c and extends in the opposite direction to each one of the positioning arches 15a, 15b, 15c.
  • each leaflet guard arch 50a, 50b, 50c has a substantially U-shaped or V-shaped structure which is closed to the inflow end 2 of stent 10.
  • each leaflet guard arch 50a, 50b, 50c has a shape that is roughly similar to the shape of the positioning arch 15a, 15b, 15c in between the corresponding leaflet guard arch 50a, 50b, 50c is arranged. Furthermore, each leaflet guard arch 50a, 50b, 50c extends in the same direction as the positioning arch 15a, 15b, 15c.
  • each arm of a leaflet guard arch 50a, 50b, 50c merges at about the mid-point of the length of an arm of a radial arch 32a, 32b, 32c into the arm of an opposing radial arch 32a, 32b, 32c.
  • the leaflet guard arches 50a, 50b, 50c project in the longitudinal direction L of the stent 10 and have a reduced length such that the positioning arches 15a, 15b, 15c can deploy during the expansion of the stent 10 and the leaflet guard arches 50a, 50b, 50c do not interfere during deployment.
  • the positioning arches 15a, 15b, 15c disposed on the stent 10 and also the retaining arches 16a, 16b, 16c may be curved in convex and arched fashion in the direction to the lower end section of the stent 10; i.e. toward the inflow end 2 of the stent 10, whereby such a rounded form may reduce injuries to the artery as well as facilitate the unfolding during the self-expansion.
  • Such a design may enable an easier insertion of the positioning arches 15a, 15b, 15c into the pockets of the native cardiac valve without correspondingly injuring the neighbouring tissue or blood vessels.
  • FIGS. 4a, 4b Another embodiment of a stent 10 adapted to be used in a prosthetic heart valve 1 for holding a valve assembly 100 attached to the stent 10 is shown by FIGS. 4a, 4b.
  • This stent embodiment differs from the stent embodiment according to FIG. 3 in the specific design of the retaining means 23 provided at the outflow end 3 of the stent 10.
  • protruding elements are provided as retaining means which are shaped to be complementary to eyelets provided in a catheter retaining head.
  • the stent 10 is provided with a plurality of commissure attachment regions l ib with a plurality of additional fastening holes 12c configured at one end of each arm 16a', 16a", 16b', 16b", 16c', 16c" of the retaining arches 16a, 16b, 16c.
  • the stent designs shown in FIGS. 3 and 4 comprise a structure having a plurality of cells 60, 70 which are provided between the arms 16a', 16a", 16b', 16b", 16c', 16c" of two adjacent retaining arches 16a, 16b, 16c on the one hand, and which form the annulus collar 40 on the other hand .
  • the depicted are provided between the arms 16a', 16a", 16b', 16b", 16c', 16c" of two adjacent retaining arches 16a, 16b, 16c on the one hand, and which form the annulus collar 40 on the other hand .
  • the annulus collar 40 defines the annulus section of the stent 10.
  • the cell structure provided between the arms of two adjacent retaining arches 16a, 16b, 16c is part of an intermediate section of the stent 10.
  • the cells 60 of the annulus collar 40 are connected to one another around the stent 10.
  • Each cell 60 is formed by a plurality of struts 61.
  • These struts 61 may be used for connecting a skirt portion 103 of a valve assembly 100 (not shown in FIGS. 3 and 4) to the annulus collar 40 of the stent 10.
  • the meeting point between two adjacent cells 60 may be used for forming a slideable connection point between the ski rt portion 103 of a valve assembly 100 and the stent 10.
  • the other parts of the struts 61, which are not aligned with the longitudinal direction of the stent 10 in the expanded condition of the stent 10 may be used for formi ng a fixed connection with the tissue material of a valve assembly 100.
  • the cell structure provided between the arms of two adjacent retaining arches 16a, 16b, 16c is a structure having a plurality of first cells 70 and a plurality of second cells 70, wherein the first cells 70 are connected to one another partly around the circumference of the stent 10 such as to form a first row of cells 70, and wherein the second cells 70 are connected to one another partly around the circumference of the stent 10 such as to form a second row of cells 70.
  • the first and second rows of cells 70 are connected to one another in the longitudinal direction of the stent 10. This is in particular derivable from FIG. 4b.
  • Each of the cells 70 is formed by a plurality of struts 71.
  • Two adjacent struts 71 of a single cell 70 merge near the bottom of the corresponding cell 70 before splitting off into two different struts 71.
  • the meeting point, where the two adjacent struts 71 merge, defines an ancon of the corresponding cell 70.
  • the cell structure between the arms of two adjacent retaining arches 16a, 16b, 16c, serves for supporting a skirt portion 103 of a valve assembly 100.
  • the tissue material of the valve assembly 100 may be connected to the struts 71 of the cells 70 by means of a plurality of stitches.
  • at least one of the plurality of stitches allows for a relative movement between the stent 10 and the tissue material of the valve assembly 100 in the longitudinal direction of the stent 10 when the stent 10 is transferred from its expanded condition into its collapsed condition.
  • This at least one stitch loops a stent section which is orientated in the direction of the longitudinal axis of the expanded stent 10.
  • the at least one stitch may be located immediately adjacent to the ancones of the corresponding cells 70.
  • the prosthetic heart valves 1 disclosed herein involve 1 percutaneous insertion of a generally tubular stent 10 with a valve assembly 10 affixed thereto, into a vessel or other tubular structure within the vascular system.
  • the stent 10 with the valve assembly 10 affixed thereto is typically delivered to a specific location inside the vascular system in a compressed state by a delivery catheter.
  • the stent 10 with the valve assembly 100 affixed thereto is deployed by expanding the stent 10 into the vessel wall.
  • the expanded stent 10 typically has a diameter that is several times larger than the diameter of the stent 10 in its compressed state.
  • the expansion of the stent 10 may be performed by several methods known in the art, such as by a mechanical expansion device (balloon catheter expansion stent) or by self-expansion.
  • the stent 10 with a valve assembly 100 affixed thereto Prior to delivery the stent 10 with a valve assembly 100 affixed thereto needs to be loaded into the delivery catheter, in particular into a catheter tip of the delivery catheter. For this purpose, the stent 10 with a valve assembly 100 affixed thereto is transferred in its compressed state by crimping .
  • the crimping process performed on the stent 10 with a valve assembly 100 affixed thereto is a critical factor that may affect the performance of the prosthetic heart valve 1 and the success of the medical procedure.
  • Careful crimping of the prosthetic heart valve 1 may be a difficult challenge for many physicians.
  • the compression forces which radially act on the stent 10 and the valve assembly 100 during crimping may be known, uncertainty about the load distribution may lead to damages of the tissue material of the valve assembly 100.
  • One cause for uncertainty is a phenomenon known as longitudinal stent deformation or lengthening during crimping.
  • Lengthening during crimping is the opposite to foreshortening during deployment of a prosthetic heart valve 1. It can be better understood by defini ng the condition within the context of change in the stent length before and after crimping .
  • the term “deployed length” describes the starting point of the stent 10 prior to crimping - that is the length of the stent 10 in its expanded state which mostly corresponds to the length of the stent 10 deployed within the lumen.
  • crimped length is defined at the end point of change during the crimping process - that is the length of the compressed stent 10 mounted on a delivery catheter prior to deployment. Lengthening is equivalent to the distance between these two points, i.e. the difference between the deployed and contained (“crimped") length.
  • Lengthening occurs to varying degrees with all stents. This is especially true for endovascular stents greater than 4.0 mm in diameter.
  • the amount of stent lengthening is determined predominately by the particular stent design and the degree of radial expansion of the respective stent sections. For example, the lengthening effect is considerably higher in sections of the stent 10 which contain a high density of structural features, for example cells and arches. On the other hand, the lengthening effect is also higher in sections of the stent 10 which are configured such as to have a higher degree of radial expansion.
  • FIG. 5a illustrates a cut-out view of a section of a cardiac valve stent 10, where the cardiac valve stent is in its expanded state, i .e. prior to crimping .
  • FIG. 5b shows this cut-out section of the stent 10, where the stent 10 is in its expanded state.
  • the cut-out view shown in FIGS. 5a and 5b illustrates the cell structure between the arms of two adjacent retaining arches 16a, 16b, 16c of the stent 10 according to FIG. 3 or 4.
  • the stent section In the expanded condition of the stent 10 shown in FIG. 5a, the stent section has a total length of 19.36 mm . This total length is increased to 24.99 mm when the stent 10 is transferred into its collapsed condition (cf. FIG. 5b). This corresponds to a longitudinal stretching of 29.1 %.
  • the lengthening of the stent 10 in the longitudinal direction during crimping is not constant in each section of the stent. Rather, in the exemplary embodiment depicted in FIGS. 5a and 5b, the upper part of the stent section shown in the cut-out view provides a longitudinal stretching of 5.75 %. The lower part of the stent section provides a longitudinal stretching of 51.4 %, whereas the intermediate part of the stent section, i .e. the part of the stent section between the upper and the lower parts, provides a longitudinal stretching of 45.6 %.
  • the lengtheni ng effect during crimping causes longitudinal stretching of the stent 10 which normally does not lead to damaging the stent structure.
  • a valve assembly 100 fixed to the stent structure is also exposed to the change of stent length. This might lead to problems because the tissue material of the valve assembly is often not capable of excessively stretching .
  • FIG. 6 showing the behavior of tissue deflection of an exemplary tissue material used for a valve assembly and having a given width.
  • the tissue material exhibits a relatively good stretchability up to 15% of the initial length of the tissue material, i.e. the tissue material without tensile force acting on the material .
  • the tissue material (pericardium) can be stretched by 15% when applying a tensile force of
  • the stretchability of the tissue material decreases considerably.
  • the tissue material is stretchable by 29% only if a tensile force of 2.76 N is applied.
  • a tensile force of 2.76 N is applied.
  • One problem addressed in the present disclosure is that there is a risk that the tensile forces, which are necessary for stretching the tissue material in a sufficient manner, are too high in order to ensure that no damaging of the tissue material occurs.
  • tissue material of a valve assembly 100 is not fixed at ancones of the stent 10; i .e. at sections of the stent 10 which are objected to an extensive longitudinal stretchi ng when transferring the stent 10 form its expanded condition to its collapsed condition.
  • the valve assembly 100 is generally mounted to the inner surface of the stent 10.
  • the valve assembly 100 it is also conceivable to mount the valve assembly 100 to the outer surface of a support stent 10. That is, the skirt portion 102 could be in direct contact with the diseased native heart valve and could be attached to the stent 10 by means of sutures. Mounting the valve assembly 100 to the outer surface of the stent 10 supports the load transfer from the leaflet 102 to the stent 10 and reduces the stress
  • valve assembly such as to obtain improved hemodynamics in the case of mounting the skirt portion 103 to the outer surface of the stent 10.
  • heart valve material which is in direct contact with the diseased native heart valve provides a good interface for sealing against leakage (i .e., paravalvular leakage), tissue in-growth and attachment.
  • valve assembly 100 An exemplary embodiment of a valve assembly 100 will be described in the following with reference to FIGS. 7 to 9e.
  • FIG. 7 illustrates a flat pattern of the valve assembly 100 material, which has an essentially T-shirt like shape.
  • the T-shirt like shape may comprise an additional reinforcement area 113 extending substantially vertical from each of the sleeves 111 of the separate pieces 120.
  • the additional reinforcement area 113 which will be described in more detail below, can be used for fastening the separate pieces 120 of the valve assembly 100 more securely to each other and to the stent 10 respectively.
  • the valve assembly 100 of this embodiment is made of at least two, more preferably three separate pieces 120 exhibiting the depicted T-shirt like shape of FIG. 7.
  • the three separate pieces 120 are connected to each other along their contiguous edges 112 by suturing, in order to form the cylindrical or conical shape of the valve assembly 100 as shown in FIGS. 3a and 3b.
  • Each of the three separate pieces 120 may be cut from an individual pericardial sack, so as to obtain three pieces 120 having similar, matching characteristics, e.g., tissue thickness and properties.
  • each of the separate pieces 120 of the third embodiment of the valve assembly 100 also comprises a bendable transition area 104, as indicated by FIG. 7. Accordingly, each of the separate pieces 120 of this embodiment is intended to represent one of the at least two, preferably three, leaflets 102 of the valve assembly 100.
  • each of the leaflets is separated by the transition area 104 from a skirt portion 103, which can be used for connecting the valve assembly 100 to a stent 10, for example, by means of sutures.
  • the bendable transition area 104 is used to pivot the leaflets about the bendable transition area 104 during the opening and closing phase of the valve assembly 100.
  • the bendable transition area 104 forms a junction between the leaflets 102 and the skirt portion 103 and progresses in a substantial U-shaped manner, similar to the cusp shape of a natural aortic or pulmonary heart valve.
  • the T-shirt like tissue pattern shown in FIG. 7 may comprise a plurality of fastening holes (not shown) provided along the progression of the transition area 104.
  • These fastening holes are preferably introduced into the tissue material of the valve assembly 100 by means of laser cutting for strengthening the tissue area around the fastening holes.
  • the fastening holes are introduced by the needle as the valve assembly 100 is sewn to the stent 10 in order to form an inventive prosthetic heart valve 11.
  • the separate piece 120 shown in FIG. 7 is preferably made of one piece of a flat pericardial tissue. This pericardial tissue can either be extracted from an animal's heart (xenograft) or a human's heart (homograft).
  • the extracted tissue may be cut by a laser or a knife or might be pressed in order to form a flat tissue pattern as illustrated by FIG. 7.
  • the separate pieces 120 could alternatively consist of any suitable synthetic material cut into the shape depicted by FIG. 7. After forming of the at least two t-shirt shaped separate pieces 120, the two or three separate pieces 120 are sewn into a cylindrical or conical shape, ready to be attached to a corresponding stent structure 10.
  • each of the separate pieces 120 comprises a flared lower end section (skirt portion 103).
  • This flared lower end section may be advantageous in order to fit the two or three separate pieces 120 of the valve assembly 100 to an annular collar 40 of the corresponding stent 10.
  • the flared lower end section of the separate pieces 120 are also necessary to adjust to a balancing motion of the inventive stent configuration.
  • the lower end section of the separate pieces also includes a zigzag like pattern, so as to conform to the struts and shape of the annular collar 40 of the stent 10.
  • FIGS. 9a to 9e The steps for connecting the two ends of two of the pieces 120 along one of the contiguous edges 112 are shown in FIGS. 9a to 9e.
  • a first step illustrated in FIG. 9a, the contiguous edges 112 are brought in contact and sleeves 111 of the separate pieces 120 are bent by an approximate angle of 90 degrees to the outside.
  • a reinforcement element 107.9 is attached to the front surface of the outwardly bent sleeves 111 by means of sutures, preferably applying a blanket stitch.
  • the contiguous edges 112 are also sewn together by means of a suture 101.1, again applying a blanket stitch.
  • FIG. 8 A more detailed front view of the aforementioned reinforcement element 107.9 is depicted in FIG. 8.
  • the reinforcement element 107.9 has a
  • extension member 1071 located at the top centre of the rectangular reinforcement element 107.9. As will be described in more detail below, the extension member 1071 is used to form a continuous edge 114 by the end of the connecting process (FIG. 9d).
  • a third step after attaching the reinforcement element 107.9 to the sleeves 111, the remaining part of the sleeves 111 as well as the additional reinforcement area 113 are folded to the front (out of the plane of projection of FIG. 9b) along the side edges of the reinforcement element 107.9.
  • This folding process is indicated by the arrows shown in FIG. 9b, the result of which can be derived from FIG. 9c.
  • another step in the process for connecting two of the separate pieces 120 includes folding the additional reinforcement areas 113 backwards into the plane of projection.
  • the additional reinforcement areas 113 are folded back over the top edge 1072 of the reinforcement element 107.9 so as to cover the reinforcement element 107.9 as shown in FIG. 9d and l ie.
  • the height of the additional reinforcement area 113 as well as the height of the extension member 1071 is chosen to eventually provide a continuous edge 114 (FIG. 9d) for attachment to the corresponding stent 10.
  • FIG. 9e shows a schematic top view of the two separate pieces 120 connected along their sleeves 111 ready for attachment to an inventive stent 10.
  • the sleeve 111 with the additional reinforcement area 113 has been folded three times so as to wrap around the enforcement element 107.9.
  • the sleeve may be attached to the reinforcement element 107.9 by a plurality of central sutures 101.5, connecting the reinforcement element with the sleeve 111 by means of a blanket stitch.
  • the connected sleeves 111 of the separate pieces 120 can be connected to an inventive stent 10, preferably along the attachment regions l ib of the stent 10, as described herein before.
  • a liner or sheath typically a fabric, polymeric or pericardial sheet, membrane, or the like, may be provided over at least a portion of the exterior of the stent 10 to cover all or most of the surface of the outside of the stent 10, extending from a location near the lower end section of the stent 10 to a location near the upper end section of the stent 10.
  • the liner may be attached to the stent 10 at at least one end, as well as at a plurality of locations between said ends thereby forming an exterior coverage.
  • Such exterior coverage provides a
  • the liner may be stitched or otherwise secured to the stent 10 along a plurality of circumferentially spaced-apart axial lines. Such attachment permits the liner to fold along a plurality of axial fold lines when the stent 10 is radially compressed.
  • the liner will further be able to open and conform to the luminal wall of the tubular frame as the frame expands.
  • the liner may heat welded, or ultrasonically welded to the stent 10.
  • the liner may be secured to the plurality of independent arches (positioning arches 15a, 15b, 15c, retaining arches 16a, 16b, 16c, auxiliary arches 18a, 18b, 18c, leaflet guard arches 50a, 50b, 50c) preferably along axial lines.
  • the liner may be secured to the annular collar 40 provided at the lower end section 2 of the stent 10.
  • the liner will preferably be circumferentially sealed against the stent 10 at at least one end.
  • thrombogenicity is achieved while maintaining the benefits of having a stent structure which is used for spreading up a valve assembly 100 and for anchoring the valve assembly 100 in place.
  • the stent 10 can be compressed from a relaxed, large diameter configuration to a small diameter configuration to facilitate introduction. It is necessary, of course, that the outer liner remain attached to the stent 10 both in its radially compressed configuration and in its expanded, relaxed configuration.
  • the liner is composed of pericardial material or conventional biological graft materials, such as polyesters, polytetrafluoroethylenes (PTFE's), polyurethanes, and the like, usually being in the form of woven fabrics, non-woven fabrics, polymeric sheets, membranes, and the like.
  • a presently preferred fabric liner material is a plain woven polyester, such as Dacron® yarn (Dupont, Wilmington, Delaware).
  • FIG. 10 is a perspective view of a prosthetic heart valve 1 comprising a stent 10 and a valve assembly 100 attached to the stent 10.
  • the structure of the stent 10 of the prosthetic heart valve 1 depicted in FIG. 1Q corresponds to the structure of the stent 10 shown in FIGS. 4a and 4b.
  • the valve assembly 100 utilized in the heart valve prosthesis 1 shown in FIG.10 is composed of at least two separate tissue pieces 120, and preferably three tissue pieces 120, each of said pieces 120 exhibiting a shape as shown in FIG. 11.
  • the separate pieces 120 are connected to each other along their zigzag panel edge 151 by suturing, in order to form the cylindrical or conical shape of the valve assembly 100.
  • Each of the at least two separate pieces 120 may be cut from an individual pericardial sack, so as to obtain the separate pieces 120 having similar, matching characteristics, e.g., tissue thickness and properties.
  • the zigzag panel edges 151 are brought in contact and sleeves 111 of the separate pieces 120 are bent by an approximate angle of 90 degrees to the outside. Subsequently, the zigzag panel edges 151 are sewn together by means of a zigzag seam 152.
  • the prosthetic heart valve 1 includes an inflow end 2, an outflow end 3, three commissure extensions 15Q defined by the retaining arches 16a, 16b, 16c of the stent 10, and a scallop or scalloped area between adjacent pairs of commissure extensions.
  • Each of the commissure extensions is attached to the V-shaped retaining arches 16a, 16b, 16c of the stent 10 with stitches 77 that are spaced from each other and extend along the both sides and the peak of each of the V-shaped structured retaining arches 16a, 16b, 16c.
  • Each of the stitches 77 is located at a corresponding fastening notch 33 provided in the retaining arches 16a, 16b, 16c.
  • the stitching can be performed using standard suture material, which has a first end that can be terminated at one end of each V-shaped retaining arch 16a, 16b, 16c and a second end that can be terminated at the other end of the same V- shaped retaining arch 16a, 16b, 16c, for example.
  • standard suture material which has a first end that can be terminated at one end of each V-shaped retaining arch 16a, 16b, 16c and a second end that can be terminated at the other end of the same V- shaped retaining arch 16a, 16b, 16c, for example.
  • a different stitching pattern can be used,
  • the valve assembly 100 is additionally secured at its inflow end 2 to the stent 10 by suturing the tissue material of the valve assembly 1Q0 to the diamond-shaped structure of the annular collar 40. Moreover, the valve assembly 100 is secured to at least some of the plurality of cells 70 provided between the arms of two adjacent retaining arches 16a, 16b, 16c by suturing the tissue material of the valve assembly 10Q in a specific zigzag pattern, as shown in FIG. 10.
  • the zigzag seam 152 between two neighbouring tissue pieces 112 may match at least partly the structure of the cells 70 in such a manner that a specific stitching pattern may be used to attach the valve assembly 100 to the structure of ceils 70.
  • the specific stitching pattern is at least partly a zigzag stitching pattern which corresponds to the zigzag seam 152 used for connecting to neighboring tissue pieces 112 to each other along their zigzag panel edges 151.
  • the specific stitching pattern which comprises at least partly a zigzag
  • the stent 10 elongates and the attached tissue resists the elongation.
  • the amount of stent elongation and the amount of resistance by the tissue depends (inter alia) on valves assembly/stitching. Previous valve stitching and valve assembly resulted in higher than desired stiffness and resistance to the stent elongation.
  • the separate valve tissue pieces 120 are stitched together and then attached to the stent 10 using surgical sutures.
  • the sutures are relatively stiff compared to the valve tissue.
  • the stitching can result in extra resistance to the stent during crimping and elongation if not configured properly.
  • Sutures that are aligned in the axial direction and connected directly to the stent 10 can prevent the stent struts from easily collapsing to the small catheter diameter.
  • the prosthetic heart valve 10 is constructed by joining at least two and preferably three panels of tissue pieces 120.
  • the configuration includes a zigzag seam 152 that is aligned with the strut structure of the plurality of cells 70 of the stent 10.
  • the specific stitching pattern which comprises at least partly a zigzag configuration and which is used to attach the valve assembly 100 to the structure of ceils 70, is much stiffer axially than the adjacent tissue due to multiple loops of suture and multiple layers of tissue.
  • a zigzag seam 152 as shown in FIG. 10 will be more compliant in the axial direction than an axially aligned seam 101.1 as shown, for example, in FIG. 2b. This improves catheter loadability. In both cases, a continuous stitch can be used to form the seam .

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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

La présente invention concerne une valvule cardiaque prothétique aplatissable (1), comprenant une endoprothèse (10) présentant un état aplati et un état dilaté et un ensemble valvule (100). L'ensemble valvule (100) est fixé sur l'endoprothèse (10) de manière telle que, dans au moins une section de la valvule cardiaque prothétique (1), un mouvement relatif entre l'endoprothèse (10) et le matériau tissulaire de l'ensemble valvule (100) dans la direction longitudinale de l'endoprothèse (10) est permis lors du passage de l'endoprothèse (10) de son état dilaté à son état aplati et vice versa.
PCT/IB2014/061969 2013-06-21 2014-06-05 Valvule cardiaque prothétique aplatissable WO2014203106A1 (fr)

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3035890A1 (fr) * 2013-08-22 2016-06-29 St. Jude Medical, Cardiology Division, Inc. Endoprothèse possédant des formes de cellules différentes
WO2016123082A1 (fr) * 2015-01-26 2016-08-04 Boston Scientific Scimed, Inc. Valvule cardiaque prothétique carré feuillet dépliante point de couture
WO2017027541A1 (fr) * 2015-08-12 2017-02-16 St. Jude Medical, Cardiology Division, Inc. Valve cardiaque rétractable, comprenant des stents ayant des armatures coniques
US9585747B2 (en) 2009-04-15 2017-03-07 Edwards Lifesciences Cardiaq Llc Vascular implant
CN111093565A (zh) * 2017-08-18 2020-05-01 爱德华兹生命科学公司 用于假体心脏瓣膜的心包密封元件
CN111568606A (zh) * 2015-07-14 2020-08-25 爱德华兹生命科学公司 假体心脏瓣膜
CN113679509A (zh) * 2020-05-19 2021-11-23 上海微创心通医疗科技有限公司 一种心脏瓣膜假体及其支架和置换系统
CN113679510A (zh) * 2020-05-19 2021-11-23 上海微创心通医疗科技有限公司 一种心脏瓣膜假体及其支架和置换系统
US11439504B2 (en) 2019-05-10 2022-09-13 Boston Scientific Scimed, Inc. Replacement heart valve with improved cusp washout and reduced loading
CN115105259A (zh) * 2022-03-28 2022-09-27 科凯(南通)生命科学有限公司 包括曲自膨胀弧的自膨心脏瓣膜支架

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004019825A1 (fr) 2002-08-13 2004-03-11 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Dispositif d'implantation et de fixation de protheses de valvules cardiaques
WO2006076890A1 (fr) 2005-01-20 2006-07-27 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Catheter destine a l'implantation transvasculaire de protheses de valvules cardiaques
WO2009094188A2 (fr) * 2008-01-24 2009-07-30 Medtronic, Inc. Stents pour des valvules cardiaques prothétiques
WO2009149462A2 (fr) * 2008-06-06 2009-12-10 Edwards Lifesciences Corporation Valvule cardiaque transcathéter de faible profil
WO2011104269A1 (fr) * 2008-02-26 2011-09-01 Jenavalve Technology Inc. Stent pour le positionnement et l'ancrage d'une prothèse valvulaire dans un site d'implantation dans le cœur d'un patient
WO2011120050A1 (fr) * 2010-03-26 2011-09-29 Thubrikar Aortic Valve, Inc. Composant valvulaire, composant de cadre et dispositif de prothèse valvulaire les comprenant destiné à être implanté dans une lumière corporelle
WO2011147849A1 (fr) * 2010-05-25 2011-12-01 Jenavalve Technology Inc. Valvule prothétique et endoprothèse mise en place par cathétérisme comprenant une valvule prothétique et un stent
WO2012082952A2 (fr) * 2010-12-14 2012-06-21 Colibri Heart Valve Llc Valvule cardiaque apte à être posée par voie percutanée, comprenant des valves à membranes repliées à feuillets intégrés

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004019825A1 (fr) 2002-08-13 2004-03-11 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Dispositif d'implantation et de fixation de protheses de valvules cardiaques
WO2006076890A1 (fr) 2005-01-20 2006-07-27 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Catheter destine a l'implantation transvasculaire de protheses de valvules cardiaques
WO2009094188A2 (fr) * 2008-01-24 2009-07-30 Medtronic, Inc. Stents pour des valvules cardiaques prothétiques
WO2011104269A1 (fr) * 2008-02-26 2011-09-01 Jenavalve Technology Inc. Stent pour le positionnement et l'ancrage d'une prothèse valvulaire dans un site d'implantation dans le cœur d'un patient
WO2009149462A2 (fr) * 2008-06-06 2009-12-10 Edwards Lifesciences Corporation Valvule cardiaque transcathéter de faible profil
WO2011120050A1 (fr) * 2010-03-26 2011-09-29 Thubrikar Aortic Valve, Inc. Composant valvulaire, composant de cadre et dispositif de prothèse valvulaire les comprenant destiné à être implanté dans une lumière corporelle
WO2011147849A1 (fr) * 2010-05-25 2011-12-01 Jenavalve Technology Inc. Valvule prothétique et endoprothèse mise en place par cathétérisme comprenant une valvule prothétique et un stent
WO2012082952A2 (fr) * 2010-12-14 2012-06-21 Colibri Heart Valve Llc Valvule cardiaque apte à être posée par voie percutanée, comprenant des valves à membranes repliées à feuillets intégrés

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9585747B2 (en) 2009-04-15 2017-03-07 Edwards Lifesciences Cardiaq Llc Vascular implant
EP3035890A1 (fr) * 2013-08-22 2016-06-29 St. Jude Medical, Cardiology Division, Inc. Endoprothèse possédant des formes de cellules différentes
WO2016123082A1 (fr) * 2015-01-26 2016-08-04 Boston Scientific Scimed, Inc. Valvule cardiaque prothétique carré feuillet dépliante point de couture
US9861477B2 (en) 2015-01-26 2018-01-09 Boston Scientific Scimed Inc. Prosthetic heart valve square leaflet-leaflet stitch
CN111568606A (zh) * 2015-07-14 2020-08-25 爱德华兹生命科学公司 假体心脏瓣膜
WO2017027541A1 (fr) * 2015-08-12 2017-02-16 St. Jude Medical, Cardiology Division, Inc. Valve cardiaque rétractable, comprenant des stents ayant des armatures coniques
US10368983B2 (en) 2015-08-12 2019-08-06 St. Jude Medical, Cardiology Division, Inc. Collapsible heart valve including stents with tapered struts
CN111093565A (zh) * 2017-08-18 2020-05-01 爱德华兹生命科学公司 用于假体心脏瓣膜的心包密封元件
US11439504B2 (en) 2019-05-10 2022-09-13 Boston Scientific Scimed, Inc. Replacement heart valve with improved cusp washout and reduced loading
CN113679509A (zh) * 2020-05-19 2021-11-23 上海微创心通医疗科技有限公司 一种心脏瓣膜假体及其支架和置换系统
CN113679510A (zh) * 2020-05-19 2021-11-23 上海微创心通医疗科技有限公司 一种心脏瓣膜假体及其支架和置换系统
CN115105259A (zh) * 2022-03-28 2022-09-27 科凯(南通)生命科学有限公司 包括曲自膨胀弧的自膨心脏瓣膜支架

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