Tricuspid valve closure regurgitation control device for an orthogonal transcatheter heart valve prosthesis

Abstract

The present invention relates to an access and occluder device, in particular a heart valve regurgitation drum and optional occlusion disc and / or annular stent for managing and providing a level of intentional regurgitation in a transcatheter heart valve replacement, in particular an orthogonally delivered transcatheter prosthetic heart valve having a first inner flow control component / valve, a first inner regurgitation control component and an outer annular support frame having compressible wire cells.SOLUTION: The compressible wire cells facilitate folding flat along the z-axis and compressing the valves vertically along the y-axis or orthogonal to the central axes of the flow control components, enabling the delivery and placement of very large diameter valves from the inferior or superior vena cavae to the tricuspid valves or transatrially to the mitral valves, having heights of about 5 to 60mm and diameters of about 25 to 80mm, without the need for an oversized catheter and without the need for delivery and placement from a catheter with a sharp approach angle.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS Provided by application data sheet in accordance with USPTO rules. Statement on Federally Supported R&D. Provided by application data sheet in accordance with USPTO rules. Names of parties to the collaborative research agreement. Provided by application data sheet in accordance with USPTO rules. Reference to a sequence listing. Provided by application data sheet in accordance with USPTO rules. Advance Disclosure Statement. Provided by application data sheet in accordance with USPTO rules. [Background technology]

[0002] The present invention relates to access and occlusion devices, and in particular to a heart valve regurgitation drum and optional occluding disc and / or tubular stent for managing and providing a level of intentional regurgitation within a transcatheter heart valve replacement (A61F2 / 2412).

[0003] 2. Description of Related Art In 1952, surgeons implanted the first artificial heart valve, a ball valve that could only be placed in the descending aorta and not in the heart itself. Because of this, it only alleviated symptoms rather than completely correcting the valve problem. However, it was a major achievement because it proved that synthetic materials could be used to create heart valves.

[0004] In 1960, a new type of valve was invented and successfully implanted. This valve, the Starr-Edwards ball valve, named after its creator, was an improvement over Hufnagel's original valve. The valve ball was slightly smaller and caged on both sides so that it could be inserted into the heart itself.

[0005] The next advancement was tilting disc technology, introduced in the late 1960s. These valves were a significant improvement over the ball design. Tilting disc technology allowed blood to flow more naturally while reducing damage to blood cells from mechanical forces. However, the struts of these valves were prone to fracture due to fatigue over time. As of 2003, over 100,000 Omniscience and 300,000 Hall-Kaster / Medtronic-Hall tilting disc valves had been implanted with essentially no mechanical failures.

[0006] In 1977, the bileaflet heart valve was introduced by St. Jude. As with natural heart valves, blood flows directly through the center of a pyrolytic carbon valve annulus mounted within a nickel-titanium housing, making these valves superior to other designs. However, a drawback of this design is that it allows some backflow. The majority of mechanical valves in use today have this design. As of 2003, over 1.3 million St. Jude valves had been deployed and over 500,000 Carbomedics valves had been deployed with no failures of either the valve leaflets or the housing. Note that the human heart beats approximately 31 million times per year.

[0007] Progress continues with compressible valves delivered via catheter, instead of requiring the trauma or complications of open-heart surgery, meaning cardiologists trained in endoscopy can In theory, heart valve replacements can be placed during outpatient surgery. However, transcatheter valves are often delivered by puncturing the apex of the heart to access the ventricle, and the puncture is often used to secure the annular valve replacement.

[0008] Furthermore, a problem with stent-style replacement valves is that they often continue to suffer from the regurgitation or leakage problems of previous generation valves and require expensive materials engineering to cope with the hundreds of millions of cycles encountered during just a few years of normal heart function. Thus, there remains a need for alternative, simpler solutions to addressing valve-related heart pathologies. Summary of the Invention

[0009] The present invention relates to access and occlusion devices, and in particular to heart valve regurgitation drums and optional occlusion components, and / or perforated tubular stents for managing and providing levels of intentional regurgitation within transcatheter heart valve replacements, and particularly within transcatheter prosthetic heart valves delivered orthogonally (longitudinal, along the z-axis).

[0010] In a preferred embodiment, a heart valve regurgitation drum with optional closure component and / or tubular stent for an orthogonally delivered transcatheter prosthetic heart valve includes a first inner flow control component / valve, a second inner regurgitation control component, and an outer annular support frame with compressible wire cells that are folded flat along the z-axis to facilitate vertical compression of the valve along the y-axis or orthogonal to the central axis of the flow control components, allowing delivery and deployment of very large diameter valves from the inferior or superior vena cava into the tricuspid valve or transseptally (transatrially, across the fossa ovalis or adjacent tissue) into the mitral valve, with a height of approximately 5-60 mm and a diameter of approximately 25-80 mm, without the need for an excessively large diameter catheter and without the need for delivery and deployment from a catheter at a sharp approach angle.

[0011] In another preferred embodiment, the present invention provides an orthogonally delivered transcatheter prosthetic heart valve having (i) a first inner flow control component, (ii) a second inner reflux control component, and (iii) an outer annular support frame; the second inner reflux control component having a bendable and compressible frame, a tissue cover attached to the frame, and a flow regulator mounted within a reinforcing ring attached to the tissue cover, wherein the flow regulator is selected from an occluder, a tubular stent, and a tubular stent having an occluder within a lumen of the tubular stent, the tissue cover having one or more radiopaque markers, mounted within the outer support frame of the prosthetic heart valve; a self-expanding annular outer support frame having a central channel, an outer circumferential wall bounded by a central vertical axis in an expanded configuration, an atrial collar attached along an upper edge of the outer wall, a distal fixation tab attached to a distal side of the outer annular support frame, and a proximal fixation tab attached to a proximal side of the outer annular support frame; and the second inner reflux control component having a bendable and compressible frame, a tissue cover attached to the frame, and a reinforcing ring attached to the tissue cover, wherein the flow regulator is selected from an occluder, a tubular stent, and a tubular stent having an occluder within a lumen of the tubular stent, the tissue cover having one or more radiopaque markers, mounted within the outer support frame of the prosthetic heart valve. and a first inner flow control component mounted within an outer annular support frame adjacent to the prosthetic heart valve, the first inner flow control component being configured to permit blood flow in a first direction through the inflow end of the valve and block blood flow in a second direction opposite the first direction through the outflow end of the valve, the first inner flow control component having a leaflet frame with two to four flexible leaflets mounted thereon, wherein each of the bendable and compressible frame of the second inner flow control component, the leaflet frame of the first inner flow control component, and the outer support frame is respectively bendable along a horizontal z-axis from a cylindrical configuration to a flattened cylindrical configuration and compressible along a vertical y-axis to a shortened configuration, the prosthetic heart valve being compressible to a compressed configuration for introduction into a body using a delivery catheter for implantation at a desired location within the body, the compressed configuration being oriented along a horizontal x-axis that is substantially parallel to the longitudinal cylindrical axis of the delivery catheter, the horizontal x-axis being oriented at an intersecting angle of 45 to 135 degrees with respect to a central vertical axis and at an intersecting angle of 45 to 135 degrees with respect to the central vertical y-axis. The device is expandable to an expanded configuration with a horizontal x-axis at an intersection angle of 135 degrees, and the valve has a height of approximately 5 to 60 mm and a diameter of approximately 25 to 80 mm, for managing intentional regurgitation in an orthogonally delivered transcatheter prosthetic heart valve and for providing a grade of intentional regurgitation.

[0012] In another preferred embodiment, the present invention provides a valve in which the annular outer support frame has an inner surface and an outer surface, the inner surface and the outer surface being covered with a biocompatible material selected from the following: an inner surface covered with pericardial tissue, an outer surface covered with a synthetic polyester fabric, and both an inner surface covered with pericardial tissue and an outer surface covered with a synthetic polyester fabric.

[0013] In another preferred embodiment, the present invention provides a valve in which the distal fixation tabs, the proximal fixation tabs, or both, are comprised of wire loops, wire frames, laser cut frames, integral frame sections, or stents, and extend approximately 10-40 mm from the sides of the annular outer support frame.

[0014] In another preferred embodiment, the present invention provides a valve further including an upper distal fixation tab attached to the distal upper edge of the annular support frame, the upper distal fixation tab being comprised of a wire loop, a wire frame, a laser cut frame, an integral frame section, or a stent, and extending approximately 2-20 mm away from the annular outer support frame.

[0015] In another preferred embodiment, the present invention provides a valve including at least one tissue anchor connected to an annular outer support frame for engaging natural tissue.

[0016] In another preferred embodiment, the present invention provides a valve wherein the annular outer support frame is comprised of compressible wire cells selected from the group consisting of braided wire cells, laser cut wire cells, photolithographically generated wire cells, 3D printed wire cells, wire cells formed from a single strand of wire intermittently connected in a wavy, zigzag, or helical pattern, or combinations thereof.

[0017] In another preferred embodiment, the present invention provides a valve in which the annular outer support frame is exteriorly covered with pericardial tissue, polyester material, or similar biocompatible material.

[0018] In another preferred embodiment, the present invention provides a method for providing intentional retrograde flow in an implanted transcatheter prosthetic heart valve, comprising the step of cutting or perforating a section of a tissue covering in a reinforcing ring of a second, inner retrograde control component according to claim 1 to form an opening by placing a catheter cutting tool in the implanted valve according to claim 1, wherein the valve according to claim 1 is implanted as a prosthetic heart valve in a patient.

[0019] In another preferred embodiment, the present invention provides a method including the additional step of placing a flow regulator in the opening selected from an occluder, a tubular stent, and a tubular stent having an occluder within the lumen of the tubular stent.

[0020] In another preferred embodiment, the present invention provides a method of controlling or correcting regurgitant flow in a patient having an orthogonally delivered transcatheter prosthetic heart valve, comprising: Step 1: Providing a bendable and compressible tricuspid valve according to claim 1; Step 2: loading the valve sideways into a delivery catheter; Step 3: advancing the valve into the tricuspid valve of the patient's heart via the inferior vena cava (IVC) or superior vena cava (SVC) via a pre-placed guidewire passed through the subannular distal tab; and Step 4: partially ejecting the valve to position the subannular distal tab and allow the valve leaflets to begin functioning. Step 5 of completing placement of the valve into the natural annulus; and step 6. advancing a cutting tool or balloon tool through the delivery catheter to the deployed valve to create a 1-5 mm opening in the tissue covering of the inner reflux control component.

[0021] In another preferred embodiment, the present invention provides a method for controlling or correcting reflux, further comprising step 7 of advancing a pacemaker wire set through an opening in the tissue covering of the inner reflux control component and attaching the pacemaker wire(s) to or near the target conduction node. [Brief explanation of the drawings]

[0022] [Figure 1] FIG. 1 is a side perspective view of an inner regurgitation control component with a radiopaque marker as part of an orthogonally deliverable transcatheter heart valve according to the present invention, in which a foldable flow control component is mounted within an annular outer support frame; the foldable (inner) flow control component has a leaflet frame with two to four flexible leaflets mounted thereon, the leaflet frame being bendable along the z-axis from a cylindrical configuration to a flattened cylindrical configuration and compressible along a vertical axis (y-axis) to a shortened configuration; and the valve having superelastic wire loop distal tabs and superelastic wire loop proximal tabs. [Figure 2] FIG. 1 is a side perspective exploded view of an embodiment of the present invention having an inner regurgitation control component with radiopaque markers, three leaflet tips or pockets mounted within a bendable and compressible inner wire frame, the inner portion being mounted within an outer wire frame with a collar component, a double tab component, and a mesh component circumferentially attached at the upper edge of the outer wire frame. [Figure 3] FIG. 1 is a side perspective view of an inner regurgitation control component having a radiopaque marker as part of an orthogonally deliverable transcatheter heart valve according to the present invention, in which a foldable flow control component is mounted within an annular outer support frame; the foldable (inner) flow control component has a leaflet frame with two to four flexible leaflets mounted thereon, the leaflet frame being bendable along the z-axis from a cylindrical configuration to a flattened cylindrical configuration and compressible along a vertical axis (y-axis) to a shortened configuration; and the valve having superelastic wire loop distal tabs and superelastic wire loop proximal tabs. [Figure 4] FIG. 1 is a side perspective exploded view of an embodiment of the present invention having a radiopaque marker, an inner regurgitation control component having three leaflet tips or pockets mounted within a bendable and compressible inner wire frame, the inner portion being mounted within an outer wire frame having a collar component circumferentially attached at the upper edge of the outer wire frame, a pair of integrated independent tab components, and a mesh component. [Figure 5] FIG. 1 is a side perspective view of an orthogonally deliverable transcatheter heart valve in a folded configuration along the z-axis (front to back when viewed from the wider side) according to the present invention. [Figure 6] FIG. 1 is a side perspective view of an orthogonally deliverable transcatheter heart valve in a vertically compressed configuration according to the present invention. [Figure 7] FIG. 1 is a side perspective view of an orthogonally deliverable transcatheter heart valve partially loaded into a delivery catheter in accordance with the present invention. [Figure 8] FIG. 1 is an end view of a delivery catheter showing a loaded valve in accordance with the present invention. [Figure 9] FIG. 10 is a top view of a folded and compressed valve ejected from a delivery catheter in a partial position to allow expansion of the leaflets and inner frame prior to installation into the native annulus. [Figure 10] FIG. 1 is a top perspective view of a valve according to the present invention having an inner reflux control component as part of a mesh spacer frame shown removed for viewing, an outer cylindrical frame with mesh sidewall coverings, and leaflets sewn to the inner portion. [Figure 11] FIG. 1 is a top perspective view of an inner reflux control component having a radiopaque marker as part of a mesh spacer frame attached to the upper edge of an outer cylindrical frame, an outer frame also having a mesh sidewall covering, an inner frame, and a valve having leaflets sewn to the inner portion, according to the present invention. [Figure 12]FIG. 1 is a bottom perspective view of an inner reflux control component as part of a mesh spacer attached to the upper edge of an outer cylindrical frame, an outer frame with a mesh sidewall cover, an inner frame, and a valve with leaflets sewn to the inner portion, according to the present invention. [Figure 13] 1 is an exploded view of a valve according to the present invention having an inner reflux control component, an outer cylindrical frame, an outer frame with a mesh sidewall cover, an inner frame, and leaflets sewn to the inner portion. [Figure 14] 1A-1C are top perspective views of the inner leaflet frame in a cylindrical configuration shown at the beginning of a process allowing the inner frame to fold and compress in accordance with the present invention. [Figure 15] FIG. 1 is a top perspective view of the medial leaflet frame in a partially folded configuration in which the wire frame side walls rotate or hinge at their lateral connection points, according to the present invention, shown as a partial first step in the process to enable folding and compression of the medial frame. [Figure 16] FIG. 1 is a side view of an inner leaflet frame in a fully folded configuration with the wire frame side walls rotated or hinged at their lateral connection points, according to the present invention, shown as the completed first step in the process to enable folding and compression of the inner frame. [Figure 17] FIG. 1 is a side view of an inner leaflet frame in a folded and vertically compressed configuration in which the wire frame side walls are vertically compressed in a pleated or accordion configuration, according to the present invention, shown as a second step in the process to enable folding and compression of the inner frame. [Figure 18] FIG. 10 is a side view of the medial leaflet frame as a linear wireframe sheet prior to assembly into a cylindrical structure in accordance with the present invention. [Figure 19] 1A-1C are side perspective views of an inner leaflet frame of a cylindrical or cylindrically-shaped (e.g., conical) configuration in accordance with the present invention. [Figure 20]FIG. 1 is a side perspective view of a band of pericardial tissue configured in a cylindrical shape with leaflet pockets sewn to the structural band in accordance with the present invention. [Figure 21] FIG. 1B is a side view of a band of pericardial tissue with leaflet pockets sewn to a structural band prior to assembly with a cylindrical leaflet component and attachment to an inner frame to form a foldable (bendable, compressible) flow control component according to the present invention. [Figure 22] FIG. 1B is a bottom view of a band of pericardial tissue with leaflet pockets sewn to a structural band prior to assembly with a cylindrical leaflet component and attachment to an inner frame to form a foldable (bendable, compressible) flow control component according to the present invention. [Figure 23] FIG. 1 is a side perspective view of a portion of a band of pericardial tissue with a single leaflet pocket sewn onto a structural band, showing the open lower edge and the parabolic upper edge sewn closed, in accordance with the present invention. [Figure 24] 1A-1C are bottom views of cylindrical leaflet components showing partial coaptation of the leaflets to form a closed fluid seal in accordance with the present invention. [Figure 25] (a)-(e) are diagrams of the process in which a valve with a pre-perforated drum inner portion is delivered orthogonally within a catheter, ejected from the catheter, and deployed into the native annulus. [Figure 26] 1 is a top perspective view of an outer wire frame in a cylindrical configuration shown at the beginning of a process allowing the outer frame to fold and compress in accordance with the present invention; FIG. [Figure 27] FIG. 1 is a top perspective view of the outer frame in a partially folded configuration in which the wire frame side walls rotate or hinge at their lateral connection points, according to the present invention, shown as a partial first step in the process to enable folding and compression of the inner frame. [Figure 28]FIG. 1 is a side view of the outer frame in a fully folded configuration with the wire frame side walls rotated or hinged at their lateral connection points, shown as the completed first step in the process to allow folding and compression of the inner frame, in accordance with the present invention. [Figure 29] FIG. 1 is a side view of the outer frame in a folded and vertically compressed configuration with the wire frame side walls vertically compressed in a pleated or accordion configuration, according to the present invention, shown as a second step in the process to allow folding and compression of the inner frame. [Figure 30] FIG. 1 is a top perspective view of an assembled valve according to the present invention, having an inner regurgitation control component with radiopaque markers and an outer frame, a flow control component with an inner leaflet frame and three sewn leaflet pockets / tips, an inner spacer frame, and a mesh cover on the spacer frame, with folds shown as dashed lines on the mesh cover. [Figure 31] FIG. 1 is a top perspective view of an assembled valve according to the present invention, including an inner reflux control component with a radiopaque marker and outer frame, a first subannular fixation / positioning tab attached to the outer frame adjacent to the flow control component, a second subannular fixation / positioning tab attached to the outer frame at a different location, an inner leaflet frame and a flow control component with three sewn leaflet pockets / tips, an inner spacer frame, and a mesh cover on the spacer frame, with folds shown as dashed lines on the mesh cover. [Figure 32]FIG. 1 is a bottom perspective view of an assembled valve according to the present invention, including an outer frame, a first subannular fixation / positioning tab attached to the outer frame adjacent to the flow control component, a second subannular fixation / positioning tab attached to the outer frame at a different location, an inner leaflet frame and a flow control component with three sewn leaflet pockets / tips, an inner spacer frame and a mesh cover on the spacer frame, with folds shown as dashed lines on the mesh cover and underneath the inner spacer frame where the hemodynamic washout cavity is covered. [Figure 33] FIG. 1 is a top view of an assembled valve according to the present invention, including an inner reflux control component and an outer frame, an inner leaflet frame and a flow control component with three sewn leaflet pockets / tips, an inner spacer frame, and a mesh cover on the spacer frame. [Figure 34] FIG. 1 is a top view of an assembled valve according to the present invention, including an inner reflux control component and outer frame, a first subannular fixation / positioning tab attached to the outer frame adjacent to the flow control component, a second subannular fixation / positioning tab attached to the outer frame in a different location, an inner leaflet frame and flow control component with three sewn leaflet pockets / tips, an inner spacer frame, and a mesh cover on the spacer frame. [Figure 35] (a)-(e) are diagrams of the step-by-step process by which the tissue drum is perforated prior to orthogonal loading of the valve onto the delivery catheter. [Figure 36] (a)-(c) are diagrams of the step-by-step process in which the tissue drum is perforated after the valve has been orthogonally ejected from the delivery catheter and placed into the native annulus. [Figure 37] FIG. 10 illustrates how a user can adapt the size of the opening to the amount of reflux desired, for example, a range of 0.5 to 2.0 grades of reflux. [Figure 38]FIG. 10 illustrates how a user can adapt the size of the lumen of a tubular stent that can be placed in the opening to accommodate the desired amount of reflux, for example, a range of 0.5 to 2.0 grades of reflux. [Figure 39] FIG. 1 is a side septal plan view of a tabbed valve according to the present invention, with the annular lower fixation and / or positioning tab extending towards the viewer and the second annular lower tab extending away, revealing a bendable and compressible wireframe structure. [Figure 40] (a)-(f) are diagrams of the closure device used to close the perforation in the inner reflux control component. [Figure 41] FIG. 1 is a top view of a valve according to the present invention partially ejected from a delivery catheter, with the distal tabs directing the valve to the deployment location (along a guidewire, not shown), the distal flow control components beginning to open, two of the three leaflets opening from their folded, flattened configuration, and the third leaflet opening from its folded configuration in which it folds back while in the delivery catheter. [Figure 42] FIG. 1B is a top view of a valve compressed (orthogonally loaded) within a delivery catheter with a first tab extending forward along the x-axis and a second, rearward tab extending rearward along the x-axis, in accordance with the present invention. [Figure 43] FIG. 1 is a top view of a valve having an outer frame, an off-center inner flow control component (leaflets within the frame), and an irregularly shaped spacer / support frame in accordance with the present invention. [Figure 44] FIG. 1 is a top view of a valve according to the present invention having an outer frame, a centrally located inner flow control component (valve leaflets within the frame), and a pair of irregularly shaped spacer / support frames on opposite sides of the inner flow control component. [Figure 45] 1 is a top view of a valve according to the present invention having an outer frame and an inner flow control component (leaflets within the frame) and multiple sewn attachment points where the inner portion is sewn to the outer portion. [Figure 46]FIG. 1 is a top view of a valve according to the present invention having a pacemaker lead wire set attached within the perforations of the second inner reflux control component, comprising an outer frame, an off-center inner flow control component, and an inner spacer frame, all three structures bendable along the same x-axis. [Figure 47] FIG. 1 is a top view of a valve according to the present invention having an outer frame, a centrally positioned inner flow control component, and a pair of smaller cylindrical inner spacer frames attached to opposite sides of the inner flow control component to provide support within the inner dimensions of the outer frame, with all four structures bendable along the same x-axis. [Figure 48] FIG. 1 is a top view of a valve according to the present invention having an outer frame, a proximally positioned offset inner flow control component, and a distal inner spacer frame, all three structures being bendable along the same x-axis. [Figure 49] FIG. 1 is a diagram of a lateral view of a human heart with a transfemoral / IVC or SVC delivery catheter ejecting an orthogonal prosthetic valve for low-angle placement access to the tricuspid valve in accordance with the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0023] The present invention is directed to a dual-tab transcatheter heart valve replacement, which is a low-profile, orthogonally delivered, implantable prosthetic heart valve having a ring-shaped or annular support frame, an inner two or three panel sleeve, elongated sub-annular distal fixation tabs extending into the right ventricular outflow tract, and elongated sub-annular proximal fixation tabs extending into the proximal sub-annular space, preferably between the anterior and posterior leaflets.

[0024] The embodiments herein, and their various features and advantageous details, will be more fully described with reference to the non-limiting embodiments illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as not to unnecessarily obscure the embodiments herein. The examples used herein are merely intended to facilitate an understanding of how the embodiments herein may be practiced and to further enable those skilled in the art to practice the embodiments herein. Therefore, the examples should not be construed as limiting the scope of the embodiments herein. This document should not be construed as defining the scope of the

[0025] Rather, 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 associated listed items.

[0026] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the overall scope of the present invention. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should be further understood that the terms "comprises" and / or "comprising," as used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0027] 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."

[0028] As will be apparent to those skilled in the art, many modifications and variations can be made without departing from its spirit and scope. Functionally equivalent methods and apparatuses within the scope of the present disclosure, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing description. Such modifications and variations are intended to fall within the scope of the appended claims. The present disclosure is to be limited only by the terms of the appended claims, along with the full scope of equivalents to which such claims are entitled. It is to be understood that the present disclosure is not limited to particular methods, reagents, compounds, compositions, or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0029] With respect to the use herein of virtually any plural and / or singular term, those skilled in the art can convert from plural to singular and / or from singular to plural as appropriate to the context and / or application. For clarity, various singular / plural permutations may be expressly stated herein.

[0030] Those skilled in the art will appreciate that, in general, the terms used in this specification, and particularly in the appended claims (e.g., the body of the appended claims), are generally intended to be "open" terms (e.g., the term "including" should be interpreted as "including without limitation," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "including without limitation," etc.). Those skilled in the art will further appreciate that, in nature, any disjunctions and / or phrases indicating two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the inclusion of one of the terms, either of the terms, or both terms. For example, the phrase "A or B" is understood to include the possibilities of "A" or "B" or "A and B."

[0031] Also, when features or aspects of the present disclosure are described in terms of a Markush group, one of skill in the art will understand that the present disclosure is thereby directed to any individual member or subgroup of members of that Markush group. You will understand that this is also stated in the

[0032] As will be appreciated by those skilled in the art, for all purposes, e.g., with respect to providing a written description, all ranges disclosed herein encompass all possible subranges and combinations thereof. Any recited range can be readily understood as fully describing and allowing for the same range to be broken down into at least equal subdivisions. As will be appreciated by those skilled in the art, a range includes each individual member.

[0033] definition Orthogonal In the description and claims herein, the term "orthogonal" is used to describe the fact that the valve of the present invention is compressed and delivered at approximately a 90-degree angle compared to conventional transcatheter heart valves. Conventional valves have a central cylindrical axis 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 sideways. Conventional valves can only expand to the extent permitted by the inner diameter of the delivery catheter. Efforts to increase the expanded diameter of conventional valves have run into the problem of trying to compress too much material and structure into too small a space. Mathematically, the term "orthogonal" refers to a 90-degree intersection angle between two lines or planes. As used herein, the term "substantially orthogonal" refers to an intersection angle in the range of 75 to 105 degrees. The intersection angle or orthogonal angle refers to both (i) the relationship between 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 a 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 flow through the prosthetic heart valve, where blood is flowing through the native annulus, e.g., from one part of the body or chamber of the heart to another downstream part of the body or chamber of the heart, such as from the atrium to the ventricle.

[0034] Transcatheter In the description and claims herein, the term "transcatheter" is used to define the process of accessing, controlling, and delivering medical devices or instruments within the lumen of a catheter placed in a cardiac chamber, as well as items delivered or controlled by such a process. Transcatheter access is known to include via the femoral artery and vein, via the brachial artery and vein, via the carotid artery and vein, via the intercostal (rib) space, and via the sub-xiphoid. Transcatheter can be synonymous with transluminal and is functionally related to the term "percutaneous" with respect to heart valve delivery.

[0035] In a preferred embodiment of the present invention, the transcatheter approach includes (i) advancement via the femoral vein through the inferior vena cava to the tricuspid valve of the heart or the pulmonary artery, (ii) advancement via the jugular vein through the superior vena cava to the tricuspid valve of the heart or the pulmonary artery, or (iii) advancement via an IVC-femoral approach or an SVC-jugular approach to the mitral valve of the heart through a transatrial approach, e.g., at or below the fossa ovalis.

[0036] Annular Support Frame In the description and claims herein, the terms "annular support frame," and "wire frame" or "flange or collar" refer to a three-dimensional structural component that is mounted within the native valve annulus and used as a leaflet structure, a flow control component, or a mounting element for a flexible reciprocating sleeve or sleeve valve.

[0037] In a preferred embodiment, the annular support frame is a self-expanding annular support frame having a central passageway and an outer periphery wall bounded by a central vertical axis in the expanded configuration. It surrounds both body parts.

[0038] The outer wall can be further defined as having an anterior wall portion and a posterior wall portion, which are connected along a proximal or proximal side (e.g., relative to the IVC) to the proximal fold region and along a far or distal side to the distal fold region.

[0039] The front wall portion may be further defined as having a collar portion at an upper front portion and a body portion at a lower front portion, and the rear wall portion may be further defined as having a collar portion at an upper back portion and a body portion at a lower back portion.

[0040] The annular support frame has a flow control component mounted within the annular support frame and configured to allow blood flow in a first direction through the inflow end of the valve and block blood flow in a second direction opposite the first direction through the outflow end of the valve.

[0041] The frame is preferably made of a superelastic metal or superelastic alloy such as Nitinol so that the frame is compressible. Preferably, the frame is constructed from a plurality of compressible wire cells having an orientation and cell shape substantially perpendicular to a central vertical axis to minimize strain on the wire cells when the annular support frame is configured in a vertical, rolled, or folded compression configuration.

[0042] Ring support frame structure The annular support frame can be a ring, cylindrical, or conical tube made from a durable, biocompatible structural material, such as Nitinol or a similar alloy. The annular support frame can be formed by fabricating the structural material as a braided wire frame, laser-cut wire frame, or wire loop. The annular support frame has a height of approximately 5-60 mm, an outer diameter of 30-80 mm, and an inner diameter of 31-79 mm, accounting for the thickness of the wire material itself. As described above, the annular support frame can have a ring-shaped, cylindrical, or conical tube-shaped side profile. It can also have a flattened cone shape, an inverted flattened cone shape (narrower at the top and wider at the bottom), a concave cylindrical shape (with a concave wall), a convex cylindrical shape (with a bulging wall), an angular hourglass shape, a curved hourglass shape, a flared top, a flared bottom, or both. In one preferred embodiment, the annular support frame used in a prosthetic heart valve placed within the tricuspid annulus may have a complex shape dictated by the anatomical structure to which the valve is attached. For example, in the tricuspid annulus, the circumference of the tricuspid valve may be rounded and oval, the septum is known to be substantially vertical, and the tricuspid valve is known to expand along the anterior-posterior line in pathological conditions. Thus, the prosthetic heart valve begins in a generally tubular configuration and is thermoformed to result in an upper atrial cuff or flange for atrial sealing and a lower trans-annular tubular or cylindrical section with an hourglass cross-section for approximately 60-80% of the circumference that fits the native annulus along the posterior and anterior annular segments, while remaining substantially vertically flat along 20-40% of the annular circumference that fits the septal annular segment.

[0043] Annular support frame cover The annular support frame is optionally partially or completely covered internally or externally by a biocompatible material such as pericardium, and may also be optionally partially or completely covered externally by a second biocompatible material such as polyester or Dacron®.

[0044] Purpose of the ring support frame The annular support frame allows a flow structure, such as a prosthetic heart valve or a reciprocally compressible sleeve, to be inserted into the lumen. The annular support frame has a central axial lumen that is diametrically attached to the annular support frame and is tensioned against the medial aspect of the native annulus, providing structural patency to the weakened annular ring.

[0045] Annular support frame optional color The annular support frame may optionally have a separate atrial collar attached to its upper (atrial) rim for placement on the atrial floor, which is used to direct blood from the atrium into the sleeve and to seal blood leaks around the annular support frame. The annular support frame may also optionally have a separate ventricular collar attached to its lower (ventricular) rim for placement in the ventricle just below the native annulus, which is used to prevent backflow leak during systole, to prevent device dislodgement during systole, to sandwich or compress the native annulus or adjacent tissue against the atrial collar, and optionally to attach to and support the sleeve / conduit.

[0046] Delivery of the annular support frame The annular support frame may be compressed for transcatheter delivery and may be expandable as a self-expanding shape memory element or using a transcatheter dilatation balloon. Some embodiments may have both an atrial collar and a ventricular collar, while other embodiments within the scope of the present invention include prosthetic heart valves with either a single atrial collar, a single ventricular collar, or no additional collar structure.

[0047] Frame material Preferably, the frame is made from a superelastic metal component, such as a laser-cut nitinol tube, or other similarly functional materials, such as flat or braided wire. Materials may be used for the frame / stent, for the collar, and / or for the anchors. The use of other shape memory alloys and polymeric composite materials, including composites containing carbon nanotubes, carbon fiber, metal fiber, glass fiber, and polymer fiber, is contemplated within the scope of the present invention. It is contemplated that the frame may be constructed as a braid, wire, or laser-cut frame. The laser-cut frame is preferably made from nitinol, but may also be made from, without limitation, stainless steel, cobalt chrome, titanium, and other functionally equivalent metals and alloys.

[0048] One important aspect of the frame design is that it is compressible and has the proposed property that, upon release, it returns to its original (uncompressed) shape. This requirement limits potential material choices to metals and plastics with shape memory properties. With regard to metals, Nitinol has proven particularly useful because it can be processed to be austenitic, martensitic, or superelastic. Martensitic and superelastic alloys can be processed to exhibit the required mechanical behavior.

[0049] Laser cutting One possible structure for the wire frame is laser cutting a thin, uniformly diametrical nitinol tube. The laser cutting creates regular cutouts in the thin nitinol tube. In one preferred embodiment, the nitinol tube expands to form a three-dimensional structure formed from diamond-shaped cells. The structure may also have additional functional elements, such as loops, anchors, etc., for attaching accessory components, such as a biocompatible cover, tissue anchors, releasable placement and removal control guides, knobs, attachments, rigging, etc.

[0050] Second, the tube is thermomechanically processed using industry-standard Nitinol forming methods. By processing the wire frame in this manner, a device is formed that has shape memory properties and quickly returns to its memorized shape once deployed.

[0051] Braided Wire Another possible construction of the wire frame envisions utilizing a simplified braiding technique using Nitinol wire and a simple braiding fixture. The wire is wrapped around the braiding fixture in a pattern until a tube of equal diameter is formed. Second, the braided wire frame is placed in a forming fixture and processed using industry-standard Nitinol forming methods.

[0052] Flow Control Component As used herein and in the claims, the term "flow control component" refers, without limitation, to a two-, three-, or four-cusp valve structure of flexible biocompatible material, such as treated or untreated pericardium, sewn or bonded to an inner annular support frame (mounted within an outer annular support frame) to function as a prosthetic heart valve. Such a valve may be a tricuspid, mitral, aortic, or pulmonary heart valve that opens to blood flowing from the atrium to the ventricle during diastole and closes from systolic intraventricular pressure applied to its outer surface. The repeated sequential opening and closing may be described as "shutting and shutting."

[0053] Countercurrent drum or second inner As used herein and in the claims, the term "reflux drum" or "second inner reflux control component" refers to a second inner annular support frame mounted within an outer annular support frame adjacent to the first inner annular support frame. The "reflux drum" or "second inner reflux control component" has a bendable and compressible frame, a tissue cover attached to the frame, and a flow regulator mounted within a reinforcing ring attached to the tissue cover, the flow regulator being selected from a passageway, an occluder, a tubular stent, and a tubular stent having an occluder within the lumen of the tubular stent, and the tissue cover having one or more radiopaque markers. This "reflux drum" or "second inner reflux control component" can be pre-drilled prior to loading the valve onto the delivery catheter, or the "reflux drum" or "second inner reflux control component" can be drilled using a catheter tool after placement of the valve in the native annulus; the drilling can be reinforced using a stent tube; and the drilling or stent tube can be sealed using a closure device such as a polyester disc, a nitinol disc, a nitinol disc with a polyester cover, a double-disc (button on each side) closure device, or a functionally similar device similar to the device used to treat patent foramen ovale but modified for use in accessing and closing, for example, a 1-2 mm drilling in a reflux drum.

[0054] Reinforcement ring The term reinforcing ring refers to a ring of material, such as pericardium, polymer, or biocompatible material, that is attached to the top surface of the tissue covering of the "reflux drum" or "second inner reflux control component." In a preferred embodiment, the reinforcing ring limits the target area for perforation and prevents the perforation from tearing or losing patency. In another preferred embodiment, a radiopaque marker used to guide the catheter cutting / balloon tool may be attached on top of or within the reinforcing ring.

[0055] Radiopaque markers The term "radiopaque marker" refers to a material that allows for visibility during fluoroscopy or other radiological imaging. Examples of radiopaque marker materials include nitinol, gold, platinum, and combinations or mixtures thereof. Radiopaque materials may also include powdered or particulate metal contained within a polymer, glass, or ceramic matrix. The present invention contemplates the use of one or more markers, e.g., 1-10, or 3-5 markers. The present invention also contemplates the use of markers attached in specific patterns or orientations to provide positioning information for the valve itself as well as targeting the perforation site. For example, using a three marker pattern provides a central targeting area but can also provide information about whether the valve is correctly oriented, such as aligning the septal collar portion of the prosthetic valve with the septal side of the tricuspid valve.

[0056] tissue anchor The terms "tissue anchor" or "plica tissue anchor" or "secondary tissue anchor," or "dart" or "pin" refer to a fastening device that connects the upper atrial frame to the native annulus tissue, usually at or near the collar periphery. The anchor may be positioned to avoid penetrating the tissue and rely solely on the compressive force of the two plate-like collars against the captured tissue, or the anchor may penetrate and secure the native tissue by itself or with an integrated fastening wire, or a combination of both. The anchor may have a dedicated fastening mechanism (e.g., a tip with a groove and a flanged shoulder that inserts or pops into a mating aperture or a series of mating apertures). The series of mating apertures allows for attachment of the anchor but prevents dislodgement when the aperture periphery is secured in the groove near the flanged shoulder. The fastening wire may be attached to or secured to the collar opposite the pin by any attachment or fastening mechanism, including a knot, a suture, a wire crimp, a wire lock with a cam mechanism, or a combination.

[0057] pillar The term "strut" refers to a length of rigid or semi-rigid material, such as Nitinol or PEEK, that may be attached to the spoked frame and runs axially or down the center of the flexible sleeve or within a seam of the flexible sleeve. The sleeve may not be attached to the strut, or the sleeve may be attached directly or indirectly to the strut.

[0058] In the following description, the term "body channel" is used to define a blood conduit or vessel in the body. Of course, the particular application of the prosthetic heart valve will determine the body channel in question. An aortic valve replacement would, for example, be implanted in or adjacent to the aortic annulus. Similarly, a tricuspid or mitral valve replacement would be implanted in the tricuspid or mitral annulus. Certain features of the invention are particularly advantageous for one implantation site or the other. However, any of the heart valve embodiments described herein could be implanted in any body channel, unless the combination is structurally impossible or excluded by claim terminology.

[0059] The term "lumen" refers to the interior of a cylindrical tube. The term "bore" refers to the inner diameter.

[0060] Displacement - The amount of fluid displaced in one complete stroke or revolution.

[0061] The ejection fraction is a measure of the percentage of blood that leaves the heart with each contraction. During each cardiac pumping cycle, the heart contracts and relaxes. As the heart contracts, it expels blood from its two pumping chambers (ventricles).

[0062] As used herein, the terms "proximal" and "distal" should be interpreted with respect to a user (e.g., a surgeon or interventional cardiologist) of the disclosed delivery device. "Proximal" should be understood as relatively closer to the user, and "distal" should be understood as relatively further away from the user.

[0063] As a further definition, the term "expandable," as used herein, refers to a heart valve component that is expandable from a first delivery diameter to a second implantation diameter. Thus, an expandable structure does not mean one that may undergo slight expansion due to an increase in temperature or other such incidental causes. Conversely, "non-expandable" refers to a completely rigid heart valve. This should not be interpreted to mean that the valve is rigid or dimensionally stable, since, for example, some slight expansion of a conventional "non-expandable" heart valve may be observed.

[0064] artificial heart valves The terms "prosthesis" or "prosthetic" encompass complete replacement of an anatomical site, e.g., a new mechanical valve replacing a natural valve, as well as medical devices that replace and / or assist, repair, or improve an existing anatomical site, e.g., the natural valve is left in place. The present invention contemplates a wide variety of (bio)prosthetic prosthetic heart valves for installation within a passive support cage. Contemplated 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) (the Edwards line of bioprostheses, the St. Jude prosthetic heart valve), as well as homogeneous and autologous valves. In the case of bioprosthetic pericardial valves, it is contemplated to use bioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, and bioprosthetic pulmonary valves.

[0065] Tether The tethers are made from a surgical-grade material, such as a biocompatible polymeric suture material. 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 an additional degree of valve compliance during the cardiac cycle.

[0066] Tine-Anchor-Tine / Barb The device can be anchored within the heart valve annulus using tines or barbs, which may be used in conjunction with or instead of one or more tethers. The tines or barbs are positioned to provide attachment to adjacent tissue. The tines are forced into the annulus tissue by mechanical means, such as using a balloon catheter. In one non-limiting embodiment, the tines may optionally be semicircular hooks that penetrate, rotate into, and securely hold the annulus tissue upon expansion of the wireframe body. The anchors are deployed by over-the-wire delivery of one or more anchors through a delivery catheter. The catheter may have multiple axial lumens for delivering various fixation tools, including anchor setting tools, force application tools, hooks, snaring tools, cutting tools, radiofrequency and radiological visualization tools and markers, and suture / thread manipulation tools. Once the anchor(s) are attached to the adjustable cuff, a tensioning tool can be used to connect to the implanted valve and adjust the length of the tethers that secure and adjust the implant as needed for proper function. It is also contemplated that the anchors may be spring loaded and may incorporate tether attachment or tether capture mechanisms within the tether surface of the anchor(s). The anchors may also have an ingrowth material, such as polyester fiber, to promote ingrowth of the anchor into the myocardium.

[0067] In one embodiment, in which the prosthetic heart valve may or may not include a ventricular collar, the anchors or darts are not attached to the lower ventricular collar, but rather are attached directly to the annular tissue or other tissue useful for fixation.

[0068] Tube and / or Covering Material - Biological Tissue As used herein, tissue refers to a biological tissue that is chemically stabilized animal pericardial tissue, such as bovine (bovine pericardium), or sheep (ovine pericardium), or pig (porcine pericardium), or horse (equine pericardium). The tissue is preferably bovine pericardial tissue. Examples of suitable tissues include those used in the products Duraguard®, Peri-Guard®, and Vascu-Guard®. All products are currently used in surgical procedures and are generally sold as being harvested from cattle under 30 months of age. Other patents and publications disclose the surgical use of thin harvested biocompatible animal tissues suitable herein as biocompatible "jackets" or sleeves for implantable stents. Examples include U.S. Pat. No. 5,554,185 to Block; U.S. Pat. No. 7,108,717 to Design & Performance-Cyprus Limited, which discloses a covered stent assembly; U.S. Pat. No. 6,440,164 to Scimed Life Systems, Inc., which discloses a bioprosthetic heart valve for implantation; and U.S. Pat. No. 5,336,616 to LifeCell Corporation, which discloses an acellular collagen-based tissue matrix for implantation.

[0069] polymer In one embodiment, the conduit may be made from a synthetic material such as polyurethane or polytetrafluoroethylene.

[0070] If a thin, durable synthetic material is intended, for example, for the cover, synthetic polymeric materials such as expanded polytetrafluoroethylene or polyester may optionally be used. Other suitable materials may optionally include thermoplastic polycarbonate urethane, polyether urethane, segmented polyether urethane, silicone polyether urethane, silicone polycarbonate urethane, and ultra-high molecular weight polyethylene. Additional biocompatible polymers optionally include polyolefins, elastomers, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, other fluoropolymers, silicone polyesters, siloxane polymers and / or oligomers, and / or polylactones, and block copolymers thereof.

[0071] Polyamide (PA) PA is an early engineering thermoplastic invented, consisting of "super polyester" fibers with a molecular weight above 10,000. PA is commonly referred to as nylon. Applications for polyamides include the manufacture of transparent tubing for cardiovascular applications, hemodialysis membranes, and percutaneous transluminal coronary angioplasty (PTCA) catheters.

[0072] Polyolefin Polyolefins include polyethylene and polypropylene, two important polymers of polyolefins, which have excellent biocompatibility and chemical resistance. In cardiovascular applications, both low-density and high-density polyethylene are utilized in the manufacture of tubing and housings. Polypropylene is used to fabricate heart valve structures.

[0073] polyester Polyesters include polyethylene terephthalate (PET), which goes by the name Dacron. PET is typically used as a knitted or woven fabric for vascular grafts. Woven PET has smaller pores, which reduces blood leakage and provides better efficiency as a vascular graft compared to knitted PET. PET grafts can also be utilized with protein coatings (collagen or albumin) to reduce blood loss and for better biocompatibility.

[39] Endothelialized PET vascular grafts have been explored as a means to increase patency rates. Additionally, polyester is a widely favored material for the manufacture of bioabsorbable stents. Poly-L-lactic acid (PLLA), polyglycolic acid (PGA), and poly(D,L-lactide / glycolide) copolymers are also widely used. Poly(PDLA) is one of the commonly used bioabsorbable polymers.

[0074] Polytetrafluoroethylene Polytetrafluoroethylene (PTFE) is a synthetic fluorocarbon polymer commonly known as Teflon by DuPont Co. Common uses of PTFE in cardiovascular engineering include vascular grafts and heart valves. PTFE sutures are also used in mitral valve repair for myxomatous disease and in surgery for anterior or posterior mitral valve prolapse. PTFE is particularly used in implantable prosthetic heart valve rings. PTFE has been successfully used as a vascular graft when the device is implanted in high-flow, large-diameter arteries, such as the aorta. Problems arise when PTFE is implanted below the aortic bifurcation, leading to the investigation of another form of PTFE called elongated PTFE (e-PTFE). Expanded PTFE is formed by compressing PTFE in the presence of a carrier medium and finally extruding the mixture. The extrudate formed by this process is then heated to near its glass transition temperature and stretched to obtain a microscopically porous PTFE known as e-PTFE. This form of PTFE has been indicated for use in narrow arteries promoting lower flow, less thrombogenicity, lower rates of restenosis and hemostasis, less calcification, and biochemically inert properties.

[0075] Polyurethane Polyurethanes have excellent physicochemical and mechanical properties and are highly biocompatible, allowing for unlimited use in blood-contacting devices. Polyurethanes have high shear strength, elasticity, and transparency. Furthermore, their surfaces offer excellent resistance to microorganisms, and the thrombosis caused by PU is nearly identical to that of versatile cardiovascular biomaterials such as PTFE. Traditionally, segmented polyurethanes (SPUs) have been used for various cardiovascular applications, such as valve structures, pacemaker leads, and ventricular assist devices.

[0076] Coated Wire Frame Material Drug-eluting wire frames are contemplated for use herein. DESs consist of three parts: the wire frame platform, the coating, and the drug. Some examples of polymer-free DESs are: Amazon Pax (MINVASYS), which uses an Amazonia CroCo (L605) cobalt-chromium (Co-Cr) wire frame, paclitaxel as the antiproliferative agent, and an abluminal coating as the drug carrier; BioFreedom (Biosensors Inc.), which uses a stainless steel base with a modified abluminal coating as the carrier surface for the antiproliferative agent Biolimus A9; Optima (CID SrI), which uses a 316L stainless steel wire frame as the base for the drug tacrolimus and an integrated turbostratic carbofilm as the drug carrier; and VESTA sync (MIV Therapeutics), which uses a GenX stainless steel (316L) base with a microporous hydroxyapatite coating as the carrier for the drug sirolimus. YUKON Select (Translumina) uses 316L stainless steel as the base for the sirolimus drug in combination with probucol.

[0077] Herein, bioabsorbable polymers may be used as a carrier matrix for drugs. Cypher, Taxus, and Endeavour are three basic types of bioabsorbable DES. Cypher (J&J, Cordis) uses a 316L stainless steel coated with polyethylene vinyl acetate (PEVA) and polybutyl methacrylate (PBMA) to hold the drug sirolimus. Taxus (Boston Scientific) uses a 316L stainless steel wire frame coated with translute styrene isoprene butadiene (SIBS) copolymer. One uses a coated wire frame to hold paclitaxel, which elutes over approximately 90 days. Endeavor (Medtronic) uses a cobalt-chromium driver wire frame to hold zotarolimus and phosphorylcholine as a drug carrier. BioMatrix uses an S-wire frame (316L) stainless steel as the base and a polylactic acid surface to hold the antiproliferative drug Biolimus. The ELIXIR-DES program (Elixir Medical Corp.) uses a cobalt-chromium (Co-Cr) base consisting of both polyester- and polylactide-coated wire frames to hold the drug novolimus. JACTAX (Boston Scientific Corp.) uses a D-lactic-polylactic acid (DLPLA)-coated (316L) stainless steel wire frame to hold paclitaxel. NEVO (Cordis Corporation, Johnson & Johnson) uses a cobalt-chromium (Co-Cr) wire frame coated with polylactic-coglycolic acid (PLGA) to hold the drug sirolimus.

[0078] Examples of preferred embodiments include the following details and features:

[0079] Example - Method for Delivery Transcatheter prosthetic heart valves may be delivered percutaneously using a transcatheter process via the IVC, carotid artery, subxiphoid, intercostal access across the chest wall, or transseptally through the fossa ovalis to the mitral annulus;

[0080] The device is delivered via catheter to the right or left atrium and expanded from a compressed shape that fits the inner diameter of the catheter lumen. The compressed valve is loaded into the delivery catheter outside the patient and pushed out of the catheter when the capsule reaches the atrium. A cardiac technician visualizes the delivery using available imaging techniques, such as fluoroscopy or ultrasound.

[0081] In a preferred embodiment, the valve is constructed in part from a shape memory material such as Nitinol®, nickel-titanium alloy, or cobalt-chromium alloy used in biomedical implants, so that the valve self-expands upon release from the catheter.

[0082] In another embodiment, the valve may be constructed of a material that requires balloon expansion after the capsule is pushed from the catheter into the atrium.

[0083] The atrial collar / frame and flow control components expand to their functional diameters and provide radial tension to secure the valve when deployed within the native annulus. Once the frame is deployed around the tricuspid or mitral annulus, fasteners secure the device around the native annulus. Further fastening of the device to the native structure may be performed to complete deployment. Further adjustments using hemodynamic imaging techniques are contemplated within the scope of the present invention to ensure the device is securely secured, positioned and oriented as planned, and functioning as a replacement or successor to the native tricuspid valve.

[0084] Example - Methods for Delivery In another preferred embodiment of the present invention, there is provided a method for orthogonal delivery of an implantable prosthetic heart valve within a body, the method comprising: (i) advancing a distal end of a guidewire to a distal location, the distal location being the pulmonary artery or the left ventricle of the heart, the guidewire starting outside the patient using femoral or brachiocephalic vein access and extending through the inferior or superior vena cava into the right atrium, and from the right atrium through the tricuspid valve into the pulmonary artery, or extending from the right atrium across the atrial septum through the mitral valve into the left ventricle with transseptal access; (ii) advancing a delivery catheter over the guidewire to a target location, the target location being the right atrium for a tricuspid valve or the left atrium for a mitral valve; and (iii) advancing and delivering an orthogonally compressed self-expandable prosthetic heart valve to a target location within a body, the compressed configuration of the valve having a long x-axis substantially parallel to a longitudinal cylindrical axis of the delivery catheter, the expanded configuration of the valve having a height of about 5-60 mm and a diameter of about 25-80 mm, the valve mounted within an annular support frame and permitting blood flow in a first direction through the inflow end of the valve. and an annular support frame having a foldable flow control component configured to block blood flow in a second direction opposite the first direction through the outflow end of the valve, the foldable (inner) flow control component having a leaflet frame with two to four flexible leaflets mounted thereon, the leaflet frame being bendable along a z-axis from a cylindrical configuration to a flattened cylindrical configuration and compressible along a vertical axis (y-axis) to a shortened configuration, a distal fixation tab attached to a distal side of the annular support frame, the distal fixation tab having a length of 10 to 40 mm and a width of 2 to 10 mm. a guidewire is threaded through a threaded opening on or in the distal fixation tab; at least one proximal fixation tab is attached to the proximal side of the annular support frame, the proximal fixation tab having a length of 2 to 25 mm and a width of 2 to 10 mm; the valve advancement tool includes an elongated sheath, the guidewire is within the lumen of the sheath, and the outer diameter of the sheath is greater than the inner diameter of the threaded opening on the distal fixation tab; the sheath is advanced distally over the guidewire, and when the distal end of the sheath contacts the proximal surface of the threaded opening, the valve advancement tool advances distally by applying a distally directed pulling force to the distal fixation tab. (iv) partially releasing the valve from the delivery catheter by advancing a sheath over the guidewire and positioning the distal fixation tabs at a desired fixation region at the target location, the desired fixation region being selected from the right ventricular outflow tract (RVOT) of the right ventricle and the subannular region below the A1-P1 anterolateral commissure of the mitral valve, and positioning the distal fixation tabs to hold the valve at an elevation angle of at least 30 degrees in a localized annular plane relative to the horizontal axis of the valve and delivery catheter;(v) completing the release of the entire valve from the delivery catheter by advancing a sheath over the guidewire to seat the valve within the native annulus by applying a downward force toward the ventricle; and (vi) seating at least one proximal fixation tab at a second desired fixation region.

[0085] Example - Methods for Delivery In another preferred embodiment of the present invention, there is provided a method for orthogonal delivery of an implantable prosthetic heart valve to a desired location within a body, including a tricuspid valve location, the method comprising the steps of delivering an expandable prosthetic heart valve to the desired location within a body by advancing a delivery catheter to the desired location within a body and releasing the valve from the delivery catheter, the valve being mounted within an annular support frame having a foldable flow control component configured to allow blood flow in a first direction through an inflow end of the valve and to block blood flow in a second direction opposite the first direction through an outflow end of the valve, the foldable (inner) flow control component having a leaflet frame having two to four flexible leaflets mounted thereon, the annular support frame is bendable along a z-axis from a cylindrical configuration to a flattened cylindrical configuration and compressible to a shortened configuration along a vertical axis (y-axis), a distal fixation tab attached to a distal side of the annular support frame, and a proximal fixation tab attached to a proximal side of the annular support frame, the valve being compressible to a compressed configuration for introduction into a body using a delivery catheter for implantation at a desired location within the body, the compressed configuration having a major axis oriented at an intersecting angle of between 45 and 135 degrees relative to a first direction, the valve being expandable to an expanded configuration having a major axis oriented at an intersecting angle of between 45 and 135 degrees relative to the first direction, the major axis of the valve in the compressed configuration being substantially parallel to the longitudinal cylindrical axis of the delivery catheter, and in the compressed configuration, the valve is approximately 5 to 60 mm high. and has a diameter of 25 to 80 mm.

[0086] Releasing the valve from the delivery catheter is selected from the steps consisting of: (i) pulling the valve from the delivery catheter using a puller wire releasably connected to the distal side of the rigid elongate push rod / valve, whereby the compressed valve is pulled out of the delivery catheter by advancing the push rod away from the delivery catheter; or (ii) pushing the valve from the delivery catheter using a rigid elongate push rod releasably connected to the proximal side of the valve, whereby the compressed valve is pushed out of the delivery catheter by advancing the push rod out of the delivery catheter.

[0087] The method of delivery may also include the additional step of anchoring one or more tissue anchors attached to the valve into native tissue.

[0088] The method of delivery may also include the additional step of positioning a distal fixation tab of the heart valve prosthesis in the right ventricular outflow tract of the right ventricle.

[0089] The method of delivery may also include the additional steps of positioning the distal fixation tab of the heart valve prosthesis in the right ventricular outflow tract of the right ventricle, and positioning the upper distal fixation tab in a supra-annular position, wherein the upper distal fixation tab provides a supra-annular downward force toward the ventricle and the distal fixation tab provides an infra-annular upward force toward the atrium.

[0090] The method of delivery may also include the additional step of rotating the heart valve prosthesis using a steerable catheter along an axis parallel to the plane of the valve annulus.

[0091] Example - Method for Loading In another preferred embodiment of the present invention, there is provided a method for orthogonally loading an implantable prosthetic heart valve into a delivery catheter, the method comprising the steps of loading the implantable prosthetic heart valve into a tapered fixture or funnel attached to the delivery catheter, the valve being mounted within an annular support frame having a flow control component configured to allow blood flow in a first direction through an inflow end of the valve and to block blood flow in a second direction opposite the first direction through an outflow end of the valve, a distal fixation tab attached to a distal side of the annular support frame, and a proximal fixation tab attached to a proximal side of the annular support frame. the valve includes a proximal fixation tab attached thereto, the loading being perpendicular or substantially perpendicular to a first direction, the valve being compressible to a compressed configuration for introduction into a body using a delivery catheter for implantation at a desired location within the body, the compressed configuration having a long x-axis oriented at an angle of between 45 and 135 degrees relative to the first direction, the valve being expandable to an expanded configuration having a long x-axis oriented at an angle of between 45 and 135 degrees relative to the first direction, the long x-axis of the valve in the compressed configuration being substantially parallel to the longitudinal cylindrical axis of the delivery catheter, and the valve having a height of about 5 to 60 mm and a diameter of about 25 to 80 mm.

[0092] Example - Method for Loading In another preferred embodiment of the present invention, a method for loading is provided, wherein the loading step includes attaching a loading accessory to the valve side wall, the valve cuff, the distal fixation tab, the proximal fixation tab, or a combination thereof, wherein the loading accessory is a push rod or pull wire, and wherein the tapered fixture or funnel has a compression element on an inner surface of the tapered fixture or funnel to facilitate compression of the uncompressed valve, irising open and closed, or spiralling.

[0093] Example - How to improve flow In another preferred embodiment of the present invention, a method for improving hemodynamic flow during implantation of a transcatheter prosthetic heart valve is provided, comprising: advancing a delivery catheter to a desired location within the body to deliver a valve as described in claim 1 to a desired location within the body; partially releasing the valve from the delivery catheter to establish blood flow around the partially released valve and through a flow control component; completely releasing the valve from the delivery catheter while maintaining attachment to the valve with a positioning catheter or wire to transition to increased blood flow through the flow control component and reduced blood flow around the valve; positioning the valve in a final attachment position to transition to full blood flow through the flow control component and minimal or no blood flow around the valve; and disconnecting and withdrawing the positioning catheter or wire from the valve.

[0094] In another preferred embodiment of the present invention, a method for improving flow is provided, wherein the distal fixation tab is an RVOT tab positioned at the RVOT during a transition from partial valve release to full valve release.

[0095] Example - Manufacturing Process In a preferred embodiment, the present invention comprises: (i) To manufacture a self-expanding annular support frame: Utilizing additive or subtractive metal or metal alloy manufacturing, The manufacturing of additive metals or metal alloys is by 3D printing or direct metal laser sintering (powder fusion), Subtractive metal or metal alloy manufacturing is photolithography, laser sintering / cutting, CNC machining, EDM, The present invention also includes a process for manufacturing an orthogonally delivered transcatheter prosthetic heart valve frame, comprising using

[0096] In another preferred embodiment, a process for manufacturing a frame for an orthogonally delivered transcatheter prosthetic heart valve is provided, comprising the steps of: (ii) mounting a flow control component within the valve frame, the flow control component allowing blood flow along a central vertical axis through the inflow end of the flow control component and blocking blood flow through the outflow end of the valve; and (iii) covering the exterior surface of the valve frame with a pericardial material or similar biocompatible material. Example - Compression Method

[0097] In another preferred embodiment, a method of compressing an implantable prosthetic heart valve is provided, comprising: (i) winding an annular support frame in one direction from one side into a compressed configuration; (ii) symmetrically winding the annular support frame from two opposite sides into a compressed configuration; (iii) flattening the annular support frame into two parallel panels substantially parallel to the longitudinal axis, and then rolling the flattened annular support frame into a compressed configuration; (iv) flattening the annular support frame along a vertical axis to reduce the vertical dimension of the valve from top to bottom; The sheet is rolled or folded into a compressed configuration using a step selected from the group consisting of:

[0098] drawing Referring now to the drawings, FIG. 1 is a side perspective view of an orthogonally deliverable transcatheter heart valve 100 having an inner reflux control component 135 mounted within an annular outer support frame 104, a collapsible flow control component 130 mounted within the annular outer support frame 104, a distal tab 268, and a proximal tab 270 in accordance with the present invention. do.

[0099] The inner reflux control component 135 consists of a tissue cover 141 , a reinforcing ring 143 , a radiopaque marker 144 , and a drum / reflux channel 135 .

[0100] The foldable (inner) flow control component 130 has a leaflet frame 231 with two to four flexible leaflets 258 mounted thereon, the leaflet frame 231 being bendable from a cylindrical configuration to a flattened cylindrical configuration along the z-axis 109 and compressible to a shortened configuration along the vertical axis 108 (y-axis).

[0101] The annular outer support frame 104 is fabricated from a shape memory material, such as a nickel-titanium alloy, e.g., NiTiNOL, and is therefore a self-expanding structure that starts from a compressed configuration. When in an expanded configuration, the annular (outer) support frame 104 has a peripheral wall 106 bounded by a central (inner) channel 104 and a central vertical axis 108, the annular outer support frame 104 having a distal side 118 and a proximal side 114.

[0102] The flow control component 130 is mounted within the annular outer support frame 104 and is configured to allow blood flow in a first direction, such as from the atrium to the ventricle, through the inflow end 132 of the valve 100 and to block blood flow in a second direction opposite the first direction through the outflow end 134 of the valve 100.

[0103] The inner reflux control component 135 is bendable and compressible, as are the inner flow control component 130 and the outer annular frame 104. The inner flow control component 130 includes a leaflet frame 231 having two to four flexible leaflets 258 mounted thereon.

[0104] The flow control component 130, and thus the leaflet frame 231, can be folded along the z-axis (front to back) from a cylindrical configuration to a flattened cylindrical configuration, like the outer frame 104, with the fold located distally and proximally taking the leaflet frame 231 out of a ring or cylindrical shape and flattening it from a ring into a two-layer band, or folding it back, or flattening it into a rectangle or square joined along two opposite sides, like a cylinder. This allows the outer frame 104 and flow control component 130 to decrease in radius along the z-axis until the sidewalls touch or nearly touch. This also allows the outer frame 104 and flow control component 130 to maintain a radius along the horizontal, or y-axis, minimizing the number of wire cells comprising the outer and inner portions that are damaged by the forces applied during the bending and / or compression required for loading into a delivery catheter.

[0105] The inner reflux control component 135, the flow control component 130, the leaflet frame 231, and the outer frame 104 are also compressible vertically (y-axis), reducing the overall height of the 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 perpendicular to the y-axis, the valve structure can maintain a very large dimension along the horizontal, or x-axis. For example, valves with diameters of 60 mm or greater can be delivered via transcatheter techniques. The length of the valve's major axis, e.g., 60 mm, is not limited by the large amounts of wire frame and covering material required for such large valves because the major axis runs parallel to the central axis of the delivery catheter. This is not possible with existing central-axis-delivered (axial) transcatheter valves. The use of a folded and compressed valve orthogonal to conventional axial-delivered valves enables previously unavailable treatment options.

[0106] FIG. 1 also shows a distal fixation tab attached to the distal side 118 of the annular outer support frame 102. Also shown are tabs 268 and proximal fixation tabs 270 attached to the proximal side 114 of the tubular outer support frame 102 .

[0107] In a preferred embodiment, the horizontal x-axis of the valve, when in the expanded configuration, lies at an angle of between 45 and 135 degrees relative to the central vertical y-axis.

[0108] 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.

[0109] In another preferred embodiment, the valve has a height of about 5 to 60 mm and a diameter of about 25 to 80 mm.

[0110] 1 also shows a guidewire sheath 310 and a guidewire 311. A lumen or guide ball 266 is shown attached to the distal end of a distal tab 268 and having a guidewire 311 threaded through the lumen 266. The lumen 266 has an inner diameter large enough to allow the guidewire 311 to extend therethrough, but the lumen 266 is not large enough to allow the sheath 310 to extend therethrough. This allows the sheath 310 to advance along the guidewire 311 until it encounters the proximal side of the lumen 266, where continued application of a pushing force against the sheath 310 pushes against the lumen, allowing the distal tab to pull the valve out of the delivery catheter and to the target location for valve deployment.

[0111] 2 is a side perspective view of an exploded view of an embodiment having an inner reflux drum 137 with markers 144, channels 135, and ring 143. FIG. 2 also shows three leaflet 258 tips or pockets mounted within a bendable and compressible inner wire frame 231 having a distal fold region 120 and a proximal fold region 116, in accordance with the present invention, the inner portion 231 being mounted within an outer wire frame 102 having a collar component 103 circumferentially attached at the upper edge 107 of the outer wire frame 104, a dual-tab component having distal tabs 268 and proximal tabs 270, and an optional mesh component of a biocompatible material that may be used to cover the spacer element 137, to cover the collar 103, to cover the inner and outer surfaces of the outer frame 102, and / or to cover the fixation tabs 268 and 270.

[0112] The atrial collar 103 is shaped to fit the natural placement site. In a tricuspid valve replacement, the atrial collar has a tall posterior wall to fit the septal region of the native valve and has a distal upper collar portion and a proximal upper collar portion. The distal collar portion may be larger than the proximal upper collar portion to occupy a larger flat space (atrium) beyond the right ventricular outflow tract (RVOT) subannular region.

[0113] 3 is a side perspective view of an orthogonally deliverable transcatheter heart valve 100 with an open regurgitation frame 139 having radiopaque markers 144. In this embodiment, the channel may have a predetermined inner diameter depending on the grade of regurgitation desired by the physician.

[0114] 3 also shows a foldable flow control component 130 mounted within the annular outer support frame 102, the foldable (inner) flow control component 130 having a leaflet frame 231 with two to four flexible leaflets 258 mounted thereon. The leaflet frame 231 is foldable along the z-axis from a cylindrical configuration to a flattened cylindrical configuration and compressible along a vertical axis (y-axis) to a shortened configuration. The valve 100 also includes superelastic wire loop distal tabs 268 / 269 and superelastic wire loop proximal tabs 270 / 271 in accordance with the present invention.

[0115] 4 is a side perspective view of an exploded view of an embodiment having an open reflux frame 139 with radiopaque markers 144. FIG. 4 also shows three leaflet tips or pockets 258 mounted within a bendable and compressible inner wire frame 231, in accordance with the present invention, which is mounted within an outer wire frame 102 having a collar component 103 circumferentially attached at the upper edge 107 of the outer wire frame 102, a pair of integral independent tab components 269, 270, and a mesh component 226. The uncovered reflux frame 139 provides controlled reflux through the valve. The uncovered reflux frame 139 can be later plugged with an inserted stent, cover, or plug once reflux is no longer required by the patient.

[0116] The atrial collar 103 is shaped to fit the natural placement site. In a tricuspid valve replacement, the atrial collar has a tall posterior wall to fit the septal region of the native valve and has a distal upper collar portion and a proximal upper collar portion. The distal collar portion may be larger than the proximal upper collar portion to occupy a larger flat space (atrium) beyond the right ventricular outflow tract (RVOT) subannular region.

[0117] Integrated tabs 269 and 271 are of unitary construction with the body of the outer frame. The tabs may vary in size and shape. In a preferred embodiment, the RVOT tabs, such as 269, may be longer to reach the pulmonary artery inlet (in the case of a tricuspid valve replacement).

[0118] Figure 5 is a side perspective view of an orthogonally deliverable transcatheter heart valve 100 in a folded configuration along the z-axis (front to back when viewed from the wider side) according to the present invention. Figure 5 shows a folded / flattened collar 103, a folded (flattened) outer frame 102 with hinge points 116, 120. Figure 5 also shows a folded / flattened inner regurgitation control component 137 with markers 144, and valve leaflets 258 mounted within the folded / flattened inner frame 231.

[0119] Figure 6 is a side perspective view of an orthogonally deliverable transcatheter heart valve 100 in a vertically compressed configuration according to the present invention. Figure 6 shows the outer frame 102 with the collar 103 folded (z-axis), compressed (y-axis), and folded (z-axis) and vertically compressed (y-axis) along the fold line between hinge points 116, 120. Figure 6 also shows the inner regurgitation control component 137 and the valve leaflets 258 mounted within the inner frame 231.

[0120] 7 is 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. FIG. 7 shows the outer frame 102, folded collar 103, inner regurgitation control component 137, and flow control component 130 having leaflets 258 and inner frame 231.

[0121] FIG. 8 is a diagram of an end view of a delivery catheter 138 showing a loaded valve 100 with the outer frame 102 and collar 103 visible, in accordance with the present invention.

[0122] Figure 9 is a top view of the folded and compressed valve being ejected from the delivery catheter 138 in a partial position to allow expansion of the leaflets 258, collar 103, and inner frame 231 prior to installation into the native annulus.

[0123] FIG. 10 is a top perspective view of a collarless valve with the internal reflux control component 137 removed for viewing, showing tissue 141, reinforcing ring 143, and channel 135. 10 also shows the outer cylindrical frame 102 with mesh sidewall covering 226, inner frame 231, and leaflets 258 sewn to inner portion 231 in accordance with the present invention.

[0124] FIG. 11 is a top perspective view of an outer frame 102 having a collarless valve with markers 144 according to the present invention, an inner reflux control component 137 attached to the upper edge 107 of the outer cylindrical frame 102, a mesh sidewall cover 226, an inner frame 231, and valve leaflets 258 sewn to the inner portion 231.

[0125] FIG. 12 is a diagram of a bottom perspective view of a collarless valve having an inner reflux control component 137 attached to the upper edge 107 of the outer cylindrical frame 102, an outer frame 102 also having a mesh sidewall cover 226, an inner frame 231, and leaflets 258 sewn to the inner frame 231.

[0126] Figure 13 is an exploded view of a collarless valve having an inner reflux control component 137 including a tissue cover 141 and a reflux frame 139. Figure 13 also shows the outer cylindrical frame 102, the outer frame 102 with a mesh sidewall cover 226, the inner frame 231, and the valve leaflets 258 attached to bands 257 and sewn to the inner frame 231 in accordance with the present invention.

[0127] FIG. 14 is a diagram of a top perspective view of the inner leaflet frame 231 (or regurgitant frame 139) in a cylindrical configuration shown at the beginning of the process allowing for folding and compression of the inner frame in accordance with the present invention.

[0128] FIG. 15 is a top perspective view of the medial leaflet frame 231 (or regurgitation frame 139) in a partially folded configuration in which the wire frame side walls rotate or hinge at their lateral connection points 116, 120 according to the present invention, shown as a partial first step in the process to enable folding and compression of the medial frame.

[0129] FIG. 16 is a side view of the medial leaflet frame 231 (or regurgitation frame 139) in a fully folded configuration 208 in which the wire frame side walls are rotated or hinged at their lateral connection points, according to the present invention, and is shown as the completed first step in the process to enable folding and compression of the medial frame 231.

[0130] FIG. 17 is a side view illustration of the medial leaflet frame 231 (or regurgitation frame 139) in a folded and vertically compressed configuration 210 in which the wire frame sidewalls are vertically compressed in a pleated or accordion configuration according to the present invention, shown as a second step in the process to enable folding and compression of the medial frame.

[0131] FIG. 18 is a side view illustration of the medial leaflet frame 231 (or regurgitant frame 139) as a linear wire frame sheet 202 prior to further assembly into a cylindrical structure in accordance with the present invention.

[0132] FIG. 19 is an illustration of a side perspective view of an inner leaflet frame 231 in a cylindrical or cylindrically-shaped (eg, conical) configuration in accordance with the present invention.

[0133] FIG. 20 is a side perspective view of a band of pericardial tissue 257 configured in a cylindrical shape with leaflet pockets 258 sewn to the structural band 257 in accordance with the present invention.

[0134] FIG. 21 illustrates a method for assembling a cylindrical leaflet component and attaching it to an inner frame to form a collapsible (bendable, compressible) flow control component in accordance with the present invention. FIG. 2B is a side view of the band of pericardial tissue 257 with the leaflet pockets sewn to the structural band 257 prior to attachment.

[0135] FIG. 22 is an illustration of an underside view of a band of pericardial tissue 257 with leaflet pockets 258 sewn to the structural band 257 prior to assembly with a cylindrical leaflet component and attachment to an inner frame to form a collapsible (bendable, compressible) flow control component according to the present invention.

[0136] FIG. 23 is a side perspective view of a portion of a band of pericardial tissue with a single leaflet pocket sewn to a structural band, showing the partial coaptation of the leaflet pocket 258 with an outwardly extending open end 261 and a closed parabolic upper edge 259 that provides attachment.

[0137] FIG. 24 is an illustration of a bottom view of a cylindrical leaflet component 258 showing complete coaptation to form a closed fluid seal in accordance with the present invention.

[0138] Figures 25(a)-(e) illustrate the process of delivering a valve with a pre-drilled drum inner portion orthogonally within a catheter, ejecting it from the catheter, and deploying it into the native annulus. Figure 25(a) shows the orthogonal valve compressed and folded within the delivery catheter and moving along a guidewire through the native annulus. Figure 25(b) shows the orthogonal valve partially ejected into the native annulus, allowing the delivery catheter to torque or position the valve as needed. Figure 25(c) shows a fully ejected valve with rvot tabs extending below the annulus to help secure the valve and elevate it at an angle where irrigation and coaptation can be performed / initiated. Figure 25(d) is a top view showing the pre-drilled drum and the reflux channel located within the periphery of the radiopaque marker. Figure 25(e) is a side perspective view showing the pre-drilled drum and the reflux channel located within the periphery of the radiopaque marker, the inner flow control component (valve leaflets and frame) mounted within the outer support frame adjacent to the inner flow control component.

[0139] FIG. 26 is a diagram of the outer wire frame 102.

[0140] FIG. 27 is a top perspective view of a partially folded configuration of the outer wire frame 102 in which the side walls rotate or hinge at their lateral connection points 116, 120 in accordance with the present invention, shown as a partial first step in the process of enabling folding and compression of the outer frame 102.

[0141] FIG. 28 is a side view illustration of the outer frame 102 in a fully folded configuration 208 in which the wire frame side walls are rotated or hinged at their lateral connection points 116, 120 in accordance with the present invention, shown as the completed first step in the process to enable folding and compression of the outer frame 102.

[0142] FIG. 29 is a side view illustration of the outer frame 102 in a folded and vertically compressed configuration 210 in which the wire frame side walls are vertically compressed in a pleated or accordion configuration in accordance with the present invention, shown as a second step in the process to enable folding and compression of the outer frame 102.

[0143] FIG. 30 is a top perspective view of an assembled valve according to the present invention, comprising an inner reflux control component 137 with markers and a reinforcing ring, an outer frame 102, an inner leaflet frame 231 and a flow control component 130 with three sewn leaflet pockets / tips 258, an inner spacer frame 137, and a mesh cover 141 on the spacer frame, with fold lines 109 shown as dashed lines.

[0144] FIG. 31 is a top perspective view of an assembled valve according to the present invention, including an inner reflux control component 137 with markers, an outer frame 102, a first subannular fixation / positioning tab 268 attached to the outer frame 102 adjacent to the flow control component 130, a second subannular fixation / positioning tab 270 attached to the outer frame at a different location, an inner leaflet frame 231 and a flow control component 130 with three sewn leaflet pockets / tips 258, an inner spacer frame 137, and a mesh cover 141 on the spacer frame, with fold line 109 shown as a dashed line and crossing the mesh cover.

[0145] Figure 32 is a diagram of a bottom perspective view of an assembled valve according to the present invention, including an outer frame 102, a first annular sub-fixation / positioning tab 268 attached to the outer frame 102 adjacent to the flow control component 130, a second annular sub-fixation / positioning tab 270 attached to the outer frame 102 at a different location, an inner leaflet frame 231 and a flow control component 130 with three sewn leaflet pockets / tips 258, an inner spacer frame 137 and a mesh cover 141 on the spacer frame, with the fold 109 shown as a dashed line and the hemodynamic washout cavity shown below the covered inner spacer frame.

[0146] FIG. 33 is a diagram of a top view of an assembled valve according to the present invention, including an inner reflux control component 137, an outer frame 102, an inner leaflet frame 231 and a flow control component 130 with three sewn leaflet pockets / tips 258, an inner spacer frame 137, and a mesh cover 141 on the spacer frame.

[0147] FIG. 34 is a diagram of a top view of an assembled valve according to the present invention, including an inner reflux control component 137 with a reinforcing ring, an outer frame 102, a first annular sub-fixation / positioning tab 268 attached to the outer frame 102 adjacent to the flow control component 130, a second annular sub-fixation / positioning tab 270 attached to the outer frame 102 at a different location, an inner leaflet frame 231 and a flow control component 130 with three sewn leaflet pockets / tips 258, an inner spacer frame 137, and a mesh cover 141 on the spacer frame.

[0148] 35(a)-(e) are diagrams of the step-by-step process by which a tissue drum is perforated prior to orthogonal loading of the valve onto a delivery catheter. Step (a) is providing an orthogonal prosthetic valve as described herein (foldable and compressible for lateral delivery using RVOT tabs, guidewire lumens, atrial collar, and proximal tabs). Step (b) is creating an opening by cutting or using a balloon device. Step (c) is folding the valve flat to prepare it for loading onto the delivery catheter. Step (d) is vertically compressing the valve to prepare it for loading onto the delivery catheter. Step (e) is laterally loading the orthogonal valve onto the delivery catheter.

[0149] Figure 36(a)-(c) are diagrams of the step-by-step process by which the tissue drum is perforated after the valve has been ejected orthogonally from the delivery catheter and positioned into the native annulus. Step (a) is to eject the valve into the native annulus and approach it horizontally at a slight elevated angle to position the RVOT tab in the subannular space leading to the right (pulmonary) valve outflow tract. Step (b) is to identify the location of the radiopaque marker using fluoroscopy. Step (c) is to create an opening by cutting or using a balloon device.

[0150] FIG. 37 illustrates how the user can adapt the size of the opening to the amount of reflux desired, for example, a range of 0.5 to 2.0 grades of reflux. Radiopaque markers can be used to help gauge how large a perforation to make.

[0151] FIG. 38 illustrates how a user can adapt the size of the lumen of a tubular stent that can be placed in the opening to accommodate the desired amount of reflux, for example, a range of 0.5 to 2.0 grades of reflux.

[0152] FIG. 39 is a lateral septal plan view of a tabbed valve 100 according to the present invention, with a sub-annular fixation and / or positioning tab 268 extending distally and a second sub-annular tab 270 extending away proximally, with a bendable and compressible wire frame structure visible, including an inner frame 231, valve leaflets 258, and an inner reflux control component 137.

[0153] Figures 40(a)-(f) are illustrations of a closure device used to close a perforation in an internal reflux control component. Step (a) is to provide an orthogonal prosthetic valve (foldable and compressible for sideways delivery with RVOT tabs, guidewire lumen, atrial collar, and proximal tabs) described herein with an internal reflux control component 137 that requires sealing. Step (b) is to access the perforation using a catheter tool. Step (c) is to expand the first disc or button on the inferior distal side of the perforation. Step (d) is to expand the second disc or button on the superior surface proximal to the perforation. Step (e) is to tighten the two discs / buttons together to create a seal that stops reflux, e.g., designed with a 1-2 mm perforation. Step (f) is to withdraw the catheter tool.

[0154] FIG. 41 is a top view of the valve partially ejected from the delivery catheter 138 with the distal tabs 268 guiding the valve to the deployment location (along a guidewire, not shown), the distal flow control component 130 beginning to open, two of the three valve leaflets 258 opening from their folded and flattened configuration, and the third leaflet opening from its folded configuration in which it folds back while in the delivery catheter 138.

[0155] FIG. 42 is a diagram of a top view of the valve 136 (orthogonally loaded) compressed within a delivery catheter 138, in which the outer frame 102 has a first tab 268 extending forward along the x-axis and a second rearward tab 270 extending rearward along the x-axis.

[0156] FIG. 43 is a diagram of a top view of a valve having an outer frame 102, an off-center inner flow control component 130 (leaflets within the frame), and an irregularly shaped spacer / support frame 137 in accordance with the present invention.

[0157] Figure 44 is a diagram of a top view of a valve according to the present invention having an outer frame 102, a centrally located inner flow control component 130 (valve leaflets within the frame), and a pair of irregularly shaped spacer / support frames 135, 137 on opposite sides of the inner flow control component 130.

[0158] Figure 45 is a diagram of a top view of a valve according to the present invention having an outer frame 102, an inner flow control component 130 (valve leaflets within the frame), and multiple sewn attachment points 129 where the inner portion 130 is sewn to the outer portion 102.

[0159] 46 is a diagram of a top view of a valve having an inner regurgitation control component 137 with a pacemaker and lead set 145 extending through the fenestrations. FIG. 46 also shows the outer frame 102, the off-center inner flow control component 130 with frame 231 and leaflets 258, and the inner spacer frame 137, in accordance with the present invention, with all three The structure is bendable along the same x-axis 109 .

[0160] 47 is a diagram of a top view of a valve according to the present invention having an inner reflux control component 137, an outer frame 102, a centrally positioned inner flow control component 130 having frame 231 and valve leaflets 258, and a pair of smaller cylindrical inner reflux control components 137, 147 attached to opposite sides of inner flow component 231 to provide support within the internal dimensions of outer frame 102, with all four structures being bendable along the same x-axis 109. Here, inner reflux control component 137 has a three-leaflet miniature valve attached adjacently next to the main flow control component, and second inner reflux control component / drum 147 has a non-perforated tissue cover, which may provide the practitioner with the opportunity to add additional reflux components at a later time if desired.

[0161] Figure 48 is a top view of a valve according to the present invention having a distal inner reflux control component 137, an outer frame 102, a frame 231 and a proximally located deflected inner flow control component 130 with valve leaflets 258, all three structures being bendable along the same x-axis 109.

[0162] FIG. 49 is an illustration of a lateral view of a human heart with a transfemoral / IVC or SVC delivery catheter 138 traversing from the right atrium to the left atrium for access to the mitral valve in accordance with the present invention. FIG. 49 shows the following orthogonal delivery steps: (1) providing a bendable, compressible prosthetic tricuspid valve; (2) loading the valve sideways into a delivery catheter; (3) advancing the valve to the heart via the IVC or SVC via a pre-placed guidewire threaded over the sub-annular distal tabs; (4) partially ejecting the valve to position the distal sub-annular tabs and allow the leaflets to begin function; (5) completing placement of the valve into the native annulus; (6) optionally, if the regurgitation drum was not opened before loading into the delivery catheter, a cutting tool or balloon tool can be advanced to create a 1-2 mm opening in the tissue covering of the drum frame; and (7) optionally, a pacemaker wire set can be advanced through the opening in the regurgitation drum and pacemaker wire(s) attached to or near the target node. Additional Definitions and Parts List

[0163] Below is a bill of materials associated with the claimed elements. Part numbers may refer to functional components and may be reused across different preferred embodiments to aid in a uniform understanding of structure-function relationships. Not all numbers may be added to the drawing sheets to avoid cluttering the drawing sheets. 100 Double-tab orthogonal delivery transcatheter prosthetic heart valve. 102 Self-expanding annular (external) support frame. 103 Color Structure. 104 central channel. 106 Perimeter wall. 107 Upper edge of outer support frame. 108 Center vertical axis. 109 Z axis, front to back, fold axis. 110 Front wall part of the exterior wall. 112 Rear wall portion of the exterior wall. 114 proximal side. 116 Proximal crease region. 117Secondary proximal fold region. 118 distal side. 120 Distal crease region. 121Secondary distal fold region. 122 Upper front color part. 124 Lower front body part of outer frame. 126 Upper color part of the back. 128 Lower back main body part. 129 Sewn attachment points from inside to outside. 130. A flow control component made from an inner frame having tissue leaflets mounted therein, the inner frame being collapsible (bendable and compressible), the inner portion mounted within an annular outer support frame and configured to allow blood flow in a first direction through the inflow end and block blood flow in an opposite second direction through the outflow end. 132 Inlet end. 134 Outflow end. 135 drum channels. 136 Compression Configuration 137 Internal backflow control components. 138 Delivery catheter. 139 Uncovered reflux frame, engineered (therapeutic) partial reflux 140 X-axis, horizontal axis, parallel to the delivery catheter central axis. 141Tissue Coverage (Plastic Deformation). 142 Intersection angle 45 to 135 degrees, from X axis to Y axis. 143 Reinforcement ring. 144 Radiopaque markers. 146Longitudinal cylindrical axis of the delivery catheter. 148 Approximately 5-60mm high. 150 Diameter of approximately 25 to 80 mm. 202 Multiple compressible wire cells - outer frame. 204 Emotional support When the frame is compressed, the wire orientation and cell shape are substantially orthogonal to the central vertical axis to minimize cell distortion. 206 vertical compression configuration. 208 Folding configuration. 210 folded and compressed configuration. 212The shape of the inner or outer frame selected from a funnel, cylinder, flattened cone, or circular hyperboloid. 220 Braided Matrix. 222 Wireframe matrix. 224 Laser cut wireframe. 226 Biocompatible Materials. 227 Flared cuff of inner frame. 228Side profile of inner frame as a flattened cone shape. 229 Non-cylindrical inner frames, for example elliptical cross sections. 230 Diameter R of 40~80mm. 231 Inner frame for attaching the valve leaflets. 232 20~60mm diameter r. 233 A set of uniform wireframe cells for the inner part. 234 Height: 5-60mm. 235Uneven variable height cells in the inner part. 236Inner surface of annular outer support frame. 237 Non-uniform cell shape, wireframe size. 238Outer surface of annular outer support frame. 239 Compressed inner part. 240 Pericardial tissue to cover the valve surface. 241 Diamond or eye shaped wire cells. 242 Synthetic polyester fabric. 243 Small holes on the medial wire frame, consistent commissure attachment. 244 Hourglass shaped outer support frame. 245 Laser cut mounting features on inner frame. 246 Upper diameter R1 from 40 to 80 mm. 248 Lower diameter R2 from 50 to 70 mm. 250 Inner diameter r of 20~60mm. 252 Height: 5-60mm. 254 20~60mm inner diameter. 256 10-40mm height. 257 Leaflet band, attachment band for leaflet pocket. 258 valve leaflets, multiple leaflets, pericardial material. 259 Sewn edges of valve leaflets. 260Round cylinder at inlet end. 261 Open edge of valve leaflet 262Flat, closable opening at outflow end. 264 Longitudinal supports in / on flow control components selected from rigid or semi-rigid posts, rigid or semi-rigid ribs, rigid or semi-rigid battens, rigid or semi-rigid panels, and combinations thereof. 266 (Optional) Lumen (ball) on distal tab. 268 The distal tab / subannular fixation tab may be RVOT or other and consists of a wire loop or wire frame, integrated frame section, or stent, extending approximately 10-40 mm away from the annular support frame. 269 ​​Independent RVOT tab. 270 Proximal tab / subannular fixation tab. 271 Separate proximal tab. 272Distal superior edge of annular support frame. 273 An upper atrial tension arm consisting of a wire loop or wire frame extending approximately 2-20 mm away from the annular support frame. 274 A lower tension arm consisting of a wire loop or wire frame, integral frame section, or stent extending approximately 10-40 mm away from the annular support frame. 276Distal side of annular support frame. 278 A tissue anchor connected to an annular support frame for engaging natural tissue. The front wall portion of the 280 frame is the first flat panel. 282 The rear wall portion of the frame is a second flat panel. 284 stitches. 285 hinges. 286 Flexible fabric span without wire cells. 287 Fabric Panels. 288 Braided Wire Cell. 289Commissural attachment - leaflets to frame. 290 Laser cut wire cell. 302 Rolling to Compression Configuration. 304 Symmetrical roll compression configuration. 306 Flattening of annular support frame panels. 308 Annular support frame compressed from top to bottom. 310 Sheathed / rigid elongated push rod / pull wire. 311 Guidewire. 312 A steerable catheter for rotating a heart valve prosthesis along an axis parallel to the plane of the valve annulus, wherein an upper tension arm attached to the valve is conformationally pressure-locked against the supranuclear tissue and a lower tension arm attached to the valve is conformationally pressure-locked against the subannular tissue.

[0164] Various of the above-disclosed and other features and functions, or alternatives thereof, may be combined into many other different systems or applications, and various presently unforeseen or unanticipated alternatives, modifications, variations, or improvements thereof, each of which is intended to be encompassed by the disclosed embodiments, may subsequently occur to those skilled in the art.

[0165] While embodiments of the present invention have been described herein, it should be noted that modifications and variations may occur to those skilled in the art in light of the above teachings. It is therefore to be understood that changes may be made in the particular embodiments of the invention disclosed which are within the scope and spirit of the invention as defined by the appended claims. Having thus described the invention with the detail 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. 1. A device for managing and providing a grade of intentional regurgitation in an orthogonally delivered transcatheter prosthetic heart valve, comprising: an orthogonally delivered transcatheter prosthetic heart valve having a first inner flow control component, a second inner regurgitation control component, and an outer annular support frame; a second inner reflux control component having a bendable and compressible frame, a tissue cover attached to the frame, and a flow regulator mounted within a reinforcing ring attached to the tissue cover, wherein the flow regulator is selected from a channel, an occluder, a tubular stent, and a tubular stent having an occluder within a lumen of the annular stent, and the tissue cover has one or more radiopaque markers, the second inner reflux control component being mounted within the outer support frame of the prosthetic heart valve; the self-expanding annular outer support frame having a central channel, a peripheral wall bounded by a central vertical axis in an expanded configuration, an atrial collar attached along an upper edge of the outer wall, a distal fixation tab attached to a distal side of the outer annular support frame, and a proximal fixation tab attached to a proximal side of the outer annular support frame; a first inner flow control component mounted within the outer annular support frame adjacent to the second inner reflux control component, the first inner flow control component configured to permit blood flow in a first direction through the inflow end of the valve and to block blood flow in a second direction opposite the first direction through the outflow end of the valve, the first inner flow control component having a leaflet frame having two to four flexible leaflets mounted thereon; each of the bendable and compressible frame of the second inner regurgitation control component, the leaflet frame of the first inner flow control component, and the outer support frame is bendable from a cylindrical configuration to a flattened cylindrical configuration along a horizontal z-axis and compressible to a shortened configuration along a vertical y-axis; the prosthetic heart valve is compressible to a compressed configuration for introduction into a body using a delivery catheter for implantation at a desired location within the body, the compressed configuration being oriented along a horizontal x-axis that is substantially parallel to a longitudinal cylindrical axis of the delivery catheter, the horizontal x-axis being oriented at an intersection angle of 45 to 135 degrees relative to the central vertical y-axis, and expandable to an expanded configuration having the horizontal x-axis at an intersection angle of 45 to 135 degrees relative to the central vertical y-axis; the valve has a height of about 5 to 60 mm and a diameter of about 25 to 80 mm; The device.

2. 2. The valve of claim 1, wherein the annular outer support frame has an inner surface and an outer surface, the inner surface and the outer surface being covered with a biocompatible material selected from the following: the inner surface being covered with pericardial tissue, the outer surface being covered with a synthetic polyester fabric, and both the inner surface being covered with pericardial tissue and the outer surface being covered with a synthetic polyester fabric.

3. 10. The valve of claim 1, wherein the distal fixation tab, the proximal fixation tab, or both, comprise a wire loop, a wire frame, a laser cut frame, an integral frame section, or a stent and extend approximately 10-40 mm away from the side of the annular outer support frame.

4. 10. The valve of claim 1, further comprising an upper distal fixation tab attached to a distal upper edge of the annular support frame, the upper distal fixation tab comprising a wire loop, a wire frame, a laser cut frame, an integral frame section, or a stent, and extending approximately 2-20 mm away from the annular outer support frame.

5. The valve of claim 1 , comprising at least one tissue anchor connected to the annular outer support frame for engaging natural tissue.

6. 10. The valve of claim 1, wherein the annular outer support frame is comprised of compressible wire cells selected from the group consisting of braided wire cells, laser cut wire cells, photolithographically produced wire cells, 3D printed wire cells, wire cells formed from a single strand of wire intermittently connected in a wavy, zigzag, or helical pattern, and combinations thereof.

7. 10. The valve of claim 1, wherein the annular outer support frame is covered on its exterior with pericardial tissue, a polyester material, or a similar biocompatible material.

8. 1. A method for providing intentional retrograde flow in an implanted transcatheter prosthetic heart valve, comprising:

10. Cutting or piercing the tissue covering of the second inner reflux control component of claim 1 to form an opening by placing a catheter cutting tool into the implanted valve of claim 1, wherein the valve of claim 1 is implanted in a patient as a prosthetic heart valve. The method comprising:

9. 10. The method of claim 8, comprising the additional step of disposing a flow regulator in the opening selected from an occluder, a tubular stent, and a tubular stent having an occluder within the lumen of the tubular stent.

10. 1. A method of controlling or correcting regurgitation in a patient having an orthogonally delivered transcatheter prosthetic heart valve, comprising: Step 1: Providing a bendable, compressible prosthetic tricuspid valve according to claim 1; Step 2: loading the valve sideways into a delivery catheter; Step 3: advancing the valve via a pre-placed guidewire threaded through a sub-annular distal tab into the tricuspid valve of the patient's heart via the inferior vena cava (IVC) or superior vena cava (SVC); Step 4: partially ejecting the valve to position the distal subannular tabs and to allow the leaflets to begin functioning; Step 5: completing placement of the valve into the native annulus; Step 6: advancing a cutting tool or balloon tool through the delivery catheter to the deployed valve to create a 1-5 mm opening in the tissue covering of the inner reflux control component; The method comprising:

11. Step 7. Advancing a pacemaker wire set through the opening in the tissue covering of the inner reflux control component to attach the pacemaker wire(s) to or near the target conductive node. The method of claim 10 further comprising:

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