WO2015123607A2 - Valvule de retenue sous-valvulaire provisoire - Google Patents

Valvule de retenue sous-valvulaire provisoire Download PDF

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Publication number
WO2015123607A2
WO2015123607A2 PCT/US2015/015965 US2015015965W WO2015123607A2 WO 2015123607 A2 WO2015123607 A2 WO 2015123607A2 US 2015015965 W US2015015965 W US 2015015965W WO 2015123607 A2 WO2015123607 A2 WO 2015123607A2
Authority
WO
WIPO (PCT)
Prior art keywords
check valve
frame structure
temporary
valve
vascular
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/US2015/015965
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English (en)
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WO2015123607A3 (fr
Inventor
Ivan Vesely
Clayton COLE
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.)
ValveXchange Inc
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ValveXchange Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ValveXchange Inc filed Critical ValveXchange Inc
Publication of WO2015123607A2 publication Critical patent/WO2015123607A2/fr
Publication of WO2015123607A3 publication Critical patent/WO2015123607A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • 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
    • 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
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61F2230/0067—Three-dimensional shapes conical
    • 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
    • A61F2250/0059—Additional features; Implant or prostheses properties not otherwise provided for temporary

Definitions

  • the present disclosure relates generally to a system for performing procedures on native or prosthetic heart valves, and more particularly to the servicing, repair, or replacement of heart valves without requiring cardiopulmonary bypass.
  • valves of the heart are more difficult. This is because the valves are inside the heart and opening the heart to expose them cannot be done with the heart pumping blood.
  • the primary candidate technology for treating heart valves without stopping the heart and opening it up is the use of catheter-implantable valves. These valves are delivered through a catheter passed up through the aorta or the aortic arch, or through the apex of the heart into the ventricular cavity. These valves consist of tissue leaflets mounted on a frame that is expanded and anchored in the vicinity of the existing diseased native valve.
  • TAVI Transcatheter Aortic Valve Implantation
  • the challenge in performing TAVI is the need to perform the procedure quickly.
  • the native heart valve is crushed against the sides of the aorta, and during that process, the patient is essentially without a valve and thus without normal cardiac output flow.
  • many current generation transcatheter valves are expanded and seated in place by way of a balloon which occludes the aorta, essentially preventing any ejection of blood from the heart.
  • the physician rapidly paces the heart, dramatically reducing its contractions and preventing the pumping of blood. This is not an ideal situation for the patient, particularly if they are already ill and compromised from the underlying valvular disease.
  • Another approach has been to augment the native valve with a temporary valve to augment the pumping of blood while the native valve is in the process of being repaired, excised, or replaced with a prosthetic valve.
  • the technology presented herein is a system for augmenting cardiac function during valve procedures, such as valve excision, valve implantation, or valve leaflet replacement, by placing a temporary check valve just upstream of the valve being treated.
  • the temporary check valve is collapsible so that it can be inserted through a small incision or port in the apex of the heart or through the aorta, into the ventricular cavity.
  • Such a system thus does not require arrest or pacing of the heart and will allow such valve repair or replacement procedures to be done without concern for time or compromise to the patients' physiology.
  • a further application of the temporary check valve is in conjunction with the placement of a valve-supporting frame without the leaflets.
  • the valve supporting frame can be incrementally dilated until it fits snugly in the patient's aortic root and the appropriately sized leaflets that fit into that frame can then be delivered.
  • the patient may be without a fully functioning valve.
  • the temporary check valve may thus help provide continuous cardiac output until the final leaflet set is delivered onto the valve frame.
  • FIG. 1 A is a schematic side isometric view of an extended temporary check valve in closed position and mounted on a tool shaft passed into the interior of the heart.
  • FIG. 1 B is a cross sectional view of the temporary check valve of FIG. 1 A as indicated by line 1 B-1 B.
  • FIG. 2A is a schematic side isometric view of an extended temporary check valve in open position.
  • FIG. 2B is a cross sectional view of the temporary check valve of FIG. 2A as indicated by line 2B-2B.
  • FIG. 3 is an isometric view of the temporary check valve of FIG. 1 A shown in vivo placed in the ventricle below the aortic valve.
  • FIG. 4A is a schematic side isometric view of the temporary check valve of FIG. 2A positioned below a valve frame of a two-part valve system.
  • FIG. 4B is a cross sectional view of the temporary check valve and prosthetic device of FIG. 4A.
  • a temporary vascular check valve 100 that can be positioned upstream within a vascular structure, below an existing valve, e.g., below the aortic valve 182 in the heart 174, and augment the function of the original valve is disclosed herein in conjunction with the accompanying figures.
  • FIG. 3 is provided as reference to indicate an exemplary use of the vascular check valve 100 within the left ventricle 178 in the heart 174.
  • vascular structure is meant to include the heart 174 and structures thereof as well as blood vessels generally.
  • a temporary check valve 100 is formed primarily as a stent-like frame structure 106 and a flow restrictive sleeve 108 positioned within the interior of the frame structure 106.
  • the frame structure 106 may formed as a mesh or cage and be understood to have three primary sections: a distal barrel section 103, an intermediate funnel section 104, and a proximal collar section 126.
  • the barrel section 103 may be cylindrical in shape.
  • the funnel section 104 may be formed as a frustum that transitions at its largest diameter into the barrel section 102.
  • the collar section 126 may by formed as a smaller diameter cylindrical shape that transitions from the smallest diameter of the funnel section 104.
  • a seal ring 122 may be provided on a distal end 1 12 of the barrel section 102.
  • a collar 142 may be provided on the proximal end of the frame structure 106 to retain the collar section 126 at the relatively smaller diameter.
  • a sleeve 108 formed from multiple annular sleeve strips 1 10 of a thin, flexible material may be attached to the interior surface of the frame structure 106 along the barrel section 102 and the funnel section 104.
  • multiple annular sleeve strips 1 10 may be attached to the frame structure 106 along only the distal edges.
  • the proximal edges of the sleeve strips 1 10 are free.
  • Each of the sleeve strips 1 10 in the barrel section 102 is positioned such that the proximal edges slightly overlap the distal edges of adjacent sleeve strips 110.
  • the funnel strip 1 18 may be formed as a frustum wall and may be attached to the frame structure 106 at both the proximal and distal edges.
  • FIGS. 1 A-2B The proximal end 1 12 of the check valve 100 in FIGS. 1 A-2B is shown emerging from the introducer sheath 164 that aids in maintaining the check valve 100 in a compressed configuration, such as when the check valve 100 is inserted into the patient, or when the check valve 100 is no longer needed and is being removed.
  • the check valve 100 is uncompressed, having fully emerged from the introducer sheath 164.
  • the check valve 100 is designed to expand when positioned within a patient.
  • FIGS. 1 A-2B show the check valve 100 in its expanded configuration.
  • the frame structure 106 of the check valve 100 is designed to expand until it either reaches a predetermined size or until it contacts a surface within the patient (for example a blood vessel wall or ventricle wall 170).
  • the frame structure 106 is maintained in the compressed configuration by being sandwiched between the tool shaft 160 and introducer sheath 164.
  • the frame structure 106 may be made of a shape memory alloy that expands at body temperatures. While FIGS. 2A-2B do not show the introducer sheath 164 or the tool shaft 162, these structures would be present in practice to maintain the proximal end 1 12 of the check valve 100 in its compressed configuration.
  • the frame structure 106 defines an interior diameter, D, at the distal end 1 12 that is greater than the interior diameter d defined at its proximal, compressed end.
  • the diameter of the proximal end, d is selected to aid in mounting the check valve 100 on the tool and inside the introducer sheath 164.
  • Compression aids in inserting the check valve 100 into a patient and positioning the check valve 100 for deployment.
  • the check valve 100 is positioned between the exterior surface of the tool and an interior surface of the introducer sheath 164.
  • the check valve 100 embodiment of FIGS. 1 A-2B defines three segments: a proximal collar section 126, a distal barrel section 102, and a funnel section 104 positioned between the barrel section 102 and collar section 126.
  • the barrel section 102 has an expanded configuration
  • the collar section 126 has a compressed configuration
  • the funnel section 104 has an intermediate configuration between the compressed and expanded configurations.
  • a sliding collar 124 may be positioned at the proximal end of the check valve 100 adjacent the collar section 126.
  • the sliding collar 124 may help position the check valve 100 along the length of the insertion and guide tool and/or may aid in pushing the check valve 100 out beyond the introducer sheath 164.
  • the check valve 100 can be repositioned along the tool shaft 160 with a control structure, for example, sliders or pull wires that are attached directly to the frame or indirectly via the sliding collar 124.
  • the tool shaft 160 may facilitate the insertion or action of additional tools and may thus move along its axis further into the heart, independent of the check valve 100.
  • the check valve 100 may be positioned near a valve being replaced or repaired, with the distal end 1 12 of the check valve 100 positioned nearest that valve. At this position, the check valve 100 is designed to prevent blood from flowing through the damaged or absent valve into the area behind the check valve 100 (e.g., the left ventricle 178, when the damaged valve is the aortic valve 182). This direction of blood flow may be termed retrograde or reverse direction blood flow, and occurs, for example, when the ventricle 178 relaxes in diastole and the pressure within the ventricle 178 drops. When the check valve 100 prevents reverse blood flow, it is said to be in the "closed position," which is depicted in FIGS. 1 A and 1 B.
  • the check valve 100 is designed to allow blood to flow freely through the frame structure 106. This direction of blood flow is termed the forward direction.
  • the sleeve structure 108 helps regulate blood flow through the check valve 100.
  • the sleeve 108 as shown in FIGS. 1 A-2B comprises a plurality of sleeve strips 1 10 arranged as adjacent cylindrical sections along the inner surface of the frame structure 106 from the proximal end 1 14 to the distal end 1 12 of the frame structure 106.
  • the proximal edge of each sleeve strip 1 10 may overlap with the distal edge of the adjacent sleeve strip 1 10 proximal to it.
  • the sleeve strips 110 may be made of any suitable material that is flexible and appropriate for use in the human body. The material may be natural or synthetic, for example, pericardium or polyurethane.
  • Each sleeve strip 1 10 is secured to the interior surface of the frame structure 106 along an inner circumference at the distal edge of the sleeve strip 1 10.
  • the sleeve strips 1 10 may be secured by sutures or pins.
  • the proximal edge of each sleeve strip 1 10 remains unsecured.
  • the distal-most strip 1 16 may alternatively be attached to the seal ring 122 to prevent gaps.
  • the funnel strip 1 18, shown in FIGS. 1 A-2B positioned at or near the proximal collar section 126 is attached to the frame structure 106 at its proximal edge and/or its proximal edge remains sandwiched between an outer surface of the tool 160 and an inner surface of the introducer sheath 164.
  • each sleeve strip 1 10 is pressed against the interior surface of the frame structure 106 and its proximal edge overlaps the adjacent proximal sleeve strip 1 10. Overlap may be up to 25%-50%.
  • This arrangement of sleeve strips 1 10 seals the check valve 100 and prevents blood flowing from the interior 120 of the check valve 100, through the frame structure 106 and into the space behind the check valve 100 (e.g., the ventricular cavity).
  • FIG. 2A-B The open position is depicted in FIG. 2A-B.
  • the unsecured proximal edges of the sleeve strips 1 10 are free to move with the blood flowing through the frame structure 106 into the interior 120 of the check valve 100.
  • blood flows in the forward direction, toward the distal end 1 12 of the check valve 100 it passes through the frame structure 106 from the exterior to the interior 120 and, because each sleeve strip 1 10 is secured only at its distal end, the sleeve strips 1 10 are free to move with the blood flow and the blood can flow through the frame structure 106 and between the sleeve strips 1 10.
  • the annular seal ring 122 which is positioned at the distal end 1 12 of the frame structure 106, is generally circular in shape.
  • the seal ring 122 is generally flexible and can increase or decrease its circumference and diameter as necessary.
  • a toroidal balloon is one possible embodiment of such an annular seal ring 122.
  • the balloon can be inflated with saline, as is done in other balloon applications.
  • a tube for inflating the balloon is not shown in the figures, but can run through the interior or exterior of the frame structure 106, and can run along the outside or inside the tool shaft 160, or can be incorporated into the wall material of the tool shaft 160. As is customary in the field, these components may be made of molded or extruded plastic.
  • the annular seal ring ⁇ 22 may be an elastomeric structure such as an O-ring that is able to expand and contract to follow the varying diameters of the frame structure 106.
  • the presently disclosed check valve 100 can be designed to mate with a variety of bioprosthetic devices.
  • the seal structure may be designed to mate with the underside or base wall 154 of an existing bioprosthetic valve 150, as well as against the inner surface of a blood vessel or areas of the heart 174 such as in or near the aortic root to displace the native aortic valve leaflets.
  • the seal ring 122 is designed to be inserted into a bioprosthetic valve 150 and dilated until it fits snugly within the base wall 154 of the bioprosthetic valve 150.
  • One embodiment of the check valve 100 seal ring 122 inserted into the bioprosthetic valve 150 is shown in FIGS. 4A-B.
  • FIGS. 4A-B show the seal ring 122 in contact with one possible bioprosthetic valve 150, here a valve frame 152 of a two-part valve system. Then an appropriately sized leaflet set may then be snapped in place to repair or complete the bioprosthetic valve 150.
  • the frame structure is manufactured of a collapsible mesh. In most
  • the collapsible mesh may be made of a biocompatible metal or polymer.
  • the collapsible mesh is made from a shape memory metal alloy, for example, shape memory alloys comprising nickel and titanium such as Nitinol, and is configured to expand radially to form a larger circumference when exposed to body temperature.
  • the frame structure is a diamond-shaped collapsible mesh that may be compressed and expanded radially. When in a compressed state, the length of the frame structure 106 may be longer than the length of the frame structure 106 when it is in the radially expanded state.
  • the collapsible mesh is compressed circumferentially at the collar section 126 by a introducer sheath 164.
  • the introducer sheath 164 When the introducer sheath 164 is retracted or the frame structure is advanced beyond the introducer sheath 164, the frame will expand circumferentially until it achieves an expansion limit or presses against another structure, for example the walls of the ventricle 178 or of a blood vessel.
  • the barrel section 102 shown in FIGS. 1 A-2B shows the frame structure at its expansion limit.
  • the collapsible mesh at the funnel section 104 has an intermediate compression level.
  • the shape shown in FIGS. 1 A-2B may be a predetermined shape.
  • the shape of the check valve 100 may result from the collar section 126 being constrained by the introducer sheath 164, such that if the collar section 126 were released from the introducer sheath 164 its interior diameter would be similar to that of the barrel section 102.
  • the seal structure may be dilated in conjunction with or independently of the frame structure 106.
  • the sleeve strips 1 10 press against the interior surface of the frame structure 106 and are supported by the mesh to form a seal against back pressure.
  • the shape of the sleeve strip 1 10 conforms to the shape of the mesh.
  • the sleeve 108 at the funnel section 104 may comprise a cone-shaped funnel strip 1 18 to conform to the shape of the expanded mesh in this section.
  • the unsecured proximal edges of the sleeve strips 1 10 project proximally toward the collar section 126 to overlap the distal edge of the adjacent, proximal sleeve strip 1 10.
  • This overlap helps to seal the check valve 100 so that there are no gaps between sleeve strips 1 10 and leakage is prevented.
  • the closed position of the check valve 100 prevents the flow of fluid back through the temporary check valve 100 into the left ventricle 178 chamber of the heart 174 during ventricular diastole.
  • the shape and size of the expanded mesh is designed to allow the sleeve strips 1 10 to be made very thin and collapsible, sleeve strips 1 10 may be thin biological or synthetic sheets, for example, pericardium or polyurethane, that can easily fold up when the check valve 100 is compressed within the introducer sheath 164. Without the mesh of the frame structure 106 supporting the sleeve strips 1 10 in the closed configuration, the sleeve strips 1 10 would need to be stiffer and stronger in order to bear the force of the fluid pressure. The distal edges of the sleeve strips 1 10 can be attached to the frame
  • the sleeve strips 1 10 can be overmolded over portions of the frame structure 106.
  • the distal edges of the sleeve strips 1 10 may be formed on or attached to a flexible wire loop, which is in turn attached to the frame structure 106. The wire loop may be used to provide additional structure to each sleeve strip 1 10 and help maintain the circular form.
  • One method of introducing the temporary check valve 100 into the ventricular cavity is through a puncture opening 172 in the ventricle 178 near the apex 176 of the heart 174 as depicted in FIG. 1 1.
  • the temporary check valve 100 is held collapsed to pass through the puncture by the introducer sheath 164. Collapse of the check valve 100 minimizes the diameter of the seal ring 122 and brings the frame structure 106 and sleeves against the exterior surface of the tool shaft 160 and the interior surface of the introducer sheath 164.
  • the check valve 100 is collapsed against the body of the tool shaft 160, the sleeve strips 1 10 are appropriately wrinkled up and folded.
  • the collapsed temporary check valve 100 may be positioned at the end of the tool shaft 160 within the introducer sheath 164 for insertion or, alternatively, the tool shaft 160 may be initially inserted and the temporary check valve 100 may be placed about the outer diameter of the tool shaft 160 and slid along the tool shaft 160 within the introducer sheath 164 until it is in an appropriate location for deployment.
  • a pull wire or rod or additional concentric shaft may be connected to the proximal edge of the frame
  • the introducer sheath 164 is moved proximally, away from the seal ring 122. Movement of the introducer sheath 164 (and body temperature where the frame is constructed of a shape memory alloy) allows expansion of the seal ring 122 and distal portion of the frame structure 106.
  • the temporary check valve 100 is usually positioned just below the existing valve inside the heart 174.
  • the seal ring 122 expands until it seals against the walls of the ventricular chamber, or the inner or under-surface of an existing prosthetic valve.
  • the seal ring 122 of the temporary check valve 100 is made of an elastically-expanding, toroidal balloon, its collapsed inner diameter may be similar to that of the introducer sheath 164.
  • the seal structure may be folded up and wrinkled as the check valve 100 is collapsed and inserted into the introducer sheath 164.
  • the seal is made from helically wound up material such as thin metal, it may be unwound in position expanding its diameter to the desired dimension.
  • the sleeve 108 is opened or closed by action of the blood flow and pressure within the ventricle 178 or other space behind the check valve 100.
  • the sleeve 108 comprises a plurality of sleeve strips 1 10
  • the sleeve strips 1 10, other than a funnel strip 1 18 in the funnel section 104 are either all open or all closed.
  • the funnel strip 1 18 is fixed to the frame structure 106 at both its distal and proximal edges, such that its proximal edge does not flap during the open configuration.
  • the ventricle 178 contracts and forces blood toward the valve (e.g., aortic valve 182) being replaced or repaired and through the temporary check valve 100.
  • the unsecured edges of the sleeve strips 1 10 move inward away from the interior surface of the frame structure 106 as the blood flows through the collapsible mesh of the frame structure 106. The blood continues past the flapping sleeve strips 1 10 into the interior 120 of the frame structure 106.
  • FIG. 2B is a cross-sectional schematic view showing how blood passes through the temporary check valve 100 when the sleeve strips 1 10 are open (i.e., flapping). The arrows show the direction of blood flow.
  • the hollow tool shaft 160 on which the temporary check valve 100 is mounted and the introducer sheath 164 may comprise a catheter that is passed through the aorta 180 from downstream of the native valve, through the native valve, and positioned upstream of the native valve as opposed to being delivered and positioned through the apex 176 of the heart 174.
  • the annular seal ring 122 may be fabricated from a solid structure, for example, an elastic hoop of wire that is self expanding once it is positioned on the interior of a ventricle chamber or vessel wall.
  • a solid structure for example, an elastic hoop of wire that is self expanding once it is positioned on the interior of a ventricle chamber or vessel wall.
  • the wire hoop may be formed of the same shape memory material as the frame structure 106, e.g., Nitinol.
  • the solid structure may have sufficient elasticity to push against the inner surface of the wall and make the necessary seal.
  • the solid structure may also contain an appropriately compliant covering material to properly deform and make contact with the wall of the ventricle chamber or vessel within which it is inserted.
  • a helically wound configuration, unwound to expand and push against the inner surface of the wall can also be used as previously described.
  • All directional references e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, and counterclockwise
  • Connection references e.g., attached, coupled, connected, and joined
  • connection references are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Reproductive Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Prostheses (AREA)

Abstract

Valvule de retenue comprenant une structure de cadre en treillis, une bague d'étanchéité extensible et une pluralité de bandes de manchon positionnées dans l'intérieur de la structure de cadre et fixées celle-ci. La valvule de retenue peut être introduite le long d'une tige d'outil, entre la tige d'outil et une gaine, pour un positionnement dans une chambre ou dans un système vasculaire. Le retrait de la gaine permet à un treillis en alliage à mémoire de forme formant la structure de cadre d'étendre et de presser la structure d'étanchéité contre une paroi adjacente. La fonction cardiaque est augmentée au cours des procédures de remplacement de valvule, comme l'excision de valvule, l'implantation de valvule, ou le remplacement de lames valvulaires, par la mise en place de la valvule de retenue provisoire juste en amont de la valvule à traiter. La valvule de retenue peut être pliée pour être introduite par une petite incision au sommet du cœur ou par l'aorte dans la cavité ventriculaire et repliée par rétraction à l'intérieur de la gaine pour retrait après la procédure.
PCT/US2015/015965 2014-02-13 2015-02-13 Valvule de retenue sous-valvulaire provisoire Ceased WO2015123607A2 (fr)

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JP2019500965A (ja) * 2016-01-07 2019-01-17 メドトロニック ヴァスキュラー インコーポレイテッド 導流器付き人工弁
US10595994B1 (en) 2018-09-20 2020-03-24 Vdyne, Llc Side-delivered transcatheter heart valve replacement
WO2020060932A1 (fr) * 2018-09-18 2020-03-26 Nanostructures, Inc. Méthodes et dispositifs reposant sur un cathéter pour une restriction de flux sanguin obstructif
US11071627B2 (en) 2018-10-18 2021-07-27 Vdyne, Inc. Orthogonally delivered transcatheter heart valve frame for valve in valve prosthesis
US11076956B2 (en) 2019-03-14 2021-08-03 Vdyne, Inc. Proximal, distal, and anterior anchoring tabs for side-delivered transcatheter mitral valve prosthesis
US11109969B2 (en) 2018-10-22 2021-09-07 Vdyne, Inc. Guidewire delivery of transcatheter heart valve
US11166814B2 (en) 2019-08-20 2021-11-09 Vdyne, Inc. Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves
US11173027B2 (en) 2019-03-14 2021-11-16 Vdyne, Inc. Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same
US11185409B2 (en) 2019-01-26 2021-11-30 Vdyne, Inc. Collapsible inner flow control component for side-delivered transcatheter heart valve prosthesis
US11202706B2 (en) 2019-05-04 2021-12-21 Vdyne, Inc. Cinch device and method for deployment of a side-delivered prosthetic heart valve in a native annulus
US11234813B2 (en) 2020-01-17 2022-02-01 Vdyne, Inc. Ventricular stability elements for side-deliverable prosthetic heart valves and methods of delivery
US11253359B2 (en) 2018-12-20 2022-02-22 Vdyne, Inc. Proximal tab for side-delivered transcatheter heart valves and methods of delivery
US11273032B2 (en) 2019-01-26 2022-03-15 Vdyne, Inc. Collapsible inner flow control component for side-deliverable transcatheter heart valve prosthesis
US11273033B2 (en) 2018-09-20 2022-03-15 Vdyne, Inc. Side-delivered transcatheter heart valve replacement
US11278437B2 (en) 2018-12-08 2022-03-22 Vdyne, Inc. Compression capable annular frames for side delivery of transcatheter heart valve replacement
US11298227B2 (en) 2019-03-05 2022-04-12 Vdyne, Inc. Tricuspid regurgitation control devices for orthogonal transcatheter heart valve prosthesis
US11331186B2 (en) 2019-08-26 2022-05-17 Vdyne, Inc. Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same
US11344413B2 (en) 2018-09-20 2022-05-31 Vdyne, Inc. Transcatheter deliverable prosthetic heart valves and methods of delivery
IT202100029579A1 (it) * 2021-11-23 2023-05-23 Leafmate S R L Dispositivo con valvola temporanea per operazioni percutanee su valvola aortica nativa o artificiale
US11786366B2 (en) 2018-04-04 2023-10-17 Vdyne, Inc. Devices and methods for anchoring transcatheter heart valve
US12186187B2 (en) 2018-09-20 2025-01-07 Vdyne, Inc. Transcatheter deliverable prosthetic heart valves and methods of delivery
US12303136B2 (en) 2016-05-26 2025-05-20 Nanostructures, Inc. System and methods for embolized occlusion of neurovascular aneurysms
US12343256B2 (en) 2019-01-10 2025-07-01 Vdyne, Inc. Anchor hook for side-delivery transcatheter heart valve prosthesis
US12588993B2 (en) 2022-10-14 2026-03-31 Vdyne, Inc. Devices and methods for delivering a prosthetic heart valve using supra-annular support

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US7914569B2 (en) * 2005-05-13 2011-03-29 Medtronics Corevalve Llc Heart valve prosthesis and methods of manufacture and use
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WO2012021527A2 (fr) * 2010-08-09 2012-02-16 Valvexchange, Inc. Valve de retenue sous-valvulaire temporaire

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JP2019500965A (ja) * 2016-01-07 2019-01-17 メドトロニック ヴァスキュラー インコーポレイテッド 導流器付き人工弁
US12303136B2 (en) 2016-05-26 2025-05-20 Nanostructures, Inc. System and methods for embolized occlusion of neurovascular aneurysms
US11786366B2 (en) 2018-04-04 2023-10-17 Vdyne, Inc. Devices and methods for anchoring transcatheter heart valve
WO2020060932A1 (fr) * 2018-09-18 2020-03-26 Nanostructures, Inc. Méthodes et dispositifs reposant sur un cathéter pour une restriction de flux sanguin obstructif
US12064364B2 (en) 2018-09-18 2024-08-20 Nanostructures, Inc. Catheter based methods and devices for obstructive blood flow restriction
US10595994B1 (en) 2018-09-20 2020-03-24 Vdyne, Llc Side-delivered transcatheter heart valve replacement
US12186187B2 (en) 2018-09-20 2025-01-07 Vdyne, Inc. Transcatheter deliverable prosthetic heart valves and methods of delivery
US11344413B2 (en) 2018-09-20 2022-05-31 Vdyne, Inc. Transcatheter deliverable prosthetic heart valves and methods of delivery
US11273033B2 (en) 2018-09-20 2022-03-15 Vdyne, Inc. Side-delivered transcatheter heart valve replacement
US11071627B2 (en) 2018-10-18 2021-07-27 Vdyne, Inc. Orthogonally delivered transcatheter heart valve frame for valve in valve prosthesis
US11109969B2 (en) 2018-10-22 2021-09-07 Vdyne, Inc. Guidewire delivery of transcatheter heart valve
US11278437B2 (en) 2018-12-08 2022-03-22 Vdyne, Inc. Compression capable annular frames for side delivery of transcatheter heart valve replacement
US11253359B2 (en) 2018-12-20 2022-02-22 Vdyne, Inc. Proximal tab for side-delivered transcatheter heart valves and methods of delivery
US12343256B2 (en) 2019-01-10 2025-07-01 Vdyne, Inc. Anchor hook for side-delivery transcatheter heart valve prosthesis
US11185409B2 (en) 2019-01-26 2021-11-30 Vdyne, Inc. Collapsible inner flow control component for side-delivered transcatheter heart valve prosthesis
US11273032B2 (en) 2019-01-26 2022-03-15 Vdyne, Inc. Collapsible inner flow control component for side-deliverable transcatheter heart valve prosthesis
US11298227B2 (en) 2019-03-05 2022-04-12 Vdyne, Inc. Tricuspid regurgitation control devices for orthogonal transcatheter heart valve prosthesis
US11173027B2 (en) 2019-03-14 2021-11-16 Vdyne, Inc. Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same
US11076956B2 (en) 2019-03-14 2021-08-03 Vdyne, Inc. Proximal, distal, and anterior anchoring tabs for side-delivered transcatheter mitral valve prosthesis
US11202706B2 (en) 2019-05-04 2021-12-21 Vdyne, Inc. Cinch device and method for deployment of a side-delivered prosthetic heart valve in a native annulus
US11179239B2 (en) 2019-08-20 2021-11-23 Vdyne, Inc. Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves
US11166814B2 (en) 2019-08-20 2021-11-09 Vdyne, Inc. Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves
US11331186B2 (en) 2019-08-26 2022-05-17 Vdyne, Inc. Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same
US11234813B2 (en) 2020-01-17 2022-02-01 Vdyne, Inc. Ventricular stability elements for side-deliverable prosthetic heart valves and methods of delivery
IT202100029579A1 (it) * 2021-11-23 2023-05-23 Leafmate S R L Dispositivo con valvola temporanea per operazioni percutanee su valvola aortica nativa o artificiale
EP4183370A1 (fr) 2021-11-23 2023-05-24 Leafmate S.r.l. Dispositif avec valve temporaire pour accompagnement percutané dans une valve aortique naturelle ou artificielle
US12588993B2 (en) 2022-10-14 2026-03-31 Vdyne, Inc. Devices and methods for delivering a prosthetic heart valve using supra-annular support

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