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WO2024158595A1 - Appareil d'implantation de valve cardiaque - Google Patents

Appareil d'implantation de valve cardiaque Download PDF

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Publication number
WO2024158595A1
WO2024158595A1 PCT/US2024/011840 US2024011840W WO2024158595A1 WO 2024158595 A1 WO2024158595 A1 WO 2024158595A1 US 2024011840 W US2024011840 W US 2024011840W WO 2024158595 A1 WO2024158595 A1 WO 2024158595A1
Authority
WO
WIPO (PCT)
Prior art keywords
motor drive
heart valve
radially
expansion portion
valve prosthesis
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.)
Ceased
Application number
PCT/US2024/011840
Other languages
English (en)
Inventor
Niall F. Duffy
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 WO2024158595A1 publication Critical patent/WO2024158595A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0001—Means for transferring electromagnetic energy to implants

Definitions

  • the present disclosure relates generally to a heart valve implant apparatus and, more particularly, to a heart valve implant apparatus comprising an expansion apparatus powered by a motor drive for expanding a heart valve prosthesis.
  • Heart valve implant apparatus for implanting a valve prosthesis within a target site of the vasculature of a patient.
  • the heart valve prosthesis can be moved from a radially-compressed position to a radially-expanded position.
  • expansion of the heart valve prosthesis can be difficult.
  • a heart valve implant apparatus comprises a heart valve prosthesis extending along a valve axis between an inflow end of the valve prosthesis and an outflow end of the valve prosthesis.
  • the heart valve prosthesis comprises a frame that is configured to expand from a radially compressed position to a radially expanded position.
  • the heart valve prosthesis comprises an expansion apparatus attached to the frame and comprising a motor drive.
  • the motor drive is configured to be electrically- powered to move the frame from the radially-compressed position to the radially-expanded position.
  • the frame comprises a first frame member located at the inflow end and a second frame member located at the outflow end.
  • the expansion apparatus comprises a first expansion portion attached to the first frame member and a second expansion portion attached to the second frame member.
  • the second expansion portion is configured to move relative to the first expansion portion.
  • the motor drive is coupled to the first expansion portion and the second expansion portion.
  • the motor drive is configured to move the second expansion portion relative to the first expansion portion to move the frame from the radially- compressed position to the radially-expanded position.
  • a delivery apparatus is configured to deliver the heart valve prosthesis and the expansion apparatus to a treatment location.
  • the delivery apparatus comprises an electrical power source in electrical communication with the motor drive.
  • the delivery apparatus is removably attached to the motor drive such that the electrical power source is configured to power the motor drive to move the second expansion portion relative to the first expansion portion.
  • the motor drive comprises an induction receiver coil.
  • the induction receiver coil is positioned at an exterior of a lumen of the heart valve prosthesis.
  • an induction transmitter coil is configured to be positioned in proximity to the induction receiver coil to induce an electric current in the induction receiver coil to electrically -power the motor drive.
  • the motor drive comprises a maximum cross-sectional dimension of less than about 3 millimeters.
  • a heart valve implant apparatus comprises a heart valve prosthesis extending along a valve axis between an inflow end of the valve prosthesis and an outflow end of the valve prosthesis.
  • the heart valve prosthesis comprises a frame that is configured to expand from a radially compressed position to a radially expanded position.
  • the heart valve implant apparatus comprises an expansion apparatus attached to the frame and comprising a motor drive that is electrically-powered.
  • the heart valve implant apparatus comprises a delivery apparatus configured to deliver the heart valve prosthesis and the expansion apparatus to a treatment location.
  • the delivery apparatus comprises an electrical power source in electrical communication with the motor drive.
  • the delivery apparatus is removably attached to the motor drive such that the electrical power source is configured to power the motor drive to move the frame from the radially- compressed position to the radially-expanded position.
  • the frame comprises a first frame member located at the inflow end and a second frame member located at the outflow end.
  • the expansion apparatus comprises a first expansion portion attached to the first frame member and a second expansion portion attached to the second frame member.
  • the second expansion portion is configured to move relative to the first expansion portion.
  • the motor drive is coupled to the first expansion portion and the second expansion portion.
  • the motor drive is configured to move the second expansion portion relative to the first expansion portion to move the frame from the radially- compressed position to the radially-expanded position.
  • the motor drive comprises a maximum cross-sectional dimension of less than about 3 millimeters.
  • methods of implanting a heart valve prosthesis comprise positioning a heart valve prosthesis at a treatment location.
  • the heart valve prosthesis comprises a frame and an expansion apparatus attached to the frame.
  • the expansion apparatus comprises a motor drive.
  • Methods comprise electrically-powering the motor drive.
  • Methods comprise expanding the heart valve prosthesis with the motor drive from a radially compressed position to a radially expanded position.
  • methods comprise attaching a delivery apparatus to the motor drive.
  • the delivery apparatus comprises an electrical power source such that the delivery apparatus electrically-powers the motor drive.
  • the delivery apparatus delivers the heart valve prosthesis to the treatment location.
  • electrically-powering the motor drive comprises delivering electrical power to the motor drive via inductive coupling.
  • electrically-powering the motor drive comprises positioning an induction transmitter coil in proximity to an induction receiver coil of the motor drive.
  • the motor drive comprises a maximum cross-sectional dimension of less than about 3 millimeters.
  • FIG. 1 schematically illustrates example aspects of a heart valve prosthesis in a radially-expanded position in accordance with aspects of the disclosure
  • FIG. 2 illustrates a side view of a portion of the heart valve prosthesis at focus area 2 of FIG. 1 in accordance with aspects of the disclosure
  • FIG. 3 schematically illustrates example aspects of a heart valve prosthesis in a radially-compressed position in accordance with aspects of the disclosure
  • FIG. 4 illustrates a side view of a portion of the heart valve prosthesis comprising a motor drive with the valve prosthesis in a radially-compressed position in accordance with aspects of the disclosure
  • FIG. 5 illustrates a side view of a portion of the heart valve prosthesis comprising the motor drive with the valve prosthesis in a radially-expanded position in accordance with aspects of the disclosure
  • FIG. 6 illustrates a side view of a portion of the heart valve prosthesis comprising the motor drive with a delivery apparatus separated from the valve prosthesis in accordance with aspects of the disclosure
  • FIG. 7 illustrates a side view of a portion of the heart valve prosthesis comprising a motor drive that is inductively coupled with an induction transmitter coil in accordance with aspects of the disclosure
  • FIG. 8 illustrates a side view of a portion of the heart valve prosthesis comprising the motor drive that is inductively coupled with the induction transmitter coil in accordance with aspects of the disclosure.
  • the term “about” means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not, and need not be, exact, but may be approximate and/or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art.
  • Ranges can be expressed herein as from “about” one value, and/or to “about” another value. When such a range is expressed, aspects include from the one value to the other value. Similarly, when values are expressed as approximations by use of the antecedent “about,” it will be understood that the value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. [0038] Directional terms as used herein - for example up, down, right, left, front, back, top, bottom, upper, lower, etc. - are made only with reference to the figures as drawn and are not intended to imply absolute orientation.
  • the terms “comprising,” “including,” and variations thereof shall be construed as synonymous and open-ended, unless otherwise indicated.
  • a list of elements following the transitional phrases comprising or including is a non-exclusive list, such that elements in addition to those specifically recited in the list may also be present.
  • the terms “substantial,” “substantially,” and variations thereof as used herein are intended to represent that a described feature is equal or approximately equal to a value or description.
  • a “substantially planar” surface is intended to denote a surface that is planar or approximately planar.
  • “substantially” is intended to denote that two values are equal or approximately equal.
  • the term “substantially” may denote values within about 10% of each other, for example, within about 5% of each other, or within about 2% of each other.
  • first,” “second,” or the like are not intended to imply a temporal aspect, a spatial aspect, an ordering, etc. Rather, such terms are merely used as identifiers, names, etc. for features, elements, items, etc.
  • a first end and a second end generally correspond to end A and end B or two different ends.
  • distal and proximal are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician.
  • self-expanding may be used in the following description with reference to one or more valve or stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration or vice versa.
  • Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudoelastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal.
  • Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol.
  • polymers that can be made to have shape memory characteristics may also be suitable for use in aspects hereof to include polymers such as polynorborene, trans-polyisoprene, styrene-butadiene, and polyurethane.
  • polymers such as polynorborene, trans-polyisoprene, styrene-butadiene, and polyurethane.
  • poly L-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers.
  • Diseases associated with heart valves can include stenosis and valvular insufficiency or regurgitation.
  • valvular stenosis causes the valve to become narrowed and hardened which can prevent blood flow to a downstream heart chamber from occurring at the proper flow rate and may cause the heart to work harder to pump the blood through the diseased valve.
  • Valvular insufficiency or regurgitation occurs when the valve does not close completely, allowing blood to flow backwards, thereby causing the heart to be less efficient.
  • a diseased or damaged valve which can be congenital, age-related, drug-induced, or in some instances, caused by infection, can result in an enlarged, thickened heart that loses elasticity and efficiency.
  • Some symptoms of heart valve diseases can include weakness, shortness of breath, dizziness, fainting, palpitations, anemia and edema, and blood clots which can increase the likelihood of stroke or pulmonary embolism. Symptoms can often be severe enough to be debilitating and/or life threatening.
  • Heart valve prostheses have been developed for repair and replacement of diseased and/or damaged heart valves.
  • Such heart valve prostheses can be percutaneously delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems.
  • Such heart valve prostheses generally include a frame or stent and a prosthetic valve mounted within the frame.
  • Such heart valve prostheses are delivered in a radially compressed or crimped configuration so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the heart valve prosthesis is expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.
  • FIG. 1 illustrates an annular heart valve prosthesis 101 for use with a heart valve implant apparatus 201 (e.g., illustrated in FIG. 2).
  • the valve prosthesis 101 can be delivered to a desired location within a body of a patient, for example, a patient’s heart.
  • the valve prosthesis 101 can be moved between a radially-compressed position and a radially-expanded position, with the valve prosthesis 101 illustrated in the radially- expanded position in FIG. 1.
  • the valve prosthesis 101 can move through a vasculature of the patient while in the radially-compressed position, and, upon reaching the desired location, can move to the radially-expanded position.
  • the valve prosthesis 101 may comprise one or more structures associated with a heart valve, for example, a frame 103, valve leaflets attached to the frame 103, commissures, etc.
  • the valve prosthesis 101 is illustrated without the valve leaflets attached to the frame 103, commissures, etc. in FIG. 1.
  • the valve prosthesis 101 comprises the valve leaflets attached to the frame 103, the commissures, etc..
  • the valve prosthesis 101 can extend along a valve axis 105 between an inflow end 107 of the valve prosthesis 101 and an outflow end 109 of the valve prosthesis 101.
  • the valve prosthesis 101 can comprise a lumen 111 extending along the valve axis 105 between the inflow end 107 and the outflow end 109.
  • the lumen 111 may be circumferentially bounded by the frame 103.
  • the frame 103 can expand from a radially-compressed position (e.g., illustrated in FIG. 3) to a radially-expanded position (e.g., illustrated in FIG. 1).
  • the frame 103 in the radially-expanded position, can comprise a first diameter 115.
  • the frame 103 can comprise one or more frame members that may be attached and interconnected.
  • the frame 103 can comprise a first frame member 117, a second frame member 119, etc.
  • the frame members 117, 119 may be pivotably attached at attachment locations 121, 123 such that the frame members 117, 119 can pivot between the radially-compressed position and the radially-expanded position.
  • the frame members 117, 119 can be pivotably attached in several ways, for example, by mechanical fasteners (e.g., rivets, screws, bolts), by snap-fitting without fasteners, etc. and/or may comprise a shape-memory material that can move to a predetermined shape.
  • the first frame member 117 may be located at the inflow end 107 and the second frame member 119 may be located at the outflow end 109.
  • the frame members 117, 119 (e.g., and the other frame members) may be substantially identical in structure and dimension.
  • the heart valve prosthesis 101 can comprise an expansion apparatus 125 attached to the frame 103.
  • the expansion apparatus 125 can function to mechanically expand the heart valve prosthesis 101 from the radially-compressed position to the radially-expanded position.
  • the expansion apparatus 125 can extend substantially parallel to the valve axis 105 between the inflow end 107 and the outflow end 109.
  • the expansion apparatus 125 can be attached to one or more of the frame members, for example, the first frame member 117 and the second frame member 119.
  • the heart valve prosthesis 101 is not limited to comprising one expansion apparatus 125, but, rather, the heart valve prosthesis 101 can comprise one or more expansion apparatuses that may be substantially identical to the expansion apparatus 125 described herein.
  • the other expansion apparatuses may be circumferentially spaced apart around the lumen 111, with the expansion apparatuses attached to an inner radial side or surface of the frame 103.
  • FIG. 2 illustrates a close-up view at focus area 2 of FIG. 1 of the heart valve prosthesis 101.
  • the heart valve prosthesis 101 is illustrated in the radially- expanded position in FIGS. 2, 5, 6, and 8, and in the radially-compressed position in FIGS. 4, and 7.
  • the heart valve implant apparatus 201 can comprise the expansion apparatus 125 which may be attached to an inner radial side of the frame 103.
  • the expansion apparatus 125 can be attached to the first frame member 117 and the second frame member 119. While FIG. 2 illustrates two frame members 117, 119 for the purposes of illustration, additional frame members may be provided and positioned between the first frame member 117 and the second frame member 119.
  • the expansion apparatus 125 can be attached to the additional frame members positioned between the first frame member 117 and the second frame member 119.
  • the expansion apparatus 125 can comprise a first expansion portion 203 and a second expansion portion 205.
  • the first expansion portion 203 may be substantially hollow such that the second expansion portion 205 can be received within a chamber of the first expansion portion 203.
  • the second expansion portion 205 can move, for example, axially, relative to the first expansion portion 203. In this way, the second expansion portion 205 can move along an axis that is substantially parallel to the valve axis 105.
  • the second expansion portion 205 can be moved relative to the first expansion portion 203 in several ways.
  • the second expansion portion 205 can be threaded and may be received within a corresponding threaded opening of the first expansion portion 203, such that the second expansion portion 205 can be rotated to move axially relative to the first expansion portion 203.
  • the expansion apparatus 125 can comprise a gear within the first expansion portion 203 such that the second expansion portion 205 can be gear driven.
  • the first expansion portion 203 can comprise a pneumatic cylinder or a hydraulic cylinder such that the second expansion portion 205 can function as a push/pull type cylinder that can move relative to the first expansion portion 203. It will be appreciated that the expansion apparatus 125 can comprise any number of variations that can facilitate movement of one expansion portion relative to the other expansion portion.
  • the first expansion portion 203 can be attached to the first frame member 117 and the second expansion portion 205 can be attached to the second frame member 119.
  • the expansion apparatus 125 can comprise a first attachment member 209 and a second attachment member 211, wherein the first attachment member 209 can attach the first expansion portion 203 to the first frame member 117 and the second attachment member 211 can attach the second expansion portion 205 to the second frame member 119.
  • the attachment members 209, 211 can comprise several methods or structures for attaching the expansion portions 203, 205 to the frame members 117, 119.
  • the attachment members 209, 211 can comprise mechanical fasteners (e.g., rivets, screws, bolts, connectors, etc.), sutures, adhesives, welds, etc.
  • the first attachment member 209 can fix the first expansion portion 203 relative to the first frame member 117
  • the second attachment member 211 can fix the second expansion portion 205 relative to the second frame member 119.
  • the expansion apparatus 125 can comprise a motor drive 215 that is electrically-powered and can move the frame 103 between the radially-expanded position and the radially-compressed position (e.g., from the radially-compressed position to the radially-expanded position and/or from the radially-expanded position to the radially- compressed position).
  • the motor drive 215 can be coupled to the first expansion portion 203 and the second expansion portion 205.
  • the motor drive 215 can move the second expansion portion 205 relative to the first expansion portion 203 to move the frame 103 between the radially-compressed position and the radially-expanded position.
  • the motor drive 215 can comprise, for example, an AC electric motor, a DC electric motor, an adjustable speed motor, etc. As will be explained below, the motor drive 215 can be powered by an electrical power source. As such, in aspects, the motor drive 215 can comprise a motor that can cause the second expansion portion 205 to move relative to the first expansion portion 203. Due to the attachment of the second expansion portion 205 to the second frame member 119 and the first expansion portion 203 to the first frame member 117, movement of the second expansion portion 205 relative to the first expansion portion 203 can cause the second frame member 119 to move axially apart from the first frame member 117 along the valve axis 105.
  • the motor drive 215 can comprise one or more components that can facilitate the conversion of electrical energy to mechanical energy, such as, for example, a power modulator, a control unit, sensor(s), etc.
  • the motor drive 215 can comprise a size such that the motor drive 215 can be positioned within or adjacent to the lumen 111 of the valve prosthesis 101 while not interfering with the function of the valve leaflets, commissure, etc..
  • the motor drive 215 can comprise a maximum cross- sectional dimension 217 (e.g., length, width, or thickness, etc.) of less than about 3 millimeters.
  • FIG. 3 illustrates the valve prosthesis 101 in the radially-compressed position.
  • the valve prosthesis 101 may be in the radially-compressed position as the valve prosthesis 101 is moved through the vasculature to a treatment location.
  • the first frame member 117 and the second frame member 119 of FIGS. 3 and 5 are illustrated when the valve prosthesis 101 is in the radially-compressed.
  • the valve prosthesis 101 in the radially-compressed position, can comprise a second diameter 301, wherein the second diameter 301 is less than the first diameter 115 (e.g., illustrated in FIG. 1).
  • expansion apparatus 125 is illustrated herein as being attached to the inner radial side of the frame 103, such a position is not intended to be limiting. Rather, in aspects, the expansion apparatus 125 and/or the motor drive 215 described herein can alternatively be positioned at, and attached to, an outer radial side of the frame 103 while functioning in a substantially identical manner as described herein.
  • the heart valve implant apparatus 201 can comprise a delivery apparatus 401 that can be attached to, and in electrical communication with, the motor drive 215.
  • the delivery apparatus 401 can deliver the valve prosthesis 101 and the expansion apparatus 125 to a desired treatment location within a body of a patient, for example, a patient’s heart.
  • the delivery apparatus 401 can comprise one or more sheaths (e.g., elongated shafts or tubular components defining a lumen) that can house at least a portion of the valve prosthesis 101.
  • the delivery apparatus 401 can comprise a handle 403 that can selectively control movement and expansion of the valve prosthesis 101.
  • the handle 403 can comprise a push-pull actuator that may be attached or connected to an end 107, 109 of the valve prosthesis 101.
  • the handle 403 can comprise a rotatable knob that may be attached to a sheath, such that when the knob is rotated, the sheath may be retracted and the valve prosthesis 101 may be deployed at a desired location.
  • the delivery apparatus 401 can comprise an electrical power source 405.
  • the power source 405 can be housed within the handle 403 or may flow through the handle 403.
  • the power source 405 can comprise several types of electrical devices that can supply electric power to the motor drive 215.
  • the power source 405 can comprise power from a power outlet (e.g., AC power), a battery housed within or connected to the handle 403, etc.
  • the delivery apparatus 401 can comprise the electrical power source 405 that can be placed in electrical communication with the motor drive 215.
  • the delivery apparatus 401 can be removably attached to the motor drive 215 such that the electrical power source 405 can power the motor drive 215 to move the second expansion portion 205 relative to the first expansion portion 203.
  • the delivery apparatus 401 can be attached to the valve prosthesis 101 such that the delivery apparatus 401 can deliver the valve prosthesis 101 to the desired treatment location.
  • the delivery apparatus 401 can be removably attached, for example, electrically connected, to the motor drive 215 via an electrical connector 409.
  • the electrical connector 409 can comprise, for example, one or more electrically-conductive wires that can extend from the handle 403 and to an end of the delivery apparatus 401.
  • the electrical connector 409 can be plugged into the motor drive 215, for example, with the motor drive 215 comprising an electrical socket that can electrically connect to the electrical connector 409.
  • the electrical connector 409 can transmit electrical power (e.g., electric current delivery) from the handle 403 and to the motor drive 215.
  • the delivery apparatus 401 can be attached to the motor drive 215 such that the electrical power source 405 can power the motor drive 215 to move the frame 103 from the radially-compressed position to the radially-expanded position.
  • the motor drive 215 may likewise comprise a battery.
  • the electrical connector 409 can be housed within a sheath, catheter, capsule, etc. of the delivery apparatus 401, with the sheath, catheter, capsule, etc. extending from the handle 403 to the valve prosthesis 101.
  • the handle 403 can comprise one or more control mechanisms (e.g., pushbuttons, switches, etc.) that can control the power of the electrical power source 405 and the motor drive 215.
  • an operator e.g., a physician
  • control mechanism can be located on or integrated with the handle 403 such that the control mechanism is physically connected to or attached to the handle 403.
  • the control mechanism can be provided in electronic communication with the delivery apparatus 401 to control the power of the electrical power source 405 and the motor drive 215.
  • the control mechanism may include a separate controller (e.g., remote, button, switch, dial) that is wired or wirelessly connected to the delivery apparatus.
  • the control mechanism may include a software program or other computer-implemented application with which a user can interact to selectively control one or more features of the delivery apparatus 401 to control the delivery of power from the power source 405 to the motor drive 215, thereby controlling actuation of the motor drive 215 moving the frame 103.
  • methods of implanting the heart valve prosthesis 101 can comprise attaching the delivery apparatus 401 to the motor drive 215, with the delivery apparatus 401 comprising the electrical power source 405 such that the delivery apparatus 401 can electrically-powers the motor drive 215.
  • Attaching the delivery apparatus 401 to the motor drive 215 can comprise electrically connecting the delivery apparatus 401 to the motor drive 215, such that methods can comprise electrically-powering the motor drive 215.
  • the delivery apparatus 401 can deliver the heart valve prosthesis 101 to the treatment location.
  • methods can comprise positioning the heart valve prosthesis 101 at the treatment location, with the heart valve prosthesis 101 comprising the frame 103 and the expansion apparatus 125 attached to the frame 103, with the expansion apparatus 125 comprising the motor drive 215.
  • methods can comprise expanding the heart valve prosthesis 101 with the motor drive 215 from the radially-compressed position (e.g., also illustrated in FIG. 3-4) to the radially-expanded position (e.g., also illustrated in FIGS. 1, 2, and 5).
  • the motor drive 215 can cause the second expansion portion 205 to move relative to the first expansion portion 203, with the second expansion portion 205 moving toward from the first expansion portion 203 and causing the expansion apparatus 125 to retract and shorten in length.
  • the second frame member 119 can move toward the first frame member 117, thus causing the valve prosthesis 101 to radially expand.
  • the delivery apparatus 401 upon the valve prosthesis 101 reaching the radially- expanded position, can be detached and separated from the valve prosthesis 101 and the motor drive 215, such that the delivery apparatus 401 can be retracted and removed from the patient’s vasculature.
  • the delivery apparatus 401 can be removed along a removal direction 601 that is away from the valve prosthesis 101.
  • the motor drive 215 can comprise a sensor that can sense when a force exerted upon the valve prosthesis 101 exceeds a threshold value. For example, as the valve prosthesis 101 moves to the radially-expanded position, the valve prosthesis 101 contacts and engages the vasculature of the patient, for example, with an outer radial side of the valve prosthesis 101 contacting the vasculature.
  • the motor drive 215 can comprise the sensor that can measure the force exerted. In aspects, when the force exerted exceeds a predetermined threshold value, the motor drive 215 may stop moving the valve prosthesis 101 to the radially-expanded position.
  • the handle 403 can comprise a vibrator or similar mechanical device that can generate vibrations. The vibrator may be coupled to the sensor such that, when the force exceeds the predetermined threshold value, the sensor may also trigger the vibrator to vibrate the handle 403, thus alerting the physician of the force.
  • FIG. 7 illustrates additional aspects of the motor drive 215 and the delivery apparatus 401, wherein the valve prosthesis 101 in FIG. 7 is in the radially-compressed position, and the valve prosthesis 101 in FIG. 8 is in the radially-expanded position.
  • the motor drive 215 and the delivery apparatus 401 are not limited to electrical power transmission via electrical wires (e.g., physically connecting the delivery apparatus 401 to the motor drive 215). Rather, in aspects, the motor drive 215 can be electrically powered via inductive coupling, such that a change in electrical current in an induction transmitter coil 701 can create a magnetic field, which can induce an electromotive force or voltage in an induction receiver coil 703 of the motor drive 215.
  • the motor drive 215 can comprise the induction receiver coil 703.
  • FIG. 7 illustrates a transference 705 of power from the induction transmitter coil 701 to the induction receiver coil 703 schematically with an arrowhead.
  • the induction receiver coil 703 can be positioned at an exterior of the lumen 111 of the valve prosthesis 101, for example, at a radially-exterior location outside of the frame 103, or axially outside of the lumen 111.
  • the frame 103 which may comprise a metal material, may not interfere with the inductive coupling and may allow the induction receiver coil 703 to be positioned in closer proximity to the induction transmitter coil 701.
  • the induction receiver coil 703 can be electrically connected to the motor drive 215 and, thus, the expansion apparatus 125, such that power from the induction receiver coil 703 can be used to control movement of the second expansion portion 205 relative to the first expansion portion 203.
  • the induction transmitter coil 701 may be positioned within, or as a part of, the delivery apparatus 401.
  • the induction transmitter coil 701 can be positioned at an end of the delivery apparatus 401 in proximity to the valve prosthesis 101 when the valve prosthesis 101 is attached to the delivery apparatus 401.
  • the induction transmitter coil 701 may be separate from the delivery apparatus 401, for example, by being positioned at an exterior of the patient’s vasculature or body.
  • the induction transmitter coil 701 can be positioned in proximity to the induction receiver coil 703 to induce an electric current in the induction receiver coil 703 to electrically-power the motor drive 215.
  • electrical current can move through the induction transmitter coil 701 (e.g., the primary winding) to create a magnetic field around the induction transmitter coil 701. Due to the induction transmitter coil 701 being positioned in proximity to the induction receiver coil 703 (e.g., the secondary winding), the induction receiver coil 703 can be located within the magnetic field, such that the magnetic field can induce an electrical current within the induction receiver coil 703. Tn this way, methods can comprise electrically-powering the motor drive 215 by delivering electrical power to the motor drive 215 via inductive coupling. That is, electrically -powering the motor drive 215 can comprise positioning the induction transmitter coil 701 in proximity to the induction receiver coil 703 of the motor drive 215.
  • methods can comprise expanding the heart valve prosthesis 101 with the motor drive 215 from the radially-compressed position (e.g., also illustrated in FIG. 3) to the radially-expanded position (e.g., also illustrated in FIG. 1), with the motor drive 215 driven via inductive coupling.
  • the motor drive 215 can cause the second expansion portion 205 to move relative to the first expansion portion 203, with the second expansion portion 205 moving toward the first expansion portion 203 and causing the expansion apparatus 125 to retract or shorten in length.
  • the second frame member 119 can move toward the first frame member 117, thus causing the valve prosthesis 101 to expand.
  • the delivery apparatus 401 can be detached and separated from the valve prosthesis 101 (e.g., retracted and removed from the patient’s vasculature), and the induction transmitter coil 701 can be moved away from the motor drive 215.
  • the motor drive 215 provides several benefits related to expansion of the valve prosthesis 101. For example, due to the motor drive 215 being attached to the expansion portions 203, 205, the motor drive 215 can control movement of the expansion portions 203, 205, and, thus, the expansion of the valve prosthesis 101. As such, the delivery apparatus 401 may not require control wires, mechanical actuators, or other devices for controlling non-electrical expansion of the valve prosthesis 101. Rather, the delivery apparatus 401 can comprise the power source 405 (e.g., or, the induction transmitter coil 701) such that the power sources 405, 701 can deliver power to the motor drive 215. As such, the motor drive 215 can control movement of the expansion portions 203, 205. In this way, construction of the delivery apparatus 401 may be simplified by avoiding the use of control wires, mechanical actuators, etc.
  • the power source 405 e.g., or, the induction transmitter coil 701
  • the heart valve prosthesis 101 discussed above relates to a mechanically-expandable frame 103
  • the disclosure is not so limited.
  • the heart valve prosthesis 101 may include one or more self-expanding components including a shape-memory material.
  • expansion and/or retraction of the heart valve prosthesis 101 may be accomplished alone with the expansion apparatus 125 or in combination with the expansion apparatus 125 and a self-expanding component.
  • a balloon or other mechanical device may be employed in combination with the expansion apparatus 125 such that a combination of forces provided by the expansion apparatus 125 and a balloon (not shown) may expand the frame 103 of the heart valve prosthesis 101.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (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)
  • Mechanical Engineering (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un appareil d'implantation de valve cardiaque comprenant une prothèse de valve cardiaque s'étendant le long d'un axe de valve entre une extrémité d'entrée de la prothèse de valve et une extrémité de sortie de la prothèse de valve. La prothèse de valve cardiaque comprend un cadre qui s'étend d'une position radialement comprimée à une position radialement déployée. La prothèse de valve cardiaque comprend un appareil d'expansion fixé au cadre et un entraînement de moteur. L'entraînement de moteur est alimenté électriquement pour déplacer le cadre de la position radialement comprimée à la position radialement déployée. L'invention concerne également des procédés d'implantation d'une prothèse de valve cardiaque.
PCT/US2024/011840 2023-01-24 2024-01-17 Appareil d'implantation de valve cardiaque Ceased WO2024158595A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363440757P 2023-01-24 2023-01-24
US63/440,757 2023-01-24

Publications (1)

Publication Number Publication Date
WO2024158595A1 true WO2024158595A1 (fr) 2024-08-02

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/011840 Ceased WO2024158595A1 (fr) 2023-01-24 2024-01-17 Appareil d'implantation de valve cardiaque

Country Status (1)

Country Link
WO (1) WO2024158595A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180110618A1 (en) * 2011-10-21 2018-04-26 Edwards Lifesciences Cardiaq Llc Actively controllable stent, stent graft, heart valve and method of controlling same
US20200297482A1 (en) * 2016-12-06 2020-09-24 Edwards Lifesciences Corporation Mechanically expanding heart valve and delivery apparatus therefor
WO2021113431A1 (fr) * 2019-12-06 2021-06-10 Edwards Lifesciences Corporation Capteurs de flexion pour mesurer un diamètre de valve en temps réel pendant une procédure
US20220257379A1 (en) * 2019-10-31 2022-08-18 Edwards Lifesciences Corporation Valves and delivery apparatuses equipped with optic fiber sensors

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180110618A1 (en) * 2011-10-21 2018-04-26 Edwards Lifesciences Cardiaq Llc Actively controllable stent, stent graft, heart valve and method of controlling same
US20200297482A1 (en) * 2016-12-06 2020-09-24 Edwards Lifesciences Corporation Mechanically expanding heart valve and delivery apparatus therefor
US20220257379A1 (en) * 2019-10-31 2022-08-18 Edwards Lifesciences Corporation Valves and delivery apparatuses equipped with optic fiber sensors
WO2021113431A1 (fr) * 2019-12-06 2021-06-10 Edwards Lifesciences Corporation Capteurs de flexion pour mesurer un diamètre de valve en temps réel pendant une procédure

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