Tricuspid regurgitation control device for orthotopic trans-catheter heart valve prosthesis

Abstract

The present invention relates to a passageway and occluder device for managing and providing intentional regurgitation levels within transcatheter heart valve replacements, and specifically ortho-delivered transcatheter prosthetic heart valves having a first inner flow control component / valve, a second inner regurgitation control component, and an outer annular support frame having a compressible wire unit that facilitates collapsing along the z-axis and compressing the valve vertically along the y-axis or orthogonally to the central axis of the flow control component, thereby allowing very large diameter valves to be delivered and deployed from the inferior vena cava or superior vena cava to the tricuspid valve, or transatrially to the mitral valve, with a height of about 5-60 mm and a diameter of about 25-80 mm, without the need for an ultra-large diameter catheter and without the need to be delivered and deployed from the catheter at an acute angle of approach.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] Provided by the Application Data Sheet according to USPTO guidelines

[0003] Advisory statement regarding federal government support for research and development

[0004] Provided by the Application Data Sheet according to USPTO guidelines

[0005] Names of the parties to the joint research agreement

[0006] Provided by the Application Data Sheet according to USPTO guidelines

[0007] References to sequence listings

[0008] Provided by the Application Data Sheet according to USPTO guidelines

[0009] Statement Regarding Prior Disclosure

[0010] Provided by the Application Data Sheet according to USPTO guidelines Background of the Invention Technical Field

[0012] The present invention relates to an access and occluder device and in particular to a heart valve regurgitant drum and optional occluding disc and / or tubular stent for managing and providing intended levels of regurgitation within a transcatheter heart valve replacement (A61F2 / 2412). Background Art

[0014] In 1952, surgeons implanted the first mechanical heart valve, a bulbous valve that could be placed only in the descending aorta, not in the heart itself. For this reason, it did not completely correct the valve problem; it only alleviated the symptoms. However, it was a significant achievement because it demonstrated that synthetic materials could be used to create heart valves.

[0015] In 1960, a new valve was invented and successfully implanted. This valve is the Starr-Edwards bulb valve, named after its founder. This valve is an improvement on Hufnagel's original valve. The bulb of the valve is slightly smaller and is enclosed on both sides, so it can be inserted into the heart itself.

[0016] The next development was the introduction of tilting disc technology in the late 1960s. These valves were a significant improvement over the ball design. The tilting cast technology allowed blood to flow in a more natural manner while reducing mechanical damage to blood cells. However, over time, the struts of these valves tended to break due to fatigue. As of 2003, more than 100,000 Omniscience and 300,000 Hall-Kaster / Medtronic-Hall tilting disc valves had been implanted with virtually no mechanical failures.

[0017] In 1977, St. Jude introduced bileaflet heart valves. Similar to natural heart valves, blood flows directly through the center of a pyrolytic carbon annulus housed within a nickel-titanium shell, making these valves superior to other designs. However, a disadvantage of this design is that it allows for some regurgitation. The vast majority of mechanical heart valves in use today have this design. As of 2003, more than 1.3 million St. Jude valves and more than 500,000 Carbomedics valves had been deployed without a single leaflet or shell failure. It should be noted that the human heart beats approximately 31 million times per year.

[0018] The development of compressible valves that can be delivered via catheters without the trauma and complications of open heart surgery continues. This means that a cardiologist trained in endoscopy could theoretically deploy a heart valve replacement during an outpatient procedure. However, transcatheter valves are typically delivered by puncturing the apex of the heart to gain access to the ventricle, and the puncture is typically used to anchor the annular valve replacement.

[0019] Additionally, stent-based replacement valves are problematic in that they often continue to suffer from the regurgitation or leakage issues of previous generations of valves and require expensive material engineering to withstand the millions of cycles encountered during just a few years of normal heart function. Therefore, there remains a need for alternative and simpler solutions to address valve-related heart disease. Summary of the Invention

[0020] The present invention relates to an access and occluder device, and in particular to a heart valve regurgitation drum and optional closure member and / or perforated tubular stent for managing and providing intentional levels of regurgitation within a transcatheter heart valve replacement, and in particular within an orthogonally (longitudinally, along the z-axis) delivered transcatheter prosthetic heart valve.

[0021] In preferred embodiments, a heart valve regurgitation cuff for transcatheter delivery of a prosthetic heart valve, optionally with a closing member and / or a tubular stent, comprises: a first inner flow control member / valve, a second inner regurgitation control member, and an outer annular support frame with a compressible wire unit that facilitates folding flat along the z-axis and compressing vertically along the y-axis or orthogonally to the central axis of the flow control member, thereby allowing delivery and deployment of very large diameter valves from the inferior vena cava or superior vena cava to the tricuspid valve, or trans-septal (trans-atrial, across the fossa ovalis or adjacent tissue) to the mitral valve, with heights of about 5-60 mm and diameters of about 25-80 mm, without the need for super-large diameter catheters and without the need to deliver and deploy from the catheter at acute approach angles.

[0022] In another preferred embodiment, the present invention provides an apparatus for managing and providing a level of intentional regurgitation within an orthogonally delivered transcatheter prosthetic heart valve, comprising: an orthogonally delivered transcatheter prosthetic heart valve having (i) a first internal flow control component (ii) a second internal regurgitation control component and (iii) an outer annular support frame, the second internal regurgitation control component having a foldable and compressible frame, a tissue cover attached to the frame, and a flow regulator mounted within a reinforcement ring, the reinforcement ring being mounted on the tissue cover, the flow regulator being selected from an occluder, a tubular branch The invention relates to a tubular stent having an occluder in its lumen, the tissue covering having one or more radiopaque markers, and the second inner reflux control component being mounted within the outer support frame of the artificial heart valve, the self-expanding annular outer support frame having a central channel, an outer peripheral wall circumscribing a central vertical axis in an expanded configuration, an atrial collar mounted along a top edge of the peripheral wall, a distal anchoring tab mounted on the distal side of the outer annular support frame, and a proximal anchoring tab mounted on the proximal side of the outer annular support frame, the first inner flow control component being adjacent to the outer annular support frame within the outer annular support frame. The second inner regurgitation control component is installed, the first inner flow control component is configured to allow blood flow through the inflow end of the valve in a first direction and prevent blood flow through the outflow end of the valve in a second direction opposite to the first direction, the first inner flow control component has a leaflet frame, 2-4 flexible leaflets are mounted on the leaflet frame, wherein each of the foldable 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 each capable of being folded from a cylindrical configuration to a flat cylindrical configuration along a horizontal z-axis and capable of being folded along a vertical z-axis. y-axis compression to a shortened configuration, wherein the artificial heart valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implantation at a desired location in the body, the compressed configuration is oriented along a horizontal x-axis that is substantially parallel to the longitudinal cylindrical axis of the delivery catheter, the horizontal x-axis is oriented to form an intersection angle of between 45-135 degrees with the central vertical y-axis, and the compressed configuration is expandable to an expanded configuration in which the horizontal x-axis forms an intersection angle of between 45-135 degrees with the central vertical y-axis, wherein the valve has a height of approximately 5-60 mm and a diameter of approximately 25-80 mm.

[0023] In another preferred embodiment, the present invention provides a valve, wherein the annular outer support frame has an inner surface and an outer surface, and the inner surface and the outer surface are covered with a biocompatible material, selected from the following items: the inner surface is covered with pericardial tissue, the outer surface is covered with a woven synthetic polyester material, and both the inner surface is covered with pericardial tissue and the outer surface is covered with a woven synthetic polyester material.

[0024] In another preferred embodiment, the present invention provides a valve wherein the distal anchoring tab, the proximal anchoring tab, or both are comprised of a coil, wire frame, laser-cut frame, integrated frame segment, or stent and extend approximately 10-40 mm away from the side of the annular outer support frame.

[0025] In another preferred embodiment, the present invention provides a valve, which also includes: an upper distal anchoring tab, which is attached to the distal upper edge of the annular support frame, and the upper distal anchoring tab is composed of a coil, a wire frame, a laser-cut frame, an integrated frame segment or a stent, and extends approximately 2-20 mm away from the annular outer support frame.

[0026] In another preferred embodiment, the present invention provides a valve comprising: at least one tissue anchor connected to the annular outer support frame for engaging native tissue.

[0027] In another preferred embodiment, the present invention provides a valve, wherein the annular outer support frame is composed of compressible wire units, and the compressible wire units are selected from the group consisting of: braided wire units, laser cut wire units, photolithographically produced wire units, 3D printed wire units, wire units formed by intermittently connected single strands of wire in a wavy, zigzag or spiral shape, or a combination thereof.

[0028] In another preferred embodiment, the present invention provides a valve, wherein the annular outer support frame is covered on the outer surface with pericardial tissue, polyester material or similar biocompatible material.

[0029] In another preferred embodiment, the present invention provides a method for providing intentional regurgitation in an implantable transcatheter artificial heart valve, comprising the following steps: cutting or perforating a segment of the tissue covering within the reinforcement ring of the second internal regurgitation control component as described in claim 1 to form an orifice by deploying a catheter cutting tool to the implantable valve as described in claim 1, wherein the valve as described in claim 1 is implanted in a patient's body as an artificial heart valve.

[0030] In another preferred embodiment, the present application provides a method comprising the additional step of deploying a flow regulator into the orifice, the flow regulator selected from the group consisting of a plug, a tubular stent, and a tubular stent having a plug within its lumen.

[0031] In another preferred embodiment, the present application provides a method of controlling or regulating regurgitation in a patient having a transcatheter prosthetic heart valve with orthogonal delivery comprising the steps of:

[0032] Step 1. Providing a foldable, compressible prosthetic tricuspid valve according to claim 1; Step 2. Laterally loading the valve into a delivery catheter;

[0033] Step 3. Advancing the valve over a pre-positioned guide wire threaded onto a subannular distal tab via the inferior vena cava (IVC) or superior vena cava (SVC) to the tricuspid valve of the heart of the patient;

[0034] Step 4. Partially ejecting the valve to position the distal subannular tab and allow the valve leaflets to begin functioning;

[0035] Step 5. Completing the deployment of the valve into the native annulus; and

[0036] Step 6. Advancing a cutting tool or balloon tool through the delivery catheter to the deployed valve and creating a 1-5 mm opening in the tissue covering of the inner regurgitation control component.

[0037] In another preferred embodiment, the present application provides a method of controlling or regulating regurgitation further comprising:

[0038] Step 7. Advancing a pacemaker lead set through the opening in the tissue covering of the inner regurgitation control component and attaching one or more pacemaker leads at or near a target conduction node. BRIEF DESCRIPTION OF DRAWINGS

[0039] Figure 1 is a depiction of a side perspective view of an inner regurgitation control component with radiopaque markers as part of an orthogonally deliverable transcatheter heart valve having a collapsible flow control component mounted within an annular outer support frame, the collapsible (inner) flow control component having a leaflet frame with 2-4 flexible leaflets mounted thereon, the leaflet frame foldable 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, and the valve having a super-elastic coil distal tab and a super-elastic coil proximal tab, in accordance with the present application.

[0040] Figure 2is an illustration of a side perspective exploded view of an embodiment of the present invention having an inner regurgitation control component with radiopaque markers, three leaflet cusps or pockets mounted within a foldable and compressible inner wire frame mounted within an outer wire frame having a loop component, a double tab component, and a mesh component circumferentially attached at a top edge of the outer wire frame.

[0041] Figure 3 is an illustration of a side perspective view of an internal regurgitation control component with a radiopaque marker as part of an orthogonally deliverable transcatheter heart valve according to the present invention, wherein the orthogonal deliverable transcatheter heart valve has a collapsible flow control component mounted within an annular outer support frame, the collapsible (inner) flow control component having a leaflet frame with 2-4 flexible leaflets mounted thereon, the leaflet frame being foldable from a cylindrical configuration to a flat cylindrical configuration along the z-axis and compressible to a shortened configuration along the vertical axis (y-axis), and the valve having superelastic coil distal tabs and superelastic coil proximal tabs.

[0042] Figure 4 is an illustration of a side perspective exploded view of an embodiment of the present invention having an inner regurgitation control component with a radiopaque marker, three leaflet cusps or pouches mounted within a foldable and compressible inner wire frame mounted within an outer wire frame having a loop component circumferentially attached at a top edge of the outer wire frame, a pair of integrated independent tab components, and a mesh component.

[0043] Figure 5 is an illustration of a side perspective view of an orthogonal deliverable transcatheter heart valve in accordance with the present invention in a collapsed configuration along the z-axis (from front to back when viewed from the wider side).

[0044] Figure 6 is an illustration of a side perspective view of an orthogonal deliverable transcatheter heart valve in a vertically compressed configuration in accordance with the present invention.

[0045] Figure 7 is an illustration of a side perspective view of an orthogonal deliverable transcatheter heart valve partially loaded into a delivery catheter in accordance with the present invention.

[0046] Figure 8 is an illustration of an end view of a delivery catheter showing a loaded valve in accordance with the present invention.

[0047] Figure 9 is an illustration of a top view of a collapsed, compressed valve expelled from a delivery catheter prior to placement in the native annulus in a partial position allowing for expansion of the leaflets and endoframe.

[0048] Figure 10 is an illustration of a top perspective view of a valve according to the present invention, having an inner regurgitation control component as part of a lattice spacing frame, shown removed for viewing; and having a lattice side wall covering, an inner frame, and an outer cylindrical frame with leaflets sutured into the inner frame.

[0049] Figure 11 is an illustration of a top perspective view of a valve according to the present invention, having an inner regurgitation control component as part of a lattice spacing frame with radiopaque markers, mounted on a top edge of an outer cylindrical frame, the outer frame further having a lattice side wall covering, an inner frame, and leaflets sutured into the inner frame.

[0050] Figure 12 is an illustration of a bottom perspective view of a valve according to the present invention, having an inner regurgitation control component as part of a lattice spacing frame, mounted on a top edge of an outer cylindrical frame, the outer frame further having a lattice side wall covering, an inner frame, and leaflets sutured into the inner frame.

[0051] Figure 13 is an illustration of an exploded view of a valve according to the present invention, having an inner regurgitation control component, an outer cylindrical frame, the outer frame having a lattice side wall covering, an inner frame, and leaflets sutured into the inner frame.

[0052] Figure 14 is an illustration of a top perspective view of an inner leaflet frame in a cylindrical configuration, shown as the beginning of a process that allows for folding and compression of the inner frame, according to the present invention.

[0053] Figure 15 is an illustration of a top perspective view of an inner leaflet frame in a partially folded configuration, with the wire frame side walls rotated or hinged at their lateral connection points, shown as a first partial step in a process that allows for folding and compression of the inner frame, according to the present invention.

[0054] Figure 16 is an illustration of 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, shown as a completed first step in a process that allows for folding and compression of the inner frame, according to the present invention.

[0055] Figure 17 is an illustration of a side view of an inner leaflet frame in a folded and vertically compressed configuration, with the wire frame side walls vertically compressed in a pleated or accordion-like folded configuration, shown as a second step in a process that allows for folding and compression of the inner frame, according to the present invention.

[0056] Figure 18is an illustration of a side view of an inner leaflet frame as a linear wire frame sheet prior to further assembly into a cylindrical structure in accordance with the present invention.

[0057] Figure 19 is an illustration of a side perspective view of an inner leaflet frame in a cylindrical or cylindrical (tapered, etc.) configuration in accordance with the present invention.

[0058] Figure 20 is an illustration of a side perspective view of a pericardial tissue band according to the present invention, the band being constructed in a cylindrical shape with leaflet pouches sutured into the structural band.

[0059] Figure 21 is an illustration of a side view of a pericardial tissue band having leaflet pockets sutured into the structural band prior to assembly into a cylindrical leaflet component and mounting on an endoframe to form a collapsible (foldable, compressible) flow control component in accordance with the present invention.

[0060] Figure 22 is an illustration of a bottom view of a pericardial tissue band having leaflet pockets sutured into the structural band before being assembled into a cylindrical leaflet component and mounted on an endoframe to form a collapsible (foldable, compressible) flow control component in accordance with the present invention.

[0061] Figure 23 is an illustration of a side perspective view of a portion of a pericardial tissue band having a single leaflet pouch sutured into the structural band showing an open bottom edge and a sutured closed top parabolic edge in accordance with the present invention.

[0062] Figure 24 is an illustration of a bottom view of a cylindrical leaflet component showing partial coaptation of the leaflets to form a closed fluid seal in accordance with the present invention.

[0063] 25(a) to 25(e) are illustrations of a procedure in which a valve having a pre-perforated drum is delivered orthogonally within a catheter, expelled from the catheter, and deployed into the native annulus.

[0064] Figure 26 is an illustration of a top perspective view of an outer wire frame in a cylindrical configuration, shown as the beginning of a process allowing the outer frame to be folded and compressed, in accordance with the present invention.

[0065] Figure 27 is an illustration of a top perspective view of an outer frame in a partially collapsed configuration with the wire frame side walls rotated or hinged at their lateral connection points, shown as part of a first step in the process of allowing the inner frame to be collapsed and compressed, in accordance with the present invention.

[0066] Figure 28is an illustration of a side view of an outer frame in a fully flat-folded configuration with the wire frame side walls rotated or hinged at their lateral connection points, shown as a completed first step in the process of allowing the inner frame to be folded and compressed, in accordance with the present invention.

[0067] Figure 29 is an illustration of a side view of an outer frame in a folded and vertically compressed configuration with the wire frame sidewalls vertically compressed in a pleated or accordion-folded configuration shown as a second step in the process of allowing the inner frame to be folded and compressed in accordance with the present invention.

[0068] Figure 30 is an illustration of a top perspective view of an assembled valve according to the present invention, wherein the assembled valve has an inner regurgitation control component with radiopaque markers, an outer frame, a flow control component with an inner leaflet frame and three sutured leaflet pockets / cusps, an inner spacer frame, and a mesh cover positioned over the spacer frame, with fold lines shown as dashed lines on the mesh cover.

[0069] Figure 31 is an illustration of a top perspective view of an assembled valve according to the present invention, wherein the assembled valve has an inner regurgitation control component and an outer frame with radiopaque markers, a first sub-annular anchoring / positioning tab mounted on the outer frame adjacent to the flow control component, a second sub-annular anchoring / positioning tab mounted at a different position on the outer frame, a flow control component with an inner leaflet frame and three sutured leaflet pockets / cusps, an inner spacer frame, and a mesh cover positioned over the spacer frame, with fold lines shown as dashed lines on the mesh cover.

[0070] Figure 32 is an illustration of a top perspective view of an assembled valve according to the present invention, wherein the assembled valve has an outer frame, a first sub-annular anchoring / positioning tab mounted on the outer frame adjacent to a flow control component, a second sub-annular anchoring / positioning tab mounted at a different position on the outer frame, a flow control component having an inner leaflet frame and three sutured leaflet pockets / cusps, an inner septal frame, and a mesh cover positioned over the septal frame, with fold lines shown as dashed lines on the mesh cover, and a hemodynamic wash chamber shown beneath the covered inner septal frame.

[0071] Figure 33 is an illustration of a top view of an assembled valve according to the present invention, wherein the assembled valve has an inner regurgitation control component and an outer frame, a flow control component with an inner leaflet frame and three sutured leaflet pockets / cusps, an inner spacer frame, and a mesh cover located above the spacer frame.

[0072] Figure 34is an illustration of a top view of an assembled valve according to the present invention, having an inner regurgitation control component and an outer frame, a first subannular anchoring / positioning tab mounted on the outer frame proximal to the flow control component, a second subannular anchoring / positioning tab mounted on the outer frame at a different location, a flow control component having an inner leaflet frame and three sutured leaflet pockets / cusps, an inner septal frame, and a mesh cover over the septal frame.

[0073] Figure 35 (a) through Figure 35 (e) is an illustration of a step-by-step process in which the tissue cone is perforated prior to orthogonal loading of the valve into the delivery catheter.

[0074] Figure 36 (a) through Figure 36 (c) is an illustration of a step-by-step process in which the tissue cone is perforated after orthogonal ejection and deployment of the valve from the delivery catheter into the native annulus.

[0075] Figure 37 is an illustration of how the user can match the size of the orifice to the desired regurgitant flow (e.g., a regurgitation level in the range of 0.5-2.0).

[0076] Figure 38 is an illustration of how the user can match the size of the lumen of the tubular stent, which can be deployed into the orifice, to the desired regurgitant flow (e.g., a regurgitation level in the range of 0.5-2.0).

[0077] Figure 39 is an illustration of a side septal plan view of a labeled valve according to the present invention, having a subannular anchoring and / or positioning tab extending toward the viewer and a second subannular tab extending away from the viewer, and having a visible foldable and compressible wire frame construction.

[0078] Figure 40 (a) through Figure 40 (f) is an illustration of a closure device for closing a perforation in the inner regurgitation control component.

[0079] Figure 41 is an illustration of a top view of a valve according to the present invention partially ejected from a delivery catheter, with a distal tab guiding the valve (along an unillustrated guide wire) toward a deployment location, a distal flow control component beginning to open, and showing two of the three leaflets open from a folded flat configuration and a third leaflet open from a folded configuration in which the third leaflet folds back on itself while in the delivery catheter.

[0080] Figure 42is an illustration of a top view of a valve according to the present invention compressed (orthogonally loaded) within a delivery catheter, with a first tab extending anteriorly along the x-axis and a second trailing edge tab extending posteriorly along the x-axis.

[0081] Figure 43 is an illustration of a top view of a valve according to the present invention having an outer frame, an eccentric inner flow control member (leaflets in the frame), and an irregularly shaped spacing frame / support frame.

[0082] Figure 44 is an illustration of a top view of a valve according to the present invention having an outer frame, a centrally located inner flow control member (leaflets in the frame), and a pair of irregularly shaped spacer / support frames on opposite sides of the inner flow control member.

[0083] Figure 45 is an illustration of a top view of a valve according to the present invention having an outer frame and an inner flow control member (leaflets in the frame) and multiple suture attachment points, wherein the inner flow control member is sutured to the outer frame.

[0084] Figure 46 is an illustration of a top view of a valve according to the present invention having a pacemaker lead set mounted within a perforation in a second inner regurgitant control member, an outer frame, an eccentric inner flow control member, and an inner septal frame, all three structures being foldable along the same x-axis.

[0085] Figure 47 is an illustration of a top view of a valve according to the present invention having an outer frame, a centrally positioned inner flow control member, and a pair of smaller cylindrical inner spacer frames mounted on opposite sides of the inner flow control member to provide support within the interior dimensions of the outer frame, all four structures being foldable along the same x-axis.

[0086] Figure 48 is an illustration of a top view of a valve according to the present invention having an outer frame, a proximally positioned offset inner flow control member, and a distal inner spacer frame, all three structures being collapsible along the same x-axis.

[0087] Figure 49 is an illustration of a side view of a human heart with a transfemoral / IVC or SVC delivery catheter having ejected an orthogonal prosthetic valve for low-angle deployment into the tricuspid valve in accordance with the present invention. DETAILED DESCRIPTION

[0088] The present invention relates to a dual-tab transcatheter heart valve replacement, which is a low-profile, orthogonally delivered implantable prosthetic heart valve having an annular or ring-shaped support frame, an inner 2 or 3-panel sleeve, a slender sub-annular distal anchoring tab extending into the right ventricular outflow tract, and a slender sub-annular proximal anchoring tab extending into the proximal subannular space, preferably between the anterior leaflet and the posterior leaflet.

[0089] With reference to the non-limiting embodiments shown in the drawings and described in detail below, more fully explain this paper embodiment and its various features and advantageous details. Omit the description of well-known components and processing technology, so as not to unnecessarily blur the embodiment herein. The example used herein is only for the convenience of understanding the mode that can be used to practice the embodiment herein, and further enables those skilled in the art to practice the embodiment herein. Therefore, example should not be interpreted as limiting the scope of the embodiment herein.

[0090] On the contrary, these embodiments are provided to make this disclosure thorough and complete and to fully convey the scope of the invention to those skilled in the art. Throughout the text, the same reference numerals refer to the same elements. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0091] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the full scope of the invention. Unless the context clearly indicates otherwise, the singular forms "a", "an", and "the" used herein are intended to include the plural forms as well. It will be further understood that the terms "comprises" and / or "comprising", when used in this specification, specify the presence of the stated features, integers, steps, operations, elements, and / or parts, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, parts, and / or groups thereof.

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

[0093] Many modifications and variations of this disclosure can be made without departing from its spirit and scope. Functionally equivalent methods and apparatuses within the scope of the disclosure, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions. Such modifications and variations are intended to fall within the scope of the appended claims. The disclosure is limited only as would be the following claims and the full scope of equivalents to which such claims are entitled. It is to be understood that this 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.

[0094] With respect to the use of substantially any plural and / or singular terms herein, those having skill in the art can translate the mutability to singular and / or plural term and vice versa as is appropriate to the context and / or application. Where considerations of clarity render either the singular or plural form the sole semantically operative form of a term, it is to be understood that all such other, contextually operative, ranges are to be implicitly combined with the only semantically operative form of the term.

[0095] Those skilled in the art will appreciate that, in general, the terms used in the specification and the appended claims (e.g., the body of the appended claims) are intended to be interpreted broadly, such that the outmost scope of the terms is used as equivalent terms. For example, the terms "comprising," "including," "having," and the like are to be construed as open-ended terms (e.g., the term "comprising" is to be construed as "including but not limited to," the term "having" is to be construed as "at least having," the term "includes" is to be construed as "including but not limited to," etc.). Those skilled in the art will further understand that virtually any disjunctive language (e.g., any "or," "and," "etc.," etc.) presenting two or more alternative terms is intended to imply that the alternative terms are collectively possible (e.g., each of the alternative terms is individually possible, or any of the alternative terms are possible in combination with one another or with one or more of the other alternative terms).

[0096] Further, where a feature or aspect of the disclosure is described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.

[0097] As those skilled in the art will appreciate, all ranges disclosed herein are also intended to encompass any and all possible sub-ranges and combinations of sub-ranges thereof, for both the minimum and maximum limits of the ranges. Any listed range can be easily recognized as sufficiently describing and enabling the same range occurring between the minimum and maximum limits. By way of example, a range of "1 to 10" is specifically intended to include any and all sub-ranges between (and including) the minimum limit of 1 and the maximum limit of 10, that is, any and all sub-ranges having a limit of less than 10, coupled with a limit of greater than 1, as well as any and all sub-ranges having a limit of less than 10, coupled with a limit of greater than 1. In this disclosure, sizes of amounts, dosages, and other quantities are not intended to be critical unless specifically indicated otherwise. In some embodiments, the amounts, dosages, and other quantities are approximations.

[0098] Definitions

[0099] Orthogonal

[0100] In the specification and claims herein, the term "orthogonal" is used to describe that the valve of the present invention is compressed and delivered at an approximately 90 degree angle compared to conventional transcatheter heart valves. Conventional valves have a central cylindrical axis that is parallel to the longitudinal axis of the delivery catheter and are deployed from the end of the delivery catheter in a manner similar to pushing a closing umbrella out of a cannula. The valve of the present invention is compressed and delivered in a lateral manner. Conventional valves can only expand to the extent that the inner diameter of the delivery catheter will allow. Efforts to increase the expanded diameter of conventional valves have encountered the problem of trying to squeeze too much material and structure into too small a space.

[0101] Mathematically, the term orthogonal refers to an angle of intersection between two lines or planes that is 90 degrees. As used herein, the term "substantially orthogonal" refers to an angle of intersection ranging from 75 degrees to 105 degrees. The angle of intersection or orthogonal angle refers to both: (i) the relationship between the longitudinal cylindrical axis of the delivery catheter and the long axis of the compression valve of the present invention, wherein the long axis is perpendicular to the central cylindrical axis of a conventional valve, and (ii) the relationship between the long axis of the compression or expansion valve of the present invention and the axis defined by blood flow through the artificial heart valve, wherein blood flows, for example, 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 through the native annulus.

[0102] Transcatheter

[0103] In the specification and claims herein, the term "transcatheter" is used to define the process of accessing, controlling, and delivering a medical device or instrument within the lumen of a catheter deployed into a chamber of the heart, as well as items delivered or controlled by such a process. Known transcatheter approaches include via the femoral artery and vein, via the brachial artery and vein, via the carotid artery and vein, via the intercostal (costal) space, and subxiphoid. Transcatheter may be synonymous with transluminal and is functionally related to the term "percutaneous" as it relates to delivery of heart valves.

[0104] In a preferred embodiment of the invention, transcatheter access includes (i) advancement via the femoral vein through the inferior vena cava to the tricuspid valve or pulmonary artery of the heart, (ii) advancement via the jugular vein through the superior vena cava to the tricuspid valve or pulmonary artery of the heart, (iii) advancement via an IVC-femoral or SVC-jugular approach (e.g., fossa ovalis or lower) to the mitral valve of the heart.

[0105] Ring support frame

[0106] As used herein and in the claims, the terms "annular support frame" and "wire frame" or "flange or ring" refer to a three-dimensional structural component that is positioned within the native valve annulus and serves as a mounting element for a leaflet structure, flow control component, or flexible reciprocating cannula or cannula valve.

[0107] In a preferred embodiment, the annular support frame is a self-expanding annular support frame having a central channel and an outer peripheral wall circumscribing a central vertical axis in the expanded configuration. The peripheral wall comprises a collar and a lower body portion.

[0108] The peripheral wall may be further defined as having a front wall portion and a back wall portion connected to the proximal fold region along a proximal side (to the IVC) or proximal side and to the distal fold region along a distal side or distal side.

[0109] The front wall portion may be further defined as having a front upper collar portion and a front lower body portion, and the rear wall portion may be further defined as having a rear upper collar portion and a rear lower body portion.

[0110] The annular support frame has a valve mounted within the annular support frame and configured to allow blood flow through the inflow end of the valve in a first direction and prevent blood flow through the outflow end of the valve in a second direction opposite the first direction.

[0111] Because the frame is preferably made of a superelastic metal or alloy (such as Nitinol), the frame is compressible. Preferably, the frame is composed of a plurality of compressible wire cells having an orientation and cell geometry that is substantially orthogonal to a central vertical axis to minimize wire cell strain when the annular support frame is configured in a vertical compressed configuration, a coiled compressed configuration, or a folded compressed configuration.

[0112] Ring support frame structure

[0113] The annular support frame can be an annular, cylindrical, or conical tube made of a durable, biocompatible structural material (such as Nitinol or a similar alloy), wherein the annular support frame is formed by manufacturing the structural material into a braided wire frame, a laser-cut wire frame, or a coil. Taking into account the thickness of the wire material itself, the annular support frame has a height of approximately 5-60 mm, an outer diameter R of 30-80 mm, and an inner diameter of 31-79 mm.

[0114] As stated above, the annular support frame can have a side profile of an annular shape, a cylindrical shape, a tapered tube shape, but can also have a flat conical shape, an inverted flat conical shape (narrower at the top, wider at the bottom), a concave cylinder (walls curved inward), a convex cylinder (walls bulging outward), an angled hourglass, a curved banded hourglass, a ring or cylinder with a flared top, a flared bottom, or both. In a preferred embodiment, the annular support frame used in a prosthetic heart valve deployed in a tricuspid annulus can have a complex shape determined by the anatomy in which the valve is mounted. For example, in a tricuspid annulus, the circumference of the tricuspid valve can be a circle that is an ellipse, the septal wall is known to be substantially vertical, and the tricuspid valve is known to dilate along the anteroposterior line in disease states. Thus, the prosthetic heart valve can begin in a generally tubular configuration, and can be heat formed to provide an upper atrial cuff or flange for atrial sealing and a lower transannular tubular or cylindrical segment, about 60-80% of the circumference of which has a hourglass cross section to conform to the native annulus along the posterior and anterior annular segments, while remaining substantially flat vertically along 20-40% of the annular circumference to conform to the septal annular segment.

[0115] Annular support frame cover

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

[0117] Use of annular support frame

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

[0119] Annular support frame optional collar

[0120] The annular support frame can optionally have a separate atrial collar attached to the upper (atrial) edge of the frame for deployment on the atrial floor, for channeling blood from the atrium into the sleeve and sealing against leakage of blood around the annular support frame. The annular support frame can also optionally have a separate ventricular collar attached to the lower (ventricular) edge of the frame for deployment in the ventricle immediately beneath the native annulus, for preventing regurgitant leakage during heart contraction, for preventing the device from moving during heart contraction, for clamping or compressing the native annulus or adjacent tissue against the atrial collar, and optionally for attaching to and supporting the sleeve / tube.

[0121] Delivery of annular support frame

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

[0123] Frame material

[0124] Preferably, the frame is made of superelastic metal components such as laser cut Nitinol tubes, or flat sheets or other similar functional materials (such as braided wire). Materials can be used for the frame / stent, collars and / or anchors. It is contemplated that other shape memory alloys and polymer composites can be used within the scope of the present invention, including composites containing carbon nanotubes, carbon fibers, metal fibers, glass fibers and polymer fibers. It is contemplated that the frame can be constructed as a braid, wire or laser cut frame. The laser cut frame is preferably made of Nitinol, but is not limited to being made of stainless steel, cobalt chromium, titanium and other functionally equivalent metals and alloys.

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

[0126] Laser Cutting

[0127] One possible wireframe configuration envisions laser cutting of uniformly sized Nitinol tubing. Laser cutting creates regular cuts in the Nitinol tubing. In a preferred embodiment, the Nitinol tubing is expanded to form a three-dimensional structure composed of diamond-shaped cells. The structure may also have additional functional elements, such as loops, anchors, etc., for attaching accessory components such as biocompatible covers, tissue anchors, releasable deployment and retrieval control guides, knobs, attachments, rigging, and the like.

[0128] Next, the tube is thermomechanically processed using industry-standard Nitinol forming methods. Processing the wire frame in this way creates a device that has shape memory properties and will easily return to its memorized shape once deployed.

[0129] Braided wire

[0130] Another possible wire frame construction envisions utilizing a simple braiding technique, using Nitinol wire and a simple braiding jig. The wire is wrapped around the braiding jig in a pattern until a constant diameter tube is formed. Next, the braided wire frame is placed on a forming jig and processed using industry-standard Nitinol forming methods.

[0131] Flow control components

[0132] In the specification and claims herein, the term "flow control member" refers in a non-limiting sense to a leaflet structure having two, three, or four leaflets made of a flexible biocompatible material (such as treated or untreated pericardium), which is sutured or attached to an inner annular support frame (mounted within an outer annular support frame) to serve as an artificial heart valve. Such a valve may be a heart valve, such as a tricuspid valve, a mitral valve, an aortic valve, or a pulmonary valve, which opens to blood flowing from the atrium to the ventricle during diastole and closes due to systolic ventricular pressure applied to the outer surface. The repeated opening and closing can be described as "reciprocating".

[0133] Reflux drum or second inner

[0134] 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 a first inner annular support frame. The "reflux drum" or "second inner reflux control component" comprises a foldable and compressible frame, a tissue cover attached to the frame, and a flow regulator mounted within a reinforcement ring, the reinforcement ring being mounted on the tissue cover, the flow regulator being selected from the group consisting of a channel, an occluder, a tubular stent, and a tubular stent having an occluder within its lumen, the tissue cover having one or more radiopaque markers. This "reflux drum" or "second internal regurgitation control component" can be pre-perforated before the valve is loaded into the delivery catheter, it can be perforated using a catheter tool after the valve has been deployed in the native annulus, the perforation can be reinforced with a stent tube, and the perforation or stent tube can be sealed with a closure device, such as a polyester disc, a nitinol disc, a nitinol disc with a polyester cover, a double disc (buttons on each side) closure device, or a functionally similar device similar to the device used to treat patent foramen ovale but modified for entering and closing a 1-2 mm perforation in the regurgitation drum.

[0135] Reinforcement ring

[0136] The term reinforcement ring refers to a ring of material, such as pericardium, a polymer, or a biocompatible material, mounted on the top surface of the tissue cover of the "reflux drum" or "second internal reflux control component." In a preferred embodiment, the reinforcement ring circumscribes the target area for the perforation and prevents the perforation from tearing or losing patency. In another preferred embodiment, a radiopaque marker for guiding a catheter cutting / balloon tool may be mounted on or within the top of the reinforcement ring.

[0137] Radiopaque markers

[0138] The term "radiopaque marker" refers to a material that allows visibility during fluoroscopy or other radiographic imaging. Examples of radiopaque marker materials include nitinol, gold, platinum, and combinations or mixtures thereof. Radiopaque materials may also include powdered or granular metals contained within a polymer, glass, or ceramic matrix. The present invention contemplates the use of one or more markers, for example, 1-10 or 3-5 markers. The present invention contemplates the use of markers mounted in a specific pattern or orientation to provide not only targeted perforation locations, but also positioning information for the valve itself. For example, the use of a three marker pattern provides a central targeting area, but may also provide information as to whether the valve is correctly oriented, such as aligning the septal ring portion of the prosthetic valve with the septal side of the tricuspid valve.

[0139] Tissue anchors

[0140] As used herein and in the claims, the terms "tissue anchor," "plication tissue anchor," "auxiliary tissue anchor," "dart," or "pin" refer to a fastening device that connects the upper atrial frame to the native annular tissue, typically at or near the perimeter of the collar. The anchor may be positioned to avoid piercing the tissue and rely solely on the compressive force of the two plate-like collars on the captured tissue, or the anchor, by itself or in conjunction with an integrated fixation wire, may pierce the native tissue to provide anchoring, or a combination of both. The anchor may have a specialized fixation mechanism that inserts or pops out into a mating orifice or array of mating orifices, such as a tip having a groove and a flanged shoulder that allows the anchor to attach but prevents detachment when the flanged shoulder locks into the groove near the perimeter of the orifice. The fixation wire may be attached or anchored to the collar opposite the pin by any attachment or anchoring mechanism, including a knot, suture, wire crimp, wire lock with a cam mechanism, or a combination thereof.

[0141] support column

[0142] The term "support post" refers to a rigid or semi-rigid length of material, such as Nitinol or PEEK, that can be mounted on a spoked frame and runs axially, down the center of a flexible sleeve, or within a sewn seam of the flexible sleeve. The sleeve may not be attached to the support post, or the sleeve may be attached directly or indirectly to the support post.

[0143] In the following description, the term "body passageway" is used to define a blood conduit or blood vessel within the body. Of course, the specific application of the artificial heart valve determines the body passageway in question. For example, an aortic valve replacement would be implanted in or adjacent to the aortic annulus. Similarly, a tricuspid or mitral valve replacement would be implanted at the tricuspid or mitral annulus. Certain features of the present invention are particularly advantageous for one or the other implantation site. However, unless the combination is structurally impossible or is excluded by the claim language, any of the heart valve embodiments described herein may be implanted in any body passageway.

[0144] The term "lumen" refers to the inside of a cylindrical tube. The term "bore" refers to the inside diameter.

[0145] Displacement – ​​The volume of fluid displaced during one complete stroke or rotation.

[0146] The ejection fraction is a measure of the percentage of blood that leaves the heart each time it contracts. During each heartbeat's pumping cycle, the heart contracts and relaxes. When the heart contracts, it ejects blood from its two pumping chambers (ventricles).

[0147] As used herein, the terms "proximal" and "distal" should be understood relative to a user of the disclosed delivery devices (e.g., a surgeon or interventional cardiologist). "Proximal" should be understood as relatively close to the user, and "distal" should be understood as relatively far from the user.

[0148] As a further point of definition, the term "expandable" is used herein to refer to a component of a heart valve that is capable of expanding from a first delivery diameter to a second implanted diameter. Thus, an expandable structure does not connote a structure that may undergo slight expansion due to elevated temperature or other such incidental causes. Conversely, "non-expandable" should not be interpreted as meaning completely rigid or dimensionally stable, as some slight expansion may be observed with, for example, conventional "non-expandable" heart valves.

[0149] artificial heart valves

[0150] The term prosthesis or artificial encompasses both complete replacement of an anatomical part, such as a new mechanical valve replacing a natural valve, and medical devices that replace and / or assist, repair or improve an existing anatomical part, such as a natural valve that is left in place. The present invention contemplates a wide variety of (bio)artificial artificial heart valves for installation in a passive assist holder. 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), (bovine, porcine, ovine) stented pericardial heart valve prostheses (Edwards series of bioprostheses, St. Jude artificial heart valves), as well as homologous and autologous transplant valves. For bioartificial pericardial valves, it is contemplated to use bioartificial aortic valves, bioartificial mitral valves, bioartificial tricuspid valves, and bioartificial pulmonary valves.

[0151] tie-downs

[0152] The tethers are made of surgical grade materials, such as biocompatible polymer suture materials. Non-limiting examples of such materials include ultra-high molecular weight polyethylene (UHMWPE), 2-0 exPFTE (polytetrafluoroethylene), or 2-0 polypropylene. In one embodiment, the tethers are inelastic. It is also contemplated that one or more of the tethers may optionally be elastic to provide an even further degree of compliance of the valve during the cardiac cycle.

[0153] Spike Teeth-Anchors-Spike Teeth / Barbs

[0154] The device can be placed within the valve annulus using spikes or barbs. These can be used in conjunction with or in place of one or more tethers. The spikes or barbs are positioned to provide attachment to adjacent tissue. The spikes are pressed into the annular tissue by mechanical means, such as using a balloon catheter. In a non-limiting embodiment, the spikes can optionally be semicircular hooks that pierce, rotate into, and securely hold the annular tissue when the wire frame body expands. The anchors are deployed by delivering one or more anchors through a delivery catheter over the wire. The catheter can have multiple axial lumens for delivering various anchoring tools, including anchor setting tools, force application tools, hooks, snare tools, cutting tools, radiofrequency and radioactive visualization tools and markers, and suture / thread manipulation tools. Once one or more anchors are attached to the adjustment band, a tensioning tool can be used to adjust the length of the tether connected to the implanted valve to adjust and secure the implant as needed for proper function. It is also envisioned that the anchors can be spring-loaded and can have a tether attachment mechanism or tether capture mechanism built into the tether surface of one or more anchors. The anchor may also have an ingrowth material, such as polyester fibers, to promote ingrowth of the anchor into the myocardium.

[0155] In one embodiment, where the prosthetic heart valve may or may not include a ventricular ring, the anchors or darts are not attached to the inferior ventricular ring, but are attached directly to the annular tissue or other tissue for anchoring.

[0156] Tube and / or covering material - biological tissue

[0157] The tissue used herein is a biological tissue that is a chemically stable pericardial tissue of an animal such as a cow (bovine pericardium) or a sheep (ovine pericardium) or a pig (porcine pericardium) or a horse (equine pericardium). Preferably, the tissue is bovine pericardial tissue. Examples of suitable tissues include those used in the product and Tissue, all products currently used in surgical procedures and marketed as harvested from livestock typically less than 30 months old. Other patents and publications disclose surgical uses of harvested biocompatible thin animal tissue suitable herein as a biocompatible "sheath" or sleeve for an implantable stent, including, for example, U.S. Patent 5,554,185 to Block; U.S. Patent 7,108,717 to Design & Performance-Cyprus Limited, which discloses a covered stent assembly; U.S. Patent 6,440,164 to ScimedLife Systems, Inc., which discloses a bioprosthetic heart valve for implantation; and U.S. Patent 5,336,616 to LifeCell Corporation, which discloses an acellular collagen-based tissue matrix for transplantation.

[0158] polymer

[0159] In a preferred embodiment, the catheter is optionally made of a synthetic material such as polyurethane or polytetrafluoroethylene.

[0160] Where a thin, durable synthetic material is envisaged, for example, for use in a covering, a synthetic polymer material such as expanded polytetrafluoroethylene or polyester may optionally be used. Other suitable materials may optionally include thermoplastic polycarbonate polyurethanes, polyether polyurethanes, segmented polyether polyurethanes, silicone polyether polyurethanes, silicone-polycarbonate polyurethanes, and ultra-high molecular weight polyethylene. Additional biocompatible polymers may optionally include polyolefins, elastomers, polyethylene glycols, polyethersulfones, polysulfones, polyvinyl pyrrolidone, polyvinyl chloride, other fluoropolymers, silicone polyesters, siloxane polymers and / or oligomers, and / or polylactones and block copolymers thereof.

[0161] Polyamide (PA)

[0162] PA is an early engineering thermoplastic consisting of "super polyester" fibers with a molecular weight greater than 10,000. It is commonly referred to as nylon. Applications for polyamide include transparent tubing for cardiovascular applications, hemodialysis membranes, and the production of percutaneous transluminal coronary angioplasty (PTCA) catheters.

[0163] polyolefins

[0164] Polyolefins include polyethylene and polypropylene, two important polymers of the polyolefin family and possess good biocompatibility and chemical resistance. In cardiovascular applications, both low-density polyethylene and high-density polyethylene are used to make tubing and casings. Polypropylene is used to make heart valve structures.

[0165] Polyester

[0166] Polyesters include polyethylene terephthalate (PET), which is used under the name Dacron. It is commonly used as a knitted or woven fabric for vascular grafts. Woven PET has smaller pores than knitted fabrics, which reduces blood leakage and has better efficiency as a vascular graft. PET grafts can also be used with protein coatings (collagen or albumin) to reduce blood loss and have better biocompatibility

[39] . PET vascular grafts with endothelial cells have been sought as a means to improve patency. In addition, polyester is a widely preferred material for making bioresorbable stents. Poly-L-lactic acid (PLLA), polyglycolic acid (PGA) and poly (D, L-lactide / glycolide) copolymer (PDLA) are some of the commonly used bioresorbable polymers.

[0167] polytetrafluoroethylene

[0168] Polytetrafluoroethylene (PTFE) is a synthetic fluorocarbon polymer from Dupont Co., with a common trade name of Teflon. Common applications of PTFE in cardiovascular engineering include vascular grafts and heart valves. PTFE sutures are used to repair the mitral valve in myxomatous disease and are also used in surgical procedures for prolapse of the anterior or posterior leaflet of the mitral valve. PTFE is particularly useful for implantable artificial heart valve rings. It 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 it is implanted below the aortic bifurcation, and another form of PTFE, called elongated PTFE (e-PTFE), has been explored. Expanded PTFE is formed by compressing PTFE in the presence of a specialized culture medium and ultimately extruding the mixture. The extrudate formed by this process is then heated to near its glass transition temperature and stretched to obtain microscopically porous PTFE, called e-PTFE. This form of PTFE is indicated for use in smaller arteries, where it has lower flow rates, promotes low thrombogenicity, lower rates of restenosis and hemostasis, less calcification, and is biochemically inert.

[0169] polyurethane

[0170] Polyurethane has good physicochemical and mechanical properties and is highly biocompatible, which allows it to be used unrestricted in blood-contacting devices. It has high shear strength, elasticity, and transparency. In addition, the surface of polyurethane has good resistance to microorganisms, and the thrombosis produced by PU is almost similar to that of multifunctional cardiovascular biomaterials (such as PTFE). Routinely, segmented polyurethane (SPU) has been used in various cardiovascular applications, such as valve structures, pacemaker leads, and ventricular assist devices.

[0171] Cover wire frame material

[0172] It is contemplated that a drug eluting wireframe is used herein. DES basically consists of three parts: a wireframe platform, a coating, and a drug. Some examples of polymer-free DES are Amazon Pax (MINVASYS), which uses AmazoniaCroCo (L605) cobalt chromium (Co-Cr) wireframe, and paclitaxel as an antiproliferative agent, and the luminal coating has been used as a carrier for the drug. BioFreedom (Biosensors Inc.), which uses stainless steel as a substrate, and a modified luminal coating as a carrier surface for the antiproliferative drug Biolimus A9. Optima (CID SrI), which uses a 316L stainless steel wireframe as a substrate for the drug tacrolimus, and utilizes an integrated turbolayer carbon membrane as a drug carrier. VESTA sync (MIV Therapeutics), which uses GenX stainless steel (316L) as a substrate, utilizes a microporous hydroxyapatite coating as a carrier for the drug sirolimus. YUKON choice (Translumina), which uses 316L stainless steel as a substrate for sirolimus and probucol combination drugs.

[0173] Bioresorbable polymers can also be used as carrier matrices for drugs in this article. Cypher, Taxus, and Endeavor are the three basic types of bioresorbable DES. Cypher (J&J, Cordis) uses 316L stainless steel coated with polyethylene vinyl acetate (PEVA) and polybutyl methacrylate (PBMA) to carry the drug sirolimus. Taxus (Boston Scientific) utilizes a 316L stainless steel wire frame coated with translute styrene isoprene butadiene (SIBS) copolymer to carry paclitaxel, which elutes over a period of approximately 90 days. Endeavor (Medtronic) uses a cobalt-chromium driven wire frame to carry zotarolimus, with phosphorylcholine as the drug carrier. BioMatrix uses an S-wire frame (316L) stainless steel with a polylactic acid surface as a substrate to carry the antiproliferative drug Biolimus. The ELIXIR-DES project (Elixir Medical Corp) includes a wire frame coated with both polyester and polylactide to carry the drug novolimus, with cobalt-chromium (Co-Cr) as the substrate. JACTAX (Boston Scientific Corp.) utilizes a D-lactic acid polylactic acid (DLPLA)-coated (316L) stainless steel wire frame to carry paclitaxel. NEVO (Cordis Corporation, Johnson & Johnson) uses a cobalt chromium (Co-Cr) wire frame coated with polylactic-co-glycolic acid (PLGA) to carry the drug sirolimus.

[0174] Examples of preferred embodiments include the following details and features.

[0175] Exemplary Delivery Methods

[0176] Transcatheter prosthetic heart valves can be delivered percutaneously using a transcatheter procedure via the femur through the IVC, carotid artery, subxiphoid, intercostal passage across the chest wall, and through the fossa ovalis transseptum to the mitral annulus.

[0177] The device is delivered to the right or left atrium via a catheter and expands 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's body and then pushed out of the catheter when the capsule reaches the atrium. Cardiac technicians use available imaging techniques (such as fluoroscopy or ultrasound) to visualize this delivery.

[0178] In a preferred embodiment, the valve self-expands when released from the catheter because it is constructed in part of a shape memory material such as Nitinol or cobalt-chromium alloys, alloys used in biomedical implants.

[0179] In another embodiment, the valve can be constructed of a material that requires balloon expansion after the capsule has been ejected from the catheter into the atrium.

[0180] The atrial collar / frame and flow control component expand to their functional diameters when they are deployed into the native annulus, providing radial tension so as to secure the valve. Once the frame is deployed around the tricuspid or mitral annulus, the fasteners secure the device around the native annulus. Additional fastening of the device to the native structure can be performed, and deployment is complete. Further adjustment using hemodynamic imaging techniques is contemplated to be within the scope of the present invention, so as to ensure that the device is safe, positioned and oriented as planned, and functions as a replacement or successor to the native tricuspid valve.

[0181] Exemplary - Delivery Method

[0182] In another preferred embodiment of the application, there is provided a method for orthogonally delivering an implantable prosthetic heart valve in vivo, the method comprising the steps of: (i) advancing a distal end of a guide wire to a distal location, wherein the distal location is the pulmonary artery or the left ventricle of the heart, wherein the guide wire starts outside the patient's body using a femoral vein access or a brachiocephalic vein access and extends through the inferior vena cava or the superior vena cava to the right atrium and from the right atrium through the tricuspid valve to the pulmonary artery, or from the right atrium extends through the mitral valve and into the left ventricle by traversing the atrial septum in a transseptal access; (ii) advancing a delivery catheter over the guide wire to a target location, wherein the target location is the right atrium of the tricuspid valve or the left atrium of the mitral valve; (iii) advancing an orthogonally compressed self-expanding prosthetic heart valve and delivering it to the target location in vivo, wherein the compressed configuration of the valve has a long x-axis substantially parallel to the longitudinal cylindrical axis of the delivery catheter, wherein the expanded configuration of the valve has a height of about 5-60 mm and a diameter of about 25-80 mm, wherein the valve comprises: an annular support frame having a collapsible flow control component mounted within the annular support frame and configured to allow blood flow through an inflow end of the valve in a first direction and to prevent blood flow through an outflow end of the valve in a second direction opposite to the first direction, the collapsible (inner) flow control component having a leaflet frame on which 2-4 flexible leaflets are mounted, the leaflet frame being foldable along a z-axis from a cylindrical configuration to a flat cylindrical body configuration and compressible along a vertical axis (y-axis) to a shortened configuration, a distal anchoring tab mounted on a distal side of the annular support frame, the distal anchoring tab having a length of 10-40 mm and a width of 2-10 mm, wherein the guide wire is threaded through a threaded orifice on or in the distal anchoring tab, at least one proximal anchoring tab mounted on a proximal side of the annular support frame, the proximal anchoring tab having a length of 2-25 mm and a width of 2-10 mm; and a valve advancing tool comprising an elongated sheath, wherein the guide wire is located within a lumen of the sheath, wherein an outer diameter of the sheath is larger than an inner diameter of the threaded orifice on the distal anchoring tab, wherein when the sheath is advanced over the guide wire in a distal direction and a distal end of the sheath contacts a proximal surface of the threaded orifice, a distally directed pulling force exerted by the sheath on the distal anchoring tab advances the valve distally through the delivery catheter; (iv) partially releasing the valve from the delivery catheter by advancing the sheath over the guide wire and positioning the distal anchoring tab at a desired anchoring region at the target location, wherein the desired anchoring region is selected from the right ventricular outflow tract (RVOT) of the right ventricle and the A l -P l(v) releasing the entire valve from the delivery catheter by advancing the sheath over the guidewire, thereby positioning the valve in the native annulus by applying a downward force in the ventricular direction; and (vi) positioning at least one proximal anchoring tab at a second desired anchoring area.

[0183] Exemplary Delivery Methods

[0184] In another preferred embodiment of the present invention, a method for orthogonally delivering an implantable artificial heart valve to a desired location in the body (including a tricuspid valve location) is provided, the method comprising the following steps: advancing a delivery catheter to the desired location in the body and delivering the expandable artificial heart valve to the desired location in the body by releasing the valve from the delivery catheter, wherein the valve includes an annular support frame having: a collapsible flow control component mounted within the annular support frame and constructed to allow blood flow through the inflow end of the valve in a first direction and to prevent blood flow through the outflow end of the valve in a second direction opposite to the first direction, the collapsible (inner) flow control component having a leaflet frame having 2-4 flexible leaflets mounted thereon, the leaflet frame being foldable from a cylindrical configuration along the z-axis It has a flat cylindrical configuration and can be compressed into a shortened configuration along a vertical axis (y-axis); a distal anchoring tab, which is mounted on the distal side of the annular support frame; and a proximal anchoring tab, which is mounted on the proximal side of the annular support frame, wherein the valve can be compressed into a compressed configuration for introduction into the body using a delivery catheter for implantation at a desired position in the body, the compressed configuration has a long axis oriented at an intersection angle of between 45-135 degrees with the first direction, and the compressed configuration can be expanded into an expanded configuration with a long axis oriented at an intersection angle of between 45-135 degrees with the first direction, wherein the long axis of the compressed configuration of the valve is substantially parallel to the longitudinal cylindrical axis of the delivery catheter, wherein the compressed configuration, wherein the valve has a height of approximately 5-60 mm and a diameter of approximately 25-80 mm.

[0185] Releasing the valve from the delivery catheter is selected from the steps consisting of: (i) pulling the valve out of the delivery catheter using a rigid, slender push rod / pull wire releasably connected to the distal side of the valve, wherein advancing the push rod away from the delivery catheter pulls the compressed valve out of the delivery catheter, or (ii) pushing the valve out of the delivery catheter using a rigid, slender push rod releasably connected to the proximal side of the valve, wherein pushing the push rod out of the delivery catheter pushes the compressed valve out of the delivery catheter.

[0186] The delivery method may further comprise the additional step of anchoring one or more tissue anchors attached to the valve into native tissue.

[0187] The delivery method may further comprise the additional step of positioning a distal anchoring tab of the heart valve prosthesis into the right ventricular outflow tract of the right ventricle.

[0188] The delivery method may also include the following additional steps: positioning the distal anchoring tab of the heart valve prosthesis in the right ventricular outflow tract of the right ventricle, and positioning the upper distal anchoring tab in a superannular position, and the upper distal anchoring tab provides a superannular downward force in the ventricular direction and the distal anchoring tab provides a subannular upward force in the atrial direction.

[0189] The delivery method may further comprise the additional step of rotating the heart valve prosthesis along an axis parallel to the plane of the valve annulus using the steerable catheter.

[0190] Example - Loading Method

[0191] In another preferred embodiment of the 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 an implantable prosthetic heart valve into a conical clamp or funnel attached to a delivery catheter, wherein the valve comprises an annular support frame having: a flow control component mounted within the annular support frame and configured to allow blood flow in a first direction through an inflow end of the valve and to prevent blood flow in a second direction opposite the first direction through an outflow end of the valve; a distal anchoring tab mounted on a distal side of the annular support frame; and a proximal anchoring tab mounted on a proximal side of the annular support frame, wherein the loading is perpendicular or substantially orthogonal to the first direction, wherein the valve is compressible into a compressed configuration for introduction into a body using the delivery catheter for implantation at a desired location within the body, the compressed configuration having a long x-axis oriented at an intersection angle of between 45-135 degrees to the first direction, and the compressed configuration is expandable into an expanded configuration having a long x-axis oriented at an intersection angle of between 45-135 degrees to the first direction, wherein the long x-axis of the compressed configuration of the valve is substantially parallel to a longitudinal cylindrical axis of the delivery catheter, wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.

[0192] Exemplary - loading method

[0193] In another preferred embodiment of the invention, there is provided a loading method, wherein the loading step comprises attaching a loading accessory to the valve side wall, valve cuff, distal anchoring tab, proximal anchoring tab, or a combination thereof, wherein the loading accessory is a push rod or pull wire, and wherein the conical clamp or funnel has compression elements on an inner surface of the conical clamp or funnel to facilitate compression, iris-ing, or screwing movement of the uncompressed valve.

[0194] Exemplary - method for improved flow

[0195] In another preferred embodiment of the invention, there is provided a method for improved hemodynamic flow during implantation of a transcatheter prosthetic heart valve, comprising: advancing a delivery catheter to a desired location within a body and delivering the valve of claim 1 to the desired location within the body; partially releasing the valve from the delivery catheter to establish blood flow around the partially released valve and to establish blood flow through the flow control component; completely releasing the valve from the delivery catheter while holding attached to the valve with a positioning catheter or wire to transition to having increased blood flow through the flow control component and reduced blood flow around the valve; and deploying the valve into a final mounted position to transition to having 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.

[0196] In another preferred embodiment of the present invention, a method for improving flow is provided wherein the distal anchoring tab is an RVOT tab positioned in the RVOT during transition from a partially deployed valve to a fully deployed valve.

[0197] Example - Manufacturing Process

[0198] In a preferred embodiment, the present invention comprises a method for manufacturing an orthogonally delivered transcatheter prosthetic heart valve frame comprising:

[0199] (i) produced using additive or subtractive metal or metal alloy manufacturing

[0200] Self-expanding annular support frame,

[0201] Among them additive metal or metal alloy manufacturing is 3D printing or direct metal laser sintering (powder melting), and among them subtractive metal or metal alloy manufacturing is photolithography, laser sintering / cutting, CNC machining, electrical discharge machining.

[0202] In another preferred embodiment, a method for manufacturing an orthogonally delivered transcatheter artificial heart valve frame is provided, which further includes the following steps: (ii) installing a flow control component within the valve frame, wherein the flow control component is constructed to allow blood flow through the inflow end of the flow control component along the central vertical axis and prevent blood flow through the outflow end of the valve; and (iii) covering the outer surface of the valve frame with pericardial material or a similar biocompatible material.

[0203] Example - Compression Method

[0204] In another preferred embodiment, a method of compression is provided wherein an implantable prosthetic heart valve is rolled or folded into a compressed configuration using a step selected from the group consisting of:

[0205] (i) rolling unilaterally from one side of the annular support frame into a compressed configuration;

[0206] (ii) rolling bilaterally from two opposite sides of the annular support frame into a compressed configuration;

[0207] (iii) flattening the annular support frame into two parallel panels substantially parallel to the long axis, and then rolling the flattened annular support frame into a compressed configuration; and

[0208] (iv) Flattening the annular support frame along the vertical axis to reduce the vertical dimension of the valve from top to bottom.

[0209] Instance-Delivery

[0210] Attached photos

[0211] Referring now to the accompanying drawings, Figure 1 is an illustration of a side perspective view of an orthogonal deliverable transcatheter heart valve 100 according to the present invention, wherein the valve 100 has an inner regurgitation 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.

[0212] The inner reflux control component 135 is composed of a tissue cover 141 , a reinforcement ring 143 , radiopaque markers 144 and a drum / reflux channel 135 .

[0213] The collapsible (inner) flow control component 130 has a leaflet frame 231 on which 2-4 flexible leaflets 258 are mounted, and the leaflet frame 231 can be folded from a cylindrical configuration to a flat cylindrical configuration along the z-axis 109 and can be compressed to a shortened configuration along the vertical axis 108 (y-axis).

[0214] The annular outer support frame 104 is made of a shape memory material such as nickel titanium alloy (e.g., NiTiNOL) and is therefore a self-expanding structure starting from a compressed configuration. The annular (outer) support frame 104 has a central (inner) channel 104 and an outer peripheral wall 106 that circumscribes a central vertical axis 108 when in the expanded configuration, and the annular outer support frame 104 has a distal side 118 and a proximal side 114.

[0215] The flow control component 130 is mounted within the annular outer support frame 104 and is constructed to allow blood flow through the inflow end 132 of the valve 100 in a first direction (e.g., atrium to ventricle) and to prevent blood flow through the outflow end 134 of the valve 100 in a second direction opposite to the first direction.

[0216] The inner regurgitant flow control member 135 is foldable and compressible like the inner flow control member 130 and the outer annular frame 104. The inner flow control member 130 includes a leaflet frame 231 on which 2-4 flexible leaflets 258 are mounted.

[0217] Like the outer frame 104, the flow control component 130 and therefore the leaflet frame 231 can be folded along the z-axis (from front to back) from a cylindrical configuration to a flat cylindrical configuration, wherein the fold lines are located on the distal side and on the proximal side, taking the leaflet frame 231 out of the ring or cylindrical shape and flattening it from the ring into a double layer band, i.e., folded on itself, or flattened like a cylinder into a rectangle or square connected together along two opposite sides. This allows the outer frame 104 and the flow control component 130 to reduce the radius along the z-axis until the side walls are in contact or close to contact. This also allows the outer frame 104 and the flow control component 130 to maintain a radius along the horizontal axis, the y-axis, to minimize the number of wire units that make up the outer frame and the inner frame that are damaged by the forces applied during the folding and / or compression required for loading into the delivery catheter.

[0218] The internal regurgitation control component 135, flow control component 130, leaflet frame 231 and outer frame 104 are also vertically (y-axis) compressible, thereby reducing the height of the entire valve structure to fit within the inner diameter of the delivery catheter 138 (not shown in this figure). By folding along the z-axis and compressing vertically along the y-axis, the valve structure is allowed to maintain a very large size along the horizontal axis or x-axis. For example, valves of 60 mm or larger diameter can be delivered via transcatheter technology. The length of the long axis of the valve (e.g., 60 mm) is not limited by the large amount of wire frame and covering material required for such a large valve because the long axis continues parallel to the central axis of the delivery catheter. This is not possible with existing central axis delivery (axial) transcatheter valves. The use of a folded, compressed valve that is orthogonal to traditional axial delivery valves allows for treatment options that were previously unavailable.

[0219] Figure 1 Also shown are distal anchor tabs 268 mounted on the distal side 118 of the annular outer support frame 102 and proximal anchor tabs 270 mounted on the proximal side 114 of the annular outer support frame 102 .

[0220] In a preferred embodiment, when in the expanded configuration, the horizontal x-axis of the valve intersects the central vertical y-axis at an angle of between 45-135 degrees.

[0221] 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.

[0222] In another preferred embodiment, the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.

[0223] Figure 1Also shown are a guidewire sheath 310 and a guidewire 311. A lumen or guide ball 266 is shown mounted on the distal end of the distal tab 268, with a guidewire 311 threaded through the lumen 266. While the inner diameter of the lumen 266 is large enough to allow the guidewire 311 to extend therethrough, the inner diameter of the lumen 266 is not large enough to allow the sheath 310 to extend therethrough. This allows the sheath 310 to be advanced along the guidewire 311 until it rests against the proximal side of the lumen 266, where continued thrust is exerted on the sheath 310 against the lumen and allows the valve to be pulled out of the delivery catheter by the distal tab and to the target location for valve deployment.

[0224] Figure 2 is an illustration of a side perspective view of an exploded view of an embodiment having an inner reverse flow drum 137 with markers 144 , channels 135 , and rings 143 . Figure 2 Also shown are three leaflet 258 cusps or pouches according to the present invention, which are mounted within a foldable and compressible inner wire frame 231 having a distal folding region 120 and a proximal folding region 116, the inner wire frame 231 being mounted within an outer wire frame 102, the outer wire frame 102 having a loop component 103 circumferentially attached to the top edge 107 of the outer wire frame 104, a double tab component having a distal (rvot) tab 268 and a proximal tab 270, and an optional mesh component having a biocompatible material, which optional mesh component can be used to cover the inner reflux drum 137, cover the loop 103, cover the inner and outer surfaces of the outer frame 102 and / or cover the anchoring tabs 268 and 270.

[0225] The atrial ring 103 is shaped to conform to the native deployment position. In tricuspid valve replacement, the atrial ring will have a high posterior wall portion to conform to the septal region of the native valve and will have a distal ring portion and a proximal upper ring portion. The distal ring portion may be larger than the proximal upper ring portion to account for the larger flat space above the (atrial) right ventricular outflow tract (RVOT) subannular region.

[0226] Figure 3 is an illustration of a side perspective view of an orthogonal deliverable transcatheter heart valve 100 having an open regurgitant frame 139 with radiopaque markers 144. In this embodiment, the passageway can have a predetermined inner diameter, depending on the physician's desired grade of regurgitation.

[0227] Figure 3Also shown is a collapsible flow control component 130 mounted within the annular outer support frame 102. The collapsible (inner) flow control component 130 has a leaflet frame 231 on which are mounted two to four flexible leaflets 258. The leaflet frame 231 is foldable from a cylindrical configuration to a flattened cylindrical configuration along the z-axis and compressible to a shortened configuration along the vertical axis (y-axis). According to the present invention, the valve 100 also has superelastic coil distal tabs 268 / 269 and superelastic coil proximal tabs 270 / 271.

[0228] Figure 4 is an illustration of a side perspective view of an exploded view of an embodiment having an open regurgitant frame 139 with radiopaque markers 144 . Figure 4 Also shown are three leaflet cusps or pouches 258 mounted within a foldable and compressible inner wire frame 231 according to the present invention, the inner wire frame 231 being mounted within an outer wire frame 102 having a loop member 103 circumferentially attached at a top edge 107 of the outer wire frame 102, a pair of integrated independent tab members 269, 270, and a mesh member 226.

[0229] The uncovered regurgitant frame 139 provides controlled regurgitation of the valve. Once the patient no longer needs regurgitation, the uncovered regurgitant frame 139 can later be plugged with a stent or cover or plug that is later inserted.

[0230] The atrial ring 103 is shaped to conform to the native deployment position. In tricuspid valve replacement, the atrial ring will have a high posterior wall portion to conform to the septal region of the native valve and will have a distal ring portion and a proximal upper ring portion. The distal ring portion may be larger than the proximal upper ring portion to account for the larger flat space above the (atrial) right ventricular outflow tract (RVOT) subannular region.

[0231] The integral tabs 269 and 271 are of one-piece construction with the body of the outer frame. The size and shape of the tabs may vary. In a preferred embodiment, the RVOT tabs (e.g., 269) may be longer to reach the entrance of the pulmonary artery (in the case of tricuspid valve replacement).

[0232] Figure 5 is an illustration of a side perspective view of an orthogonal deliverable transcatheter heart valve 100 in accordance with the present invention in a collapsed configuration along the z-axis (from front to back when viewed from the wider side). Figure 5 A folded (flat) outer frame 102 is shown with a folded / flat collar 103 , hinge points 116 , 120 . Figure 5 Also shown are the folded / flattened inner regurgitation control member 137 with markers 144 and the leaflets 258 mounted within the folded / flattened inner frame 231 .

[0233] Figure 6 is an illustration of a side perspective view of an ortho-deliverable transcatheter heart valve 100 in a vertically compressed configuration according to the present invention. Figure 6 shows outer frame 102 with folding (z-axis) and vertically compressing (y-axis) of collar 103 along a fold line between articulation points 116, 120. Figure 6 also shows inner regurgitation control member 137 and leaflets 258 mounted within inner frame 231.

[0234] Figure 7 is an illustration of a side perspective view of an ortho-deliverable transcatheter heart valve 100 partially loaded into delivery catheter 138 according to the present invention. Figure 7 shows outer frame 102, folding collar 103, inner regurgitation control member 137 and flow control member 130 with leaflets 258 and inner frame 231.

[0235] Figure 8 is an illustration of an end view of delivery catheter 138 showing loaded valve 100 according to the present invention, with outer frame 102 and collar 103 visible.

[0236] Figure 9 is an illustration of a top view of a folded, compressed valve ejected from delivery catheter 138 prior to being seated in a native annulus, in a partial position allowing leaflets 258, collar 103 and inner frame 231 to expand.

[0237] Figure 10 is an illustration of a top perspective view of a valve without a collar, with inner regurgitation control member 137 removed for viewing, and showing tissue 141, reinforcing ring 143 and passageway 135. Figure 10 also shows outer cylindrical frame 102 with mesh sidewall covering 226, inner frame 231 and leaflets 258 stitched into inner frame 231 according to the present invention.

[0238] Figure 11 is an illustration of a top perspective view of a valve without a collar according to the present invention, with marker 144 and inner regurgitation control member 137 mounted on top edge 107 of outer cylindrical frame 102, outer frame 102 also having mesh sidewall covering 226, inner frame 231 and leaflets 258 stitched into inner frame 231.

[0239] Figure 12is an illustration of a bottom perspective view of a valve without a ring according to the present invention, the valve having an inner regurgitation control component 137 mounted on the top edge 107 of an outer cylindrical frame 102, the outer frame 102 also having a mesh sidewall cover 226, an inner frame 231 and leaflets 258 sewn into the inner frame 231.

[0240] Figure 13 is an illustration of an exploded view of a valve without a ring having an internal regurgitation control component 137 including a tissue cover 141 and a regurgitation frame 139 . Figure 13 Also shown is an outer cylindrical frame 102 having a mesh sidewall covering 226, an inner frame 231 and leaflets 258 mounted on straps 257 and sewn into the inner frame 231 in accordance with the present invention.

[0241] Figure 14 is an illustration of a top perspective view of the inner leaflet frame 231 (or regurgitant frame 139) in a cylindrical configuration, shown as the beginning of the process allowing the inner frame to be folded and compressed, in accordance with the present invention.

[0242] Figure 15 is an illustration of a top perspective view of an inner leaflet frame 231 (or regurgitant frame 139) in accordance with the present invention in a partially folded configuration with the wire frame side walls rotated or hinged at their lateral connection points 116, 120, shown as part of a first step in the process of allowing the inner frame to be folded and compressed.

[0243] Figure 16 is an illustration of a side view of an inner leaflet frame 231 (or regurgitant frame 139) in accordance with the present invention in a fully folded configuration 208, wherein the wire frame side walls are rotated or hinged at their lateral connection points, shown as a completed first step in the process of allowing folding and compression of the inner frame 231.

[0244] Figure 17 is an illustration of a side view of an inner leaflet frame 231 (or regurgitant frame 139) in a folded and vertically compressed configuration 210 according to the present invention, wherein the wire frame side walls are vertically compressed in a pleated or accordion-like folded configuration, which is shown as a second step in the process of allowing the inner frame to be folded and compressed.

[0245] Figure 18 is an illustration of a side view of an inner leaflet frame 231 (or reverse flow frame 139) as a linear wire frame sheet 202 prior to further assembly into a cylindrical structure in accordance with the present invention.

[0246] Figure 19 is an illustration of a side perspective view of an inner leaflet frame 231 in a cylindrical or cylindrical (tapered, etc.) configuration in accordance with the present invention.

[0247] Figure 20 is an illustration of a side perspective view of a pericardial tissue band 257 configured in a cylindrical shape with leaflet pouches 258 sutured into the structural band 257 in accordance with the present invention.

[0248] Figure 21 is an illustration of a side view of a pericardial tissue band 257 having leaflet pockets sutured into the structural band 257 prior to assembly into a cylindrical leaflet component and mounting on an endoframe to form a collapsible (foldable, compressible) flow control component in accordance with the present invention.

[0249] Figure 22 is an illustration of a bottom view of a pericardial tissue strip 257 having leaflet pockets 258 sutured into the structural strip 257 prior to assembly into a cylindrical leaflet component and mounting on an inner frame to form a collapsible (foldable, compressible) flow control component in accordance with the present invention.

[0250] Figure 23 is an illustration of a side perspective view of a portion of a pericardial tissue band having a single leaflet pouch sutured into the structural band according to the present invention showing the leaflet pouch 258 partially engaged with an extended open edge 261 and a sutured edge 259 as a closed top parabolic edge providing attachment.

[0251] Figure 24 is an illustration of a bottom view of a cylindrical leaflet component 258 showing fully engaged to form a closed fluid seal in accordance with the present invention.

[0252] Figures 25(a) to 25(e) are illustrations of a process in which an orthogonal valve having a pre-perforated drum is delivered within a catheter, expelled from the catheter, and deployed into the natural annulus. Figure 25(a) shows a compressed and folded orthogonal valve positioned within a delivery catheter and moved along a guidewire through the natural annulus. Figure 25(b) shows the orthogonal valve partially expelled into the natural annulus, wherein the delivery catheter is able to twist or position the valve as needed. Figure 25(c) shows the fully expelled valve, wherein the valve tabs extend in a sub-annular manner to help anchor the valve, and the valve is held upward at an angle to allow for implementation / initiation of washing and engagement. Figure 25(d) is a top view showing the pre-perforated drum and regurgitant channel positioned within the periphery of a radiopaque marker. Figure 25(e) is a side perspective view and shows the pre-perforated drum and regurgitant channel positioned within the periphery of a radiopaque marker, with the inner regurgitant control component mounted adjacent to the inner flow control component (leaflets and frame) within the outer support frame.

[0253] Figure 26 is a diagram of the outer wire frame 102 .

[0254] Figure 27is an illustration of a top perspective view of an outer wire frame 102 in a partially folded configuration with the side walls rotated or hinged at their lateral connection points 116 , 120 , shown as part of a first step in a process that allows the outer frame 102 to be folded and compressed, in accordance with the present invention.

[0255] Figure 28 is an illustration of a side view of the outer frame 102 in a fully flat-folded configuration 208 with the wire frame side walls rotated or hinged at their lateral connection points 116 , 120 , shown as a completed first step in the process of allowing the outer frame 102 to be folded and compressed, in accordance with the present invention.

[0256] Figure 29 is an illustration of a side view of the outer frame 102 in a folded and vertically compressed configuration 210 according to the present invention, wherein the wire frame sidewalls are vertically compressed in a pleated or accordion-type folded configuration, shown as a second step in the process of allowing the outer frame 102 to be folded and compressed.

[0257] Figure 30 is an illustration of a top perspective view of an assembled valve according to the present invention, wherein the assembled valve has an inner regurgitation control component 137 with markers and reinforcement rings, an outer frame 102, a flow control component 130 with an inner leaflet frame 231 and three sutured leaflet pockets / cusps 258, an inner spacer frame 137, and a mesh cover 141 located above the spacer frame, with the fold line 109 shown as a dotted line.

[0258] Figure 31 is an illustration of a top perspective view of an assembled valve according to the present invention, wherein the assembled valve has an inner regurgitation control component 137 with a marker, an outer frame 102, a first sub-annular anchoring / positioning tab 268 mounted on the outer frame 102 adjacent to the flow control component 130, a second sub-annular anchoring / positioning tab 270 mounted at a different position on the outer frame, a flow control component 130 having an inner leaflet frame 231 and three sutured leaflet pockets / cusps 258, an inner spacer frame 137, and a mesh cover 141 located above the spacer frame, with the fold line 109 shown as a dotted line and crossing the mesh cover.

[0259] Figure 32is an illustration of a bottom perspective view of an assembled valve according to the present invention, wherein the assembled valve has an outer frame 102, a first sub-annular anchoring / positioning tab 268 mounted on the outer frame 102 adjacent to the flow control component 130, a second sub-annular anchoring / positioning tab 270 mounted at a different position on the outer frame 102, a flow control component 130 having an inner leaflet frame 231 and three sutured leaflet pockets / cusps 258, an inner spacer frame 137, and a mesh cover 141 located above the spacer frame, the fold line 109 is shown as a dotted line, and the hemodynamic wash chamber is shown as being below the covered inner spacer frame.

[0260] Figure 33 is an illustration of a top view of an assembled valve according to the present invention, wherein the assembled valve has an inner regurgitation control component 137, an outer frame 102, a flow control component 130 having an inner leaflet frame 231 and three sutured leaflet pockets / cusps 258, an inner spacer frame 137, and a mesh cover 141 located above the spacer frame.

[0261] Figure 34 is an illustration of a top perspective view of an assembled valve according to the present invention, wherein the assembled valve has an inner regurgitation control component 137 with a reinforcement ring, an outer frame 102, a first sub-annular anchoring / positioning tab 268 mounted on the outer frame 102 adjacent to the flow control component 130, a second sub-annular anchoring / positioning tab 270 mounted at a different position on the outer frame 102, a flow control component 130 having an inner leaflet frame 231 and three sutured leaflet pockets / cusps 258, an inner spacer frame 137, and a mesh cover 141 located above the spacer frame.

[0262] Figure 35 (a) to Figure 35 (e) is an illustration of a step-by-step process in which the tissue drum is perforated prior to orthogonally loading the valve into a delivery catheter. Step (a) illustrates the step of providing an orthogonal prosthetic valve as described herein (foldable, compressible for lateral delivery, having a rvot tab, a guidewire lumen, an atrial collar, and a proximal tab). Step (b) illustrates the step of creating an opening by cutting or using a balloon device. Step (c) illustrates the step of folding the valve flat in preparation for loading into the delivery catheter. Step (d) illustrates the step of vertically compressing the valve in preparation for loading the valve into the delivery catheter. Step (e) illustrates the step of loading the orthogonal valve laterally into the delivery catheter.

[0263] Figure 36 (a) to Figure 36(c) is an illustration of a step-by-step process in which the tissue drum is perforated after the valve is orthogonally ejected from the delivery catheter and deployed into the native annulus. Step (a) illustrates the step of ejecting the valve into the native annulus, approaching horizontally at a slightly elevated angle to position the rvot tab into the subannular space leading to the right (pulmonary) valve outflow tract. Step (b) illustrates the step of positioning the radiopaque marker using fluoroscopy. Step (c) illustrates the step of creating an opening by cutting or using a balloon device.

[0264] Figure 37 is a graphical representation of how the user can match the size of the orifice to the desired amount of reflux (eg, a reflux grade in the range of 0.5-2.0). Radiopaque markers may be used to assist in measuring the size of the perforation to be made.

[0265] Figure 38 is an illustration of how a user can match the size of the lumen of a tubular stent that can be deployed into an orifice to match the desired amount of reflux (eg, a reflux grade in the range of 0.5-2.0).

[0266] Figure 39 is an illustration of a lateral septal plan view of a tagged valve 100 according to the present invention, wherein the tagged valve has a sub-annular anchoring and / or positioning tab 268 extending toward the distal side and a second sub-annular tab 270 extending toward the proximal side and has a visible foldable and compressible wire frame structure, including an inner frame 231, leaflets 258 and an inner regurgitation control component 137.

[0267] Figure 40 (a) to Figure 40 (f) is an illustration of a closure device for closing a perforation in an internal regurgitation control component. Step (a) illustrates the steps of providing an orthogonal prosthetic valve as described herein (foldable, compressible for lateral delivery, having rvot tabs, a guidewire lumen, an atrial collar, and a proximal tab), the orthogonal prosthetic valve having an internal regurgitation control component 137 that requires sealing. Step (b) illustrates the steps of accessing the perforation using a catheter tool. Step (c) illustrates the steps of expanding a first disc or button on the distal underside of the perforation. Step (d) illustrates the steps of expanding a second disc or button on the proximal top side of the perforation. Step (e) illustrates the steps of tightening the two discs / buttons together to create a seal to block regurgitation engineered in, for example, a 1-2 mm perforation. Step (f) illustrates the steps of withdrawing the catheter tool.

[0268] Figure 41is an illustration of a top view of the valve partially expelled from the delivery catheter 138, with the distal tab 268 guiding the valve (along a guide wire not shown) to the deployment position, the distal flow control component 130 beginning to open, and showing two of the three leaflets 258 opening from a folded flat configuration and the third leaflet opening from a folded configuration, in which the third leaflet is folded back on itself while in the delivery catheter 138.

[0269] Figure 42 is an illustration of a top view of a valve compressed 136 (orthogonally loaded) within a delivery catheter 138 having an outer frame 102 with a first tab 268 extending forwardly along the x-axis and a second trailing edge tab 270 extending rearwardly along the x-axis.

[0270] Figure 43 is an illustration of a top view of a valve according to the present invention having an outer frame 102 , an eccentric inner flow control member 130 (leaflets in the frame), and an irregularly shaped spacing / support frame 137 .

[0271] Figure 44 is an illustration of a top view of a valve according to the present invention having an outer frame 102, a centrally positioned inner flow control component 130 (leaflets in the frame), and a pair of irregularly shaped spacer / support frames 135, 137 located on opposite sides of the inner flow control component 130.

[0272] Figure 45 is an illustration of a top view of a valve according to the present invention having an outer frame 102 and an inner flow control component 130 (leaflets in the frame) and a plurality of suture attachment points 129 where the inner flow control component 130 is sutured to the outer frame 102 .

[0273] Figure 46 is a top view of the valve with the internal regurgitation control component 137, with the pacemaker and lead set 145 extending through the perforation. Figure 46 Also shown are outer frame 102 , eccentric inner flow control member 130 with frame 231 and leaflets 258 , and inner spacer frame 137 , all three structures being collapsible along the same x-axis 109 , in accordance with the present invention.

[0274] Figure 47is an illustration of a top view of a valve according to the present invention having an inner regurgitation control member 137, an outer frame 102, a centrally located inner flow control member 130 having a frame 231 and leaflets 258, and a pair of smaller cylindrical inner regurgitation control members 137, 147 mounted on opposite sides of the inner flow control member 231 to provide support within the interior dimensions of the outer frame 102, with all four structures being foldable along the same x-axis 109. Here, the inner regurgitation control member 137 has a tri-leaflet microvalve mounted adjacent to the primary flow control member, and the secondary inner regurgitation control member / drum 147 has a non-perforated tissue cover that may later provide the physician with the opportunity to add additional regurgitation if desired.

[0275] Figure 48 is an illustration of a top view of a valve according to the present invention having a distal inner regurgitation control member 137, an outer frame 102, a proximally positioned eccentric inner flow control member 130 having a frame 231 and leaflets 258, all three structures being foldable along the same x-axis 109.

[0276] Figure 49 is an illustration of a side view of a human heart with a transfemoral / IVC or SVC delivery catheter 138 traversing from the right atrium to the left atrium to access the mitral valve in accordance with the present invention. Figure 49 The orthogonal delivery steps are shown:

[0277] 1. Provide a foldable and compressible artificial tricuspid valve;

[0278] 2. Load the valve laterally into the delivery catheter;

[0279] 3. Advance the valve into the heart via the IVC or SVC over a pre-placed guidewire threaded onto the distal tab of the subannular valve;

[0280] 4. Partially expel the valve to position the distal subannular tabs and allow the valve leaflets to begin functioning;

[0281] 5. Complete deployment of the valve into the native annulus.

[0282] 6. Optional: If the reflux drum is not open prior to loading into the delivery catheter, a cutting tool or balloon tool may be advanced and a 1-2 mm opening created in the tissue covering of the drum frame.

[0283] 7. Optionally: A pacemaker lead set may be advanced through the opening in the regurgitant drum and one or more pacemaker wires attached at or near the target node.

[0284] Additional definitions and parts lists

[0285] A parts list relating to claimed elements is provided below. Part numbers can refer to functional components and can be reused in different preferred embodiments to aid in uniform understanding of structure-function relationships. To avoid cluttering the figures, not every number can be added to the figures.

[0286] 100 transcatheter prosthetic heart valve of double-tab orthogonal delivery.

[0287] 102 self-expanding annular (outer) support frame.

[0288] 103 collar structure.

[0289] 104 central passage.

[0290] 106 outer peripheral wall.

[0291] 107 top edge of outer support frame.

[0292] 108 central vertical axis.

[0293] 109 Z-axis, front-to-back, fold line axis.

[0294] 110 front wall portion of peripheral wall.

[0295] 112 back wall portion of peripheral wall.

[0296] 114 proximal side.

[0297] 116 proximal fold region.

[0298] 117 auxiliary proximal fold region.

[0299] 118 distal side.

[0300] 120 distal fold region.

[0301] 121 auxiliary distal fold region.

[0302] 122 front upper collar portion.

[0303] 124 front lower body portion of outer frame.

[0304] 126 back upper collar portion.

[0305] 128 back lower body portion.

[0306] 129 attachment point for inside-out suturing.

[0307] 130 A flow control component made of an inner frame having tissue leaflets mounted therein, collapsible (foldable and compressible), the inner frame mounted within an annular outer support frame and configured to allow blood flow in a first direction through the inflow end and to prevent blood flow in an opposite, second direction through the outflow end.

[0308] 132 Inflow end.

[0309] 134 outflow end.

[0310] 135 drum ch.

[0311] 136 compressed configuration

[0312] 137 Internal reflux control components.

[0313] 138 Delivery catheter.

[0314] 139 Uncovered Reflux Frame, Engineering (Treatment) of Partial Reflux

[0315] 140 X-axis, horizontal axis, parallel to the central axis of the delivery catheter

[0316] 141 Tissue Covering (Plastic Deformation).

[0317] 142 Intersection angle 45-135 degrees, X-axis and Y-axis.

[0318] 143 Reinforcement ring.

[0319] 144 Radiopaque markers.

[0320] 146Longitudinal cylindrical axis of the delivery catheter.

[0321] 148 Approximately 5-60mm in height.

[0322] 150 Approximately 25-80mm in diameter.

[0323] 202 Multiple compressible wire units - outer frame.

[0324] 204 orientation and cell geometry, substantially orthogonal to the central vertical axis to minimize line element strains when the annular support frame is compressed.

[0325] 206 Vertical compression configuration.

[0326] 208 Folded configuration.

[0327] 210 Folded and compressed configuration.

[0328] 212 The inner frame shape or the outer frame shape is selected from a funnel, a cylinder, a flat cone or a circular hyperboloid.

[0329] 220 Braided Matrix.

[0330] 222Wireframe matrix.

[0331] 224 Laser cut wire frame.

[0332] 226 Biocompatible materials.

[0333] 227 Trumpet-shaped cuff on inner frame.

[0334] 228 The side profile of the inner frame is a flat cone shape.

[0335] 229 Non-cylindrical inner frame, e.g., elliptical cross-section.

[0336] 230 40-80mm diameter R.

[0337] 231Inner frame for mounting leaflets.

[0338] 232 20-60mm diameter r.

[0339] 233Uniform wire frame unit group within the frame.

[0340] 234 5-60mm height.

[0341] 235Non-uniform variable height units within the inner frame.

[0342] 236Inner surface of the annular outer support frame.

[0343] 237 Non-uniform cell geometry, wireframe size.

[0344] 238 The outer surface of the annular outer support frame.

[0345] 239 Compressed inner frame.

[0346] 240 Pericardial tissue, used to cover the valve surface.

[0347] 241 Diamond or eye-shaped line units.

[0348] 242 woven synthetic polyester material.

[0349] 243Eyelets on inner wire frame, consistent commissural attachment.

[0350] 244 External support frame having an hourglass shape.

[0351] 245 Laser cut attachment features on inner frame.

[0352] 246 40-80mm top diameter R1.

[0353] 248 50-70mm bottom diameter R2.

[0354] 250 20-60mm inner diameter.

[0355] 252 5-60mm height.

[0356] 254 20-60mm inner diameter.

[0357] 256 10-40mm height.

[0358] 257 Leaflet strap, a mounting strap for the leaflet sac.

[0359] 258 Lobules, multiple lobules, pericardial material.

[0360] 259Sutured margins of leaflets.

[0361] 260 Flow into a round cylinder at the end.

[0362] 261 Open edge of leaflet

[0363] 262Flat closable orifice at outflow end.

[0364] 264 Longitudinal supports in / on the flow control component are selected from the group consisting of rigid or semi-rigid columns, rigid or semi-rigid ribs, rigid or semi-rigid rods, rigid or semi-rigid panels, and combinations thereof.

[0365] 266(Any) lumen(bulb) on distal tab.

[0366] 268 Distal tab / sub-annular anchoring tab, which can be rvot or other, made of a coil or wire frame, integrated frame segment or stent, extending about 10-40 mm away from the annular support frame.

[0367] 269 ​​Independent RVOT tab.

[0368] 270 Proximal tab / sub-annular anchoring tab.

[0369] 271Independent proximal tab.

[0370] 272The distal upper edge of the annular support frame.

[0371] 273 The upper atrial tension arm, composed of a coil or wire frame, extends approximately 2-20 mm away from the annular support frame.

[0372] 274 The lower tension arm, formed from a coil or wire frame, an integrated frame section or bracket, extends approximately 10-40 mm away from the annular support frame.

[0373] 276 distal side of the annular support frame.

[0374] 278 tissue anchors connected to the annular support frame for engaging native tissue.

[0375] 280 the anterior wall portion of the frame is a first flat panel.

[0376] 282 the posterior wall portion of the frame is a second flat panel.

[0377] 284 sutured seam.

[0378] 285 hinge.

[0379] 286 flexible fabric span without any wire elements.

[0380] 287 fabric panel.

[0381] 288 braided wire elements.

[0382] 289 coaptation attachment - leaflets to frame.

[0383] 290 laser cut wire elements.

[0384] 302 rolled into compressed configuration.

[0385] 304 rolled into compressed configuration bilaterally.

[0386] 306 flattening of annular support frame panels.

[0387] 308 compression of annular support frame from top to bottom.

[0388] 310 sheath / rigid elongated push rod / pull wire.

[0389] 311 guide wire.

[0390] 312 steerable catheter for rotating a heart valve prosthesis along an axis parallel to the plane of the valve annulus, wherein an upper tension arm mounted on the valve is conformationally pressure-locked on the annulus tissue and wherein a lower tension arm mounted on the valve is conformationally pressure-locked on the subannular tissue.

[0391] Various above-disclosed and other features and functions can be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements can be subsequently made by others and each such alternative, modification, variation or improvement is intended to be encompassed by the disclosed embodiments.

[0392] While embodiments of the present invention have been described herein, it should be noted that modifications and variations may be made by those skilled in the art in light of the above teachings. Therefore, it should be understood that changes may be made in the 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 details and particularity required by the patent laws, what is claimed and desired protected by Letters Patent is set forth in the appended claims.

Claims

1. A laterally deliverable artificial heart valve, the artificial heart valve comprising: an outer frame defining a central channel extending along a central y-axis of the outer frame, the outer frame having an outer peripheral wall circumscribing the central y-axis; a flow control component disposed within the central channel and coupled to the outer frame, the flow control component having an inner frame and a set of leaflets coupled to the inner frame, the flow control component configured to allow blood to flow through the inflow end of the prosthetic heart valve in a first direction to the outflow end of the prosthetic heart valve and to prevent blood from flowing through the outflow end of the prosthetic heart valve in a second direction opposite to the first direction; and a backflow control component disposed within the central channel and along the tissue cover, the tissue cover being attached to a top edge of the outer frame to cover a portion of the central channel outside the inner frame of the flow control component, the backflow control component having a reinforcement ring mounted on the tissue cover, the backflow control component being configured to be perforated to form an orifice along the tissue cover and within the reinforcement ring, the backflow control component being configured to selectively allow blood to backflow in a second direction through the orifice; The artificial heart valve is configured to be folded along a horizontal z-axis and compressed along a central y-axis so that the artificial heart valve is in a compressed configuration for delivery via a delivery catheter, the horizontal z-axis of the artificial heart valve being approximately perpendicular to the longitudinal cylindrical axis of the delivery catheter when the artificial heart valve is placed in the delivery catheter, and the artificial heart valve is configured to transition to an expanded configuration when the artificial heart valve is released from the delivery catheter.

2. The artificial heart valve according to claim 1, wherein: The flow control member transitions from a generally cylindrical configuration to a generally flat configuration when the prosthetic heart valve transitions to the compressed configuration.

3. The artificial heart valve according to claim 1, wherein: The central y-axis is a first central y-axis extending through the outer frame, and the flow control member is disposed within the central passage and coupled to the outer frame such that a second central y-axis extending through the flow control member is offset relative to the first central y-axis.

4. The artificial heart valve according to claim 3, wherein: The reflux control component is disposed within the central channel and along the tissue cover such that a third central y-axis extending through the reflux control component is offset relative to the first central y-axis and the second central y-axis.

5. The artificial heart valve according to claim 1, wherein: The reflux control component includes at least one radiopaque marker.

6. The artificial heart valve according to claim 1, wherein: The size of the orifice is based at least in part on a desired reflux level through the reflux control component, with a reflux level of 0.5-2.

0.

7. A laterally deliverable artificial heart valve, the artificial heart valve comprising: an outer frame defining a central passage extending along a first central y-axis through the outer frame, the outer frame having an outer peripheral wall circumscribing the first central y-axis; a flow control member having a first inner frame and a set of leaflets coupled to the first inner frame, the flow control member disposed within the central passageway and coupled to the outer frame such that a second central y-axis extending through the flow control member is offset relative to the first central y-axis; and a reflux control component having a second inner frame and a tissue cover coupled to the second inner frame, the reflux control component being disposed within the central channel and along the tissue cover, the tissue cover being attached to a top edge of the outer frame to cover a portion of the central channel outside the first inner frame, the reflux control component having a reinforcement ring mounted on the tissue cover, the reflux control component being configured to be perforated to form an orifice along the tissue cover and within the reinforcement ring, the reflux control component having a third central y-axis extending through the reflux control component, the third central y-axis being offset relative to the first central y-axis and the second central y-axis; The artificial heart valve is capable of being compressed in a first direction parallel to the horizontal z-axis and is capable of being compressed in a second direction parallel to the first center y-axis, the second center y-axis and the third center y-axis to place the artificial heart valve in a flat compressed configuration for lateral delivery via a delivery catheter, wherein the horizontal x-axis of the artificial heart valve is approximately parallel to the longitudinal cylindrical axis extending through the lumen of the delivery catheter when the artificial heart valve is placed in the lumen of the delivery catheter, and the horizontal x-axis of the artificial heart valve is perpendicular to each of the horizontal z-axis, the first center y-axis, the second center y-axis and the third center y-axis.

8. The artificial heart valve according to claim 7, wherein: The prosthetic heart valve is configured to transition to an expanded configuration when the prosthetic heart valve is released from the delivery catheter.

9. The artificial heart valve according to claim 7, wherein: The prosthetic heart valve is flattened in a first direction and compressed in a second direction to place the prosthetic heart valve in a compressed configuration; The outer frame, the first inner frame, and the second inner frame each transition from a generally cylindrical configuration to a generally flattened configuration when the prosthetic heart valve is flattened in a first direction.

10. The artificial heart valve according to claim 7, wherein: The reflux control component includes at least one radiopaque marker.

11. The artificial heart valve according to claim 7, wherein: a flow control component configured to allow blood to flow through the inflow end of the prosthetic heart valve in a first direction to the outflow end of the prosthetic heart valve and to prevent blood from flowing through the outflow end of the prosthetic heart valve in a second direction opposite to the first direction; and The backflow control component is configured to selectively allow backflow of blood through the orifice in a second direction.

12. The artificial heart valve according to claim 7, wherein: The size of the orifice is based at least in part on a desired reflux level through the reflux control component, with a reflux level of 0.5-2.

0.

13. The artificial heart valve according to claim 12, wherein: The diameter of the orifice is between 1 mm and 5 mm.

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