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WO2025158372A1 - Prothèse de valvule cardiaque transcathéter avec segments de déviation pour la prévention de la lvoto - Google Patents

Prothèse de valvule cardiaque transcathéter avec segments de déviation pour la prévention de la lvoto

Info

Publication number
WO2025158372A1
WO2025158372A1 PCT/IB2025/050806 IB2025050806W WO2025158372A1 WO 2025158372 A1 WO2025158372 A1 WO 2025158372A1 IB 2025050806 W IB2025050806 W IB 2025050806W WO 2025158372 A1 WO2025158372 A1 WO 2025158372A1
Authority
WO
WIPO (PCT)
Prior art keywords
heart valve
valve prosthesis
transcatheter heart
frame
deflecting
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2025/050806
Other languages
English (en)
Inventor
Torey HOVEST
Erik C. GRISWOLD
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Inc
Original Assignee
Medtronic Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Inc filed Critical Medtronic Inc
Publication of WO2025158372A1 publication Critical patent/WO2025158372A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue

Definitions

  • the present technology is related generally to transcatheter heart valve prostheses, and more specifically to transcatheter heart valve prostheses with a deflecting segment.
  • the human heart is a four chambered, muscular organ that provides blood circulation through the body during a cardiac cycle.
  • the four main chambers include the right atrium and right ventricle which supplies the pulmonary circulation, and the left atrium and left ventricle which supplies oxygenated blood received from the lungs to the remaining body.
  • atrioventricular valves tricuspid and mitral valves
  • semilunar valves pulmonary valve and aortic valve
  • valves contain leaflets or cusps that open and shut in response to blood pressure changes caused by the contraction and relaxation of the heart chambers.
  • the leaflets move apart from each other to open and allow blood to flow downstream of the valve, and coapt to close and prevent backflow or regurgitation in an upstream manner.
  • Diseases associated with heart valves can include stenosis and valvular insufficiency or regurgitation.
  • valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve.
  • Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient.
  • a diseased or damaged valve which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency.
  • Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots, which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and/or life threatening.
  • Transcatheter heart valve prostheses have been developed for repair and replacement of diseased and/or damaged heart valves. Such transcatheter heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based systems. Transcatheter heart valve prostheses can be delivered while in a low profile or compressed/collapsed arrangement so that the transcatheter heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the transcatheter heart valve prosthesis can be expanded to engage tissue at the diseased heart valve region to, for instance, hold the transcatheter heart valve prosthesis in position.
  • a portion of the transcatheter heart valve prosthesis may protrude or extend into the left ventricle, and more specifically into the left ventricular outflow tract (LVOT).
  • LVOT left ventricular outflow tract obstruction
  • TMVR transcatheter mitral valve replacement
  • TMVR transcatheter mitral valve replacement
  • Extension of transcatheter heart valve prostheses into the left ventricular outflow tract (LVOT) can cause increased risk to patients for obstruction and restriction of blood flow to the aortic valve.
  • the techniques and devices of this disclosure generally relate to transcatheter heart valve prostheses with a deflecting segment configured to deflect, deform, tilt or a distal portion of the transcatheter heart valve prosthesis.
  • Deflecting, deforming, or tilting of the distal portion of the transcatheter heart valve prosthesis by the deflecting segment deflects an outflow end out of the transcatheter heart valve prosthesis out of the left ventricular outflow tract (LVOT).
  • LVOTO left ventricular outflow tract obstruction
  • LVOT left ventricular outflow tract obstruction
  • a transcatheter heart valve prosthesis comprises: a frame having an inflow end and an outflow end, the frame having a radially collapsed configuration for delivery and a radially expanded configuration for deployment within a native heart valve; a deflecting segment disposed at the outflow end of the frame; and a prosthetic valve component disposed within and coupled to the frame.
  • the deflecting segment is configured to radially extend from the outflow end of the frame such that with the frame radially expanded within a native mitral valve the deflecting segment engages an interventricular septum to tilt, deform, or deflect a distal portion of the transcatheter heart valve prosthesis in a direction away from the interventricular septum.
  • a radial plane of the deflecting segment in the radially expanded configuration, extends at an angle between about 60 degrees and about 90 degrees or about 70 degrees to about 90 degrees or about 80 degrees to about 90 from a central longitudinal axis of the frame.
  • the frame in the transcatheter heart valve prosthesis of any of the preceding or following examples, includes an inner frame configured to support the prosthetic valve component and a fixation frame coupled to and surrounding the inner frame.
  • the deflecting segment in another example hereof, is a plurality of deflecting segments. [0013] In another example hereof, in the transcatheter heart valve prosthesis of any of the preceding or following examples, the deflecting segment is a J-shaped curve.
  • the deflecting segment comprises two J-shaped curves, wherein the two J-shaped curves curve in opposite directions.
  • the deflecting segment in the transcatheter heart valve prosthesis of any of the preceding or following examples, is a loop shape.
  • the deflecting segment is self-expanding.
  • the deflecting segment is balloon expandable.
  • the transcatheter heart valve prosthesis in another example hereof, in the transcatheter heart valve prosthesis of any of the preceding or following examples, is balloon expandable.
  • a method comprises: delivering a transcatheter heart valve prosthesis to a site of a native mitral valve, the transcatheter heart valve prosthesis including a frame, a prosthetic valve coupled to the frame, and a deflecting segment coupled to an outflow portion of the frame; and radially expanding the transcatheter heart valve prosthesis to a radially expanded configuration such that the frame engages at least one of the native leaflets and a native annulus of the native mitral valve, and the deflecting segment engages tissue of an interventricular septum, wherein the deflecting segment tilts, deforms, or deflects a distal portion of the frame in a direction away from the interventricular septum.
  • a radial plane of the deflecting segment extends at an angle between about 60 degrees and about 90 or about 70 degrees to about 90 degrees or about 80 degrees to about 90 degrees from a central longitudinal axis of the frame.
  • the deflecting segment in the radially expanded configuration, is a plurality of deflecting segments.
  • the deflecting segment comprises two J- shaped curves
  • radially expanding the heart valve prosthesis comprises radially expanding the two J-shaped curves such that the two J-shaped curves curve in opposite directions.
  • the deflecting segment in the radially expanded configuration, is a loop shape.
  • radially expanding the heart valve prosthesis comprises releasing the heart valve prosthesis from a restraint to enable the heart valve prosthesis to self-expand.
  • radially expanding the heart valve prosthesis comprises: balloon expanding the frame of the heart valve prosthesis; and after balloon expanding the frame, balloon expanding the deflecting segment to tilts, deforms, or deflects a distal portion of the frame in a direction away from the interventricular septum.
  • balloon expanding the frame comprises using a first balloon catheter to radially expand the frame
  • balloon expanding the deflecting segment comprises using a second balloon catheter to radially expand the deflecting segment
  • the first balloon catheter is delivered transseptally to the native mitral valve
  • the second balloon catheter is delivered in a retrograde approach through a native aortic valve, into a left ventricular outflow tract, and into the deflecting segment.
  • FIG. 1 depicts a schematic illustration of a heart having native valve structures.
  • FIG. 2 depicts a schematic sectional illustration of a left ventricle of a heart showing anatomical structures and a native mitral valve.
  • FIG. 3 depicts a schematic sectional illustration of a heart and a transcatheter heart valve prosthesis deployed within a native mitral valve of the heart.
  • FIG. 4 depicts a perspective view of an example transcatheter heart valve prosthesis.
  • FIG. 5 depicts a perspective view of an inner frame and prosthetic valve component of the transcatheter heart valve prosthesis of FIG. 4.
  • FIG. 6 depicts a perspective view of a plurality of deflecting segments for a transcatheter heart valve prosthesis according to an embodiments hereof.
  • FIG. 7 depicts a perspective view of a transcatheter heart valve prosthesis with the plurality of deflecting segments of FIG. 6.
  • FIG. 8 depicts a side view of the transcatheter heart valve prosthesis of FIG. 7, in situ, in a radially expanded configuration.
  • FIG. 9 depicts a perspective view of the transcatheter heart valve prosthesis of FIG. 7, in situ, in the radially expanded configuration.
  • FIG. 10 depicts a perspective view of a deflecting segment of a transcatheter heart valve prosthesis according to embodiments hereof.
  • FIG. 11 depicts a perspective view of a transcatheter heart valve prosthesis with the deflecting segment of FIG. 10.
  • FIG. 12 depicts a side view of the transcatheter heart valve prosthesis of FIG. 11, in situ, in a radially expanded configuration.
  • FIG. 13 depicts a perspective view of the transcatheter heart valve prosthesis of FIG. 11, in situ, in the radially expanded configuration.
  • FIG. 14 depicts a perspective view of a plurality of deflecting segments of a transcatheter heart valve prosthesis according to an embodiments hereof.
  • FIG. 15 depicts a perspective view of a transcatheter heart valve prosthesis with the plurality of deflecting segments of FIG. 14.
  • FIG. 16 depicts a side view of the transcatheter heart valve prosthesis of FIG. 15, in situ, in a radially expanded configuration.
  • FIG. 17 depicts a perspective view of the transcatheter heart valve prosthesis of FIG. 15, in situ, in the radially expanded configuration.
  • FIG. 18A the transcatheter heart valve prosthesis of FIG. 7 disposed in a capsule of a delivery system.
  • FIG. 18B the transcatheter heart valve prosthesis of FIG. 7 partially deployed from a distally translating capsule.
  • FIG. 19 depicts a transcatheter heart valve prosthesis with a deflecting segment according to embodiments hereof.
  • FIG. 20 depicts a side cross-sectional view of the transcatheter heart valve prosthesis of FIG. 19 in a radially collapsed configuration in a distal portion of a delivery device according to embodiments hereof.
  • FIG. 21 depicts the transcatheter heart valve prosthesis of FIG. 19 radially expanded in situ by a balloon of a delivery device.
  • FIG. 22 depicts a perspective view of the transcatheter heart valve prosthesis of FIG. 19, in situ, prior to balloon expansion of the deflecting segment.
  • FIG. 23 depicts a perspective view of the transcatheter heart valve prosthesis of FIG. 19, in situ, with a balloon of a balloon catheter in an unexpanded state disposed through the deflecting segment in the radially collapsed configuration.
  • FIG. 24 depicts a perspective view of the transcatheter heart valve prosthesis of FIG. 19, in situ, with the balloon of the balloon catheter in an expanded state and the deflecting segment in the radially expanded configuration.
  • FIG. 25 depicts a side view of the transcatheter heart valve prosthesis of FIG. 19, in situ, with the deflecting segment in the radially expanded configuration.
  • FIG. 26 depicts a perspective view of a dock assembly with a deflecting segment in a deployed configuration, according to an embodiment hereof.
  • FIG. 27 depicts a side view of the dock assembly of FIG. 26, in situ, with a transcatheter heart valve prosthesis disposed therein in a radially expanded configuration.
  • FIG. 28 depicts a perspective view of the dock assembly of FIG. 26, in situ, with a transcatheter heart valve prosthesis disposed therein in a radially expanded configuration.
  • distal and proximal when used in the following description to refer to a native vessel, native valve, or a device to be implanted into a native vessel or native valve, such as a transcatheter heart valve prosthesis, are with reference to the direction of blood flow.
  • distal and distal refer to positions in a downstream direction with respect to the direction of blood flow
  • proximal and proximally refer to positions in an upstream direction with respect to the direction of blood flow.
  • self-expanding is used in the following description with reference to one or more stent structures and deflecting segments of the prostheses hereof is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration.
  • selfexpanding materials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal.
  • Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol.
  • Embodiments disclosed herein are directed to deflecting segments extending radially outward from an outflow end of a transcatheter heart valve prosthesis .
  • the deflecting segments extend substantially perpendicular to a longitudinal axis of the left ventricular outflow tract (LVOT) when deployed.
  • LVOT left ventricular outflow tract
  • Each deflecting segment is configured to engage or contact an interventricular septum to deflect, deform, or tilt a distal portion of the transcatheter heart valve prosthesis in a direction away from the interventricular septum to reduce the risk of left ventricular outflow tract obstruction (LVOTO).
  • LVOTO left ventricular outflow tract obstruction
  • FIG. 1 is a schematic sectional illustration of a heart HE that depicts the four heart chambers (right atrium RA, right ventricle RV, left atrium LA, left ventricle LV) and native valve structures (tricuspid valve TV, mitral valve MV, pulmonary valve PV, aortic valve AV).
  • FIG. 2 is a schematic sectional illustration of a left ventricle LV and left atrium LA of a heart HE showing anatomical structures and a native mitral valve MV.
  • the heart HE comprises the left atrium LA that receives oxygenated blood from the lungs via the pulmonary veins.
  • the left atrium LA pumps the oxygenated blood through the mitral valve MV and into the left ventricle LV during ventricular diastolic.
  • the left ventricle LV contracts during systole and blood flows outwardly through the aortic valve AV, into the aorta into the remainder of the body.
  • valve leaflets LF of the mitral valve MV meet evenly to close and prevent backflow of blood during contractions of the left ventricle LV.
  • the valve leaflets LF attach the surrounding heart structure via a dense, fibrous ring of connective tissue, called an annulus AN which is distinct from both the leaflet tissue LF as well as the adjoining muscular tissue of the heart wall.
  • the flexible leaflet tissue of the mitral valve leaflets LF are connected to papillary muscles PM, which extend upwardly from the lower wall of the left ventricle LV, and the inter-ventricular septum IV S, via branching tendons called chordae tendineae CT.
  • mitral valve leaflets LF In a heart HE having a mitral valve MV in which the valve leaflets LF do not sufficiently co-opt or meet, leakage from the left ventricle LV into the left atrium LA may occur.
  • Several structural defects can cause the mitral valve leaflets LF to prolapse in this manner, and subsequent regurgitation to occur, including ruptured chordae tendineae CT, impairment of papillary muscles PM, e.g., due to his ischemic heart disease, and enlargement of the heart, and/or mitral valve annulus AN, e.g., cardiomyopathy.
  • FIG. 3 is a schematic sectional illustration of a heart HE, that depicts a transcatheter heart valve prosthesis, commonly referred to as a transcatheter mitral valve or TMV, deployed within the native mitral valve MV.
  • An outflow end of the transcatheter mitral valve TMV extends into the left ventricular outflow tract LVOT and reduces blood flow therethrough. This is commonly referred to as left ventricular outflow tract obstruction (LVOTO).
  • LVOTO left ventricular outflow tract obstruction
  • FIGS. 4-5 illustrate a transcatheter heart valve prosthesis 100 upon which the embodiments of deflecting segments herein may be utilized.
  • the transcatheter heart valve prosthesis 100 is illustrated herein to facilitate description of the present disclosure.
  • the following description of the transcatheter heart valve prosthesis 100 is merely exemplary in nature and is not intended to limit the disclosure or the application and uses of the disclosure. It is understood that any number of alternate transcatheter heart valve prostheses can be used with the deflecting segments described herein.
  • Other non-limiting examples of transcatheter heart valve prostheses that can be used with the deflecting segments described herein are described in U.S. Patent No. 11,318,083 to McVeigh et al., U.S. Patent No.
  • the transcatheter heart valve prosthesis 100 is configured with a radially collapsed configuration for delivery within a vasculature (not shown) and to return to a radially expanded configuration when deployed, as shown in FIG. 4.
  • the transcatheter heart valve prosthesis 100 When the transcatheter heart valve prosthesis 100 is in the radially collapsed configuration, the transcatheter heart valve prosthesis 100 has a low profile suitable for delivery to and deployment within a native heart valve via a suitable delivery catheter that may be tracked to the deployment site of the native heart valve of a heart via any one of a transseptal, retrograde, or transapical approach.
  • the example transcatheter heart valve prosthesis 100 includes an inner frame 102 surrounded by and coupled to a fixation frame 104.
  • a prosthetic valve component 106 is disposed within and coupled to the inner frame 102.
  • the prosthetic valve component 106 includes at least one valve leaflet 108 disposed within and secured to the inner frame 102.
  • the inner frame 102 and the fixation frame 104 described herein as elements of the transcatheter heart valve prosthesis 100 may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as nitinol, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials.
  • suitable biocompatible materials e.g., stainless steel, nickel titanium alloys such as nitinol, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials.
  • the inner frame 102 may be a tubular stent-like structure that defines a lumen 110 from an inflow end 112 of the inner frame 102 to an outflow end 114 of the inner frame 102, as best shown in FIG. 5.
  • the inner frame 102 is configured to support the prosthetic valve component 106 therein.
  • the inner frame 102 includes a plurality of crowns 122 and a plurality of struts 124 defining a plurality of side openings 126.
  • the inner frame 102 may include an inner skirt 116 coupled to an inner surface of the inner frame 102.
  • the inner skirt 116 may be of various materials such as, but not limited to a natural or biological material such as pericardium or another membranous tissue such as intestinal submucosa, or a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE, which creates a one-way fluid passage when attached to the stent.
  • a natural or biological material such as pericardium or another membranous tissue such as intestinal submucosa
  • a low-porosity woven fabric such as polyester, Dacron fabric, or PTFE, which creates a one-way fluid passage when attached to the stent.
  • the prosthetic valve component 106 of the transcatheter heart valve prosthesis 100 is capable of regulating flow therethrough via the valve leaflets 108 that may form a replacement valve.
  • FIGS. 4-5 illustrate a prosthetic valve component having three (3) leaflets, although a single leaflet or bicuspid leaflet configuration may be used in embodiments hereof. Adjoining pairs of valve leaflets 108 are attached to one another at their lateral ends to form leaflet commissures 109A, 109B, 109C, as shown in FIG. 5. When deployed in situ, the prosthetic valve component 106 in a closed state is configured to block blood flow in one direction to regulate blood flow through the lumen 110 of the inner frame 102.
  • the valve leaflets 108 may be formed of various flexible materials including, but not limited to natural pericardial material such as tissue from bovine, equine or porcine origins, or synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials.
  • natural pericardial material such as tissue from bovine, equine or porcine origins
  • synthetic materials such as polytetrafluoroethylene (PTFE), DACRON® polyester, pyrolytic carbon, or other biocompatible materials.
  • the fixation frame 104 may be a generally tubular stent-like structure that functions as an anchor for the transcatheter heart valve prosthesis 100 to secure its deployed position within a native annulus.
  • the fixation frame 104 includes an inflow end 148 and an outflow end 142.
  • the outflow end 142 of the fixation frame 104 may be coupled to the outflow end 114 of the inner frame 102.
  • the fixation frame 104 is configured to engage heart tissue at or below an annulus of a native heart valve, such as an annulus of a native mitral valve.
  • the fixation frame 104 includes a plurality of crowns 134 and a plurality of struts 136 defining a plurality of side openings 138.
  • the fixation frame 104 includes one or more cleats, prongs, spikes, barbs, or other fixation elements 118 that extend outward from an exterior side thereof to engage heart tissue.
  • the fixation frame 104 may include a fixation skirt 146 attached to and lining an inner surface of the fixation frame 104. In the embodiment of FIG. 4, the fixation skirt 146 extends to the outflow end 142 of the fixation frame 104.
  • the fixation skirt 146 may be a natural or biological material such as pericardium or another membranous tissue such as intestinal submucosa, or may be a low-porosity woven fabric, such as polyester, Dacron fabric, or PTFE.
  • the transcatheter heart valve prosthesis 100 may further include other elements such as, but not limited to a brim 120 that extends outwardly from the inflow end 148 of the fixation frame 104.
  • the brim 120 may act as an atrial retainer, if present, and to serve such a function the brim 120 may be configured to engage tissue above a native annulus to thereby inhibit downstream migration of the transcatheter heart valve prosthesis 100, for e.g., during atrial systole.
  • FIGS. 6-26 show embodiments of deflecting segments for use with transcatheter heart valve prostheses. Each embodiment will be described in greater detail below as part of a transcatheter heart valve prosthesis, similar to the transcatheter heart valve prosthesis 100 described above, except for the deflecting segment or plurality of deflecting segments. Accordingly, other parts of the transcatheter heart valve prosthesis 100 will use the same reference numerals, such as, but not limited to, the inner frame 102, the fixation frame 104, the prosthetic valve component 106, the inner skirt 116, the crowns 134, the outflow end 142, and the fixation skirt 146. Thus, these parts need not be described again.
  • Each of the deflecting segment embodiments is configured to tilt, deform, or deflect a distal portion of the transcatheter heart valve prosthesis in a direction away from the intraventricular septum when deployed within a native mitral valve and in a radially expanded configuration.
  • Each embodiment of deflecting segments is configured to tilt, deform, or deflect the distal portion of the transcatheter heart valve prosthesis to minimize or eliminate transcatheter heart valve prosthesis obstruction within the left ventricular outflow tract to improve blood flow therethrough to an aortic valve.
  • the deflecting segment or plurality of deflecting segments may be relatively stiff as to tilt or deflect the entire frame away from the left ventricular outflow tract and the portion of the frame to which the deflecting segment couples may be relatively compliant to ensure deformation of the frame 104 when the deflecting segment engages tissue of the interventricular septum, as described below.
  • the transcatheter heart valve prosthesis 100 includes a first deflecting segment 680A and a second deflecting segment 680B.
  • the first and second deflecting segments 680A, 680B are each curved.
  • each deflecting segment 680 is a J-shaped curve.
  • the first deflecting segment 680A includes a first end 682A, a second end 684A, and an apex 686A, as shown in FIG. 6.
  • the second deflecting segment 680B includes a first end 682B, a second end 684B, and an apex 686B.
  • Each deflecting segment 680 has a radially collapsed configuration for delivery and a radially expanded configuration when deployed. Further, in embodiments, each deflecting segment 680 may be extended linearly for delivery to the treatment site.
  • the transcatheter heart valve prosthesis 100, the first deflecting segment 680A and the second deflecting segment 680B are each self-expanding.
  • the first deflecting segment 680A and the second deflecting segment 680B are each configured to deflect, deform, or tilt a distal portion 188 of the transcatheter heart valve prosthesis 100 when in the radially expanded configuration.
  • the first end 682 of each deflecting segment 680 is coupled to a corresponding crown 134 of the fixation frame 104 as shown in FIG. 7. Accordingly, the first end 682A of the first deflecting segment 680A is coupled to a corresponding crown 134A, and the first end 682B of the second deflecting segment 680B is coupled to a corresponding crown 134B.
  • each deflecting segment 680 is coupled to a corresponding crown 134 such that when the transcatheter heart valve prosthesis 100 deployed and is properly rotationally aligned with native mitral valve MV, the apex 686 of each deflecting segment 680 engages tissue of the interventricular septum when the deflecting segments 680 are in the radially expanded configuration.
  • the first deflecting segment 680A and the second deflecting segment 680B are configured such that the second end 684A is adjacent to the second end 684B when the first deflecting segment 680A and the second deflecting segment 680B are each in the radially expanded configuration.
  • Each deflecting segment 680 may be wrapped or wound circumferentially at the outflow end 142 of the fixation frame 104 when in the radially collapsed configuration for delivery, as shown in FIGS 18A and 18B described below. Wrapping of each deflecting segment 680 at the outflow end 142 of the fixation frame 104 for delivery to a desired treatment location ensures proper release at the outflow end 142 such that each deflecting segment 680 radially expands to engage or contact tissue at the interventricular septum IVS and does not become caught or sandwiched between the fixation frame 104 and an anterior leaflet of the native mitral valve during deployment.
  • the deflecting segment 680 may be extended distally from the outflow end 142 of the fixation frame 104 during delivery, as shown generally in FIG. 20.
  • Each deflecting segment 680 described herein as an element of the transcatheter heart valve prosthesis 100 may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as nitinol, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials.
  • suitable biocompatible materials e.g., stainless steel, nickel titanium alloys such as nitinol, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials.
  • each deflecting segment 680 may be a separate piece coupled to the corresponding crown 134 of the fixation frame 104 by, for example, and not by way of limitation, rivets, sutures, soldering, welding, staples, or other fasteners, mechanical interlocking, snap fit, friction, or interference fit, or any combination thereof.
  • each deflecting segment 680 may be formed unitarily (i.e., in one piece) with the fixation frame 104 or the inner frame 102.
  • FIGS 8-9 illustrate the transcatheter heart valve prosthesis 100 with the plurality of deflecting segments 680A, 680B in the radially expanded configuration, in situ.
  • the plurality of deflecting segments 680 each extends radially outward from the outflow end 142 of the fixation frame 104
  • a radial plane RP1 of the deflecting segments 680 is disposed at an angle 61 relative to the longitudinal axis LAI of the transcatheter heart valve prosthesis 100.
  • the angle 61 may be in a range of 60° to 90°, or 70° to 90°, 80° to 90° .
  • each deflecting segment 680 deploys at or under the outflow end 142 of the fixation frame 104 such that each deflecting segment 680 deploys under an anterior leaflet AL and around or through the chordae tendineae CT of a native mitral valve MV.
  • FIG. 9 illustrates each deflecting segment 680 deployed and in the radially expanded configuration, with the apex 686 of each deflecting segment 680 engaging tissue at the interventricular septum IVS.
  • the self-expanding force of each deflecting segment 680 translates to an outward radial force GF pressing the apex 686 against the interventricular septum IVS, and an inward radial force IF pressing on the corresponding crown 134 by the corresponding first end 682 of the deflecting segment 680, as shown in FIG. 9.
  • the inward radial force IF drives, pushes, or translates the corresponding crown 134 and adjacent portions of the fixation frame 104 radially inward to deflect, deform, or tilt a distal portion 188 of the transcatheter heart valve prosthesis 100 away from the interventricular septum IVS and out of the left ventricle outflow tract LVOT of the left ventricle LV.
  • the outflow end 142 and the fixation skirt 146 extend less into the left ventricular outflow tract LVOT.
  • Left ventricular outflow tract obstruction LVOTO is therefore reduced, and blood flow through the left ventricular outflow tract LVOT to an aortic valve AV is improved.
  • the deflecting segments 680A, 680B are arranged such that they curve away from each other.
  • the second ends 684A, 684B are adjacent to each other and the apexes 686A, 686B are spaced from each other.
  • Such an arrangement provides an open space between the deflecting segments 680A, 680B for blood to flow through.
  • the deflecting segments 680A, 680B are arranged such as minimize disruption of blood flow through the left ventricular outflow tract LVOT.
  • first deflecting segment 680A and a second deflecting segment 680B this is not meant to be limiting, and more or fewer deflecting segments 680 may be utilized.
  • first deflecting segment 680A and the second deflecting segment 680B are illustrated and described herein a coupled to adjacent crowns 134 of the fixation frame 104, in other non-limiting embodiments each of the plurality of deflecting segments may be coupled to the same crown of the fixation frame, or to non-adjacent crowns of the fixation frame.
  • the deflecting segments 680A, 680B need not be coupled to crowns 134 of the fixation frame. Instead, the deflecting segments 680A, 680B may be coupled to other portions of the frame of the transcatheter heart valve prosthesis 100.
  • FIGS. 10-13 illustrate the transcatheter heart valve prosthesis 100 with a deflecting segment 1080 according to embodiments hereof.
  • the deflecting segment 1080 is a loop shape including a first end 1082 and a second end or apex 1084, as shown in FIG. 10.
  • the transcatheter heart valve prosthesis 100 and the deflecting segment 1080 are each self-expanding.
  • the deflecting segment 1080 is configured to deflect, deform, or tilt a distal portion of the transcatheter heart valve prosthesis 100 when the transcatheter heart valve prosthesis 100 and the deflecting segment 1080 are in the radially expanded configuration. As shown in FIG.
  • the first end 1082 of the deflecting segment 1080 is coupled to a crown 134 of the frame of the transcatheter heart valve prosthesis 100.
  • the deflecting segment 1080 is coupled to the frame such that when the transcatheter heart valve prosthesis 100 is properly rotationally oriented within the native mitral valve MC, the apex 1084 of the deflecting segment 1080 engages tissue of the interventricular septum IVS when the deflecting segment 1080 is in the radially expanded configuration.
  • the transcatheter heart valve prosthesis 100 may be rotationally oriented during delivery such that the crown 134 to which the deflecting segment 1080 is coupled faces the interventricular septum IVS, such as by rotating a delivery catheter.
  • the deflecting segment 1080 may be pivoted such that the deflecting segment 1080 is wrapped circumferentially at or distal of the outflow end 142 ofthe fixation frame 104. In other words, the deflecting segment 1080 is pivoted approximately 180 degrees from the deployed configuration such that the second end 1084 is disposed opposite the crown 134 to which the first end 1082 is coupled.
  • This delivery configuration is shown generally in FIGS. 18A and 18B.
  • the deflecting segment 1080 may be extended distally from the outflow end 142 of the fixation frame 104, as shown generally in FIG. 20.
  • the deflecting segment 1080 may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as nitinol, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials.
  • the deflecting segment 1080 may be coupled to the corresponding crown 134 of the fixation frame 104 by methods such as, but not limited to rivets, sutures, soldering, welding, staples, or other fasteners, mechanical interlocking, snap fit, friction, or interference fit, or any combination thereof.
  • the deflecting segment 1080 need not be coupled to a crown 134 of the fixation frame 104. Instead, the deflecting segment 1080 may be coupled to other portions of the frame of the transcatheter heart valve prosthesis 100. Further, as noted above, the deflecting segment 1080 may be formed unitarily (i.e., as one piece) with the fixation frame 104 or the inner frame 102.
  • the transcatheter heart valve prosthesis 100 with the deflecting segment 1080 in the radially expanded configuration, in situ, is illustrated in FIGS. 12-13.
  • the deflecting segment 1080 extends radially outward from the outflow end 142 of the fixation frame 104.
  • a radial plane RP2 ofthe deflecting segment 1080 is disposed at an angle 62 relative to the longitudinal axis LAI of the transcatheter heart valve prosthesis 100.
  • the angle 62 may be in a range of 60° to 90° or 70° to 90° or 80° to 90°.
  • the angle 02 ensures that the deflecting segment 1080 deflect, deform, or tilt the distal portion 188 of the transcatheter heart valve prosthesis 100 away from the left ventricular outflow tract LVOT (i.e., laterally in FIG. 12), rather than supporting the transcatheter heart valve prosthesis 100 longitudinally (i.e., vertically in FIG. 12).
  • the angle 02 also ensures that the deflecting segment 1080 deploys at or under the outflow end 142 of the fixation frame 104 and under an anterior leaflet AL and around or through chordae tendineae CT of a native mitral valve MV.
  • the apex 1084 ofthe deflecting segment 1080 engages tissue at the interventricular septum IVS when in the radially expanded configuration, and the self-expanding force ofthe deflecting segment 1080 exerts an outward radial force OF against the interventricular septum IVS, and an inward radial force IF against the corresponding crown 134 at the first end 1082 of the deflecting segment 1080.
  • the inward radial force IF pushes the corresponding crown 134 and adjacent portions of the fixation frame 104 radially inward to deflect, deform, or tilt a distal portion 188 of the transcatheter heart valve prosthesis 100 away from the interventricular septum IVS and out of the left ventricle outflow tract LVOT.
  • the outflow end 142 and the fixation skirt 146 are deflected out of the left ventricular outflow tract LVOT and left ventricular outflow tract obstruction LVOTO is therefore reduced. Accordingly, blood flow through the left ventricular outflow tract LVOT to an aortic valve AV is improved.
  • the transcatheter heart valve prosthesis 100 includes a plurality of deflecting segments 1480A, 1480B, 1480C, according to embodiments hereof.
  • Each deflecting segment 1480 is a loop including a first end 1482 and a second end or apex 1484, as shown in FIG. 14.
  • the transcatheter heart valve prosthesis 100 and the deflecting segments 1480 are self-expanding.
  • Each deflecting segment 1480 is configured to deflect, deform, or tilt a distal portion of the transcatheter heart valve prosthesis 100 when the transcatheter heart valve prosthesis 100 and the deflecting segment 1480 are in the radially expanded configuration.
  • the plurality of deflecting segments 1480 is configured to minimize trauma to abutting tissue of the interventricular septum IVS by distributing the force against the interventricular septum IVS across a plurality of second ends 1484 abutting the interventricular septum IVS instead of a single second end in embodiments with a single loop. Further, the plurality of deflecting segments minimizes entanglement with chordae tendineae and could minimize alignment dependency of the delivery system as a more substantial radial arc of the heart valve prosthesis 100 has deflecting segments 1480. [0088] In an embodiment, each first end 1482 of each deflecting segment 1480 is coupled to a crown 134 disposed at an outflow end 142 of the fixation frame 104, as shown in FIG. 15.
  • each first end 1482 is coupled to the same crown.
  • the transcatheter heart valve prosthesis 100 may be rotationally oriented during delivery such that the crown 134 to which the deflecting segments 1480 are coupled faces the interventricular septum IVS, such as by rotating a delivery catheter.
  • each deflecting segment 1480 may be pivoted such that the deflecting segment 1480 is wrapped circumferentially at or distal of the outflow end 142 of the fixation frame 104. In other words, each deflecting segment 1480 is pivoted approximately 180 degrees from the deployed configuration such that the second end 1484 is disposed opposite the crown 134 to which the first end 1482 is coupled.
  • This delivery configuration is shown generally in FIGS. 18A and 18B.
  • the deflecting segments 1480 may be extended distally from the outflow end 142 of the fixation frame 104, as shown generally in FIG. 20.
  • Each deflecting segment 1480 may be made from any number of suitable biocompatible materials, e.g., stainless steel, nickel titanium alloys such as nitinol, cobalt chromium alloys such as MP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers, pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or any number of other materials or combination of materials.
  • Each deflecting segment 1480 may be coupled to the corresponding crown 134 of the fixation frame 104 by methods such as, but not limited to rivets, sutures, soldering, welding, staples, or other fasteners, mechanical interlocking, snap fit, friction, or interference fit, or any combination thereof.
  • each deflecting segment is coupled to a corresponding crown, and that each deflecting segment may be coupled to any suitable corresponding crown, in any combination.
  • the deflecting segments 1480 need not be coupled to a crown 134 of the fixation frame 104. Instead, the deflecting segments 1480 may be coupled to other portions of the frame of the transcatheter heart valve prosthesis 100. Further, as noted above, the deflecting segment 1080 may be formed unitarily (i.e., as one piece) with the fixation frame 104 or the inner frame 102.
  • FIGS. 16-17 illustrate the transcatheter heart valve prosthesis 100 with the plurality of deflecting segments 1480 in the radially expanded configuration, in situ.
  • FIG. 16 shows the plurality of deflecting segment 1480 extending radially outward from the outflow end 142 of the fixation frame 104.
  • a radial plane RP3 of the deflecting segments 1480 is disposed at an angle 03 relative to the longitudinal axis LAI of the transcatheter heart valve prosthesis 100.
  • the angle 03 may be in a range of 60° to 90° or 70° to 90 or 80 to 90.
  • the angle 03 ensures that the deflecting segments 1480 deflect, deform, or tilt the distal portion 188 of the transcatheter heart valve prosthesis 100 away from the left ventricular outflow tract LVOT (i.e., laterally in FIG. 16), rather than supporting the transcatheter heart valve prosthesis 100 longitudinally (i.e., vertically in FIG. 16).
  • the angle 03 also ensures that each deflecting segment 1480 deploys at or under the outflow end 142 of the fixation frame 104, under the anterior leaflet AL of the native mitral valve MV, and around or through chordae tendineae CT.
  • each deflecting segment 1480 engages tissue at the interventricular septum IVS when in the radially expanded configuration.
  • the selfexpanding force of each deflecting segment 1480 exerts an outward radial force OF against the interventricular septum IVS, which provides an opposite inward radial force IF against the corresponding crown 134 of the fixation frame 104.
  • the outward radial force OF against the interventricular septum IVS is distributed at to several locations, thereby minimizing trauma to engaged tissue of the interventricular septum IVS.
  • the inward radial force IF pushes the corresponding crown 134 and adjacent portions of the fixation frame 104 radially inward to deflect, deform, or tilt a distal portion 188 of the transcatheter heart valve prosthesis 100 away from the interventricular septum IVS and out of the left ventricle outflow tract LVOT, as shown in FIG. 17.
  • the outflow end 142 and the fixation skirt 146 of the fixation frame 104 are deflected out of the left ventricular outflow tract LVOT.
  • Left ventricular outflow tract obstruction LVOTO is therefore reduced, and blood flow through the left ventricular outflow tract LVOT to an aortic valve AV is improved.
  • Embodiments of FIGS. 6-17 include self-expanding transcatheter heart valve prostheses and self-expanding deflecting segments. These transcatheter heart valve prostheses embodiments may be delivered to a native mitral valve by various delivery devices including various deployment capsules including a proximally retracting capsule, a distally advancing capsule, or a split capsule having both a proximally retracting portion and a distally advancing portion.
  • the deployment from a proximally retracting capsule and a transseptal route to the native mitral valve deploys the deflecting segment or plurality of deflecting segments first, or at the same time as an outflow end of the heart valve prosthesis. When deployed early in the deployment process, the deflecting segment may assist with visualization and positioning of the transcatheter heart valve prosthesis.
  • deployment from a distally advancing capsule 502 of a delivery system 500 and a transseptal route to the native mitral valve deploys the frame or frames of the transcatheter heart valve prosthesis 100 first.
  • the deflecting segment or plurality of deflecting segments 680, 1080, 1480 are deployed after the frame or frames of the transcatheter heart valve prosthesis 100.
  • the frame of the heart valve prosthesis 100 engages an anterior leaflet of the native heart valve prior to deployment of the deflecting segment 680, 1080, 1480.
  • deployment of the deflecting segment or plurality of deflecting segments after the frame or frames of the transcatheter heart valve prosthesis further ensures the deflecting segment or plurality of deflecting segments do not become caught or sandwiched between the anterior leaflet of the native mitral valve and the frame of the transcatheter heart valve prosthesis because the transcatheter heart valve prosthesis previously engaged the anterior leaflet.
  • the deflecting segments may extend longitudinally from the fixation frame 104 or inner frame 102 in the radially compressed delivery configuration. Upon release from the capsule, the deflecting segment(s) return to their pre-set shape extending at an angle from the fixation frame 104 or the inner frame 102 such that the deflecting segments engage the interventricular septum IVS, as described above.
  • FIGS. 19-25 illustrate a balloon expandable transcatheter heart valve prosthesis 200 with a balloon expandable deflecting segment 1980, according to an embodiment herein.
  • FIG. 19 illustrates the balloon expandable transcatheter heart valve prosthesis 200 in a radially expanded configuration.
  • FIG. 20 illustrates a distal portion of a delivery device 300 with the transcatheter heart valve prosthesis 200 in a radially collapsed configuration disposed on an outer surface of a balloon 302 of the delivery device 300.
  • FIG. 21 illustrates the transcatheter heart valve prosthesis 200 being radially expanded by the balloon 302 in situ at a native mitral valve.
  • FIGS. 22-25 illustrate the transcatheter heart valve prosthesis 200 with the deflecting segment 1880, in situ, during delivery and deployment.
  • the transcatheter heart valve prosthesis 200 may be any balloon expandable transcatheter heart valve prosthesis.
  • the transcatheter heart valve prosthesis 200 generally includes a balloon expandable frame 202 and a prosthetic valve 206 disposed within and coupled to the frame 202.
  • the transcatheter heart valve prosthesis 200 includes an inflow end 208 and an outflow end 210.
  • the balloon expandable deflecting segment 1980 includes a first end 1982, a second end 1984, and an apex 1986.
  • the deflecting segment 1980 is balloon expandable from the collapsed or delivery state to an expanded or deployed state .
  • the deflecting segment 1980 is configured to deflect, deform, or tilt a distal portion of the transcatheter heart valve prosthesis 200 when the deflecting segment 1980 is in the deployed state at the site of a native mitral valve, as described below.
  • balloon expandable devices such as the frame 202 and the deflecting segment 1980 are also described as plastically deformable. In other words, upon expansion, the device plastically deforms to maintain the shape to which it was expanded.
  • use of a balloon expandable frame 202 and a balloon expanded deflecting segment 1980 ensures that the balloon expandable frame 202 remains deflecting out of the left ventricular outflow tract LVOT because the frame 202 is plastically deformed to that position and the deflecting segment 1980 is plastically deformed to the shape that pushes the frame 202 out of the left ventricular outflow tract LVOT.
  • the deflecting segment 1980 is substantially U-shaped, as shown in FIG. 19.
  • the first end 1882 may be coupled to a first crown 234A and the second end 1884 may be coupled to a crown 234B at the outflow end 210 of the frame 202, however, this is not meant to be limiting.
  • the deflecting segment 1880 is coupled to the frame 202 such that when the transcatheter heart valve prosthesis 200 is properly rotationally oriented within the native mitral valve, the deflecting segment 1980 is oriented such that the apex 1986 of the deflecting segment 1980 is directed towards the interventricular septum when the deflecting segment 1980 is in the radially expanded configuration.
  • the deflecting segment 1980 may be made from any number of suitable biocompatible plastically deformable materials, non-limiting examples of which include stainless steel or other suitable metal, such as platinum iridium, cobalt chromium alloys such as MP35N, or various types of polymers or other materials known to those skilled in the art, including said materials coated with various surface deposits to improve clinical functionality, or any number of other materials or combination of materials.
  • the deflecting segment 1980 may be a separate piece coupled to the corresponding crowns 234 by, for example, and not by way of limitation, rivets, sutures, soldering, welding, staples, or other fasteners, mechanical interlocking, snap fit, friction, or interference fit, or any combination thereof.
  • the deflecting segment 1980 may be formed unitarily (i.e., as one piece) with the frame 202.
  • the transcatheter heart valve prosthesis 200 is configured to be radially collapsed to the collapsed state onto an outer surface 304 of a balloon 302 of a delivery device 300, as shown in FIG. 20. With the transcatheter heart valve prosthesis 200 disposed on the outer surface 304 of the balloon 302, the deflecting segment 1980 is disposed distal of the outflow end 210 of the frame 202 of the transcatheter heart valve prosthesis 200.
  • the delivery device 300 may include components such as, but not limited to an inner shaft 306 including a lumen (not shown), the balloon 302 disposed on a distal portion 308 of the inner shaft 306 and in fluid communication with the lumen (not shown), and may further include an outer sheath 310 slidably disposed over the inner shaft 306, the balloon 302, and the transcatheter heart valve prosthesis 200.
  • the delivery device 300 is exemplary only, and may assume various configurations suitable to deliver and deploy the transcatheter heart valve prosthesis 200 to a desired treatment location.
  • the delivery device 300 may be configured to deliver and deploy the transcatheter heart valve prosthesis 200 to, for example, and not by way of limitation, a native mitral valve.
  • FIG. 21 shows the delivery device 300 transseptally delivered to the site of a native mitral valve.
  • the balloon 302 of the delivery device 300 has been radially expanded to radially expand the frame 202 of the transcatheter heart valve prosthesis 200.
  • the deflecting segment 1980 is rotated radially outward due to its release from outer sheath 310.
  • FIG. 22 shows the transcatheter heart valve prosthesis 200 with the delivery device 300 removed such that the frame 202 is in the radially expanded configuration at the site of the native mitral valve MV, with the deflecting segment 1980 disposed adjacent the interventricular septum IVS.
  • a balloon catheter 400 is advanced through the vasculature, over the aortic arch, through the aortic valve AV, and through the deflecting segment such that a balloon 402 of the balloon catheter 400 is disposed within the deflecting segment 1980 and adjacent the frame 202 of the transcatheter heart valve prosthesis 200.
  • the balloon catheter 400 may be any balloon catheter suitable for the purposes described herein.
  • the balloon 402 is inflated to expand the deflecting segment 1980 to the expanded state such that the deflecting segment 1980 engages or contacts tissue at the interventricular septum IVS and drives, pushes, or translates the corresponding crowns 234 to which the deflecting segment 1980 is coupled radially inward to deflect, deform, or tilt a distal portion 288 of the transcatheter heart valve prosthesis 200 away from the interventricular septum IVS and out of the left ventricle outflow tract.
  • the outflow end 210 of the frame 202 extends less into the left ventricular outflow tract LVOT.
  • both the deflecting segment 1980 and the frame 202 are plastically deformable, both are configured to maintain their corresponding shape after the balloon 402 is deflated. In other words, the deflecting segment 1980 will maintain its radially expanded shape and the frame 202 will maintain its deformed shape away from the left ventricular outflow tract LVOT. [00107] As illustrated in FIG.
  • a radial plane RP4 of the deflecting segment 1980 is disposed at an angle 64 relative to the longitudinal axis LA2 of the transcatheter heart valve prosthesis 200.
  • the angle 64 may be in a range of 60° to 90° or 70° to 90° or 80° to 90°. The angle 64 ensures that the deflecting segments 1980 deflects, deforms, or tilts the distal portion 188 of the frame 202 of the transcatheter heart valve prosthesis 200 away from the left ventricular outflow tract LV6T (i.e., laterally in FIG.
  • the angle 64 also ensures that the deflecting segment 1980 deploys at or under the outflow end 210 of the frame 202, under the anterior leaflet AL of the native mitral valve MV, and around or through chordae tendineae CT.
  • FIGS. 26-28 illustrate a dock assembly 2400 with a deflecting segment 2430, according to an embodiment hereof.
  • FIG. 26 illustrates the dock assembly 2400 in a deployed configuration.
  • FIGS. 27-28 illustrate the dock assembly 2400 in the deployed configuration, in situ.
  • the dock assembly 2400 may be used in conjunction with expandable transcatheter heart valve prostheses, for example, the transcatheter heart valve prosthesis 100, at a native mitral valve.
  • the dock assembly 2400 is configured to form a spiral, stable implant site into which the transcatheter heart valve prosthesis may be implanted, and to deflect, deform, or tilt a distal portion of the transcatheter heart valve prosthesis away from an interventricular septum and out of the left ventricular outflow tract (LVOT).
  • LVOT left ventricular outflow tract
  • the dock assembly 2400 is a flexible shaft and may be made of a shape memory material such that the dock assembly 2400 may be straightened for delivery and coil upon deployment. Accordingly, the dock assembly 2400 includes a delivery configuration for delivery to the site of a native valve, and a deployed configuration when deployed at the site of the native valve.
  • the dock assembly 2400 may be formed of materials such as, but not limited to stainless steel, nitinol, polymer or any other suitable biocompatible material or combination of materials.
  • the dock assembly 2400 may be delivered and deployed to a native valve by methods, procedures, and devices known to those familiar in the art.
  • FIG. 26 illustrates an exemplary dock assembly 2400 with the deflecting segment 2430 in the deployed configuration for use at the site of a native mitral valve.
  • the dock assembly 2400 includes a coil 2402 with a plurality of turns along a longitudinal axis LA3 of the dock assembly 2400.
  • the dock assembly 2400 is configured to be disposed at a native mitral valve.
  • the dock assembly 2400 includes a proximal segment 2410, a central segment 2420, and a deflecting segment 2430.
  • the proximal segment 2410 includes a proximal end 2412 and a distal end 2414.
  • the proximal segment 2410 is configured to stabilize the dock assembly 2400 at the desired position and rotational orientation at the native mitral valve prior to deployment of the transcatheter heart valve prosthesis when the dock assembly 2400 is in the deployed configuration.
  • a proximal portion of the proximal segment 2410 may extend proximal or upstream of the annulus of the native mitral valve.
  • the proximal segment 2410 may include a single turn of the coil 2402 or a portion thereof.
  • the central segment 2420 includes a proximal end 2422 coupled to the distal end 2414 of the proximal segment 2410, and a distal end 2424.
  • the central segment 2420 is configured to encircle leaflets of the native mitral valve when the dock assembly 2400 is in the deployed configuration.
  • the central segment 2420 is further configured to provide a stable implant site for the transcatheter heart valve prosthesis.
  • the central segment 2420 may include a plurality of turns of the coil 2402.
  • the deflecting segment 2430 includes a proximal end 2432 coupled to the distal end 2424 of the central segment 2420, a distal end 2434, and a distal tip 2436 disposed at the distal end 2434.
  • the deflecting segment 2430 is an arc segment and includes an apex 2438.
  • the deflecting segment 2430 is configured to be disposed within the left ventricular outflow tract when the dock assembly 2400 is in the deployed configuration.
  • a distal portion of the deflecting segment 2430 is less flexible than a proximal portion of the deflecting segment 2430.
  • the deflecting segment 2430 is configured to deflect, deform, or tilt a distal portion of the transcatheter heart valve prosthesis when the dock assembly 2400 is in the deployed configuration and the transcatheter heart valve prosthesis is in the radially expanded configuration and deployed within the dock assembly 2400.
  • the deflection, deformation, or tilting of the distal portion of the corresponding transcatheter heart valve prosthesis, such as the transcatheter heart valve prosthesis 100 will now be described with reference to FIGS. 27-28.
  • FIG. 27 illustrates the dock assembly 2400 in situ, in the deployed configuration disposed within a native mitral valve MV, and the transcatheter heart valve prosthesis 100 in the radially expanded configuration disposed and anchored therein.
  • the transcatheter heart valve prosthesis 100 is anchored within the central segment 2420 of the dock assembly 2400.
  • the dock assembly 2400 is rotationally oriented such that the apex 2438 of the deflecting segment 2430 engages tissue at the interventricular septum IVS .
  • An angle 65 between a longitudinal axis LA 1 of the deflecting segment transcatheter heart valve prosthesis 100 and a radial plane RP5 of the deflecting segment 2430 may be in the range of 60° to 90° or 70° to 90° or 80° to 90°.
  • the deflecting segment 2430 is disposed at or under an outflow end of the transcatheter heart valve prosthesis 100, under the leaflets LF of the native mitral valve MV, and around or through chordae tendineae CT.
  • the self-expanding force of the deflecting segment 2430 exerts an outward radial force OF against the interventricular septum IVS and exerts an inward radial force on or against a distal portion 188 of the transcatheter heart valve prosthesis 100.
  • the inward radial force of the deflecting segment 2430 on the distal portion 188 of the transcatheter heart valve prosthesis 100 deflects, deforms, or tilts the distal portion 188 of the transcatheter heart valve prosthesis 100 away from the interventricular septum IVS, and out of the left ventricle outflow tract LVOT. Accordingly, left ventricular outflow track obstruction LVOTO is reduced and blood flow through the left ventricular outflow tract LVOT and aortic valve AV is improved.
  • Example 1 A transcatheter heart valve prosthesis having a radially expanded configuration and a radially collapsed configuration, the transcatheter heart valve prosthesis comprising: a frame having an inflow end and an outflow end, the frame having a radially collapsed configuration for delivery and a radially expanded configuration for deployment within a native heart valve; a deflecting segment disposed at the outflow end of the frame; and a prosthetic valve component disposed within and coupled to the frame, wherein the deflecting segment is configured to radially extend from the outflow end of the frame such that with the frame radially expanded within a native mitral valve the deflecting segment engages an interventricular septum to tilt, deform, or deflect a distal portion of the transcatheter heart valve prosthesis in a direction away from the interventricular septum.
  • Example 2 The transcatheter heart valve prosthesis of Example 1, wherein in the radially expanded configuration, a radial plane of the deflecting segment extends at an angle between about 60 degrees and about 90 degrees or about 70 degrees to about 90 degrees or about 80 degrees to about 90 from a central longitudinal axis of the frame.
  • Example 3 The transcatheter heart valve prosthesis of Example 1 or Example 2, wherein the frame includes an inner frame configured to support the prosthetic valve component and a fixation frame coupled to and surrounding the inner frame.
  • Example 4 The transcatheter heart valve prosthesis of any one of Examples 1 to 4.
  • the deflecting segment is a plurality of deflecting segments.
  • Example 5 The transcatheter heart valve prosthesis of any one of Examples 1 to 4.
  • Example 6 The transcatheter heart valve prosthesis of Example 5, wherein the deflecting segment comprises two J-shaped curves, wherein the two J-shaped curves curve in opposite directions.
  • Example 7 The transcatheter heart valve prosthesis of any one of Examples 1 to 4, wherein the deflecting segment the deflecting segment is a loop shape.
  • Example 8 The transcatheter heart valve prosthesis of any one of Examples 1 to 7, wherein the deflecting segment is self-expanding.
  • Example 9 The transcatheter heart valve prosthesis of Example 1, wherein the deflecting segment is balloon expandable.
  • Example 10 The transcatheter heart valve prosthesis of Example 9, wherein the transcatheter heart valve prosthesis is balloon expandable.
  • Example 11 The transcatheter heart valve prosthesis of any one of Examples 1 to 7, wherein the transcatheter heart valve prosthesis is self-expanding.
  • Example 12 A method comprising: delivering a transcatheter heart valve prosthesis to a site of a native mitral valve, the transcatheter heart valve prosthesis including a frame, a prosthetic valve coupled to the frame, and a deflecting segment coupled to an outflow portion of the frame; and radially expanding the transcatheter heart valve prosthesis to a radially expanded configuration such that the frame engages at least one of the native leaflets and native annulus of the native mitral valve, and the deflecting segment engages tissue of an interventricular septum, wherein the deflecting segment tilts, deforms, or deflects a distal portion of the frame in a direction away from the interventricular septum.
  • Example 13 The method of Example 12, wherein in the radially expanded configuration, a radial plane of the deflecting segment extends at an angle between about 60 degrees and about 90 or about 70 degrees to about 90 degrees or about 80 degrees to about 90 degrees from a central longitudinal axis of the frame.
  • Example 14 The method of Examples 12 or Example 13, wherein the deflecting segment is a plurality of deflecting segments.
  • Example 15 The method of any one of Examples 12 to 14, wherein the deflecting segment comprises two J-shaped curves, and wherein radially expanding the heart valve prosthesis comprises radially expanding the two J-shaped curves such that the two J-shaped curves curve in opposite directions.
  • Example 16 The method of any one of Examples 12 to 14, wherein the deflecting segment is a loop shape.
  • Example 17 The method of any one of Examples 12 to 16, wherein radially expanding the heart valve prosthesis comprises releasing the heart valve prosthesis from a restraint to enable the heart valve prosthesis to self-expand.
  • Example 18 The method of Example 12, wherein radially expanding the heart valve prosthesis comprises: balloon expanding the frame of the heart valve prosthesis; and after balloon expanding the frame, balloon expanding the deflecting segment to tilts, deforms, or deflects a distal portion of the frame in a direction away from the interventricular septum.
  • Example 19 The method of Example 18, wherein: balloon expanding the frame comprises using a first balloon catheter to radially expand the frame; and balloon expanding the deflecting segment comprises using a second balloon catheter to radially expand the deflecting segment.
  • Example 20 The method of Example 19, wherein: the first balloon catheter is delivered transseptally to the native mitral valve; and the second balloon catheter is delivered in a retrograde approach through a native aortic valve, into a left ventricular outflow tract, and into the deflecting segment.

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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

L'invention concerne une prothèse de valvule cardiaque transcathéter comprenant un cadre ayant une extrémité d'entrée et une extrémité de sortie, le cadre ayant une configuration repliée radialement pour la pose et une configuration étendue radialement pour le déploiement dans une valvule cardiaque native. Un segment de déviation est disposé à l'extrémité de sortie du cadre, et un composant de valvule prothétique est disposé dans le cadre et couplé à celui-ci. Le segment de déviation est configuré pour s'étendre radialement depuis l'extrémité de sortie du cadre de sorte que, avec le cadre radialement déployé dans une valvule mitrale native, le segment de déviation vient en prise avec un septum interventriculaire pour incliner, déformer ou dévier une partie distale de la prothèse de valvule cardiaque transcathéter dans une direction s'éloignant du septum interventriculaire.
PCT/IB2025/050806 2024-01-26 2025-01-24 Prothèse de valvule cardiaque transcathéter avec segments de déviation pour la prévention de la lvoto Pending WO2025158372A1 (fr)

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US63/625,538 2024-01-26

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