WO2018039589A1 - Heart valve docking coils and systems - Google Patents

Heart valve docking coils and systems Download PDF

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Publication number
WO2018039589A1
WO2018039589A1 PCT/US2017/048659 US2017048659W WO2018039589A1 WO 2018039589 A1 WO2018039589 A1 WO 2018039589A1 US 2017048659 W US2017048659 W US 2017048659W WO 2018039589 A1 WO2018039589 A1 WO 2018039589A1
Authority
WO
WIPO (PCT)
Prior art keywords
turn
diameter
docking device
coiled anchor
docking
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/US2017/048659
Other languages
English (en)
French (fr)
Inventor
Darshin S. PATEL
Boaz Manash
Khen PERLMUTTER
Eyal LEIBA
Yoav ROZEN
Dinesh L. SIRIMANNE
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
Priority to BR122020019883-4A priority Critical patent/BR122020019883B1/pt
Priority to EP17844506.0A priority patent/EP3451974B1/en
Priority to ES17844506T priority patent/ES2824903T3/es
Priority to SG11201901442RA priority patent/SG11201901442RA/en
Priority to MX2019002107A priority patent/MX2019002107A/es
Priority to IL298843A priority patent/IL298843B2/en
Priority to BR122020019887-7A priority patent/BR122020019887B1/pt
Priority to CA3034894A priority patent/CA3034894A1/en
Priority to IL318912A priority patent/IL318912A/en
Priority to DK17844506.0T priority patent/DK3451974T3/da
Priority to BR112019003222-3A priority patent/BR112019003222B1/pt
Priority to EP20168287.9A priority patent/EP3708121B1/en
Priority to EP20168273.9A priority patent/EP3708120B1/en
Priority to AU2017314943A priority patent/AU2017314943B2/en
Priority to JP2019511382A priority patent/JP7214626B2/ja
Priority to PL17844506T priority patent/PL3451974T3/pl
Application filed by Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Priority to MYPI2019000950A priority patent/MY200754A/en
Priority to BR122020019881-8A priority patent/BR122020019881B1/pt
Priority to CN201780061715.XA priority patent/CN109789019B/zh
Priority to EP20168290.3A priority patent/EP3711712A1/en
Publication of WO2018039589A1 publication Critical patent/WO2018039589A1/en
Priority to IL264915A priority patent/IL264915B2/en
Anticipated expiration legal-status Critical
Priority to JP2023005225A priority patent/JP2023055746A/ja
Priority to AU2023200569A priority patent/AU2023200569B2/en
Priority to JP2024190742A priority patent/JP2025023967A/ja
Priority to AU2024264649A priority patent/AU2024264649B2/en
Ceased legal-status Critical Current

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
    • 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
    • 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
    • A61F2/2436—Deployment by retracting a sheath
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0649—Coils or spirals
    • 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
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval
    • 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
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0036—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular

Definitions

  • valve replacement While open surgical procedure options are more readily available, there has been much less development in terms of commercially available ways to replace a mitral valve through catheter implantation and/or other minimal or less invasive procedures. Replacement of a mitral valve is more difficult than aortic valve replacement in many respects, for example, due to the non-circular physical structure of the mitral valve, its sub-annular anatomy, and more difficult access to the valve.
  • the various docking devices for docking a prosthetic valve at a native valve of a heart can also have a coiled anchor (e.g., which can be the same as or similar to other coiled anchors described in this disclosure) that has a proximal tip and a distal tip and at least one central turn (e.g., a full or partial central turn, which can be the same as or similar to other central turns/coils or functional turns/coils described in this disclosure) that defines a diameter.
  • the coiled anchor can also have an upper turn that is connected to the at least one central turn.
  • a cover layer can surround the coiled anchor along all or at least a part of the at least one central turn. The cover layer can be connected to the coiled anchor.
  • a docking device for docking a prosthetic valve at a native valve of a heart can have a coiled anchor that includes a hollow tube.
  • the hollow tube can have a proximal lock feature and a distal lock feature.
  • the cuts can have a pattern and shape that incorporates one or both of longitudinal and transverse cuts. Where the cuts have a pattern and shape that incorporate both longitudinal and transverse cuts, these can form teeth and grooves in the hollow tube.
  • the docking device can also have a wire, and the distal end of the wire can be secured to the distal lock feature.
  • Fig. 10 shows a perspective view of a modified version of the coil anchor of Figs. 3 to 5;
  • FIG. 11A schematically shows an open view of a laser-cut tube to be used as a coil anchor and a tensioning wire according to an embodiment of the invention
  • Fig. 13 shows a perspective view of the laser-cut coil anchor of Fig. 11 in an assembled and actuated state, and with the frame of a prosthetic valve held therein;
  • Fig. 22A shows an embodiment of a suture looped through a coiled anchor
  • Fig. 24 shows a distal end of a coil skeleton or core of a docking device according to another embodiment of the invention.
  • Fig. 25 shows a proximal end of a coil skeleton or core of a docking device according to an embodiment of the invention
  • Fig. 26 shows a proximal end of the docking device of Fig. 25, with a cover layer attached over the coil skeleton or core.
  • the distal end of the docking device 1 then circles around the mitral anatomy (e.g., native mitral leaflets and/or the chordae tendineae) located in the left ventricle, so that all or at least some of the native leaflets and/or the chordae tendineae are corralled or gathered by and held in (e.g., encircled by) the coils of the docking device 1.
  • mitral anatomy e.g., native mitral leaflets and/or the chordae tendineae
  • the docking device 1 can be more securely held or retained at a proper positioning and orientation at the native valve annulus (e.g., native mitral annulus) before the THV is implanted and expanded therein.
  • the native valve annulus e.g., native mitral annulus
  • Such self- retention of the docking device 1 will more effectively prevent undesirable shifting or tilting of the docking device 1 before the prosthetic valve is fully implanted, thereby improving performance of the implant as a whole.
  • a ventricular position of the docking device 1 does not have to be adjusted or readjusted during or after releasing the atrial portion of the docking device 1 from the delivery catheter 1010.
  • Various other methods of releasing the atrial portion of the docking device 1 can also be employed.
  • the stabilization coil/turn e.g., atrial coil
  • it can be held in place and/or
  • the delivery catheter 1010 can be removed to make room for a separate delivery catheter for delivering the THV, or in some embodiments, the delivery catheter 1010 can be adjusted and/or repositioned if the prosthetic valve is to be delivered through the same catheter 1010.
  • the guide sheath 1000 can be left in place and the prosthetic valve or THV delivery catheter can be inserted and advanced through the same guide sheath 1000 after the delivery catheter 1010 is removed.
  • Fig. 8 shows a cross-sectional view of a portion of a patient's heart with the docking device 1 of Figs. 3 to 5 positioned at the mitral position and prior to delivery of the THV.
  • the native mitral valve can still continue to operate substantially normally, and the patient can remain stable, since the valve leaflets are not substantially restrained by the docking station. Therefore, the procedure can be performed on a beating heart without the need for a heart-lung machine. Furthermore, this allows the practitioner more time flexibility to implant the valve prosthesis, without the risk of the patient being in or falling into a position of hemodynamic compromise if too much time passes between the implantation of the docking device 1 and the later valve implantation.
  • FIG. 10 shows a perspective view of a modified version of the coil anchor or docking device 1 of Figs. 3 to 5.
  • the docking device 100 in Fig. 10 has a central region 110, a lower region 120, and an upper region 130 that can be the same as or similar to the respective central, lower, and upper regions 10, 20, 30 in the previously described docking device 1.
  • the docking device 100 can include features and characteristics that are the same as or similar to features and characteristics described with respect to docking device 1, and can also be implanted using the same or similar steps.
  • the docking device 100 includes an additional extension 140 substantially positioned between the central region 110 and upper region 130.
  • the extension 140 can be angled relative to the central axis of the docking device 100, but will generally serve as a vertical or axial spacer that spaces apart the adjacent connected portions of the docking device 100 in a vertical or axial direction, so that a vertical or axial gap is formed between the coil portions on either side of the extension 140 (e.g., a gap can be formed between an upper or atrial side and a lower or ventricular side of the docking device 100).
  • the extension 140 of the docking device 100 is intended to be positioned through (e.g., crossing) or near the native valve annulus, in order to reduce the amount of the docking device 100 that passes through or pushes or rests against the native annulus when the docking device 100 is implanted. This could potentially reduce the stress or strain applied by the docking device 100 on the native mitral valve.
  • the extension 140 is positioned at and passes through or crosses at one of the
  • the finally implanted dock and valve combination should be placed high at the native valve, in some cases as high as possible, to anchor the valve to a clear zone of the native mitral leaflets.
  • the native mitral leaflets are generally smoother above the coaptation line (e.g., above where the leaflets come together when the mitral valve is closed) and rougher below the coaptation line.
  • the smoother area or zone of the native leaflets are much more collagenous and stronger, thereby providing a more secure anchoring surface for the prosthetic valve than the rougher area or zone. Therefore, in most cases, the docking device should be placed as high as possible at the native valve during insertion, while also having sufficient retention force to anchor the prosthetic valve or THV.
  • the locking wire can be in a laser-cut hypotube, or the locking wire can be in a tube that is not laser cut.
  • the locking wire can be a suture, tether, wire, strip, etc., and the locking wire can be made of a variety of materials, e.g., metal, steel, NiTi, polymer, fiber, Dyneema, other biocompatible materials, etc.
  • the docking device 200 can more effectively hold its shape and size, the radial inward pressure from the docking device 200 on the valve 40 can cause a flaring effect at the ends of the frame of the valve 40, thereby providing an even more secure hold between the docking device 200 and the valve 40.
  • the docking device 200 can be modified in various ways in other embodiments.
  • the docking device can be made from or include shape memory materials other than NiTi, or in some embodiments can be made from non- shape memory materials, such as stainless steel, from other biocompatible materials, and/or a combination of these.
  • shape memory materials other than NiTi
  • non- shape memory materials such as stainless steel
  • a similar or slightly modified docking device can also be used to dock replacement valves at other native valve sites, for example, at the tricuspid valve, pulmonary valve, or at the aortic valve.
  • the docking device 200 described above, and similar devices using a tensioning or locking wire can provide several advantages over other docking devices, such as devices where a locking wire is not used.
  • the locking wire provides a user with the ability to control an amount of the radial outward and inward forces applied on and by the docking device through effecting and adjusting the tension in the locking wire, without compromising a desired profile of the docking device or the ability to deliver the docking device through a catheter or via minimally invasive techniques.
  • Figure 11A illustrates a tensioning wire 219 that is held below the teeth 218 or looped around teeth 218, then pulled through the opening 217 and crimped at the opening 217 to set the shape of the docking device.
  • the laser cuts in the tube make the docking device more flexible, enabling the docking device to be introduced through catheters that may have relatively small bend radii at certain locations.
  • Various mechanisms can further be incorporated or added to one or more of the docking devices described herein (e.g., herein docking devices 1, 100, 200, 300, 400, 500, 600, and 1100), for example, in order to increase the retention force between the docking device and a replacement valve that is expanded therein.
  • the docking devices described herein e.g., herein docking devices 1, 100, 200, 300, 400, 500, 600, and 1100
  • coil-shaped docking devices will have two open or free ends after implantation.
  • the coil can partially unwind and increase in diameter due to the outward pressure applied by the expanding valve on the coil, which in turn reduces the retention force applied by the coil on the valve.
  • the docking device 300 in Fig. 14 includes a main coil 310 (which can be similar in size and shape to one of the docking devices described above) and anchors 320 extending from the two free ends of the coil 310.
  • the anchors 320 are sized, shaped, or otherwise configured to embed themselves into the surrounding tissue (e.g., into the atrial and/or ventricular walls), for example, when a replacement valve is expanded in the docking device 300.
  • the anchors 320 can be barbed to promote ingrowth once the anchors 320 are embedded into the heart walls or other tissue.
  • the anchors can be any of many different shapes and sizes.
  • the anchors can extend from the end or from any area near the end.
  • anchors or barbs can also be positioned at various locations along the length and outer surface of the docking device.
  • the ePTFE tube covering can be attached to the docking device coil at the coverings proximal and distal ends. It can be laser welded on to the coil, or radiopaque markers can be placed on the outside of the ePTFE tube covering or PET braid and swaged to the materials to hold them in place to the coil.
  • Fig. 19 shows a perspective view of an exemplarycoil anchor or docking device.
  • the docking device 1100 in Fig. 19 can be the same as or similar in structure to the docking device 100 in Fig. 10 described above and can include any of the features and characteristics described with respect to docking device 100.
  • Docking device 1100 can also include a central region 1110, a lower region 1120, an upper region 1130, and an extension region 1140.
  • the lower and upper regions 1120, 1130 can form larger coil diameters than the central region 1110, and the extension region 1140 can space the upper region 1130 apart from the central region 1110 in a vertical direction, also similarly as previously described.
  • the docking device 1100 can optionally further include securing holes 1164 near each of the proximal tip and distal tip .
  • the securing holes 1164 can be used to further secure the cover layer 1170 to the wire core 1160, for example, via a suture or other tie-down.
  • This and/or similar securing measures can further prevent slipping or movement between the core 1160 and the cover layer 1170 during deployment and/or retrieval of the docking device 1100.
  • the cover layer 1170 can be adhered, melted, molded, etc. around the core without suturing.
  • the release suture provides a more secure attachment of the docking device 1100 to the delivery catheter, and can also allow for a pulling retrieval of the docking device 1100 when retraction of the position of the docking device 1100, partial retrieval, or full retrieval is desired.
  • Fig. 22C illustrates a closer view of the release suture 163 looped through the bore 1162 of the docking device 1100, where the exterior of the delivery catheter 1010 has been cut away.
  • a pusher device 1165 is configured as a pusher tube with a lumen extending therethrough, e.g., from end to end. The suture in this embodiment runs through a longitudinal bore through the pusher device/tube 1165 held within the delivery catheter 1010.
  • Fig. 23 shows a distal end of a coil skeleton or core of a docking device according to another embodiment of the invention.
  • the distal end of the coil/core 710 can be made of or include Nitinol, another shape memory metal or material, and/or non-shape memory materials.
  • the distal end of the coil/core 710 has a substantially flat or rectangular cross-section, with a distal ring-shaped tip 712.
  • the sutures 930 serve to anchor and attach the cover layer 920 to the coil skeleton/core 910, while also masking or covering the sharp edges of the slit hole 912, to protect the pull wire 940 from being damaged or ruptured by the docking device 900, and conversely to protect the docking device 900 from being damaged by the pull wire 940, during retrieval or other pulling of the docking device 900.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Vehicle Body Suspensions (AREA)
  • Burglar Alarm Systems (AREA)
  • External Artificial Organs (AREA)
  • Surgical Instruments (AREA)
PCT/US2017/048659 2016-08-26 2017-08-25 Heart valve docking coils and systems Ceased WO2018039589A1 (en)

Priority Applications (25)

Application Number Priority Date Filing Date Title
JP2019511382A JP7214626B2 (ja) 2016-08-26 2017-08-25 心臓弁ドッキング・コイルとシステム
ES17844506T ES2824903T3 (es) 2016-08-26 2017-08-25 Sistemas y espirales de amarre de válvula cardíaca
SG11201901442RA SG11201901442RA (en) 2016-08-26 2017-08-25 Heart valve docking coils and systems
MX2019002107A MX2019002107A (es) 2016-08-26 2017-08-25 Bobinas y sistemas de acoplamiento de valvulas cardiacas.
IL298843A IL298843B2 (en) 2016-08-26 2017-08-25 Heart valve springs and anchoring systems
BR122020019887-7A BR122020019887B1 (pt) 2016-08-26 2017-08-25 Sistema para implantar um dispositivo de atracação
CA3034894A CA3034894A1 (en) 2016-08-26 2017-08-25 Heart valve docking coils and systems
IL318912A IL318912A (en) 2016-08-26 2017-08-25 Heart valve springs and anchoring systems
DK17844506.0T DK3451974T3 (da) 2016-08-26 2017-08-25 Hjerteklapdokningsspoler og -systemer
BR112019003222-3A BR112019003222B1 (pt) 2016-08-26 2017-08-25 Dispositivo de atracação para atracar uma válvula protética e sistema para implantaruma válvula protética
EP20168287.9A EP3708121B1 (en) 2016-08-26 2017-08-25 Heart valve docking coils and systems
EP20168273.9A EP3708120B1 (en) 2016-08-26 2017-08-25 Heart valve docking coils and systems
AU2017314943A AU2017314943B2 (en) 2016-08-26 2017-08-25 Heart valve docking coils and systems
BR122020019883-4A BR122020019883B1 (pt) 2016-08-26 2017-08-25 dispositivo de atracação para atracar uma válvula protética
CN201780061715.XA CN109789019B (zh) 2016-08-26 2017-08-25 心脏瓣膜对接线圈和系统
PL17844506T PL3451974T3 (pl) 2016-08-26 2017-08-25 Układy i spirale osadzające zastawkę serca
MYPI2019000950A MY200754A (en) 2016-08-26 2017-08-25 Heart valve docking coils and systems
BR122020019881-8A BR122020019881B1 (pt) 2016-08-26 2017-08-25 dispositivo de atracação para atracar uma válvula protética
EP17844506.0A EP3451974B1 (en) 2016-08-26 2017-08-25 Heart valve docking coils and systems
EP20168290.3A EP3711712A1 (en) 2016-08-26 2017-08-25 Heart valve docking coils and systems
IL264915A IL264915B2 (en) 2016-08-26 2019-02-19 Springs and anchoring systems for heart valves
JP2023005225A JP2023055746A (ja) 2016-08-26 2023-01-17 心臓弁ドッキング・コイルとシステム
AU2023200569A AU2023200569B2 (en) 2016-08-26 2023-02-03 Heart valve docking coils and systems
JP2024190742A JP2025023967A (ja) 2016-08-26 2024-10-30 心臓弁ドッキング・コイルとシステム
AU2024264649A AU2024264649B2 (en) 2016-08-26 2024-11-14 Heart valve docking coils and systems

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US201662380117P 2016-08-26 2016-08-26
US62/380,117 2016-08-26
US201662395940P 2016-09-16 2016-09-16
US62/395,940 2016-09-16
US15/682,287 2017-08-21
US15/682,287 US10463479B2 (en) 2016-08-26 2017-08-21 Heart valve docking coils and systems
US15/684,836 2017-08-23
US15/684,836 US10687938B2 (en) 2016-08-26 2017-08-23 Heart valve docking system

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