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WO2025235350A1 - Dispositif d'amarrage pour un implant prothétique - Google Patents

Dispositif d'amarrage pour un implant prothétique

Info

Publication number
WO2025235350A1
WO2025235350A1 PCT/US2025/027699 US2025027699W WO2025235350A1 WO 2025235350 A1 WO2025235350 A1 WO 2025235350A1 US 2025027699 W US2025027699 W US 2025027699W WO 2025235350 A1 WO2025235350 A1 WO 2025235350A1
Authority
WO
WIPO (PCT)
Prior art keywords
turn
wire
docking device
proximal
distal
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/US2025/027699
Other languages
English (en)
Inventor
Adeeb Saiduddin
George Nichola HALLAK
Andrea J. KIM
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 WO2025235350A1 publication Critical patent/WO2025235350A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • A61F2/885—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Definitions

  • the prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size.
  • An anchoring or docking device can be used in conjunction with an expandable prosthetic implant, for example a prosthetic valve, at an implant site such as a native heart valve.
  • the anchoring device can be used to securely hold the prosthetic implant in place at the implant site when the prosthetic implant is expanded.
  • Docking devices can, for example, provide a stable anchoring site, landing zone, or implantation zone at the implant site in which prosthetic implants can be expanded or otherwise secured.
  • a docking device can comprise a wire having a distal turn, a proximal turn, and a spacer.
  • a docking device can further comprise one or more of the components disclosed herein.
  • the wire can be arranged to define an inner lumen with a central, longitudinal axis.
  • the distal turn can be coaxially disposed with the central, longitudinal axis and can define a first inner diameter.
  • the distal turn can have a first end portion and a second end portion, where each of the first end portion and the second end portion can be disposed along the first inner diameter.
  • the proximal turn can be coaxially disposed with the central, longitudinal axis and can define a second inner diameter.
  • the proximal turn can have a first end portion and a second end portion, where each of the first end portion and the second end portion can be disposed along the second inner diameter.
  • the spacer can extend linearly along the inner lumen between the first end portion of the proximal turn and the second end portion of the distal turn.
  • the distal turn can extend a first length around the first portion of a prosthetic implant
  • the proximal turn can extend a second length around a second portion of the prosthetic implant
  • the spacer can extend a third length between the distal turn and the proximal turn.
  • the distal turn, the proximal turn, and the spacer can be configured to contact native leaflets.
  • the distal turn, the proximal turn, and the spacer can be configured to contact native leaflets along all or substantially all of the first, second, and third lengths.
  • the spacer can be disposed linearly at a constant radial distance from the central, longitudinal axis along the lumen inner diameter.
  • the distal turn can extend at least 360 degrees circumferentially around the central, longitudinal axis.
  • the proximal turn can extend greater than 270 degrees and less than 370 degrees circumferentially around the central, longitudinal axis.
  • the wire can have a leading turn extending distally from the distal turn.
  • the wire can have an ascending segment extending proximally from the proximal turn.
  • the wire can have a stabilization turn extending proximally from the ascending segment.
  • the docking device can comprise at least one cover disposed over at least a portion of the wire between a distal end of the wire and a proximal end of the wire.
  • the docking device can comprise an expandable guard disposed over at least a portion of the wire.
  • the distal turn can be disposed in a first plane and the proximal turn can be disposed in a second plane.
  • the second plane can be parallel to the first plane.
  • the second plane can be disposed at an angle to the first plane.
  • a docking device for a prosthetic implant comprises: a wire defining a lumen and a central, longitudinal axis, the wire having: a first turn disposed around a first portion of the prosthetic implant; a second turn disposed around a second portion of the prosthetic implant; and a spacer extending between the first turn and the second turn, wherein the first turn, the second turn, and the spacer are configured to contact native leaflets.
  • a docking device for a prosthetic implant comprises a wire having a distal turn and a proximal turn, wherein the distal turn and the proximal turn define a lumen with a central, longitudinal axis and a lumen inner diameter, and wherein the proximal turn is offset an axial distance from the distal turn along the central, longitudinal axis by a spacer disposed linearly at a constant radial distance from the central, longitudinal axis along the lumen inner diameter.
  • a docking device for a prosthetic implant comprises a wire arranged to define an inner lumen with a central, longitudinal axis, the wire having: a distal turn coaxially disposed with the central, longitudinal axis and defining a first inner diameter, wherein the distal turn has a first end portion and a second end portion each disposed along the first inner diameter; a proximal turn coaxially disposed with the central, longitudinal axis and defining a second inner diameter, wherein the proximal turn has a first end portion and a second end portion each disposed along the second inner diameter; and a spacer extending linearly along the inner lumen between the first end portion of the proximal turn and the second end portion of the distal turn an axial distance along the central, longitudinal axis.
  • a docking device for a prosthetic implant comprises a wire having: a single, distal turn; a single, proximal turn; a leading turn extending distally from the single, distal turn; an ascending segment disposed proximally to the single, proximal turn; and a stabilization turn extending proximally from the ascending segment, wherein the single, distal turn and the single, proximal turn are configured to define a lumen with a central, longitudinal axis, and wherein the single, proximal turn is offset an axial distance from the single, distal turn along the central, longitudinal axis by a spacer extending linearly along the lumen.
  • a docking device of a prosthetic implant comprises an outflow support portion; an inflow support portion; and an axial spacer portion extending between the outflow support portion and the inflow support portion, wherein the outflow support portion extends circumferentially at least 360 degrees, defines a first portion of a lumen, and comprises a first inner diameter, wherein the inflow support portion extends circumferentially greater than 270 degrees and less than 370 degrees, defines a second portion of the lumen radially aligned with the first portion of the lumen, and comprises a second inner diameter equal or substantially equal to the first inner diameter, and wherein the axial spacer portion extends circumferentially less than 90 degrees and is radially aligned with the first portion of the lumen and the second portion of the lumen.
  • a docking device of a prosthetic implant comprises one or more of the components recited in Examples 1-29, 36-43, and 45 below.
  • a method of fabricating a docking device can comprise forming a wire with a distal turn and forming the wire with a proximal turn. In addition to these steps, a method of fabricating a docking device can further comprise one or more of the steps disclosed herein.
  • the distal turn and the proximal turn can together define a lumen with a central, longitudinal axis and an inner diameter and the method can comprise forming the wire with a spacer extending linearly between the distal turn and the proximal turn at a radial distance from the central, longitudinal axis along the inner diameter of the lumen.
  • the method can comprise extending a cover over at least a portion of the wire between a distal end of the wire and a proximal end of the wire.
  • the method can comprise covering at least a portion of the wire with an expandable guard.
  • the method can comprise forming the wire with a first bend between the distal turn and the spacer and forming the wire with a second bend between the proximal turn and the spacer. [0047] In some examples, the method can comprise heat treating the first bend, the second bend, or both the first and second bends. [0048] In some examples, the method can comprise reducing a thickness of the wire at the first bend, the second bend, or both the first and second bends.
  • a method of fabricating a docking device comprises: forming a wire with a distal turn; forming the wire with a proximal turn, where the distal turn and the proximal turn together define a lumen with a central, longitudinal axis and an inner diameter; and forming the wire with a spacer extending linearly between the distal turn and the proximal turn at a radial distance from the central, longitudinal axis along the inner diameter of the lumen.
  • a method of fabricating a docking device comprises one or more of the steps recited in Examples 30-35 and 44 below.
  • FIG.1 is a perspective view of a wire of a docking device, according to an example.
  • FIG.2 is a perspective view of a docking device comprising the wire of FIG.1.
  • FIG.3A is a cross-sectional view of the docking device taken along line 3A-3A depicted in FIG.2.
  • FIG.3B is a cross-sectional view of the docking device taken along the same line as in FIG.3A, except in FIG.3B, the docking device is in a delivery configuration.
  • FIG.4 is a perspective view of a wire of a docking device, according to an example.
  • FIG.5 is a perspective view of a wire of a docking device, according to an example.
  • FIG.6 is a schematic view showing a delivery apparatus and the docking device of FIG.2 during an implantation procedure within a patient’s native mitral valve, according to an example.
  • FIG.7 is a perspective view of a prosthetic heart valve, according to an example.
  • FIG.8 is a perspective view of the prosthetic heart valve of FIG.7 in the docking device of FIG.2.
  • DETAILED DESCRIPTION General Considerations [0061] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another.
  • proximal refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site.
  • docking devices can be used in conjunction with expandable prosthetic implants, such as prosthetic valves.
  • the docking devices can be used at an implantation site (for example, a native valve annulus of a native mitral, tricuspid, or other heart valve) to secure and stabilize the expandable prosthetic implants in place when implanted.
  • implantation site for example, a native valve annulus of a native mitral, tricuspid, or other heart valve
  • docking devices can be configured to wrap around native valve leaflets of a native valve.
  • the docking devices can provide a radially inward force on the prosthetic implant and/or, in some examples, the native valve leaflets.
  • a portion of the docking device can be configured to wrap around the native valve leaflets of the native mitral valve on a ventricular side of the native valve.
  • the expanded prosthetic valve can provide a radially outward force. The radially outward force of the expanded prosthetic valve can cooperate with the radially inward force of the docking device to hold the prosthetic valve in place.
  • an inflow end region and an outflow end region of the prosthetic valve can expand to a deployed diameter while a central region of the prosthetic valve may only partially expand. Expanding all regions of the prosthetic implant evenly can be desirable to improve flow through the prosthetic implant. [0068] Therefore, a need exists for a docking device that can secure a prosthetic implant in place while allowing portions of the prosthetic implant, such as a central region of the prosthetic implant, to evenly expand when deployed. Described herein are docking devices configured with central regions that can promote uniform expansion.
  • the prosthetic implant can be a prosthetic valve
  • the docking devices can be configured to improve expansion in a central region of the prosthetic valve while securing the prosthetic valve in place at an inflow end portion and an outflow end portion of the prosthetic valve.
  • the examples described herein are directed toward prosthetic valves, the docking devices detailed below can be used with other types of prosthetic implants, such as a stents or grafts.
  • FIG.1 shows an exemplary wire for a docking device, where the wire is configured with a distal loop, a proximal loop, and a spacer between the distal and proximal loops in lieu of additional functional loops.
  • the prosthetic implants disclosed herein may be prosthetic valves, grafts, or stents which may be used with a variety of implant delivery apparatuses and implanted via various delivery procedures, examples of which will be discussed in more detail below.
  • the disclosed prosthetic implants can be prosthetic valves.
  • the prosthetic valves can be implanted within a docking device that is implanted within a native heart valve or a vessel.
  • the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No.2017/0231756, which is incorporated by reference herein.
  • the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. WO2020/247907, which is incorporated by reference herein.
  • the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No. 2019/0000615, which is incorporated by reference herein.
  • a docking device can comprise a wire 100 with a distal end 100d and a proximal end 100p, where the wire 100 can be made from a shape memory material (e.g., Nitinol) that is shape-set into a deployed configuration as seen in FIG.1.
  • the wire 100 can assume a three-dimensional arrangement (e.g., a substantially coiled shape) having a plurality of turns defining an inner lumen (also referred to herein as a “lumen”) Lw with a central, longitudinal axis 101 and a lumen inner diameter.
  • a docking device comprising the wire 100 can be straightened and/or bent into other shapes during delivery through a body.
  • the wire can return to its deployed, shape-set configuration (e.g., the substantially coiled or helical shape shown in FIG.1) when it exits and is no longer constrained by a delivery sleeve.
  • a distal end portion of the wire 100 in the deployed, shape- set configuration can have a leading turn 102 extending distally to the distal end 100d of the wire 100.
  • a proximal end portion of the wire 100 in the deployed configuration can have a stabilization turn 104 extending proximally to the proximal end 100p of the wire 100.
  • the leading and stabilization turns 102, 104 can be partial turns around the central, longitudinal axis 101.
  • leading and stabilization turns 102, 104 can extend or be rotated less than 360 degrees, such as in the ranges of 45-90 degrees, 90-180 degrees, 180- 240 degrees, or 240-270 degrees, etc. around the central, longitudinal axis 101.
  • the wire 100 can further have a distal turn (also referred to herein as a “first turn,” a “single, distal turn,” or an “outflow support portion”) 106, a proximal turn (also referred to herein as a “second turn,” a “single, proximal turn,” or an “inflow support portion”) 108, an ascending segment 109, and a spacer (also referred to herein as an “axial spacer”) 110 when in the deployed, shape-set configuration of FIG.1.
  • the distal turn 106 can be a single, full turn or loop around the central, longitudinal axis 101.
  • the distal turn 106 can extend in a substantially circular fashion approximately 360 degrees (i.e., in a full and complete circle) circumferentially around the central, longitudinal axis 101 in a first diameter 111. In some examples, the distal turn can extend between 350-370 degrees or between 355-365 degrees circumferentially around the central, longitudinal axis 101. As shown in FIG.1, the distal turn 106 can be disposed in a first plane P1, where the first plane P1 can be normal to the central, longitudinal axis 101. [0077] The proximal turn 108 can be a single turn extending around the central, longitudinal axis 101.
  • the proximal turn 108 can extend in a substantially circular fashion greater than 270 degrees and less than 370 degrees circumferentially around the central, longitudinal axis 101 (e.g., less than a full and complete circle in some instances).
  • the proximal turn 108 can extend circumferentially around the central, longitudinal axis 101 between 315- 370 degrees, 320-350 degrees, 330-360 degrees, or between 350-370 degrees, etc. around the central, longitudinal axis 101 in a second diameter 112.
  • the proximal turn can extend circumferentially around the central, longitudinal axis 101 between 355-365 degrees, which can be advantageous for retention.
  • the distal turn 106 can be coaxial with the proximal turn 108 and the central, longitudinal axis 101. Additionally, the proximal turn 108 can be disposed in a second plane P2, where the second plane P2 can be parallel to the first plane and normal to the central, longitudinal axis 101. [0078] In some examples, the first plane P1, the second plane P2, or both the first and second planes P1, P2 can be disposed at an angle with respect to each other and/or the central, longitudinal axis 101. [0079] In some examples, the distal turn 106 and the proximal turn 108 can have an irregular or non-circular shape (e.g., D-shaped).
  • the leading turn 102 can extend distally from a first end portion 114 of the distal turn 106.
  • the leading turn 102 can help more easily guide the corresponding docking device around and/or through chordae tendineae of a native valve and around the native leaflets of the native valve (for example, a native mitral valve, tricuspid valve, etc. as described above).
  • the leading turn 102 can have a larger diameter than the first diameter 111 of the distal turn 106 as shown in in FIG.1.
  • the leading turn 102 can be disposed in the first plane P1.
  • the stabilization turn 104 can extend proximally from a proximal end portion 119 of the ascending segment 109 and be disposed in a third plane P3.
  • the third plane P3 can be parallel to the first and second planes P1, P2 and normal to the central, longitudinal axis 101.
  • the stabilization turn 104 can be configured to help stabilize the corresponding docking device in the desired position.
  • the diameter of the stabilization turn 104 can be larger (e.g., at least 2 mm larger in diameter) than the second diameter 112 of the proximal turn 108 so that the stabilization turn 104 can flare or extend outwardly to abut or push against surrounding walls of native tissue (e.g., a heart, for example, in an atrium) in which the corresponding docking device is deployed, thereby improving the ability of the docking device to stay in its desired position prior to the implantation of a prosthetic valve.
  • the diameter of the stabilization turn 104 can be desirably larger than the annulus, native valve plane, and/or atrium for better stabilization.
  • the stabilization turn 104 can have a diameter that is equal or substantially equal (e.g., within +/- 2 mm) to the second diameter 112 of the proximal turn 108, as shown in FIG.1.
  • the ascending segment 109 of the wire 100 is disposed between the proximal turn 108 and the stabilization turn 104.
  • the ascending segment 109 extends from a second end portion 116 of the proximal turn 108 and, as such, a distal end portion 118 of the ascending segment 109 is disposed at a radial distance from the central, longitudinal axis 101 corresponding to a radius of the second diameter 112.
  • the ascending segment 109 can extend axially in a direction parallel to the central, longitudinal axis 101, spacing the stabilization turn 104 (i.e., the third plane P3) an axial distance 120 from the proximal turn 108 (i.e., the second plane P2).
  • the proximal end portion 119 of the ascending segment 109 is disposed at a radial distance from the central, longitudinal axis 101 corresponding to a radius of second diameter 112.
  • the ascending segment 109 can be oriented at an angle with respect to the central, longitudinal axis 101 such that the ascending segment 109 is canted or sloped.
  • the slope of the ascending segment 109 and the radial distance of the proximal end portion 119 of the ascending segment 109 from the central, longitudinal axis 101 can be specified to position the stabilization turn 104 within an implantation site, such as a heart, in a specific orientation, for example, into abutment against surrounding walls of native tissue as described above.
  • the spacer 110 is disposed between the distal turn 106 and the proximal turn 108, extending between a second end portion 126 of the distal turn 106 and a first end portion 128 of the proximal turn 108.
  • a distal end portion 132 of the spacer 110 is disposed at a radial distance from the central, longitudinal axis 101 corresponding to a radius of the first diameter 111 and a proximal end portion 136 of the spacer 110 is disposed at a radial distance from the central, longitudinal axis 101 corresponding to a radius of the second diameter 112.
  • the spacer 110 can be absent any turns and can extend linearly along an axis 138 in a direction parallel to the central, longitudinal axis 101 and normal to the first and second planes P1, P2, generally along the inner diameter defined by the inner lumen Lw.
  • the spacer 110 can orient the proximal turn 108 at an axial distance 140 from the distal turn 106.
  • the axis 138 of the spacer 110 can be disposed at an angle along the inner diameter of the inner lumen L w with respect to the central, longitudinal axis 101 and the first and second planes P1, P2.
  • the first and second diameters 111, 112 can be equal or substantially equal (e.g., within +/- 1 mm or within +/- 0.5 mm).
  • the first and second diameters 111, 112 can be different, with either the first diameter 111 being larger than the second diameter 112, or vice versa.
  • the first and second diameters 111, 112 can be specified to suit requirements of a particular prosthetic valve (such as for example, an outer diameter, a desired inner radial force, or the like).
  • a particular prosthetic valve such as for example, an outer diameter, a desired inner radial force, or the like.
  • the inner diameter of the inner lumen Lw formed by the wire 100 can vary axially along the central, longitudinal axis 101 and be generally selected based on the size of the desired corresponding docking device and the prosthetic valve to be implanted.
  • the distal turn 106 can define a first portion of the inner lumen Lw formed by the wire 100 and the proximal turn 108 can define a second portion inner lumen Lw formed by the wire 100, wherein the second portion of the inner lumen Lw can be radially aligned with the first portion of the inner lumen L w .
  • at least portions of the wire 100 between the distal and proximal ends 100d, 100p can have covers.
  • the corresponding docking device comprises the wire 100 with any such covers.
  • the inner lumen L w formed by the wire 100 relates to an inner lumen (also referred to herein as a “lumen”) Ld of the corresponding docking device.
  • an inner diameter of the docking device depends on the inner lumen Lw of the corresponding shape-set wire 100 and thicknesses of any covers protruding into the inner lumen L w of the wire 100. Therefore, the first and second diameters 111, 112 can be specified taking into consideration any covers to be included with the corresponding docking device. [0089] For example, the first and second diameters 111, 112 can be specified and configured such that an inner diameter of the corresponding docking device is smaller than an outer diameter of the prosthetic valve when the prosthetic valve is radially expanded. A smaller inner diameter, in some instances, can better hold the prosthetic valve in place.
  • the first diameter 111 can measure between 18-25 mm or between 20-23 mm (e.g., 21.7 mm +/- 0.9 mm). In some examples, the second diameter 112 can measure between 18- 25 mm or between 20-23 mm (e.g., 21.7 mm +/- 0.9 mm).
  • a length of the spacer 110, and the distance between the first and second planes P1, P2, can be specified to suit requirements of the corresponding prosthetic valve (such as for example, axial length, or the like).
  • the axial distance between the first and second planes P1, P2 can measure between 1.5-4.5 mm, 2-4 mm, 2-3 mm, or 3-4 mm.
  • the spacer 110 is free of any functional turns and can extend in a substantially linear fashion when deployed, generally along the inner diameter of the inner lumen L w , the spacer 110 can be arranged to impart little or no inward radial force on the native valve it surrounds. That is, the spacer 110 can contribute a reduced inward radial force in comparison to the inward radial force provided by the distal turn 106 and the proximal turn 108. As such, a prosthetic valve in a central region of the spacer 110 can expand more freely. [0091] As seen in FIG.1, the spacer 110 can have a distal bend 150 transitioning the spacer 110 to the distal turn 106.
  • the spacer 110 can have a proximal bend 152 transitioning the spacer 110 to the proximal turn 108.
  • the ascending segment 109 can have a distal bend 160 transitioning the ascending segment 109 to the proximal turn 108.
  • the ascending segment 109 can have a proximal bend 162 transitioning the ascending segment 109 to the stabilization turn 104.
  • the wire 100 when the wire 100 is straightened and/or bent into other shapes, for instance during delivery, the wire 100 can undergo strain, particularly in areas with relatively sharp curves such as at the distal and proximal bends 150, 152 of the spacer 110 and/or the distal and proximal bends 160, 162 of the ascending segment 109.
  • regions of the distal and proximal bends 150, 152 of the spacer 110 and/or the distal and proximal bends 160, 162 of the ascending segment 109 can be heat treated to increase elasticity and reduce localized stresses, preventing or reducing the likelihood of cracking or fracture.
  • Examples of wires with heat treatment are disclosed in U.S. Provisional Application No.63/574,769, filed April 04, 2024, which is incorporated by reference herein.
  • a thickness of the wire 100 in regions of the distal and proximal bends 150, 152 of the spacer 110 and/or the distal and proximal bends 160, 162 of the ascending segment 109 can be reduced (e.g., in a grinding operation) to increase localized elasticity and reduce stresses.
  • Examples of wires with reduced diameter are disclosed in U.S. Patent No.10,463,479, which is incorporated by reference herein.
  • FIG.2 shows a docking device 200 comprising the wire 100 of FIG.1.
  • the docking device 200 can be configured and deployed such as disclosed in U.S. Publication No.2023/0255755 and PCT Publication No. WO2022/087336, which are incorporated by reference herein.
  • the docking device 200 can comprise the wire 100 and a plurality of covers.
  • At least a portion of the wire 100 of FIG.1 can be surrounded by a first cover 212 forming a covered wire assembly 202 (also referred to herein as a “wire assembly”).
  • the first cover 212 can have a tubular shape and thus can also be referred to as a “tubular member.”
  • the first cover 212 can cover an entire length of the wire 100 as shown in FIG.2.
  • the first cover 212 can cover only a selected portion or portions of the wire 100.
  • the first cover 212 can be coated on and/or bonded on wire 100.
  • the first cover 212 can be a cushioned, padded-type layer protecting the wire 100.
  • the first cover 212 can be constructed of various native and/or synthetic materials.
  • the first cover 212 can include expanded polytetrafluoroethylene (ePTFE).
  • the first cover 212 can be configured to be fixedly attached to the wire 100 (e.g., by means of textured surface resistance, suture, glue, thermal bonding, or any other means) so that relative axial movement between the first cover 212 and the wire 100 is restricted or prohibited.
  • the docking device 200 can further comprise a guard assembly (also referred to herein as a “guard”) 204.
  • the guard 204 when the docking device 200 is in the deployed configuration, can be configured to cover a portion of the wire assembly 202 corresponding to the proximal turn 108 of the wire 100.
  • a first end of the guard 204 can be fixed to a portion of the wire assembly 202 corresponding to the first end portion 128 of the proximal turn 108.
  • the second end of the guard 204 can extend around the wire assembly 202 corresponding to the proximal turn 108, up to the first end portion 116.
  • the guard 204 can extend approximately 270 degrees from the first end portion 128 of the proximal turn 108 around the central, longitudinal axis Ld of the docking device 200 along the wire assembly 202. In some examples, the guard 204 can extend between 90 and 120 degrees from the first end portion 128, between 120 and 180 degrees from the first end portion 128, or between 180 and 270 degrees from the first end portion 128. [0100] As seen in FIGS.3A-3B, the guard 204 can comprise an expandable member 216 and a second cover 218 (also referred to as a “outer cover”) surrounding an outer surface of the expandable member 216.
  • the first cover 212 can extend (completely or partially) through the expandable member 216.
  • the expandable member 216 can extend radially outwardly from the wire assembly 202 (and the first cover 212) and be movable between a radially compressed (and axially elongated) state and a radially expanded (and axially foreshortened) state. That is, the expandable member 216 can axially foreshorten when it moves from the radially compressed state to the radially expanded state and can axially elongate when it moves from the radially expanded state to the radially compressed state.
  • the expandable member 216 can be radially compressed by the delivery sleeve and remain in the radially compressed (and axially elongated) state.
  • the radially compressed (and axially elongated) expandable member 216 can contact the first cover 212 surrounding the wire assembly 202 so that no gap or cavity exists between the first cover 212 (and/or the wire assembly 202) and the expandable member 216, as shown in FIG.3B.
  • the expandable member 216 can radially expand (and axially foreshorten) so that a gap or cavity 211 can be created between the first cover 212 and the expandable member 216, as shown in FIG.3A.
  • the guard member 204, the first cover 212, the second cover 218, and the expandable member 216 can comprise additional features as described in U.S. Publication No.2023/0255755 and PCT Publication No. WO2022/087336.
  • the inner lumen Lw formed by the wire 100 relates to the inner lumen L d of the corresponding docking device 200.
  • an inner diameter of the inner lumen Ld of the docking device 200 can depend on the inner lumen Lw of the corresponding wire 100 and thicknesses of the first cover 212 and the guard 204 when the expandable member 216 is radially expanded.
  • the thicknesses of the guard 204, the first cover 212, the second cover 218, and the expandable member 216 can be specified along with the first and second diameters 111, 112 to ensure sufficient radial tension between the docking device 200 and a prosthetic valve to better hold the prosthetic valve in place.
  • a radius of a wire bend can be selected to reduce localized stresses and strains when in a straightened configuration (e.g., a delivery configuration).
  • a wire 300 has an alternate shape-set, delivery configuration comprising a spacer 310 with a distal bend 350 and a proximal bend 352 forming distal and proximal transitions, respectively.
  • Features and portions of the wire 300 in FIG.4 correspond to features and portions of the wire 100 of FIG.1 and, as such, reference numbers for the wire 300 correspond to reference numbers for the wire 100.
  • the spacer 310 of the wire 300 corresponds to the spacer 110 of the wire 100.
  • the radii of the distal and proximal bends 350, 352 of the spacer 310 of the wire 300 are shown larger than the radii of the distal and proximal bends 150, 152 of the spacer 110 of the wire 100.
  • the radius of the distal bend 350, the radius of the proximal bend 352, or both the radii of the distal and proximal bends 350, 352 can be specified to optimize and/or reduce localized stresses and strains in those areas.
  • a wire spacer can be disposed at an angle.
  • a wire 400 can have an alternate shape-set, delivery configuration comprising a spacer 410.
  • the spacer 410 can extend generally along the inner diameter of the inner lumen Lw and have an axis 438 disposed at an angle 470 with respect to the central, longitudinal axis 401 of the wire 400.
  • the wire 400 can assume a three-dimensional arrangement (e.g., a substantially coiled shape) having a plurality of turns defining an inner lumen Lw with a central, longitudinal axis 401 and a lumen inner diameter.
  • FIG.5 correspond to features and portions of the wire 100 of FIG.1 and, as such, reference numbers for wire 400 correspond to reference numbers for wire 100.
  • the spacer 410 of the wire 400 corresponds to the spacer 110 of the wire 100.
  • descriptions above regarding the wire 100 apply to the corresponding features of the wire 400 and are incorporated into the description herein.
  • the angle 470 of the spacer 410 with respect to the central, longitudinal axis 401 can be greater than 0 degrees and less than 45 degrees, for example, between 25-40 degrees, 15-30 degrees, 15-45 degrees, or 10-45 degrees.
  • a slope of the spacer 410 can be specified as a circumferential span in degrees around the central, longitudinal axis 401.
  • a distal end of the spacer 410 can be defined where a distal bend 450 tangentially meets a linear portion of the spacer 410.
  • a proximal end of the spacer 410 can be defined where a proximal bend 452 tangentially meets the linear portion of the spacer 410.
  • the circumferential span can be defined as the distance between the distal and proximal ends of the spacer 410 projected onto a circumference of the wire 400 about the central, longitudinal axis 401. In some examples, the circumferential span can extend less than 45 degrees around the central, longitudinal axis 401. In some examples, the circumferential span can extend less than 20 degrees around the central, longitudinal axis 401. In some examples, the circumferential span can extend less than 10 degrees around the central, longitudinal axis 401. In some examples, the circumferential span can extend less than 5 degrees around the central, longitudinal axis 401.
  • the angle 470 of the axis 438 can result in the distal bend 450 and the proximal bend 452 configured with larger radii compared to the distal and proximal bends 350, 352 of the wire 300 and the distal and proximal bends 150, 152 of the wire 100.
  • the larger radii can lead to reduced stresses and strains in areas of the distal and proximal bends 450, 452 when the wire 400 is in a straightened and/or delivery configuration, thus improving resistance to cracking or fracture.
  • a radius of the distal bend 450 can measure between 5-16 mm, 6-15 mm, 7-15 mm, or 8-13 mm.
  • a radius of the proximal bend 452 can measure between 5-16 mm, 6-15 mm, 7-15 mm, or 8-13 mm.
  • the angle 470 of the axis 438 of the spacer 410 can also result in a proximal turn 408 with an incomplete, circular span. That is, because the spacer 410 is disposed at the angle 470 with respect to the central, longitudinal axis 401, the proximal turn 408 between a first end portion 428 and a second end portion 416 can extend less than 360 degrees in a circular fashion around the central, longitudinal axis 401.
  • the proximal turn 408 between the first end portion 428 and the second end portion 416 can extend 280-330 degrees in a circular loop circumferentially around the central, longitudinal axis 401.
  • the proximal turn 408 can extend between 280-300 degrees or between 300-330 degrees circumferentially about the central, longitudinal axis 401.
  • the angle 470, the distal and proximal bends 450, 452, and the circular span of the proximal turn 408 around the central, longitudinal axis 401 can be specified to optimize the stresses and strains within the wire 400 and the inward radial force provided by the spacer 410, the distal turn 406, and the proximal turn 408.
  • FIG.6 depicts a portion of a transcatheter heart valve replacement procedure utilizing a docking device, for example, the docking device 200.
  • FIG.6 illustrates the procedure using the docking device 200, it is understood that any docking device and wire (such as wires 100, 300, or 400 for example) disclosed herein can be utilized.
  • a user delivers and implants the docking device 200 at a patient’s native heart valve, for example a native mitral valve as shown in FIG.5, using a docking device delivery apparatus 500.
  • the docking device 200 in this example can expand to the shape-set, deployed configuration as shown in FIG.2, encircling the native valve leaflets and/or the native chordae tendineae of the native mitral valve.
  • the docking device delivery apparatus 500 can be removed from the patient, leaving the docking device 200 secured at the implantation site.
  • a prosthetic valve for example a prosthetic valve 600 as shown in FIG.7 or any prosthetic valve described herein, can be implanted within the native valve and the docking device 200 using a prosthetic valve delivery apparatus. Once delivered to the implantation site at the native valve, the prosthetic valve 600 can be expanded from a collapsed, delivery configuration into a deployed configuration as shown in FIG.8 within the deployed docking device 200.
  • FIG.8 depicts the prosthetic valve 600 expanded within the docking device 200 with the native valve (for example, native valve leaflets and/or chordae tendineae) and surrounding anatomy omitted for clarity.
  • a portion of the docking device 200 corresponding to the distal turn 106 can be configured to encircle an outflow end portion 610 of the prosthetic valve 600.
  • a portion of the docking device 200 corresponding to the ascending segment 109 can be configured to extend along an inflow end portion 620 of the prosthetic valve 600.
  • a portion of the docking device 200 corresponding to the spacer 110 can be configured to extend along a central region 630 of the prosthetic valve 600.
  • the portion of the docking device 200 corresponding to the spacer 110 is free of any turns and extends in a substantially linear fashion when deployed rather than circumferentially, the portion of the docking device 200 corresponding to the spacer 110 can impart a reduced inward radial force on the native valve and/or the prosthetic valve 600 it surrounds.
  • the central region 630 of the prosthetic valve 600, across which the portion of the docking device 200 corresponding to the spacer 110 extends can expand radially, which can promote uniform expansion throughout the prosthetic valve 600.
  • the portions of the docking device 200 corresponding to the distal and proximal turns 106, 108 can circumferentially secure the prosthetic valve 600 in place.
  • the wires 300 or 400 can be used in lieu of wire 100 in the docking device 200 and, as such, the central region 630 of the prosthetic valve 600 across which the portion of the docking device 200 corresponding to the spacers 310 or 410 extends, can be similarly free to expand radially.
  • the examples described herein are drawn primarily toward prosthetic valves within docking devices, the docking devices can be used with other types of prosthetic implants such as stents or grafts.
  • a central portion of a docking device can be configured with a linear spacer to promote even prosthetic implant expansion for improved flow.
  • Delivery Techniques [0122] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta.
  • the prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand).
  • a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve.
  • a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.
  • the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus.
  • the prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve.
  • a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.
  • the prosthetic valve For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus.
  • the prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve.
  • a similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.
  • Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.
  • the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature.
  • the disclosed delivery approaches are not intended to be limited.
  • Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.
  • Sterilization Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat/thermal, pressure, steam, radiation, and/or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat/thermal sterilization include steam sterilization and autoclaving.
  • Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam.
  • Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Additional Examples of the Disclosed Technology [0128] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.
  • Example 1 A docking device for securing a prosthetic heart valve at a native heart valve, the docking device comprising: a wire defining a lumen with a central, longitudinal axis, the wire having: a first turn disposed around a first portion of the prosthetic heart valve; a second turn disposed around a second portion of the prosthetic heart valve; and a spacer extending between the first turn and the second turn, wherein the first turn, the second turn, and the spacer are configured to contact native leaflets.
  • Example 3 The docking device of any example herein, particularly example 2, wherein the first length extends at least 360 degrees circumferentially around the central, longitudinal axis. [0132] Example 4.
  • Example 5 The docking device of any example herein, particularly any one of examples 2-3, wherein the second length extends greater than 270 degrees and less than 370 degrees circumferentially around the central, longitudinal axis.
  • Example 5 The docking device of any example herein, particularly any one of examples 1-4, wherein the spacer extends parallel to the central, longitudinal axis.
  • Example 6 The docking device of any example herein, particularly any one of examples 1-4, wherein the spacer is disposed at an angle with respect to the central, longitudinal axis.
  • Example 7 Example 7.
  • Example 8 The docking device of any example herein, particularly any one of examples 1-7, wherein a proximal-most portion of the docking device is configured to contact native tissue in a patient’s left atrium. [0137] Example 9.
  • a docking device for a prosthetic implant comprising: a wire having a distal turn and a proximal turn, wherein the distal turn and the proximal turn define a lumen with a central, longitudinal axis and a lumen inner diameter, and wherein the proximal turn is offset an axial distance from the distal turn along the central, longitudinal axis by a spacer disposed linearly at a constant radial distance from the central, longitudinal axis along the lumen inner diameter.
  • Example 12 The docking device of any example herein, particularly any one of examples 9-10, wherein the spacer is disposed at an angle with respect to the central, longitudinal axis.
  • Example 12 The docking device of any example herein, particularly example 11, wherein the angle is greater than 0 degrees and less than 45 degrees.
  • Example 13 The docking device of any example herein, particularly example 11, wherein the angle is greater than 0 degrees and less than 45 degrees.
  • a docking device for a prosthetic implant comprising: a wire arranged to define an inner lumen with a central, longitudinal axis, the wire having: a distal turn coaxially disposed with the central, longitudinal axis and defining a first inner diameter, wherein the distal turn has a first end portion and a second end portion each disposed along the first inner diameter; a proximal turn coaxially disposed with the central, longitudinal axis and defining a second inner diameter, wherein the proximal turn has a first end portion and a second end portion each disposed along the second inner diameter; and a spacer extending linearly along the inner lumen between the first end portion of the proximal turn and the second end portion of the distal turn an axial distance along the central, longitudinal axis.
  • Example 14 The docking device of any example herein, particularly example 13, wherein the first inner diameter and the second inner diameter are equal or substantially equal.
  • Example 15 The docking device of any example herein, particularly any one of examples 13-14, wherein the spacer extends parallel to the central, longitudinal axis.
  • Example 16 The docking device of any example herein, particularly any one of examples 13-14, wherein the spacer is disposed at an angle with respect to the central, longitudinal axis.
  • Example 17 The docking device of any example herein, particularly example 16, wherein the angle is greater than 0 degrees and less than 45 degrees.
  • Example 19 The docking device of any example herein, particularly any one of examples 13-17, wherein the distal turn extends at least 360 degrees circumferentially around the central, longitudinal axis.
  • Example 19 The docking device of any example herein, particularly any one of examples 13-18, wherein the proximal turn extends greater than 270 degrees and less than 370 degrees circumferentially around the central, longitudinal axis.
  • Example 20 The docking device of any example herein, particularly any one of examples 13-19, wherein the wire further has a leading turn extending distally from the distal turn, an ascending segment extending proximally from the proximal turn, and a stabilization turn extending proximally from the ascending segment.
  • Example 21 Example 21.
  • Example 22 The docking device of any example herein, particularly any one of examples 13-20, further comprising at least one cover disposed over at least a portion of the wire between a distal end of the wire and a proximal end of the wire.
  • Example 22 The docking device of any example herein, particularly any one of examples 13-21, further comprising an expandable guard disposed over at least a portion of the wire.
  • Example 23 The docking device of any example herein, particularly any one of examples 13-22, wherein the distal turn is disposed in a first plane and the proximal turn is disposed in a second plane parallel to the first plane.
  • Example 24 Example 24.
  • a docking device for a prosthetic implant comprising: a wire having: a single, distal turn; a single, proximal turn; a leading turn extending distally from the single, distal turn; an ascending segment disposed proximally to the single, proximal turn; and a stabilization turn extending proximally from the ascending segment, wherein the single, distal turn and the single, proximal turn are configured to define a lumen with a central, longitudinal axis, and wherein the single, proximal turn is offset an axial distance from the single, distal turn along the central, longitudinal axis by a spacer extending linearly along the lumen.
  • Example 26 The docking device of any example herein, particularly example 24, wherein the single, proximal turn and the single, distal turn have equal or substantially equal inner diameters.
  • Example 26 The docking device of any example herein, particularly any one of examples 24-25, wherein the spacer extends parallel to the central, longitudinal axis.
  • Example 27 The docking device of any example herein, particularly any one of examples 24-25, wherein the spacer is disposed at an angle with respect to the central, longitudinal axis.
  • Example 28 Example 28.
  • Example 29 The docking device of any example herein, particularly any one of examples 24-27, further comprising a first bend disposed between the single, distal turn and the spacer and a second bend disposed between the single, proximal turn and the spacer.
  • Example 29 The docking device of any example herein, particularly example 28, wherein the first bend, the second bend, or both the first and second bends have a radius of 4- 16 mm.
  • Example 30 The docking device of any example herein, particularly any one of examples 24-27, further comprising a first bend disposed between the single, distal turn and the spacer and a second bend disposed between the single, proximal turn and the spacer.
  • a method of fabricating a docking device comprising: forming a wire with a distal turn; forming the wire with a proximal turn, wherein the distal turn and the proximal turn together define a lumen with a central, longitudinal axis and an inner diameter; and forming the wire with a spacer extending linearly between the distal turn and the proximal turn at a radial distance from the central, longitudinal axis along the inner diameter of the lumen.
  • Example 31 The method of any example herein, particularly example 30, further comprising extending a cover over at least a portion of the wire between a distal end of the wire and a proximal end of the wire.
  • Example 33 The method of any example herein, particularly any one of examples 30-31, further comprising covering at least a portion of the wire with an expandable guard.
  • Example 33 The method of any example herein, particularly any one of examples 30-32, further comprising forming the wire with a first bend between the distal turn and the spacer and forming the wire with a second bend between the proximal turn and the spacer.
  • Example 34 The method of any example herein, particularly example 33, further comprising heat treating the first bend, the second bend, or both the first and second bends.
  • Example 35 The method of any example herein, particularly example 33, further comprising reducing a thickness of the wire at the first bend, the second bend, or both the first and second bends.
  • Example 36 A docking device of a prosthetic implant, the docking device comprising: an outflow support portion; an inflow support portion; and an axial spacer portion extending between the outflow support portion and the inflow support portion, wherein the outflow support portion extends circumferentially at least 360 degrees, defines a first portion of a lumen, and comprises a first inner diameter, wherein the inflow support portion extends circumferentially greater than 270 degrees and less than 370 degrees, defines a second portion of the lumen radially aligned with the first portion of the lumen, and comprises a second inner diameter equal or substantially equal to the first inner diameter, and wherein the axial spacer portion extends circumferentially less than 90 degrees and is radially aligned with the first portion of the lumen and the second portion of the lumen.
  • Example 37 The docking device of any example herein, particularly example 36, wherein the first inner diameter is within a range of 20.8-22.6 mm.
  • Example 38 The docking device of any example herein, particularly either of examples 36 or 37, wherein the second inner diameter is within a range of 20.8-22.6 mm.
  • Example 39 The docking device of any example herein, particularly any one of examples 36-38, wherein the axial spacer portion extends circumferentially less than 45 degrees.
  • Example 40 The docking device of any example herein, particularly any one of examples 36-38, wherein the axial spacer portion extends circumferentially less than 20 degrees.
  • Example 41 The docking device of any example herein, particularly any one of examples 36-38, wherein the axial spacer portion extends circumferentially less than 20 degrees.
  • Example 42 The docking device of any example herein, particularly any one of examples 36-38, wherein the axial spacer portion extends circumferentially less than 10 degrees.
  • Example 42 The docking device of any example herein, particularly any one of examples 36-38, wherein the axial spacer portion extends circumferentially less than 5 degrees.
  • Example 43 The docking device of any example herein, particularly any one of examples 36-38, wherein the axial spacer portion extends circumferentially less than 2 degrees.
  • Example 44 A method comprising sterilizing the prosthetic heart valve, apparatus, docking device, wire, and/or assembly of any example.
  • Example 45 A method comprising sterilizing the prosthetic heart valve, apparatus, docking device, wire, and/or assembly of any example.
  • the features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated.
  • any one or more of the features of one docking device can be combined with any one or more features of another docking device.
  • any one or more features of one wire can be combined with any one or more features of another wire.
  • the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Landscapes

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

Abstract

Un dispositif d'amarrage pour un implant prothétique peut comprendre un fil définissant une lumière interne avec un axe longitudinal central. Le fil peut avoir une spire distale et une spire proximale, chacune disposée de manière coaxiale avec l'axe longitudinal central. La spire distale définit un premier diamètre interne et a une première partie d'extrémité et une seconde partie d'extrémité disposées chacune le long du premier diamètre interne. La spire proximale définit un second diamètre interne et a une première partie d'extrémité et une seconde partie d'extrémité disposées chacune le long du second diamètre interne. Le fil peut avoir un élément d'espacement s'étendant linéairement sur une distance axiale le long de la lumière interne entre la première partie d'extrémité de la spire proximale et la seconde partie d'extrémité de la spire distale. La spire distale, la spire proximale et l'espaceur peuvent être configurés pour entrer en contact avec des cuspides natives.
PCT/US2025/027699 2024-05-06 2025-05-05 Dispositif d'amarrage pour un implant prothétique Pending WO2025235350A1 (fr)

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US202463643038P 2024-05-06 2024-05-06
US63/643,038 2024-05-06

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013128432A1 (fr) * 2012-02-28 2013-09-06 Mvalve Technologies Ltd. Structure de support de valvule cardiaque
US20170231756A1 (en) 2016-02-05 2017-08-17 Edwards Lifesciences Corporation Devices and systems for docking a heart valve
US20180271652A1 (en) * 2013-08-12 2018-09-27 Mitral Valve Technologies Sarl Apparatus and methods for implanting a replacement heart valve
US20190000615A1 (en) 2017-06-30 2019-01-03 Edwards Lifesciences Corporation Docking stations for transcatheter valves
US10463479B2 (en) 2016-08-26 2019-11-05 Edwards Lifesciences Corporation Heart valve docking coils and systems
WO2020247907A1 (fr) 2019-06-07 2020-12-10 Edwards Lifesciences Corporation Systèmes, dispositifs et procédés de traitement de valvules cardiaques
WO2022087336A1 (fr) 2020-10-23 2022-04-28 Edwards Lifesciences Corporation Dispositif d'accueil de valve prothétique
US20230255755A1 (en) 2020-10-29 2023-08-17 Edwards Lifesciences Corporation Apparatus and methods for reducing paravalvular leakage

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013128432A1 (fr) * 2012-02-28 2013-09-06 Mvalve Technologies Ltd. Structure de support de valvule cardiaque
US20180271652A1 (en) * 2013-08-12 2018-09-27 Mitral Valve Technologies Sarl Apparatus and methods for implanting a replacement heart valve
US20170231756A1 (en) 2016-02-05 2017-08-17 Edwards Lifesciences Corporation Devices and systems for docking a heart valve
US10463479B2 (en) 2016-08-26 2019-11-05 Edwards Lifesciences Corporation Heart valve docking coils and systems
US20190000615A1 (en) 2017-06-30 2019-01-03 Edwards Lifesciences Corporation Docking stations for transcatheter valves
WO2020247907A1 (fr) 2019-06-07 2020-12-10 Edwards Lifesciences Corporation Systèmes, dispositifs et procédés de traitement de valvules cardiaques
US20220079749A1 (en) * 2019-06-07 2022-03-17 Edwards Lifesciences Corporation Systems, devices, and methods for treating heart valves
WO2022087336A1 (fr) 2020-10-23 2022-04-28 Edwards Lifesciences Corporation Dispositif d'accueil de valve prothétique
US20230255755A1 (en) 2020-10-29 2023-08-17 Edwards Lifesciences Corporation Apparatus and methods for reducing paravalvular leakage

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