Tricuspid valve regurgitation control device for orthogonal transcatheter heart valve prosthesis

Abstract

The invention relates to a tricuspid regurgitation control device for an orthogonal transcatheter heart valve prosthesis. The invention also relates to access and occluder devices, in particular heart valve regurgitation drums and optionally closure discs and / or tubular stents, for managing and providing intentional regurgitation levels within transcatheter heart valve substitutes and in particular orthogonally delivered transcatheter prosthetic heart valves, an orthogonal delivery transcatheter prosthetic heart valve has a first inner flow control member / valve, a second inner reflux control member, and an outer annular support frame with a compressible wire unit that facilitates flat folding along the z-axis and compression of the valve vertically along the y-axis or orthogonal to the central axis of the flow control member, the present invention relates to a valvular delivery and deployment system, in particular to a valvular delivery and deployment system, which allows delivery and deployment of very large diameter valves from the inferior or superior vena cava to the tricuspid valve or trans-atrial delivery and deployment to the mitral valve, the valves having a height of about 5-60 mm and a diameter of about 25-80 mm, without extra-large diameter catheters and without delivery and deployment from catheters at acute access angles.

Description

[0001] This application is a divisional application of the application for patent application 202080018634.3, filed on March 5, 2020, entitled “Tricuspid Regurgitation Control Device for Orthogonal Transcatheter Heart Valve Prosthesis”.

[0002] Cross Reference to Related Applications

[0003] Provided by Applicant under USPTO guidelines from the Application Data Sheet

[0004] Statement as to Federally Sponsored Research

[0005] Provided by Applicant under USPTO guidelines from the Application Data Sheet

[0006] Name of Applicant(s) under Joint Research Agreement

[0007] Provided by Applicant under USPTO guidelines from the Application Data Sheet

[0008] Reference to Sequence Listing

[0009] Provided by Applicant under USPTO guidelines from the Application Data Sheet

[0010] Statement as to Prior Disclosure

[0011] Provided by Applicant under USPTO guidelines from the Application Data Sheet BACKGROUND TECHNICAL FIELD

[0012] The present invention relates to a passageway and occluder device and in particular to a heart valve regurgitation drum and optional closure disc and / or tubular stent for managing and providing intentional regurgitation levels within a transcatheter heart valve replacement (A61F 2 / 2412). BACKGROUND

[0013] In 1952, a surgeon implanted the first mechanical heart valve, which was a ball valve that could only be placed in the descending aorta, not in the heart itself. For this reason, it did not completely correct the valve problem, only alleviated the symptoms. However, it was a major achievement because it proved that synthetic materials could be used to create heart valves.

[0014] In 1960, a new valve was invented and successfully implanted. This valve was the Starr-Edwards ball valve, named after its founders. This valve was a modification of Hufnagel's original valve. The ball of the valve was slightly smaller and was encased from both sides, so it could be inserted into the heart itself.

[0015] The next development was the tilting disc technology introduced in the late 1960s. These valves were a major improvement over the ball design. The tilting disc technology allowed blood to flow in a more natural manner while reducing the mechanical forces on blood cells. However, over time, the struts of these valves tended to break from fatigue. As of 2003, more than 100,000 Omniscience and 300,000 Hall-Kaster / Medtronic-Hall tilting disc valves had been implanted with essentially no mechanical failures.

[0016] In 1977, St. Jude introduced the bileaflet heart valve. Similar to the natural heart valve, blood flows directly through the center of pyrolytic carbon valve rings mounted within a nickel-titanium housing, which makes these valves superior to other designs. However, this design has the disadvantage of allowing 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 with no failures of the leaflets or housing. It should be noted that the human heart beats approximately 31 million times per year.

[0017] The development of compressible valves delivered via catheter, without the trauma and complications of open heart surgery, continued. This meant that cardiologists trained in endoscopy could, in theory, deploy heart valve replacements during an outpatient procedure. However, transcatheter valves are typically delivered through a puncture in the apex of the heart to access the ventricle, and the puncture is typically used to anchor the annular valve replacement.

[0018] Additionally, the problem with stented replacement valves is that they typically continue to have the regurgitation or leakage problems of the previous generations of valves, and require expensive materials engineering to cope with the millions of cycles encountered during the short few years of normal heart function. Thus, there remains a need for alternative and simpler solutions to address heart disease related to valves. SUMMARY

[0019] The present invention relates to a passageway and occluder device, and in particular to a heart valve regurgitation drum and optional closure member and / or punctured tubular stent for managing and providing a level of intentional regurgitation within transcatheter heart valve replacements, and in particular within transcatheter prosthetic heart valves delivered orthogonally (longitudinally, along the z-axis).

[0020] 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 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 deliver and deploy from the catheter at an acute angle of approach.

[0021] In another preferred embodiment, the present application provides a device for managing and providing a level of intentional regurgitation within an ortho -delivered transcatheter prosthetic heart valve comprising: an ortho-delivered transcatheter prosthetic heart valve having (i) a first inner flow control component (ii) a second inner regurgitation control component having a foldable and compressible frame, a tissue cover attached to the frame, and a flow regulator mounted within a reinforcing ring mounted on the tissue cover, the flow regulator selected from the group consisting of a occluder, a tubular stent, and a tubular stent with an occluder within its lumen, the tissue cover having one or more radiopaque markers, and the second inner regurgitation control component mounted within the outer support frame of the prosthetic heart valve, the self-expanding annular outer support frame having a central passage, an outer peripheral wall circumscribing a central vertical axis in an expanded configuration, an atrial cuff mounted along a top edge of the peripheral wall, a distal anchoring tab mounted on a distal side of the outer annular support frame, and a proximal anchoring tab mounted on a proximal side of the outer annular support frame, the first inner flow control component mounted within the outer annular support frame adjacent to the second inner regurgitation control component, the first inner flow control component 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 first inner flow control component having a leaflet frame on which 2-4 flexible leaflets are mounted, 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 individually foldable along a horizontal z-axis from a cylindrical configuration to a flat cylindrical body configuration and compressible along a vertical y-axis to a shortened configuration, wherein the prosthetic heart valve is compressible to a compressed configuration for introduction into a body using a delivery catheter for implantation at a desired location within the body, the compressed configuration oriented along a horizontal x-axis substantially parallel to a longitudinal cylindrical axis of the delivery catheter, the horizontal x-axis oriented at an intersection angle between 45-135 degrees from the central vertical y-axis, and the compressed configuration is expandable to an expanded configuration having the horizontal x-axis at an intersection angle between 45-135 degrees from the central vertical y-axis, wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.

[0022] In another preferred embodiment, the present application provides a valve, wherein the annular outer support frame has an inner surface and an outer surface, the inner surface and the outer surface are covered with a biocompatible material selected from the group consisting of: 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.

[0023] In another preferred embodiment, the present application provides a valve, wherein the distal anchoring tab, the proximal anchoring tab, or both are composed of a coil, a wire frame, a laser cut frame, an integrated frame section, or a stent, and extend about 10-40 mm away from the side of the annular outer support frame.

[0024] In another preferred embodiment, the present application provides a valve, further comprising: an upper distal anchoring tab attached to a distal upper edge of the annular support frame, the upper distal anchoring tab is composed of a coil, a wire frame, a laser cut frame, an integrated frame section, or a stent, and extends about 2-20 mm away from the annular outer support frame.

[0025] In another preferred embodiment, the present application provides a valve, comprising: at least one tissue anchor connected to the annular outer support frame for engaging native tissue.

[0026] In another preferred embodiment, the present application provides a valve, wherein the annular outer support frame is composed of compressible wire units selected from the group consisting of: braided wire units, laser cut wire units, photo lithographically produced wire units, 3D printed wire units, wire units formed from intermittently connected single wires in a wave shape, zigzag shape, or spiral shape, or combinations thereof.

[0027] In another preferred embodiment, the present application provides a valve, wherein the annular outer support frame is covered on the outer surface with pericardial tissue, a polyester material, or similar biocompatible material.

[0028] In another preferred embodiment, the present application provides a method of providing intentional regurgitation in an implantable transcatheter prosthetic heart valve, comprising the steps of: cutting or perforating a section of the tissue cover within the reinforcing ring of a second inner regurgitation control component as claimed in claim 1 by deploying a catheter cutting tool to the implantable valve as claimed in claim 1 to form an orifice, wherein the valve as claimed in claim 1 is implanted as a prosthetic heart valve in a patient.

[0029] 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.

[0030] 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:

[0031] Step 1. Providing a foldable, compressible prosthetic tricuspid valve according to claim 1; Step 2. Laterally loading the valve into a delivery catheter;

[0032] 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;

[0033] Step 4. Partially ejecting the valve to position the distal subannular tab and allow the valve leaflets to begin functioning;

[0034] Step 5. Completing the deployment of the valve into the native annulus; and

[0035] 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.

[0036] In another preferred embodiment, the present application provides a method of controlling or regulating regurgitation further comprising:

[0037] 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

[0038] 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.

[0039] Figure 2is an illustration of a side perspective exploded view of an embodiment of an inner regurgitation control component with radiopaque markers, three leaflet cusp or pockets mounted within a foldable and compressible inner wire frame, the inner wire frame mounted within an outer wire frame, the outer wire frame having a collar component attached circumferentially at the top edge of the outer wire frame, a double tab component, and a mesh component, according to the present invention.

[0040] Figure 3 is an illustration of a side perspective view of an inner regurgitation control component with radiopaque markers as part of an orthogonally deliverable transcatheter heart valve with 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, according to the present invention.

[0041] Figure 4 is an illustration of a side perspective exploded view of an embodiment of an inner regurgitation control component with radiopaque markers, three leaflet cusp or pockets mounted within a foldable and compressible inner wire frame, the inner wire frame mounted within an outer wire frame, the outer wire frame having a collar component attached circumferentially at the top edge of the outer wire frame, a pair of integrated independent tab components, and a mesh component, according to the present invention.

[0042] Figure 5 is an illustration of a side perspective view of an orthogonally deliverable transcatheter heart valve in a folded configuration along a z-axis (from front to back when viewed from a wider side), according to the present invention.

[0043] Figure 6 is an illustration of a side perspective view of an orthogonally deliverable transcatheter heart valve in a vertically compressed configuration, according to the present invention.

[0044] Figure 7 is an illustration of a side perspective view of an orthogonally deliverable transcatheter heart valve partially loaded into a delivery catheter, according to the present invention.

[0045] Figure 8 is an illustration of an end view of a delivery catheter showing a loaded valve, according to the present invention.

[0046] Figure 9 is an illustration of a top view of a folded, compressed valve in a partial position, as ejected from a delivery catheter prior to being seated in a native annulus, allowing leaflets and inner frame to expand, according to the present invention.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] Figure 18is an illustration of a side view of an inner leaflet frame as a linear linear frame panel prior to further assembly into a cylindrical structure according to the present invention.

[0056] Figure 19 is an illustration of a side perspective view of an inner leaflet frame in a cylindrical or cylindrical (conical, etc.) configuration according to the present invention.

[0057] Figure 20 is an illustration of a side perspective view of a pericardial tissue band according to the present invention, the band configured in a cylindrical shape with leaflet pockets sewn into the structural band.

[0058] Figure 21 is an illustration of a side view of a pericardial tissue band with leaflet pockets sewn into the structural band prior to assembly into a cylindrical leaflet component and mounting on an inner frame to form a collapsible (foldable, compressible) flow control component according to the present invention.

[0059] Figure 22 is an illustration of a bottom view of a pericardial tissue band with leaflet pockets sewn into the structural band prior to assembly into a cylindrical leaflet component and mounting on an inner frame to form a collapsible (foldable, compressible) flow control component according to the present invention.

[0060] Figure 23 is an illustration of a side perspective view of a portion of a pericardial tissue band with a single leaflet pocket sewn into the structural band showing an open bottom edge and a sewn closed top parabolic edge according to the present invention.

[0061] Figure 24 is an illustration of a bottom view of a cylindrical leaflet component showing partial engagement of leaflets to form a closed fluid seal according to the present invention.

[0062] Figures 25(a) through 25(e) are illustrations of a process in which a valve with pre-perforated in-drum is delivered orthogonally within a catheter, ejected from the catheter and deployed into a native annulus according to the present invention.

[0063] Figure 26 is an illustration of a top perspective view of an outer linear frame in a cylindrical configuration according to the present invention, shown as the beginning of a process that allows folding and compression of the outer frame.

[0064] Figure 27 is an illustration of a top perspective view of an outer frame in a partially folded configuration according to the present invention, in which linear frame sidewalls are rotated or hinged at their lateral connection points, shown as a part of a first step in a process that allows folding and compression of the inner frame.

[0065] Figure 28is an illustration of a side view of an outer frame in a fully collapsed configuration according to the present invention, with wire frame sidewalls rotated or hinged at their lateral connection points, shown as the first step in the process of allowing folding and compression of the inner frame.

[0066] Figure 29 is an illustration of a side view of an outer frame in a folded and vertically compressed configuration according to the present invention, with wire frame sidewalls vertically compressed in a pleated or accordion folded configuration, shown as the second step in the process of allowing folding and compression of the inner frame.

[0067] Figure 30 is an illustration of a top perspective view of an assembled valve according to the present invention, with 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 septal frame, and a mesh cover over the septal frame, with folding lines shown as dashed lines on the mesh cover.

[0068] Figure 31 is an illustration of a top perspective view of an assembled valve according to the present invention, with an inner regurgitation control component with radiopaque markers and an outer frame, a first subannular anchoring / positioning tab mounted on the outer frame adjacent to the flow control component, a second subannular anchoring / positioning tab mounted on the outer frame at a different location, a flow control component with an inner leaflet frame and three sutured leaflet pockets / cusps, an inner septal frame, and a mesh cover over the septal frame, with folding lines shown as dashed lines on the mesh cover.

[0069] Figure 32 is an illustration of a top perspective view of an assembled valve according to the present invention, with an outer frame, a first subannular anchoring / positioning tab mounted on the outer frame adjacent to the flow control component, a second subannular anchoring / positioning tab mounted on the outer frame at a different location, a flow control component with an inner leaflet frame and three sutured leaflet pockets / cusps, an inner septal frame, and a mesh cover over the septal frame, with folding lines shown as dashed lines on the mesh cover, and a hemodynamic washing cavity shown as beneath the covered inner septal frame.

[0070] Figure 33 is an illustration of a top perspective view of an assembled valve according to the present invention, with 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 septal frame, and a mesh cover over the septal frame.

[0071] 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.

[0072] Figure 35 (a) through Figure 35 (e) is an illustration of a stepwise process in which the tissue cone is perforated prior to orthogonal loading of the valve into the delivery catheter.

[0073] Figure 36 (a) through Figure 36 (c) is an illustration of a stepwise process in which the tissue cone is perforated after orthogonal ejection of the valve from the delivery catheter and deployment into the native annulus.

[0074] 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).

[0075] 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).

[0076] 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.

[0077] Figure 40 (a) through Figure 40 (f) is an illustration of a closure device for closing a perforation in the inner regurgitation control component.

[0078] 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.

[0079] Figure 42is an illustration of a top view of a valve compressed (orthogonally loaded) within a delivery catheter according to the present invention, with a first tab extending forward along the x-axis and a second trailing tab extending rearward along the x-axis.

[0080] Figure 43 is an illustration of a top view of a valve according to the present invention, with an outer frame, eccentric inner flow control component (leaflet in frame), and irregularly shaped spacer / support frame.

[0081] Figure 44 is an illustration of a top view of a valve according to the present invention, with an outer frame, centrally located inner flow control component (leaflet in frame), and a pair of irregularly shaped spacer / support frames on opposite sides of the inner flow control component.

[0082] Figure 45 is an illustration of a top view of a valve according to the present invention, with an outer frame and inner flow control component (leaflet in frame) and a plurality of suture attachment points, where the inner flow control component is sutured to the outer frame.

[0083] Figure 46 is an illustration of a top view of a valve according to the present invention, with a pacemaker lead set mounted within perforations in a second inner reflux control component, an outer frame, eccentric inner flow control component, and inner spacer frame, all three structures foldable along the same x-axis.

[0084] Figure 47 is an illustration of a top view of a valve according to the present invention, with an outer frame, centrally located inner flow control component, and a pair of smaller cylindrical inner spacer frames mounted on opposite sides of the inner flow control component to provide support within the inner dimensions of the outer frame, all four structures foldable along the same x-axis.

[0085] Figure 48 is an illustration of a top view of a valve according to the present invention, with an outer frame, proximally located biased inner flow control component, and distal side inner spacer frame, all three structures foldable along the same x-axis.

[0086] Figure 49 is an illustration of a side view of a human heart with a transfemoral / IVC or SVC delivery catheter according to the present invention, which has ejected an orthogonal prosthetic valve for low angle deployment into the tricuspid valve. DETAILED DESCRIPTION

[0087] The present invention relates to a dual tab percutaneous 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, an elongated subannular distal anchoring tab extending into the right ventricular outflow tract, an elongated subannular proximal anchoring tab extending into the proximal subannular space, preferably between the anterior and posterior leaflets.

[0088] The embodiments herein, and various features and advantageous details thereof, are explained more fully with reference to the non-limiting implementations, as described in the description below. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein can be practiced and to further enable people skilled in the art to practice the embodiments herein. Accordingly, the examples should not limit the scope of the embodiments herein.

[0089] Rather, these embodiments are provided so that the present disclosure will be thorough and complete, and will fully convey the scope of the application to those skilled in the art. Identical reference numerals refer to identical elements throughout. The term "and / or" as used herein refers to and encompasses any and all combinations of one or more of the associated listed items.

[0090] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the full scope of the present application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising", when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0091] 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 is to be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior application. As used in this document, the term "comprises" means "comprises but not limited to".

[0092] 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.

[0093] 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.

[0094] 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).

[0095] 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.

[0096] As those skilled in the art will appreciate, all ranges disclosed herein include any and all possible subranges, and the subranges' combinations. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters etc. Understand that each individual member is also a subrange.

[0097] Definitions

[0098] Orthogonal

[0099] 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 a substantially 90 degree angle as compared to conventional transcatheter heart valves. Conventional valves have a central cylindrical axis that is parallel to the longitudinal axis of the delivery catheter and are deployed from the end of the delivery catheter in a manner similar to pushing a closed umbrella out of a sleeve. The valve of the present invention is compressed and delivered in a lateral manner. Conventional valves can only expand to the extent permitted by the inner diameter of the delivery catheter. Efforts to increase the expanded diameter of conventional valves have encountered problems trying to compress too much material and structure into too small a space.

[0100] In mathematics, the term orthogonal refers to the intersection angle between two lines or planes of 90 degrees. As used herein, the term "substantially orthogonal" refers to an intersection angle ranging from 75 degrees to 105 degrees. The intersection angle or orthogonal angle refers to both (i) the relationship between the longitudinal cylindrical axis of the delivery catheter and the long axis of the compressed valve of the present invention, where the long axis is perpendicular to the central cylindrical axis of the conventional valve, and (ii) the relationship between the long axis of the compressed or expanded valve of the present invention and the axis defined by the flow of blood through the prosthetic heart valve, where the blood flows, for example, downstream from one part of the body or chamber of the heart to another part of the body or chamber of the heart, such as from the atrium to the ventricle through the native annulus.

[0101] Transcatheter

[0102] 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 that is deployed into a chamber of the heart, and the 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 via the subxiphoid. Transcatheter can be synonymous with transluminal and functionally related to the term "percutaneous" as it relates to the delivery of a heart valve.

[0103] In preferred embodiments of the present invention, the transcatheter approach includes (i) via the femoral vein through the inferior vena cava to the tricuspid valve or pulmonary artery of the heart, (ii) via the jugular vein through the superior vena cava to the tricuspid valve or pulmonary artery of the heart, (iii) via the IVC-femoral or SVC-jugular vein approach through a transatrial route (e.g., fossa ovalis or lower) to the mitral valve of the heart.

[0104] Annular support frame

[0105] In the specification and claims herein, the term "annular support frame" as well as "wire frame" or "flange or collar" refers to a three-dimensional structural component that is seated within the native valve annulus and serves as a mounting element for the leaflet structure, flow control component or flexible shuttle or cuff valve.

[0106] In preferred embodiments, the annular support frame is a self-expanding annular support frame having a central passage and an outer peripheral wall circumscribing a central vertical axis in an expanded configuration. The peripheral wall comprises a collar and a lower body portion.

[0107] The peripheral wall can be further defined as having an anterior wall portion and a posterior wall portion, the anterior wall portion and posterior wall portion connected to a proximal fold region along a proximal (to the IVC) or proximal side and to a distal fold region along a distal or distal side.

[0108] The anterior wall portion can be further defined as having an anterior upper collar portion and an anterior lower body portion, and the posterior wall portion can be further defined as having a posterior upper collar portion and a posterior lower body portion.

[0109] The annular support frame has a mounting within the annular support frame and is 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 the first direction.

[0110] As the frame is preferably made of a super-elastic metal or alloy, such as Nitinol, the frame is compressible. Preferably, the frame is composed of a plurality of compressible wire units having an orientation and unit geometry substantially orthogonal to the central vertical axis to minimize wire unit strain when the annular support frame is configured as a vertical compressed configuration, a coiled compressed configuration, or a folded compressed configuration.

[0111] Annular support frame structure

[0112] The annular support frame can be an annular, or cylindrical or conical tube made of a durable biocompatible structural material, such as Nitinol or similar alloys, wherein the annular support frame is formed by manufacturing the structural material as a braided wire frame, a laser cut wire frame, or a coil. The annular support frame has a height of about 5-60 mm, an outer diameter dimension R of 30-80 mm, and an inner diameter dimension of 31-79 mm, taking into account the thickness of the wire material itself.

[0113] 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.

[0114] Annular support frame cover

[0115] 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).

[0116] Use of annular support frame

[0117] 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.

[0118] Annular support frame optional collar

[0119] 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.

[0120] Delivery of annular support frame

[0121] The annular support frame can be compressed for transcatheter delivery and can be able to expand as a self-expanding shape memory element or using a transcatheter expansion balloon. Some embodiments can have both an atrial collar and a ventricular collar, while other embodiments within the scope of the invention include prosthetic heart valves having a single atrial collar, a single ventricular collar, or no additional collar structure.

[0122] Frame material

[0123] Preferably, the frame is made of a super-elastic metal component such as laser cut Nitinol tubing, or flat sheet or other similarly functional material such as braided wire. The material can be used for the frame / stent, collar, and / or anchors. It is contemplated that other shape memory alloys as well as polymer composites are used within the scope of the 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-chrome, titanium, and other functionally equivalent metals and alloys.

[0124] One key aspect of the frame design is that it is compressible, and has the property that upon release it reverts to its original (uncompressed) shape. This requirement limits the potential material selection to metals and plastics that have shape memory properties. With respect to metals, Nitinol has been found to be particularly useful because it can be processed into austenitic, martensitic, or super-elastic. The martensitic and super-elastic alloys can be processed to exhibit the desired mechanical behavior.

[0125] Laser cutting

[0126] One possible construction of a wire frame contemplates laser cutting equi-diameter Nitinol tubing. The laser cutting forms regular cuts in the Nitinol tubing. In one preferred embodiment, the Nitinol tubing is expanded to form a three-dimensional structure formed of diamond cells. The structure can also have additional functional elements for attaching accessory components such as biocompatible coverings, tissue anchors, releasable deployment and retrieval control guides, knobs, attachments, rigging, etc., e.g., loops, anchors, etc.

[0127] Second, the tubing is heat mechanically processed using industry standard Nitinol forming methods. Treating the wire frame in this way will form a device that has shape memory properties and will readily revert to the memorized shape once deployed.

[0128] Braided wire

[0129] Another possible construction of a wire frame envisions the use of simple braiding techniques that use Nitinol wire and simple braiding jigs. The wire is wrapped in a pattern on the braiding jig until an isodiametric tube is formed. Next, the braided wire frame is placed on a forming jig and processed using industry standard Nitinol forming methods.

[0130] Flow control component

[0131] In the specification and claims herein, the term "flow control component" refers in a non-limiting sense to a 2 leaflet, 3 leaflet, 4 leaflet leaflet structure with a flexible biocompatible material such as processed or unprocessed pericardium, the leaflet structure sewn or joined to an inner annular support frame (mounted within an outer annular support frame) for use as a prosthetic heart valve. Such a valve can be a heart valve such as a tricuspid valve, mitral valve, aortic valve or a pulmonary valve that opens to blood flow from atrium to ventricle during diastole and closes due to the systolic ventricular pressure applied to the outer surface. The sequential opening and closing can be described as "reciprocating".

[0132] Regurgitant drum or second inner

[0133] In the specification and claims herein, the term "regurgitant drum" or "second inner flow control component" refers to a second inner annular support frame mounted within an outer annular support frame proximal to the first inner annular support frame. The "regurgitant drum" or "second inner flow control component" has a foldable and compressible frame, a tissue covering attached to the frame, and a flow regulator mounted within a reinforcing ring mounted on the tissue covering, the flow regulator selected from a channel, a plug, a tubular stent, and a tubular stent with a plug within its lumen, the tissue covering having one or more radiopaque markers. Such a "regurgitant drum" or "second inner flow control component" can be pre-perforated before loading the valve into a delivery catheter, it can be perforated after the valve has been deployed into a native annulus using catheter tools, the perforations can be reinforced using a stent tube, and the perforations or stent tube can be sealed using a closure device such as a polyester disc, a Nitinol disc, a Nitinol disc with a polyester covering, a dual disc (button on each side) closure device, or a functionally similar device similar to that used to treat patent foramen ovale but modified for accessing and closing a 1-2 mm perforation in the regurgitant drum.

[0134] Reinforcing ring

[0135] The term reinforcing ring refers to a ring of material such as pericardium, polymer or biocompatible material mounted on the top surface of the tissue covering of the "regurgitant drum" or "second inner reflux control component". In a preferred embodiment, the reinforcing ring circumscribes the target area for puncture and prevents the puncture from tearing or losing patency. In another preferred embodiment, radio-opaque markers for guiding the catheter cutting / balloon tool can be mounted on top of or within the reinforcing ring.

[0136] Radio-opaque markers

[0137] The term "radio-opaque marker" refers to a material that allows visibility during fluoroscopy or other radiological imaging. Examples of radio-opaque marker materials include nitinol, gold, platinum and combinations or mixtures thereof. Radio-opaque materials can also include powdered or particulate 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 not only provide a targeted puncture location, but also to provide positioning information with respect to the valve itself. For example, the use of a three marker pattern provides a central target area, but can also provide information as to whether the valve is properly oriented, such as aligning the septal collar portion of the prosthetic valve with the septal side of the tricuspid valve.

[0138] Tissue anchors

[0139] The term "tissue anchor" or "pleat tissue anchor" or "auxiliary tissue anchor" or "darts" or "pins" in the specification and claims herein refers to a fastening device that typically connects the superior atrial frame to the native annular tissue at or near the periphery of the collar. The anchors can be positioned to avoid puncturing the tissue and rely solely on the compression force of the two plate-like collars on the captured tissue, or the anchors themselves or with integral fixation wires can puncture the native tissue to provide anchoring, or a combination of both. The anchors can have a specialized fixation mechanism that inserts or pops into a mating orifice or array of mating orifices that allows the anchor to attach, but prevents dislodgement when locked into a groove at the orifice periphery near a flanged shoulder. The fixation wires can be attached or anchored to the collar opposite the pin by any attachment or anchoring mechanism including a nub, suture, wire crimp, wire lock with a cam mechanism or combinations thereof.

[0140] Support posts

[0141] 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 spoke frame and that continues axially, or down the center of a flexible sleeve, or within the sutured seam of a flexible sleeve. The sleeve can not be attached to the support post, or the sleeve can be attached to the support post, either directly or indirectly.

[0142] In the following description, the term "body passageway" is used to define a blood conduit or vessel within the body. Of course, the particular application of the prosthetic heart valve determines the body passageway in question. For example, an aortic valve replacement will be implanted in or adjacent to the aortic annulus. Likewise, a tricuspid or mitral valve replacement will 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 structurally impossible to combine, or excluded by the claim language, any of the heart valve embodiments described herein can be implanted in any body passageway.

[0143] The term "lumen" refers to the inside of a cylindrical tube. The term "bore" refers to the inside diameter.

[0144] Displacement - the volume of fluid displaced by one complete stroke or rotation.

[0145] Ejection fraction is a measure of the percentage of blood that leaves the heart with each contraction. During each pumping cycle of the heart, the heart contracts and relaxes. When the heart contracts, it ejects blood from two pumping chambers (ventricles).

[0146] As used herein, the terms "proximal" and "distal" are to be understood relative to a user (e.g., a surgeon or interventional cardiologist) of the disclosed delivery devices. "Proximal" is to be understood as being relatively close to the user, and "distal" is to be understood as being relatively far from the user.

[0147] 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 imply a structure that can undergo slight expansion due to a temperature increase or other such incidental cause. Rather, "non-expandable" is not to be construed to mean completely rigid or dimensionally stable, as some slight expansion can be observed, for example, with conventional "non-expandable" heart valves.

[0148] Prosthetic heart valve

[0149] The term prosthesis or artificial encompasses both complete replacement of an anatomical part, such as a new mechanical valve replacing a native valve, and replacement and / or assistance, repair or improvement of an existing anatomical part, such as a medical device where a native valve is left in place. For installation within a passive auxiliary holder, the present invention contemplates a wide variety of (bio)artificial heart valve prostheses. 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 mechanical heart valve), and homograft and autograft valves. For bioprosthetic pericardial valves, the use of bioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, and bioprosthetic pulmonary valves is contemplated.

[0150] Tethers

[0151] The tethers are made of surgical grade materials such as biocompatible polymeric 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 non-elastic. It is also contemplated that one or more of the tethers can optionally be elastic to provide an even further degree of compliance of the valve during the cardiac cycle.

[0152] Tines-anchor-tines / barbs

[0153] The device can be deployed within the valve annulus by use of tines or barbs. These can be used in conjunction with or in place of one or more tethers. The tines or barbs are positioned to provide attachment with adjacent tissue. The tines are pressed into the annular tissue by mechanical means such as use of a balloon catheter. In one non-limiting embodiment, the tines can optionally be semi-circular hooks that pierce, rotate into, and securely hold the annular tissue as the frame body expands in line. The anchors are deployed by one or more anchors passing over a delivery catheter in line. The catheter can have multiple axial lumens for delivery of various anchoring tools, including anchoring deployment tools, force application tools, hooks, avulsion tools, cutting tools, radiofrequency and radiopaque visualization tools and markers, and suture / suture thread manipulation tools. Once the one or more anchors are attached to the adjustment band, a tensioning tool can be used to adjust the length of the tethers connected to the implanted valve to adjust and secure the implant as needed for proper function. It is also contemplated that the anchors can be spring-loaded and can have tether attachment mechanisms or tether capture mechanisms built into the tethering face of the one or more anchors. The anchors can also have an ingrowth material such as polyester fiber to promote ingrowth of the anchors into the myocardium.

[0154] In one embodiment where the prosthetic heart valve can or can not include a ventricular collar, the anchors or darts are not attached to a lower ventricular collar, but are attached directly to the annular tissue or other tissue used for anchoring.

[0155] Tube and / or covering material - biological tissue

[0156] Tissue as used herein is biological tissue which is chemically stable pericardial tissue of an animal, such as bovine (bovine pericardium) or ovine (ovine pericardium) or porcine (porcine pericardium) or equine (equine pericardium). Preferably, the tissue is bovine pericardial tissue. Examples of suitable tissue include tissue used in the products and Tissue, all of which are currently used in surgical procedures and sold as typically harvested from less than 30 month old livestock. Other patents and publications disclose the surgical use of harvested biocompatible animal thin tissue as suitable herein for use as a biocompatible "jacket" or sleeve for implantable stents, 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 Scimed Life Systems, Inc., which discloses a bioprosthetic heart valve for implantation; and U.S. Patent 5,336,616 to LifeCell Corporation, which discloses a non-cellular collagen-based tissue matrix for transplantation.

[0157] Polymer

[0158] In a preferred embodiment, the catheter is optionally made of a synthetic material such as polyurethane or polytetrafluoroethylene.

[0159] In the case where a thin, durable synthetic material is contemplated, for example, for a covering, a synthetic polymeric material such as expanded polytetrafluoroethylene or a polyester can optionally be used. Other suitable materials can optionally include thermoplastic polycarbonate polyurethane, polyether polyurethane, segmented polyether polyurethane, silicone polyether polyurethane, silicone-polycarbonate polyurethane, and ultra-high molecular weight polyethylene. Additional biocompatible polymers can optionally include polyolefins, elastomers, polyethylene glycol, polyether sulfone, polysulfone, polyvinylpyrrolidone, polyvinyl chloride, other fluoropolymers, silicone polyesters, siloxane polymers and / or oligomers, and / or polylactones and block copolymers using the same.

[0160] Polyamide (PA)

[0161] PA is an early engineering thermoplastic that consists of "super polyester" fibers with a molecular weight greater than 10,000. It is commonly known as nylon. Applications of polyamides include clear tubing for cardiovascular applications, hemodialysis membranes, and the production of percutaneous transluminal coronary angioplasty (PTCA) catheters.

[0162] Polyolefins

[0163] Polyolefins include polyethylene and polypropylene, which are two important polymers of polyolefins and have good biocompatibility and chemical resistance. In cardiovascular applications, both low-density polyethylene and high-density polyethylene are used to manufacture tubing and housings. Polypropylene is used to manufacture heart valve structures.

[0164] Polyesters

[0165] Polyesters include the use of polyethylene terephthalate (PET) with the name Dacron. It is commonly used as a knitted or woven fabric for vascular grafts. Woven PET has smaller pores compared to knitted fabric, which reduces blood leakage and has better efficiency as a vascular graft. PET grafts can also be used for protein coating (collagen or albumin) for reducing blood loss and having better biocompatibility

[39] . PET vascular grafts with endothelial cells have been searched as a means for improving patency. Furthermore, polyesters are widely preferred materials for the manufacture of bioabsorbable stents. Poly-L-lactic acid (PLLA), polyglycolic acid (PGA), and poly(D, L-lactide / glycolide) copolymer (PDLA) are some of the commonly used bioabsorbable polymers.

[0166] Polytetrafluoroethylene

[0167] Polytetrafluoroethylene (PTFE) is a synthetic fluorocarbon polymer of Dupont Co. with the common trade name Teflon. Common applications of PTFE in cardiovascular engineering include vascular grafts and heart valves. PTFE sutures are used for the repair of mitral valves in myxomatous disease and also for surgical procedures of anterior or posterior leaflet prolapse of the mitral valve. PTFE is particularly used for implantable prosthetic 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 finally extruding the mixture. The extrudate formed by this process is then heated close to its glass transition temperature and stretched to obtain microscopically porous PTFE called e-PTFE. This form of PTFE is indicated for smaller arteries, which have lower flow rates, promote low thrombogenicity, lower rates of restenosis and hemostasis, less calcification, and biochemical inertness.

[0168] polyurethane

[0169] Polyurethane has good physico-chemical and mechanical properties and has a high degree of biocompatibility, which allows unrestricted use in blood contact devices. It has high shear strength, elasticity and transparency. Furthermore, the surface of polyurethane has good resistance to microorganisms and thrombus formation resulting from PU is almost similar to that of multifunctional cardiovascular biomaterials such as PTFE. Conventionally, segmented polyurethane (SPU) has been used for various cardiovascular applications such as valve structures, pacemaker leads and ventricular assist devices.

[0170] covering wire frame material

[0171] It is envisaged that drug eluting wire frames are used herein. DES essentially consists of three parts: a wire frame platform, a coating and a drug. Some of the examples of DES without polymer are Amazon Pax (MINVASYS) which uses Amazonia CroCo (L605) cobalt-chromium (Co-Cr) wire frame and paclitaxel as an anti-proliferative agent and an intracavitary coating has been used as a carrier for the drug. BioFreedom (Biosensors Inc.) which uses stainless steel as a substrate and a modified intracavitary coating as a carrier surface for the anti-proliferative drug Biolimus A9. Optima (CID S.r.I.) which uses 316L stainless steel wire frame as a substrate for the drug tacrolimus and utilizes an integrated turbo layer carbon film as a drug carrier. VESTAsync (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 the drug combination of sirolimus with probucol.

[0172] Bioabsorbable polymers can also be used herein as carrier matrices for drugs. Cypher, Taxus and Endeavor are three basic types of bioabsorbable DES. Cypher (J&J, Cordis) uses 316L stainless steel coated with polyethylene vinyl acetate (PEVA) and polybutyl methacrylate (PBMA) to carry the drug sirolimus. Taxus (Boston Scientific) utilizes a 316L stainless steel wire frame coated with translute styrene isoprene butadiene (SIBS) copolymer to carry paclitaxel which elutes over a period of about 90 days. Endeavor (Medtronic) uses a cobalt-chrome driven wire frame to carry zotarolimus with phosphoryl choline as the drug carrier. BioMatrix employs an S- wire frame (316L) stainless steel with a surface of polylactic acid as a substrate to carry the anti-proliferative drug Biolimus. ELIXIR-DES project (Elixir Medical Corp) includes both polyester and polylactide coated wire frames to carry the drug Novolimus and cobalt-chrome (Co-Cr) as a 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-chrome (Co-Cr) wire frame coated with polylactic-co-glycolic acid (PLGA) to carry the drug sirolimus.

[0173] Examples of preferred embodiments include the following details and features.

[0174] Exemplary - Delivery Methods

[0175] Transcatheter prosthetic heart valves can be delivered percutaneously using transcatheter procedures via a femoral access through the IVC, carotid artery, subxiphoid, intercostal pass through the chest wall, and transseptally through the fossa ovalis to the mitral annulus.

[0176] The device is delivered via a catheter to the right or left atrium 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 and then pushed out of the catheter when the capsule reaches the atrium. The heart treatment technician visualizes this delivery using available imaging techniques such as fluoroscopy or ultrasound.

[0177] In preferred embodiments, the valve self-expands upon release from the catheter because it is partially composed of a shape memory material such as Nickel-titanium alloy or cobalt-chrome alloy, alloys used in biomedical implants.

[0178] 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.

[0179] 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.

[0180] Exemplary - Delivery Method

[0181] 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 la subannular region below the anterior lateral commissure, wherein positioning the distal anchor tab holds the valve at an elevated angle of at least 30 degrees from a horizontal axis of the valve and a local annular plane, wherein partially releasing the valve allows blood to partially flow around the prosthetic valve and through the native leaflets and partially flow through the flow control component of the prosthetic valve to provide a gradual blood flow transition from flow through the native leaflets to full flow through the prosthetic valve; (v) completing the release of the entire valve from the delivery catheter by advancing the sheath over the guide wire to seat the valve in the native annulus by applying a downward force in the direction of the ventricle; and (vi) seating the at least one proximal anchor tab at a second desired anchor region.

[0182] Exemplary delivery method

[0183] In another preferred embodiment of the present invention, there is provided a method for orthogonal delivery of an implantable prosthetic heart valve to a desired location in the body, including a tricuspid valve location, the method comprising the steps of: advancing a delivery catheter to a desired location in the body and delivering an expandable prosthetic heart valve to the desired location in the body by releasing the valve from the delivery catheter, 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 leaves are mounted, the leaflet frame being foldable along a z-axis from a cylindrical configuration to a flattened cylindrical body configuration and compressible along a vertical axis (y-axis) to a shortened configuration; a distal anchor tab mounted on a distal side of the annular support frame; and a proximal anchor tab mounted on a proximal side of the annular support frame, wherein the valve is compressible to a compressed configuration for introduction into the body using the delivery catheter for implantation at the desired location in the body, the compressed configuration having a long axis oriented at an intersection angle of between 45-135 degrees from the first direction and the compressed configuration is expandable to an expanded configuration having a long axis oriented at an intersection angle of between 45-135 degrees from the first direction, wherein the long axis of the compressed configuration of the valve is substantially parallel to a longitudinal cylindrical axis of the delivery catheter, wherein the compressed configuration, wherein the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.

[0184] Releasing the valve from the delivery catheter is selected from the group consisting of: (i) using a rigid elongate push rod / pull wire releasably connected to the distal side of the valve to pull the valve out of the delivery catheter, wherein advancing the push rod away from the delivery catheter pulls the compressed valve out of the delivery catheter, or (ii) using a rigid elongate push rod releasably connected to the proximal side of the valve to push the valve out of the delivery catheter, wherein advancing the push rod out of the delivery catheter pushes the compressed valve out of the delivery catheter.

[0185] The delivery method can further comprise the additional step of anchoring the one or more tissue anchors attached to the valve into native tissue.

[0186] The delivery method can further comprise the additional step of positioning the distal anchoring tab of the heart valve prosthesis into the right ventricular outflow tract of the right ventricle.

[0187] The delivery method can further comprise the additional step of positioning the distal anchoring tab of the heart valve prosthesis into the right ventricular outflow tract of the right ventricle and positioning the upper distal anchoring tab into a supra-annular position, and the upper distal anchoring tab provides a supra-annular downward force in the ventricular direction and the distal anchoring tab provides a sub-annular upward force in the atrial direction.

[0188] The delivery method can further comprise the additional step of rotating the heart valve prosthesis along an axis parallel to the plane of the valve annulus using a steerable catheter.

[0189] Exemplary-loading method

[0190] 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.

[0191] Exemplary - loading method

[0192] 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.

[0193] Exemplary - method for improved flow

[0194] 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.

[0195] In another preferred embodiment of the application, there is provided a method for improving flow, wherein the distal anchoring tab is an RVOT tab positioned in the RVOT during the transition from partial to full release of the valve.

[0196] Example - manufacturing process

[0197] In one preferred embodiment, the application comprises a method for manufacturing a percutaneously deliverable transcatheter prosthetic heart valve frame comprising:

[0198] (i) producing the

[0199] self-expanding annular support frame,

[0200] wherein the additive metal or metal alloy manufacturing is 3D printing or direct metal laser sintering (powder melting), and wherein the subtractive metal or metal alloy manufacturing is photo-etching, laser sintering / cutting, CNC machining, electrical discharge machining.

[0201] In another preferred embodiment, there is provided a method for manufacturing a percutaneously deliverable transcatheter prosthetic heart valve frame further comprising the steps of: (ii) installing a flow control component within the valve frame, the flow control component being configured to allow blood flow through an inflow end of the flow control component along a central vertical axis and to prevent blood flow through an outflow end of the valve; (iii) covering an outer surface of the valve frame with a pericardial material or similar biocompatible material.

[0202] Example - compression method

[0203] In another preferred embodiment, there is provided a compression method, wherein the implantable prosthetic heart valve is rolled or folded into a compressed configuration using a step selected from the group consisting of:

[0204] (i) rolled into a compressed configuration unilaterally from one side of the annular support frame;

[0205] (ii) rolled into a compressed configuration bilaterally from two opposite sides of the annular support frame;

[0206] (iii) flattened the annular support frame into two parallel panels substantially parallel to the long axis, and then rolled the flattened annular support frame into a compressed configuration; and

[0207] (iv) flattened the annular support frame along a vertical axis to reduce the vertical dimension of the valve from top to bottom.

[0208] Example - delivery

[0209] Drawings

[0210] Reference will now be made to the drawings, Figure 1 is a side perspective view of a quadrature deliverable transcatheter heart valve 100 having 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, in accordance with the present application.

[0211] The inner regurgitation control component 135 is comprised of a tissue covering 141, a reinforcing ring 143, radiopaque markers 144, and a drum / regurgitation passage 135.

[0212] The collapsible (inner) flow control component 130 has a leaflet frame 231 with 2-4 flexible leaflets 258 mounted thereon, the leaflet frame 231 is foldable along the z-axis 109 from a cylindrical configuration to a flat cylindrical configuration and is compressible along the vertical axis 108 (y-axis) to a shortened configuration.

[0213] 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) passage 104 circumscribing the central vertical axis 108 when in an expanded configuration and an outer peripheral wall 106, and the annular outer support frame 104 has a distal side 118 and a proximal side 114.

[0214] The flow control component 130 is mounted within the annular outer support frame 104 and is configured to allow blood flow in a first direction (e.g., atrium to ventricle) through an inflow end 132 of the valve 100 and to prevent blood flow in a second direction opposite the first direction through an outflow end 134 of the valve 100.

[0215] The inner regurgitation control component 135 is foldable and compressible like the inner flow control component 130 and the outer annular frame 104. The inner flow control component 130 includes a leaflet frame 231 with 2-4 flexible leaflets 258 mounted thereon.

[0216] Like outer frame 104, flow control component 130 and thus leaflet frame 231 can be folded along the z-axis (from front to back) from a cylindrical configuration into a flattened cylindrical configuration with the fold line on the distal side and on the proximal side, disengaging leaflet frame 231 from the ring or cylindrical shape and flattening it from the ring into a double layer band, i.e., folded over itself, or flattened like a cylinder into a rectangle or square that is joined together along two opposite sides. This allows outer frame 104 and flow control component 130 to reduce the radius along the z-axis until the sidewalls touch or nearly touch. This also allows outer frame 104 and flow control component 130 to maintain the radius along the horizontal axis, y-axis, to minimize the number of wire units that make up the outer and inner frames that are damaged by the forces applied during the folding and / or compression needed to load into a delivery catheter.

[0217] Inner reflux control component 135, flow control component 130, leaflet frame 231, and outer frame 104 are also vertically (y-axis) compressible, reducing the height of the overall valve structure to fit within the inner diameter of 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 dimension along the horizontal axis or x-axis. For example, a 60 mm or larger diameter valve can be delivered via transcatheter techniques. 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 needed for such a large valve because the long axis runs parallel to the central axis of the delivery catheter. This is not possible with prior central axis delivery (axial) transcatheter valves. The use of a folded compressed valve orthogonal to the conventional axial delivery valve allows for previously unavailable treatment options.

[0218] Figure 1 A distal anchoring tab 268 mounted on the distal side 118 of the annular outer support frame 102 and a proximal anchoring tab 270 mounted on the proximal side 114 of the annular outer support frame 102 are also shown.

[0219] In a preferred embodiment, the horizontal x-axis of the valve when in the expanded configuration intersects the central vertical y-axis at an angle between 45-135 degrees.

[0220] 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.

[0221] In another preferred embodiment, the valve has a height of about 5-60 mm and a diameter of about 25-80 mm.

[0222] Figure 1A guide wire sheath 310 and guide wire 311 are also shown. A lumen or guide ball 266 is shown mounted on the distal end of the distal tab 268 and the guide wire 311 is threaded through the lumen 266. While the inner diameter of the lumen 266 is large enough to allow the guide wire 311 to extend through, the inner diameter of the lumen 266 is not large enough to allow the sheath 310 to extend through. This causes the sheath 310 to advance along the guide wire 311 until it comes to rest against the proximal side of the lumen 266 with the continued application of pushing force on the sheath 310 pushing against the lumen and allowing the valve to be pulled out of the delivery catheter by the distal tab to the target location for deployment of the valve.

[0223] Figure 2 is an illustration of a side perspective view of an exploded view of an embodiment with an inner regurgitant drum 137 with markers 144, a channel 135 and a ring 143. Figure 2 Also shown are three leaflet 258 cusp or pockets according to the present invention mounted within a foldable and compressible inner wire frame 231 with a distal folded region 120 and a proximal folded region 116, mounted within an outer wire frame 102 with a collar component 103 attached circumferentially at the top edge 107 of the outer wire frame 104, a double tab component with distal (rvot) tab 268 and proximal tab 270 and an optional mesh component with a biocompatible material that can be used to cover the inner regurgitant drum 137, cover the collar 103, cover the inner and outer faces of the outer frame 102 and / or cover the anchoring tabs 268 and 270.

[0224] The atrial collar 103 is shaped to conform to the native deployed location. In a tricuspid replacement, the atrial collar will have a high back wall portion to conform to the septal region of the native valve and will have a distal collar portion and a proximal upper collar portion. The distal collar portion can be larger than the proximal upper collar portion to account for the larger flat space above the (atrial) right ventricular outflow tract (RVOT) subannular region.

[0225] Figure 3 is an illustration of a side perspective view of an orthogonally deliverable transcatheter heart valve 100 with an open regurgitant frame 139 with radiopaque markers 144. In this embodiment, the channel can have a predetermined inner diameter depending on the regurgitation level desired by the physician.

[0226] 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 having a leaflet frame 231 with 2-4 flexible leaflets 258 mounted thereon. The leaflet frame 231 is foldable along the z-axis from a cylindrical configuration to a flat cylindrical configuration, and is compressible along the vertical axis (y-axis) to a shortened configuration. In accordance with the present invention, the valve 100 also has a super-elastic coil distal tab 268 / 269 and a super-elastic coil proximal tab 270 / 271.

[0227] 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 cusp or pockets 258 mounted within the foldable and compressible inner wire frame 231 in accordance with the present invention, the inner wire frame 231 being mounted within the outer wire frame 102, which has a collar component 103 attached circumferentially at the top edge 107 of the outer wire frame 102, a pair of integral independent tab components 269, 270, and a mesh component 226.

[0228] The uncovered regurgitant frame 139 provides controlled regurgitation for the valve. Once the patient no longer requires regurgitation, the uncovered regurgitant frame 139 can later be plugged with a later inserted stent or covering or plug.

[0229] The atrial collar 103 is shaped to conform to the native deployed location. In a tricuspid replacement, the atrial collar will have a high posterior wall portion to conform to the septal region of the native valve, and will have a distal collar portion and a proximal upper collar portion. The distal collar portion can be larger than the proximal upper collar portion to account for the larger flat space above the (atrial) right ventricular outflow tract (RVOT) subannular region.

[0230] The integral tabs 269 and 271 are of unitary construction with the main body of the outer frame. The tabs can be different in size and shape. In a preferred embodiment, the RVOT tab (e.g., 269) can be longer to reach into the inlet of the pulmonary artery (in the case of a tricuspid replacement).

[0231] Figure 5 is an illustration of a side perspective view of an orthogonal deliverable transcatheter heart valve 100 in a folded configuration along the z-axis (from front to back when viewed from the wider side) in accordance with the present invention. Figure 5 The folded (flat) outer frame 102 is shown with folded / flat collar 103, hinge points 116, 120. Figure 5 The folded / flat inner regurgitant control component 137 is also shown with markers 144, and leaflets 258 mounted within the folded / flat inner frame 231.

[0232] Figure 6 is an illustration of a side perspective view of an orthotopic deliverable transcatheter heart valve 100 in a vertically compressed configuration according to the present invention. Figure 6 shows the outer frame 102 with the folding (z-axis) and vertically compressing (y-axis) of the collar 103 along the folding line between the articulation points 116, 120. Figure 6 Also shown are the inner regurgitation control member 137 and leaflets 258 mounted within the inner frame 231.

[0233] Figure 7 is an illustration of a side perspective view of an orthotopic deliverable transcatheter heart valve 100 partially loaded into a delivery catheter 138 according to the present invention. Figure 7 shows the outer frame 102, the folding collar 103, the inner regurgitation control member 137 and the flow control member 130 with leaflets 258 and inner frame 231.

[0234] Figure 8 is an illustration of an end view of a delivery catheter 138 showing the loaded valve 100 according to the present invention, with the outer frame 102 and the collar 103 visible.

[0235] Figure 9 is an illustration of a top view of a folded compressed valve being ejected from the delivery catheter 138 prior to being seated in a native annulus, thus in a partial position allowing the leaflets 258, the collar 103 and the inner frame 231 to expand.

[0236] Figure 10 is an illustration of a top perspective view of a valve without a collar, with the inner regurgitation control member 137 removed for viewing, and showing tissue 141, a reinforcing ring 143 and a passage 135. Figure 10 Also shown is an outer cylindrical frame 102 with a mesh sidewall covering 226, an inner frame 231 and leaflets 258 stitched into the inner frame 231 according to the present invention.

[0237] Figure 11 is an illustration of a top perspective view of a valve without a collar according to the present invention, with a marker 144 and an inner regurgitation control member 137 mounted on a top edge 107 of an outer cylindrical frame 102, the outer frame 102 also having a mesh sidewall covering 226, an inner frame 231 and leaflets 258 stitched into the inner frame 231.

[0238] Figure 12is an illustration of a bottom perspective view of a valve without a collar according to the present invention, the valve having an inner regurgitation control component 137 mounted on a top edge 107 of an outer cylindrical frame 102, the outer frame 102 further having a mesh sidewall covering 226, an inner frame 231 and leaflets 258 stitched into the inner frame 231.

[0239] Figure 13 is an illustration of an exploded view of a valve without a collar according to the present invention, the valve having an inner regurgitation control component 137, the inner regurgitation control component 137 including a tissue covering 141 and a regurgitation frame 139. Figure 13 Also shown is an outer cylindrical frame 102 according to the present invention, the outer frame 102 having a mesh sidewall covering 226, an inner frame 231 and leaflets 258 mounted on bands 257 and stitched into the inner frame 231.

[0240] Figure 14 is an illustration of a top perspective view of an inner leaflet frame 231 (or regurgitation frame 139) in a cylindrical configuration according to the present invention, shown as the beginning of the process allowing folding and compression of the inner frame.

[0241] Figure 15 is an illustration of a top perspective view of an inner leaflet frame 231 (or regurgitation frame 139) in a partially folded configuration according to the present invention, with the wire frame sidewalls rotated or hinged at their lateral connection points 116, 120, shown as a first step in the process allowing folding and compression of the inner frame.

[0242] Figure 16 is an illustration of a side view of an inner leaflet frame 231 (or regurgitation frame 139) in a fully folded configuration 208 according to the present invention, with the wire frame sidewalls rotated or hinged at their lateral connection points, shown as a completed first step in the process allowing folding and compression of the inner frame 231.

[0243] Figure 17 is an illustration of a side view of an inner leaflet frame 231 (or regurgitation frame 139) in a folded and vertically compressed configuration 210 according to the present invention, with the wire frame sidewalls vertically compressed in a pleated or accordion folded configuration, shown as a second step in the process allowing folding and compression of the inner frame.

[0244] Figure 18 is an illustration of a side view of an inner leaflet frame 231 (or regurgitation frame 139) as a linear wire frame sheet 202 before further assembly into a cylindrical structure according to the present invention.

[0245] Figure 19 is an illustration of a side perspective view of an inner leaflet frame 231 in a cylindrical or cylindrical (conical, etc.) configuration according to the present invention.

[0246] Figure 20 is an illustration of a side perspective view of a pericardial tissue strip 257 according to the present application, the strip 257 configured in a cylindrical shape with leaflet pockets 258 sewn into the structural strip 257.

[0247] Figure 21 is an illustration of a side view of a pericardial tissue strip 257 according to the present application with leaflet pockets sewn 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.

[0248] Figure 22 is an illustration of a bottom view of a pericardial tissue strip 257 according to the present application with leaflet pockets 258 sewn 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.

[0249] Figure 23 is an illustration of a side perspective view of a portion of a pericardial tissue strip according to the present application with a single leaflet pocket sewn into the structural strip, showing the leaflet pocket 258 partially engaged with the extended open edge 261 and the sewn edge 259 portion as a closed top parabolic edge providing attachment.

[0250] Figure 24 is an illustration of a bottom view of a cylindrical leaflet component 258 according to the present application showing full engagement to form a closed fluid seal.

[0251] Figures 25(a) through 25(e) are illustrations of a process in which a valve with pre-perforated drum is delivered orthogonally within a catheter, ejected from the catheter and deployed into a native annulus. Figure 25(a) shows a compressed and folded orthogonal valve located within a delivery catheter and moved along a guide wire through a native annulus. Figure 25(b) shows the orthogonal being partially ejected into the native annulus with the delivery catheter able to twist or position the valve as needed. Figure 25(c) shows the valve fully ejected with the rvot tab extending in a sub-annular fashion to help anchor the valve and the valve held at an angle upward to allow washing and engagement to be implemented / initiated. Figure 25(d) is a top view showing the pre-perforated drum and regurgitant passageway located within the perimeter of radio-opaque markers. Figure 25(e) is a side perspective view and shows the pre-perforated drum and regurgitant passageway located within the perimeter of radio-opaque markers with the inner regurgitant control component mounted within the outer support frame adjacent to the inner flow control component (leaflet and frame).

[0252] Figure 26 is an illustration of an outer wire frame 102.

[0253] Figure 27is an illustration of a top perspective view of an outer frame 102 having a partially folded configuration, with the side walls rotated or hinged at their lateral connection points 116, 120, shown as a first step in the process of allowing folding and compression of the outer frame 102, in accordance with the present invention.

[0254] Figure 28 is an illustration of a side view of an outer frame 102 in a fully flat-fold 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 folding and compression of the outer frame 102, in accordance with the present invention.

[0255] Figure 29 is an illustration of a side view of an outer frame 102 in a folded and vertically compressed configuration 210, with the wire frame side walls vertically compressed in a pleated or accordion-fold configuration, shown as a second step in the process of allowing folding and compression of the outer frame 102, in accordance with the present invention.

[0256] Figure 30 is an illustration of a top perspective view of an assembled valve having an inner regurgitation control component 137 with markers and a reinforcing ring, an outer frame 102, a flow control component 130 with an inner leaflet frame 231 and three sutured leaflet pockets / cusps 258, an inner septum frame 137, and a mesh cover 141 over the septum frame, with folding lines 109 shown as dashed lines, in accordance with the present invention.

[0257] Figure 31 is an illustration of a top perspective view of an assembled valve having an inner regurgitation control component 137 with markers, 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 on the outer frame at a different location, a flow control component 130 with an inner leaflet frame 231 and three sutured leaflet pockets / cusps 258, an inner septum frame 137, and a mesh cover 141 over the septum frame, with folding lines 109 shown as dashed lines and traversing the mesh cover, in accordance with the present invention.

[0258] Figure 32is an illustration of a bottom perspective view of an assembled valve according to the present invention, the assembled valve having an outer frame 102, a first subannular anchoring / positioning tab 268 mounted on the outer frame 102 proximal to the flow control component 130, a second subannular anchoring / positioning tab 270 mounted on the outer frame 102 at a different location, a flow control component 130 having an inner leaflet frame 231 and three sutured leaflet pockets / cusps 258, an inner septal frame 137, and a mesh cover 141 over the septal frame.

[0259] Figure 33 is an illustration of a top view of an assembled valve according to the present invention, the assembled valve having 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 septal frame 137, and a mesh cover 141 over the septal frame.

[0260] Figure 34 is an illustration of a top perspective view of an assembled valve according to the present invention, the assembled valve having an inner regurgitation control component 137 with a reinforcing ring, an outer frame 102, a first subannular anchoring / positioning tab 268 mounted on the outer frame 102 proximal to the flow control component 130, a second subannular anchoring / positioning tab 270 mounted on the outer frame 102 at a different location, a flow control component 130 having an inner leaflet frame 231 and three sutured leaflet pockets / cusps 258, an inner septal frame 137, and a mesh cover 141 over the septal frame.

[0261] Figure 35 (a) to Figure 35 (e) is an illustration of a stepwise process in which a tissue drum is perforated prior to loading the valve orthogonally into a delivery catheter. Step (a) illustrates the step of providing an orthogonal prosthetic valve (foldable, compressible for lateral delivery, with rvot tabs, guide wire lumen, atrial collar, and proximal tab) as described herein. Step (b) illustrates the step of creating an opening by cutting or using a balloon device. Step (c) illustrates the step of laying flat the valve in preparation for loading into a delivery catheter. Step (d) illustrates the step of vertically compressing the valve in preparation for loading the valve into a delivery catheter. Step (e) illustrates the step of laterally loading the orthogonal valve into a delivery catheter.

[0262] Figure 36 (a) to Figure 36(c) is an illustration of a stepwise procedure where the tissue drum is perforated after the valve is ejected orthogonally from the delivery catheter and deployed into the native annulus. Step (a) shows 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) shows the step of positioning the radiopaque markers using fluoroscopy. Step (c) shows the step of creating the opening by cutting or using a balloon device.

[0263] Figure 37 is an illustration of how the user can match the size of the orifice to the desired regurgitant flow (e.g., regurgitant level in the range of 0.5-2.0). Radiopaque markers can be used to assist in measuring the size of the perforation to be made.

[0264] Figure 38 is an illustration of how the user can match the size of the lumen of a tubular stent, which can be deployed into the orifice, to the desired regurgitant flow (e.g., regurgitant level in the range of 0.5-2.0).

[0265] Figure 39 is an illustration of a side septal plan view of a labeled valve 100 according to the present invention, having a subannular anchoring and / or positioning tab 268 extending toward the distal side and a second subannular tab 270 extending toward the proximal side and having a visible foldable and compressible wire frame construction, including inner frame 231, leaflets 258, and inner regurgitant control component 137.

[0266] Figure 40 (a) to Figure 40 (f) is an illustration of a closure device for closing a perforation in an inner regurgitant control component. Step (a) shows the step of providing an orthogonal prosthetic valve (foldable, compressible for lateral delivery, with rvot tab, guide wire lumen, atrial collar, and proximal tab) as described herein, having an inner regurgitant control component 137 that needs to be sealed. Step (b) shows the step of accessing the perforation using a catheter tool. Step (c) shows the step of expanding a first disc or button on the distal underside of the perforation. Step (d) shows the step of expanding a second disc or button on the proximal top side of the perforation. Step (e) shows the step of cinching the two discs / buttons together, creating a seal to block regurgitation engineered in, e.g., a 1-2 mm perforation. Step (f) shows the step of withdrawing the catheter tool.

[0267] Figure 41is an illustration of a top view of a valve partially ejected from a delivery catheter 138, with a distal tab 268 guiding the valve (along an unillustrated guide wire) toward a deployment location, a distal flow control component 130 beginning to open, and showing two of three leaflets 258 opened from a folded flat configuration and a third leaflet opened from a folded configuration in which the third leaflet folds back on itself while in the delivery catheter 138.

[0268] Figure 42 is an illustration of a top view of a valve compressed 136 (orthogonally loaded) within a delivery catheter 138, the valve having an outer frame 102 with a first tab 268 extending forward along an x-axis and a second trailing tab 270 extending rearward along the x-axis.

[0269] Figure 43 is an illustration of a top view of a valve according to the present invention, the valve having an outer frame 102, an eccentric inner flow control component 130 (leaflets in frame), and an irregularly shaped spacer / support frame 137.

[0270] Figure 44 is an illustration of a top view of a valve according to the present invention, the valve having an outer frame 102, a centrally located inner flow control component 130 (leaflets in frame), and a pair of irregularly shaped spacer / support frames 135, 137 on opposite sides of the inner flow control component 130.

[0271] Figure 45 is an illustration of a top view of a valve according to the present invention, the valve having an outer frame 102 and an inner flow control component 130 (leaflets in frame) and a plurality of suture attachment points 129, wherein the inner flow control component 130 is sutured to the outer frame 102.

[0272] Figure 46 is a top view of a valve with an inner reflux control component 137, with a pacemaker and lead set 145 extending through a perforation. Figure 46 Also shown is an outer frame 102 according to the present invention, an eccentric inner flow control component 130 with a frame 231 and leaflets 258, and an inner spacer frame 137, all three structures foldable along the same x-axis 109.

[0273] Figure 47is an illustration of a top view of a valve according to the present invention, the valve having an inner regurgitation control component 137, an outer frame 102, a centrally located inner flow control component 130 having a frame 231 and leaflets 258, and a pair of smaller cylindrical inner regurgitation control components 137, 147 mounted on opposite sides of the inner flow control component 231 to provide support within the inner dimension of the outer frame 102, all four structures foldable along the same x-axis 109. Here, the inner regurgitation control component 137 has a three-leaflet microvalve mounted immediately proximal to the main flow control component, and the second inner regurgitation control component / drum 147 has an unperforated tissue cover which can later provide the physician with the opportunity to add additional regurgitation as needed.

[0274] Figure 48 is an illustration of a top view of a valve according to the present invention, the valve having a distal side inner regurgitation control component 137, an outer frame 102, a proximally located eccentric inner flow control component 130 having a frame 231 and leaflets 258, all three structures foldable along the same x-axis 109.

[0275] Figure 49 is an illustration of a side view of a human heart according to the present invention, the human heart having a transfemoral / IVC or SVC delivery catheter 138 traversing from the right atrium to the left atrium to access the mitral valve. Figure 49 shows the orthogonal delivery steps:

[0276] 1. Provide a foldable, compressible prosthetic tricuspid valve;

[0277] 2. Load the valve laterally into the delivery catheter;

[0278] 3. Advance the valve over a pre-positioned guide wire threaded onto a subannular distal tab via the IVC or SVC to the heart;

[0279] 4. Partially eject the valve to position the distal subannular tab and allow the valve leaflets to begin functioning;

[0280] 5. Complete the deployment of the valve into the native annulus.

[0281] 6. Optionally: if the regurgitation drum was not opened prior to loading into the delivery catheter, a cutting tool or balloon tool can be advanced and create a 1-2 mm opening in the tissue covering of the drum frame.

[0282] 7. Optionally: a pacemaker lead set can be advanced through the opening in the regurgitation drum and one or more pacemaker wires attached at or near the target node.

[0283] Additional definitions and parts list

[0284] 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.

[0285] 100 transcatheter prosthetic heart valve of dual-tab orthogonal delivery.

[0286] 102 self-expanding annular (outer) support frame.

[0287] 103 collar structure.

[0288] 104 central passage.

[0289] 106 outer peripheral wall.

[0290] 107 top edge of outer support frame.

[0291] 108 central vertical axis.

[0292] 109 Z-axis, from front to back, fold line axis.

[0293] 110 front wall portion of peripheral wall.

[0294] 112 back wall portion of peripheral wall.

[0295] 114 proximal side.

[0296] 116 proximal fold region.

[0297] 117 auxiliary proximal fold region.

[0298] 118 distal side.

[0299] 120 distal fold region.

[0300] 121 auxiliary distal fold region.

[0301] 122 front upper collar portion.

[0302] 124 front lower body portion of outer frame.

[0303] 126 back upper collar portion.

[0304] 128 back lower body portion.

[0305] 129 suture attachment points for inside-out.

[0306] 130 flow control component, made of an inner frame with tissue leaflets mounted therein, collapsible (foldable and compressible), the inner frame mounted within an annular outer support frame and configured to allow blood flow through the inflow end portion in a first direction and to prevent blood flow through the outflow end portion in an opposite second direction.

[0307] 132 inflow end portion.

[0308] 134 outflow end portion.

[0309] 135 pumping channel.

[0310] 136 compressed configuration

[0311] 137 inner regurgitation control component.

[0312] 138 delivery catheter.

[0313] 139 uncovered regurgitation frame, engineered (therapeutic) partial regurgitation

[0314] 140 X-axis, horizontal axis, parallel to the delivery catheter central axis

[0315] 141 tissue covering (plastic deformation).

[0316] 142 intersection angle 45-135 degrees, X-axis and Y-axis.

[0317] 143 stiffening ring.

[0318] 144 radiopaque marker.

[0319] 146 longitudinal cylindrical axis of the delivery catheter.

[0320] 148 height of about 5-60 mm.

[0321] 150 diameter of about 25-80 mm.

[0322] 202 multiple compressible wire units - outer frame.

[0323] 204 orientation and unit geometry, substantially orthogonal to the central vertical axis to minimize wire unit strain when compressing the annular support frame.

[0324] 206 vertical compressed configuration.

[0325] 208 folded configuration.

[0326] 210 folded and compressed configuration.

[0327] 212 inner frame shape or outer frame shape, selected from a funnel, a cylinder, a flat cone or a circular hyperboloid.

[0328] 220 Braided substrate.

[0329] 222 Wire frame substrate.

[0330] 224 Laser cut wire frame.

[0331] 226 Biocompatible material.

[0332] 227 Horn shaped cuff on inner frame.

[0333] 228 Side profile of inner frame is flat cone shape.

[0334] 229 Non-cylindrical inner frame, e.g. elliptical cross section. 230 Diameter R of 40-80mm.

[0335] 231 Inner frame for mounting leaflets.

[0336] 232 Diameter r of 20-60mm.

[0337] 233 Uniform wire frame unit group of inner frame.

[0338] 234 Height of 5-60mm.

[0339] 235 Non-uniform variable height unit of inner frame.

[0340] 236 Inner surface of annular outer support frame.

[0341] 237 Non-uniform unit geometry, wire frame size. 238 Outer surface of annular outer support frame.

[0342] 239 Compressed inner frame.

[0343] 240 Pericardial tissue for covering valve surface.

[0344] 241 Diamond or eye-like wire units.

[0345] 242 Braided synthetic polyester material.

[0346] 243 Eyelet on inner wire frame, consistent commissure attachment. 244 Outer support frame with hourglass shape.

[0347] 245 Laser cut attachment features on inner frame.

[0348] 246 Top diameter R1 of 40-80mm.

[0349] 248 Bottom diameter R2 of 50-70mm.

[0350] 250 Inner diameter of 20-60mm.

[0351] 252 height of 5-60 mm.

[0352] 254 inner diameter of 20-60 mm.

[0353] 256 height of 10-40 mm.

[0354] 257 leaflet band, mounting band for leaflet pocket.

[0355] 258 leaflet, plurality of leaflets, pericardial material.

[0356] 259 sutured edge of leaflet.

[0357] 260 cylindrical at the inflow end.

[0358] 261 open edge of leaflet

[0359] 262 flattened closable aperture at the outflow end.

[0360] 264 longitudinal support in / on the flow control component, selected from rigid or semi-rigid post, rigid or semi-rigid rib, rigid or semi-rigid rod, rigid or semi-rigid panel, and combinations thereof.

[0361] 266 (any) lumen (ball) on the distal tab.

[0362] 268 distal tab / subannular anchoring tab, can be rvot or other, constructed from coil or wire frame, integrated frame segment or stent, extending about 10-40 mm away from the annular support frame.

[0363] 269 independent RVOT tab.

[0364] 270 proximal tab / subannular anchoring tab.

[0365] 271 independent proximal tab.

[0366] 272 distal upper edge of the annular support frame.

[0367] 273 upper atrial tension arm, constructed from coil or wire frame, extending about 2-20 mm away from the annular support frame.

[0368] 274 lower tension arm, constructed from coil or wire frame, integrated frame segment or stent, extending about 10-40 mm away from the annular support frame.

[0369] 276 distal side of the annular support frame.

[0370] 278 tissue anchor, connected to the annular support frame for engaging native tissue.

[0371] 280 The front wall portion of the frame is a first flat panel.

[0372] 282 The back wall portion of the frame is a second flat panel.

[0373] 284 Stitched seam.

[0374] 285 Hinge.

[0375] 286 Flexible fabric span, without any wire elements.

[0376] 287 Fabric panel.

[0377] 288 Braided wire elements.

[0378] 289 Commisure attachment - leaflets to frame.

[0379] 290 Laser cut wire elements.

[0380] 302 Rolled into compressed configuration.

[0381] 304 Rolled into compressed configuration bilaterally.

[0382] 306 Flattening of annular support frame panel.

[0383] 308 Compressing annular support frame from top to bottom.

[0384] 310 Sheath / rigid elongate push rod / pull wire.

[0385] 311 Guide wire.

[0386] 312 Steerable catheter for rotating 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.

[0387] 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.

[0388] Having thus described embodiments of the application, it is noted that modifications and variations can be made by persons skilled in the art in light of the above teachings. It is therefore to be understood that changes can be made in the particular embodiments of the application disclosed which are within the scope and spirit of the application as defined by the appended claims. Having thus described the application with the detail and particularity required by the patent laws, what is wanted to be secured by Letters Patent is set forth in the scope of the claims which follow that application is not limited to the embodiments disclosed herein but it is intended to cover anything falling within the scope of the appended claims.

Claims

1. A prosthetic heart valve, comprising: an outer frame defining a central passage extending along a first central axis extending through the outer frame; a flow control component mounted within the central passage and coupled to the outer frame such that a second central axis extending through the flow control component is offset relative to the first central axis, the flow control component configured to allow blood to flow in a first direction along the second central axis and to prevent blood from flowing in a second direction opposite the first direction; and a regurgitation control component disposed within the central passage and coupled to the outer frame such that a third central axis extending through the regurgitation control component is offset relative to the first central axis and the second central axis, the regurgitation control component configured to selectively allow controlled regurgitation in the second direction.

2. The prosthetic valve of claim 1, wherein: the outer frame forms a plurality of compressible wire cells, the orientation and cell geometry of the wire cells allowing the outer frame to be compressed along the first central axis, the outer frame further forming a pair of hinge points that allow the outer frame to be folded along a longitudinal axis that is perpendicular to the first central axis and extends through the hinge points; the prosthetic heart valve is configured to be compressed along the first central axis and folded along the longitudinal axis to place the prosthetic valve in a compressed configuration for lateral delivery via a delivery catheter; the prosthetic heart valve is configured to transition into an expanded configuration when the prosthetic heart valve is released from the delivery catheter.

3. The prosthetic valve of claim 1, wherein, the flow control component is elastically deformable from a generally cylindrical configuration to a generally flat configuration when the prosthetic valve is in the compressed configuration.

4. The prosthetic valve of claim 1, wherein, the regurgitation control component includes a tissue cover that selectively defines an orifice, the orifice configured to allow the controlled regurgitation in the second direction.

5. The prosthetic valve of claim 4, wherein, a size of the orifice is based at least in part on a desired regurgitation level through the regurgitation control component, the regurgitation level being 0.5-2.

0.

6. The prosthetic valve of claim 5, wherein, the tissue cover is coupled to a reinforcing ring of the regurgitation control component, the reinforcing ring circumscribing the orifice, the reinforcing ring configured to limit tearing of the tissue cover associated with the orifice.

7. The prosthetic valve of claim 1, wherein, the flow control component includes an inner frame and a plurality of leaflets coupled to the inner frame and configured to allow blood to flow in the first direction and to prevent blood from flowing in the second direction; and the regurgitation control component includes a plurality of leaflets configured to allow the controlled regurgitation in the second direction and to prevent blood from flowing in the first direction through the regurgitation control component.

8. The prosthetic valve of claim 7, wherein, the regurgitation control component is a first regurgitation control component, the prosthetic valve further comprising: a second regurgitation control component disposed within the central passage and coupled to the outer frame such that a fourth central axis extending through the regurgitation control component is offset relative to the first central axis, the second central axis, and the third central axis, the second regurgitation control component selectively defining an orifice configured to allow controlled regurgitation in the second direction.

9. The prosthetic valve of claim 8, wherein, the second regurgitation control component includes a tissue cover configured to prevent the controlled regurgitation through the second regurgitation control component; the tissue cover is configured to be perforated to allow the controlled regurgitation through the second regurgitation control component.

10. A prosthetic heart valve, comprising: an outer frame defining a central passage extending along a central axis extending through the outer frame; a flow control component mounted within the central passage and coupled to the outer frame, the flow control component configured to allow blood to flow in a first direction along the central axis and to prevent blood from flowing in a second direction opposite the first direction; a drum attached to a top edge of the outer frame to cover a portion of the central passage adjacent to and outside of the flow control component; a first regurgitation control component disposed within the central passage and coupled to the drum, the first regurgitation control component configured to selectively allow controlled regurgitation in the second direction; and a second regurgitation control component disposed within the central passage and coupled to the drum, the second regurgitation control component configured to selectively allow controlled regurgitation in the second direction.

11. The prosthetic valve of claim 10, wherein, the outer frame forms a plurality of compressible wire cells, the orientation and cell geometry of the wire cells allowing the outer frame to be compressed along a first central axis, the outer frame further forming a pair of hinge points that allow the outer frame to be folded along a longitudinal axis that is perpendicular to the first central axis and extends through the hinge points; the prosthetic heart valve is configured to be compressed along the first central axis and folded along the longitudinal axis to place the prosthetic valve in a compressed configuration for lateral delivery via a delivery catheter; the prosthetic heart valve is configured to transition to an expanded configuration when the prosthetic heart valve is released from the delivery catheter.

12. The prosthetic valve of claim 10, wherein, the flow control component is elastically deformable from a generally cylindrical configuration to a generally flat configuration when the prosthetic valve is in the compressed configuration.

13. The prosthetic valve of claim 1, wherein, at least one of the first and second regurgitation control components includes a tissue cover that selectively defines an orifice configured to allow controlled regurgitation in the second direction.

14. The prosthetic valve of claim 13, wherein, a size of the orifice is based at least in part on a desired regurgitation level through the regurgitation control component, the regurgitation level being 0.5-2.

0.

15. The prosthetic valve of claim 14, wherein, the tissue cover includes a reinforcing ring circumscribing the orifice, the reinforcing ring configured to limit tearing of the tissue cover associated with the orifice.

16. The prosthetic valve of claim 10, wherein, the flow control component includes an inner frame and a plurality of leaflets coupled to the inner frame and configured to allow blood to flow in the first direction and to prevent blood from flowing in the second direction; and the first regurgitation control component includes a plurality of leaflets configured to allow at least a portion of controlled regurgitation in the second direction through the first regurgitation control component and to prevent blood from flowing in the first direction through the first regurgitation control component.

17. The prosthetic valve of claim 16, wherein, the at least a portion of controlled regurgitation is a first portion of controlled regurgitation, the second regurgitation control component selectively defining an orifice configured to allow a second portion of controlled regurgitation in the second direction.

18. A laterally deliverable prosthetic heart valve, the prosthetic valve comprising: an outer frame defining a central passage extending along a central axis of the outer frame; a flow control component mounted within the central passage and configured to allow blood to flow in a first direction along the central axis from an inflow end portion to an outflow end portion of the flow control component and to prevent blood from flowing in a second direction opposite the first direction; and a regurgitation control component disposed within the central passage and coupled to the outer frame, the regurgitation control component configured to selectively allow controlled regurgitation of the prosthetic valve. The prosthetic valve is configured to be compressed in an axial direction parallel to the central axis and folded along a longitudinal axis perpendicular to the central axis to place the prosthetic valve in a compressed configuration for lateral delivery via a delivery catheter, wherein the central axis of the outer frame is perpendicular to a longitudinal axis extending through a lumen of the delivery catheter.

19. The prosthetic valve of claim 18, wherein, The outer frame forms a plurality of compressible wire cells, the orientation and cell geometry of the wire cells allowing the outer frame to be compressed in the axial direction, the outer frame further forming a pair of hinge points, the hinge points allowing the outer frame to be folded along a longitudinal axis extending through the hinge points.

20. The prosthetic valve of claim 18, wherein, The central axis is a first central axis extending through the outer frame, the flow control component being disposed within the central passage and coupled to the outer frame such that a second central axis extending through the flow control component is offset from the first central axis.

21. The prosthetic valve of claim 20, wherein, The regurgitation control component is disposed within the central passage and coupled to the outer frame such that a third central axis extending through the regurgitation control component is offset from the first central axis and the second central axis.

22. The prosthetic valve of claim 18, wherein, The regurgitation control component includes a tissue cover that selectively defines an orifice, the orifice being configured to allow controlled regurgitation of the prosthetic valve.

23. The prosthetic valve of claim 22, wherein, The size of the orifice is based at least in part on a desired regurgitation level through the regurgitation control component, the regurgitation level being 0.5-2.

0.

24. The prosthetic valve of claim 22, wherein, The tissue cover includes a reinforcing ring that circumscribes the orifice.

25. The prosthetic valve of claim 24, wherein, The reinforcing ring is configured to limit tearing associated with the orifice.

26. The prosthetic valve of claim 24, wherein, The regurgitation control component includes at least one radiopaque marker mounted on the reinforcing ring.

27. The prosthetic valve of claim 18, wherein, The flow control component includes an inner frame and a plurality of leaflets coupled to the inner frame and configured to allow blood flow in a first direction and to prevent blood flow in a second direction.

28. The prosthetic valve of claim 27, wherein, The regurgitation control component includes a plurality of leaflets configured to allow controlled regurgitation in the second direction through the regurgitation control component and to prevent blood flow in the first direction through the regurgitation control component.

29. The prosthetic valve of claim 27, wherein, The regurgitation control component is a first regurgitation control component, the prosthetic valve further comprising: a second regurgitation control component disposed within the central passage and coupled to the outer frame, the second regurgitation control component being configured to selectively allow controlled regurgitation of the prosthetic valve.

30. The prosthetic valve of claim 29, wherein, The first regurgitation control component includes a plurality of leaflets configured to allow controlled regurgitation in the second direction through the regurgitation control component and to prevent blood flow in the first direction through the regurgitation control component; and The second regurgitation control component selectively defines an orifice configured to allow controlled regurgitation through the second regurgitation control component.

31. The prosthetic valve of claim 30, wherein, The second regurgitation control component includes a tissue cover configured to prevent controlled regurgitation through the second regurgitation control component.

32. The prosthetic valve of claim 31, wherein, The tissue cover is configured to be perforated to allow controlled regurgitation through the second regurgitation control component.

33. A laterally deliverable prosthetic heart valve, the prosthetic valve comprising: an outer frame defining a central passage extending along a central axis of the outer frame, the outer frame forming a plurality of compressible wire cells, the orientation and cell geometry of the wire cells allowing the outer frame to be compressed in an axial direction parallel to the central axis, the outer frame further forming a pair of hinge points, the hinge points allowing the outer frame to be folded along a longitudinal axis extending through the hinge points; a flow control component mounted within the central passage and configured to permit blood to flow in a first direction from an inflow end to an outflow end of the flow control component along the central axis and to prevent blood from flowing in a second direction opposite the first direction; and a regurgitation control component disposed within the central passage and coupled to the drum, the drum attached to the top edge of the outer frame to cover a portion of the central passage adjacent to and outside of the flow control component, the regurgitation control component configured to selectively permit controlled regurgitation of the prosthetic valve in the second direction.

34. The prosthetic valve of claim 33, wherein, the prosthetic valve configured to be compressed axially and folded along a longitudinal axis perpendicular to the central axis to place the prosthetic valve in a compressed configuration for lateral delivery via a delivery catheter, wherein the longitudinal axis of the outer frame is parallel to a longitudinal axis extending through a lumen of the delivery catheter; and the prosthetic valve configured to transition to an expanded configuration when released from the delivery catheter.

35. The prosthetic valve of claim 33, wherein, the central axis is a first central axis extending through the outer frame, the flow control component disposed within the central passage and coupled to the outer frame such that a second central axis extending through the flow control component is offset relative to the first central axis.

36. The prosthetic valve of claim 35, wherein, the regurgitation control component disposed within the central passage and coupled to the drum such that a third central axis extending through the regurgitation control component is offset relative to the first central axis and the second central axis.

37. The prosthetic valve of claim 33, wherein, the regurgitation control component includes a tissue cover coupled to the drum, the tissue cover selectively defining an orifice configured to permit controlled regurgitation of the prosthetic valve in the second direction.

38. The prosthetic valve of claim 37, wherein, a size of the orifice is based at least in part on a desired regurgitation level through the regurgitation control component, the regurgitation level being 0.5-2.

0.

39. The prosthetic valve of claim 37, wherein, the regurgitation control component includes a reinforcement ring coupled to the tissue cover and circumscribing the orifice.

40. The prosthetic valve of claim 39, wherein, the reinforcement ring is configured to limit tearing associated with the orifice.

41. The prosthetic valve of claim 39, wherein, the regurgitation control component includes at least one radiopaque marker mounted on the reinforcement ring.

42. The prosthetic valve of claim 33, wherein, the flow control component includes an inner frame and a plurality of leaflets coupled to the inner frame and configured to permit blood to flow in the first direction and to prevent blood from flowing in the second direction.

43. The prosthetic valve of claim 42, wherein, the regurgitation control component includes a plurality of leaflets configured to permit controlled regurgitation in the second direction through the regurgitation control component and to prevent blood from flowing in the first direction through the regurgitation control component.

44. The prosthetic valve of claim 42, wherein, the regurgitation control component is a first regurgitation control component, the prosthetic valve further comprising: a second regurgitation control component disposed within the central passage and coupled to the drum, the second regurgitation control component configured to selectively permit controlled regurgitation of the prosthetic valve.

45. The prosthetic valve of claim 44, wherein, the first regurgitation control component includes a plurality of leaflets configured to permit controlled regurgitation in the second direction through the regurgitation control component and to prevent blood from flowing in the first direction through the regurgitation control component; and the second regurgitation control component selectively defines an orifice configured to permit controlled regurgitation through the second regurgitation control component.

46. The prosthetic valve of claim 45, wherein, the second regurgitation control component includes a tissue cover configured to prevent controlled regurgitation through the second regurgitation control component.

47. The prosthetic valve of claim 46, wherein, the tissue cover is configured to be perforated to permit controlled regurgitation through the second regurgitation control component.

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