Patent ID: 12186187

DETAILED DESCRIPTION

Disclosed embodiments are directed to a transcatheter heart valve replacement that includes a low profile, orthogonally delivered, implantable prosthetic valve.

The term “valve prosthesis” or “prosthetic valve” can refer to a combination of a frame and a leaflet or flow control structure, and can encompass both complete replacement of an anatomical part, e.g. anew mechanical valve replaces a native valve, as well as medical devices that take the place of and/or assist, repair, or improve existing anatomical parts, e.g. native valve is left in place.

The disclosed valves include a member that can be seated within a native valve annulus and can be used as a mounting element for a leaflet structure, a flow control component, or a flexible reciprocating sleeve or sleeve-valve. It may or may not include such a leaflet structure or flow control component, depending on the embodiment. Such members can be referred to herein as an “annular support frame,” “tubular frame,” “wire frame,” “flange,” “collar,” or similar terms.

The annular support frame can have a central axial lumen where a prosthetic valve or flow-control structure, such as a reciprocating compressible sleeve, is mounted across the diameter of the lumen. The annular support frame may have an outer circumferential surface for engaging native annular tissue that is also tensioned against the inner aspect of the native annulus and provides structural patency to a weakened native annular ring.

The annular support frame may optionally have a separate atrial collar attached to the upper (atrial) edge of the frame, for deploying on the atrial floor, that is used to direct blood from the atrium into the sleeve and to seal against blood leakage around the annular support frame. The annular support frame may also optionally have a separate ventricular collar attached to the lower (ventricular) edge of the frame, for deploying in the ventricle immediately below the native annulus that is used to prevent regurgitant leakage during systole, to prevent dislodging of the device during systole, to sandwich or compress the native annulus or adjacent tissue against the atrial collar, and optionally to attach to and support the sleeve/conduit.

The annular support frame may have a flow control component mounted within the annular support frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve.

The term “flow control component” can refer in a non-limiting sense to a leaflet structure having 2-, 3-, 4-leaflets of flexible biocompatible material such a treated or untreated pericardium that is sewn or joined to a annular support frame, to function as a prosthetic heart valve. Such a valve can be a heart valve, such as a tricuspid, mitral, aortic, or pulmonary, that is open to blood flowing during diastole from atrium to ventricle, and that closes from systolic ventricular pressure applied to the outer surface. Repeated opening and closing in sequence can be described as “reciprocating.” The flow control component is contemplated to include a wide variety of (bio)prosthetic artificial heart valves, including ball valves (e.g. Starr-Edwards), bileaflet valves (St. Jude), tilting disc valves (e.g. Bjork-Shiley), stented pericardium heart-valve prosthesis' (bovine, porcine, ovine) (Edwards line of bioprostheses, St. Jude prosthetic valves), as well as homograft and autograft valves. Bioprosthetic pericardial valves can include bioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetic tricuspid valves, and bioprosthetic pulmonary valves.

In some embodiments, the flow control component and the annular support frame can be separate structures, and delivered separately. In such embodiments, the term “valve frame” or “prosthetic valve frame” or “valve-in-valve” can refer to a three-dimensional structural component, usually tubular, cylindrical, or oval or ring-shaped, and that can be seated within a native valve annulus and used as a mounting element for a commercially available valve such as a Sapien®, Sapien 3®, and Sapien XT® from Edwards Lifesciences, the Inspiris Resilia aortic valve from Edwards Lifesciences, the Masters HP 15 mm valve from Abbott, Lotus Edge valve from Boston Scientific, the Crown PRT leaflet structure from Livanova/Sorin, the Carbomedics family of valves from Sorin, or other flow control component, or a flexible reciprocating sleeve or sleeve-valve.

In some embodiments, the annular support frame used in the prosthetic heart valve may be deployed in the tricuspid annulus and may have a complex shape determined by the anatomical structures where the valve is being mounted. For example, in the tricuspid annulus, the circumference of the tricuspid valve may be a rounded ellipse, the septal wall is known to be substantially vertical, and the tricuspid is known to enlarge in disease states along the anterior-posterior line.

In some embodiments, the annular support frame used in the prosthetic heart valve may be deployed in the mitral annulus and may have a complex shape determined by the anatomical structures where the valve is being mounted. For example, in the mitral annulus, the circumference of the mitral valve may be a rounded ellipse, the septal wall is known to be substantially vertical, and the mitral is known to enlarge in disease states.

The annular support frame may be compressed for transcatheter delivery and may be expandable as a self-expandable shape-memory element or using a transcatheter expansion balloon. Some embodiments may have both an atrial collar and a ventricular collar, whereas other embodiments include prosthetic heart valves having either a single atrial collar, a single ventricular collar, or having no additional collar structure.

The term “expandable” as used herein may refer to a component of the heart valve capable of expanding from a first, delivery diameter to a second, implantation diameter. An expandable structure, therefore, does not mean one that might undergo slight expansion from a rise in temperature, or other such incidental cause. Conversely, “non-expandable” should not be interpreted to mean completely rigid or a dimensionally stable, as some slight expansion of conventional “non-expandable” heart valves, for example, may be observed.

The atrial collar can be shaped to conform to the native deployment location. In a mitral replacement, the atrial collar will be configured with varying portions to conform to the native valve. In one embodiment, the collar will have a distal and proximal upper collar portion. The distal collar portion can be larger than the proximal upper collar portion to account for annular or subannular geometries.

In some embodiments, the annular support frame can have a central channel and an outer perimeter wall circumscribing a central vertical axis in an expanded configuration. The perimeter wall can encompass both the collar and the lower body portions.

The perimeter wall can be further defined as having a front wall portion and a back wall portion, which are connected along a near side (to the inferior vena cava (“IVC”)) or proximal side to a proximal fold area, and connected along a far or distal side to a distal fold area. This front wall portion can be further defined as having a front upper collar portion and a front lower body portion, and the back wall portion can be further defined as having a back upper collar portion and a back lower body portion.

The valves may be compressed and delivered in a sideways manner. The shape of the expanded valve can be that of a large diameter shortened cylinder with an extended collar or cuff. The valves can be compressed, in some embodiments, where the central axis of the valve is roughly perpendicular to (orthogonal to) the lengthwise axis of the delivery catheter. In some embodiments, the valves can be compressed vertically, similar to collapsing the height of a cylinder accordion-style from taller to shorter, and the valves are also compressed by folding a front panel against a back panel. In other embodiments, the valves can be compressed by rolling.

The terms “side-delivered”, “side-delivery”, “orthogonal”, “orthogonally delivered” and so forth are used to describe that the valves are compressed and delivered at a roughly 90 degree angle compared to traditional transcatheter heart valves. Orthogonal delivery is a transverse delivery where a perimeter distal sidewall exits the delivery catheter first, followed by the central aperture, followed by the proximal sidewall.

Mathematically, the term orthogonal refers to an intersecting angle of 90 degrees between two lines or planes. As used herein, the term “substantially orthogonal” refers to an intersecting angle ranging from 75 to 105 degrees. The intersecting angle or orthogonal angle refers to both (i) the relationship between the lengthwise cylindrical axis of the delivery catheter and the long-axis of the compressed valve, where the long-axis is perpendicular to the central cylinder axis of traditional valves, and (ii) the relationship between the long-axis of the compressed or expanded valve and the axis defined by the blood flow through the prosthetic valve where the blood is flowing, e.g. from one part of the body or chamber of the heart to another downstream part of the body or chamber of the heart, such as from an atrium to a ventricle through a native annulus.

The annular support frame can be a ring, or cylindrical or conical tube, but may also have a side profile of a flat-cone shape, an inverted flat-cone shape (narrower at top, wider at bottom), a concave cylinder (walls bent in), a convex cylinder (walls bulging out), an angular hourglass, a curved, graduated hourglass, a ring or cylinder having a flared top, flared bottom, or both.

The annular support frame may have a height in the range of about 5-60 mm, may have an outer diameter dimension, R, in the range of about 30-80 mm, and may have an inner diameter dimension in the range of about 31-79 mm, accounting for the thickness of the wire material itself.

In some embodiments, the horizontal x-axis of the valve is orthogonal to (90 degrees), or substantially orthogonal to (75-105 degrees), or substantially oblique to (45-135 degrees) to the central vertical y-axis when in an expanded configuration.

In some embodiments, the horizontal x-axis of the compressed configuration of the valve is substantially parallel to a lengthwise cylindrical axis of the delivery catheter.

In some embodiments, the valve can have a compressed height (y-axis) and width (z-axis) of 6-15 mm, preferably 8-12 mm, and more preferably 9-10 mm, and an expanded deployed height of about 5-60 mm, preferably about 5-30 mm, and more preferably about 5-20 mm or even 8-12 mm or 8-10 mm. In some embodiments, the length of the valve, x-axis, does not require compression since it can extend along the length of the central cylindrical axis of the delivery catheter.

In some embodiments, the valve can have an expanded diameter length and width of 25-80 mm, preferably 40-80 mm, and in certain embodiments length and/or width may vary and include lengths of 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, and 80 mm, in combination with widths that are the same or different as the length.

In some embodiments, the valve can be centric, or radially symmetrical. In other embodiments, the valve can be eccentric, or radially (y-axis) asymmetrical. In some eccentric embodiments, the outer frame may have a D-shape (viewed from the top) so the flat portion can be matched to the mitral annulus near the anterior leaflet.

In some embodiments, the inner frame holding the leaflet tissue is 25-29 mm in diameter, the outer frame is 50-70 mm in diameter, and the collar structure extends beyond the top edge of the outer frame by 10-30 mm to provide a seal on the atrial floor against perivalvular leaks (PVLs).

The annular support frame may be made from a variety of durable, biocompatible structural materials. Preferably, the frame is made from superelastic metal wire, such as a Nickel-Titanium alloy (e.g. Nitinol™) wire or other similarly functioning material. The material may be used for the frame/stent, for the collar, and/or for anchors. It is contemplated to use other shape memory alloys such as Cu—Zn—Al—Ni alloys, Cu—Al—Ni alloys, as well as polymer composites including composites containing carbon nanotubes, carbon fibers, metal fibers, glass fibers, and polymer fibers.

The frame design is preferably compressible and when released has the stated property that it returns to its original (uncompressed) shape. This requirement limits the potential material selections to metals and plastics that have shape memory properties. With regards to metals, Nitinol has been found to be especially useful since it can be processed to be austenitic, martensitic or super elastic. Martensitic and super elastic alloys can be processed to demonstrate the required compression features.

The frame may be constructed as a braid, wire, or laser cut wire frame. Such materials are available from any number of commercial manufacturers, such as Pulse Systems. One possible construction of the wire frame envisions the laser cutting of a thin, isodiametric Nitinol tube. The laser cuts form regular cutouts in the thin Nitinol tube. In one embodiment, the Nitinol tube expands to form a three-dimensional structure formed from diamond-shaped cells.

The structure may also have additional functional elements, e.g. loops, anchors, etc. for attaching accessory components such as biocompatible covers, tissue anchors, releasable deployment and retrieval control guides, knobs, attachments, rigging, and so forth. Secondarily the tube is placed on a mold of the desired shape, heated to the Martensitic temperature and quenched. The treatment of the wire frame in this manner will form a device that has shape memory properties and will readily revert to the memory shape at the calibrated temperature. Laser cut wire frames are preferably made from Nitinol, but also without limitation made from stainless steel, cobalt chromium, titanium, and other functionally equivalent metals and alloys.

Alternatively, a frame can be constructed utilizing simple braiding techniques. Using a Nitinol wire—for example, a 0.012″ wire—and a simple braiding fixture, the wire can be wound on the braiding fixture in a simple over/under braiding pattern until an isodiametric tube is formed from a single wire. The two loose ends of the wire are coupled using a stainless steel or Nitinol coupling tube into which the loose ends are placed and crimped. Angular braids of approximately 60 degrees have been found to be particularly useful. Secondarily, the braided wire frame is placed on a shaping fixture and placed in a muffle furnace at a specified temperature to set the wire frame to the desired shape and to develop the martensitic or super elastic properties desired.

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

Accordingly, a prosthetic heart valve may start in a roughly tubular configuration, and be heat-shaped to provide an upper atrial cuff or flange for atrial sealing and a lower trans-annular tubular or cylindrical section having an hourglass cross-section for about 60-80% of the circumference to conform to the native annulus along the posterior and anterior annular segments while remaining substantially vertically flat along 20-40% of the annular circumference to conform to the septal annular segment.

The annular support frame is optionally internally or externally covered, partially or completely, with a biocompatible material such as pericardium. The annular or tubular frame may also be optionally externally covered, partially or completely, with a second biocompatible material such as polyester or Dacron®. Disclosed embodiments may use tissue, such as a biological tissue that is a chemically stabilized pericardial tissue of an animal, such as a cow (bovine pericardium), sheep (ovine pericardium), pig (porcine pericardium), or horse (equine pericardium). Preferably, the tissue is bovine pericardial tissue. Examples of suitable tissue include that used in the products Duraguard®, Peri-Guard®, and Vascu-Guard®, all products currently used in surgical procedures, and which are marketed as being harvested generally from cattle less than 30 months old. Other patents and publications disclose the surgical use of harvested, biocompatible animal thin tissues suitable herein as biocompatible “jackets” or sleeves for implantable stents, including for example, U.S. Pat. No. 5,554,185 to Block, U.S. Pat. No. 7,108,717 to Design & Performance-Cyprus Limited disclosing a covered stent assembly, U.S. Pat. No. 6,440,164 to Scimed Life Systems, Inc. disclosing a bioprosthetic valve for implantation, and U.S. Pat. No. 5,336,616 to LifeCell Corporation discloses acellular collagen-based tissue matrix for transplantation.

In some embodiments, components may be fabricated from a synthetic material such a polyurethane or polytetrafluoroethylene. Where a thin, durable synthetic material is contemplated, e.g. for a covering, synthetic polymer materials such expanded polytetrafluoroethylene or polyester may optionally be used. Other suitable materials may optionally include thermoplastic polycarbonate urethane, polyether urethane, segmented polyether urethane, silicone polyether urethane, silicone-polycarbonate urethane, and ultra-high molecular weight polyethylene. Additional biocompatible polymers may optionally include polyolefins, elastomers, polyethylene-glycols, polyethersulphones, polysulphones, polyvinylpyrrolidones, polyvinylchlorides, other fluoropolymers, silicone polyesters, siloxane polymers and/or oligomers, and/or polylactones, and block co-polymers using the same.

Polyamides (PA)—PA is an early engineering thermoplastic invented that consists of a “super polyester” fiber with molecular weight greater than 10,000. It is commonly called Nylon. Application of polyamides includes transparent tubings for cardiovascular applications, hemodialysis membranes, and also production of percutaneous transluminal coronary angioplasty (PTCA) catheters.

Polyolefin—Polyolefins include polyethylene and polypropylene are the two important polymers of polyolefins and have better biocompatibility and chemical resistance. In cardiovascular uses, both low-density polyethylene and high-density polyethylene are utilized in making tubing and housings. Polypropylene is used for making heart valve structures.

Polyesters—Polyesters includes polyethylene-terephthalate (PET), using the name Dacron. It is typically used as knitted or woven fabric for vascular grafts. Woven PET has smaller pores, which reduces blood leakage and better efficiency as vascular grafts compared with the knitted one. PET grafts are also available with a protein coating (collagen or albumin) for reducing blood loss and better biocompatibility. PET vascular grafts with endothelial cells have been searched as a means for improving patency rates. Moreover, polyesters are widely material for the manufacturing of bioabsorbable stents. Poly-L-lactic acids (PLLA), polyglycolic acid (PGA), and poly(D, L-lactide/glycolide) copolymer (PDLA) are some of the commonly used bioabsorbable polymers.

Polytetrafluoroethylene—Polytetrafluoroethylene (PTFE) is synthetic fluorocarbon polymer with the common commercial name of Teflon by DuPont Co. Common applications of PTFE in cardiovascular engineering include vascular grafts and heart valves. PTFE sutures are used in the repair of mitral valve for myxomatous disease and in surgery for prolapse of the anterior or posterior leaflets of mitral valves. PTFE is particularly used in implantable prosthetic heart valve rings. It has been successfully used as vascular grafts when the devices are implanted in high-flow, large-diameter arteries such as the aorta. Problem occurs when it is implanted below aortic bifurcations and another form of PTFE called elongated-PTFE (e-PTFE) was explored. Expanded PTFE is formed by compression of PTFE in the presence of career medium and finally extruding the mixture. Extrudate formed by this process is then heated to near its glass transition temperature and stretched to obtain microscopically porous PTFE known as e-PTFE. This form of PTFE was indicated for use in smaller arteries with lower flow rates promoting low thrombogenicity, lower rates of restenosis and hemostasis, less calcification, and biochemically inert properties.

Polyurethanes—Polyurethane has good physiochemical and mechanical properties and is highly biocompatible which allows unrestricted usage in blood contacting devices. It has high shear strength, elasticity, and transparency. Moreover, the surface of polyurethane has good resistance for microbes and the thrombosis formation by PU is almost similar to the versatile cardiovascular biomaterial like PTFE. Conventionally, segmented polyurethanes (SPUs) have been used for various cardiovascular applications such as valve structures, pacemaker leads and ventricular assisting device.

In some embodiments, frame components may include drug-eluting wire frames. Drug-eluting wire frames may consist of three parts: wire frame platform, coating, and drug. Some of the examples for polymer free coated frames are Amazon Pax (MINVASYS) using Amazonia CroCo (L605) cobalt chromium (Co—Cr) wire frame with Paclitaxel as an antiproliferative agent and abluminal coating have been utilized as the carrier of the drug. BioFreedom (Biosensors Inc.) using stainless steel as base with modified abluminal coating as carrier surface for the antiproliferative drug Biolimus A9. Optima (CID S.r.I.) using 316 L stainless steel wire frame as base for the drug Tacrolimus and utilizing integrated turbostratic carbofilm as the drug carrier. VESTA sync (MIV Therapeutics) using GenX stainless steel (316 L) as base utilizing microporous hydroxyapatite coating as carrier for the drug Sirolimus. YUKON choice (Translumina) used 316 L stainless steel as base for the drugs Sirolimus in combination with Probucol.

Biosorbable polymers may also be used herein as a carrier matrix for drugs. Cypher, Taxus, and Endeavour are the three basic type of bioabsorbable DES. Cypher (J&J, Cordis) uses a 316 L stainless steel coated with polyethylene vinyl acetate (PEVA) and poly-butyl methacrylate (PBMA) for carrying the drug Sirolimus. Taxus (Boston Scientific) utilizes 316 L stainless steel wire frames coated with translute Styrene Isoprene Butadiene (SIBS) copolymer for carrying Paclitaxel, which elutes over a period of about 90 days. Endeavour (Medtronic) uses a cobalt chrome driver wire frame for carrying zotarolimus with phosphorylcholine as drug carrier. BioMatrix employing S-Wire frame (316 L) stainless steel as base with polylactic acid surface for carrying the antiproliferative drug Biolimus. ELIXIR-DES program (Elixir Medical Corp) consisting both polyester and polylactide coated wire frames for carrying the drug novolimus with cobalt-chromium (Co—Cr) as base. JACTAX (Boston Scientific Corp.) utilized D-lactic polylactic acid (DLPLA) coated (316 L) stainless steel wire frames for carrying Paclitaxel. NEVO (Cordis Corporation, Johnson & Johnson) used cobalt chromium (Co—Cr) wire frame coated with polylactic-co-glycolic acid (PLGA) for carrying the drug Sirolimus.

The disclosed valve embodiments may be delivered by a transcatheter approach. 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 heart chamber, as well as an item that has been delivered or controlled by such as process. Transcatheter access is known to include via femoral artery and femoral vein, via brachial artery and vein, via carotid and jugular, via intercostal (rib) space, and via sub-xyphoid. Transcatheter can be synonymous with transluminal and is functionally related to the term “percutaneous” as it relates to delivery of heart valves.

In some embodiments, the transcatheter approach includes: (i) advancing to the tricuspid valve or pulmonary artery of the heart through the inferior vena cava via the femoral vein, (ii) advancing to the tricuspid valve or pulmonary artery of the heart through the superior vena cava via the jugular vein, (iii) advancing to the mitral valve of the heart through a trans-atrial approach, e.g. fossa ovalis or lower, via the IVC-femoral or the SVC jugular approach.

In some of the disclosed embodiments, the prosthetic valve is secured in part to native tissue by a tissue anchor. The term “tissue anchor” or “plication tissue anchor” or “secondary tissue anchor,” or “dart” or “pin” refers to a fastening device that connects the upper atrial frame to the native annular tissue, usually at or near the periphery of the collar. The anchor may be positioned to avoid piercing tissue and just rely on the compressive force of the two plate-like collars on the captured tissue, or the anchor, itself or with an integrated securement wire, may pierce through native tissue to provide anchoring, or a combination of both. The anchor may have a specialized securement mechanism, such as a pointed tip with a groove and flanged shoulder that is inserted or popped into a mated aperture or an array of mated apertures that allow the anchor to attach, but prevent detachment when the aperture periphery locks into the groove near the flanged shoulder. The securement wire may be attached or anchored to the collar opposite the pin by any attachment or anchoring mechanisms, including a knot, a suture, a wire crimp, a wire lock having a cam mechanism, or combinations.

In some of the disclosed embodiments, the prosthetic valve can be seated within the native valvular annulus through the use of tines or barbs. The tines or barbs are located to provide attachment to adjacent tissue. Tines are forced into the annular tissue by mechanical means such as using a balloon catheter. In one non-limiting embodiment, the tines may optionally be semi-circular hooks that upon expansion of the wire frame body, pierce, rotate into, and hold annular tissue securely. Anchors are deployed by over-wire delivery of an anchor or anchors through a delivery catheter. The catheter may have multiple axial lumens for delivery of a variety of anchoring tools, including anchor setting tools, force application tools, hooks, snaring tools, cutting tools, radio frequency and radiological visualization tools and markers, and suture/thread manipulation tools. Once the anchor(s) are attached to the moderator band, tensioning tools may be used to adjust the length of tethers that connect to an implanted valve to adjust and secure the implant as necessary for proper functioning. It is also contemplated that anchors may be spring-loaded and may have tether-attachment or tether-capture mechanisms built into the tethering face of the anchor(s). Anchors may also have in-growth material, such as polyester fibers, to promote in-growth of the anchors into the myocardium. In one embodiment, where a prosthetic valve may or may not include a ventricular collar, the anchor or dart is not attached to a lower ventricular collar, but is attached directly into annular tissue or other tissue useful for anchoring.

Some disclosed embodiments include a support post. The term “support post” refers to a rigid or semi-rigid length of material such as Nitinol or PEEK, that may be mounted on a spoked frame and that runs axially, or down the center of, or within a sewn seam of, the flexible sleeve. The sleeve may be unattached to the support post, or the sleeve may be directly or indirectly attached to the support post.

The term “body channel” may be used to define a blood conduit or vessel within the body, and the particular application of the disclosed embodiments of prosthetic heart valves determines the body channel at issue. An aortic valve replacement, for example, would be implanted in, or adjacent to, the aortic annulus. Likewise, a tricuspid or mitral valve replacement would be implanted at the tricuspid or mitral annulus. Certain features are particularly advantageous for one implantation site or the other. However, unless the combination is structurally impossible, or excluded by claim language, any of the heart valve embodiments described herein could be implanted in any body channel.

As used herein, the term “lumen” can refer to the inside of a cylinder or tube. The term “bore” can refer to the inner diameter.

FIG.1is an illustration of a low profile, e.g. 8-20 mm, side-loaded prosthetic valve shown deployed into the native annulus.

FIG.2is an illustration of a low profile, e.g. 8-20 mm, side-loaded prosthetic valve having frame102and sleeve110shown compressed or housed within the delivery catheter118.

FIG.3is an illustration of a low profile, e.g. 8-20 mm, side-loaded prosthetic valve shown ejected from the delivery catheter118and positioned against the anterior side of the native annulus. While the valve is held at this oblique angle by secondary catheter150, valve function and patient condition are assessed, and if appropriate, the valve is completely deployed within the native annulus, and anchored using traditional anchoring elements.

FIG.4is an illustration of an open cross-section view of a low profile, side-loaded prosthetic valve and shows the inner valve sleeve110and frame102.

FIG.5is an illustration of a low profile, side-loaded heart valve prosthesis according to an embodiment having a braid or laser-cut construction for the tubular frame102, with a valve sleeve110that extends beyond the bottom of the tubular frame.FIG.5shows a longer lower tension arm126for extending sub-annularly towards the RVOT, and a shorter upper tension arm128for extending over the atrial floor.

FIG.6is an illustration of a low profile, side-loaded heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve compressed within a delivery catheter118.FIG.6shows the valve attached to a secondary steerable catheter150for ejecting, positioning, and anchoring the valve. The secondary catheter150can also be used to retrieve a failed deployment of a valve.

FIG.7is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve shown partially compressed within a delivery catheter and partially ejected from the delivery catheter.FIG.7shows that while the valve is still compressed the lower tension arm can be manipulated through the leaflets and chordae tendineae to find a stable anterior-side lodgment for the distal side of the valve.

FIG.8is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve engaging the tissue on the anterior side of the native annulus with the curved distal sidewall of the tubular frame sealing around the native annulus.FIG.8shows the valve held by the steerable secondary catheter at an oblique angle while valve function is assessed.

FIG.9is an illustration of a heart valve prosthesis having a braid or laser-cut tubular frame and extended valve sleeve fully deployed into the tricuspid annulus. The distal side of the valve is shown engaging the tissue on the anterior side of the native annulus with the curved distal sidewall of the tubular frame sealing around the native annulus, and with the proximal sidewall tension-mounted into the posterior side of the native annulus.

FIG.10is an illustration of a plan view of an embodiment of a prosthetic valve shown in a compressed configuration within a delivery catheter.FIG.10shows the tubular frame wall rolled-over, outwardly, resulting in a 50% reduction in height of the catheter-housed valve. The low profile, side-loaded valves do not require the aggressive, strut-breaking, tissue-tearing, stitch-pulling forces that traditional transcatheter valves are engineered to mitigate.

FIG.11is an illustration of a cross-sectional view of an embodiment of a compressed valve within a delivery catheter118. This cross-sectional end view shows one embodiment of a single-fold compression configuration where the tubular frame wall102and attached two-panel sleeve110are rolled-over, outwardly, five times, resulting in a 50% reduction in height, and providing the ability to fit within the inner diameter of a 1 cm (10 mm) delivery catheter.

FIG.12is an illustration of a cross-sectional view of another embodiment of a compressed valve within a delivery catheter. This cross-sectional end view shows another embodiment of a single-fold compression configuration where the tubular frame wall and attached two-panel sleeve are folded-over, outwardly, four times, resulting in a 50% reduction in height, and providing the ability to fit within the inner diameter of a 1 cm (10 mm) delivery catheter.

FIG.13is an illustration of a cross-sectional view of an embodiment of the prosthetic valve to further illustrate how the folding and rolling configurations can be effectuated due to the minimal material requirement of the low profile, side-loaded valve102,110.

FIG.14A,14B,14Cis an illustration of a sequence of a low profile valve being rolled into a configuration for placement within a delivery catheter. Tubular frame102having aperture106supports sleeve110.

FIG.51Cis an illustration of an end view of a low profile valve that has been longitudinally rolled and loaded within a delivery catheter118, and shows frame102and sleeve110.

FIGS.16A to16Dillustrate one embodiment showing a four step (a)-(d) process for orthogonally compressing a prosthetic valve to provide a long-axis that is co-planar or parallel with the lengthwise axis of a delivery catheter. These figures shows that a prosthetic valve having a tubular frame made of a cuff and a trans-annular tubular section, having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, is compressible along a long-axis that is parallel to a lengthwise axis of a delivery catheter. These figures show that the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter where said compressed configuration has a long-axis that is perpendicular to the blood flow direction axis, i.e. oriented at an intersecting (orthogonal) angle of between 45-135 degrees, e.g. 90 degrees, to the first (blood flow) direction, and where the long-axis of the compressed configuration of the valve is substantially parallel to a lengthwise 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.FIG.16Ashows an illustration of an uncompressed valve.FIG.16Bshows an illustration of an initial rolling or folding of the cuff. The folding or rolling can be inwards as shown here, or may be outwardly rolled, or may also be flattened together for rolling the entire valve up from bottom to top.FIG.16Cshows an illustration of a valve that has been rolled or folded, using multiple folds or rolls, along a long-axis into a tube-shape.FIG.16Dshows an illustration of a completely compressed valve, that has been folded or rolled, using a compression accessory, and which is then loaded into the delivery catheter. Such a compressed valve may be self-expanding when released from the delivery catheter using shape-memory alloys, or the valve may be balloon expanded in a secondary process once the valve is released from the delivery catheter.

Referring now to the drawings,FIG.17Ais an illustration of a side perspective view of a side deliverable transcatheter heart valve100with fold area116according to an embodiment.FIG.17Ashows a distal fold area116in the collar portion105that permits compression of the valve without subjecting the annular frame102or inner flow control component130to damaging compression forces.

FIG.17Bis an illustration of a side perspective view of the valve showing an anterior side122of the valve commence a unilateral rolling process302.FIG.17Bshows two fold areas, proximal (near)120and distal (far)116. The fold areas116,120may be devoid of wire cells or may consist of cells that are large or oriented to minimize the folding or rolling damage from the compression process. Leaflets258of the flow control component are visible from this angle.

FIG.17Cis an illustration of a side perspective view of the valve showing a second rolling step of a unilateral rolling process302. Anterior collar122is rolled over to the central distal fold116and proximal fold116with posterior-septal collar126in an unrolled expanded configuration.

FIG.17Dis an illustration of a side perspective view of the valve showing a third rolling step of a unilateral rolling process302. The valve continues to be roll compressed towards the posterior-septal collar126.

FIG.17Eis an illustration of a side perspective view of the valve showing a completion of the unilateral rolling process to achieve a roll-compressed configuration136.

FIG.18Ais an illustration of a side perspective view of the valve showing two (2) sides of the valve commence a bilateral rolling process304, with two of four (shown) fold areas, distal fold120and second distal fold121. Anterior collar122and posterior-septal collar126are shown with outer frame wall106and leaflets258in dashed line for reference.

FIG.18Bis an illustration of a side perspective view of the valve showing a second rolling step of a bilateral rolling process304. The rim of the annular support frame is shown rolling inward towards the central axis146. Distal fold120and second distal fold121are shown opposite from proximal fold area116and second proximal fold area117. Flow control leaflets258are shown for reference.

FIG.18Cis an illustration of a side perspective view of the valve showing a third rolling step of a bilateral rolling process304. Here, the rolled rim is further rolled inward towards the central axis.

FIG.18Dis an illustration of a side perspective view of the valve showing a completion of the bilateral rolling compression process304shown rolled inward towards the central axis146.FIG.18Dshows a roll-compressed valve as it would appear in a compressed configuration within a delivery catheter (not shown).

FIG.19Ais an illustration of a side perspective view of a compressed valve where orthogonal compression uses both rolling and folding302. The lower portion is rolled, and the upper collar portion is folded lengthwise around axis146.

FIG.19Bis an illustration of a side perspective view of a partially uncompressed valve showing unrolling of the lower body portion and unfolding of the flattened upper collar portion.FIG.19Bshows the fold areas116,120in the collar portion.

FIG.19Cis an illustration of a side perspective view of the valve showing an uncompressed valve showing an unrolled lower body portion and an unfolded upper collar portion. Fold areas in the collar are wider as the valve assumes its expanded configuration.

FIG.19Dis an illustration of a side perspective view of the uncompressed valve showing a different side/orientation, which is 90 degrees from the prior views.

FIG.20is an illustration of a side perspective view of a valve having a circular hyperboloid (hourglass) shape. Wire frame details are not shown since in practice the external surface would preferably be covered with Dacron polyester to facilitate in-growth. Distal fold area120and proximal fold area116are shown book-ending the anterior collar122and posterior-septal collar126along horizontal axis140with front anterior wall110and central channel104shown, according to an embodiment.

FIG.21is an illustration of a cut away view of a valve having a circular hyperboloid (hourglass) shape.FIG.21shows that inner leaflet258and inner frame of flow control component (not visible) are attached to the inner surface of the annular frame, with collar portion105attached to subannular anchor portion269via wall portion106. Here, the flow control component is only attached at the top edge although other non-limiting attachments are contemplated, e.g. mid-wall, multiple attachment points, etc.

FIG.22is an illustration of an exploded view of a valve having a funnel collar122,126and cylinder body shape110,112.FIG.22shows one variation where the wire cell is used to create opposing panels, which are joined using fabric strain minimizing panels at distal120and proximal116fold areas.FIG.22also shows a three-leaflet258embodiment mounted on an inner U-shaped wire frame236

FIG.23is an illustration of a side view of a two (2) panel280,282embodiment of the valve.FIG.23shows that diamond wire cell298for the collar portion may be one large diamond in height, while the lower body portion may be constructed using two smaller diamond wire cells in height. Dashed line illustrates where the inner flow control component is attached but not shown.

FIG.24is an illustration of a side view of a roll-compressed two-panel embodiment of the valve136.

FIG.25is an illustration of an exploded view of a valve having a funnel collar122,126and cylinder body shape110,112.FIG.25shows one variation where the wire cell is used to create the entire opposing panels.FIG.25also shows a three-leaflet258embodiment mounted on an inner U-shaped wire frame236.

FIG.26is an illustration of a side view of a two-panel280,282embodiment of the valve.FIG.26shows that wave wire cell296for the collar portion may be one large wave cell in height, while the lower body portion may be constructed using one or two smaller wave wire cells in height. Dashed line illustrates where the inner flow control component is attached but not shown.

FIG.27is an illustration of a side view of a roll-compressed two-panel embodiment of the valve136.

FIG.28is an illustration of a side perspective view of a valve with a folding gap116,120in the wave wire frame296. Dashed line illustrates where the inner flow control component is attached but not shown.

FIG.29is an illustration of a top view of a valve with a folding gap116,120in the wave wire frame296. Central flow control component opening is shown as a horizontal linear gap262.

FIG.30is an illustration of a side perspective view of a valve with a folding gap286in a generic annular support wire frame298. Dashed line illustrates where the inner flow control component236is attached but not shown. Wire frame details are not shown since in practice the external surface would preferably be covered with Dacron polyester242to facilitate in-growth.

FIG.31is an illustration of a top view of a valve with a folding gap286in the generic annular support wire frame298. Central flow control component258opening is shown as a three-leaflet structure.

FIG.32Ais an illustration of a side perspective view of a valve with a folding gap286in the wire frame where the gap is covered with a fabric mesh spanning the gap. Fabric folding panels284are illustrated on the proximal and distal sides of the lower body portion. Polyester cover242for the body portion of outer frame is also shown.

FIG.32Bis an illustration of a side view of a partially rolled lower body portion211of valve frame/sheet.FIG.32Bshows that the lower body portion211is unfurled towards the septal leaflet. Native anterior and posterior native leaflets are shown in foreground.

FIG.33Ais an illustration of a side perspective view of valve having a flat collar and cylinder body.FIG.33Ashows fold areas116,120in the collar and in the lower body portion284.

FIG.33Bis an illustration of a side perspective view of the flattened, partially compressed valve210.FIG.33Bshows the two sides of the collar slide inward, compressing the fold areas116,120, to collapse the central axial opening, while flattening the lower body portion along seam284.

FIG.33Cis an illustration of a side perspective view of the flattened, partially compressed valve210with the lower body portion being compressed by rolling402.

FIG.33Dis an illustration of a side perspective view of the flattened, partially compressed valve210with the lower body portion being completely compressed211by rolling up to the collar portion.

FIG.33Eis an illustration of a side perspective view of the flattened, compressed valve208with the lower body portion compressed by rolling and folded onto the flattened upper collar.

FIG.34Ais an illustration of a side perspective view of a composite laser-cut workpiece prior to expansion into the valve frame.FIG.34Ashows that a wire loop300in combination with a wire mesh or wire braid298can be combined in a single wire frame.

FIG.34Bis an illustration of a side perspective view of the composite laser-cut workpiece after expansion into a valve wireframe.FIG.34Bshows collar having a braid or laser wire cell296, and lower having a wire loop300.

FIG.35Ais an illustration of a side perspective view of a laser-cut orthogonal cell workpiece prior to expansion into the valve frame panels.FIG.35Aillustrates asymmetric irregular rounded wire cells301.

FIG.35Bis an illustration of a side perspective view of the laser-cut orthogonal workpiece after expansion into the valve wireframe panels280,282, prior to assembly.FIG.35Bshows rounded, horizontally oriented wire cells303for minimizing wire strain during folding, rolling and compression.

FIG.36Ais an illustration of a side perspective view of a laser-cut orthogonal cell workpiece with zig-zag/diamond shape cells298prior to expansion into the valve frame panels.

FIG.36Bis an illustration of a side perspective view of the laser-cut orthogonal workpiece with zig-zag/diamond shape cells298after expansion into the valve wireframe panels280,282, prior to assembly.FIG.36Billustrates diamond-shaped, horizontally oriented wire cells298for minimizing wire strain during folding, rolling and compression.

FIG.37Ais an illustration of a side perspective view of valve wireframe panels280,282that are stitched along the side edges284to form a three-dimensional valve having an arc-shape collar122,126and a cylinder body with an internal flow control component130mounted within the body portion.

FIG.37Bis an illustration of a top perspective view of valve wireframe panels that are stitched along the side edges284to form a three-dimensional valve having an arc-shape collar122,126and a cylinder body with an internal flow control component130mounted within the body portion. Dashed line illustrates where the inner flow control component is attached but not shown.

FIG.37Cis an illustration of a side perspective view of the two-panel embodiment being compressed by rolling402.FIG.37Cshows two panels, sewn along the joining (stitched, joined) edges284.

FIG.37Dis an illustration of a side perspective view of a two-panel embodiment rolled208at least 1 turn, and up to 1.5 turns, or at least 360 degrees, and up to at least 540 degrees.

FIG.38Ais an illustration of a top view of a single sheet305of metal or metal alloy with compressible cells cut or formed into a first and second collar panel and a first and second body portion.FIG.38Ashows a cut and fold design.FIG.38Ashows where the collar can be folded so that the two points A on the collar are brought together, and the lower portion can be folded so that the two points B on the lower portion are brought together to form a three-dimensional valve structure with partial folding to minimize the requirement for extensive sewing.

FIG.38Bis an illustration of a top perspective view of the single sheet valve frame305after folding, assembly, and attachment along the open seams.

FIG.38Cis an illustration of a side perspective view of the single sheet valve frame305after folding, assembly, and attachment along the open seams.

FIG.39is an illustration of a side perspective view of a valve formed from a series of horizontal wave-shaped wires297connected at connection points, with an upper collar portion, and an hourglass shape for the body portion.

FIG.40is an illustration of a side perspective view of a valve formed from a series of (vertical) zigzag-shaped wires296connected at connection points, with an upper collar portion, and an hourglass shape for the body portion. Sewing features are shown along the joining edges.

FIG.41Ais an illustration of a top perspective view of a valve upper collar portion formed from a series of fan-shaped asymmetric, irregular rounded cells/wires303connected circumferentially to the top peripheral edge of the lower body portion.

FIG.41Bis an illustration of a cut away view of a valve upper collar portion formed from a series of fan-shaped asymmetric, irregular rounded cells/wires303connected circumferentially to the top peripheral edge of the lower body portion, and shows half of the flow control component mounted with the lower body portion.

FIG.41Cis an illustration of a side perspective view of an upper cuff or collar in a partially expanded configuration, showing how the elongated fan-shape asymmetric, irregular rounded cells/wires303permit elongation and radial compression.

FIG.41Dis an illustration of a side perspective view of a two-panel embodiment of a flow control component.

FIG.41Eis an illustration of a side perspective view of a lower body portion having a braided wire cell construction296.

FIG.41Fis an illustration of a side perspective view of a lower body portion having a diamond laser-cut wire cell construction298.

FIG.41Gis an illustration of a side perspective view of a lower body portion having a connected-wave wire cell construction297.

FIG.42is an illustration of a top view of flat wire frame of metal or metal alloy having compressible wire cells configured in a strain minimizing orientation to facilitate orthogonal loading and delivery of a prosthetic tricuspid valve.FIG.42shows outer wave cells296used for a collar portion with inner diamond cells298used for a body portion of the outer frame.

FIG.43is an illustration of a top view of smaller sized flat wire frame of metal or metal alloy having compressible wire cells configured in a strain minimizing orientation to facilitate orthogonal loading and delivery of a prosthetic tricuspid valve.FIG.43shows outer wave cells296used for a collar portion with inner diamond cells298used for a body portion of the outer frame.

FIG.44is an illustration of a side perspective view of a wire frame in a funnel configuration (heat set) showing compressible wire cells configured in a strain minimizing orientation to facilitate orthogonal loading and delivery of a prosthetic tricuspid valve.FIG.44shows outer diamond cells298used for a collar portion with inner diamond cells298used for a body portion of the outer frame.

FIG.45is an illustration of a side perspective view of an wire frame in a funnel configuration (heat set) showing compressible wire cells configured in a strain minimizing orientation to facilitate orthogonal loading and delivery of a prosthetic tricuspid valve.FIG.45shows outer diamond cells298used for a collar portion with inner diamond cells298used for a body portion of the outer frame.

FIG.46is an illustration of a top view down the central axis of a wire frame in a funnel configuration (heat set) showing compressible wire cells configured in a strain minimizing orientation to facilitate orthogonal loading and delivery of a prosthetic tricuspid valve.FIG.46shows outer wave cells296used for a collar portion with inner diamond cells298used for a body portion of the outer frame.

FIG.47Ais an illustration of a side perspective view of a metal alloy sheet that has been etched partially on a single side using photolithography and resistive masks.

FIG.47Bis an illustration of a side perspective view of a metal alloy sheet that has been etched partially in a two-sided configuration using photolithography and resistive masks.

FIG.48is an illustration of a plan view of an embodiment of a heart valve prosthesis with a valve frame102having a distal upper tension arm128and lower tension arm126mounted on, and anchored to, the anterior leaflet side of the native annulus, and having a mechanical anchor element, e.g. proximal sealing cuff,130for anchoring on the posterior and septal side of the native annulus. The sealing cuff130may be a short tab on the posterior side of the valve or may be a semi-circular or circular collar or cuff that engages the atrial floor to seal the annulus from perivalvular leaks.

FIG.49is an illustration of a plan view of another embodiment of a heart valve prosthesis according to an embodiment with a valve frame having a distal upper and lower tension arm mounted on, and anchored to, the anterior leaflet side of the native annulus, and having a mechanical anchor element, e.g. hourglass annular seal,132for anchoring on the posterior and/or septal side of the native annulus. The hourglass, or concave, sealing cuff132may be only a short segment on the posterior side of the valve or may be a semi-circular or circular combined upper and lower collar or cuff that engages the atrial floor and the ventricular ceiling to seal the annulus from perivalvular leaks. This embodiment may also include embodiments having a partial collar. This embodiment may be used in conjunction with other anchoring elements described herein.

FIG.50is an illustration of a plan view of a heart valve prosthesis100according to an embodiment with a valve frame102having upper tension arm128and lower tension arm126mounted on and anchoring to the annulus.FIG.50shows lower tension arm/tab126extending into the Right Ventricular Outflow Tract (RVOT). The lateral, or side-loaded, delivery of the valve100through the inferior vena cava provides for direct access to the valve annulus without the need to deliver a compressed valve around a right angle turn, as is required for IVC delivery of axially, or vertically loaded, traditional transcatheter valves.FIG.50shows one embodiment where a screw or other anchor device138is used in conjunction with the tension-mounting method described herein where upper and lower tension arms on the anterior leaflet side anchor the valve in place, and a secondary anchor element completes the securement of the valve in the annular site.

FIG.50shows polyester mesh covering108a valve tubular frame102encircling a collapsible flow control sleeve110.FIG.50also shows the frame102having Nitinol wire frame in diamond shapes with a biocompatible covering. In one embodiment, the frame may have a pericardial material on top and a polyester material, e.g. surgical Dacron®, underneath to be in contact with the native annulus and promote ingrowth.

FIG.51Ais an illustration of a plan view of a low profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having an annulus support loop140and an upper and lower tension arm142,144formed as a unitary or integral part, and covered with a biocompatible material. This embodiment shows how a low profile, side-loaded valve can have a very large diameter, 40-80 mm, with requiring an excessively large delivery catheter, as would be required by a large diameter valve that is delivered using the traditional, vertical or axial, orientation.

FIG.51Bis an illustration of a top view of a low profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having an annulus support loop140, an upper and lower tension arm142,144formed as a unitary or integral part, an inner two-panel conical valve sleeve110, and covered with a biocompatible material.FIG.51Bshows the inner two-panel sleeve and the reciprocating collapsible aperture at the lower end for delivering blood to the ventricle.

FIG.51Cis an illustration of a bottom view of a low profile, e.g. 10 mm in height, wire loop embodiment of the heart valve prosthesis having an annulus support loop, an upper and lower tension arm formed as a unitary or integral part, an inner two-panel conical valve sleeve, and covered with a biocompatible material.FIG.51Cshows a plan view of the inner two-panel sleeve110and the collapsible terminal aperture156at the ventricular side.

FIG.51Dis an illustration of a compressed and elongated wire loop embodiment of the heart valve prosthesis disposed within a delivery catheter118and having a ring shaped tubular frame102with braid/laser-cut104and an upper and lower tension arm142,144formed as a unitary or integral part.FIG.51Dillustrates how a large diameter valve, using side loading, can be delivered.

FIG.51Eis an illustration of a compressed and elongated wire loop embodiment of the heart valve prosthesis partially ejected, and partially disposed within, a delivery catheter and having an annulus support loop and an upper and lower tension arm formed as a unitary or integral part.FIG.51Eshows how a valve can be partially delivered for positioning in the annulus. The lower tension arm144can be used to navigate through the tricuspid leaflets and chordae tendineae while the valve body, the tubular frame,102is still within the steerable IVC delivery catheter118.

FIG.52Ais an illustration of a plan view of a heart valve prosthesis partially mounted within the valve annulus. By using the side-loaded valve of the disclosed embodiments, the distal side of the prosthesis142,144can be mounted against the anterior aspect of the native annulus, and valve function can be assessed. By allowing two pathways for blood flow, the first through the native valve near the posterior leaflet, and the second through the central aperture of the prosthetic valve, a practitioner can determine if the heart is decompensating or if valve function is less than optimal.

FIG.52Bis an illustration of a plan view of a heart valve prosthesis completely seated within the valve annulus.FIG.52Bshows that the valve can be secured in place once the valve function assessment shows that the deployment is successful. Importantly, since the valve is a low profile valve, and fits easily within a standard, e.g. 8-12 mm, delivery catheter without requiring the forceful loading of typical transcatheter valves, the side-loading valve can be easily retrieved using the same delivery catheter that is used to deploy the valve.

FIG.53Ais an illustration of a heart valve prosthesis according to an embodiment in a compressed, intra-catheter phase. The lower and upper tension arms144,142are elongated to the right and the prosthetic valve102is shown laterally compressed in the delivery catheter118. The lateral compression is a function of the use of minimal structural materials, e.g. a minimal inner valve sleeve110, and the relatively short height of the outer cylindrical frame102. This lateral delivery provides for very large, e.g. up to 80 mm or more, valve prosthesis to be delivered. The lateral delivery also avoids the need to perform a 90-degree right turn when delivering a valve using the IVC femoral route. This sharp delivery angle has also limited the size and make up of prior valve prostheses, but is not a problem for the inventive valve herein.

FIG.53Bis an illustration of a profile, or plan, view of a wire-frame embodiment of the heart valve prosthesis according to an embodiment in an un-compressed, post-catheter-ejection phase.FIG.53Bshows an embodiment where the upper wire-frame tension arm142is attached to the tubular frame102, but the lower tension arm144is shaped in an S-shape and connects only to the upper tension arm142.

FIG.53Cis an illustration of a top view of a heart valve prosthesis according to an embodiment having covered wire loop for the upper tension arm(s).FIG.53Cshows the tubular frame102having an inner sleeve110sewn into the central aperture106, with the two (2) panels extending downward (into the page) in a ventricular direction.FIG.53Cshows the upper tension arms142oriented towards the anterior leaflet side of the atrial floor, shown in dashed outline.

FIG.53Dis an illustration of a plan view of a heart valve prosthesis according to an embodiment having a wire loop construction for the upper142and lower144tension arms.

FIG.53Eis an illustration of a cut away plan view of a heart valve prosthesis according to an embodiment, and shows the inner panel valve sleeve110mounted within the inner space defined by the tubular frame.FIG.53Eshows an elongated two-panel valve sleeve110that extends into the sub-annular leaflet space. The tubular frame102shown inFIG.53Eis about 10 mm in height and the valve sleeve110extends about 10 mm below the bottom of the tubular frame, resulting in a valve 20 mm in total height.

FIG.53Fis an illustration of a bottom view of a heart valve prosthesis according to an embodiment having a covered wire loop for the lower tension arm144.FIG.53Fshows the tubular frame102having an inner sleeve110sewn into the central aperture, with the two (2) panels extending upward (out of the page) in a ventricular direction.FIG.53Fshows the lower tension arm144oriented towards the anterior leaflet side of the ventricular ceiling, shown in dashed outline.

FIG.54Ais an illustration of a profile, or plan, view of a braid or laser-cut frame embodiment of the heart valve prosthesis according to an embodiment in an un-compressed, post-catheter-ejection phase.FIG.54Ashows an embodiment where the upper braid or laser-cut tension arm128is attached to the upper edge of the tubular frame102, and the lower tension arm126is attached to the lower edge of the tubular frame102.

FIG.54Bis an illustration of a top view of a heart valve prosthesis according to an embodiment having covered braid or laser-cut frame102for the upper tension arm128.FIG.54Bshows the tubular frame102having an inner sleeve110sewn into the central aperture, with the two (2) panels extending downward (into the page) in a ventricular direction.FIG.54Bshows the upper tension arm128oriented towards the anterior leaflet side of the atrial floor, shown in dashed outline.

FIG.54Cis an illustration of a plan view of a heart valve prosthesis according to an embodiment having a braid or laser-cut frame construction102for the upper and lower tension arms128,126.

FIG.54Dis an illustration of a cut away plan view of a heart valve prosthesis according to an embodiment, and shows the inner panel valve sleeve110mounted within the inner space defined by the tubular frame102.

FIG.54Eis an illustration of a bottom view of a heart valve prosthesis according to an embodiment having a covered braid or laser-cut frame for the lower tension arm.FIG.54Eshows the tubular frame102having an inner sleeve110sewn into the central aperture, with the two (2) panels extending upward (out of the page) in a ventricular direction.FIG.54Eshows the lower tension arm126oriented towards the anterior leaflet side of the ventricular ceiling, shown in dashed outline.

FIG.55Ais an illustration of a side perspective view of a valve having a circular hyperboloid (hourglass) shape with an extended RVOT tab268. Wire frame details are not shown since in practice the external surface would preferably be covered with Dacron polyester to facilitate in-growth. Distal fold area120and proximal fold area116are shown book-ending the anterior collar122and posterior-septal collar126along horizontal axis140with front anterior wall110and central channel104shown, according to an embodiment.

FIG.55Bis an illustration of a cut away view of a valve having a circular hyperboloid (hourglass) shape and RVOT tab268.FIG.55Bshows that inner leaflet258and flow control component inner frame (not visible) are attached to the inner surface of the annular frame, with collar portion105attached to subannular anchor portion268via wall portion106. Here, it is only attached at the top edge although other non-limiting attachments are contemplated, e.g. mid-wall, multiple attachment points, etc.

FIG.56Ais an illustration of a side view of a vertically compressible valve144with internal non-extending leaflets and compressible orthogonal (wide) cells, in an expanded configuration144.

FIG.56Bis an illustration of a side view of a vertically compressible valve with internal non-extending leaflets and compressible orthogonal (wide) cells, in a compressed configuration206.

FIG.57Ais an illustration of a side view of a vertically compressible valve with extended leaflets and compressible orthogonal (wide) cells, in an expanded configuration144.

FIG.57Bis an illustration of a side view of a vertically compressible valve with extended leaflets and compressible orthogonal (wide) cells, in a compressed configuration206where the wire frame is reduced in height and the extended leaflets are rolled up.

FIG.58Ais an illustration of a side perspective view of a valve formed from a single continuous wire300, with an upper collar portion, an hourglass shape for the body portion, and an RVOT tab extending away from the lower edge of the body portion.

FIG.58Bis an illustration of a top view of a valve formed from a single continuous wire300, with an upper collar portion, an hourglass shape for the body portion (not shown), and an RVOT tab extending away from the lower edge of the body portion.

FIG.59is an illustration of a side perspective view of a valve formed from a series of wave-shaped wires296connected at connection points, with an upper collar portion, an hourglass shape for the body portion, and an RVOT tab extending away from the lower edge of the body portion.

FIG.60is an illustration of a side perspective view of a valve formed from a series of horizontal wave-shaped wires297connected at connection points, with an upper collar portion, an hourglass shape for the body portion, and an RVOT tab extending away from the lower edge of the body portion. Sewing features are shown along the joining edges.

FIG.61is an illustration of a top view of flat wire frame having an RVOT tab of metal or metal alloy having compressible wire cells configured in a strain minimizing orientation to facilitate orthogonal loading and delivery of a prosthetic tricuspid valve.FIG.61shows outer diamond cells298used for a collar portion with inner wave cells296used for a body portion of the outer frame, and diamond cells298used for the subannular tab268.

FIG.62is an illustration of a top view of a wire frame with RVOT tab in a funnel configuration (heat set) showing compressible wire cells configured in a strain minimizing orientation to facilitate orthogonal loading and delivery of a prosthetic tricuspid valve.FIG.62shows outer diamond cells298used for a collar portion with inner diamond cells298used for a body portion of the outer frame, and diamond cells used for the subannular tab268.

FIG.63is an illustration of a side view of a wire frame with RVOT tab in a funnel configuration (heat set) showing compressible wire cells configured in a strain minimizing orientation to facilitate orthogonal loading and delivery of a prosthetic tricuspid valve.FIG.63shows outer diamond cells298used for a collar portion with inner diamond cells298used for a body portion of the outer frame, and diamond cells used for the subannular tab268.

FIG.64is an illustration of a side perspective view of a wire frame with RVOT tab in a funnel configuration (heat set) showing compressible wire cells configured in a strain minimizing orientation to facilitate orthogonal loading and delivery of a prosthetic tricuspid valve.FIG.64shows outer diamond cells298used for a collar portion with inner diamond cells298used for a body portion of the outer frame, and irregular shaped cells used for the subannular tab268.

FIG.65Ais an illustration of a top view of a heart valve prosthesis according to an embodiment having braid or laser-cut wire frame102and shown mounted within a cross-sectional view of the atrial floor at the annulus.

FIG.65Bis an illustration of a bottom view of a heart valve prosthesis according to an embodiment having braid or laser-cut wire frame102for a lower tension arm126and shown mounted within a cross-sectional view of the ventricular ceiling at the annulus.FIG.65Bshows the two-panel valve sleeve110in an open position106, e.g. atrial systole and ventricular diastole.FIG.66shows the RVOT as a darkened circle.

FIG.66is an illustration of a heart valve prosthesis according to an embodiment having a wire loop construction for the tubular frame102, with two vertical support posts154extending down the edge on opposing sides of the sleeve110. During compression into the delivery catheter118(not shown), the posts154are engineered to fold horizontally during compression, and to elastically unfold during ejection to deploy the valve sleeve110.

FIG.67is an illustration of a two-panel embodiment of an inner valve sleeve110.

FIG.68Ais an illustration of one embodiment of an inner valve sleeve110having two rigid support posts154.

FIG.68Bis an illustration of a cut away plan view of a heart valve prosthesis according to an embodiment, and shows a two-post embodiment154of the inner panel valve sleeve110mounted within the inner space defined by the tubular frame102.

FIG.69is an illustration of a three-panel embodiment of an inner valve sleeve110.

FIG.70Ais an illustration of a three-panel embodiment of an inner valve sleeve110having three rigid support posts154.

FIG.70Bis an illustration of a cut away plan view of a heart valve prosthesis according to an embodiment, and shows a three-panel, three-post embodiment of the inner panel valve sleeve mounted within the inner space defined by the tubular frame.

FIG.71Ais an illustration of one embodiment of a partial cut-away interior view of a tri-leaflet embodiment of a low profile, e.g. 8-20 mm, side-loaded prosthetic valve.

FIG.71Bis an illustration of another embodiment of a partial cut-away interior view of a tri-leaflet embodiment of a low profile, e.g. 8-20 mm, side-loaded prosthetic valve.

FIG.71Cis an illustration of a top view of a tri-leaflet embodiment of a low profile, e.g. 8-20 mm, side-loaded prosthetic valve.

FIG.72is a flowchart describing one set of method steps for delivery of a low profile, side-loaded prosthetic valve.

FIG.73is an illustration of a side view of human heart anatomy, with an inset showing the geometric relationship between the inferior vena cava (IVC), the three leaflet cusps of the tricuspid valve—anterior, posterior, septal—the right ventricular outflow tract (RVOT), and the pulmonary artery (PA).

FIG.74is an illustration of a side perspective view of a side delivered valve seated with the native tricuspid annulus with collar portion laying atrially above the tricuspid annulus and leaflets, lower body portion extending into and through the annulus to provide corrective hemodynamic flow from the flow control component, and RVOT footer tab and RVOT/PA extender wire.

FIG.75Ais an illustration of a plan view of a native right atrium of a human heart, and shows the superior vena cava (SVC), the inferior vena cava (IVC), the right atrium (RA), the tricuspid valve and annulus (TCV), the anterior leaflet (A), the posterior leaflet (P), the septal leaflet (S), the right ventricle (RV), and the right ventricular outflow tract (RVOT).

FIG.75Bis an illustration of a heart valve prosthesis according to an embodiment being delivered to tricuspid valve annulus.FIG.75Bshows braided/laser cut-frame lower tension arm126ejected from the delivery catheter118and being directed through the annulus and towards the right ventricular outflow tract.

FIG.75Cis an illustration of a heart valve prosthesis according to an embodiment being delivered to tricuspid valve annulus.FIG.75Cshows braided/laser cut-frame lower tension arm126and upper tension arm128ejected from the delivery catheter118, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus.

FIG.75Dis an illustration of a heart valve prosthesis according to an embodiment being delivered to tricuspid valve annulus.FIG.75Dshows the entire braided/laser cut-frame valve102ejected from the delivery catheter118, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus, and at least one tissue anchor anchoring the proximal side of the prosthesis into the annulus tissue.

FIG.76Ais an illustration of a heart valve prosthesis according to an embodiment being delivered to tricuspid valve annulus and shows step1in a valve assessment process.FIG.76Ashows braided/laser cut-frame lower tension arm ejected from the delivery catheter and being directed through the annulus and towards the right ventricular outflow tract.

FIG.76Bis an illustration of a heart valve prosthesis according to an embodiment being delivered to tricuspid valve annulus, and shows Step2in a valve assessment process.FIG.76Bshows braided/laser cut-frame lower tension arm and upper tension arm ejected from the delivery catheter, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus.FIG.76Bshows that a steerable anchoring catheter can hold the valve at an oblique angle in a pre-attachment position, so that the valve can be assessed, and once valve function and patient conditions are correct, the steerable anchoring catheter can push the proximal side of the valve from its oblique angle, down into the annulus. The steerable anchoring catheter can then install one or more anchoring elements.

FIG.76Cis an illustration of a heart valve prosthesis according to an embodiment that has been delivered to tricuspid valve annulus, and shows Step3in a valve assessment process.FIG.76Cshows the entire braided/laser cut-frame valve ejected from the delivery catheter, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus, and at least one tissue anchor anchoring the proximal side of the prosthesis into the annulus tissue.

FIG.77Ais an illustration of a side perspective view of a valve that is vertically compressed206without folding and loaded into a delivery catheter138. By using horizontal rather than tradition vertical diamond shaped cells, the frame can be compressed from top to bottom. This allows for orthogonal delivery of a much larger diameter valve than can be delivered using tradition axial compression. Additionally, the orthogonal delivery provides access from the IVC to the tricuspid annulus using a subannular distal-side anchoring tab268. Normally, a traditional axial valve would need to make a 90-120 degree right turn before expelling the transcatheter valve. By providing a valve that can be directly expelled into the distal side of the tricuspid annulus, the sharp right turn is avoided due to the inventive design.

FIG.77Bis an illustration of a side perspective view of a partially expelled or released valve402from a delivery catheter138that allows a transition from native blood flow through the native tricuspid valve to a partial flow around the prosthetic valve and into the native annulus and a partial flow thru an inflow end132and out of an outflow end134of the prosthetic valve into the native annulus. Guide wire311is shown pig-tailed into the pulmonary artery.

The rigid pull rod/wire310in some embodiments is engineered to ride over the guide wire, thus allowing the valve to be delivered exactly where intended. The distal subannular tab268can be directed into the right ventricular outflow tract (RVOT) and provides anchoring to the valve while it is being positioned and assessed.

FIG.77Cis an illustration of a side perspective view of a fully expelled or released valve from a delivery catheter138that is lodged using the distal tab268against the distal surface of the annulus and held using the rigid pusher310elevated at an angle above the native annulus prior to complete deployment. This allows a further transition from native blood flow through the native tricuspid valve with a partial flow around the prosthetic valve and into the native annulus, and an increasing partial flow thru an inflow end132and out of an outflow end134of the prosthetic valve into the native annulus.FIG.77Calso shows guide wire311and proximal side subannular anchoring tab (proximal tab)270.

FIG.77Dis an illustration of a side perspective view of a fully expelled or released valve100that is completely seated into the native annulus, and that allows a smooth transition from native blood flow to a full, complete flow thru the prosthetic valve into the native annulus. The valve is anchored using subannular distal tab268and subannular proximal tab270, and supra-annular (atrial) upper tension arm271. Corrected replacement flow is shown by flow thru an inflow end132and out of an outflow end134of the prosthetic valve into the native annulus.

FIG.78Ais an illustration of a side perspective view of a valve that is vertically compressed206without folding and loaded into a delivery catheter138, and shows an extended inner leaflet component in a rolled configuration. Guide wire311and RVOT tab268are shown extended into the pulmonary artery and allowing the valve to be precisely delivered.

FIG.78Bis an illustration of a side perspective view of a partially expelled or released valve402from a delivery catheter138, with a partially unfurled extended inner leaflet component258.FIG.78Bshows a transition from native blood flow through the native tricuspid valve to a partial flow around the prosthetic valve and into the native annulus and a partial flow132,134thru the prosthetic valve into the native annulus. The valve has a distal mid-wall arch above the RVOT tab268for engaging the native annulus.

FIG.78Cis an illustration of a side perspective view of a fully expelled or released valve, with a fully unfurled extended inner leaflet component258, where the valve is lodged using the distal tab268against the distal surface of the annulus and held using the rigid pusher310elevated at an angle above the native annulus prior to complete deployment. This allows a further transition from native blood flow through the native tricuspid valve with a partial flow around the prosthetic valve and into the native annulus, and an increasing partial flow thru an inflow end132and out of an outflow end134of the prosthetic valve into the native annulus.FIG.78Cshows distal mid-wall arch engaging the distal native annulus and shows proximal mid-wall arch raised above the native annulus in preparation for a smooth transition to prosthetic flow when the valve is seated in the native annulus.

FIG.78Dis an illustration of a side perspective view of a fully expelled or released valve100that is completely seated into the native annulus, and that allows a smooth transition from native blood flow to a full, complete flow thru the prosthetic valve into the native annulus. The valve is anchored using subannular distal tab268and subannular proximal tab270, and supra-annular (atrial) upper tension arm271. Corrected replacement flow through leaflets258is shown by flow thru an inflow end132and out of an outflow end134of the prosthetic valve into the native annulus.

FIG.79Ais an illustration of a side view of a compressed valve within a delivery catheter138.FIG.79Ashows how a central tube or wire310can be distally attached to the distal edge or RVOT tab118and by pushing on the rigid tube or wire310, the compressed valve136can be pulled from the end closest to the catheter138deployment end139. This pulling action avoids pushing the valve out of the delivery catheter138, causing additional radial expansion and radial forces that can damage the valve when it is compressed within the delivery catheter138.

FIG.79Bis an illustration of a side view of a partially compressed valve402that is partially released from the delivery catheter138and shows how blood flow can begin its transition. The gradual, smooth transition from native flow to flow through the prosthesis by pulling on the rigid pusher310attached to the distal subannular anchoring tab268avoids the sphincter effect where the heart is cut off from the flow, resulting in a dry pump action, and causing heart failure. When the valve is partially open exposing only a part of the collar105, on a small fraction of right atrial blood flow is going through the prosthetic valve, but the washing effect provides for a smooth transition to a larger volume going through the prosthesis.

FIG.79Cis an illustration of a side view of a partially compressed valve402, that is partially released from the delivery catheter138and shows how blood flow can begin its transition. The gradual, smooth transition from native flow to flow through the prosthesis from an inflow end132to an outflow end134by pulling from the distal subannular anchoring tab268avoids the sphincter effect where the heart is cut off from the flow, resulting in a dry pump action, and causing heart failure. When the valve is partially open exposing only a part of the collar105, on a small fraction of right atrial blood flow is initially going through the prosthetic valve, with an increasing amount transitioning from flow around the valve to flow going through the valve, with the washing effect providing for a smooth transition to a larger volume going through the prosthesis.

FIG.79Dis an illustration of a side view of an expanded uncompressed valve orthogonally released from the delivery catheter138, and still releasably attached to the distal pull wire/deployment control wire or hypotube310via the distal tab/RVOT tab268. Collar105and frame body106are fully expanded permitting functioning of the flow control component130.FIG.79Dshows that the valve can be positioned or re-positioned using the rigid pull wire310. Since the blood flow is not blocked, this allows the interventionalist the opportunity and time to ensure correct orientation of the valve, especially where the distal tab (mitral)/RVOT tab (tricuspid) embodiment is used to assist in anchoring. Once proper orientation is achieved, the valve can be slowly seated into the native tricuspid annulus, providing a smooth blood flow transition from the native flow to the prosthetic flow.FIG.79Dalso shows release mechanism410for releasing the rigid pull device310from the valve body by pulling on a trigger wire that is attached to a release hook, lock, bead, or other mechanism.

FIG.79Eis an illustration of a side view of an uncompressed valve showing transition to all blood flow through the flow control component130of the valve and no flow around the valve during to atrial sealing of the anterior collar122and posterior-septal collar126.

FIG.80Ais an illustration of a side view of a rolled valve136within a delivery catheter138and being advanced by a distal rigid pull wire/draw-wire310(or far-side push-pull wire) attached to the leading edge of the valve collar.

FIG.80Bis an illustration of a side view of a partially unrolled valve that has been deployed from the catheter by action of the pushing rod310on the distal upper edge272.

FIG.80Cis an illustration of a side view of a partially released unrolled valve that has been deployed from the catheter, and shows pushing rod310maintaining connection to the valve while anterior collar portion122is unrolled and leaflets258are uncovered.

FIG.80Dis an illustration of a side view of a completely released unrolled valve where the rigid pull device310is used to position the valve within the native annulus and obtain a good perivalvular seal with anterior collar122and posterior-septal collar126to transition to blood flow through the prosthetic leaflets258.FIG.80Dalso shows release mechanism410for releasing the rigid pull device310from the valve body by pulling on a trigger wire that is attached to a release hook, lock, bead, or other mechanism.

FIG.81is an illustration of a side view of a compressed combination construction valve307within a delivery catheter, and shows draw/pulling wire attached to the forward end of the compressed valve to pull the valve out of the catheter.

FIG.82Ais an illustration of a side or plan transparent view of a delivery catheter138loaded with a side-delivered (orthogonal) valve100having a tension arm269with a guidewire collar element265and a guidewire311extending through the guidewire collar265with a guidewire sheath310pushing against the guidewire collar element265. Inset shows a non-limiting example of a guidewire collar265attached to a tension arm269with guidewire311through the aperture of the guidewire collar265and hypotube sheath310stopped by the larger circumference of the guidewire collar265, permitting pushing on the tension arm269to pull the valve100out of the delivery catheter138.

FIG.82Bis another non-limiting example of a guidewire collar291attached to a tension arm269with guidewire311through the aperture of the guidewire collar291and hypotube sheath310stopped by the larger circumference of the guidewire collar291, permitting pushing on the tension arm269to pull the valve out of the delivery catheter138.

FIG.82Cis another non-limiting example of a guidewire collar292attached to a tension arm269with guidewire311through the aperture of the guidewire collar292and hypotube sheath310stopped, as it slides over the guidewire—the guidewire is in the lumen of the hypotube sheath—by the larger circumference of the guidewire collar292, permitting pushing on the tension arm269to pull the valve out of the delivery catheter138.

FIG.82Dis another non-limiting example of a guidewire collar293attached to a tension arm269with guidewire311through the aperture of the guidewire collar293and hypotube sheath310stopped by the larger circumference of the guidewire collar293, permitting pushing on the tension arm269to pull the valve out of the delivery catheter138.

FIG.83Ais an illustration of step1of a 6-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.83Ashows a 0.035 guidewire311with hypotube sheath delivered to the right ventricular outflow tract (RVOT).

FIG.83Bis an illustration of step2of a 6-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.83Bshows a 24-34 Fr delivery catheter138being advanced over the guidewire311to and through the native tricuspid annulus to the right ventricle.

FIG.83Cis an illustration of step3of a 6-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.83Cshows a capsule/compression catheter301having a compressed valve136therein where the capsule301is loaded into the proximal end of the delivery catheter138and the valve is withdrawn from the capsule301into the delivery catheter138, with sheathed guidewire311threaded through the valve and providing a wire path to the RVOT, planned deployment location.

FIG.83Dis an illustration of step4of a 6-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.83Dshows the valve advanced up and out of the catheter138and deployed into the native annulus by pushing on the outer sheath310of the guidewire311to pull the valve144up the catheter and into position. Tension arm269is used to position the expanded valve144.

FIG.83Eis an illustration of step5of a 6-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.83Eshows a pushing catheter310, or steerable catheter, being used to push the proximal side of the valve144into position within the annulus.

FIG.83Fis an illustration of step6of a 6-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.83Fshows withdrawal of the delivery system and anchoring of the proximal side of the valve to the annular tissue.FIG.83Fshows expanded valve144with atrial sealing collar facing the atrium, valve body deployed within the native annulus and extending from atrium to ventricle, anchoring tension arm269is shown extending subannularly into the RVOT area, and guidewire collar/ball265is shown at a distal end of the tension arm. Guide wire311and delivery catheter138are being withdrawn.

FIG.84Ais an illustration of step1of an 8-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.84Ashows an 8 Fr guidewire311advanced from the femoral through the inferior vena cava (IVC) to the right atrium.

FIG.84Bis an illustration of step2of an 8-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.84Bshows a balloon catheter294advanced over the guidewire311through the native annulus and into the RVOT to expand and push aside valve and leaflet tissue, chordae tendineae that might tangle transcatheter delivery of the valve.

FIG.84Cis an illustration of step3of an 8-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.84Cshows a 0.035 guidewire311with hypotube sheath delivered to the right ventricular outflow tract (RVOT).

FIG.84Dis an illustration of step4of an 8-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.84Dshows a 24-34 Fr delivery catheter138being advanced over the guidewire311to and through the native tricuspid annulus to the right ventricle.

FIG.84Eis an illustration of step5of an 8-step process for delivery of an orthogonal prosthetic valve136(compressed configuration) to the tricuspid annulus.FIG.84Eshows a capsule301having a compressed valve136therein where the capsule301or compression catheter is loaded into the proximal end of the delivery catheter138and the compressed valve136is advanced through the delivery catheter138, with sheathed guidewire311threaded through the valve and providing a wire path to the RVOT, planned deployment location.

FIG.84Fis an illustration of step6of an 8-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.84Fshows the expanded valve144advanced up the catheter, expelled, and deployed into the native annulus by pushing on the outer sheath (310) of the guidewire311to pull the valve, pulling from the guidewire collar at the distal end of the tension arm269, up the catheter138and into position. Tension arm269is used to position the valve.

FIG.84Gis an illustration of step7of an 8-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.84Gshows a hypotube sheath/guidewire311, or steerable catheter, being used to push the proximal side (114) nearest the IVC or access point, of the valve144into position within the annulus.

FIG.84His an illustration of step8of an 8-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.84Hshows withdrawal of the delivery system and anchoring of the proximal side of the valve144to the annular tissue and anchoring the distal side of the valve using the distal subannular anchoring tension arm269.

FIG.85Ais an illustration of step1of a 6-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.85Ashows the compressed side-deliverable valve136advanced up the catheter138using pushing sheath or rod310and deployed into the native annulus by following the track of the guidewire311, which is disposed in the lumen of the pushing sheath310.

FIG.85Bis an illustration of step2of a 6-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.85Bshows pushing on the outer sheath310of the guidewire311tracking along with the guidewire311threaded through the guidewire collar265to pull the valve up the catheter138and into position, partially expelling the valve with tension arm269into the RVOT and the distal side of the valve lodged against the annular wall.

FIG.85Cis an illustration of step3of a 6-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.85Cshows a pushing catheter310extending from the delivery catheter138being used to push the proximal side of the valve into position within the annulus.

FIG.85Dis an illustration of step4of a 6-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.85Dshows how tension arm269is used to position the valve while pushing catheter310being used to push the proximal side of the valve into position within the annulus to allow the proximal subannular anchoring tab (proximal tab)270to engage and secure the valve against the native tissue.

FIG.85Eis an illustration of step5of a 6-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.85Eshows how pushing catheter310delivers a tissue anchor278to secure the proximal side of the valve to the annular tissue.

FIG.85Fis an illustration of step6of a 6-step process for delivery of an orthogonal prosthetic valve to the tricuspid annulus.FIG.85Fshows withdrawal of the delivery system and anchoring of the proximal side of the valve to the annular tissue.

FIG.86Ais an illustration of step1of a 6-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.86Ashows a 0.035 guidewire311with hypotube sheath delivered to the right ventricular outflow tract (RVOT) through the superior vena cava (SVC).

FIG.86Bis an illustration of step2of a 6-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.86Bshows a 24-34 Fr delivery catheter138being advanced over the guidewire to and through the native tricuspid annulus to the right ventricle.

FIG.86Cis an illustration of step3of a 6-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.86Cshows a capsule301having a compressed valve136therein where the capsule301is loaded into the proximal end of the delivery catheter138and the valve is either withdrawn from the capsule301into the delivery catheter138for further advancement or capsule301is used to advance within the delivery catheter138, with sheathed guidewire311threaded through the valve and providing a wire path to the RVOT, planned deployment location.

FIG.86Dis an illustration of step4of a 6-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.86Dshows the expanded valve144advanced up and expelled out of the catheter138and deployed into the native annulus by pushing on the outer sheath (310) of the guidewire311to pull the valve by the ball265up the catheter138and into position. Tension arm269is used as a ball265mount, to position the valve during deployment, and to provide subannular anchoring on the distal side.

FIG.86Eis an illustration of step5of a 6-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.86Eshows a pushing catheter310extending from the delivery catheter138being used to push the proximal side of the valve into position within the annulus.

FIG.86Fis an illustration of step6of a 6-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.86Fshows withdrawal of the delivery system and anchoring of the proximal side of the expanded valve144to the annular tissue

FIG.87Ais an illustration of the trans-septal (femoral-IVC) delivery of a low profile, e.g. 8-20 mm, side-loaded prosthetic mitral valve shown partially housed within the delivery catheter, and partially ejected for deployment into the native mitral annulus.

FIG.87Bis an illustration of a low profile, e.g. 8-20 mm, side-loaded prosthetic mitral valve shown housed within the delivery catheter

FIG.87Cis an illustration of a low profile, e.g. 8-20 mm, side-loaded prosthetic mitral valve shown partially housed within a delivery catheter and partially laterally ejected from the delivery catheter and positioned for deployment against the anterior side of the native mitral annulus.

FIG.87Dis an illustration of a low profile, e.g. 8-20 mm, side-loaded prosthetic mitral valve shown ejected from the delivery catheter and positioned against the anterior side of the native mitral annulus.

FIG.87Eis an illustration of a side or plan view of a low profile, e.g. 8-20 mm, side-loaded prosthetic valve shown deployed into the native mitral annulus.

FIG.88Ais an illustration of a rotational lock embodiment where the prosthetic valve is delivered to the native annulus with an off-set sub-annular tension arm/tab126positioned below the native annulus, and an off-set supra-annular tension arm/tab128positioned above the native annulus, while the tubular frame102is partially rolled off-set from the annular plane along a longitudinal axis.

FIG.88Bis an illustration of a rotational lock embodiment where the prosthetic valve is delivered to the native annulus with an off-set sub-annular tension arm/tab126positioned below the native annulus, and an off-set supra-annular tension arm/tab128positioned above the native annulus, while the tubular frame102is rolled into functional position parallel to the annular plane. Once the valve is rolled into position, and the tension arms are locked against the sub-annular and supra-annular tissues, the valve can also be further anchored using traditional anchoring elements as disclosed herein.

FIG.89Ais an illustration of a heart valve prosthesis according to an embodiment being delivered to tricuspid valve annulus.FIG.89Ashows wire-frame lower tension arm144ejected from the delivery catheter118and being directed through the annulus and towards the right ventricular outflow tract.FIG.89Ashows an embodiment of an accordion-compressed low profile valve122and shows the lower tension arm directed towards the anterior leaflet for placement into the RVOT.

FIG.89Bis an illustration of a heart valve prosthesis according to an embodiment being delivered to tricuspid valve annulus.FIG.89Bshows wire-frame lower tension arm144and upper tension arm142ejected from the delivery catheter118, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus.FIG.89Balso shows steerable anchoring catheter150attached to a proximal anchoring tab152. While the valve is held in a pre-seating position, the valve can be assessed, and once valve function and patient conditions are correct, the steerable anchoring catheter can push the proximal side of the valve from its oblique angle, down into the annulus. The steerable anchoring catheter can then install one or more anchoring elements152.

FIG.89Cis an illustration of a heart valve prosthesis according to an embodiment being delivered to tricuspid valve annulus.FIG.89Cshows the entire valve ejected from the delivery catheter, the wire-frame lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper wire-frame tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus, and at least one tissue anchor anchoring the proximal side of the prosthesis into the annulus tissue.

FIGS.90A-90Cshow a plan view of a tissue anchor having a floating radio-opaque marker. This figure shows the tissue anchor accessing the annular tissue with the radio-opaque marker at the distal end of the anchor and in contact with the atrial surface of the annular tissue. This figure shows the tissue anchor advancing into the annular tissue with the radio-opaque marker threaded onto the tissue anchor and maintaining position on the atrial surface of the annular tissue. This figure shows the tissue anchor completely advanced into the annular tissue such that the tissue anchor and the threaded floating marker are now adjacent, indicating the desired depth, tension, and/or plication of the tissue anchor with respect to the annular tissue

FIG.91Ais an illustration of a plan view of a tissue anchor having a straight thread and a constant pitch.

FIG.91Bis an illustration of a plan view of a tissue anchor having a straight thread and a variable pitch.

FIG.91Cis an illustration of a plan view of a tissue anchor having a tapered thread and a constant pitch.

FIG.91Dis an illustration of a plan view of a tissue anchor having a sunken taper thread and a variable pitch.

FIG.92Ais an illustration of Step1of a 4-step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG.92Ashows a low profile valve being inserted into the valve annulus and low profile valve having an integral anchor delivery conduit or channel with an anchor disposed in the lumen of the channel and an anchor delivery catheter attached to the anchor.

FIG.92Bis an illustration of Step2of a 4-step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG.92Bshows a low profile valve completely deployed within the valve annulus and an integral anchor delivery conduit or channel with an anchor disposed in the lumen of the channel and an anchor delivery catheter attached to the anchor.

FIG.92Cis an illustration of Step3of a 4-step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG.92Cshows the anchor being pushed out of the lumen of the delivery conduit or channel and into the annular tissue.

FIG.92Dis an illustration of Step4of a 4-step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG.92Dshows the anchor in a locked position after being pushed out of the lumen of the delivery conduit or channel and into the annular tissue, thus anchoring the proximal side of the low profile valve.

FIG.93Ais an illustration of Step1of a 5-step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG.93Ashows catheter delivery of an attachment wire with the clip housed within the lumen of the clip delivery catheter.

FIG.93Bis an illustration of Step2of a 5-step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG.93Bshows the clip delivery catheter inserted into an intra-annular space and shows an attachment wire and shows the clip housed within the lumen of the clip delivery catheter.

FIG.93Cis an illustration of Step3of a 5-step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG.93Cshows a receiver element ejected from the delivery catheter and positioned behind tissue to be captured.

FIG.93Dis an illustration of Step4of a 5-step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG.93Dshows an anchor element piercing the annular tissue and inserting into a receiver element.

FIG.93Eis an illustration of Step5of a 5-step process for clipping a low profile valve to annular tissue, as shown here in a non-limiting example of clipping to a proximal or anterior side of the native annulus.FIG.93Eshows that the clip delivery catheter is withdrawn and the anchor element and receiver element are connected to the annular tissue and connected by connector wire to the low profile valve.

FIG.94is a flowchart showing an embodiment of a method for orthogonal delivery of implantable prosthetic valve to a desired location in the body, the method comprising the steps: advancing a delivery catheter to the desired location in the body and delivering an expandable prosthetic valve to the desired location in the body by releasing the valve from the delivery catheter, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a lengthwise 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.

FIG.95is a flowchart showing an embodiment of a method for orthogonally loading an implantable prosthetic valve into a delivery catheter, the method comprising the steps: loading an implantable prosthetic valve into a tapering fixture or funnel attached to a delivery catheter, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein said loading is perpendicular or substantially orthogonal to the first direction, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a lengthwise 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.

FIG.96Ais an illustration of an open cross-section view of a low profile, side-loaded prosthetic valve frame and shows an example of a commercially available valve110mounted within the inner surface of frame102.

FIG.96Bis an illustration of a low profile, side-loaded valve frame according to an embodiment having a braid or laser-cut construction for the tubular frame102.FIG.96Bshows a longer lower tension arm126for extending sub-annularly towards the RVOT, and a shorter upper tension arm128for extending over the atrial floor.FIG.96Bshows an elongated two-panel valve sleeve110that extends into the sub-annular leaflet space. The tubular frame102shown inFIG.96Bis about 10 mm in height and the valve sleeve110extends about 10 mm below the bottom of the tubular frame, resulting in a valve 20 mm in total height.

FIG.96Cis an illustration of a low profile, side-loaded valve frame prosthesis having a braid or laser-cut tubular frame and extended valve sleeve compressed within a delivery catheter118.FIG.96Cshows the valve attached to a secondary steerable catheter150for ejecting, positioning, and anchoring the valve frame. The secondary catheter150can also be used to retrieve a failed deployment of a valve frame.

FIG.96Dis an illustration of a valve frame having a braid or laser-cut tubular frame shown partially compressed within a delivery catheter, and partially ejected from the delivery catheter.FIG.96Dshows that while the valve frame is still compressed the lower tension arm can be manipulated through the leaflets and chordae tendineae to find a stable anterior-side lodgment for the distal side of the valve frame.

FIG.96Eis an illustration of a valve frame having a braid or laser-cut tubular frame engaging the tissue on the anterior side of the native annulus with the curved distal sidewall of the tubular frame sealing around the native annulus.FIG.96Eshows the valve frame held by the steerable secondary catheter at an oblique angle while valve frame function is assessed.

FIG.96Fis an illustration of a heart valve frame prosthesis having a braid or laser-cut tubular frame fully deployed into the tricuspid annulus. The distal side of the valve is shown engaging the tissue on the anterior side of the native annulus with the curved distal sidewall of the tubular frame sealing around the native annulus, and with the proximal sidewall tension-mounted into the posterior side of the native annulus.

FIG.97Ais an illustration of a valve frame according to an embodiment being delivered to tricuspid valve annulus.FIG.97Ashows braided/laser cut-frame lower tension arm126ejected from the delivery catheter118and being directed through the annulus and towards the right ventricular outflow tract.

FIG.97Bis an illustration of a valve frame according to an embodiment being delivered to tricuspid valve annulus.FIG.97Bshows braided/laser cut-frame lower tension arm126and upper tension arm128ejected from the delivery catheter118, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve frame about the annulus.

FIG.97Cis an illustration of a valve frame prosthesis according to an embodiment being delivered to tricuspid valve annulus.FIG.97Cshows the entire braided/laser cut-frame102ejected from the delivery catheter118, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve frame about the annulus, and at least one tissue anchor anchoring the proximal side of the prosthesis into the annulus tissue.FIG.97Cshows how a commercial valve can be secondarily deployed into the opening of the frame.

FIG.98Ais an illustration of a valve frame according to an embodiment being delivered to tricuspid valve annulus and shows step1in a valve assessment process.FIG.98Ashows braided/laser cut-frame lower tension arm ejected from the delivery catheter and being directed through the annulus and towards the right ventricular outflow tract.

FIG.98Bis an illustration of a valve frame prosthesis according to an embodiment being delivered to tricuspid valve annulus, and shows Step2in a valve frame assessment process.FIG.98Bshows braided/laser cut-frame lower tension arm and upper tension arm ejected from the delivery catheter, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve frame about the annulus.FIG.98Bshows that a steerable anchoring catheter can hold the valve frame at an oblique angle in a pre-attachment position, so that the valve frame can be assessed, and once valve frame function and patient conditions are correct, the steerable anchoring catheter can push the proximal side of the valve frame from its oblique angle, down into the annulus. The steerable anchoring catheter can then install one or more anchoring elements.

FIG.98Cis an illustration of a valve frame prosthesis according to an embodiment that has been delivered to tricuspid valve annulus, and shows Step3in a valve frame assessment process.FIG.98Cshows the entire braided/laser cut-frame valve frame ejected from the delivery catheter, the lower tension arm directed through the annulus and into the right ventricular outflow tract, and the upper tension arm staying in a supra-annular position, and causing a passive, structural anchoring of the distal side of the valve about the annulus, and at least one tissue anchor anchoring the proximal side of the prosthesis into the annulus tissue.FIG.98Cshows how a commercial valve can be secondarily deployed into the opening of the frame.

FIG.99Ais an illustration of a commercial valve that can be mounted within the disclosed frame.

FIG.99Bis an illustration of a commercial valve that can be mounted within the frame110having two rigid support posts154.

FIG.99Cis an illustration of a commercial valve that can be mounted within the frame, having a three-panel embodiment.

FIG.99Dis an illustration of a commercial valve that can be mounted within the frame, having a three-panel embodiment and having three rigid support posts154.

FIG.100is an illustration of the heart and shows an approximate location of the valves, the left and right atrium, the left and right ventricles, and the blood vessels that enter and exit the chambers of the heart.

FIG.101Ais an illustration of a low profile, e.g. 8-20 mm, side-loaded valve frame shown housed within the delivery catheter.

FIG.101Bis an illustration of a low profile, e.g. 8-20 mm, side-loaded valve frame shown partially housed within a delivery catheter and partially laterally ejected from the delivery catheter and positioned for deployment against the anterior side of the native annulus.

FIG.101Cis an illustration of a low profile, e.g. 8-20 mm, side-loaded valve frame shown ejected from the delivery catheter and positioned against the anterior side of the native annulus.

FIG.101Dis an illustration of a side or plan view of a low profile, e.g. 8-20 mm, side-loaded valve frame shown deployed into the native annulus of a heart valve.

FIG.101Eis an illustration of a side view of two types of deliverable valves, the first is a self-expanding transcatheter valve, and the second is a commercially-approved transcatheter balloon-expandable prosthetic valve being vertically deployed into the central lumen of the already (laterally, horizontally, orthogonally) deployed valve frame.

FIG.101Fis an illustration of a side view of a commercially approved transcatheter self-expandable prosthetic valve mounted within the central lumen of the already (laterally, horizontally, orthogonally) deployed valve frame.

FIG.101Gis an illustration of a side view of a commercially approved transcatheter balloon-expandable prosthetic valve mounted within the central lumen of the already (laterally, horizontally, orthogonally) deployed valve frame.

FIG.102Ais an illustration of step1of a 4-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.102Ashows a co-axial compressed valve136being loaded using a compression capsule or compression catheter301into the distal end of the delivery catheter138, with the sheathed310guidewire311threaded through the tension arm269and guidewire collar291.

FIG.102Bis an illustration of step2of a 4-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.102Bshows a co-axial compressed valve136being delivered to the distal end of the delivery catheter138, with the hypotube310sheathed guidewire311threaded through the tension arm269and channel-type guidewire collar291.

FIG.102Cis an illustration of step3of a 4-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.102Cshows a co-axial compressed valve136partially expelled from the delivery catheter138, with the tension arm269and channel-type guidewire collar291being positioned into the RVOT.

FIG.102Dis an illustration of step4of a 4-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.102Dshows that, once positioned, the self-expanding valve144can be completely expelled from the delivery catheter and deployed as a prosthetic valve.

FIG.103Ais an illustration of step1of a 7-step process for delivery of a co-axial prosthetic balloon-expandable valve to the tricuspid annulus.FIG.103Ashows a 0.035 guidewire31with hypotube sheath310delivered to the right ventricular outflow tract (RVOT) through the superior vena cava (SVC).

FIG.103Bis an illustration of step2of a 7-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.103Bshows a 24-34 Fr delivery catheter138being advanced over the guidewire311/310to and through the native tricuspid annulus to the right ventricle.

FIG.103Cis an illustration of step3of a 7-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.103Cshows a capsule301having a compressed valve143therein where the capsule301is loaded into the proximal end of the delivery catheter138and the valve is withdrawn/delivered from the capsule301into the delivery catheter138, with sheathed guidewire311threaded through the valve and providing a wire path to the RVOT, planned deployment location.

FIG.103Dis an illustration of step4of a 7-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.103Dshows the valve143advanced up the catheter and deployed into the native annulus by pushing on the outer hypotube sheath310of the guidewire311to pull the valve143up the catheter138and into position. Tension arm266is used to position the valve.

FIG.103Eis an illustration of step5of a 7-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.103Eshows a steerable balloon catheter295being used to push the proximal side of the valve143into position within the annulus.

FIG.103Fis an illustration of step6of a 7-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.103Fshows balloon expansion of the co-axial valve143in the native annulus and anchoring of the proximal side of the valve to the annular tissue.

FIG.103Gis an illustration of step7of a 7-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.103Gshows withdrawal of the delivery system and anchoring of the proximal side of the expanded valve143to the annular tissue.

FIG.104Ais an illustration of step1of a 6-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.104Ashows the delivery catheter deployed to the native annulus.

FIG.104Bis an illustration of step2of a 6-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.104Bshows a co-axial balloon-expandable valve143being loaded into the delivery catheter138, with the hypotube310sheathed guidewire311threaded through the tension arm269and channel-type guidewire collar291.

FIG.104Cis an illustration of step3of a 6-step process for delivery of a co-axial balloon-expandable prosthetic valve143to the tricuspid annulus.FIG.104Cshows a co-axial valve143being delivered to the proximal end of the delivery catheter138, with the hypotube310sheathed guidewire311threaded through the tension arm and guidewire collar291.

FIG.104Dis an illustration of step4of a 6-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.104Dshows a co-axial valve143partially expelled from the delivery catheter138, with the tension arm and guidewire collar291being positioned into the RVOT.FIG.104Dshows balloon catheter295connected to the valve143.

FIG.104Eis an illustration of step5of a 6-step process for delivery of a co-axial prosthetic valve to the tricuspid annulus.FIG.104Eshows that, once positioned and expanded by the balloon catheter294, the balloon-expanded co-axial valve143can be completely deployed into the inner circumference of the native annulus to function as a prosthetic valve.

FIG.104Fis an illustration of step6of a 6-step process for delivery of a co-axial prosthetic valve143to the tricuspid annulus.FIG.104Fshows the deployed valve.

EXAMPLES

Example—One embodiment of an orthogonally delivered transcatheter prosthetic valve has a tubular frame with a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a lengthwise 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. Importantly, this heart valve substitute does not have a traditional valve configuration, can be delivered to the heart using the inferior vena cava (IVC/femoral transcatheter delivery pathway compressed within a catheter, and expelled from the catheter to be deployed without open heart surgery.

Example—In another embodiment of a transcatheter valve, comprises: a cylindrical tubular frame having a height of about 5-60 mm and an outer diameter of about 25-80 mm, said tubular frame comprised of a braid, wire, or laser-cut wire frame having a substantially circular central aperture, said tubular frame partially covered with a biocompatible material; a collapsible flow control component disposed within the central aperture, said sleeve having a height of about 5-60 mm and comprised of at least two opposing leaflets that provide a reciprocating closable channel from a heart atrium to a heart ventricle; an upper tension arm attached to a distal upper edge of the tubular frame, the upper tension arm comprised of stent, segment of tubular frame, wire loop or wire frame extending from about 10-30 mm away from the tubular frame; a lower tension arm extending from a distal side of the tubular frame, the lower tension arm comprised of stent, segment of tubular frame, wire loop or wire frame extending from about 10-40 mm away from the tubular frame; and at least one tissue anchor to connect the tubular frame to native tissue.

Example—In another embodiment of a transcatheter valve, there is provided a feature wherein the sleeve is shaped as a conic cylinder, said top end having a diameter of 30-35 mm and said bottom end having a diameter of 8-20 mm.

Example—In another embodiment of a transcatheter valve, there is provided a feature wherein the cover is comprised of polyester, polyethylene terephthalate, decellularized pericardium, or a layered combination thereof.

Example—In an embodiment, there is also provided a method for orthogonal delivery of implantable prosthetic valve to a desired location in the body, the method comprising the steps: (i) advancing a delivery catheter to the desired location in the body and delivering an expandable prosthetic valve to the desired location in the body by releasing the valve from the delivery catheter, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a lengthwise 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.

Example—In an embodiment, there is also provided a method for orthogonally loading an implantable prosthetic valve into a delivery catheter, the method comprising the steps: loading an implantable prosthetic valve sideways into a tapering fixture or funnel attached to a delivery catheter, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a lengthwise 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.

Example—In an embodiment, there is also provided a method for orthogonally loading an implantable prosthetic valve into a delivery catheter, the method comprising the steps: (i) loading an implantable prosthetic valve into a tapering fixture or funnel attached to a delivery catheter, wherein the valve comprises a tubular frame having a flow control component mounted within the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve, wherein said loading is perpendicular or substantially orthogonal to the first direction, wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the first direction, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a lengthwise 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.

Example—The transcatheter prosthetic heart valve may be percutaneously delivered using a transcatheter process via the femoral through the IVC, carotid, sub-xyphoid, intercostal access across the chest wall, and trans-septal to the mitral annulus through the fossa ovalis. The device is delivered via catheter to the right or left atrium and is expanded from a compressed shape that fits with the internal diameter of the catheter lumen. The compressed valve is loaded external to the patient into the delivery catheter, and is then pushed out of the catheter when the capsule arrives to the atrium. The cardiac treatment technician visualizes this delivery using available imaging techniques such as fluoroscopy or ultrasound, and in an embodiment the valve self-expands upon release from the catheter since it is constructed in part from shape-memory material, such as Nitinol®, a nickel-titanium alloy used in biomedical implants.

In another embodiment, the valve may be constructed of materials that requires balloon-expansion after the capsule has been ejected from the catheter into the atrium.

The atrial collar/frame and the flow control component are expanded to their functional diameter, as they are deployed into the native annulus, providing a radial tensioning force to secure the valve. Once the frame is deployed about the tricuspid annulus, fasteners secure the device about the native annulus. Additional fastening of the device to native structures may be performed, and the deployment is complete. Further adjustments using hemodynamic imaging techniques are contemplated to ensure the device is secure, is located and oriented as planned, and is functioning as a substitute or successor to the native tricuspid valve.

Example—One embodiment of an orthogonally delivered transcatheter prosthetic valve frame has a tubular frame, wherein the valve frame is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the central, cylindrical axis of the native annulus, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the central, cylindrical axis of the native annulus, wherein the long-axis of the compressed configuration of the valve is substantially parallel to a lengthwise 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. This heart valve frame can be delivered to the heart using the inferior vena cava (IVC/femoral transcatheter delivery pathway compressed within a catheter, and expelled from the catheter to be deployed without open heart surgery.

Example—In another embodiment of a transcatheter valve frame, comprises: a cylindrical tubular frame having a height of about 5-60 mm and an outer diameter of about 25-80 mm, said tubular frame comprised of a braid, wire, or laser-cut wire frame having a substantially circular central aperture, said tubular frame partially covered with a biocompatible material; an upper tension arm attached to a distal upper edge of the tubular frame, the upper tension arm comprised of stent, segment of tubular frame, wire loop or wire frame extending from about 10-30 mm away from the tubular frame; a lower tension arm extending from a distal side of the tubular frame, the lower tension arm comprised of stent, segment of tubular frame, wire loop or wire frame extending from about 10-40 mm away from the tubular frame; and at least one tissue anchor to connect the tubular frame to native tissue.

Example—In an embodiment, there is also provided a method for orthogonal delivery of implantable prosthetic valve frame to a desired location in the body, the method comprising the steps: (i) advancing a delivery catheter to the desired location in the body and delivering an expandable prosthetic valve frame to the desired location in the body by releasing the valve frame from the delivery catheter, wherein the valve frame is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the central, cylindrical axis of the native annulus, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the central, cylindrical axis of the native annulus, wherein the long-axis of the compressed configuration of the valve frame is substantially parallel to a lengthwise cylindrical axis of the delivery catheter, wherein the valve frame has a height of about 5-60 mm and a diameter of about 25-80 mm.

Example—In an embodiment, there is also provided a method for orthogonally loading an implantable prosthetic valve frame into a delivery catheter, the method comprising the steps: loading an implantable prosthetic valve frame sideways into a tapering fixture or funnel attached to a delivery catheter, wherein the valve frame is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a desired location in the body, said compressed configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the central, cylindrical axis of the native annulus, and expandable to an expanded configuration having a long-axis oriented at an intersecting angle of between 45-135 degrees to the central, cylindrical axis of the native annulus, wherein the long-axis of the compressed configuration of the valve frame is substantially parallel to a lengthwise cylindrical axis of the delivery catheter, wherein the valve frame has a height of about 5-60 mm and a diameter of about 25-80 mm.

Example—The transcatheter prosthetic heart valve may be percutaneously delivered using a transcatheter process via the femoral through the inferior vena cava (IVC), superior vena cava (SVC), jugular vein, brachial vein, sub-xyphoid, intercostal access across the chest wall, and trans-septal through the fossa ovalis. The device is delivered via catheter to the right or left atrium and is expanded from a compressed shape that fits with the internal diameter of the catheter lumen. The compressed valve is loaded external to the patient into the delivery catheter, and is then pushed out of the catheter when the capsule arrives to the atrium. The cardiac treatment technician visualizes this delivery using available imaging techniques such as fluoroscopy or ultrasound, and in an embodiment the valve frame self-expands upon release from the catheter since it is constructed in part from shape-memory material, such as Nitinol®, a nickel-titanium alloy used in biomedical implants.

In another embodiment, the valve frame may be constructed of materials that requires balloon-expansion after the capsule has been ejected from the catheter into the atrium. The atrial collar/frame is expanded to their functional diameter, and deployed into the native annulus, providing a radial tensioning force to secure the valve frame. Once the frame is deployed about the tricuspid annulus, fasteners secure the device about the native annulus. Additional fastening of the device to native structures may be performed, and the deployment is complete. Further adjustments using hemodynamic imaging techniques are contemplated in order to ensure the device is secure, is located and oriented as planned, and is functioning.

Example—Compression methods. In another embodiment, there is provided a method of compressing, wherein the implantable prosthetic heart valve is rolled or folded into a compressed configuration using a step selected from the group consisting of: (i) unilaterally rolling into a compressed configuration from one side of the annular support frame; (ii) bilaterally rolling into a compressed configuration from two opposing sides of the annular support frame; (iii) flattening the annular support frame into two parallel panels that are substantially parallel to the long-axis, and then rolling the flattened annular support frame into a compressed configuration; and (iv) flattening the annular support frame along a vertical axis to reduce a vertical dimension of the valve from top to bottom.

The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. 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 may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.

Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concepts to those skilled in the art. Like numbers refer to like elements throughout. As used herein the term “and/or” includes any and all combinations of one or more of the associated listed items.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the full scope of the claims. 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.

Unless defined otherwise, all technical and scientific terms used herein have the same meanings 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 invention. As used in this document, the term “comprising” means “including, but not limited to.”

Many modifications and variations can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. 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 present disclosure is to be limited only by the terms of the appended claims, along with the full scope of equivalents to which such claims are entitled. It is to be understood that 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.

With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity.

It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.”

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

As will be understood by one skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal subparts. As will be understood by one skilled in the art, a range includes each individual member.

While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.

Where schematics and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components may be modified. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made. Any portion of the apparatus and/or methods described herein may be combined in any combination, except mutually exclusive combinations. The embodiments described herein can include various combinations and/or sub-combinations of the functions, components, and/or features of the different embodiments described.