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WO2020006026A1 - Prothèse de valvule cardiaque souple - Google Patents

Prothèse de valvule cardiaque souple Download PDF

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Publication number
WO2020006026A1
WO2020006026A1 PCT/US2019/039145 US2019039145W WO2020006026A1 WO 2020006026 A1 WO2020006026 A1 WO 2020006026A1 US 2019039145 W US2019039145 W US 2019039145W WO 2020006026 A1 WO2020006026 A1 WO 2020006026A1
Authority
WO
WIPO (PCT)
Prior art keywords
struts
leaflet
flexible
mesh band
frame
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/US2019/039145
Other languages
English (en)
Inventor
Bashir Akhavan TAFTI
Karl Im
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.)
University of California Berkeley
University of California San Diego UCSD
Original Assignee
University of California Berkeley
University of California San Diego UCSD
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 University of California Berkeley, University of California San Diego UCSD filed Critical University of California Berkeley
Publication of WO2020006026A1 publication Critical patent/WO2020006026A1/fr
Anticipated expiration legal-status Critical
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
    • A61F2/2412—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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9528—Instruments specially adapted for placement or removal of stents or stent-grafts for retrieval of 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body
    • A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Definitions

  • the present invention relates to medical devices and methods, particularly those that relate to the treatment of valve insufficiency, also referred to as valve regurgitation.
  • valve insufficiency also referred to as valve regurgitation.
  • the use of prosthetic valves delivered by traditional surgical implantation methods, or by less invasive percutaneous catheter or minimally invasive transapical methods are one possible treatment for valvar insufficiency.
  • the heart of vertebrate animals is divided into four chambers, and is equipped with four valves (the mitral, aortic, pulmonary and tricuspid valves) that ensure that blood pumped by the heart flows in a forward direction through the cardiovascular system.
  • the mitral valve of a healthy heart prevents the backflow of blood from the left ventricle into the left atrium of the heart, and has two flexible leaflets (anterior and posterior cusps) that close when the left ventricle contracts.
  • the aortic valve prevents the backflow of blood from the aorta into the left ventricle of the heart, and comprises three flexible leaflets (left, right and posterior cusps) that close after the left ventricle contracts.
  • the pulmonary valve prevents the backflow of blood from the pulmonary artery into the right ventricle of the heart, and comprises three flexible leaflets (right, left and posterior cusps) that close after the right ventricle contracts, or after ventricular systole.
  • the tricuspid valve prevents the backflow of blood from the right ventricle into the right atrium of the heart, and comprises two flexible leaflets (anterior and posterior cusps) that close when the right ventricle contracts.
  • the Mitrial Valve leaflets are attached to a fibrous annulus, and their free edges are tethered by subvalvular chordae tendineae to papillary muscles in the left ventricle to prevent them from prolapsing into the left atrium during the contraction of the left ventricle.
  • Various cardiac diseases or degenerative changes may cause dysfunction in any of these portions of the mitral valve apparatus, causing the mitral valve to become abnormally narrowed or dilated, or to allow blood to leak (i.e. regurgitate) from the left ventricle back into the left atrium. Any such impairments compromise cardiac sufficiency, and can be debilitating or life threatening.
  • Numerous surgical methods and devices have accordingly been developed to treat heart valve dysfunction, including open-heart surgical techniques for replacing, repairing or reshaping the native heart valve apparatus, and the surgical implantation of various prosthetic devices such as annuloplasty rings to modify the anatomy of the native heart valve. Additionally, less invasive transcatheter techniques for the delivery of replacement heart valve assemblies have been developed. In such techniques, a prosthetic valve is generally mounted in a crimped state on the end of a flexible catheter and advanced through a blood vessel or the body of the patient until the valve reaches the implantation site. The prosthetic valve is then expanded to its functional size at the site of the defective native valve.
  • the present invention relates to a flexible heart valve.
  • the valve is made up of several parts including: a deployable frame; a mesh band that forms the interface between the device and the valvular apparatus; a deployable hooking mechanisms allowing the prosthetic to securely attach to the valvular and subvalvular apparatus; and a retrieval hook allowing for the repositioning and removal of the prosthetic valve once it has been initially positioned.
  • the deployable frame comprises a plurality of struts that attach proximally to a proximal collar and distally to a distal collar that are aligned along the central axis of the frame.
  • the frame comprises up to and including five struts; in one embodiment, the frame comprises more than five struts. In one embodiment spacing between each struts are even; in one embodiment, the spacing between the struts are not even.
  • the plurality of struts comprises a non-ferromagnetic, flexible material. In one embodiment, the non-ferromagnetic flexible material is a shape-memory material.
  • the present invention comprises a mesh band that attaches to the deployable frame at a seam along each strut of the frame.
  • the mesh band is not attached to every strut leaving an opening where there are no mesh band in between the struts.
  • the mesh band comprises a plurality of fibers.
  • the plurality of fibers comprises a non-ferromagnetic, flexible material.
  • the non-ferromagnetic, flexible material is a shape-memory material.
  • the mesh band comprises a plurality of leaflet struts designed to support the leaflet formation and coaptation and flexible tethers extending from the leaflet struts which are attached to the frame struts.
  • a single leaflet formation resembles a posterior leaflet, while the opposite side of the frame has enough spacing between at least a first and second strut for the native anterior leaflet to extend fully into the valve frame’s central axis to coapt with the new leaflet that resembles the posterior leaflet.
  • the present invention comprises a plurality of anchoring hooks that secure the prosthetic valve to the valvular apparatus.
  • the anchoring hooks are embedded in frames that are positioned within the mesh band along struts of the deployable frame.
  • anchoring hooks are embeded in frames outside of the mesh band along the struts of the deployable frame.
  • the anchoring hooks are embedded within the mesh band in between the struts.
  • the present invention comprises a retrieval hook that attaches to the proximal collar of the deployable frame.
  • the retrieval hook comprises a rigid, non-ferromagnetic material.
  • the present invention relates to a method of removing or repositioning the flexible heart valve prosthesis by inserting a valve prosthetic removal device through the vasculature into the heart of the subject, the device comprising a fixed elongated member with a loop or hook and a reducing member.
  • the method comprises threading the loop or hook of the elongated member through the retrieval hook of the prosthetic.
  • the method comprises withdrawing the prosthetic into the reducing member by way of applying tension to the retrieval hook.
  • the method comprises removing the prosthetic device from the heart through the vasculature of the subject.
  • a flexible heart valve prosthetic device in one aspect, includes a flexible frame comprising a plurality of struts disposed radially around a central axis, a first and second strut of the plurality of struts defining an entry space for a native anterior leaflet; a retrieval hook positioned at the proximal and/or distal ends of the plurality of struts; and a leaflet disposed within the flexible frame and configured to mate with the native anterior leaflet.
  • a flexible heart valve prosthetic device in one embodiment, includes a flexible frame having a plurality of struts disposed radially around a central axis and defining a space configured to accept entry of a native anterior leaflet to an interior portion of the frame including the central axis; a mesh band attached to each of the plurality of struts between their proximal ends and their distal ends; and a leaflet at least partially radially disposed within the mesh band and configured to mate with the native anterior leaflet.
  • the device includes at least one strut having a length shorter than one or more of the plurality of struts, the at least one strut at least partially defining the space configured to accept entry of the native anterior leaflet.
  • the device includes at least one strut having a structure different than one or more of the plurality of struts, the at least one strut at least partially defining the space configured to accept entry of the native anterior leaflet.
  • the device includes a bend in two or more of the plurality of struts to at least partially define the space configured to accept entry of the native anterior leaflet.
  • the device includes a first spacing between two or more of the plurality of struts that is larger than a second spacing between two or more of the remaining plurality of struts to at least partially define the space configured to accept entry of the native anterior leaflet.
  • the device includes a deployable anchoring assembly comprising a deployable hook positioned on each of the plurality of struts within the mesh band.
  • the device includes a retrieval hook positioned at the proximal and/or distal ends of the plurality of struts.
  • the plurality of struts deploys away from the central axis of the device.
  • the plurality of struts are constructed from a non -ferromagnetic, flexible material.
  • the non ferromagnetic, flexible material is selected from the group consisting of: a chromium alloy, stainless steel, a titanium alloy, and Nitinol.
  • the plurality of struts comprises a coating with an anti -thrombolytic or immunosuppressant agent.
  • the mesh band comprises a plurality of fibers.
  • the mesh band comprises a leaflet strut.
  • the leaflet strut is constructed from non-ferromagnetic, flexible material.
  • the mesh band is constructed from a non -ferromagnetic biocompatible material.
  • the non-ferromagnetic biocompatible material is selected from the group consisting of: a chromium alloy, stainless steel, a titanium alloy, and Nitinol.
  • the leaflet is constructed from a biological material or a medical grade synthetic material.
  • the biological material is preserved biological tissue collected from a donor wherein the donor species is selected from the group consisting of human, bovine, equine, and porcine.
  • the medical grade synthetic material is a fiber- reinforced matrix material.
  • Figure 1 A is a top perspective view of a flexible heart valve prosthesis according to one embodiment.
  • Figure 1B is a side view and
  • Figure 1C is an bottom perspective view of the flexible heart valve prosthesis shown in Fig. 1 A.
  • Figure 2A is a top perspective view of a flexible heart valve prosthesis having tethers according to one embodiment.
  • Figure 2B is a side view and
  • Figure 2C is an bottom perspective view of the flexible heart valve prosthesis shown in Fig. 2A.
  • Figure 2D is a top perspective view of the flexible heart valve prosthesis shown in Fig. 2A with leaflets of the valve in an open state.
  • Figure 3 A is a top perspective view of a prosthetic valve leaflet layer in a closed configuration according to one embodiment.
  • Figure 3B is a top perspective view of the valve of 3 A in an open configuration
  • Figure 3C is a bottom perspective view of the valve of 3 A in a partially open configuration.
  • Figure 4A is a magnified view of a barb according to one embodiment.
  • Figure 4B is an isolated view of a deployable frame attached that attaches to a mesh band according to one embodiment.
  • Figure 4C is an isolated view of a deployable frame that attaches to a mesh band, the deployable frame having multiple leaflet struts according to one embodiment.
  • Figure 4D is a partial view of a deployable barb assembly in an expanded and deployed state
  • Figure 4E is a partial view of a deployable barb assembly in an un-expanded and un-deploy ed state.
  • Figures 4F-4H show alternate views of a barb assembly according to one embodiment.
  • Figures 5A-5C are alternate magnified perspective views of a hook according to one embodiment.
  • Figure 6A is a partial cutaway view of a flexible heart valve prosthesis connected to a placement device within a placement catheter according to one embodiment.
  • Figure 6B is a partial cutaway view of a flexible heart valve prosthesis in a partially deployed state according to one embodiment. It should be appreciated that elements not shown for illustrative purposes in this or other embodiments (such as for example mesh band, deployable barb assembly, leaflets, tethers, etc.) can be part of the flexible heart valve prosthesis as described throughout the embodiments and as would be understood by those having ordinary skill in the art.
  • Figure 7A is a flow chart of a method for removing a prosthetic valve device from the heart according to one embodiment.
  • Figure 7B is a flow chart of a method for placing a prosthetic valve device according to one embodiment.
  • Figure 7C is a flow chart of a method for removing a prosthetic valve device according to one embodiment.
  • Figure 8A is a side functional view and Figure 8B is a perspective functional view of a flexible heart valve prosthesis having a strut and leaflet
  • the present invention generally relates to medical devices and implants, in particular prosthetic heart valves use to treat valve regurgitation.
  • the prosthetic heart valve offers a design with minimal components to improve ease of placement over existing designs.
  • Embodiments of the present invention provide a flexible heart valve prosthetic device that is non-invasively placed through use of a transcatheter, anchors to the annulus of the heart valve through use of a deployable barb mechanism, and has features enabling its removal in the event a repositioning or a new valve replacement is required.
  • an exemplary flexible heart valve prosthesis 100 comprising five primary structural elements: (1) a deployable frame 200; (2) a mesh band 300; (3) a deployable barb assembly 400; (4) a retrieval hook 500; and (5) leaflets 600 that attach to the frame 200.
  • the deployable frame 200 of the present invention is that it is less bulky and comprises minimal structural material compared to other prosthetic heart valves that are placed transcatheter.
  • the strut design facilitates ease of collapsing the frame (see for example Fig. 6B showing the external struts in a partially collapsed state) so that the frame can fit into a delivery or retrieval catheter for placement and removal within the body.
  • the radial compression is accomplished by applying longitudinal tension to the frame drawing frame 200 into the reducing member.
  • the primary structural element of the flexible heart valve prosthetic 100 is the deployable frame 200.
  • the deployable frame 200 comprises a strut structure with a plurality of struts 202 that meet at the proximal end of prosthetic 100 and are attached to a proximal collar 204. At the distal end, struts 202 meet and attach at a distal collar 206. The proximal collar 204 and distal collar 206 are aligned along a central axis 101. Also attached at the proximal end of the deployable frame 200 is a retrieval hook 500 forming the most proximal structure of the prosthetic 100.
  • deployable frame 200 is constructed from a non ferromagnetic, flexible, shape memory material, such as Nitinol.
  • any biocompatible, rigid, yet flexible material may be used, such as a medical grade alloy or polymer.
  • deployable frame 200 is constructed from materials such as chromium alloy, stainless steel, and titanium alloy.
  • the biocompatible materials described herein may also include an anti-thrombogenic coating to prevent the incidence of embolism.
  • the material may also include a coating comprising an immunosuppressant, e.g., rapamycin (sirolimus).
  • a connection between one or more struts can be a rigid, a semi-rigid, or a flexible connection made by welding, sintering, or any other suitable method known in the art.
  • the connection is a movable hinge.
  • two or more struts can be cut, machined, or cast from the same block of material.
  • struts 202 are assembled to convey an expanding bias. As such, when struts 202 are compressed inwardly toward the central axis 101, an expanding bias is created, forcing the frame to return to its relaxed, expanded state when the compressive force is removed.
  • the thermally-set shape of each of struts 202 is formed to a curvature having a circumferential region of maximum diameter forming a medial band of the flexible frame.
  • the circumferential region of maximum diameter has a bias towards the distal end of prosthetic 100, the point farthest from the point of ejection from the placement catheter.
  • the circumferential region of maximum diameter has a bias towards the proximal end of prosthetic 100.
  • the circumferential region of maximum diameter has a bias towards the medial region of prosthetic 100.
  • the struts of the frame may comprise variable stiffness to accommodate the dynamics within the beating heart.
  • the frame profile may be substantially formed to fit the profile of the native valve annulus (i.e. the frame designed for deployment into the mitral valve apparatus may have a substantially irregular continuous shape, or substantially D-shaped profile.
  • the mesh band 300 is a continuous region that forms the contact surface between the valve annulus and the prosthetic 100. As depicted specifically in Figures 4B and 4C, in one embodiment, the mesh band 300 comprises a plurality of crossing fibers 302. In one embodiment, the plurality of crossing fibers is composed of non
  • ferromagnetic biocompatible material selected from a group comprising chromium alloy, stainless steel, and titanium alloy including Nitinol.
  • the biocompatible material is assembled into a deployable mesh according to a grid-like pattern.
  • Mesh band 300 attaches to deployable frame 200 along the circumferential region of maximum curvature of each strut.
  • Mesh band 300 attaches at contact seams 304 on the inner surface of mesh band 300 as depicted in Figure 2.
  • Mesh band 300 is compressible about axis 101 commensurate with deployable frame 200, and likewise expands in concert with the deployable frame 200 upon deployment, reinforcing the shape of mesh band 300.
  • a connection between one or more struts 202 and the mesh band 300 can be a rigid, a semi-rigid, or a flexible connection made by welding, sintering, or any other suitable method known in the art.
  • the connection is a movable hinge.
  • the connection is a rigid seam.
  • Mesh band 300 comprises mesh fibers 302 and anchoring barb assembly 400 securing prosthetic 100 to a valve annulus. Embedded in mesh fibers 302 are barb frames 412 for barbs 416. In one embodiment, barb frames 412 are aligned with frame strut 202 attachment points/contact seams 304, depicted in Figure 2.
  • Mesh band 300 comprises one or more materials with anti-thrombogenic and/or immunosuppressant properties as similar to that of deployable frame 200.
  • mesh band 300 is composed of an alloy, polymer, or any other biocompatible material that is rigid, and/or flexible, and/or elastic similar to struts 202. In one embodiment, mesh band 300 is composed of polyethylene, polyester, nylon, PTFE, ePTFE alone or in combination. In one embodiment, mesh band 300 comprises bioresorbable materials including but not limited to PLA and PGLA.
  • mesh band 300 comprises a plurality of leaflet struts 306.
  • Leaflet struts 306 serve as frames for leaflet attachment prior to valve placement.
  • the leaflet struts 306 and mesh band 300 is preferably fabricated from a single piece of metallic material that has been cut so as to permit the heart valve prosthesis 100 to be compressed into a compact, generally tubular delivery configuration, and expanded into the deployment configuration further described herein.
  • the leaflet struts 306 of the prosthetic valve 100 may be fabricated from a shape-memory alloy such as a nickel -titanium alloy like nitinol, and in expandable embodiments, the leaflet struts 306 may be fabricated from any metallic material, such as chromium alloy or stainless steel, that is suitable for implantation into the body. In some embodiment, the leaflet struts may be made of polyethylene, polyester, nylon, PTFE or ePTFE.
  • leaflet struts forming the leaflet are only on the posterior side of the valve 100 where while the deployable frame 200 has wide enough opening between the struts 202 to allow the native anterior leaflet to enter the prosthetic valve in close proximity to the newly formed single leaflet valve (see e.g. Figs. 8A and 8B).
  • a leaflet tether 440 can be made of the same material as leaflet struts 306 and attached to leaflet struts 306, connected at the a lower portion of struts 202 to act as a chord to provide tension support while limiting the leaflet from prolapse much like chordae tendineae.
  • One or more leaflet tethers 440 can connect to a portion of each leaflet 602, such as the bottom tip of each leaflet 602 to bias it properly for resisting prolapse.
  • the seams 604 of the leaflets 600 push open 604’ (Fig.
  • leaflet tethers 440 are slacked. While the leaflets 600 are closed (Fig. 2A), the leaflet tethers 440 are taught to prevent prolapse. Since for example blood pressure in atria can periodically be much lower than that in the ventricles, the leaflets may attempt to evert to the low pressure region. The leaflet tethers 440 prevent prolapse by remaining taut and pulling the flaps, holding them in closed position. A lower barb 430 can also be introduced to a lower portion of the struts to anchor to native leaflets in the body.
  • the metallic material may be of a single thickness throughout the entirety of the strut portion, and in others may vary in thickness so as to facilitate variations in the radial force that is exerted by the anchor portion in specific regions thereof, to increase or decrease the flexibility of the anchor portion in certain regions, and/or to control the process of compression in preparation for deployment and the process of expansion during deployment.
  • mesh band 300 may include extensions towards one end of the valve frame that extend beyond the native valve orifice.
  • the extensions protrude from a region of the prosthesis that may facilitate interaction with the native valve.
  • the extensions form a securing surface stabilizing native valve leaflets during the filling stage of the heart chamber.
  • mesh band 300 may be absent and frame strut spaced wide enough to facilitate interactions with the native valve.
  • the native anterior valve interacts with the prosthetic posterior valve, forming a seal during the emptying stage of the heart chamber (see e.g. Figs. 8A and 8B).
  • the prosthetic comprises a deployable anchoring barb assembly 400 that securely embeds in the heart wall.
  • Anchoring the device into the heart wall advantageously allows the prosthetic valve leaflets 602 to open and close with fluid dynamics and heart muscle movement associated with the cardiac cycle so that the device can replicate normal valve function.
  • the deployable anchoring barb assembly 400 comprises barbs 416 shown in Figures 4B and 4C incorporated into mesh band 300.
  • the barb assembly 400 is secured to barb frame 412 which is embedded in mesh fibers 302 of mesh band 300.
  • barb assemblies 410 or 420 can be positioned on one or more struts 202 of the deployable frame 200, such that barbs 416 point generally away from central axis 101 of prosthetic 100 and towards the annulus of the valve. Barbs 416 secure and anchor the prosthetic 100 against the valve annulus as would be understood by those skilled in the art.
  • Figure 4D a deployable barb assembly in an expanded and deployed state
  • Figure 4E shows a deployable barb assembly in an un-expanded and un-deploy ed state.
  • Barbs 416 can be on every strut 202 or
  • intersection/seam 302 of struts 202 and mesh band 300 can be present on alternate struts 202 or intersections 304 of struts 202 and mesh band 300, or any other combination of configurations.
  • Barbs 416 may project out from the prosthetic 100 perpendicularly, or otherwise be slanted in a proximal leaning or distal leaning direction. In alternate embodiments, barbs 416 project out from the prosthetic 100 in a combination of perpendicular, proximally slanted, and distally slanted orientations. Barbs 416 in certain embodiments can protrude through a slit or slot in the mesh 300 upon expansion and deployment from the delivery catheter. In certain embodiments, while the device remains in the delivery catheter, the slit remains closed and only opens upon pressure actuation from the deploying barb and/or from expansion of the frame.
  • barbs 416 can take a number of shapes, including curved, straight and variable thickness embodiments.
  • barb assemblies 410 can be positioned also at the intersection of two or more mesh fibers 302.
  • Barbs 416 are hinged at the bottom of barb frames 412, or at some portion further up along the openings.
  • the hinge 418 acts as a strategic flex point so that while in a semi-compressed or compressed state, as struts 202 or mesh fibers 302 and mesh band 300 are compressed towards the central axis 101 of prosthetic 100, barbs 416 fold back about the flex point or hinge 418 and into barb frame 412, towards the central axis 101 of the prosthetic 100.
  • the hinge 418 can be created structurally, for instance by the removal or reduction of framing material (e.g. formation of opening of frame 412), creating a point of flexion along the frame 412. Alternatively, the hinge 418 can be created by a manufacturing step that incorporates a less rigid material at the desired flexion point, or by the introduction of additives that reduce material rigidity at the flexion point. Another method of forming the hinge 418 includes a mechanical joint connecting two or more moving parts. Alternate embodiments do not have a hinge 418, and otherwise feature a contiguous member and composition of material along the length of the struts 202 and the mesh fibers 302. Minimal exposure of barbs 416 above the surface of the prosthetic 100 while in the semi-compressed and compressed states facilitates smooth advancement and retraction of the prosthetic 100 during loading, placement and retrieval procedures.
  • prosthetic valves according to embodiments of the present invention can fit into smaller delivery and retrieval catheters and devices, providing for greater ease of placement and retrieval for those skilled in the art of placement of such devices.
  • the retrieval hook feature is largely advantageous over standard heart valve prostheses that traditionally required open-heart procedures to remove and generally offer no opportunities for repositioning once initially placed by catheter or open procedure.
  • prosthetic heart valve retrieval hook assembly 500 attaches to prosthetic 100 at proximal collar 204 and comprises a hollow channel 102 through which placement catheter guidewire (not shown) can extend through the center of prosthetic 100 in line with central axis 101.
  • Hook body element 504 terminates in hook 502 which can be grasped and pulled in a manner that reintroduces prosthetic 100 into a placement catheter (not shown) resulting in a compressed state allowing one skilled in the art to retrieve prosthetic 100.
  • applying tension to hook 502 withdraws it into a retrieving catheter comprising a reducing member. This tension compresses struts 202 and mesh band 300 into compact, tubular conformation allowing for retrieval, replacement or repositioning of prosthetic heart valve 100.
  • a placement device 700 including a placement hook 702 can releasably attach to the retrieval hook for placement or retrieval of the prosthetic 100.
  • the placement device can be sized to fit within the lumen of a placement or retrieval catheter 704.
  • a snare 750 having a loop 752 at its distal end can be used in placement or retrieval of the prosthetic 100.
  • elements not shown in Fig. 6B for illustrative purposes are part of the prosthetic 100 and are also collapsible.
  • the prosthetic 100 is shaped to easily slide and collapse within the lumen of a catheter.
  • collapsing the device by sliding pulling the prosthetic into the lumen of a catheter advantageously retracts the barbs, causing less trauma to the patient during placement and removal procedures.
  • Deploying the device by pushing it out of the lumen benefits from these same advantages, enhancing ease of placement while minimizing trauma to the patient.
  • the flexibility and small profile of the device during placement and removal benefits both the medical professional performing the procedure and the patient.
  • the prosthetic valve 100 may have an open configuration (Fig. 3B) in which the prosthetic valve leaflets 602 are disposed away from one another and the seams 604’ are open, and a closed configuration (Fig. 3 A) in which the prosthetic valve leaflet seams 604 engage one another. Blood flows freely through the prosthetic valve 100 and leaflets 600 in the open configuration, and retrograde blood flow across the prosthetic valve 100 is substantially prevented in the closed configuration.
  • the prosthetic valve 100 reduces or eliminates valve regurgitation.
  • the prosthetic valve 100 may comprise a therapeutic agent, and may elute the therapeutic agent from the prosthetic valve 100 into adjacent tissue.
  • the plurality of prosthetic valve leaflets 602 may comprise a tricuspid or bicuspid leaflet configuration. It should be appreciated that there is no limitation to the number of leaflets used. At least a portion of the one or more prosthetic valve leaflets 602 may comprise tissue or a synthetic material. As shown in certain embodiments, one or more of the plurality of prosthetic valve leaflets 602 may be disposed over one or more leaflet struts 306 that are radially biased inward relative to the mesh band 300. In one embodiment, the one or more leaflet struts may comprise one or more suture holes extending therethrough and that may be sized to receive a suture for attaching valve leaflets 602 to leaflet struts 306. As shown specifically in Fig. 3C, an anchoring point 606 having extra material, an opening, or some other special structure can be used to anchor tethers as described in various embodiments.
  • the leaflets 602 may be fabricated from a single piece or from multiple pieces of standard biologic prosthetic materials, such as cryo- or chemically-preserved pericardium (e.g. bovine, equine, porcine, human), or from standard suitable synthetic prosthetic materials (e.g. fiber-reinforced matrix materials) well known in the art, and may be sewn or otherwise adhered to the leaflet struts 306 to form the valve leaflets 602 in any standard suitable manner.
  • standard biologic prosthetic materials such as cryo- or chemically-preserved pericardium (e.g. bovine, equine, porcine, human), or from standard suitable synthetic prosthetic materials (e.g. fiber-reinforced matrix materials) well known in the art, and may be sewn or otherwise adhered to the leaflet struts 306 to form the valve leaflets 602 in any standard suitable manner.
  • the leaflets 602 may also include chordae, wherein longitudinal fibers attach the leaflets to the frame.
  • the chordae may be composed of any flexible biocompatible material, including metallic and polymer fibers.
  • prosthetic 100 of the present invention offers a device and procedure for safely removing the placed valve and implanting a replacement prosthetic without requiring an open-heart procedure.
  • a method of removing the flexible heart valve prosthesis 100 includes the steps of inserting the valve prosthetic removal device through the vasculature into the heart of the subject 802, threading the loop or hook of the device through retrieval hook of prosthetic 804, withdrawing the prosthetic into reducing member by applying tension to the retrieval hook 806, and removing the prosthetic device from the heart through the vasculature of the subject 808.
  • the method can include the steps of inserting the compressed heart valve contained within the placement catheter (not shown), guiding the placement catheter into the orifice of the appropriate valve of the heart to be replaced, ejecting the valve 100 from the placement catheter by partially releasing tension on prosthetic 100 in its compressed state thereby unsheathing prosthetic from placement catheter, verifying that mesh band 300 is appropriately aligned with heart valve annulus, releasing remainder of tension or fully unsheathing prosthetic heart valve prosthetic 100 resulting in full expansion to resting state of: deployable frame 200, mesh band 300, and anchoring barbs 400.
  • the placement guidewire utilizes hook 500 to guide placement and deployment of prosthetic 100. Upon release of tension, frame 200 and mesh band 300 deploy to their resting state against a heart annulus.
  • barb assembly 400/hooks 416 actuate and embed in wall of heart once frame 200 and mesh band 300 reach their resting fully deployed state.
  • tension can be achieved by engaging retrieval hook 500 with a placement catheter and withdrawing frame into the placement catheter in order to reduce diameter of frame 200 and mesh band 300. The device compresses to a tubular conformation.
  • One skilled in the art can then reposition and redeploy prosthetic 100 so that frame 200 and mesh band 300 are more suitably located, and anchoring barb assembly 400 then secure prosthetic into a new position.
  • the valve prosthetic is delivered to the mitral valve by use of catheter via a trans-venous approach by crossing the septal wall from right atrium to left atrium and initially positioned near the annulus of the mitral valve.
  • the placement catheter may include unsheathing a tubular member to expose barb assembly 400/hooks 416 and frame 200.
  • the prosthetic 100 can be completely exposed or partially exposed outside the catheter when hooks 416 are allowed to engage the valve annulus, or the left atrial wall. Movement of the placement catheter can provide control of the prosthesis during the deployment.
  • prosthetic 100 can be delivered to the mitral valve via flexible catheter in a transfermoal approach, crossing the aortic valve into the left ventricle and the mitral valve orifice.
  • two flexible catheters can be used wherein a first catheter is placed via transvenous approach and a second catheter is placed via transfemoral approach.
  • One flexible catheter is used to hold hook 500 and apply tension to the catheter introduced through the septal wall.
  • the two-catheter method can provide a more stable and controlled deployment and accurate positioning of the prosthesis across the mitral annulus.
  • a method of insertion includes the steps of inserting a placement device into the patient’s vasculature 852, advancing the placement device to a target placement position 854, deploying the placement member and advancing the valve prosthetic device to a target treatment area 856, detaching the placement member from the valve prosthetic device 858, retracting the placement member within the placement device 860, and withdrawing the placement device from the patient’s vasculature 862.
  • a method of removal includes the steps of inserting the retrieval device into patient’s vasculature 902, advancing the retrieval device to a target retrieval position 904, deploy the retrieval member and attaching to the valve prosthetic device 906, retracting the valve prosthetic device within retrieval device 908, and withdraw the retrieval device valve prosthetic device from the patient’s vasculature 910.
  • the flexible heart valve prosthesis 1000 includes five primary structural elements: (1) a deployable frame 1200 formed by multiple struts 1202; (2) a mesh band 1300; (3) a deployable barb assembly (not shown); (4) a retrieval hook 1500; and (5) at least one leaflet 1600 that attaches to the frame 1200.
  • the strut design of the deployable frame 1200 facilitates ease of collapsing the frame so that the frame can fit into a delivery or retrieval catheter for placement and removal within the body.
  • the struts 1202 of the deployable frame 1200 are spaced apart sufficient to allow the native anterior leaflet 1011 and the native chordae 1012 of the native anterior valve to enter interior portions the frame 1200 toward the central axis 1001.
  • the native valve 1011, 1012 can interact and mate with the prosthesis 1000 valve (posterior leaflet prosthetic valve 1600 attached to the mesh band 1300 and the prosthetic chordae 1601 attached to the deployable frame 1200), forming a seal with the prosthetic valve during the emptying stage of the heart chamber.
  • the spacing needed between struts 1202 to allow the native anterior leaflet 1011 and the native chordae 1012 to enter the inside the frame 1200 can be formed by leaving certain struts out, bending or shaping struts apart, or spacing certain struts further apart. In one embodiment, certain struts do not extend beyond a top portion of the frame, leaving an opening in the lower portion of the frame where the native valve can enter. For example, with reference specifically to Fig.
  • the struts are eliminated on a lower portion of the frame 1200 to form a lower entry space 1013 configured to allow entry of the native anterior leaflet into interior portions of the frame 1200.
  • the mesh band 1300 goes around the entire circumference of the deployable frame 122 and a single leaflet formation 1600 is formed to resemble the posterior leaflet.
  • the frame 1200 can be configured with enough spacing between struts for the native anterior leaflet to extend into the valve frame’s interior towards the central axis to coapt with the single leaflet 1600.
  • certain lower struts below the mesh band are removed or spaced further apart to form a lower entry space 1013 and allow for entry of the native anterior leaflet 1011, while upper struts 1014 above the mesh and remain above the lower entry space 1013.
  • one or more of the struts can include a bend, different structure (e.g. shape, thickness, geometry, etc.), reduced or increased length, or increased spacing relative to the other struts to accommodate the anatomy of the native valve.
  • the mesh band 1300 attaches to the deployable frame 1200 along an entire circumferential region of the maximum curvature of only certain struts 1202.
  • the mesh band 1300 attaches to the deployable frame 1200 along only a partial circumferential region of the maximum curvature of only certain struts 1202.
  • the mesh band and frame struts can be configured in various ways.
  • the mesh band is primarily on one side or portion of the deployable frame 1200 with only a single leaflet formation 1600 to resemble the posterior leaflet, while the opposite side of the frame 1200 has enough spacing between the struts for the native anterior leaflet to extend fully into the valve frame’s central axis.
  • the mesh band is not attached to every strut for forming the single posterior leaflet. According to various embodiments, function of the native anterior leaflet is maintained instead of being functionally isolated by the prosthetic heart valve.

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

La présente invention concerne un dispositif prothétique de valvule cardiaque souple comprenant un cadre souple ayant une pluralité d'entretoises disposées radialement autour d'un axe central et définissant un espace conçu pour accepter l'entrée d'un feuillet antérieur natif dans une partie intérieure du cadre comprenant l'axe central. Une bande maillée est fixée à chacune de la pluralité d'entretoises entre leurs extrémités proximales et leurs extrémités distales. Un feuillet est au moins partiellement disposé radialement à l'intérieur de la bande maillée et conçu pour s'accoupler avec le feuillet antérieur natif. L'invention concerne également un procédé d'ancrage amovible d'une prothèse de valvule cardiaque souple à l'intérieur de l'anneau du cœur d'un sujet.
PCT/US2019/039145 2018-06-26 2019-06-26 Prothèse de valvule cardiaque souple Ceased WO2020006026A1 (fr)

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US201862689981P 2018-06-26 2018-06-26
US62/689,981 2018-06-26

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3912563A3 (fr) * 2020-05-21 2022-01-26 St. Jude Medical, Cardiology Division, Inc. Mécanisme de pose d'un element d'occlusion en biomateriau

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140243878A1 (en) * 2013-02-25 2014-08-28 Cook Medical Technologies Llc Conical vena cava filter with jugular or femoral retrieval
WO2016209970A1 (fr) * 2015-06-22 2016-12-29 Edwards Lifescience Cardiaq Llc Implant de valve cardiaque pouvant être commandé de manière active et procédés de commande de celui-ci
WO2017127939A1 (fr) * 2016-01-29 2017-08-03 Neovasc Tiara Inc. Valvule prothétique permettant d'éviter une obstruction empêchant l'écoulement
WO2018112276A1 (fr) * 2016-12-14 2018-06-21 The Regents Of The University Of California Prothèse de valvule cardiaque souple

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140243878A1 (en) * 2013-02-25 2014-08-28 Cook Medical Technologies Llc Conical vena cava filter with jugular or femoral retrieval
WO2016209970A1 (fr) * 2015-06-22 2016-12-29 Edwards Lifescience Cardiaq Llc Implant de valve cardiaque pouvant être commandé de manière active et procédés de commande de celui-ci
WO2017127939A1 (fr) * 2016-01-29 2017-08-03 Neovasc Tiara Inc. Valvule prothétique permettant d'éviter une obstruction empêchant l'écoulement
WO2018112276A1 (fr) * 2016-12-14 2018-06-21 The Regents Of The University Of California Prothèse de valvule cardiaque souple

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3912563A3 (fr) * 2020-05-21 2022-01-26 St. Jude Medical, Cardiology Division, Inc. Mécanisme de pose d'un element d'occlusion en biomateriau
US11883014B2 (en) 2020-05-21 2024-01-30 St. Jude Medical, Cardiology Division, Inc. Biomaterial occluder delivery mechanism
US12336698B2 (en) 2020-05-21 2025-06-24 St. Jude Medical, Cardiology Division, Inc. Biomaterial occluder delivery mechanism

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