Cinching device and method for deploying a laterally delivered prosthetic heart valve in a native annulus

Abstract

The present invention relates to an anchoring channel and a subannular anchor for transcatheter heart valve replacement (A61F2 / 2412), and in particular for an orthogonally delivered transcatheter prosthetic heart valve having an annular support frame having a compressible wire unit that facilitates rolling and folding of the valve longitudinally or orthogonally to the central axis of the flow control component, thereby allowing very large diameter valves to be delivered and deployed from the inferior vena cava or superior vena cava to the tricuspid valve, or delivered and deployed transatrially to the mitral valve, the valve having a height of approximately 5 mm-60 mm and a diameter of approximately 25 mm-80 mm, without the need for an overly large diameter catheter and without the need for delivery and deployment from the catheter at an acute approach angle.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Provisional Application Serial No. 62 / 843,424, filed May 4, 2019, entitled “Cinch Device and Method for Deployment of an Orthogonal Prosthetic Heart Valve in a Native Annulus,” the disclosure of which is incorporated herein by reference in its entirety. Background Art

[0003]

[0014] The embodiments described herein relate to prosthetic heart valves, and in particular to cinch devices and methods for deploying an orthogonal prosthetic heart valve within a native annulus.

[0004] Prosthetic heart valves can present challenges to delivery and deployment within the heart, particularly for delivery that is performed through a catheter through the patient's vasculature rather than through a surgical approach. Traditional transcatheter delivery of prosthetic valves typically involves compressing the valve in a radial direction and loading the valve into a delivery catheter so that the valve's central annulus axis is parallel to the longitudinal axis of the delivery catheter. The valve is deployed from the end of the delivery catheter and expands outward in a radial direction from the central annulus axis. However, the expanded size (e.g., diameter) of a conventional valve may be limited by the inner diameter of the delivery catheter. Conflicting interests in minimizing the size of the delivery catheter pose a challenge to increasing the expanded diameter of a conventional valve (e.g., attempting to squeeze too much material and structure into too small a space).

[0005]

[0006] Therefore, a need exists for a prosthetic valve having one or more deployment-assisting features while maintaining a relatively small compressed size that allows for transcatheter delivery of the valve. Summary of the Invention

[0006] The present invention relates to a tightening device for reducing the circumference of a valve across the annular sidewall during deployment and then releasing the tightening device to expand the circumference to full size and obtain a reliable seal of the autologous annulus for transcatheter heart valve replacement, the valve having a proximal subannular anchoring tab and a distal subannular anchoring tab, and specifically a side-delivered (longitudinal) transcatheter prosthetic heart valve with an annular support frame having a compressible wire unit that facilitates rolling, folding, and compressing the valve in height and / or width along the longitudinal direction or orthogonal to the central axis of the flow control component, thereby allowing very large diameter valves to be delivered and deployed directly from the inferior vena cava into the tricuspid valve, for example, with a height of about 5mm-60mm and a diameter of about 25mm-80mm, without the need for an overly large diameter catheter and without the need for delivery and deployment from the catheter at an acute approach angle. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1 is a schematic cross-sectional side view according to an embodiment.

[0008] Figure 2 is a schematic bottom view according to an embodiment.

[0009] Figure 3 is a schematic cross-sectional side view according to an embodiment of a proximal tether assembly.

[0010] Figure 4 is a schematic cross-sectional side view according to an embodiment of a distal tether assembly.

[0011] Figure 5 is an image of an embodiment of the present invention in which a cinch assembly is attached to an orthogonally deliverable valve.

[0012] Figure 6 is an illustration of an embodiment of a valve prior to tightening, wherein the proximal side is blocked in a supraannular (atrial) position and the distal side is partially positioned over the annular ring, wherein the distal subannular (ventricular) tab and the distal atrial cuff form a distal concave circumferential channel in the valve circumferential wall.

[0013] Figure 7 is an illustration of an embodiment of a valve during cinch, wherein the proximal side is cinched or temporarily retracted inward to allow the proximal side of the valve to be inserted downwardly into the valve annulus such that by forcing (or fitting) the proximal side into the annulus, the proximal side can be released to move it from a supraannular position to an annular position and provide a tension fit against the annular ring. The distal side is shown partially seated onto the annular ring with the distal subannular (ventricular) tab and distal atrial cuff forming a distal concave circumferential channel in the valve circumferential wall.

[0014] Figure 8 is an illustration of one non-limiting embodiment of a cinching system in a released position at step 1 of 3 steps, whereby a pull tether and attached pull ring have constricted the atrial portion of the cinching tether (above the valve annulus) while the cinching tether is threaded through an eyelet in the annulus between a lower mounting element attached to the peripheral wall below the annulus and an upper mounting element, shown as a cinching ring, secured to an anchored steerable catheter, wherein the steerable catheter passes through the cinching ring.

[0015] Figure 9is an illustration of a non-limiting embodiment of a lacing system in a lacing position at step 2 of 3 steps, whereby a pull tether and attached pull ring have constricted and pulled the atrial portion of the lacing tether (above the valve annulus), wherein the lower portion of the lacing tether (below the annulus) shortens anteriorly and pulls the valve frame peripheral wall to a (body) compressed position, wherein the lacing tether is threaded through an eyelet in the annulus between a lower mounting element attached to the peripheral wall below the annulus and an upper mounting element, shown as a lacing ring, which is secured to an anchored steerable catheter, wherein the steerable catheter passes through the lacing ring.

[0016] Figure 10 is an illustration of a non-limiting embodiment of a tightening system returned to a released position at step 3 of 3 steps, whereby the valve is positioned into the native annulus by lowering the tightened / compressed proximal circumferential wall into the annular ring and releasing the tightening system to allow the circumferential wall to press against the proximal expansion of the native annulus.

[0017] Figure 11 is a diagram illustrating one non-limiting embodiment of a cinch system showing a steerable catheter being actuated (rotated, unscrewed) to disengage from a (threaded) receiver.

[0018] Figure 12 is a diagram illustrating one non-limiting embodiment of a cinch system and showing a steerable catheter being pulled out of a cinch loop / eyelet of a cinch tether, wherein the steerable catheter is fully withdrawn into a delivery catheter and out of the patient.

[0019] Figure 13 is a diagram illustrating one non-limiting embodiment of a cinch system and showing a pull tether and its loop being pulled out of a cinch loop / eyelet of the cinch tether, wherein the pull tether is fully withdrawn into the delivery catheter and out of the patient.

[0020] Figure 14 is another illustration of one non-limiting embodiment of a lacing system and shows the steerable catheter and pull tether and its loop being pulled out of the lacing loop / eyelet of the lacing tether, wherein the steerable catheter and pull tether are fully withdrawn into the delivery catheter and out of the patient.

[0021] Figure 15 is an illustration of a deployed / positioned valve in which the cinch tethers may be used to be trimmed away, or left in place to be incorporated into ingrowing tissue.

[0022] Figure 16is an illustration of a non-limiting embodiment of step 1 of a four-step delivery process for a prosthetic heart valve for orthogonal delivery having a distal anchoring tab / tension arm placed into a distal subannular position with the distal peripheral wall wedged against the native annulus, a folded / retracted proximal tab attached to a proximal tab catheter, and a cinching system mounted to the valve.

[0023] Figure 17 is an illustration of a non-limiting embodiment of step 2 of the 4 steps of the delivery process for a prosthetic heart valve for orthogonal delivery, and shows the proximal side (circumferential wall) of the valve body being tightened / retracted inward to reduce the size (diameter, circumference) of the valve body so that the valve can be placed into the native annulus.

[0024] Figure 18 is an illustration of one non-limiting embodiment of step 3 of the 4 steps of the delivery process for a prosthetic heart valve for orthogonal delivery, and illustrates the release of the fastening system and the deployment of the proximal tabs, wherein the fastening system releases the compressive force on the valve body and allows the valve to expand radially into the native annulus, and wherein the proximal tab catheter deploys the folded / collapsed proximal tabs away from the valve body to provide a proximal anchoring element for the valve.

[0025] Figure 19 is a diagram showing one non-limiting embodiment of step 4 of the 4 steps of the delivery process for a prosthetic heart valve for orthogonal delivery, wherein the valve has been deployed and the cinch system and proximal tab catheter are being withdrawn into the delivery catheter and out of the patient.

[0026] Figure 20 is an illustration of step 1 of 2 steps of a non-limiting preferred twisting embodiment of a cinching system, wherein the valve is in an expanded configuration and a steerable catheter is connected to a plurality of traction and cinching (combination) tethers, wherein each tether is strung through a separate eyelet in the annulus and mounted to the valve body wall below the annulus of the valve, wherein rotation of the steerable catheter shortens the tethers anteriorly and twists or twists the valve body to a narrower radial dimension for ease of insertion and positioning into the native annulus.

[0027] Figure 21 is an illustration of step 2 of 2 steps of a non-limiting preferred twisting embodiment of a cinching system, wherein the valve is in a radially compressed configuration, wherein rotation of the manipulable catheter shortens the tethers anteriorly, thereby twisting or twisting the valve body to a narrower radial dimension to facilitate insertion and positioning of the valve into the native annulus.

[0028] Figure 22is an illustration of step 1 of 2 steps of one non-limiting preferred cinch band embodiment of a cinch system, wherein the valve is in an expanded configuration and a steerable catheter is connected to a roller cylinder, wherein a cinch band is encircled around the valve body and mounted to the valve body wall beneath the annulus of the valve, wherein rotation of the steerable catheter rotates the roller cylinder and shortens the cinch band anteriorly to reduce the valve body to a narrower radial dimension for ease of insertion and positioning into the native annulus.

[0029] Figure 23 is an illustration of step 2 of 2 steps of a non-limiting preferred tightenable band embodiment of a tightening system, wherein the valve is in a radially compressed configuration, wherein rotation of the steerable catheter rolls a portion of the band onto a roller cylinder and shortens the band forward, thereby reducing the valve body to a narrower radial dimension to facilitate insertion and positioning of the valve into the native annulus.

[0030] Figure 24 is an illustration of a side perspective view of an orthogonally deliverable transcatheter heart valve having distal right ventricular outflow tract (RVOT) tabs, proximal tabs, in accordance with the present invention.

[0031] Figure 25 is an illustration of a side view of a single tether lacing member having a delivery catheter that fits over a releasable tether lock surrounding a peripheral wall and an anchor-mountable element for connection to the tether lock in accordance with the present invention.

[0032] Figure 26 is an illustration of a side view of a double tether lacing member having a delivery catheter over a releasable tether lock surrounding a peripheral wall and an anchor-mountable element for connection to the tether lock in accordance with the present invention.

[0033] Figure 27 is an illustration of a side view of a double tether lacing member according to the present invention having a delivery catheter over a releasable tether lock surrounding a peripheral wall and an anchor-mountable element for connection to the tether lock and to a folded-over proximal tab.

[0034] Figure 28 is an illustration of a side view of a single tether lacing member having a delivery catheter over a releasable tether lock surrounding a peripheral wall and an anchor-mountable element for connection to the tether lock and to a folded-over proximal tab in accordance with the present invention.

[0035] Figure 29 is a top view illustration of the valve in a constricted configuration.

[0036] Figure 30 is a top view illustration of the valve in the expanded configuration.

[0037] Figure 31 is a top view illustration of the valve in a bilaterally restrained configuration (septal and anterior, both restrained).

[0038] Figure 32 is a top view illustration of the valve in a bilaterally expanded configuration (septal and anterior, both expanded) with tethers installed.

[0039] Figure 33 is a top view illustration of the valve in a bilaterally restrained configuration (septal and anterior, both restrained) with tethers installed.

[0040] Figure 34 is a graph showing the percentage reduction of the major axis R1 of the valve's ellipse and the calculated circumference contraction.

[0041] Figure 35 is a graph showing the percentage reduction of the minor axis r1 of the valve ellipse and the calculated circumference contraction.

[0042] Figure 36 is a graph showing the percentage reduction of the major axis R1 of the valve's ellipse and the calculated circumference contraction.

[0043] Figure 37 is a top (nadir) view of a cross-section of the heart and illustrates the relationship between various anatomical features.

[0044] Figure 38 is an illustration of a valve delivery catheter that works in conjunction with a cinch device catheter to deliver the valve to the native annulus and then release / unclamp the valve to achieve a good seal while more predictably seating the valve in the annulus.

[0045] Figure 39 is an illustration of one type of wire frame panel showing a wire frame configuration that is balanced between horizontal and lateral compression.

[0046] Figure 40 is an illustration of one type of wire frame panel showing a wire frame configuration that is more prone to horizontal compression than lateral compression.

[0047] Figure 41 is an illustration of a prosthetic tricuspid valve delivered percutaneously via the femoral vein.

[0048] Figure 42 is an illustration of one type of wire frame panel showing a wire frame configuration that is more prone to horizontal compression than lateral compression.

[0049] Figure 43 is an illustration of one type of wire frame panel showing a wire frame configuration that is balanced between horizontal and lateral compression.

[0050] Figure 44 is an illustration of the valve cinched and seated in the tricuspid annulus.

[0051] Figure 45 is an illustration of the valve being released after being cinched and seated in the tricuspid annulus.

[0052] Figure 46 is an illustration of the valve cinched and seated in the mitral annulus.

[0053] Figure 47 is an illustration of the valve being released after being cinched and seated in the mitral annulus.

[0054] Figure 48 is an illustration of a side perspective view of an internal regurgitant control component with radiopaque markings as part of an orthogonally deliverable transcatheter heart valve according to the present invention, the heart valve having a collapsible flow control component mounted within an annular external support frame, the collapsible (inner) flow control component having a leaflet frame with 2-4 flexible leaflets mounted thereon, the leaflet frame being foldable from a cylindrical configuration to a flat cylindrical configuration along the z-axis and compressible to a shortened configuration along the vertical axis (y-axis), and the valve having a superelastic wire ring distal tab and a superelastic wire ring proximal tab.

[0055] Figure 49 is an illustration of a side perspective exploded view of an embodiment of the present invention having an inner backflow control component with radiopaque markings, with three leaflet tips or pouches mounted within a foldable and compressible inner wire frame, which is internally mounted within an outer wire frame having a collar component circumferentially attached at a top edge of the outer wire frame, a double tab component, and a mesh component.

[0056] Figure 50 is an illustration of a side perspective exploded view of an embodiment of an inner backflow control component having radiopaque markings, three leaflet tips or pouches mounted within a foldable and compressible inner wire frame, which is internally mounted within an outer wire frame having a collar component circumferentially attached at a top edge of the outer wire frame, a pair of integrated independent tab components, and a mesh component in accordance with the present invention.

[0057] Figure 51 is an illustration of a side perspective view of an orthogonally deliverable transcatheter heart valve in accordance with the present invention in a collapsed configuration along the z-axis (front to back when viewed from the wide side).

[0058] Figure 52 is an illustration of a side perspective view of an orthogonally deliverable transcatheter heart valve in a vertically compressed configuration in accordance with the present invention.

[0059] Figure 53is an illustration of a side perspective view of an orthogonally deliverable transcatheter heart valve partially loaded into a delivery catheter in accordance with the present invention. DETAILED DESCRIPTION

[0060] The present invention relates to a tightening device for reducing the size of a valve from distal to proximal to facilitate deployment of a large orthogonal valve into a native annulus and then releasing the tightening configuration and allowing the valve to expand once positioned within the annulus to achieve a secure seal for a double-tack transcatheter heart valve replacement, which is a low-profile, orthogonally delivered implantable prosthetic heart valve having an annular or annular support frame, an inner 2-panel or 3-panel sleeve, an elongated proximal subannular anchoring tab extending into the right ventricular outflow tract, preferably an elongated proximal subannular anchoring tab extending into the proximal subannular space between the anterior and posterior leaflets.

[0061] In some embodiments, the embodiments described herein relate to a laterally delivered transcatheter prosthetic heart valve with an integrated tightening device, the laterally delivered transcatheter prosthetic heart valve comprising: (a) a self-expanding annulus support frame having a central channel and an outer peripheral wall that surrounds a central vertical axis in an expanded configuration, an atrial sealing ring disposed around at least a portion of a top edge of the outer peripheral wall, the annulus support frame having a distal side and a proximal side; (b) an integrated tightening device comprising an elongated tether or strap attached to the annulus support frame that is actuated by a control handle of a steerable catheter to tighten or reduce a radial dimension of a proximal side of the annulus support frame; and (c) a flow control component mounted within the annulus support frame and configured to allow blood to flow through the inflow end of the valve in a first direction and to prevent blood from flowing in a second direction opposite to the first direction. flow through the outflow end of the valve; (d) a distal anchoring tab or tension arm below the annulus, which is attached to the distal portion of the peripheral wall and extends 10mm-40mm away from the peripheral wall; (e) a proximal anchoring tab or tension arm below the annulus, which is attached to the proximal portion of the peripheral wall and extends 5mm-20mm away from the peripheral wall; wherein the valve can be compressed to a compressed configuration for introduction into the body using a delivery catheter for implantation at a desired location in the body, the compressed configuration being oriented along a horizontal axis at an angle of between 45 degrees and 135 degrees to the central vertical axis, and expandable to an expanded configuration having a horizontal axis at an angle of between 45 degrees and 135 degrees to the central vertical axis; wherein the horizontal axis of the compressed configuration of the valve is substantially parallel to the longitudinal cylindrical axis of the delivery catheter; wherein the valve has a height of approximately 5mm-60mm and a diameter of approximately 25mm-80mm.

[0062] Any of the prosthetic heart valves described herein can include an integrated cinching device having two (2) or more tethers.

[0063] Any of the prosthetic heart valves described herein can include where the integrated tightening device comprises a single-pull tether mechanism, a dual-tether pull system, a multi-tether twisting mechanism, or a band tightening mechanism.

[0064] Any of the prosthetic heart valves described herein can include wherein the tether is braided polyethylene, treated pericardial tissue, ePTFE, or Nitinol.

[0065] Any of the prosthetic heart valves described herein can include wherein the tether or strap has a toothed portion and the release element has a releasable pawl element that engages the teeth.

[0066] Any of the prosthetic heart valves described herein can include where a first tether or strap is attached to a top portion of the septal side of the peripheral wall and a second tether or strap is attached to a bottom portion of the septal side of the peripheral wall.

[0067] Any of the prosthetic heart valves described herein may include a proximal anchoring tab in which a tether or strap is releasably attached to the proximal anchoring tab below the annulus, and the proximal anchoring tab is configured to move from a folded position against the peripheral wall to an expanded position folded away from the peripheral wall, wherein the proximal anchoring tab has a tab anchoring element and the tether or strap has a tab release element that cooperates with the tab anchoring element to move the proximal anchoring tab from the folded position to the expanded position.

[0068] Any of the prosthetic heart valves described herein can include where the annulus support frame is covered with a biocompatible material.

[0069] Any of the prosthetic heart valves described herein may include one in which the annulus support frame includes a plurality of compressible wire cells having an orientation and cell geometry substantially orthogonal to a central vertical axis to minimize wire cell strain when the annulus support frame is configured in a vertical compressed configuration, a rolled compressed configuration, or a folded compressed configuration.

[0070] Any of the prosthetic heart valves described herein may include wherein the annulus support frame has a lower body portion and an upper ring portion, wherein the lower body portion in the expanded configuration forms a shape selected from a funnel, a cylinder, a flat cone, or a circular hyperboloid.

[0071] Any of the prosthetic heart valves described herein can include wherein the annulus support frame comprises a braided wire or laser-cut wire frame, and the annulus support frame is covered with a biocompatible material.

[0072] Any of the prosthetic heart valves described herein can include a side profile in which the annulus support frame has a flat-conical shape with a diameter R of 40 mm-80 mm, a diameter r of 20 mm-60 mm, and a height of 5 mm-60 mm.

[0073] Any of the prosthetic heart valves described herein may include an annulus support frame having an inner surface and an outer surface, wherein the inner surface and the outer surface are covered with a biocompatible material selected from the following: the inner surface is covered with pericardial tissue, the outer surface is covered with a woven synthetic polyester material, and the inner surface is covered with pericardial tissue and the outer surface is covered with a woven synthetic polyester material.

[0074] Any of the prosthetic heart valves described herein may include an annulus support frame having an hourglass shaped side profile with a top diameter R1 of 40-80 mm, a bottom diameter R2 of 50-70 mm, an inner diameter r of 20-60 mm, and a height of 5-60 mm.

[0075] Any of the prosthetic heart valves described herein can include wherein the valve in the expanded configuration has a central vertical axis that is substantially parallel to the first direction.

[0076] Any of the prosthetic heart valves described herein can include wherein the flow control component has an inner diameter of 20 mm-40 mm and multiple leaflets of pericardial material are connected at the inflow end to form a rounded cylinder and have a flat, closable aperture at the outflow end.

[0077] Any of the prosthetic heart valves described herein may include a flow control component supported by one or more longitudinal supports integrated into or mounted to the flow control component, the one or more longitudinal supports being selected from rigid or semi-rigid posts, rigid or semi-rigid ribs, rigid or semi-rigid slats, rigid or semi-rigid panels, and combinations thereof.

[0078] Any of the prosthetic heart valves described herein may include wherein the subannular distal anchoring tab comprises a wire ring, a wire frame, a laser-cut frame, an integrated frame segment, or a stent, and the distal anchoring tab extends approximately 20 mm-40 mm distally away from the annular support frame.

[0079] Any of the prosthetic heart valves described herein can include wherein the proximal anchoring tab comprises a wire ring, a wire frame, a laser cut frame, an integrated frame segment, or a stent, and the proximal anchoring tab extends approximately 10 mm-20 mm proximally away from the annulus support frame.

[0080] Any of the prosthetic heart valves described herein may include an upper distal anchoring tab attached to the distal upper edge of the annulus support frame, the upper distal anchoring tab comprising a wire ring, a wire frame, a laser-cut frame, an integrated frame segment, or a stent, and extending approximately 10 mm-20 mm away from the annulus support frame.

[0081] Any of the prosthetic heart valves described herein can include wherein at least one tissue anchor is connected to the annulus support frame for engaging autologous tissue.

[0082] Any of the prosthetic heart valves described herein may include one in which the peripheral wall comprises a front wall portion as a first flat panel and a rear wall portion as a second flat panel, and wherein the proximal fold region and the distal fold region each comprise a sutured seam, a fabric panel, a rigid hinge, or a flexible fabric span without any wire elements.

[0083] Any of the prosthetic heart valves described herein may include one in which the annulus support frame comprises a compressible wire unit selected from the group consisting of: a braided wire unit, a laser cut wire unit, a photolithographically produced wire unit, a 3D printed wire unit, a wire unit formed from a single strand of wire that is intermittently connected in a wavy, zigzag, or spiral shape, and combinations thereof.

[0084] Any of the prosthetic heart valves described herein may include wherein the present invention provides a method for manufacturing a transcatheter prosthetic heart valve frame for orthogonal delivery, the method comprising: using additive or subtractive metal or metal alloy manufacturing to produce a self-expanding annulus support frame, the annulus support frame having a central channel and a peripheral wall surrounding a central vertical axis in an expanded configuration, an atrial sealing collar disposed around at least a portion of a top edge of the peripheral wall, the annulus support frame having a distal side and a proximal side, an integrated tightening device, a flow control component mounted within the annulus support frame and configured to allow blood to flow through an inflow end of the valve in a first direction and to prevent blood from flowing through an outflow end of the valve in a second direction opposite to the first direction, an integrated subannular anchor system attached to the annulus support frame, the anchor system comprising an elongated tether or strap attached at a distal end to a rigid ring, and a slidable anchor attached to the elongated tether or strap. A slidable locking element of the strip, a distal anchoring tab mounted on the distal side of the annulus support frame, a proximal anchoring tab mounted on the proximal side of the annulus support frame, wherein the valve can be compressed to a compressed configuration for introduction into the body using a delivery catheter for implantation at a desired position in the body, the compressed configuration is oriented along a horizontal axis at an angle of between 45 degrees and 135 degrees to the central vertical axis, and can be expanded to an expanded configuration with a horizontal axis at an angle of between 45 degrees and 135 degrees to the central vertical axis, wherein the horizontal axis of the compressed configuration of the valve is substantially parallel to the longitudinal cylindrical axis of the delivery catheter, wherein the valve has a height of approximately 5 mm to 60 mm and a diameter of approximately 25 mm to 80 mm, wherein additive metal or metal alloy manufacturing is 3D printing or direct metal laser sintering (powder melting), and wherein subtractive metal or metal alloy manufacturing is photolithography, laser sintering / cutting, CNC machining, or electrical discharge machining.

[0085] Any of the prosthetic heart valves described herein may include the following additional steps: (ii) mounting a flow control component within the valve frame, wherein the flow control component is configured to allow blood to flow through the inflow end of the flow control component along a central vertical axis and to prevent blood from flowing through the outflow end of the valve, (iii) covering the outer surface of the valve frame with pericardial material or a similar biocompatible material.

[0086] Any of the methods for compressing an implantable prosthetic heart valve for longitudinally orthogonal release of the valve from a delivery catheter may include the steps of: flattening, rolling, or folding the implantable prosthetic heart valve into a compressed configuration, wherein the major axis of the compressed configuration of the valve is substantially parallel to the longitudinal cylindrical axis of the delivery catheter, wherein the implantable prosthetic heart valve includes an annulus support frame having a flow control component mounted within the annulus support frame and configured to allow blood to flow through the inflow end of the valve in a first direction and prevent blood from flowing through the outflow end of the valve in a second direction opposite to the first direction, an integrated tightening system attached to the annulus support frame, a distal anchoring tab mounted on the distal side of the annulus support frame, and a proximal anchoring tab mounted on the proximal side of the annulus support frame, wherein the valve has a height of approximately 5 mm-60 mm and a diameter of approximately 25 mm-80 mm.

[0087] In another preferred embodiment, the implantable prosthetic heart valve is rolled or folded into a compressed configuration using steps selected from the group consisting of: unilaterally rolling into a compressed configuration from one side of the annulus support frame, bilaterally rolling into a compressed configuration from two opposite sides of the annulus support frame; flattening the annulus support frame into two parallel panels substantially parallel to the long axis, and then rolling the flat annulus support frame into a compressed configuration; and flattening the annulus support frame along a vertical axis to reduce the vertical dimension of the valve from top to bottom.

[0088] In another preferred embodiment, a method for orthogonally delivering an implantable prosthetic heart valve to a desired location within the body may include the following steps: advancing a delivery catheter to the desired location within the body, and delivering the expandable prosthetic heart valve to the desired location within the body by releasing the valve from the delivery catheter, wherein the valve includes a self-expanding annulus support frame having a central channel and a peripheral wall surrounding a central vertical axis in an expanded configuration, an atrial sealing ring disposed around at least a portion of a top edge of the peripheral wall, the annulus support frame having a distal end and a proximal end, an integrated tightening device; a flow control component mounted within the annulus support frame and configured to allow blood to flow through an inflow end of the valve in a first direction and to prevent blood from flowing through an outflow end of the valve in a second direction opposite to the first direction, the flow control component being mounted on the distal side of the annulus support frame. A distal anchoring patch, and a proximal anchoring patch mounted on the proximal side of the valve ring support frame, wherein the valve can be tightened into a tightened configuration having an elliptical circumference reduced by 5%-30% from the expanded configuration, or having a tightened configuration in which the major axis of the top edge is reduced in diameter by 5%-30%, wherein the valve can be compressed to a compressed configuration with a height of 5mm-10mm and a width of 5mm-10mm so as to be introduced into the body using a delivery catheter for implantation at a desired position in the body, the compressed configuration having a major axis oriented at an angle of between 45 degrees and 135 degrees to a first direction, and can be expanded to an expanded configuration having a major axis oriented at an angle of between 45 degrees and 135 degrees to the first direction, wherein the major axis of the compressed configuration of the valve is substantially parallel to the longitudinal cylindrical axis of the delivery catheter, wherein the valve has a height of approximately 5mm-60mm and a diameter of approximately 25mm-80mm.

[0089] With reference to the non-limiting embodiments shown in the drawings and described in detail in the following description, the embodiments herein and their various features and advantageous details are explained more comprehensively. The description of known components and processing techniques has been omitted to avoid unnecessarily obscuring the embodiments herein. The embodiments used herein are merely for the convenience of understanding the manner in which the embodiments herein may be practiced, and further enable those skilled in the art to practice the embodiments herein. Therefore, examples should not be construed as limiting the scope of the embodiments herein.

[0090] On the contrary, these embodiments are provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those skilled in the art. Like numbers refer to like elements throughout. As used herein, the term "and / or" includes any and all combinations of one or more of the relevant listed items.

[0091] The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the full scope of the invention. As used herein, the singular forms "a", "an" and "the" are also intended to include the plural forms, unless the context clearly indicates otherwise. It should also be understood that when used in this specification, the terms "include" and / or "comprise" specify the presence of the features, wholes, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, wholes, steps, operations, elements, parts and / or groups thereof.

[0092] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Nothing in this disclosure should be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention. As used in this document, the term "comprising" means "including but not limited to."

[0093] Without departing from its spirit and scope, many modifications and variations can be made, as will be apparent to those skilled in the art. In addition to those methods and apparatuses enumerated herein, functionally equivalent methods and apparatuses within the scope of the present disclosure will be apparent to those skilled in the art based on the foregoing description. Such modifications and variations are intended to fall within the scope of the appended claims. The present disclosure is limited only by the terms of the appended claims and the full scope of equivalents to which such claims are entitled. It should be understood that the present disclosure is not limited to specific methods, reagents, compounds, compositions, or biological systems, which can of course vary. It should also be understood that the terms used herein are merely for the purpose of describing specific embodiments and are not intended to be limiting.

[0094] With respect to the use of substantially any plural and / or singular terms herein, those skilled in the art can convert the plural to the singular and / or the singular to the plural according to the context and / or application. For the sake of clarity, various singular / plural arrangements may be explicitly set forth herein.

[0095] Those skilled in the art will understand that, in general, the terms used herein, and particularly in the appended claims (e.g., the bodies of the appended claims), are generally considered to be "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "comprising" should be interpreted as "including but not limited to," etc.). Those skilled in the art will further understand that, whether in the specification, claims, or drawings, almost any disjunctive conjunction and / or phrase that presents two or more alternatives should be understood to contemplate the possibility of including one, either, or both. For example, the phrase "A or B" will be understood to include the possibility of "A" or "B" or "A and B."

[0096] In addition, where features or aspects of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.

[0097] As will be understood by one skilled in the art, for any and all purposes, such as for providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be readily considered to fully describe the same range and enable the same range to be broken down into at least equal subportions. As will be understood by one skilled in the art, a range includes each individual member.

[0098] definition

[0099] Integrated tightening device

[0100] In the specification and claims herein, the terms "integrated lacing device", "lacing" are used to describe an elongated tether that is attached to the frame of the valve in such a manner that pulling the tether will fold / tighten / bend the circumferential wall of the annulus support frame, thereby reducing the circumference of the entire valve, making it easier to deploy the valve into the native annulus. The tether is attached (externally) to or extends (internally) through the body / circumferential wall and / or annulus portion of the prosthetic valve. In a preferred embodiment, the lacing device may have radiopaque markings or radiopaque materials or structures so that the delivery system catheter can be guided through the patient's body to the site where the valve is installed or is to be installed. In a preferred embodiment, the delivery of the orthogonal valve is (longitudinally delivered, with height compression and width compression) through the femoral vein to the inferior vena cava (IVC) to the right atrium of the heart for anchoring of the prosthetic tricuspid heart valve replacement, followed by IVC delivery of the anchoring system to install the subannular anchor.

[0101] Laterally delivered, sideways delivered, or orthogonally delivered

[0102] In the specification and claims herein, the terms "laterally delivered," "lateral delivery," or "orthogonal" are used to describe that the valve of the present invention is compressed and delivered at an approximately 90 degree angle compared to conventional transcatheter heart valves. Conventional valves have a central cylindrical axis that is parallel to the longitudinal axis of the delivery catheter and are deployed from the end of the delivery catheter in a manner similar to pushing a closed umbrella out of a sleeve. The valve of the present invention is compressed and delivered in a lateral manner. Conventional valves can only expand as large as the inner diameter of the delivery catheter will allow. Efforts to increase the expanded diameter of conventional valves have encountered the problem of trying to squeeze too much material and structure into too small a space. Mathematically, the term orthogonal refers to an intersection angle of 90 degrees between two lines or planes. As used herein, the term "substantially orthogonal" refers to an intersection angle in the range of 75 degrees to 105 degrees. The intersection angle or orthogonal angle refers to the relationship between (i) the longitudinal cylindrical axis of the delivery catheter and the long axis of the compressed valve of the present invention, where the long axis is perpendicular to the central cylindrical axis of the conventional valve, and (ii) the relationship between the long axis of the compressed or expanded valve of the present invention and the axis defined by the blood flowing through the prosthetic valve, where the blood is flowing, for example, from one part of the body or heart chamber to another downstream part of the body or heart chamber, such as, from the atrium to the ventricle through the native valve annulus.

[0103] Transcatheter

[0104] In the specification and claims herein, the term "transcatheter" is used to define the process of accessing, controlling, and delivering a medical device or apparatus within the lumen of a catheter that is deployed into a chamber of the heart, as well as items that have been delivered or controlled by such a process. Known transcatheter approaches include transfemoral artery and vein, transbrachial artery and vein, transcarotid artery and vein, intercostal (rib) space, and beneath the xiphoid process. Transcatheter may be synonymous with transluminal and is functionally related to the term "percutaneous" as it relates to delivery of heart valves.

[0105] In a preferred embodiment of the present invention, the transcatheter approach includes (i) advancement through the inferior vena cava via the femoral vein to the tricuspid valve or pulmonary artery of the heart, (ii) advancement through the superior vena cava via the jugular vein to the tricuspid valve or pulmonary artery of the heart, and (iii) advancement through a transatrial approach (e.g., lower in the fossa ovalis) via the IVC femoral vein or SVC jugular vein approach to the mitral valve of the heart.

[0106] Annuli support frame

[0107] In the specification and claims herein, the terms "annulus support frame" and "wire frame" or "flange" or "ring" refer to a three-dimensional structural component that is positioned within the annulus of a native valve and serves as a mounting element for a leaflet structure, a flow control component, or a flexible reciprocating sleeve or sleeve valve.

[0108] In a preferred embodiment, the annulus support frame is a self-expanding annulus support frame having a central channel and a peripheral wall surrounding a central vertical axis in an expanded configuration. The peripheral wall encompasses both the collar and the lower body portion.

[0109] The peripheral wall may be further defined as having a front wall portion and a rear wall portion connected to the proximal fold region along a proximal side (of the IVC) or proximal side and connected to the distal fold region along a distal side or distal side.

[0110] The front wall portion may be further defined as having a front upper collar portion and a front lower body portion, and the rear wall portion may be further defined as having a rear upper collar portion and a rear lower body portion.

[0111] The annulus support frame has a flow control component mounted therein and configured to allow blood to flow through the inflow end of the valve in a first direction and to prevent blood from flowing through the outflow end of the valve in a second direction opposite the first direction.

[0112] Because the frame is preferably made of a superelastic metal or alloy such as Nitinol, the frame is compressible. Preferably, the frame is composed of a plurality of compressible wire cells having an orientation and cell geometry that is substantially orthogonal to a central vertical axis to minimize wire cell strain when the annulus support frame is configured in a vertical compressed configuration, a rolled compressed configuration, or a folded compressed configuration.

[0113] Valve ring support frame structure

[0114] The annulus support frame can be a ring made of a durable, biocompatible structural material such as nitinol or a similar alloy, or a cylindrical or conical tube, wherein the annulus support frame is formed by manufacturing the structural material into a braided wire frame, a laser cut wire frame or a wire ring. Taking into account the thickness of the wire material itself, the height of the annulus support frame is about 5mm-60mm, the outer diameter R is 30mm-80mm, and the inner diameter is 31mm-79mm. As described above, the annulus support frame can have a side profile of a ring shape, a cylindrical shape, or a conical tube shape, but can also have the following side profiles: a flat cone shape, an inverted flat cone shape (narrower at the top and wider at the bottom), a concave cylinder (walls curved inward), a convex cylinder (walls bulging outward), an angular hourglass, a curved graduated hourglass, a ring or cylinder with an outward-flared top, an outward-flared bottom, or both. In a preferred embodiment, an annular support frame used in a prosthetic heart valve deployed in the tricuspid annulus can have a complex shape determined by the anatomy in which the valve is mounted. For example, in the tricuspid annulus, the circumference of the tricuspid valve can be a rounded ellipse, the septal wall is known to be substantially vertical, and the tricuspid valve is known to dilate along an anterior-posterior line in a diseased state. Thus, the prosthetic heart valve can begin with a generally tubular configuration and be thermoformed to provide a supra-atrial cuff or flange for atrial sealing and a lower transannular tubular or cylindrical section having an hourglass cross-section that occupies approximately 60%-80% of the circumference to conform to the native annulus along the posterior and anterior annular segments, while remaining substantially vertically flat along 20%-40% of the annular circumference to conform to the septal annulus segment.

[0115] Annuli support frame covering

[0116] The annulus support frame is optionally partially or completely covered internally or externally with a biocompatible material, such as pericardium. The annulus support frame may also optionally be partially or completely covered externally with a second biocompatible material, such as polyester or Dacron(R).

[0117] Valve ring support frame application

[0118] The annulus support frame has a central axial lumen, wherein a prosthetic heart valve or a flow control structure (such as a reciprocating compressible sleeve) is mounted across the diameter of the lumen. The annulus support frame is also tensioned against the inner face of the native annulus and provides structural patency for the weakened annulus.

[0119] Optional ring for valve ring support frame

[0120] The annulus support frame may optionally have a separate atrial ring attached to the upper (atrial) edge of the frame for deployment on the atrial floor, the atrial ring for directing blood from the atria into the sleeve and for sealing blood leakage around the annulus support frame. The annulus support frame may also optionally have a separate ventricular ring attached to the lower (ventricular) edge of the frame for deployment in the ventricle just below the native annulus, the ventricular ring for preventing backflow leakage during systole, preventing device displacement during systole, clamping or compressing the native annulus or adjacent tissue against the atrial ring, and optionally attached to and supporting the sleeve / catheter.

[0121] Annuli support frame delivery

[0122] The annulus support frame can be compressed for transcatheter delivery and can be expanded as a self-expandable shape memory element or using a transcatheter expansion balloon. Some embodiments may have both an atrial ring and a ventricular ring, while other embodiments within the scope of the invention include prosthetic heart valves with a single atrial ring, a single ventricular ring, or no additional ring structure.

[0123] Frame material

[0124] Preferably, the frame is made of a superelastic metal component, such as a laser cut Nitinol tube, or a flat sheet or other similar functional material, such as a braided wire. This material can be used for the frame / stent, for the collar and / or for the anchor. It is contemplated that other shape memory alloys and polymer composites can be used within the scope of the present invention, including composites containing carbon nanotubes, carbon fibers, metal fibers, glass fibers and polymer fibers. It is contemplated that the frame can be constructed as a braid, wire or a laser cut frame. The laser cut frame is preferably made of Nitinol, but can also be made of, but not limited to, stainless steel, cobalt chromium, titanium and other functionally equivalent metals and alloys.

[0125] A key aspect of the frame design is that it is compressible and has the property of returning to its original (uncompressed) shape when released. This requirement limits potential material choices to metals and plastics that have shape memory properties. With respect to metals, Nitinol has been found to be particularly useful because it can be processed to be austenitic, martensitic, or superelastic. Martensitic and superelastic alloys can be processed to exhibit desired mechanical behavior.

[0126] Annuli frame anchor elements

[0127] The tightening tethers are releasably attached to the valve and include various mechanisms for how to actuate the tethers. In one embodiment, the ends of the tethers have a release device and the remainder of the tethers pass through a guide hole or tube mounted on the frame. In another embodiment, the tethers are attached to multiple locations so as to fold one or both sides (the peripheral wall) of the valve in one large bend or in multiple smaller bends. In another embodiment, there may be more than one tether. For example, in one embodiment, there may be two tethers on one side of the valve, thereby reducing only one side. In another embodiment, there may be tethers on opposite sides of the valve (e.g., the septal side and the front side) to shrink or collapse the circumference of the valve.

[0128] Laser Cutting

[0129] One possible configuration of the wire frame contemplates laser cutting of thin, uniform-diameter Nitinol tubes. Laser cutting creates regular cuts in the thin Nitinol tubes. In a preferred embodiment, the Nitinol tubes are expanded to form a three-dimensional structure formed from diamond-shaped cells. This structure can also have additional functional elements, such as rings, anchors, etc., for attaching accessory components such as biocompatible coverings, tissue anchors, releasable deployment and retrieval control guides, knobs, attachments, rigging, etc.

[0130] Next, the tube is thermomechanically processed using industry-standard Nitinol forming methods. Treating the wire frame in this way creates a device with shape memory properties that will easily return to its memorized shape once deployed.

[0131] Braided wire

[0132] Another possible wire frame configuration envisions utilizing a simple braiding technique using Nitinol wire and a simple braided fixture. The wire is wrapped around the braided fixture in a pattern until a tube of uniform diameter is formed. Next, the braided wire frame is placed on a forming fixture and processed using industry-standard Nitinol forming methods.

[0133] Flow control components

[0134] In the specification and claims herein, the term "flow control member" refers in a non-limiting sense to a leaflet structure of a flexible biocompatible material (such as treated or untreated pericardium sutured or attached to an annular support frame) having 2, 3, or 4 leaflets that functions as a prosthetic heart valve. Such a valve can be a heart valve, such as the tricuspid valve, mitral valve, aortic valve, or pulmonary valve, which opens to blood flow from the atria to the ventricles during diastole and closes upon application of ventricular systolic pressure to the outer surface. The repeated opening and closing in sequence can be described as "reciprocating". In the valve-in-valve embodiment, the flow control component is contemplated to also include a variety of (bio)prosthetic heart valves, including ball valves (e.g., Starr-Edwards), bileaflet valves (St. Jude), tilting disc valves (e.g., Bjork-Shiley), stented pericardial heart valve prostheses (bovine, porcine, ovine) (Edwards bioprosthetic series, St. Jude prosthetic valves), as well as homograft valves and autologous graft valves. Bioprosthetic pericardial valves may include bioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, and bioprosthetic pulmonary valves.

[0135] Transcatheter

[0136] The term "transcatheter" is used to define the process of entering, controlling and / or delivering a medical device or instrument within the lumen of a catheter that is deployed into a chamber of the heart (or other desired location in the body), as well as items that have been delivered or controlled by such a process. Known transcatheter access includes cardiac access through the lumen of the femoral artery and / or femoral vein, through the lumen of the brachial artery and / or brachial vein, through the lumen of the carotid artery, through the lumen of the jugular vein, through the intercostal (rib) space and / or the space below the xiphoid process, etc. Transcatheter can be synonymous with transluminal and is functionally related to the term "percutaneous" because it involves the delivery of heart valves. As used herein, the term "lumen" can refer to the inside of a cylinder or tube. The term "bore" can refer to the inner diameter of a lumen.

[0137] Tissue anchors

[0138] In the specification and claims herein, the term "tissue anchor" or "pleated tissue anchor" or "secondary tissue anchor" or "dart" or "pin" refers to a fastening device that connects the superior atrial frame to the native annular tissue, typically at or near the perimeter of the collar. The anchor can be positioned to avoid piercing the tissue and rely solely on the compressive force of the two plate-like collars on the captured tissue, or the anchor itself or in combination with an integrated fixation wire can pierce the native tissue to provide anchoring, or a combination of both. The anchor can have a dedicated fixation mechanism, such as a pointed tip with a groove and a flanged shoulder that inserts or springs into a mating hole or array of mating holes that allows the anchor to attach but prevents disengagement when the perimeter of the holes locks into the grooves near the flanged shoulder. The fixation wire can be attached or anchored to the collar opposite the pin by any attachment or anchoring mechanism, including a knot, suture, wire crimp, wire lock with a cam mechanism, or a combination thereof.

[0139] support column

[0140] The term "support post" refers to a length of rigid or semi-rigid material, such as Nitinol or PEEK, that can be mounted on a spoked frame and extends axially, either down the center of a flexible sleeve, or within a sewn seam of a flexible sleeve. The sleeve may not be attached to the support post, or the sleeve may be attached directly or indirectly to the support post.

[0141] In the following description, the term "body passageway" is used to define a blood duct or vessel within the body. Of course, the specific application of the prosthetic heart valve will determine the body passageway in question. For example, an aortic valve replacement will be implanted in or adjacent to the aortic valve annulus. Similarly, a tricuspid or mitral valve replacement will be implanted at the tricuspid or mitral valve annulus. Certain features of the present invention are particularly advantageous for one implantation site or the other. However, unless such combination is structurally impossible or is excluded by the claim language, any of the heart valve embodiments described herein may be implanted in any body passageway.

[0142] The term "lumen" refers to the interior of a cylindrical tube. The term "caliber" refers to the inner diameter.

[0143] Displacement - The volume of fluid displaced by one complete stroke or rotation.

[0144] The ejection fraction is a measure of the percentage of blood that leaves the heart with each contraction. During each heartbeat, the heart contracts and relaxes. When the heart contracts, it ejects blood from its two pumping chambers (ventricles).

[0145] As a further point of definition, the term "expandable" is used herein to refer to a component of a heart valve that is capable of expanding from a first delivery diameter to a second implanted diameter. Thus, an expandable structure does not necessarily refer to a structure that may expand slightly due to elevated temperature or other such incidental causes. Conversely, "non-expandable" should not be interpreted as meaning completely rigid or dimensionally stable, as, for example, some degree of slight expansion can be observed with conventional "non-expandable" heart valves.

[0146] Prosthetic heart valves

[0147] The terms "prosthesis" or "prosthetic" encompass complete replacements of an anatomical part (e.g., a new mechanical valve replaces a native valve), as well as medical devices that replace and / or assist, repair, or improve an existing anatomical part (e.g., a native valve is left in situ). For installation within the passive assist cage, the present invention contemplates a variety of (bio)prosthetic heart valves. Contemplated as being within the scope of the present invention are ball valves (e.g., Starr-Edwards), bileaflet valves (St. Jude), tilting disc valves (e.g., Bjork-Shiley), stented pericardial heart valve prostheses (bovine, porcine, ovine) (Edwards bioprosthetic line, St. Jude prosthetic heart valves), as well as homograft valves and autograft valves. For bioprosthetic pericardial valves, the use of bioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, and bioprosthetic pulmonary valves is contemplated.

[0148] Tether-

[0149] The tethers are made of surgical grade materials, such as biocompatible polymer suture materials. Non-limiting examples of such materials include ultra-high molecular weight polyethylene (UHMWPE), 2-0 exPFTE (polytetrafluoroethylene), or 2-0 polypropylene. In one embodiment, the tethers are inelastic. It is also contemplated that one or more of the tethers may optionally be elastic to provide a greater degree of compliance of the valve during the cardiac cycle.

[0150] Tines-Anchors-Tine / Barb

[0151] The device can be positioned within the valve annulus using tines or barbs. These can be used in conjunction with or in place of one or more tethers. The tines or barbs are positioned to provide attachment to adjacent tissue. The tines are forced into the annular tissue by mechanical means, such as using a balloon catheter. In one non-limiting embodiment, the tines can optionally be semicircular hooks that pierce, rotate into, and securely hold the annular tissue when the wire frame body expands. The anchor is deployed by delivering one or more anchors through the wire using a delivery catheter. The catheter can have multiple axial lumens for delivering various anchoring tools, including anchor setting tools, force application tools, hooks, snare tools, cutting tools, radiofrequency and radiological visualization tools and markers, and suture / thread manipulation tools. Once the anchor is attached to the restraining band, a tensioning tool can be used to adjust the length of the tether connected to the implanted valve to adjust and secure the implant as needed for proper function. It is also contemplated that the anchor can be spring-loaded and have a tether attachment or tether capture mechanism built into the tethering surface of the anchor. The anchor may also have an ingrowth material, such as polyester fibers, to promote ingrowth of the anchor into the myocardium.

[0152] In one embodiment, where the prosthetic heart valve may or may not include a ventricular collar, the anchor or dart is not attached to the inferior ventricular collar, but is instead attached directly to the annular tissue or other tissue for anchoring.

[0153] polymer

[0154] In some embodiments, the components can be made of synthetic materials such as polyurethane or polytetrafluoroethylene (PTFE). Where a thin, durable synthetic material is envisioned (e.g., for a covering), a synthetic polymer material such as expanded PTFE or polyester can optionally be used. Other suitable materials can optionally include thermoplastic polycarbonate polyurethane, polyether polyurethane, multi-block polyether polyurethane, silicone polyether polyurethane, polyether ether ketone (PEEK), silicone polycarbonate polyurethane, polypropylene, polyethylene, low density polyethylene, high density polyethylene, and ultra-high molecular weight polyethylene. Additional biocompatible polymers may optionally include elastomers, polyolefins, polyethylene glycol, polyethersulfone, polysulfone, polyvinyl pyrrolidone, polyvinyl chloride, other fluoropolymers, polyesters, polyethylene terephthalate (PET) (e.g., Dacron), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly(D,L-lactide / glycolide) copolymer (PDLA), silicone polyesters, polyamides (nylon), PTFE, elongated PTFE, expanded PTFE, polyurethanes, silicone polymers and / or oligomers, and / or polylactones, and block copolymers thereof.

[0155] part

[0156] In some embodiments, the valve frame and / or its components can be made of biocompatible metals, metal alloys, polymer-coated metals, etc. Suitable biocompatible metals and / or metal alloys can include stainless steel (e.g., 316L stainless steel), cobalt-chromium (Co-Cr) alloys, nickel-titanium alloys (e.g., ) etc. Suitable polymer coatings may include polyethylene vinyl acetate (PEVA), polybutyl methacrylate (PBMA), translute styrene-isoprene-butadiene (SIBS) copolymer, polylactic acid, polyester, polylactide, D-lactic polylactic acid (DLPLA), etc.

[0157] Covering

[0158] Any valve frame and / or its parts or components may be partially or completely covered internally or externally with a biocompatible material such as pericardium. The valve frame may also optionally be partially or completely covered externally with a second biocompatible material such as polyester or The disclosed embodiments may utilize tissue, such as biological tissue that is chemically stable pericardial tissue of an animal such as a cow (bovine pericardium), a sheep (ovine pericardium), a pig (porcine pericardium), or a horse (equine pericardium). Preferably, the tissue is bovine pericardial tissue. Examples of suitable tissues include those in the product and and tissues used in all products currently used in surgery and marketed as generally obtained from cattle less than 30 months of age.

[0159] Covering wire frame material

[0160] Drug eluting wire frames are envisioned for use herein. DES essentially consists of three parts: a wire frame platform, a coating, and a drug. Some examples of polymer-free DES are Amazon Pax (MINVASYS) using an Amazonia CroCo (L605) cobalt-chromium (Co-Cr) wire frame, in which paclitaxel is used as an antiproliferative agent, and a coating from the lumen has been used as a carrier for the drug. BioFreedom (Biosensors Inc.) uses stainless steel as a substrate, in which a modified coating from the lumen serves as a carrier surface for the antiproliferative drug Biolimus A9. Optima (CID Srl) uses a 316L stainless steel wire frame as a substrate for the drug Tacrolimus, and uses an integrated mixed-layer carbon film as a drug carrier. VESTA sync (MIV Therapeutics) uses GenX stainless steel (316L) as a substrate and a microporous hydroxyapatite coating as a carrier for the drug Sirolimus. YUKON choice (Translumina) uses 316L stainless steel as the base for the combination of sirolimus and probucol.

[0161] Bioabsorbable polymers can also be used as carrier matrices for drugs in this article. Cypher, Taxus, and Endeavour are three basic types of bioabsorbable DES. Cypher (J&J, Cordis) uses 316L stainless steel coated with polyethylene vinyl acetate (PEVA) and polybutyl methacrylate (PBMA) to carry the drug sirolimus. Taxus (Boston Scientific) uses a 316L stainless steel wire frame coated with translute styrene-isoprene-butadiene (SIBS) copolymer to carry paclitaxel, which elutes over a period of approximately 90 days. Endeavour (Medtronic) uses a cobalt-chromium driven wire frame to carry zotarolimus and phosphorylcholine as drug carriers. BioMatrix uses an S-wire frame (316L) stainless steel as a substrate, with a polylactic acid surface used to carry the antiproliferative drug suomosu. The ELIXIR-DES procedure (Elixir Medical Corp.) involves a polyester and polylactide-coated wire frame to carry the drug novolimus with cobalt-chromium (Co-Cr) as the substrate. JACTAX (Boston Scientific Corp.) utilizes a 316L stainless steel wire frame coated with D-lactic acid polylactic acid (DLPLA) to carry paclitaxel. NEVO (Cordis Corporation, Johnson & Johnson) uses a cobalt-chromium (Co-Cr) wire frame coated with polylactic-co-glycolic acid (PLGA) to carry the drug sirolimus.

[0162] Example

[0163] Transcatheter prosthetic heart valves can be delivered to the mitral annulus using a transcatheter procedure transfemorally, through the IVC, carotid artery, below the xiphoid process, through intercostal routes, across the chest wall, and transseptally through the fossa ovalis.

[0164] The device is delivered to the right or left atrium via a catheter and expands from a compressed shape that fits within the inner diameter of the catheter lumen. The compressed valve is loaded into the delivery catheter outside the patient's body and then pushed out of the catheter once the capsule reaches the atrium. A cardiac technician uses available imaging techniques, such as fluoroscopy or ultrasound, to visualize the delivery.

[0165] In a preferred embodiment, the valve self-expands when released from the catheter because it is constructed in part of a shape memory material, such as Nickel-titanium alloys, or cobalt-chromium alloys, are alloys used in biomedical implants.

[0166] In another embodiment, the valve may be constructed of a material that requires balloon expansion after the balloon has been ejected from the catheter into the atrium.

[0167] As the atrial collar / frame and flow control components are deployed into the native annulus, they expand to their functional diameters, providing radial tension to secure the valve. Once the frame is deployed around the tricuspid annulus, fasteners secure the device around the native annulus. Additional fastening of the device to the native structure may be performed, and deployment is complete. Additional adjustments using hemodynamic imaging techniques are contemplated as being within the scope of the present invention to ensure that the device is secure, positioned and oriented as planned, and is functioning as a replacement or substitute for the native tricuspid valve.

[0168] Example - Delivery Process

[0169] Orthogonal delivery steps: providing a foldable, compressible prosthetic tricuspid valve, loading the valve laterally into a delivery catheter, advancing the valve via the IVC or SVC to the heart on a pre-placed guide wire that is threaded onto the guide wire ring of the distal subannular tab, partially expelling the valve to position the distal subannular tab to wedge the channel of the valve body against the distal annular ring with the atrial collar positioned on the top surface of the annular tissue area and allowing the valve leaflets to begin functioning, radially reducing the proximal side of the valve body using a tightening system, completing the deployment of the valve by placement into the native annulus, and extending / expanding the proximal subannular anchoring tab.

[0170] Example - Manufacturing Method

[0171] In a preferred embodiment, the present invention includes a method for manufacturing an orthogonally delivered transcatheter prosthetic heart valve frame, the method comprising: using additive or subtractive metal or metal alloy manufacturing to produce a self-expanding valve ring support frame, wherein the additive metal or metal alloy manufacturing is 3D printing or direct metal laser sintering (powder fusion), and wherein the subtractive metal or metal alloy manufacturing is photolithography, laser sintering / cutting, CNC machining, or electrical discharge machining.

[0172] In another preferred embodiment, a method for manufacturing an orthogonally delivered transcatheter prosthetic heart valve frame is provided, the method further comprising the steps of: (ii) mounting a flow control component within the valve frame, the flow control component being configured to allow blood to flow through an inflow end of the flow control component along a central vertical axis and to prevent blood from flowing through an outflow end of the valve, and (iii) covering the outer surface of the valve frame with pericardial material or a similar biocompatible material.

[0173] Example - Compression Method

[0174] In another preferred embodiment, a compression method is provided, wherein an implantable prosthetic heart valve is rolled or folded into a compressed configuration using steps selected from the group consisting of: unilaterally rolling into a compressed configuration from one side of the annulus support frame, bilaterally rolling into a compressed configuration from two opposite sides of the annulus support frame; flattening the annulus support frame into two parallel panels substantially parallel to the long axis, and then rolling the flat annulus support frame into a compressed configuration; and flattening the annulus support frame along a vertical axis to reduce the vertical dimension of the valve from top to bottom.

[0175] Attached photos

[0176] Now referring to the accompanying drawings, Figure 1 is a schematic cross-sectional side view according to an embodiment. Figure 1 15. The diagram shows how the perimeter (circumference) of the lower transannular portion 106 of the valve 100 can be cinched inward. This allows the valve to be designed with an oversized transannular circumference, for example 5%-20%, typically 10%-15%, to promote a tight fit of the valve within the native annulus and provide a good seal to prevent paravalvular leak (PVL). The cinching process pulls the proximal wall inward and reduces the circumference of the transannular segment 106. This allows the oversized valve to fall into the native annulus during valve deployment. Then, once the valve is positioned as desired, the transannular segment is pushed back to its full or nearly full circumference and thereby forms a tight, sealed fit of the prosthetic valve in the native annulus.

[0177] Figure 2 is a schematic bottom view according to an embodiment. Figure 2 The figure shows a view from below and illustrates how the perimeter (circumference) of the lower transannular portion of the valve is cinched inward, here at the proximal end of the transannular section of the valve. This excess transannular circumference, for example 5%-20%, typically 10%-15%, promotes a tight fit of the valve within the native annulus and provides a good seal to prevent paravalvular leak (PVL).

[0178] Figure 3 is a schematic cross-sectional side view according to an embodiment of the proximal tether. Figure 3106 . This allows the valve to be designed with an oversized transannular circumference, for example 5%-20%, typically 10%-15%, to facilitate a tight fit of the valve within the native annulus and provide a good seal to prevent paravalvular leak (PVL). The proximal cinching tether 105 illustrates a non-limiting mechanism for performing the cinching procedure. The cinching tether 105 is advanced from a delivery catheter (not shown) through a guide member such as an eyelet 111. In this embodiment, the cinching tether 105 is advanced through the eyelet through the collar 103 to a cinching tether mount on the proximal side 114 of the lower transannular segment 106 of the valve 100. Pulling the cinching tether proximally toward the operator pulls the proximal wall inward and reduces the circumference of the transannular segment 106. This allows an oversized valve to fall into the native annulus during valve deployment. Then, once the valve is positioned as desired, the tether 105 can be advanced (or released if the trans-annular segment is spring-biased into a folded configuration) to push the proximal side 114 back to its full or nearly full circumference and thereby form a tight sealing fit of the prosthetic valve in the native annulus.

[0179] Figure 4 is a schematic cross-sectional side view according to an embodiment of a distal tether. Figure 4 106 . The figure shows how the perimeter (circumference) of the lower transannular portion 106 of the valve 100 can be cinched inwardly. This allows the valve to be designed with an oversized transannular circumference, for example 5%-20%, typically 10%-15%, to promote a tight fit of the valve within the native annulus and provide a good seal to prevent paravalvular leak (PVL). The distal cinching tether 105 shows a non-limiting mechanism for performing the cinching procedure. The cinching tether 105 is advanced from a delivery catheter (not shown) through a guide member such as an eyelet 111. In this embodiment, the cinching tether 105 is advanced through the eyelet through the collar 103 to a cinching tether mount on the proximal side 114 of the lower transannular segment 106 of the valve 100. Pulling the cinching tether proximally toward the operator pulls the proximal wall inwardly and reduces the circumference of the transannular segment 106. This allows an oversized valve to fall into the native annulus during valve deployment. Then, once the valve is positioned as desired, the tether 105 can be advanced (or released if the trans-annular segment is spring-biased into a folded configuration) to push the proximal side 114 back to its full or nearly full circumference and thereby form a tight sealing fit of the prosthetic valve in the native annulus.

[0180] Figure 5 is an image of an embodiment of the present invention in which a cinch assembly is attached to an orthogonally deliverable valve.

[0181] Figure 5A valve is shown having a valve cuff / ring 103 surrounding the top edge of a cylindrical valve body with leaflets 258 disposed in a flow control component 130 mounted within the axial lumen of the valve body and a pierceable seal mounted adjacent the flow control component.

[0182] Figure 5 Also shown is a lacing system 105-107-111, illustrated in non-limiting aspects, wherein a steerable catheter / control cable 107 extends from a transcatheter delivery catheter and is temporarily mounted in a receiver element in the distal portion of the collar 103. The steerable catheter is passed through a lacing ring on the lacing tether 105, and the lacing tether is threaded through an eyelet 111 in the collar 103 between the steerable catheter and a tether mount 112 on the valve body, wherein the lacing tether ring is positioned at an atrial-side position above the collar, and the lacing tether mount 112 is positioned below the collar.

[0183] Figure 5 It is shown that by pulling the pull tether 105, it will apply a radial compression or tightening force on the valve body so that the proximal side can be positioned and lowered into the annulus while the distal side is held against the annulus, and when released, causes the valve to tension fit into the annulus.

[0184] Figure 5 Also shown is a proximal anchoring tab 270 attached to the proximal tab control catheter. The proximal anchoring tab begins in a folded or stowed configuration, and after the valve body is forced into the annulus, the proximal anchoring tab can be unfolded or released to extend away from the valve body and provide a subannular anchoring force (upward) on the proximal side. The upward force of the lower proximal anchor is balanced by the proximal collar, providing a supraannular downward force. Similarly, on the distal side, the distal collar (downward force, ventricular direction) and the distal anchoring tab (upward force, atrial direction) provide upper and lower interlayer anchoring mechanisms for the valve.

[0185] Figure 6 is an illustration of an embodiment of a valve prior to tightening, wherein the proximal side is blocked in a supraannular (atrial) position and the distal side is partially positioned over the annular ring, wherein the distal subannular (ventricular) tab and the distal atrial cuff form a distal concave circumferential channel in the valve circumferential wall.

[0186] Figure 7 is an illustration of an embodiment of a valve during cinch, wherein the proximal side is cinched or temporarily retracted inward to allow the proximal side of the valve to be inserted downwardly into the valve annulus such that by forcing (or fitting) the proximal side into the annulus, the proximal side can be released to move it from a supraannular position to an annular position and provide a tension fit against the annular ring. The distal side is shown partially seated onto the annular ring with the distal subannular (ventricular) tab and distal atrial cuff forming a distal concave circumferential channel in the valve circumferential wall.

[0187] Figure 8 is an illustration of one non-limiting embodiment of a cinching system in a released position at step 1 of 3 steps, whereby a pull tether and attached pull ring have constricted the atrial portion of the cinching tether (above the valve annulus) while the cinching tether is threaded through an eyelet in the annulus between a lower mounting element attached to the peripheral wall below the annulus and an upper mounting element, shown as a cinching ring, secured to an anchored steerable catheter, wherein the steerable catheter passes through the cinching ring.

[0188] Figure 9 is an illustration of a non-limiting embodiment of a lacing system in a lacing position at step 2 of 3 steps, whereby a pull tether and attached pull ring have constricted and pulled the atrial portion of the lacing tether (above the valve annulus), wherein the lower portion of the lacing tether (below the annulus) shortens anteriorly and pulls the valve frame peripheral wall to a (body) compressed position, wherein the lacing tether is threaded through an eyelet in the annulus between a lower mounting element attached to the peripheral wall below the annulus and an upper mounting element, shown as a lacing ring, which is secured to an anchored steerable catheter, wherein the steerable catheter passes through the lacing ring.

[0189] Figure 10 is an illustration of a non-limiting embodiment of a tightening system returned to a released position at step 3 of 3 steps, whereby the valve is positioned into the native annulus by lowering the tightened / compressed proximal circumferential wall into the annular ring and releasing the tightening system to allow the circumferential wall to press against the proximal expansion of the native annulus.

[0190] Figure 11 is a diagram illustrating one non-limiting embodiment of a cinch system showing a steerable catheter being actuated (rotated, unscrewed) to disengage from a (threaded) receiver.

[0191] Figure 12 is a diagram illustrating one non-limiting embodiment of a cinch system and showing a steerable catheter being pulled out of a cinch loop / eyelet of a cinch tether, wherein the steerable catheter is fully withdrawn into a delivery catheter and out of the patient.

[0192] Figure 13 is a diagram illustrating one non-limiting embodiment of a cinch system and showing a pull tether and its loop being pulled out of a cinch loop / eyelet of the cinch tether, wherein the pull tether is fully withdrawn into the delivery catheter and out of the patient.

[0193] Figure 14is another illustration of one non-limiting embodiment of a lacing system and shows the steerable catheter and pull tether and its loop being pulled out of the lacing loop / eyelet of the lacing tether, wherein the steerable catheter and pull tether are fully withdrawn into the delivery catheter and out of the patient.

[0194] Figure 15 is an illustration of a deployed / positioned valve in which the cinch tethers may be used to be trimmed away, or left in place to be incorporated into ingrowing tissue.

[0195] Figure 16 is an illustration of a non-limiting embodiment of step 1 of a four-step delivery process for a prosthetic heart valve for orthogonal delivery having a distal anchoring tab / tension arm 258 placed into a distal subannular position with the distal peripheral wall wedged onto the native annulus, a folded / retracted proximal tab 270 attached to a proximal tab catheter, and a tightening system 105-107-111-112 mounted to the valve.

[0196] Figure 17 is an illustration of a non-limiting embodiment of step 2 of the 4 steps of the delivery process for a prosthetic heart valve for orthogonal delivery, and shows the proximal side (circumferential wall) of the valve body being tightened / retracted inward to reduce the size (diameter, circumference) of the valve body so that the valve can be placed into the native annulus.

[0197] Figure 18 is an illustration of one non-limiting embodiment of step 3 of the 4 steps of the delivery process for a prosthetic heart valve for orthogonal delivery, and illustrates the release of the fastening system and the deployment of the proximal tabs, wherein the fastening system releases the compressive force on the valve body and allows the valve to expand radially into the native annulus, and wherein the proximal tab catheter deploys the folded / collapsed proximal tabs away from the valve body to provide a proximal anchoring element for the valve.

[0198] Figure 19 is a diagram showing one non-limiting embodiment of step 4 of the 4 steps of the delivery process for a prosthetic heart valve for orthogonal delivery, wherein the valve has been deployed and the cinch system and proximal tab catheter are being withdrawn into the delivery catheter and out of the patient.

[0199] Figure 20is an illustration of step 1 of 2 steps of a non-limiting preferred twisting embodiment of a cinching system, wherein the valve is in an expanded configuration and a steerable catheter is connected to a plurality of traction and cinching (combination) tethers, wherein each tether is strung through a separate eyelet in the annulus and mounted to the valve body wall below the annulus of the valve, wherein rotation of the steerable catheter shortens the tethers anteriorly and twists or twists the valve body to a narrower radial dimension for ease of insertion and positioning into the native annulus.

[0200] Figure 21 is an illustration of step 2 of 2 steps of a non-limiting preferred twisting embodiment of a cinching system, wherein the valve is in a radially compressed configuration, wherein rotation of the manipulable catheter shortens the tethers anteriorly, thereby twisting or twisting the valve body to a narrower radial dimension to facilitate insertion and positioning of the valve into the native annulus.

[0201] Figure 22 is an illustration of step 1 of 2 steps of one non-limiting preferred cinch band embodiment of a cinch system, wherein the valve is in an expanded configuration and a steerable catheter is connected to a roller cylinder, wherein a cinch band is encircled around the valve body and mounted to the valve body wall beneath the annulus of the valve, wherein rotation of the steerable catheter rotates the roller cylinder and shortens the cinch band anteriorly to reduce the valve body to a narrower radial dimension for ease of insertion and positioning into the native annulus.

[0202] Figure 23 is an illustration of step 2 of 2 steps of a non-limiting preferred tightenable band embodiment of a tightening system, wherein the valve is in a radially compressed configuration, wherein rotation of the steerable catheter rolls a portion of the band onto a roller cylinder and shortens the band forward, thereby reducing the valve body to a narrower radial dimension to facilitate insertion and positioning of the valve into the native annulus.

[0203] Figure 24 is an illustration of a side perspective view of an orthogonally deliverable transcatheter heart valve having distal right ventricular outflow tract (RVOT) tabs, proximal tabs, in accordance with the present invention.

[0204] Figure 25 is an illustration of a side view of a single tether lacing member having a delivery catheter that fits over a releasable tether lock surrounding a peripheral wall and an anchor-mountable element for connection to the tether lock in accordance with the present invention.

[0205] Figure 26 is an illustration of a side view of a double tether lacing member having a delivery catheter over a releasable tether lock surrounding a peripheral wall and an anchor-mountable element for connection to the tether lock in accordance with the present invention.

[0206] Figure 27is an illustration of a side view of a double tether lacing member according to the present invention having a delivery catheter over a releasable tether lock surrounding a peripheral wall and an anchor-mountable element for connection to the tether lock and to a folded-over proximal tab.

[0207] Figure 28 is a side view illustration of the valve in a constricted configuration.

[0208] Figure 29 is a top view illustration of the valve in a constricted configuration.

[0209] Figure 30 is a top view illustration of the valve in the expanded configuration.

[0210] Figure 31 is a top view illustration of the valve in a bilaterally restrained configuration (septal and anterior, both restrained).

[0211] Figure 32 is a top view illustration of the valve in a bilaterally expanded configuration (septal and anterior, both expanded) with tethers installed.

[0212] Figure 33 is a top view illustration of the valve in a bilaterally restrained configuration (septal and anterior, both restrained) with tethers installed.

[0213] Figure 34 is a graph showing the percentage reduction of the major axis R1 of the valve's ellipse and the calculated circumference contraction.

[0214] Figure 35 is a graph showing the percentage reduction of the minor axis r1 of the valve ellipse and the calculated circumference contraction.

[0215] Figure 36 is a graph showing the percentage reduction of the major axis R1 of the valve's ellipse and the calculated circumference contraction.

[0216] Figure 37 is a top (nadir) view of a cross-section of the heart and illustrates the relationship between various anatomical features.

[0217] Figure 38 is an illustration of the following five-step process: (a) a valve delivery catheter works together with a tightening device catheter to (b) deliver the valve to the native annulus, (c) position the distal subannular anchoring tab, and then (d) position and release / loosen the valve to achieve a good seal while the valve is more predictably positioned in the annulus, and then (e) extend the proximal subannular anchoring tab.

[0218] Figure 39 is an illustration of one type of wire frame panel showing a wire frame configuration that is balanced between horizontal and lateral compression.

[0219] Figure 40 is an illustration of one type of wire frame panel showing a wire frame configuration that is more prone to horizontal compression than lateral compression.

[0220] Figure 41 is an illustration of a prosthetic tricuspid valve delivered percutaneously via the femoral vein.

[0221] Figure 42 is an illustration of one type of wire frame panel showing a wire frame configuration that is more prone to horizontal compression than lateral compression.

[0222] Figure 43 is an illustration of one type of wire frame panel showing a wire frame configuration that is balanced between horizontal and lateral compression.

[0223] Figure 44 is an illustration of valve 100 cinched and positioned in the tricuspid annulus with delivery catheter 138 accessed through the IVC.

[0224] Figure 45 is an illustration of the valve 100 released after being cinched and seated in the tricuspid annulus.

[0225] Figure 46 is an illustration of valve 100 cinched and positioned in the mitral annulus.

[0226] Figure 47 is an illustration of valve 100 released after being cinched and positioned in the mitral annulus, with delivery catheter 138 accessed through the IVC via a transseptal puncture.

[0227] Referring again to the accompanying drawings, Figure 48 is an illustration of a side perspective view of an orthogonally deliverable transcatheter heart valve 100 according to the present invention, which has an annular outer support frame 102, a collapsible flow control component 130 mounted within the annular outer support frame 102, a distal patch 268 and a proximal patch 270. Figure 48 Shown are the tether 105, control cable 107 and tether eyelet 111. The proximal wall 114 is shown here in an expanded configuration.

[0228] The internal flashback control component 135 includes a tissue covering 141 , a reinforcement ring 143 , radiopaque markers 144 , and a drum / flashback channel 135 .

[0229] The collapsible (inner) flow control component 130 has a leaflet frame 231 on which 2-4 flexible leaflets 258 are mounted, and the leaflet frame 231 can be folded from a cylindrical configuration to a flat cylindrical configuration along the z-axis 109 and can be compressed to a shortened configuration along the vertical axis 108 (y-axis).

[0230] The annulus outer support frame 102 is made of a shape memory material, such as a nickel-titanium alloy, e.g., Nitinol, and is thus a self-expanding structure starting from a compressed configuration. The annulus (external) support frame 102 has a central (inner) channel and a peripheral wall 106 (spanning the annulus segment) surrounding a central vertical axis 108 when in the expanded configuration, and has a distal side 118 and a proximal side 114.

[0231] The flow control component 130 is mounted within the annulus outer support frame 102 and is configured to allow blood to flow through the inflow end 132 of the valve 100 in a first direction (e.g., atrium to ventricle) and to prevent blood from flowing through the outflow end 134 of the valve 100 in a second direction opposite to the first direction.

[0232] The inner regurgitant flow control component 135 is foldable and compressible, similar to the inner flow control component 130 and the outer annulus frame 102. The inner flow control component 130 includes a leaflet frame 231 on which 2-4 flexible leaflets 258 are mounted.

[0233] The flow control component 130, and therefore the leaflet frame 231, like the outer frame 102, can be folded from a cylindrical configuration to a flat cylindrical configuration along the z-axis (from front to back), wherein the fold line is located on the distal side and on the proximal side, obtaining the leaflet frame 231 in a ring shape or cylindrical shape and flattening it from the ring into a double layer band, i.e. folding on itself, or like a cylinder flattened into a rectangle or square connected along two opposite sides. This allows the outer frame 102 and the flow control component 130 to reduce the radius along the z-axis until the side walls touch or almost touch. This also allows the outer frame 102 and the flow control component 130 to maintain a radius along the horizontal axis (y-axis) to minimize the number of wire units that make up the outside and inside, which are destroyed by the forces applied during the folding and / or compression necessary for loading into the delivery catheter.

[0234] The internal regurgitation control component 135, flow control component 130, leaflet frame 231 and outer frame 102 are also vertically (y-axis) compressible, thereby reducing the height of the entire valve structure to fit within the inner diameter of the delivery catheter 138 (not shown in this figure). By folding along the z-axis and compressing vertically along the y-axis, the valve structure is allowed to maintain a very large size along the horizontal or x-axis. For example, valves of 60 mm or larger diameter can be delivered via transcatheter technology. The length of the long axis of the valve (e.g., 60 mm) is not limited by the large amount of wire frame and covering material required for such a large valve because it extends parallel to the central axis of the delivery catheter. This is not possible with existing central axis delivery (axial) transcatheter valves. The use of a folded, compressed valve that is orthogonal to traditional axial delivery valves allows for treatment options that were previously unavailable. Figure 48 Also shown are distal anchoring tabs 268 mounted on the distal side 118 of the annular outer support frame 102 and proximal anchoring tabs 270 mounted on the proximal side 114 of the annular outer support frame 102.

[0235] In a preferred embodiment, when in the expanded configuration, the horizontal x-axis of the valve makes an angle of between 45 degrees and 135 degrees with the central vertical y-axis.

[0236] In a preferred embodiment, the horizontal x-axis of the compressed configuration of the valve is substantially parallel to the longitudinal cylindrical axis of the delivery catheter.

[0237] In another preferred embodiment, the valve has a height of about 5 mm to 60 mm and a diameter of about 25 mm to 80 mm. Figure 48 Also shown are a guide wire sheath 310 and a guide wire 311. A lumen or guide ball 266 is shown mounted on the distal end of the distal tab 268, with the guide wire 311 extending through the lumen 266. While the inner diameter of the lumen 266 is large enough to allow the guide wire 311 to extend therethrough, the inner diameter of the lumen 266 is not large enough to allow the sheath 310 to extend therethrough. This allows the sheath 310 to be advanced along the guide wire 311 until it extends upward against the proximal side of the lumen 266, where continued thrust on the sheath 310 pushes against the lumen and allows the valve to be pulled out of the delivery catheter through the distal tab and to the target location for deployment of the valve.

[0238] Figure 49 is an illustration of a side perspective view of an exploded view of an embodiment having an inner return drum 137 with indicia 144 , channels 135 , and rings 143 . Figure 49Also shown are three leaflet 258 tips or pouches mounted within a foldable and compressible inner wire frame 231 having a distal fold region 120 and a proximal fold region 116, the inner portion 231 being mounted within an outer wire frame 102 having a loop component 103 circumferentially attached at the top edge 107 of the outer wire frame 102, a double tab component having a distal (RVOT) tab 268 and a proximal tab 270, and an optional mesh component of biocompatible material that can be used to cover the spacer element 137, cover the loop 103, cover the inner and outer faces of the outer frame 102, and / or cover the anchor tabs 268 and 270.

[0239] The atrial ring 103 is shaped to conform to the native deployment position. In tricuspid valve replacement, the atrial ring will have a high posterior wall portion to conform to the septal region of the native valve and will have a distal upper ring portion and a proximal upper ring portion. The distal ring portion may be larger than the proximal upper ring portion to account for the larger flat space above the subannular region of the (atrial) right ventricular outflow tract (RVOT).

[0240] Figure 50 is an illustration of a side perspective view of an exploded view of an embodiment of an open reflow frame 139 with radiopaque markers 144 . Figure 50 Also shown are three leaflet tips or pockets 258 mounted within a foldable and compressible inner wire frame 231 mounted within an outer wire frame 102 having a collar member 103 circumferentially attached at a top edge 107 of the outer wire frame 102, uncovered spacers 139, a pair of integrated independent tab members 269, 270, and a mesh member 226 in accordance with the present invention.

[0241] The uncovered regurgitant frame 139 provides controlled regurgitation of the valve. Once the patient no longer requires regurgitation, the uncovered regurgitant frame 139 can then be plugged with a later inserted stent or cover or plug.

[0242] The atrial ring 103 is shaped to conform to the native deployment position. In tricuspid valve replacement, the atrial ring will have a high posterior wall portion to conform to the septal region of the native valve and will have a distal upper ring portion and a proximal upper ring portion. The distal ring portion may be larger than the proximal upper ring portion to account for the larger flat space above the subannular region of the (atrial) right ventricular outflow tract (RVOT).

[0243] The integrated tabs 269 and 271 are of unitary construction with the body of the outer frame. The size and shape of the tabs may vary. In a preferred embodiment, the RVOT tabs, such as 269, may be longer to reach the entrance of the pulmonary artery (in the case of tricuspid valve replacement).

[0244] Figure 51 is an illustration of a side perspective view of an orthogonally deliverable transcatheter heart valve 100 in accordance with the present invention in a collapsed configuration along the z-axis (front to back when viewed from the wide side). Figure 51 A folded (flat) outer frame 102 is shown with a folded / flat collar 103, hinge points 116, 120. Figure 51 Also shown are the folded / flattened internal backflow control member 137 , designated 144 , and the leaflets 258 mounted within the folded / flattened internal frame 231 .

[0245] Figure 52 is an illustration of a side perspective view of an orthogonally deliverable transcatheter heart valve 100 in a vertically compressed configuration in accordance with the present invention. Figure 52 The outer frame 102 is shown folded (z-axis) and vertically compressed (y-axis) with the collar 103 folded (z-axis) and compressed (y-axis) along the fold line between the hinge points 116 , 120 . Figure 52 Also shown are the internal backflow control component 137 and the leaflets 258 mounted within the internal frame 231 .

[0246] Figure 53 is an illustration of a side perspective view of an orthogonally deliverable transcatheter heart valve 100 partially loaded into a delivery catheter 138 in accordance with the present invention. Figure 53 The outer frame 102, the folded collar 103, the inner backflow control member 137, and the flow control member 130 having leaflets 258 and the inner frame 231 are shown.

[0247] Various of the above-disclosed and other features and functions, or alternatives thereof, may be combined into many other different systems or applications. Various presently unforeseen or unanticipated substitutions, modifications, variations, or improvements may subsequently be made by those skilled in the art, each of which is also intended to be encompassed by the disclosed embodiments.

[0248] While embodiments of the present invention have been described herein, it should be noted that modifications and variations may be made by those skilled in the art in light of the above teachings. Therefore, it should be understood that changes may be made in the specific embodiments of the invention disclosed, provided that such changes are within the scope and spirit of the invention as defined by the appended claims. Having described the invention with the details and particularity required by the patent laws, what is claimed and desired to be protected by Letters Patent is set forth in the appended claims.

Claims

1. A transcatheter prosthetic heart valve with an orthogonal delivery and an integrated tightening device, the valve comprising: a self-expanding annulus support frame having a central channel and a peripheral wall surrounding a central vertical axis in an expanded configuration, an atrial sealing ring disposed around at least a portion of a top edge of the peripheral wall, the annulus support frame having a distal side and a proximal side, an integrated cinching device having an elongated tether or strap releasably attached at a distal end to the annulus support frame, the tether or strap being actuatable by a control handle of a steerable catheter to cinch or reduce the proximal radial dimension of the annulus support frame; a flow control member mounted within the annulus support frame and configured to allow blood to flow through an inflow end of the valve in a first direction and to prevent blood from flowing through an outflow end of the valve in a second direction opposite to the first direction, a distal subannular anchoring tab or tension arm attached to a distal portion of the peripheral wall and extending away from the peripheral wall, and a proximal subannular anchoring tab or tension arm attached to a proximal portion of the peripheral wall and extending away from the peripheral wall, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implantation at a desired location in the body, the compressed configuration being oriented along a horizontal axis at an angle between 45 degrees and 135 degrees to the central vertical axis, and the valve is expandable to an expanded configuration having a horizontal axis at an angle between 45 degrees and 135 degrees to the central vertical axis, Wherein the horizontal axis of the compressed configuration of the valve is substantially parallel to the longitudinal cylindrical axis of the delivery catheter.

2. The valve of claim 1, wherein the integrated tightening device has two or more tethers.

3. The valve of claim 1, wherein the integrated tightening device comprises a single-tether pull mechanism, a dual-tether pull system, a multi-tether twisting mechanism, or a band tightening mechanism.

4. The valve of claim 2, wherein the tether is braided polyethylene, treated pericardial tissue, ePTFE, or nitinol.

5. The valve of claim 1 , wherein the tether or strap has a toothed portion and the release element has a releasable pawl element that engages the teeth.

6. The valve of claim 1 , wherein a first tether or strap is attached to a top portion of the septal side of the peripheral wall and a second tether or strap is attached to a bottom portion of the septal side of the peripheral wall.

7. A valve as described in claim 1, wherein the tether or strip is releasably attached to the proximal anchoring tab below the valve annulus, and the proximal anchoring tab is configured to move from a folded position against the peripheral wall to an expanded position folded away from the peripheral wall, wherein the proximal anchoring tab has a tab anchoring element, and the tether or strip has a tab release element, which cooperates with the tab anchoring element to move the proximal anchoring tab from the folded position to the expanded position.

8. The valve of claim 1, wherein the annulus support frame is covered with a biocompatible material.

9. A valve as described in claim 1, wherein the annulus support frame comprises a plurality of compressible wire units having an orientation and unit geometry substantially orthogonal to the central vertical axis so as to minimize wire unit strain when the annulus support frame is configured in a vertical compression configuration, a rolled compression configuration, or a folded compression configuration.

10. A valve as described in claim 1, wherein the valve ring support frame has a lower body portion and an upper ring portion, wherein the lower body portion in the expanded configuration forms a shape selected from a funnel, a cylinder, a flat cone or a circular hyperboloid.

11. The valve of claim 1 , wherein the annulus support frame comprises a braided wire or laser-cut wire frame, and the annulus support frame is covered with a biocompatible material.

12. The valve of claim 1, wherein the annulus support frame has a side profile in the shape of a flat cone with a diameter R of 40 mm to 80 mm, a diameter r of 20 mm to 60 mm, and a height of 5 mm to 60 mm.

13. A valve as described in claim 1, wherein the valve ring support frame has an inner surface and an outer surface, and the inner surface and the outer surface are covered with a biocompatible material, which is selected from the following situations: the inner surface is covered with pericardial tissue, the outer surface is covered with a woven synthetic polyester material, and the inner surface is covered with pericardial tissue and the outer surface is covered with a woven synthetic polyester material.

14. The valve of claim 1, wherein the annulus support frame has an hourglass-shaped side profile with a top diameter R1 of 40mm-80mm, a bottom diameter R2 of 50mm-70mm, an inner diameter r of 20mm-60mm, and a height of 5mm-60mm.

15. The valve of claim 1, wherein the valve in the expanded configuration has a central vertical axis that is substantially parallel to the first direction.

16. The valve of claim 1, wherein the flow control member has an inner diameter of 20 mm-40 mm and a plurality of leaflets of pericardial material connected at the inflow end to form a rounded cylinder and having a flat, closable hole at the outflow end.

17. A valve as described in claim 1, wherein the flow control component is supported by one or more longitudinal supports integrated into or mounted on the flow control component, and the one or more longitudinal supports are selected from rigid or semi-rigid columns, rigid or semi-rigid ribs, rigid or semi-rigid slats, rigid or semi-rigid panels, and combinations thereof.

18. A valve as described in claim 1, wherein the distal anchoring tab below the annulus comprises a wire ring, a wire frame, a laser-cut frame, an integrated frame segment, or a stent, and the distal anchoring tab extends 20 mm-40 mm away from the distal side of the annulus support frame.

19. The valve of claim 1 , wherein the proximal anchoring tab comprises a wire ring, a wire frame, a laser-cut frame, an integrated frame segment, or a stent, and the proximal anchoring tab extends 10 mm-20 mm away from the proximal side of the annulus support frame.

20. The valve of claim 1 , further comprising an upper distal anchoring patch attached to the distal upper edge of the annulus support frame, the upper distal anchoring patch comprising a wire ring, a wire frame, a laser-cut frame, an integrated frame segment, or a stent, and extending 10 mm-20 mm away from the annulus support frame.

21. The valve of claim 1, comprising at least one tissue anchor connected to the annulus support frame for engaging autologous tissue.

22. A valve as described in claim 1, wherein the peripheral wall includes a front wall portion as a first flat panel and a rear wall portion as a second flat panel, and wherein the proximal folding region and the distal folding region each include a sutured seam, a fabric panel, a rigid hinge, or a flexible fabric span without any wire elements.

23. A valve as described in claim 1, wherein the annulus support frame includes a compressible wire unit, and the compressible wire unit is selected from the group consisting of: a braided wire unit, a laser cut wire unit, a photolithographically produced wire unit, a 3D printed wire unit, a wire unit formed by a single strand of wire connected discontinuously in a wavy, zigzag or spiral shape, and a combination thereof.

Images