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WO2025171212A1 - Appareil de coupe de feuillet - Google Patents

Appareil de coupe de feuillet

Info

Publication number
WO2025171212A1
WO2025171212A1 PCT/US2025/014939 US2025014939W WO2025171212A1 WO 2025171212 A1 WO2025171212 A1 WO 2025171212A1 US 2025014939 W US2025014939 W US 2025014939W WO 2025171212 A1 WO2025171212 A1 WO 2025171212A1
Authority
WO
WIPO (PCT)
Prior art keywords
flap
wire
optionally
window
examples
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/US2025/014939
Other languages
English (en)
Inventor
Yousef NARANJANI
Nima V. NIA
Cheyenne Victoria Josephine STEWART
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.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
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 Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of WO2025171212A1 publication Critical patent/WO2025171212A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1442—Probes having pivoting end effectors, e.g. forceps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A61B2017/00783—Valvuloplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22097—Valve removal in veins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00369—Heart valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/144—Wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1475—Electrodes retractable in or deployable from a housing

Definitions

  • the present disclosure relates to methods and devices for cutting through a target tissue that can be a leaflet, such as an anterior leaflet of a mitral valve.
  • the heart is a muscular organ which pumps blood through the blood vessels of the circulatory system by contraction and expansion.
  • blood flows in a single direction therethrough due to heart valves, which prevent backflow.
  • the heart valves open and close accordingly, while muscle heart tissues contracts.
  • These muscle heart tissues can include various types of cavities and formations.
  • Ischemic heart disease can lead to valve regurgitation, such as mitral regurgitation.
  • valve regurgitation such as mitral regurgitation. This is caused by the combination of weakened papillary muscles and dilation of the left ventricle, which displaces the papillary muscles and enlarges the annulus of the mitral valve. This prevents the leaflets from sealing properly when the valve is closed, resulting in blood flowing back from the left ventricle into the left atrium - a condition known as mitral regurgitation.
  • mitral regurgitation This increases total stroke volume and decreases cardiac output, leading to the weakening of the left ventricle due to volume and pressure overload of the left atrium.
  • prosthetic heart valves that include leaflets mounted in compressible and expandable frames can be delivered with less trauma to the patient than through open heart surgery.
  • a leaflet cutting apparatus comprises a shaft and a flap pivotably coupled to a head portion of the shaft.
  • This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and/or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.
  • the flap can comprise a flap proximal end, a flap base opposite to the flap proximal end, a first flap sidewall and a second flap sidewall extending between the flap base and the flap proximal end, a flap inner surface, and a flap outer surface opposite to the flap inner surface.
  • the wire is optionally slidably coupled to the flap and the cutting portion is optionally configured to move along the flap.
  • the cutting portion is optionally configured to slide along the flap when the first wire portion and the second wire portion are proximally pulled through the shaft.
  • the wire can comprise an electrically conductive core configured to conduct electricity towards the cutting portion.
  • the first window sidewall is optionally aligned with the first flap sidewall
  • the second window sidewall is optionally aligned with the second flap sidewall
  • the window ceiling is optionally aligned with the flap proximal end.
  • the wire is optionally movably coupled to at least one guide recess of the apparatus.
  • the at least one guide recess can comprise a first guide recess formed on the flap.
  • the first guide recess can optionally continuously extend along the first flap sidewall, the flap proximal end, and the second flap sidewall.
  • the first wire portion can optionally continuously extend from the cutting portion along the first guide recess.
  • the at least one guide recess can comprise a second guide recess formed on the head portion and extending along edges of the window.
  • the second guide recess can optionally continuously extend along the first window sidewall, the window ceiling, and the second window sidewall.
  • the cutting portion when the wire is pulled, is optionally configured to slide along a path extending proximally from a position proximate the flap base towards the proximal end of the flap, slide laterally at or parallel to the flap proximal end towards the second flap sidewall, and slide distally from a position at or proximate to the flap proximal end towards the flap base.
  • the apparatus can comprise two tubular arms extending through the shaft, wherein the head portion can comprise two head openings through which the corresponding tubular arms are configured to extend away from or closer to the head portion.
  • the head openings are optionally positioned on opposite sides of the window.
  • the head openings are optionally closer to the flap base than the flap proximal end.
  • the head openings are optionally distal to the flap base.
  • the tubular arms are optionally axially movable relative to the shaft. [0031] In some examples, when portions of the tubular arms residing in the shaft are distally pushed, distal ends of the tubular arms are optionally configured to move away from the head portion. [0032] In some examples, the tubular arms can comprise a first tubular arm and a second tubular arm, wherein the wire can optionally extend through the second tubular arm and is optionally axially movable relative to the second arm.
  • first wire portion and the second wire portion can optionally extend through the second tubular arm and past a tube opening of the first tubular arm towards the distal end of the second tubular arm.
  • the distal ends of the tubular arms are optionally configured to be closer to the flap base than the flap proximal end when the tubular arms are extended away from the head portion.
  • the first tubular arm is optionally fluidly coupled to an insulator fluid injection port, and is optionally configured to eject insulator fluid from the distal end of the first tubular arm.
  • the first guide recess can optionally continuously extend along the flap inner surface, the flap proximal end, and the flap outer surface.
  • first wire portion can optionally continuously extend from the cutting portion along the first guide recess.
  • the apparatus comprises at least one insulator fluid injection tube disposed around a portion of the wire and having an opening at a distal end thereof, directed towards the cutting portion, wherein the at least one insulator fluid injection tube is optionally configured to eject insulator fluid through its opening.
  • a method comprises positioning a head portion of a leaflet cutting apparatus distal to a leaflet of a valve.
  • This basic method can preferably be provided with any one or more of the steps described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic method can preferably also be provided with any one or more of the steps shown in the figures and/or described in conjunction with the figures, either in addition to or alternatively to the steps of the examples described hereafter.
  • the method comprises moving a flap pivotably coupled to the head portion, to an open state of the flap.
  • the method comprises retracting the head portion so as to position a portion of the leaflet between the flap and the head portion, such that a cutting portion of a wire slidably coupled to the flap is distal to a free edge of the leaflet.
  • the method comprises cutting through the leaflet via the cutting portion.
  • the cutting through the leaflet optionally comprises positioning the cutting portion such that an electrically conductive surface thereof is oriented towards a free edge of the leaflet when the leaflet is positioned between the flap and the head portion, prior to the cutting.
  • the cutting through the leaflet optionally comprises providing an electric current to the cutting portion such that the electric current creates a cut through the leaflet when the cutting portion is contacting the leaflet.
  • the method optionally comprises, after the positioning the leaflet between the flap and the head portion and before the cutting the leaflet, moving the flap towards a closed state, thereby tightly grasping the leaflet between the flap and the head portion.
  • the moving the cutting portion along the flap optionally comprises moving the cutting portion along edges of the flap.
  • the moving the cutting portion along edges of the flap optionally comprises proximally moving the cutting portion along a first sidewall of the flap towards a proximal end of the flap, laterally moving the cutting portion along the proximal end of the flap from the first sidewall to a second sidewall of the flap, and distally moving the cutting portion along the second sidewall from the proximal end of the flap towards a base of the flap.
  • the method optionally comprises pushing two tubular arms of the apparatus, thereby extending distal portions thereof, through head opening of the head portions, away from the head portions.
  • the extending the distal portion of the tubular arms optionally comprises distancing distal ends of the tubular arms away from opposite sides of the flap.
  • the moving the cutting portion along the flap optionally comprises proximally moving the cutting portion along an inner surface of the flap, toward a proximal end of the flap.
  • the cutting through the leaflet optionally comprises forming a slit splitting the leaflet.
  • Fig. 1 A is a cross-sectional view the right-side of a human heart.
  • Fig. IB shows an exemplary prosthetic valve implanted in the native mitral valve.
  • FIG. 2 shows an exemplary leaflet cutting apparatus.
  • FIGs. 3A and 3B are perspectives view of a distal portion of the apparatus, showing a flap of the apparatus in a closed state and an open state, respectively.
  • Fig. 4 shows a distal portion of an exemplary apparatus including a pull-member configured to move the flap to the open state.
  • Figs. 5A and 5B show an exemplary apparatus including a rod configured to move the flap between the closed state illustrated in Fig. 5A, and the open state illustrated in Fig. 5B.
  • Fig. 6 is a perspective view of a distal portion of an exemplary apparatus, equipped with a cutting portion configured to move along edges of the flap.
  • Fig. 7A is an enlarged view of region 7A of Fig. 6.
  • Fig. 7B is a view of the region of Fig. 7A, showing the cutting portion proximally moved relative to its position in Fig. 7A.
  • Fig. 8 shows an exemplary cutting portion having part thereof covered by insulating layers.
  • Fig. 9 shows an exemplary cutting portion entirely covered by an insulating layer except for an exposed electrically conductive surface.
  • Figs. 10A-10E illustrate steps in an exemplary method for utilizing the leaflet cutting apparatus, up to the point of grasping a leaflet between the flap and the head portion.
  • Figs. 11A-11E illustrate movement of the cutting portion of an exemplary apparatus to cut a section of the leaflet.
  • Figs. 12A-12B illustrate steps of the method that can be performed after cutting the leaflet.
  • Fig. 13 shows an exemplary leaflet cutting apparatus including a contrast injection member.
  • Fig. 14A is a perspective view of a distal portion of an exemplary apparatus, having guide recesses through which portions of the wire can extend without the aid of sutures.
  • Fig. 14B is an enlarged perspective view of the flap of the apparatus of Fig. 14A.
  • Fig. 14C is a cross-sectional view along line 14C- 14C of Fig. 14B.
  • FIG. 15 is a perspective view of a distal portion of an exemplary apparatus equipped with two tubular arms.
  • Figs. 16A-16B illustrate some steps in an exemplary method for utilizing the leaflet cutting apparatus of Fig. 15.
  • FIG. 17 is a perspective view of a distal portion of an exemplary apparatus in which one of the tubular arms is further utilized to eject insulator fluid from a distal opening thereof.
  • Fig. 18 is a perspective view of a distal portion of an exemplary apparatus comprising insulator fluid injection tubes disposed around the wire.
  • FIG. 19 is a perspective view of a distal portion of an exemplary apparatus, equipped with a cutting portion configured to move along an inner surface of the flap.
  • Figs. 20A-20C illustrate some steps in an exemplary method for utilizing the leaflet cutting apparatus of Fig. 19.
  • proximal and distal are defined relative to the use position of a delivery apparatus. In general, the end of the delivery apparatus closest to the user of the apparatus is the proximal end, and the end of the delivery apparatus farthest from the user (for example, the end that is inserted into a patient’s body) is the distal end.
  • axial direction has been used herein to describe the arrangement and assembly of components relative to the geometry of the frame of the prosthetic valve, or the geometry of an inflatable balloon that can be used to expand a prosthetic valve.
  • Such terms have been used for convenient description, but the disclosed examples are not strictly limited to the description.
  • directions parallel to the specified direction as well as minor deviations therefrom are included.
  • a description of a component extending along an axial direction of the frame does not require the component to be aligned with a center of the frame; rather, the component can extend substantially along a direction parallel to a central axis of the frame.
  • integrally formed and unitary refer to a construction that does not include any welds, fasteners, or other means for securing separately formed pieces of material to each other.
  • a step of performing a second action and/or of forming a second component may be performed prior to a step of performing a first action and/or of forming a first component.
  • the term “substantially” means the listed value and/or property and any value and/or property that is at least 75% of the listed value and/or property. Equivalently, the term “substantially” means the listed value and/or property and any value and/or property that differs from the listed value and/or property by at most 030%.
  • “at least substantially parallel” refers to directions that are fully parallel, and to directions that diverge by up to 27.5 degrees.
  • a reference numeral that includes an alphabetic label is to be understood as labeling a particular example of the structure or component corresponding to the reference numeral. Accordingly, it is to be understood that components sharing like names and/or like reference numerals (for example, with different alphabetic labels or without alphabetic labels) may share any properties and/or characteristics as disclosed herein even when certain such components are not specifically described and/or addressed herein.
  • each device such as a delivery apparatus that can optionally carry a prosthetic valve of a separate cutting apparatus, can optionally be provided in the left atrium of a patient and can be used to pierce, lacerate, slice, tear, cut or otherwise modify a leaflet or commissure of the existing valvular structure.
  • the existing valvular structure can be a native mitral valve.
  • the modification can avoid, or at least reduce the likelihood of, issues that leaflets of the existing valvular structure might otherwise cause once the prosthetic heart valve has been fully installed, for example, interference of flow from the left ventricle towards the aortic leaflet.
  • a mitral valve it should be understood that the disclosed examples can be adapted to deliver devices that can modify existing valvular structure, and in some implementations, implant prosthetic devices, to and/or in any of the native annuluses of the heart (for example, the aortic, pulmonary, mitral, and tricuspid annuluses), and can be used with any of various delivery approaches (for example, retrograde, antegrade, transseptal, transventricular, transatrial, etc.).
  • FIG. 1A illustrates an anatomy of the right-side of a human heart 10.
  • a cross-sectional view showing both the right-side and the left-side of the heart 10 is further illustrated in Fig. 10A, for example.
  • the anatomical structure of the heart 10 and blood vessels extending therefrom will be described herein with reference to Figs. 1A and 10A collectively.
  • the heart has a four-chambered conical structure that includes the right atrium 18, the right ventricle 20, the left atrium 26 and the left ventricle 28.
  • the wall separating between the left and right sides of the heart is referred to as the septum 24.
  • the native mitral valve 30 is positioned between the left atrium 26 and the left ventricle 28.
  • the native tricuspid valve 22 is positioned between the right atrium 18 and the right ventricle 20.
  • the native aortic valve 14 separates the left ventricle 28 from the aorta 12.
  • the native mitral valve 30 comprises a mitral annulus 32 and a pair of mitral leaflets 39 extending downward from the annulus 32.
  • the leaflets 34 of the mitral valve 30 include an anterior leaflet 38 and a posterior leaflet 36.
  • the anterior leaflet 38 and the posterior leaflet 36 function together as a one-way valve to allow blood flow from the left atrium 26 to the left ventricle 28.
  • oxygenated blood flows from the left atrium 26, through the mitral valve 30, into the left ventricle 28.
  • the blood pressure within the left ventricle 28 increases so as to urge to two mitral leaflets 34 to coapt, thereby preventing blood flow from the left ventricle 28 back to the left atrium 26.
  • contraction of the left ventricle 28 forces the oxygen rich blood through the aortic valve 14 and aorta 12 into the body through the circulatory system.
  • Valvular heart disease can affect functioning of native heart valves, including the mitral valve 30.
  • Mitral regurgitation occurs when the native mitral valve 30 fails to close properly and blood flows back into the left atrium 26 from the left ventricle 28 during systole. Possible causes of this include leaflet prolapse, dysfunctional papillary muscles, issues with chordae tendineae, and/or stretching of the mitral valve annulus due to left ventricle dilation.
  • a prosthetic valve can be implanted in a malfunctioning native heart valve to prevent or inhibit blood backflow.
  • Fig. IB shows an exemplary prosthetic valve 55 that can be implanted in a native heart valve, such as the mitral valve 30.
  • prosthetic valve refers to any type of a prosthetic valve deliverable to a patient's target site over a catheter, which is radially expandable and compressible between a radially compressed, or crimped, state, and a radially expanded state.
  • the prosthetic valve can be crimped on or retained by an implant delivery apparatus (not shown) in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site.
  • the expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state.
  • a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state.
  • a prosthetic valve of the current disclosure may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve.
  • Balloon expandable valves generally involve a procedure of inflating a balloon within a prosthetic valve, thereby expanding the prosthetic valve within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with a delivery apparatus (not shown).
  • Self-expandable valves include a frame that is shape-set to automatically expand as soon an outer retaining shaft or capsule (not shown) is withdrawn proximally relative to the prosthetic valve.
  • Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion.
  • the mechanical actuation mechanism usually includes a plurality of expansion and locking assemblies (such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT/US 2021/052745 and U.S. Provisional Application Nos. 63/85,947 and 63/209904, each of which is incorporated herein by reference in its entirety), releasably coupled to respective actuation assemblies of a delivery apparatus, controlled via a handle (not shown) for actuating the expansion and locking assemblies to expand the prosthetic valve to a desired diameter.
  • expansion and locking assemblies such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT/US 2021/052745 and U.S. Provisional Application Nos. 63/85,947 and 63/209904, each of which is incorporated herein by reference in its entirety
  • outflow refers to a region of the prosthetic valve through which the blood flows through and out of the prosthetic valve 50.
  • inflow refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 50.
  • the struts 58 can optionally include a plurality of angled struts and vertical or axial struts. At least some of the struts 58 can optionally be pivotable or bendable relative to each other, so as to permit frame expansion or compression.
  • the frame 52 can optionally be formed from a single piece of material, such as a metal tube, via various processes such as, but not limited to, laser cutting, electroforming, and/or physical vapor deposition, while retaining the ability to collapse/expand radially in the absence of hinges and like.
  • a valvular structure 62 of the prosthetic valve 50 can optionally include a plurality of prosthetic valve leaflets 64 (for example, three leaflets), positioned at least partially within the frame 52, and configured to regulate flow of blood through the prosthetic valve 50 from the inflow end 54 to the outflow end 56. While three leaflets 64 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Fig. 1A, it will be clear that a prosthetic valve 50 can optionally include any other number of leaflets 64. Adjacent leaflets 64 can optionally be arranged together to form commissures 66 that are coupled (directly or indirectly) to respective portions of the frame 52, thereby securing at least a portion of the valvular structure 62 to the frame 52.
  • the prosthetic valve leaflets 64 can optionally be made from, in whole or part, biological material (for example, pericardium), bio-compatible synthetic materials, or other such materials. Further details regarding transcatheter prosthetic valves, including the manner in which leaflets 64 can optionally be coupled to the frame 52 of the prosthetic valve 50, can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202, and 11,135,56, all of which are incorporated herein by reference in their entireties. [0110] In some examples, the prosthetic valve 50 can optionally comprise at least one skirt or sealing member.
  • the prosthetic valve 50 can optionally include an inner skirt 70, which can optionally be secured to the inner surface of the frame 52.
  • Such an inner skirt 70 can optionally be configured to function, for example, as a sealing member to prevent or decrease perivalvular leakage.
  • An inner skirt 70 can optionally further function as an anchoring region for leaflets 64 to the frame 52, and/or function to protect the leaflets 64 against damage which may be caused by contact with the frame 52, for example during valve crimping or during working cycles of the prosthetic valve 50.
  • An inner skirt 70 can optionally he disposed around and attached to the inner surface of frame 52, while the leaflets can optionally be sutured to the inner skirt along a scalloped line (not shown).
  • An inner skirt 70 can optionally be coupled to the frame 52 via sutures or another form of coupler.
  • the prosthetic valve 50 can optionally comprise, in some examples, an outer skirt 68 mounted on the outer surface of frame 52, configured to function, for example, as a sealing member retained between the frame 52 and the surrounding tissue of the native annulus against which the prosthetic valve is mounted, thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 50.
  • the outer skirt 68 can optionally be coupled to the frame 52 via sutures or another form of coupler.
  • any of the inner skirt and/or outer skirt can optionally be made of various suitable biocompatible materials, such as, but not limited to, various synthetic materials (for example, PET) or natural tissue (for example pericardial tissue).
  • the inner skirt 70 can optionally be formed of a single sheet of material that extends continuously around the inner surface of frame 52.
  • the outer skirt 68 can optionally be formed of a single sheet of material that extends continuously around the outer surface of frame 52.
  • the cells 60 defined by interconnected struts 58, define openings having any of a variety of shapes, such as diamond-shaped openings, hexagonal openings, and the like. While some of the cells 60 can optionally be covered by the inner skirt and/or the outer skirt, at least a portion of the cells 60 can optionally remain uncovered, such as cells 60 which are closer to the outflow end 56 of the prosthetic valve.
  • a prosthetic valve 50 implanted in the native mitral valve 30 may displace the anterior leaflet 38 towards and into the left ventricle outflow tract (LVOT) 45, which may at least partly obstruct the LVOT 40, thereby reducing blood flow leaving the heart towards the aorta 12.
  • LVOT left ventricle outflow tract
  • the anterior leaflet 38 can optionally be modified by components of a leaflet cutting apparatus 100 prior to implantation of a prosthetic valve 50 within the native mitral valve 30.
  • the anterior leaflet 38 can optionally be modified by cutting or splitting at least a portion thereof using the cutting apparatus 100. The modification thus disrupts the impermeable obstruction that would otherwise be formed by the anterior leaflet 38, thereby allowing blood to cross uncovered open cells 60 of the prosthetic valve, towards the LVOT 40 and aorta 12.
  • FIG. 2 illustrates an exemplary leaflet cutting apparatus 100, which can optionally include a head portion 114 at a distal end portion of a shaft 112, a flap 130 that can optionally transition between a closed state and an open state, such as by moving towards and away from a corresponding window 120 of the head portion 114, and a wire 150 (examples of which are shown in Figs. 6-9 and 15-24) having a cutting portion 156 configured to cut through a leaflet retained between the flap 130 an a window 120.
  • a wire 150 examples of which are shown in Figs. 6-9 and 15-24
  • a leaflet cutting apparatus 100 can optionally include a handle 102 and an outer catheter 110.
  • the shaft 112 can optionally extend through the outer catheter 110.
  • the outer catheter 110 and the shaft 112 can optionally be configured to be axially movable relative to each other. For example, a distally oriented movement of the shaft 112 relative to the outer catheter 110, can optionally expose the head portion 114 from a lumen of the outer catheter 110.
  • the apparatus 100 can optionally further include a nosecone 116 that can optionally be conical or frustoconical in shape, configured to facilitate advancement of the apparatus 100 through the patient's vasculature.
  • a nosecone shaft (concealed from view in Fig. 2) can optionally extend proximally from the nosecone 116, such as through the shaft 112, towards and into the handle 102.
  • the nosecone 116 and nosecone shaft can collectively define a guidewire lumen (concealed from view in Fig. 2), terminating with a guidewire opening 119 (indicated, for example, in Figs. 15 and 17-18)) at a distal end 118 of the nosecone 116, through which a guidewire 80 (indicated, for example, in Figs. 10A- 10B) can pass.
  • the nosecone 116 can optionally be integrally formed with the head portion 114. In some examples, the nosecone 116 can optionally be provided as a separate component that can optionally be either affixed to the head portion 114, or can optionally be configured to axially move closer or farther from the distal end of the head portion 114.
  • the proximal ends of various components of apparatus 100 can optionally be coupled to the handle 102.
  • the handle 102 can optionally be maneuvered by an operator (for example, a clinician or a surgeon) to axially advance or retract components of the leaflet cutting apparatus 100, such as the shaft 112, as well as to move the flap 130 between the closed and open state, to provide electric current to the cutting portion 156 of the wire 150, and/or to facilitate movement of the wire 150.
  • Figs. 3A and 3B show perspective view of a distal portion of the apparatus 100, including a head portion 114 thereof, in a closed state and an open state, respectively, of the flap 130.
  • the head portion 114 can optionally include a window 120 cut through a thickness of a wall of the head portion 114, the window 120 defining a window ceiling 124 at a proximal end of the window 120, and window sidewalls 122 extending distally from the window ceiling 124.
  • the flap 130 defines a flap proximal end 142, flap sidewalls 140 extending distally from the flap proximal end 142, and a flap base 136 opposite to the flap proximal end 142, optionally aligned with a distal end of the window 120, opposite to the window ceiling 124.
  • the flap further comprises an outer surface 134, facing away from the head portion 114, and an opposite inner surface 132 (indicated, for example, in Fig. 4).
  • the flap inner surface 132 can optionally be textured, as illustrated for example in Figs. 14B-14C, to ensure proper engagement with a leaflet and prevent slippage of the leaflet grasped between the flap 130 and the head portion 114. This can be achieved by various manners, such as forming the inner surface 132 itself as a rough surface, or by covering the surface of the flap 130 with a textured layer.
  • the flap 130 can optionally be pivotably connected to the head portion 114. As mentioned above, the flap 130 is movable between a closed position, shown in Fig. 3 A, and an open position, shown in Fig. 3B, wherein the inner surface 132 and the flap proximal end 142 are closer to the window 120 than in the open state.
  • the outer surface 134 of the flap 1 0 can optionally be substantially flush with the outer surface of the head portion 114 in the closed state, as illustrated in Fig. 3 A.
  • the flap proximal end 142 can optionally be aligned with the window ceiling 124, and the flap sidewalls 140 can optionally be aligned with the window sidewalls 122, in the closed state of the flap.
  • Apparatus 100 a further comprises a link 174 pivotably connected on one end thereof (such as a proximal end of the link 174) to the flap proximal end 142 (such as to an end of the flap proximal end 142), while the opposite end of the link 174 (such as its distal end) is connected, at a joint 172, to a pull-member 170 of the apparatus 100 a .
  • the pull-member 170 can optionally be any of a wire, string, cable and the like.
  • the pull-member 170 extends proximally from the joint 172, such as through the shaft 112, towards and into the handle 102, wherein the handle 102 is configured to selectively pull the pull-member 170 or release tension from the pull-member 170.
  • FIGs. 5A and 5B show a distal portion of an exemplary apparatus 100 b in a closed state and an open state, respectively, of the flap 130 b .
  • Apparatus 100 b is an exemplary implementation of apparatus 100, and thus can optionally include any of the features described for apparatus 100, except that apparatus 100 b includes a mechanism configured to move a flap 130 b that is not necessarily biased to a specific position, between the closed and open states.
  • the rod 178 extends proximally from the joint 172, such as through the shaft 112, towards and into the handle 102, wherein the handle 102 can optionally be configured to selectively pull or push the rod 178.
  • the rod 178 can optionally be in the form of a wire, a cable, a shaft, and the like, which is flexible enough to bend along curved regions of the shaft 112 when passed through curved regions of the patient's vasculature, and can optionally have sufficient columnar strength to axially push the joint 172 of flap internal extension 138 without buckling or collapsing.
  • the pin 180 can optionally be in an upper or proximal end of the slot 182, as illustrated in Fig. 5 A.
  • the rod 178 When the rod 178 is pulled in the proximal direction 82, it moves the joint 172 therewith, thereby causing the flap 130 b to move to the open state, farther from the window 120, while the slot 182 of the flap 130 b is slid over the pin 180, positioning the pin at the opposite lower, or distal, end of the slot 182, as illustrated in Fig. 4.
  • An opposite distally-oriented movement of the rod 178 will push the joint 172 in a distal direction therewith, moving the flap 130 b back towards the window 120, as shown for the closed position in Fig. 5A.
  • the flap 130 b does not need to be biased to a specific state, such as the closed state, but is rather actively moved by the rod 178 between the two states.
  • a biasing member such as a spring, can optionally be added to bias the flap 130 to the closed state, which can optionally be used in combination with the rod 178 described above, configured to assist in closing of the flap 130, thereby reducing the push force required by the rod 178.
  • FIG. 6 is a perspective view of a distal portion of an exemplary apparatus 100 c shown in an open state of the flap 130 c .
  • Fig. 7A is an enlarged view of region 7 A of Fig. 6, in aposition of the cutting portion 156 along the cutting path, prior to applying a pull force on wire 150.
  • Fig. 7B is a view of the region of Fig. 7A, showing the cutting portion 156 moved, relative to its position in Fig. 7A, upon initial pulling of the pull wire 150.
  • Apparatus 100 c is an exemplary implementation of apparatus 100, and thus can optionally include any of the features described for apparatus 100, except that wire 150 of apparatus 100 c extends along edges of both the flap 130 and the window 120 in a manner that defines an advancement path of the cutting portion 156, upon pulling of the wire 150, along at least part of a circumference of the flap 130 and window 120.
  • the two wire portions 150a and 150b can optionally be connected to each other at a portion of the wire 150 passing through the shaft 112 towards the handle 102, such that proximally pulling a single wire portion may simultaneously move both wire portions 150a and 150b and the cutting portion 156 along the path defined by the flap 130 and/or window 120.
  • the cutting portion 156 can optionally be initially positioned at or proximate to the flap base 136, meaning that the cutting portion 156 is closer to the flap base 136 and farther from the flap proximal end 142 in an initial position, which can optionally be the position of the cutting portion 156 during advancement of apparatus 100 through the patient's vasculature, towards the site of treatment.
  • the window 120 can optionally include a first window sidewall 122a and a second window sidewall 122b at opposite sides of the window 120
  • the flap 130 can optionally include a first flap side wall 140a and a second flap sidewall 140b at opposite sides of the flap 130.
  • the width of the flap, defined between the flap sidewalls 140a and 140b is substantially equal to, or slightly less than, the width of the window 120 defined between window sidewalls 122a and 122b, allowing the window 120 to accommodate the flap 130 therein in the closed state.
  • a first guide recess 160a extends along edges of the flap 130 c
  • a second guide recess 160b extends along edges of the window 120.
  • the first guide recess 160a can optionally continuously extend along the first flap sidewall 140a, the flap proximal end 142, and the second flap sidewall 140b.
  • the second guide recess 160b can optionally continuously extend along the first window sidewall 122a, the window ceiling 124, and the second window sidewall 122b.
  • the first wire portion 150a can optionally extend from the cutting portion 156 into and along the first guide recess 160a
  • the second wire portion 150b can optionally extend from the cutting portion 156 into and along the second guide recess 160b.
  • the first wire portion 150a can optionally enter into the first guide recess 160a at an entry point which is closer to distal end of the first flap sidewall 140a (e.g., closer to the flap base 136), and exit the first guide recess 160a at an exit point which is closer to distal end of the second flap sidewall 140b (e.g., closer to the flap base 136), extending therefrom into the head portion 114 and proximally through the shaft 112, towards the handle 102.
  • the second wire portion 150b can optionally enter into the second guide recess 160b at an entry point which is closer to distal end of the first window sidewall 122a, and exit the second guide recess 160b at an exit point which is closer to distal end of the second window sidewall 122b, extending therefrom into the head portion 114 and proximally through the shaft 112, towards the handle 102.
  • the guide recess 160 comprises a groove 162 formed at the corresponding edge of the flap 130 or the window 120. A portion of the wire 150 extending through such a guide recess 160 will have part of the wire situated inside the groove 162, and part of it protruding outwards from the corresponding edge or groove 162 thereof.
  • a series of sutures 196 can optionally be used to attach the wire 150 to the corresponding edge of the flap 130 and/or window 120 along the grooves 162.
  • the handle 102 can optionally include an adjustment member, such as the rotatable knob 106c illustrated in Fig. 2, configured to control retraction of the wire 150.
  • the knob 106c can optionally be operatively coupled to a proximal end of the wire 150, such as to the proximal end of both wire portion 150a, 150b, such that rotating the knob 106c can optionally facilitate retraction of the wire portions 150a, 150b, thereby pulling the cutting portion 156 along a path defined by the flap 130 and/or window 120, which can be optionally a path of the corresponding guide recess(es) 160.
  • the wire 150 is electrically conductive, configured to deliver electric current therealong, including to the cutting portion.
  • at least part of the cutting portion 156 has an exposed electrically conductive surface 158.
  • the electric current source 108 generates an electric current, and outputs the generated electric current to the wire 150.
  • the generated electric current is an alternating current.
  • the frequency of the alternating current is a radio-frequency (RF), i.e. from about 20 kHz to 300 GHz.
  • RF radio-frequency
  • the wire 150 conducts electricity from the proximal portion to the cutting portion 156, such as via wire portion 150a, 150b.
  • an exposed electrically conductive surface of the cutting portion 156 is configured to output RF energy.
  • This example of a cutting portion 156 e takes advantage of the fact that in some examples, the electrically conductive surface 158 may be sufficient to cut either a leaflet tissue and/or sutures, such as sutures 196, while all other regions of the wire 150 e and its cutting portion 156 e can optionally be electrically insulated, to reduce risk of damaging anatomical structures and/or other components of the apparatus 100 when electric current is supplied to the cutting portion 156 c .
  • delivery of an apparatus 100 begins by advancing a semi-rigid guidewire 80 into a right atrium 18 of a heart 10 of the patient.
  • the procedure is typically performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and/or echocardiography.
  • the guidewire 80 provides a guide for the subsequent advancement of the outer catheter 110 therealong and into the right atrium 18. Once distal end portion of the outer catheter 110 has entered the right atrium 18, the guidewire 80 is retracted from the subject's body.
  • the outer catheter 110 is typically configured for initial advancement through the patient's vasculature into the right atrium 18 and through the septum 24, until the distal end portion of the outer catheter 110 is positioned in the left atrium 26.
  • the distal end portion of the outer catheter 110 can be then optionally steered such that it is positioned in a desired spatial orientation within the left atrium 26.
  • Such an optional steering procedure can be performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and/or echocardiography.
  • the apparatus 100 is advanced through the vasculature into the right atrium 18 using a suitable point of origin typically determined for a given patient.
  • the apparatus 100 is introduced into the femoral vein of the patient, through the inferior vena cava 16, into the right atrium 18, and into the left atrium 26 transseptally, typically through the fossa ovalis (hidden from view in Fig. 10A).
  • the apparatus 100 is introduced into the basilic vein, through the subclavian vein to the superior vena cava, into the right atrium 18, and into the left atrium 26 transseptally, typically through the fossa ovalis (not shown).
  • the apparatus 100 is introduced into the external jugular vein, through the subclavian vein to the superior vena cava, into the right atrium 18, and into the left atrium 26 transseptally, typically through the fossa ovalis (not shown).
  • a resilient needle and a dilator are advanced through the outer catheter 110 and/or through the shaft 112 and into the heart 10.
  • the dilator is advanced to the septum 24, and the needle is pushed from within the dilator and is allowed to puncture the septum to create an opening that facilitates passage of the dilator and subsequently the outer catheter 110 and/or shaft 112 therethrough and into the left atrium 26.
  • the head portion 114 can optionally be fully or partially retained inside the outer catheter 110.
  • the head portion 114 can be at least partially retained inside the outer catheter 110, while the nosecone 116 can be exposed, extending past the distal end of the outer catheter 1 10, to facilitate smooth passage of the apparatus 100 through the vasculature and anatomic structures.
  • the shaft 112 can optionally be axially advanced relative to the outer catheter 110, so as to expose the head portion 114, as illustrated in Fig. 10B.
  • the flap 130 is in a closed state as the head portion 114 is exposed, and the head portion can optionally be further advanced in the distal direction, through the mitral valve 30 and into the left ventricle 28, as shown in Fig. 10C.
  • the handle 102 can optionally include an adjustment member, such as the rotatable knob 106d illustrated in Fig. 2, configured to control axial movement of the shaft 112.
  • the knob 106d can optionally be operatively coupled to a proximal end of the shaft 112, such that rotating the knob 106d in one direction can facilitate advancement of the shaft 112, thereby exposing the head portion 114 out of the outer catheter 110, and rotating the knob 106d in the opposite direction can optionally facilitate retraction of the shaft 112, thereby reconcealing it inside the outer catheter 110.
  • Advancement of the head portion 114 into the left ventricle 28, with the flap 130 retained in the closed state, can optionally be performed until the flap 130 is positioned below the mitral leaflets 34, for example such that the flap proximal end 142 is distal to the free edge of the anterior leaflet 38, at which point the flap 130 can be moved to the open state, as shown in Fig. 10D.
  • the flap 130 can optionally be moved to an open state, when positioned distal to the anterior leaflet 38 as shown in Fig. 10D, distancing the flap proximal end 142 away from the window ceiling 124 at a distance sufficient to conveniently position the distal end of the leaflet 38 therein, when the head portion 114 is proximally pulled to the position shown in Fig. 10E.
  • the opening and closing of the flap 130 can optionally be controllably adjusted by the user (e.g., clinician), to adjust the distance according to patient-specific anatomy.
  • Figs. 11A-11E illustrate some steps in an exemplary method for utilizing a leaflet cutting apparatus 100, such as apparatus 100 c , for cutting a target leaflet.
  • the steps illustrated in Figs. 11 A- HE can optionally be performed subsequent to the steps described above with respect to Figs. 10A-10E, to cut a section of the anterior leaflet 38, which can optionally be a U-shaped cut-out, or have any other shape, dictated by the path of advancement of the cutting portion 156.
  • the cutting portion 156 of the wire 150 which is in close proximity to the flap base 136, is positioned distally to a free edge of the leaflet 38, with the electrically conductive surface 158 facing the free edge of the leaflet 38. Retraction of the wire 150 while electric current is provided to its cutting portion 156, causes the cutting portion 156 to cut through the leaflet as it travels along the path defined by the guide recess(es) 160.
  • proximal pulling of the proximal ends of the wire portion 150a, 150b further moves the cutting portion 156 to cut through the leaflet 38 along the flap proximal end 142, traveling in a lateral direction 84 between the first flap sidewall 140a and the second flap sidewall 140b, as shown in Fig. 11C.
  • proximal pulling of the proximal ends of the wire portion 150a, 150b further moves the cutting portion 156 to cut through the leaflet 38 along the second flap sidewall 140b, traveling in the distal direction 86 as shown in Fig. HD, until the cutting portion passes the free edge of the leaflet 38, as shown in Fig. 1 IE, at which point the wire 150 can optionally be further pulled, or pulling of the wire 150 can optionally terminate, and at which point electric current no longer needs to be supplied to wire 150.
  • a fully U-shaped segment of tissue is cut and completely separated from the rest of the leaflet 38.
  • the flap 130 and/or window can optionally be formed to have any desired shape, such as V-shape, semi-circular or otherwise curved shapes, and the like.
  • the path along which the cutting portion 156 is configured to travel can optionally be different from the shape of flap 130 and/or window 120.
  • At least some portions of one or more guide recesses 160 can optionally extend through portions of the flap 130 and/or head portion 1 14 that are not necessarily parallel to the edges of the flap 130 and/or window 120.
  • the apparatus 100 can be retrieved from the patient's body, as shown in Fig. 12B, with the cut-out tissue segment safely secured to the head portion 114 and removed therewith.
  • This procedure of cutting the anterior leaflet 38 helps prevent the anterior leaflet 38 from obstructing or otherwise interfering with the LVOT 40.
  • the shaft 112 can be proximally pulled to as to reconceal the head portion 114 and the cut-out tissue segment secured thereto, inside the outer catheter 110, subsequent to completion of the cutting procedure.
  • a new prosthetic valve 50 can be implanted in the native mitral valve 30, as illustrated in Fig.
  • the apparatus 100 can be retrieved while the guidewire 80 remains in position, and the new prosthetic valve 50 can be delivered over the guidewire 80.
  • the shaft 112 can be retrieved while the outer catheter 110 remains in position, and the new prosthetic valve 50 can be delivered through the outer catheter 110.
  • a guide recess 160 includes a slot 164 leading to an inner semi-circular channel 166.
  • the slot 164 is open ended at the surface along which the guide recess 160 is defined, and is continuous with the inner semi-circular channel 166, positioned inside the wall material of the corresponding flap 130 or head portion 114 surrounding the window 120, below the corresponding surface at the opposite end of the slot 164.
  • the guide recesses 160 illustrated in Figs. 14B-14C is shown to include a slot 164 extending from the flap inner surface 132 to an inner semi-circular channel 166 residing inside the flap 130 f .
  • Fig. 15 is a perspective view of a distal portion of an exemplary apparatus 100 8 shown in an open state of the flap 130 s .
  • Apparatus 100 s is an exemplary implementation of apparatus 100, and thus can optionally include any of the features described for apparatus 100, except that apparatus 100 g does not include guide recesses 160 the follow the contour of the flap 130 and/or window 120.
  • the leaflet cutting apparatus 100 g includes two tubular arms 144 extending through the shaft 112 8 , wherein the tubular arms 144 can optionally extend radially away from the head portion 114 s , with the portions of the arms 144 extending away from the head portion 114 g positioned on opposite sides of the flap 130 g .
  • the head portion 114 g further comprises a retaining channel 125 extending along at least part of the window ceiling 124, as illustrated in Fig. 15.
  • the retaining channel 125 can optionally be a channel formed through the material of head portion 114 g with an entry opening and an exit opening at two sides of the window ceiling 124.
  • the retaining channel 125 is configured to support the second wire portion 150b, such that the second wire portion 150b can optionally extend from the distal end 146b of the second arm 144b, towards and along the window ceiling 124, optionally passing through a retaining channel 125, and towards the loop 169, in close proximity to the distal end 146a of the first arm 144a.
  • FIGs. 16A-16B illustrate some steps in an exemplary method for utilizing a leaflet cutting apparatus 100, such as apparatus 100 g , for cutting a target leaflet. Steps illustrated in Figs. 16A-16B can optionally be performed subsequent to steps described above with respect to Figs. 10A-10E, to cut a section of the anterior leaflet 38.
  • tubular arms 144 Prior to retraction of the wire 150 to cut a section of the leaflet 38, the tubular arms 144 can be distally pushed, causing distal portions thereof to extend outwards through the head openings 148, in an outwardly oriented direction 88, distancing the distal ends 146 of the tubular arms 144 farther away from the head portion 114. While Fig. 16A illustrated deployment of the tubular arms 144 in an outwardly oriented direction 88 after positioning the leaflet 38 between the flap 130 s and the window 120, which can optionally be performed subsequent to the step described above with respect to Fig.
  • tubular arms 144 can optionally be similarly deployed to extend outwardly in direction 88 out of the head portion 144 8 prior to positioning of the leaflet 38 between the flap 130 g and the head portion 114 s , such as subsequent to positioning of the head portion 114 g distal to the mitral valve 30, as described above with respect to Fig. 10D, but before proximal retraction of the head portion 114 s to position the leaflet 38 in the position illustration in Fig. 10E.
  • Both wire portions 150a, 150b can optionally be axially movable through and relative to the second tubular arm 144b, and the flexible retainer 168 can optionally be axially movable, optionally in a passive manner, relative to the first tubular arm 144a.
  • retraction of the wire 150 while electric current is provided to its cutting portion 156 causes the cutting portion 156 to cut through the leaflet as it travels along a path 90 defined between the distal end 146a of the first arm 144a, the regions of the flap proximal end 142 and window ceiling 124, and the distal end 146b of the second arm 144b.
  • the leaflet cutting apparatus 100 can optionally include one or more tubes through which insulator fluid can be injected towards the cutting member 156.
  • insulator fluid 94 such as nonionic 5% dextrose
  • the first tubular arm 144a can optionally be fluidly coupled, in such examples, to an insulator fluid injection port 104 located on the handle 102 of the apparatus 100, such as port 104b illustrated in Fig. 2.
  • an insulator fluid injection port 104 located on the handle 102 of the apparatus 100, such as port 104b illustrated in Fig. 2.
  • the injection tubes 184 are configured to move along with the wire 150 such that the openings 186 remain in the same position relative to the cutting portion 156. This allows the injected insulation fluid 94 to be directed towards the moving portion of the cut tissue as the cutting portion 156 travels along the designated cutting path. While injection tubes 184 are illustrated around wire 150 of apparatus 100 g in Fig. 18, it is to be understood that injection tubes 184 can optionally be similarly added around the wire 150 of any other exemplary apparatus 100 disclosed herein, such as apparatus 100 c described above or apparatus 100 h which will be described below.
  • the first wire portion 150a can optionally extend from the inside of the head portion 114 h outwards through the opening 198, then extend proximally from the opening 198, over the flap outer surface 134, bend over the flap proximal end 142, and extend distally over the flap inner surface 132, terminating at the cutting portion 156 proximate the flap base 136.
  • the first wire portion 150a is equally distanced from both of the flap sidewalls 140a and 140b.
  • the portion of the wire 150 extending over the flap 130 h can optionally pass along a guide recess 160 that can optionally be formed over the flap outer surface 134, the flap proximal end 142, and the flap inner surface 132, wherein the guide recess 160 can optionally be implemented according to any example described herein, such as by including a groove 162, optionally utilized with sutures 196, or by including a slot 164 leading to an inner channel 166.
  • the guide recess 160 is equally distanced from both of the flap sidewalls 140a and 140b.
  • FIGs. 20A-20C illustrate some steps in an exemplary method for utilizing a leaflet cutting apparatus 100, such as apparatus 100 h , for cutting a target leaflet. Steps illustrated in Figs. 20A-20C can optionally be performed subsequent to steps described above with respect to Figs. 10A-10E, to split the anterior leaflet 38 but forming a linear cut. [0199] When the leaflet 38 is properly positioned between the flap 130 and the window 120 as described above with respect to Fig.
  • the cutting portion 156 of the wire 150 of apparatus 100 h which is in close proximity to the flap base 136 along the flap inner surface 132, is positioned distally to a free edge of the leaflet 38, with the electrically conductive surface 158 facing the free edge of the leaflet 38, as shown in Fig. 20A.
  • a leaflet cutting apparatus comprising: a shaft comprising a head portion; a flap pivotably coupled to the head portion, the flap comprising: a flap proximal end; a flap base opposite to the flap proximal end; a first flap sidewall and a second flap sidewall extending between the flap base and the flap proximal end; a flap inner surface; and a flap outer surface opposite to the flap inner surface; and a wire extending through the shaft and comprising a cutting portion, wherein the wire is slidably coupled to the flap and the cutting portion is configured to move along the flap; wherein the flap is configured to move between an open state and a closed state, such that the flap proximal end is at a greater distance from the head portion in the open state than in the closed state.
  • Example 3 The apparatus of any example herein, particularly of example 1 or 2, wherein the wire comprises a first wire portion and a second wire portion continuously extending from the cutting portion and through the shaft.
  • Example 8 The apparatus of any example herein, particularly of example 7, wherein, when a leaflet is grasped between the flap and the head portion, the electrically conductive surface is oriented towards a free edge of the leaflet.
  • Example 9 The apparatus of any example herein, particularly of example 6 or 7, wherein the cutting portion comprises an insulating layer covering regions that exclude the electrically conductive surface, while the electrically conductive surface is an exposed surface.
  • Example 10 The apparatus of any example herein, particularly of any one of examples 7 to 9, wherein the electrically conductive surface is configured to output radio-frequency energy.
  • Example 11 The apparatus of any example herein, particularly of example 3, wherein each of the first wire portion and the second wire portion comprises an electrically conductive core surrounded by an insulating layer.
  • Example 12 The apparatus of any example herein, particularly of any one of examples 6 to 11, further comprising an electric current source configured to provide electric current to the wire.
  • Example 13 The apparatus of any example herein, particularly of example 12, wherein the provided electric current is an alternating current.
  • Example 15 The apparatus of any example herein, particularly of any one of examples 12 to 14, wherein the electric current source is configured, responsive to a user input, to alternately provide the electric current and not provide the electric current.
  • Example 16 The apparatus of any example herein, particularly of example 3, wherein the head portion comprises a window configured to accommodate the flap in the closed state, the window comprising a first window sidewall, a second window sidewall, and a window ceiling extending between the first and the second window sidewalls.
  • Example 18 The apparatus of any example herein, particularly of example 16 or 17, wherein the wire is movably coupled to at least one guide recess of the apparatus.
  • Example 19 The apparatus of any example herein, particularly of example 18, wherein the at least one guide recess comprises a groove over which the wire extends.
  • Example 20 The apparatus of any example herein, particularly of example 19, wherein the wire is coupled to the at least one guide recess by sutures looped around the wire.
  • Example 21 The apparatus of any example herein, particularly of example 20, wherein, when the wire is slid along the at least one guide recess, the cutting portion is configured to cut through one or more of the sutures.
  • Example 24 The apparatus of any example herein, particularly of any one of examples 18 to 23, wherein the at least one guide recess comprises a first guide recess formed on the flap.
  • Example 25 The apparatus of any example herein, particularly of example 24, wherein the first guide recess continuously extends along the first flap sidewall, the flap proximal end, and the second flap sidewall.
  • Example 26 The apparatus of any example herein, particularly of example 25, wherein the first wire portion continuously extends from the cutting portion along the first guide recess.
  • Example 27 The apparatus of any example herein, particularly of any one of examples
  • the at least one guide recess comprises a second guide recess formed on the head portion and extending along edges of the window.
  • Example 28 The apparatus of any example herein, particularly of example 27, wherein the second guide recess continuously extends along the first window sidewall, the window ceiling, and the second window sidewall.
  • Example 29 The apparatus of any example herein, particularly of example 28, wherein the head portion further comprises a step extending from the first window sidewall, the window ceiling, and the second window sidewall, and wherein the second guide recess is formed on a window outer surface defined by the step.
  • Example 30 The apparatus of any example herein, particularly of example 29, wherein the second wire portion continuously extends from the cutting portion along the second guide recess.
  • the cutting portion when the wire is pulled, the cutting portion is configured to slide along a path extending proximally from a position proximate the flap base towards the proximal end of the flap, slide laterally at or parallel to the flap proximal end towards the second flap sidewall, and slide distally from a position at or proximate to the flap proximal end towards the flap base.
  • Example 32 The apparatus of any example herein, particularly of example 31, wherein, when a leaflet is positioned between the flap and the window, the cutting portion is configured to cut a section of the leaflet having the shape of the path along which the cutting portion is slid during pulling of the wire.
  • Example 34 The apparatus of any example herein, particularly of example 33, wherein the head openings are positioned on opposite sides of the window.
  • Example 35 The apparatus of any example herein, particularly of example 33 or 34, wherein the head openings are closer to the flap base than the flap proximal end.
  • Example 36 The apparatus of any example herein, particularly of example 35, wherein the head openings are distal to the flap base.
  • Example 37 The apparatus of any example herein, particularly of any one of examples 33 to 36, wherein the tubular arms are axially movable relative to the shaft.
  • Example 39 The apparatus of any example herein, particularly of example 38, wherein the tubular arms comprise a first tubular arm and a second tubular arm, wherein the wire extends through the second tubular arm and is axially movable relative to the second arm.
  • Example 40 The apparatus of any example herein, particularly of example 39, wherein the first wire portion and the second wire portion extend through the second tubular arm and past a tube opening of the first tubular arm towards the distal end of the second tubular arm.
  • Example 41 The apparatus of any example herein, particularly of example 40, wherein the cutting portion is coupled to a loop extending from or coupled to the first tubular arm.
  • Example 42 The apparatus of any example herein, particularly of example 41, further comprising a flexible retainer attached to the loop and extending through the first tubular arm.
  • Example 43 The apparatus of any example herein, particularly of example 42, wherein the flexible retainer is axially movable relative to the first tubular arm.
  • Example 45 The apparatus of any example herein, particularly of any one of examples 40 to 44, wherein the distal ends of the tubular arms are configured to be closer to the flap base than the flap proximal end when the tubular arms are extended away from the head portion.
  • Example 46 The apparatus of any example herein, particularly of example 45, wherein the cutting portion is positioned closer to the distal end of the first tubular arm than the flap proximal end when the tubular arms are extended away from the head portion.
  • Example 47 The apparatus of any example herein, particularly of example 46, wherein the first wire portion continuously extends from the cutting portion, towards and over the flap proximal portion, and towards the distal end of the first tubular arm.
  • Example 48 The apparatus of any example herein, particularly of example 47, wherein the first wire portion is slidably movable over the flap proximal end.
  • Example 50 The apparatus of any example herein, particularly of any one of examples 47 to 49, wherein the second wire portion continuously extends from the cutting portion, towards and along the window ceiling, and towards the distal end of the first tubular arm.
  • Example 52 The apparatus of any example herein, particularly of example 50 or 51, wherein the second wire portion is slidably coupled to the window ceiling in a manner that prevents it from spontaneously falling of the window ceiling.
  • Example 53 The apparatus of any example herein, particularly of example 52, wherein the window ceiling comprises a retaining channel through which the second wire portion extends.
  • Example 54 The apparatus of any example herein, particularly of any one of examples 39 to 53, wherein the first tubular arm is fluidly coupled to an insulator fluid injection port, and is configured to eject insulator fluid from the distal end of the first tubular arm.
  • Example 55 The apparatus of any example herein, particularly of example 24, wherein the first guide recess continuously extends along the flap inner surface, the flap proximal end, and the flap outer surface.
  • Example 56 The apparatus of any example herein, particularly of example 55, wherein the first wire portion continuously extends from the cutting portion along the first guide recess.
  • Example 57 The apparatus of any example herein, particularly of example 56, wherein the head portion further comprises a through-opening distal to the flap base, and wherein the first wire portion is configured to extend from the flap outer surface into the head portion through the through-opening.
  • Example 58 The apparatus of any example herein, particularly of any one of examples 55 to 57, wherein the first guide recess is equally distanced from both of the flap first and second sidewalls.
  • Example 59 The apparatus of any example herein, particularly of any one of examples 55 to 58, wherein a portion of the first wire portion that is coupled to the flap is equally distanced from both of the flap first and second sidewalls.
  • Example 60 The apparatus of any example herein, particularly of any one of examples 55 to 59, wherein the cutting portion is positioned between the flap inner surface and the window, at a position closer to the flap base than to the flap proximal end.
  • Example 63 The apparatus of any example herein, particularly of any one of examples 1 to 62, further comprising at least one insulator fluid injection tube disposed around a portion of the wire and having an opening at a distal end thereof, directed towards the cutting portion, wherein the at least one insulator fluid injection tube is configured to eject insulator fluid through its opening.
  • Example 64 The apparatus of any example herein, particularly of any one of examples 1 to 63, further comprising a contrast injection member configured to eject contrast fluid through one or more openings thereof.
  • Example 65 The apparatus of any example herein, particularly of any one of examples 1 to 64, further comprising an outer catheter disposed around the shaft, wherein the shaft is axially movable relative to the outer catheter.
  • Example 66 The apparatus of any example herein, particularly of any one of examples 1 to 65, further comprising a pull-member axially extending through the shaft and coupled at a joint to a link, wherein the link is rotatably connected to an internal extension of the flap at an end opposite to the joint, and wherein the flap is rotatably coupled to the head portion by a pin which is proximal to, and radially aligned with, the joint.
  • Example 67 The apparatus of any example herein, particularly of example 66, wherein, when the pull-member is proximally pulled, the joint and the pin move closer to each other, thereby moving the flap towards the open state.
  • Example 68 The apparatus of any example herein, particularly of example 67, wherein the flap is biased towards the closed state when no pull force is applied to the pull-member.
  • Example 69 The apparatus of any example herein, particularly of example 68, further comprising a spring coupled to the flap and configured to bias the flap towards the closed state.
  • Example 70 The apparatus of any example herein, particularly of any one of examples 1 to 65, further comprising a rod coupled at a joint to an internal extension of the flap.
  • Example 71 The apparatus of any example herein, particularly of example 70, wherein the flap is coupled to a pin of the head portion, wherein the pin extends through a slot of the internal extension of the flap.
  • Example 72 The apparatus of any example herein, particularly of example 70 or 71, wherein the flap is configured to move towards the open state when the rod is proximally pulled.
  • Example 81 The method of any example herein, particularly of any one of examples 77 to 80, wherein the electric current is provided by an electric current source.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Plasma & Fusion (AREA)
  • Medical Informatics (AREA)
  • Otolaryngology (AREA)
  • Physics & Mathematics (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente divulgation concerne des dispositifs de coupe de tissu qui peuvent être utilisés pour couper à travers un feuillet, tel qu'un feuillet antérieur d'une valve mitrale. Dans un exemple, un appareil de coupe de tissu comprend un arbre comprenant une partie tête, un rabat couplé de façon pivotante à la partie tête, et un fil s'étendant à travers l'arbre et se terminant par une partie de coupe. Le fil est couplé de manière coulissante au rabat et la partie de coupe est configurée pour se déplacer le long du rabat. Le rabat est configuré pour se déplacer entre un état ouvert et un état fermé, de telle sorte que l'extrémité proximale de rabat se trouve à une distance plus grande de la partie tête dans l'état ouvert qu'à l'état fermé.
PCT/US2025/014939 2024-02-09 2025-02-07 Appareil de coupe de feuillet Pending WO2025171212A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202463551610P 2024-02-09 2024-02-09
US63/551,610 2024-02-09

Publications (1)

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WO2025171212A1 true WO2025171212A1 (fr) 2025-08-14

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PCT/US2025/014939 Pending WO2025171212A1 (fr) 2024-02-09 2025-02-07 Appareil de coupe de feuillet

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WO (1) WO2025171212A1 (fr)

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US7993394B2 (en) 2008-06-06 2011-08-09 Ilia Hariton Low profile transcatheter heart valve
US8652202B2 (en) 2008-08-22 2014-02-18 Edwards Lifesciences Corporation Prosthetic heart valve and delivery apparatus
US9155619B2 (en) 2011-02-25 2015-10-13 Edwards Lifesciences Corporation Prosthetic heart valve delivery apparatus
US9339384B2 (en) 2011-07-27 2016-05-17 Edwards Lifesciences Corporation Delivery systems for prosthetic heart valve
US9393110B2 (en) 2010-10-05 2016-07-19 Edwards Lifesciences Corporation Prosthetic heart valve
US10603165B2 (en) 2016-12-06 2020-03-31 Edwards Lifesciences Corporation Mechanically expanding heart valve and delivery apparatus therefor
US11135560B1 (en) 2015-03-19 2021-10-05 Us Synthetic Corporation Aqueous leaching solutions and methods of leaching at least one interstitial constituent from a polycrystalline diamond body using the same
WO2023139576A1 (fr) * 2022-01-18 2023-07-27 Rambam Medtech Ltd. Dispositifs de sectionnement de valvule
WO2023200706A1 (fr) * 2022-04-15 2023-10-19 Edwards Lifesciences Corporation Procédés et appareil d'élimination de dispositifs de réparation de valvule

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6730118B2 (en) 2001-10-11 2004-05-04 Percutaneous Valve Technologies, Inc. Implantable prosthetic valve
US7393360B2 (en) 2001-10-11 2008-07-01 Edwards Lifesciences Pvt, Inc. Implantable prosthetic valve
US7510575B2 (en) 2001-10-11 2009-03-31 Edwards Lifesciences Corporation Implantable prosthetic valve
US7993394B2 (en) 2008-06-06 2011-08-09 Ilia Hariton Low profile transcatheter heart valve
US8652202B2 (en) 2008-08-22 2014-02-18 Edwards Lifesciences Corporation Prosthetic heart valve and delivery apparatus
US9393110B2 (en) 2010-10-05 2016-07-19 Edwards Lifesciences Corporation Prosthetic heart valve
US9155619B2 (en) 2011-02-25 2015-10-13 Edwards Lifesciences Corporation Prosthetic heart valve delivery apparatus
US9339384B2 (en) 2011-07-27 2016-05-17 Edwards Lifesciences Corporation Delivery systems for prosthetic heart valve
US11135560B1 (en) 2015-03-19 2021-10-05 Us Synthetic Corporation Aqueous leaching solutions and methods of leaching at least one interstitial constituent from a polycrystalline diamond body using the same
US10603165B2 (en) 2016-12-06 2020-03-31 Edwards Lifesciences Corporation Mechanically expanding heart valve and delivery apparatus therefor
WO2023139576A1 (fr) * 2022-01-18 2023-07-27 Rambam Medtech Ltd. Dispositifs de sectionnement de valvule
WO2023200706A1 (fr) * 2022-04-15 2023-10-19 Edwards Lifesciences Corporation Procédés et appareil d'élimination de dispositifs de réparation de valvule

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