US20170056215A1 - Stent assemblies including passages to provide blood flow to coronary arteries and methods of delivering and deploying such stent assemblies - Google Patents

Abstract

An anchor stent assembly to be used with a valve component includes a generally tubular frame having a first end and a second end, the frame defining a central passage and a central axis. A secondary passage is defined between n inner surface of the frame and an outer surface of an inner rib disposed closer to the central axis than the frame. An extension tube is disposed through the secondary passage. The extension tube includes an extension tube lumen having a first opening at a first end of the extension tube and a second opening at a second end of the extension tube.

Description

FIELD OF THE INVENTION
• Embodiments hereof relate to heart valve prostheses and methods for intraluminally deploying heart valve prostheses, and in particular, to heart valve prostheses including coronary access and methods of intraluminally delivering and deploying such heart valve prostheses.
BACKGROUND OF THE INVENTION
• Heart valves, such as the mitral, tricuspid, aortic, and pulmonary valves, are sometimes damaged by disease or by aging, resulting in problems with the proper functioning of the valve. Heart valve problems generally take one of two forms: stenosis in which a valve does not open completely or the opening is too small, resulting in restricted blood flow; or insufficiency in which blood leaks backward across a valve when it should be closed.
• Heart valve replacement has become a routine surgical procedure for patients suffering from valve regurgitation or stenotic calcification of the leaflets. Conventionally, the vast majority of valve replacements entail full sternotomy in placing the patient on cardiopulmonary bypass. Traditional open surgery inflicts significant patient trauma and discomfort, requires extensive recuperation times, and may result in life-threatening complications.
• To address these concerns, efforts have been made to perform cardiac valve replacements using minimally invasive techniques. In these methods, laparoscopic instruments are employed to make small openings through the patient's ribs to provide access to the heart. While considerable effort has been devoted to such techniques, widespread acceptance has been limited by the clinician's ability to access only certain regions of the heart using laparoscopic instruments.
• Still other efforts have been focused upon percutaneous transcatheter (or transluminal) delivery of replacement cardiac valves to solve the problems presented by traditional open surgery and minimally invasive surgical methods. In such methods, a valve prosthesis is compacted for delivery in a catheter and then advanced, for example through an opening in the femoral artery and through the descending aorta to the heart, where the prosthesis is then deployed in the valve annulus (e.g., the aortic valve annulus).
• Various types and configurations of prosthetic heart valves are used in percutaneous valve procedures to replace diseased natural human heart valves. The actual shape and configuration of any particular prosthetic heart valve is dependent to some extent upon the valve being replaced (i.e., mitral valve, tricuspid valve, aortic valve, or pulmonary valve). In general, prosthetic heart valve designs attempt to replicate the function of the valve being replaced and thus will include valve leaflet-like structures used with either bioprostheses or mechanical heart valve prostheses. If bioprostheses are selected, the replacement valves may include a valved vein segment or pericardial manufactured tissue valve that is mounted in some manner within an expandable stent frame to make a valved stent. In order to prepare such a valve for percutaneous implantation, one type of valved stent can be initially provided in an expanded or uncrimped condition, then crimped or compressed around a balloon portion of a catheter until it is close to the diameter of the catheter. In other percutaneous implantation systems, the stent frame of the valved stent can be made of a self-expanding material. With these systems, the valved stent is crimped down to a desired size and held in that compressed state within a sheath, for example. Retracting the sheath from this valved stent allows the stent to expand to a larger diameter, such as when the valved stent is in a desired position within a patient.
• While some problems of traditional open-heart surgery are overcome by percutaneous transcatheter (transluminal) methods, there are still risks associated with the method including post implantation percutaneous coronary intervention, coronary perfusion, and heart block.
• Post implantation coronary access with traditional transcatheter valve implantation (TAVI) may be limited by factors such as implantation height, strut width and cell opening size. Despite technical efforts to optimize valve prostheses placement, these factors may limit future access to coronary arteries and procedures to coronary arteries following transcatheter valve implementation.
• Coronary perfusion refers to the pressure gradient between aortic pressure and left ventricle pressure. This gradient drives blood flow into the coronary arteries. Implantation placement, height, cell opening size, partial coronary obstruction, and stent alignment may negatively impact blood flow to the coronary arteries.
• Heart block is an abnormal heart rhythm where the heart beats too slowly, called bradycardia. With heart block, the electrical signals that provide normal heart rhythm are either partially or totally blocked between the upper and lower heart. Improper placement of an aortic valve prosthesis is considered a possible contributor to heart block.
• There is a need for devices and methods that allow for simultaneous creation of coronary access during transcatheter valve implementation (TAVI) procedures. There is also a need for devices and methods to deploy valve prostheses further from the aortic annulus to minimize heart block in patients undergoing transcatheter valve implantation (TAVI) procedures.
BRIEF SUMMARY OF THE INVENTION
• Embodiments hereof are related to an anchor stent assembly to be used with a valve component. The anchor stent assembly has a radially compressed delivery configuration and a radially expanded deployed configuration. The stent assembly includes a generally tubular frame having a first end and a second end, the frame defining a central passage and a central axis. A secondary passage is defined between an inner surface of the frame and an outer surface of an inner rib disposed closer to the central axis than the frame. An extension tube is disposed through the secondary passage. The extension tube includes an extension tube lumen having a first opening at a first end of the extension tube and a second opening at a second end of the extension tube. The anchor stent assembly may include two secondary passages with two extension tubes such that the anchor stent assembly may be deployed in the aorta and the extension tubes may be circumferentially aligned with respective ostia of the left and right coronary arteries.
• Embodiments hereof are also directed to a method of implanting a stent assembly at a location in an aorta. The method includes advancing the stent assembly in a radially compressed delivery configuration to the location in the aorta. The stent assembly includes a generally tubular frame having a first end and a second end, a central passage, a central axis, a secondary passage formed between an inner surface of the frame and an outer surface of an inner rib closer to the central axis than the frame, and an extension tube extending through the secondary passage, the extension tube being coupled to the frame and having an extension tube lumen. The method further includes rotationally orienting the stent assembly such that the extension tube is generally circumferentially aligned with an ostium of a coronary artery. The stent assembly is then deployed from the radially compressed delivery configuration to a radially expanded deployed configuration at the location within the aorta. With the stent assembly in place, a coronary stent is advanced in a radially compressed delivery configuration through the extension tube lumen such that a first portion of the coronary stent resides within the extension tube lumen and a second portion of the coronary stent extends into the coronary artery. The coronary stent is then deploying the coronary stent assembly from the radially compressed delivery configuration to a radially expanded deployed configuration. The method may further include delivering a valve component in a radially compressed delivery configuration to a location within a native aortic valve and deploying the valve component such that the valve component expands from the radially compressed delivery configuration to a radially expanded configuration. The valve component may be situated such that a portion of the valve component is disposed within the central passage of the anchor stent assembly when both are deployed.
• Embodiments hereof are also directed to an anchor stent assembly for use with a valve component. The anchor stent assembly includes a radially compressed delivery configuration and a radially expanded deployed configuration. The stent assembly includes a generally tubular frame having a proximal end and a distal end and defining a central passage and a central axis. A secondary passage is defined between an inner surface of the frame and an outer surface of an inner rib closer to the central axis than the frame. A proximal alignment arm is coupled to the frame at the proximal end of the frame. A skirt is coupled to the inner rib and the proximal alignment arm such that a coronary channel is defined between an outer surface of the skirt and the frame. In an embodiment, the secondary passage comprises two secondary passages, and the stent assembly is configured to be rotationally oriented such that one of the secondary passages is circumferentially aligned with an ostium of the left coronary artery and the other of the secondary passages is circumferentially aligned with an ostium of the right coronary artery. The portion of the skirt attached to the proximal alignment arm defines a coronary pocket between the outer surface of the skirt and the aortic sinus in which the proximal alignment arm is disposed.
• Embodiments hereof are also directed to a method of implanting an anchor stent assembly at a location within an aorta. The anchor stent assembly includes a frame with a central passage and a central axis, a secondary passage formed between an inner surface of the frame and an outer surface of an inner rib closer to the central passage, a proximal alignment arm extending proximally from a proximal end of the frame, and a skirt coupled to the inner rib and the proximal alignment arm. The anchor stent assembly is advanced in a radially compressed delivery configuration to the location in the aorta. The method includes rotationally orienting the anchor stent assembly such that the secondary passage is generally circumferentially aligned with an ostium of a coronary artery. The method further includes deploying the anchor stent assembly from the radially compressed delivery configuration to a radially expanded deployed configuration at the location within the aorta such that the proximal alignment arm extends into an aortic sinus below the ostium of the coronary artery and a coronary channel is formed between an outer surface of the skirt at the inner rib and an inner surface of aorta, and a coronary pocket is formed between the outer surface of the skirt at the proximal alignment arm and an inner surface of the aortic sinus. The method may further include delivering a valve component in a radially compressed delivery configuration to a location within a native aortic valve, and deploying the valve component such that the valve component expands from the radially compressed delivery configuration to a radially expanded deployed configuration.
• Embodiments hereof are also directed to a valve assembly including a generally tubular frame, a prosthetic valve coupled to the frame, a coronary orifice extending between an inner surface and an outer surface of the frame, and a coronary arm having a first end coupled to the coronary orifice. The coronary arm has a generally tubular structure and defines a longitudinal passage with a longitudinal axis. The coronary arm includes a longitudinally collapsed delivery configuration wherein a second end of the coronary arm is adjacent the first end, and a longitudinally extended deployed configuration wherein the second end is spaced from the first end. The prosthetic valve may include two coronary arms and is configured to be deployed at a native aortic valve such that one of the coronary arms extends into the left coronary artery and the other coronary arm extends into the right coronary artery.
• Embodiments hereof are also directed to a method of implanting a valve assembly at a location of a native valve. The valve assembly includes a generally tubular frame defining a central passage and a central axis. A prosthetic valve is coupled to the frame. A coronary orifice extends between an inner surface and an outer surface of the frame. A coronary arm includes a first end coupled to the coronary orifice of the frame. A second end of the coronary arm is disposed adjacent to the first end with the coronary arm in a longitudinally collapsed delivery configuration. The method includes advancing the valve assembly in a radially compressed delivery configuration with the coronary arm in the longitudinally collapsed configuration to the location of the native valve. The valve assembly is rotationally oriented such that the coronary arm is aligned with an ostium of a coronary artery. The valve assembly is deployed such that the frame expands from the radially compressed delivery configuration to a radially expanded deployed configuration with the frame engaging an inner surface of the native valve and the aortic sinuses. The coronary arm is from the longitudinally compressed delivery configuration to a longitudinally extended deployed configuration such that the second end of the coronary arm is extended away from the first end and the second end is disposed within the coronary artery. The valve assembly may include two coronary arms, and the method includes rotationally orienting the valve assembly such that one of the two coronary arms is aligned with the left coronary artery and the other of the two coronary arms is aligned with the right coronary artery.
BRIEF DESCRIPTION OF DRAWINGS
• The foregoing and other features and advantages of the invention will be apparent from the following description of embodiments hereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the invention and to enable a person skilled in the pertinent art to make and use the invention. The drawings are not to scale.
• FIG. 1 is a schematic illustration of a prior art stented valve prosthesis.
• FIG. 2 is a schematic illustration of the prior art stented valve prosthesis ofFIG. 1.
• FIG. 3 is a schematic illustration of an anchor stent assembly in accordance with an embodiment hereof.
• FIGS. 4A and 4B are schematic illustrations of an anchor stent assembly in accordance with another embodiment hereof.
• FIGS. 5-13 are schematic illustrations of an embodiment of a method for delivering and deploying a valve prosthesis at an aortic valve with the anchor stent assembly ofFIG. 3 deployed in the aorta above the aortic sinuses.
• FIGS. 14-19 are schematic illustrations of an embodiment of a method for delivering and deploying a valve prosthesis at a native aortic valve with the anchor stent assembly ofFIG. 4B deployed in the aorta above the aortic sinuses.
• FIGS. 20A-20B are schematic illustrations of a valve prosthesis in accordance with another embodiment hereof.
• FIGS. 21-27 are schematic illustrations of an embodiment of a method for delivering and deploying the valve prosthesis ofFIGS. 20A-20B at an aortic valve.
DETAILED DESCRIPTION OF THE INVENTION
• Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal” when used in the following description to refer to a catheter or delivery system are with respect to a position or direction relative to the treating clinician. Thus, “distal” and “distally” refer to positions distant from or in a direction away from the clinician and “proximal” and “proximally” refer to positions near or in a direction toward the clinician. When the terms “distal” and “proximal” are used in the following description to refer to a device to be implanted into a vessel, such as an anchor stent assembly or valve component, they are used with reference to the direction of blood flow from the heart. Thus, “distal” and “distally” refer to positions in a downstream direction with respect to the direction of blood flow and “proximal” and “proximally” refer to positions in an upstream direction with respect to the direction of blood flow.
• FIGS. 1 and 2 show an exemplary conventional valve prosthesis similar to the Medtronic CoreValve® transcatheter aortic valve replacement valve prosthesis and as described in U.S. Patent Application Publication No. 2011/0172765 to Nguyen et al. (hereinafter “the '765 publication”), which is incorporated by reference herein in its entirety. As shown inFIGS. 1 and 2,valve prosthesis100 includes an expandable generallytubular frame102 having avalve body104 affixed to its interior surface, e.g., by sutures.Frame102 preferably comprises a self-expanding structure formed by laser cutting or etching a metal alloy tube comprising, for example, stainless steel or a shape memory material such as nickel titanium. The frame has an expanded deployed configuration, which is impressed upon the metal alloy tube using techniques known in the art.Valve body104 preferably comprises individual leaflets assembled to a skirt, where all of the components are formed from a natural or man-made material, including but not limited to, mammalian tissue, such as porcine, equine or bovine pericardium, or a synthetic or polymeric material.
• Frame102 in the exemplary embodiment includes anoutflow section106, aninflow section110, and aconstriction region108 between the inflow and outflow sections.Frame102 may comprise a plurality of cells having sizes that vary along the length of the prosthesis. When configured as a replacement for an aortic valve,inflow section110 extends into and anchors within the aortic annulus of a patient's left ventricle andoutflow section106 is positioned in the patient's ascending aorta.Frame102 also may includeeyelets130 for use in loading theheart valve prosthesis100 into a delivery catheter.
• Valve body104 may include askirt121 affixed to frame102, andleaflets112,114,116.Leaflets112,114,116 may be attached along their bases to skirt121, for example, using sutures or a suitable biocompatible adhesive. Adjoining pairs of leaflets are attached to one another at their lateral ends to formcommissures124,126,128, withfree edges118,120,122 of the leaflets forming coaptation edges that meet in an area of coaptation, as described in the '765 publication and shown inFIG. 2 hereof.
• The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although the description of the invention is in the context of transcatheter aortic valve implantation, the invention may also be used in any other body passageways where it is deemed useful. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.
• FIG. 3 shows an embodiment of ananchor stent assembly200 including ananchor stent202 andextension tubes270.Anchor stent202 is sized and designed to deploy in the aorta above the aortic sinuses of a heart, as described in more detail below. Anchor stent assembly is configured to be used with a valve component, as will be described in more detail below.
• Anchor stent202 includes aframe206 having a first orproximal end212, and a second ordistal end210, as shown inFIG. 3.Frame206 is a generally tubular configuration having acentral passage208.Frame206 is a stent structure as is known in the art and may be self-expanding.Frame206 includes a first, radially compressed configuration for delivery and a second, radially expanded or deployed configuration when deployed at the desired site. In the radially expanded configuration,frame206 may have a diameter that is generally about 2-5 millimeters larger than the diameter of the location in which the frame is to be installed, in order to create opposing radial forces between the outward radial force of the frame against an inward resisting force of the vessel.
• Frame206 is constructed of a series of vertical struts orstringers220 arranged parallel to a central longitudinal axis LA1 offrame206.Stringers220 are spaced radially from the central longitudinal axis LA1 and are spaced circumferentially from each other around a circumference of theframe206.Stringers220 are connected by a series of radially collapsible outer struts orribs224 that run circumferentially betweenadjacent stringers220. The outer surfaces ofouter ribs224 and the outer surfaces ofstringer220 form the outer surface offrame206. While the embodiment ofFIG. 3 showsanchor stent206 with ten (10)stringers220 connected by six (6) rows ofouter ribs224, it is not meant to limit the design, and it is understood that more orfewer stringers220 andouter ribs224 may be provided depending on the specific requirements of the components, devices, and procedures being utilized.
• A first extension tube channel orsecondary passage221ais formed betweenadjacent stringers220aand220band betweenouter ribs224 and correspondinginner ribs222 disposed betweenstringers220aand220b.Inner ribs222 are disposed closer to central longitudinal axis LA1 thanouter ribs224 such that firstextension tube channel221ais formed betweenouter ribs224 andinner ribs222 and firstextension tube channel221aextends longitudinally fromfirst end212 tosecond end210 offrame206. Similarly, a second extension tube channel orsecondary passage221bis formed betweenadjacent stringers220cand220dand betweenouter ribs224 and correspondinginner ribs222 disposed betweenstringers220cand220d.Inner ribs222 are disposed closer to central longitudinal axis LA1 thanouter ribs224 such that secondextension tube channel221bis formed betweenouter ribs224 andinner ribs222 and secondextension tube channel221bextends fromfirst end212 tosecond end210 offrame206. First and secondextension tube channels221a/221bare spaced apart from each other around the circumference offrame206 such that they generally align with circumferentially with a corresponding coronary artery when deployed adjacent the aortic sinuses of an aortic valve. Thus, first and secondextension tube channels221a/221bare generally spaced circumferentially approximately 120 degrees apart.
• Stringers220,outer ribs224 andinner ribs222 are collapsible structures and may be constructed of materials such as, but not limited to, stainless steel, Nitinol, or other suitable materials for the purposes disclosed herein.Outer ribs224 andinner ribs222 may be connected tostringers220 by methods such as, but not limited to fusing, welding, or other methods suitable for the purposes disclosed herein. Alternatively,frame206, includingstringers220,outer ribs224, andinner ribs222 may be formed by cutting a pattern from a tube, such as by laser-cutting, chemical etching, or other suitable methods. In other embodiments, the pattern may be cut from a flat sheet of material and then rolled to formframe206. Althoughframe206 has been described withstringers220,outer ribs224, andinner ribs222, other structures may be used to formframe206, such as, but not limited to, rings formed from sinusoidally shaped struts, struts forming cells (such as diamond shaped or hexagonally shaped cells), and other structures. The details of such structures are not essential provided that the frame includes a central passage and at least one secondary passage as described herein.
• Extension tubes270 are disposed within respectiveextension tube channels221a/221bofframe206. In the embodiment shown,extension tubes270 extend fromfirst end212 tosecond end210 offrame206. However, in other embodiments, extension tubes need not extend the entire length offrame206.Extension tubes270 include afirst end272 adjacentfirst end212 offrame206, and asecond end274 adjacentsecond end210 ofanchor frame206.First end272 ofextension tube270 may be flared as shown such that the diameter offirst end272 is greater than the diameter ofsecond end274. Eachextension tube270 forms a respectiveextension tube lumen276.Extension tube270 is constructed of materials such as, but not limited to woven polyester, Dacron mesh, and PTFE (woven, mesh, or elecrospun), or other materials suitable for the purposes disclosed herein.Extension tube270 may be connected to anchorframe206 at innerrib contact point226 and outerrib contact point227 and may be attached by methods such as, but not limited to sutures, adhesives, fusing, welding, or other methods suitable for the purposes disclosed herein.
• Although the embodiment ofFIG. 3 has been shown withextension tube channels220a/220bwith arespective extension tube270 disposed therein, both theextension tube channels220 andextension tubes270 are not required. For example, and not by way of limitation, in another embodiment,extension tube channels220 are eliminated and extension tubes are attached to an inner surface ofouter ribs224, In such an embodiment,inner ribs222 are eliminated such thatextension tube channels220 are not formed. In another example,extension tube channels220 are formed, butextension tubes270 are not disposed therein. Instead, respective coronary stents, as described in more detail below, may extend throughextension tube channels220. In such an embodiment, it is preferable that the coronary stents are covered stents or stent grafts.
• Another embodiment of ananchor stent assembly300 is shown inFIGS. 4A and 4B.Anchor stent assembly300 includes ananchor stent302 including proximal alignment arms and a skirt to form coronary pockets, as described in more detail below.Anchor stent302 is sized and configured to be deployed within the aorta, above the aortic sinuses of a heart, with the proximal alignment arms extending into aortic sinuses, as described in more detail below.
• Anchor stent302 includes aframe306 having a first orproximal end312, and a second ordistal end310, as shown inFIGS. 4A and 4B.Frame306 is a generally tubular configuration having acentral passage308.Frame306 is a stent structure as is known in the art and may be self-expanding.Frame306 includes a first, radially compressed configuration for delivery and a second, radially expanded or deployed configuration when deployed at the desired site.Frame306 may be constructed of materials such as, but not limited to, stainless steel, Nitinol, or other suitable materials for the purposes disclosed herein. In the radially expanded configuration,frame306 may have a diameter that is generally about 2-5 millimeters larger than the diameter of the location in which the frame is to be installed, in order to create opposing radial forces between the outward radial force of the frame against an inward resisting force of the vessel.
• Frame306 is constructed of a series of vertical struts orstringers320360 arranged parallel to a central longitudinal axis LA2 offrame306.Stringers320 are spaced radially from the central longitudinal axis LA2 and are spaced circumferentially from each other around the circumference offrame306.Stringers320 are connected by a series of radially collapsible outer struts orribs324 that run circumferentially betweenadjacent stringers320. The outer surfaces ofouter ribs324 and the outer surfaces ofstringers320 for the outer surface offrame306. While the embodiment ofFIG. 4A showsanchor stent302 with ten (10)stringers320 connected by six (6) rows ofouter ribs324, it is not meant to limit the design, and it is understood that more orfewer stringers320 andouter ribs324 may be provided depending on the specific requirements of the components, devices, and procedures being utilized.
• A first extension channel orsecondary passage321ais formed betweenadjacent stringers320aand320band betweenouter ribs324 and correspondinginner ribs322 disposed betweenstringers320aand320b.Inner ribs322 are disposed closer to central longitudinal axis LA2 thanouter ribs324 such thatfirst extension channel321ais formed betweenouter ribs324 andinner ribs322 andfirst extension channel321aextends longitudinally fromfirst end310 tosecond end312. Similarly, a second extension channel orsecondary passage321bis formed betweenadjacent stringers320cand320dand betweenouter ribs324 and correspondinginner ribs322 disposed betweenstringers320cand320d.Inner ribs322 are disposed closer to central longitudinal axis LA1 thanouter ribs324 such thatsecond extension channel321bis formed betweenouter ribs324 andinner ribs322 andsecond extension channel321bextends fromfirst end312 tosecond end310 offrame306. First andsecond extension channels321a/321bare spaced apart from each other around the circumference offrame306 such that they generally align circumferentially with a corresponding coronary artery when deployed adjacent the aortic sinuses of an aortic valve. Thus, first andsecond channels321a/321bare generally spaced circumferentially approximately 120 degrees apart.
• As described above,frame306 is generally similar to frame206 ofFIG. 3. As explained with respect to frame206,stringers320,outer ribs324 andinner ribs322 offrame306 are collapsible structures such as wire and may be constructed of materials such as, but not limited to, stainless steel, Nitinol, or other suitable materials for the purposes disclosed herein.Outer ribs324 andinner ribs322 may be connected tostringers320 by methods such as, but not limited to fusing, welding, or other methods suitable for the purposes disclosed herein. Alternatively,frame306, includingstringers320,outer ribs324, andinner ribs322 may be formed by cutting a pattern from a tube, such as by laser-cutting, chemical etching, or other suitable methods. In other embodiments, the pattern may be cut from a flat sheet of material and then rolled to formframe306. Althoughframe306 has been described withstringers320,outer ribs324, andinner ribs322, other structures may be used to formframe306, such as, but not limited to, rings formed from sinusoidally shaped struts, struts forming cells (such as diamond shaped or hexagonally shaped cells), and other structures. The details of such structures are not essential provided that the frame includes a central passage and at least one extension channel as described herein.
• Anchor stent302 further includesproximal alignment arms362,364, and366 extending proximally fromfirst end312 offrame306. In the embodiment shown inFIGS. 4A and 4B, eachproximal alignment arm362,364, and366 is in the form of a wire loop with first and second ends of the wire attached to frame306. In particular,first arm362 includes first and second ends attached to frame306 atconnections361 and363 respectively, as shown inFIG. 4A. Similarly,second arm364 includes first and second ends attached to frame306 atconnections365 and367, respectively, andthird arm366 includes first and second ends attached to frame306 atconnections369 and371, respectively.Connections361,363,365,367,369, and371 may be formed by the material ofproximal alignment arms362,364, and366, and frame306 being fused or welded together. Alternatively, the connections may be mechanical connections such as, but not limited to, sutures or otherwise tied, a crimp connector to crimp ends of the arms to frame306, or other suitable connections.Proximal alignment arms362,364, and366 include a radially compressed configuration for delivery to the treatment site and a radially expanded or deployed configuration. In the radially expanded configuration,proximal alignment arms362,364, and366 have a combined diameter such that they fit into the aortic sinuses. For example, and not by way of limitation, in the radially expanded configuration, the combined diameter ofproximal alignment arms362,364, and366 may be in the range of 29 mm-39 mm. As shown inFIGS. 4A and 4B, in the radially expanded configuration,proximal alignment arms362,364, and366 flare outwardly fromfirst end312 offrame306. AlthoughFIG. 4A shows three (3) proximal alignment arms with connections approximately equally spaced around the circumference offrame306, more or fewer arms may be utilized, and the arms need not be equally spaced around the circumference offrame306. At least two of the proximal alignment arms (364 and366 inFIG. 4A) are configured such that they encircle, but do not obstruct, the left and right ostia of the coronary arteries, as described in more detail below.
• Anchor stent assembly300 further includes askirt380 attached to an inside surface thereof to separatecentral passage308 fromextension channels321aand321b, as shown inFIG. 4B. As shown inFIG. 4B,skirt380 has a second end372 coupled tosecond end310 ofanchor frame306 and afirst end374 coupled toproximal alignment arms362,364, and366. An outer surface ofskirt380 forms acoronary pocket382 at each ofproximal alignments arms362,364,366. Thecoronary pocket382 formed withskirt380 andproximal alignment arm364 is generally longitudinally aligned withextension channel321b. Thecoronary pocket382 formed withskirt380 and proximal alignment arm366 (not shown inFIG. 4B) is generally longitudinally aligned withextension channel321a.Coronary pockets382 encircle the left and right coronary ostia whenanchor stent assembly300 is in the radially expanded configuration at the desired deployment site, as shown in more detail below.Skirt380 is a generally cylindrical tube constructed of cloth or fabric material. The fabric may comprise any suitable material including, but not limited to, woven polyester such as polyethylene terephthalate, polytetrafluoroethylene (PTFE), or other biocompatible materials.Skirt380 is secured to frame306 and the proximal alignment arms in a manner such as, but not limited to, sutures, laser or ultrasonic welding, or other methods suitable for the purposes disclosed herein. In another embodiment,first end374 ofskirt380 may be coupled tofirst end312 offrame306 such thatskirt380 does not extend proximally to the proximal alignment arms. In such an embodiment,extension channels321a,321bare generally circumferentially aligned with the coronary ostia, but disposed above the ostia, and theproximal alignment arms364,366 encircle the ostia to assist in prevent blockage thereof by a valve component, described in more detail below.
• With anchor stent assembly deployed withframe306 in the aorta andproximal alignment arms362,364,366 disposed within the aortic sinuses,skirt380 is configured such that the wall of the aortic sinuses andskirt380 attached to frame306 andinner ribs322 enclose extension channels321 such that each extension channel321 and correspondingcoronary pocket382 forms acoronary channel376 for direct path for blood flow to the left or right coronary ostia.
• An embodiment of a method of delivering and deploying an anchor stent assembly and a corresponding valve component is schematically represented inFIGS. 5-13.FIGS. 5-13 describe the method with respect to anchorstent assembly200 ofFIG. 3.FIGS. 5-13 are not drawn to scale regarding relative lengths ofanchor stent assembly200 and the valve component. The valve component is identified herein asvalve component240.Valve component240 is generally includes aprosthetic valve250 attached to a frame242 (shown schematically inFIG. 13). The combination offrame242 andprosthetic valve250 can assume various configurations. For example, and not by way of limitation,valve component240 may be similar tovalve prosthesis100 shown inFIGS. 1-2. Further,valve component240 may be similar to the valve component described in U.S. Patent Application Publication No. 2015/0119974, including a common inventor herewith and assigned to Medtronic, Inc., the contents of which are incorporated by reference herein in their entirety.
• In the method, aguidewire502 is advanced distally, i.e., away from the clinician, through theaorta400, past thesinotubular junction414, and into theaortic sinuses412 in the region of theaortic valve416 andannulus418, as shown inFIG. 5.Guidewire502 may be introduced through an opening or arteriotomy through the wall of femoral artery in the groin region of the patient by methods known to those skilled in the art, such as, but not limited to, the Seldinger technique.Guidewire502 is advanced into the descending (or abdominal) aorta (not shown), the aortic arch (not shown), and the ascendingaorta402, as shown inFIG. 5.FIG. 5 also shows twocoronary arteries420 and their correspondingcoronary ostia422. AlthoughFIGS. 5-13 show a retrograde percutaneous femoral procedure, it is not meant to limit the method of use and other procedural methods may be used. For example, and not by way of limitation, retrograde percutaneous implantation via subclavian/axillary routes, direct apical puncture, and the use of direct aortic access via either ministernotomy or right anterior thoracotomy may also be used.
• FIG. 6 shows adelivery system500 for deliveringanchor stent assembly200 being advanced distally, i.e., away from the clinician, overguidewire502 to a location in ascendingaorta402 adjacent theaortic sinuses412.Delivery system500 may be any suitable delivery system for delivering stents and/or stent grafts. In the embodiment shown schematically,anchor stent assembly200 includes a self-expandinganchor stent202 andextension tubes270. Accordingly,delivery system500 generally includes an inner orguidewire shaft508, which includes a guidewire lumen (not shown) for receivingguidewire502. A proximal end ofguidewire502 may be back loaded into the guidewire lumen (not shown) ofinner shaft508 through a distal opening (not shown) ininner shaft508.Delivery system500 may be an over-the-wire type catheter, or a rapid exchange catheter, or other catheter devices.Delivery system500 further generally may include adistal tip501, anouter sheath504 that maintainsanchor stent assembly200 in the radially compressed or delivery configuration during intraluminal delivery through the vasculature, as shown inFIG. 6, and may also include a pusher orstopper506, and other features.Delivery system500 and/oranchor stent assembly200 may also include, for example, radiopaque markers such that the clinician may determine whendelivery system500 and/oranchor stent assembly200 is in the proper location and alignment for deployment.
• Oncedelivery system500 has been advanced to the desired location, such as whenfirst end212 ofanchor stent202 is generally aligned withsinotubular junction414, andextension tubes270 rotationally aligned withcoronary ostia422,outer sheath504 is retracted proximally, i.e., towards the clinician, as shown inFIG. 7. Asouter sheath504 is retracted,frame206 ofanchor stent202 expands radially outward, engaging the inner wall of the ascendingaorta402, as shown inFIG. 7.
• Outer sheath504 is further retracted proximally, i.e., towards the clinician, to complete deployment ofanchor stent assembly200 fromouter sheath504. In other words,sheath504 is retracted such thatanchor stent assembly200 is no longer constrained bysheath504.
• Withanchor stent assembly200 fully deployed,delivery system500 may be retracted proximally, i.e., towards the clinician, and removed in a manner consistent with current procedures known to those in the art.Anchor stent assembly200 remains in the fully deployed configuration withextension tubes270 generally rotationally aligned with, but not obstructingcoronary ostia422, as shown inFIG. 8.
• Asteerable catheter530 is advanced distally, i.e., away from the clinician and into one ofextension tubes270, as shown inFIG. 9.Steerable catheter530 is guided into and throughextension tube270 and intocoronary ostium422 andcoronary artery420. Guidance may occur from one of several methods including, but not limited to, x-ray fluoroscopy, ultrasound imaging, electromagnetic tracking, radiopaque markers, or other methods suitable for the purposes disclosed herein.
• Once in place withinextension tube270 andcoronary artery420, aguidewire502 is extended throughcatheter530. Withguidewire502 positioned throughextension tube270 and intocoronary artery420,steerable catheter530 is retracted proximally, i.e., toward the clinician, and removed in a manner consistent with current procedures known to those in the art.Guidewire502 remains disposed throughextension tube270 and intocoronary artery420, as shown inFIG. 10.
• A coronarystent delivery system550 for delivering acoronary stent552 is advanced distally, i.e., away from the clinician, overguidewire502 to a location in thecoronary artery420 viacoronary ostium422, as shown inFIG. 11.Delivery system550 may be any suitable delivery system for delivering coronary stents and/or stent grafts as is known in the art. In the embodiment shown schematically,coronary stent552 is a balloon-expandable stent including a graft (i.e., a balloon-expandable stent graft), but other types of stents may be used (e.g., self-expanding, uncovered, etc.). Accordingly,delivery system550 generally may include a guidewire shaft (not shown), a distal tip (not shown), and a balloon (not shown) on whichcoronary stent552 is disposed in a radially compressed or delivery configuration during intraluminal delivery, as shown inFIG. 11. Coronarystent delivery system550 may also include other features, for example, radiopaque markers such that the clinician may determine whendelivery system550 and/orcoronary stent552 is in the proper location for deployment.
• Oncedelivery system550 has been advanced to the desired location, the balloon is inflated, causingcoronary stent552 to expand radially outward, engaging the inner wall ofextension tube270 and inner wall ofcoronary artery420, as shown inFIG. 12. Coronarystent delivery system550 is retracted proximally, i.e., toward the clinician, and removed in a manner consistent with procedures known to those in the art. The same method described above is repeated for the othercoronary artery420 to deliver and deploy a secondcoronary stent552. Thus, inFIG. 12, twocoronary stents552 are shown deployed partially within a respectivecoronary artery420 and partially within arespective extension tube270.
• Valve component240 may now be delivered and deployed at the nativeaortic valve416 using methods and procedures known in the art. As shown inFIG. 13,valve component240 may include aprosthetic valve250 disposed within valve aframe242. As also shown inFIG. 13,frame242 ofvalve component240 may overlap withostia422 of thecoronary arteries420 without being concerned with blocking flow to the coronary arteries. This is so because blood flow to the coronary arteries flows throughextension tubes270 andcoronary stents552 intocoronary arteries420. This also provides an increased landing zone for the valve component. Any location between the annulus and before which the native valve leaflets are no longer captured by the valve frame is a valid landing zone for the proximal (i.e., inflow) end of the valve frame. Thus, the valve frame could be placed farther away from the annulus which may result in less incidence of heart block. Further, a fully skirted valve component may be used, which may result in less paravalvular leakage (PVL), without blocking flow to the coronary arteries. Further, if future procedures are required in a coronary artery (balloon angioplasty, stent placement, etc.), access to the coronary arteries may be achieved through thecoronary stents552. Further, although not shown inFIG. 13,frame242 ofvalve component240 may extend into the ascending aorta such thatframe242 is disposed withincentral passage208 offrame206 ofanchor stent202, as explained in more detail in U.S. Patent Application Publication No. 2015/0119974 assigned to Medtronic, Inc., the contents of which are incorporated by reference herein in their entirety.
• FIGS. 14-19 show schematically a method of delivering and deployinganchor stent assembly300 ofFIG. 4B and a valve component.FIGS. 14-19 are not drawn to scale regarding relative lengths ofanchor stent assembly300 andvalve component240.
• Similar to the description above, guidewire502 is advanced distally, i.e., away from the clinician, through theaorta400, past thesinotubular junction414, and into theaortic sinuses412 in the region of theaortic valve416 andannulus418, as shown inFIG. 14.Guidewire502 may be introduced through an opening or arteriotomy through the wall of femoral artery in the groin region of the patient by methods known to those skilled in the art, such as, but not limited to, the Seldinger technique.Guidewire502 is advanced into the descending (or abdominal) aorta (not shown), the aortic arch (not shown), and the ascendingaorta402, as shown inFIG. 14. AlthoughFIGS. 14-19 show a retrograde percutaneous femoral procedure, it is not meant to limit the method of use and other procedural methods may be used. For example, and not by way of limitation, retrograde percutaneous implantation via subclavian/axillary routes, direct apical puncture, and the use of direct aortic access via either ministernotomy or right anterior thoracotomy may also be used.
• Adelivery system500 for deliveringanchor stent assembly300 being advanced distally, i.e., away from the clinician, overguidewire502 to a location in theaortic sinuses412, as shown inFIG. 15.Delivery system500 may be any suitable delivery system for delivering stents and/or stent grafts. In the embodiment shown schematically,anchor stent302 ofanchor stent assembly300 is a self-expanding stent. Accordingly,delivery system500 generally includes an inner orguidewire shaft508, which includes a guidewire passage (not shown) for receivingguidewire502. A proximal end ofguidewire502 may be back loaded into the guidewire passage (not shown) ofinner shaft508 through a distal opening (not shown) ininner shaft508.Delivery system500 may be an over-the-wire type catheter, or a rapid exchange catheter, or other catheter devices.Delivery system500 further generally may include adistal tip501, anouter sheath504 that maintainsanchor stent302 in the radially compressed or delivery configuration during intraluminal delivery through the vasculature, as shown inFIG. 15, and may also include a pusher orstopper506, and other features.Delivery system500 and/oranchor stent assembly300 may also include, for example, radiopaque markers such that the clinician may determine whendelivery system500 and/oranchor stent assembly300 is in the proper location and alignment for deployment.
• Oncedelivery system500 has been advanced to the desired location, such as whenfirst end312 offrame306 ofanchor stent302 is generally aligned withsinotubular junction414, andproximal alignment arms364 and366 are rotationally aligned with and encircle, but do not obstruct,coronary ostia422,outer sheath504 is retracted proximally, i.e., towards the clinician, as shown inFIG. 16. Asouter sheath504 is retracted, proximal alignment arms362 (not shown),364 (not shown), and366 engage the inner wall of theaortic sinuses412, and frame306 ofanchor stent302 expands radially outward, engaging the inner wall of ascendingaorta402, as shown inFIG. 16.
• Outer sheath504 is further retracted proximally, i.e., towards the clinician, to complete deployment ofanchor stent assembly300 fromouter sheath504. In other words,sheath504 is retracted such thatanchor stent assembly300 is no longer constrained bysheath504.
• Withanchor stent assembly300 fully deployed,delivery system500 may be refracted proximally, i.e., towards the clinician, and removed in a manner consistent with procedures known to those in the art.Anchor stent assembly300 remains in the fully deployed configuration such thatextension channels321a/321bare generally rotationally aligned with respectivecoronary ostia422 andproximal arms364 and366 encircle, but do not obstructcoronary ostia422, as shown inFIG. 17 (with skirt removed for clarity) andFIG. 18 (withskirt380 in place).Skirt380, whenanchor stent assembly300 is in the expanded deployed configuration, defines extension channels321 andcoronary pockets382 between an outer surface ofskirt380 and the inner surface of the wall of the ascending aorta/aortic sinuses, providing unrestricted blood flow tocoronary artery420, as indicated by coronary bloodflow direction arrow386 ofFIG. 18. Because coronary pockets283 are relatively large,extension channels321a/321bdo not need to be perfectly rotationally aligned with the correspondingcoronary ostia422 and blood will still funnel to thecoronary ostia422 and into thecoronary artery420.
• Valve component240, as described above, may now be delivered and deployed at the nativeaortic valve416 using methods and procedures known in the art. Once in place, prosthetic valve350 resides within valve frame342 atannulus418 as shown inFIG. 19. As also shown inFIG. 13,frame242 ofvalve component240 may overlap withostia422 of thecoronary arteries420 without being concerned with blocking flow to the coronary arteries. This is so because blood flow to the coronary arteries flows throughextension channels321a/321bandcoronary pockets382 intocoronary arteries420. This also provides an increased landing zone for the valve component. Any location between the annulus and before which the native valve leaflets are no longer captured by the valve frame is a valid landing zone for the proximal (i.e., inflow) end of the valve frame. Thus, the valve frame could be placed farther away from the annulus which may result in less incidence of heart block. Further, a fully skirted valve component may be used, which may result in less paravalvular leakage (PVL), without blocking flow to the coronary arteries. Further, if future interventional procedures are required in a coronary artery (balloon angioplasty, stent placement, etc.), access to the coronary arteries may be achieved through extension channels321. Further, although not shown inFIG. 19,frame242 ofvalve component240 may extend into the ascending aorta such thatframe242 is disposed withincentral passage308 offrame306 ofanchor stent302, as explained in more detail in U.S. Patent Application Publication No. 2015/0119974 assigned to Medtronic, Inc., the contents of which are incorporated by reference herein in their entirety.
• FIGS. 20A and 20B show an embodiment of anintegrated valve assembly600 including aframe606, aprosthetic valve620, andcoronary arms650.Valve assembly600 is sized and designed to deploy within the aortic sinuses and annulus of a heart, as described in more detail below.
• Frame606 includes afirst end612 and asecond end610, as shown inFIGS. 20A and 20B.Frame606 is a generally tubular configuration having acentral passage608 and a central longitudinal axis LA3.Frame606 is a stent structure as is known in the art and may be self-expanding. Frame606 acoronary orifice660 between an inner surface and an outer surface offrame606.Coronary orifice660 is an opening through the wall offrame606.Coronary orifice660 may be a separate opening or may be an opening defined by cells inframe606.Coronary orifice660 is described in more detail below in the description ofcoronary arms650. Generally,frame606 includes a first, radially compressed configuration for delivery and a second, radially expanded or deployed configuration when deployed at the desired site.Frame606 is a collapsible structure and may be constructed of materials such as, but not limited to, stainless steel, Nitinol, cobalt-chromium alloys, or other suitable materials for the purposes disclosed herein.
• Eachcoronary arm650 is a generally tubular structure, defining alongitudinal passage658 with a longitudinal axis LA4. Longitudinal axis LA4 is generally transverse to longitudinal axis LA3. Although longitudinal axis LA4 has been defined with respect to one of thecoronary arms650, those skilled in the art would recognize that the coronary arms do not need to align with each other. Instead,coronary arms650 extend fromframe606 at locations such thatcoronary arms650 can extend into a respective coronary artery, as described in more detail below. Thus,coronary arms650 may be longitudinally offset, if appropriate.Coronary arms650 may includestruts651 coupled tograft material652, similar to a stent-graft construction.Struts651 may be any suitable material generally used in stent, such as, but not limited to, stainless steel or Nitinol.Struts651 may be the same material asframe606.Graft material652 may be any suitable material generally used for a graft such as, but not limited to, woven polyester such as polyethylene terephthalate, polytetrafluoroethylene (PTFE), other polymers, or other biocompatible materials.Graft material652 and struts651 may be coupled by sutures, fusion, or other coupling methods known in the art. Further,graft material652 may be coupled to the outer surface or inner surface ofstruts651.Coronary arms650 may be coupled to frame606 by fusion, laser or ultrasonic welding, mechanical connections such as sutures, or other methods suitable for the purposes disclosed herein. In another embodiment, struts651 ofcoronary arms650 may be constructed integrally withframe606.
• Coronary arms650 have afirst end656 and asecond end654, and a longitudinally collapsed delivery configuration and a longitudinally extended deployed configuration. When in the longitudinally collapsed delivery configuration,second end654 is adjacent tofirst end656, as shown inFIG. 20B. When in the longitudinally extended deployed configuration,second end654 is spaced fromfirst end656, as shown inFIG. 20A. Thus, as described,coronary arms650 telescope from the longitudinally collapsed delivery configuration to the longitudinally extended deployed configuration.Coronary arms650 may be of any length suitable for the purposes disclosed herein. For example, and not by way of limitation,coronary arms650 may have a length in the range of 15 mm-300 mm.
• Coronary arms650 are configured such that the longitudinal axis of eachcoronary arm650 generally aligns with a corresponding longitudinal axis of the coronary artery into which it is to be inserted.
• While the embodiment ofFIGS. 20A-20B shows telescopingcoronary arms650 as series ofcircular struts651 coupled tograft material652 to form concentrically connected cylinders, it is not meant to limit the design, and it is understood that other materials and configurations may be employed such that depending on the specific requirements of the components, devices, and procedures.
• Prosthetic valve620 may be any prosthetic valve. For example, and not by way of limitation,prosthetic valve620 may be similar tovalve body104 described above with respect toFIGS. 1 and 2, or as described in the '765 publication.Prosthetic valve620 is coupled to and disposed withinframe606 ofvalve assembly600.
• A method of delivering and deployingvalve assembly600 in accordance with an embodiment hereof is schematically represented inFIGS. 21-27. As shown inFIG. 21, aguidewire702 advanced distally, i.e., away from the clinician, through theaorta400, past thesinotubular junction414, and into theaortic sinuses412 in the region of theaortic valve416 andannulus418.Guidewire702 may be introduced through an opening or arteriotomy through the wall of femoral artery in the groin region of the patient by methods known to those skilled in the art, such as, but not limited to, the Seldinger technique.Guidewire702 is advanced into the descending (or abdominal) aorta (not shown), the aortic arch (not shown), and the ascendingaorta402, as shown inFIG. 21. Twocoronary arteries420 and their correspondingcoronary ostia422 are also shown inFIG. 21. AlthoughFIGS. 21-27 show a retrograde percutaneous femoral procedure, it is not meant to limit the method of use and other procedural methods may be used. For example, and not by way of limitation, retrograde percutaneous implantation via subclavian/axillary routes, direct apical puncture, and the use of direct aortic access via either ministernotomy or right anterior thoracotomy may also be used.
• A delivery system700 for deliveringvalve assembly600 is advanced distally, i.e., away from the clinician, overguidewire702 to a location at theannulus418 of the heart, as shown inFIG. 22. Delivery system700 may be any suitable delivery system for delivering stents and/or stent grafts. In the embodiment shown schematically,valve assembly600 is a self-expandingframe606. Accordingly, delivery system700 generally includes an inner orguidewire shaft708, which includes a guidewire passage (not shown) for receivingguidewire702. A proximal end ofguidewire702 may be back loaded into the guidewire passage (not shown) ofinner shaft708 through a distal opening (not shown) ininner shaft708. Delivery system700 may be an over-the-wire type catheter, or a rapid exchange catheter, or other catheter devices. Delivery system700 further generally may include adistal tip701, anouter sheath704 that maintainsvalve assembly600 in the radially compressed or delivery configuration during intraluminal delivery through the vasculature, as shown inFIG. 22 and may also include a pusher orstopper706, and other features. Delivery system700 and/orvalve assembly600 may also include, for example, radiopaque markers such that the clinician may determine when delivery system700 and/orvalve assembly600 is in the proper location and alignment for deployment.
• Once delivery system700 has been advanced to the desired location such that eachcoronary arm650 is generally rotationally and longitudinally aligned with the correspondingcoronary ostium422 of the correspondingcoronary artery420,outer sheath704 is retracted proximally, i.e., towards the clinician, to deployframe606 ofvalve assembly600, as shown inFIG. 23. Asframe606 expands radially outward,frame606 separates the native leaflets ofaortic valve416.
• Outer sheath704 is further retracted proximally, i.e., towards the clinician, to complete deployment ofvalve assembly600 fromouter sheath704.Sheath704 is retracted such thatvalve assembly600 is no longer constrained bysheath704 and expands radially outward, as shown inFIG. 24.
• Withvalve assembly600 fully deployed, delivery system700 may be retracted proximally, i.e., towards the clinician, and removed in a manner consistent with procedures known to those in the art.Valve assembly600 remains in the fully deployed configuration withcoronary arms650 in the longitudinally collapsed delivery configuration and aligned of the correspondingcoronary arteries420, as shown inFIG. 24.
• A steerable catheter orpushrod730 is advanced distally, i.e., away from the clinician and into onecoronary arms650, as shown inFIG. 25.Pushrod730 may be guided by x-ray fluoroscopy, ultrasound imaging, electromagnetic tracking, radiopaque markers, or other methods suitable for the purposes disclosed herein.
• Once in place within telescopingcoronary arm650,pushrod730 is advanced distally i.e., away from the clinician, such thatdistal end732 ofpushrod730 engagessecond end654 ofcoronary arm650 and pushessecond end654 ofcoronary arm650.Pushrod730 continues to be advanced to extendsecond end654 ofcoronary arm650 intocoronary artery420, thereby deployingcoronary arm650 from its longitudinally collapsed delivery configuration to its longitudinally extended deployed configuration, as shown inFIG. 26. In another embodiment, a pushrod may be part of delivery system700 such that a separate pushrod is not needed.
• Oncecoronary arm650 is in its longitudinally extended deployed configuration withsecond end654 ofcoronary arm650 disposed withincoronary artery420,steerable catheter730 is retracted proximally, i.e., toward the clinician, and removed in a manner consistent with procedures known to those in the art. The procedure is repeated for the othercoronary arm650.
• In another embodiment,coronary arms650 may be formed of shape memory material such that they are self-extending. Accordingly, the pre-formed shape of eachcoronary arm650 is the longitudinally extended deployed configuration. Thecoronary arms650 are collapsed to the longitudinally collapsed delivery configuration when loaded intoouter sheath704. Whenouter sheath704 is retracted, as described above,coronary arms650 return to their pre-formed, longitudinally extended configuration without the use of thepushrod730 described above.
• Valve assembly600 is shown in a fully deployed configuration shown inFIG. 27.Valve assembly600 withcoronary arms650 maintains blood flow to the coronary arteries. Further,coronary arms650 provide support forframe606 whencoronary arms650 are deployed in the coronary arteries. Thus,frame606 is not required to provide as much radial force to maintainframe606 at the desired location as compared to prosthetic valve assemblies withoutcoronary arms650. Further,coronary arms650 provide access to the coronary arteries for future interventional procedures (e.g., balloon angioplasty, stent placement).
• While various embodiments according to the present invention have been described above, it should be understood that they have been presented by way of illustration and example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the appended claims and their equivalents. It will also be understood that each feature of each embodiment discussed herein, and of each reference cited herein, can be used in combination with the features of any other embodiment

Claims (31)

What is claimed is:

1. A stent assembly having a radially compressed delivery configuration and a radially expanded deployed configuration, the stent assembly comprising:

a generally tubular frame having a first end and a second end, the frame defining a central passage and a central axis;

a secondary passage, defined between an inner surface of the frame and an outer surface of an inner rib closer to the central axis than the frame; and

an extension tube extending through the secondary passage, the extension tube including an extension tube lumen having a first opening at a first end of the extension tube and a second opening at a second end of the extension tube.

2. The stent assembly ofclaim 1, wherein the stent assembly is configured to be deployed within an aorta adjacent to the aortic sinuses.

3. The stent assembly ofclaim 2, wherein the secondary passage is aligned parallel with the central axis of the frame.

4. The stent assembly ofclaim 2, wherein the secondary passage comprises two passages, and the extension tube comprises two extension tubes, with each extension tube extending through a corresponding one of the secondary passages.

5. The stent assembly ofclaim 2, wherein the extension tube is configured such that the extension tube aligns circumferentially with, but does not obstruct, an ostium of a coronary artery.

6. The stent assembly ofclaim 2, wherein the extension tube is configured to receive a coronary stent.

7. The stent assembly ofclaim 6, wherein the extension tube is configured such that a first portion of the coronary stent is disposed within the extension tube and a second portion of the coronary stent extends into the coronary artery.

8. The stent assembly ofclaim 6, wherein when the stent assembly and the coronary stent are in their second, radially expanded deployed configuration, the extension tube is in fluid communication with the coronary stent and the coronary stent is in fluid communication with the coronary artery.

9. A method of implanting a stent assembly at a location in an aorta comprising the steps of:

advancing the stent assembly in a radially compressed delivery configuration to the location in the aorta, wherein the stent assembly comprises a generally tubular frame having a first end and a second end, a central passage, a central axis, a secondary passage formed between an inner surface of the frame and an outer surface of an inner rib closer to the central axis than the frame, and an extension tube extending through the secondary passage, the extension tube being coupled to the frame and having an extension tube lumen;

rotationally orienting the stent assembly such that the extension tube generally circumferentially aligned with an ostium of a coronary artery;

deploying the stent assembly from the radially compressed delivery configuration to a radially expanded deployed configuration at the location within the aorta;

advancing a coronary stent in a radially compressed delivery configuration through the extension tube lumen such that a first portion of the coronary stent resides within the extension tube lumen and a second portion of the coronary stent extends into the coronary artery; and

deploying the coronary stent assembly from the radially compressed delivery configuration to a radially expanded deployed configuration.

10. The method ofclaim 9, further comprising the steps of:

delivering a valve component in a radially compressed delivery configuration to a location within a native aortic valve; and

deploying the valve component such that the valve component expands from the radially compressed delivery configuration to a radially expanded configuration.

11. The method ofclaim 9, wherein the secondary passage of the stent assembly comprises two secondary passages and the extension tube comprises two extensions tubes disposed within a respective one of the two secondary passages, wherein the step of rotationally orienting the stent assembly comprises circumferentially aligning one of the extension tubes with the ostium of the left coronary artery and circumferentially aligning the other of the two extension tubes with the right coronary artery.

12. A stent assembly having a radially compressed delivery configuration and a radially expanded deployed configuration, the stent assembly comprising:

a generally tubular frame having a first end and a second end, the frame defining a central passage and a central axis;

a secondary passage, defined between an inner surface of the frame and an outer surface of an inner rib closer to the central axis than the frame;

a proximal alignment arm, wherein the proximal alignment arm is coupled to the frame at the first end of the frame; and

a skirt coupled to the inner rib and the proximal alignment arm such that a coronary channel is defined between an outer surface of the skirt and the frame.

13. The stent assembly ofclaim 12, wherein the stent assembly is configured to be deployed within an aorta with the proximal alignment arm deployed in a sinus of an aortic valve.

14. The stent assembly ofclaim 13, wherein the secondary passage is generally parallel with the central axis of the frame.

15. The stent assembly ofclaim 13, wherein the secondary passage comprises two secondary passages.

16. The stent assembly ofclaim 13, wherein the proximal alignment arm extends from a proximal end of the frame, the proximal alignment arm configured to be deployed in an aortic sinus, the proximal alignment arm further configured such that a proximal end of the proximal alignment arm extends below an ostium of a coronary artery.

17. The stent assembly ofclaim 13, wherein the proximal alignment arm comprises two proximal alignment arms.

18. The stent assembly ofclaim 13, wherein the coronary channel is configured to rotationally align with an ostium of the coronary artery.

19. The stent assembly ofclaim 13, wherein with the stent assembly deployed in the aorta, the proximal alignment arm encircles an ostium of a coronary artery, and a coronary pocket is defined between the outer surface of the skirt and the aortic sinus in which the proximal alignment arm is disposed.

20. The stent assembly ofclaim 19, wherein when in the radially expanded deployed configuration, the coronary channel is in fluid communication with the coronary pocket and the coronary pocket is in fluid communication with the coronary artery.

21. A method of implanting a stent assembly at a location of an aorta comprising the steps of:

advancing the stent assembly in a radially compressed delivery configuration to the location of the aorta, wherein the stent assembly includes a frame with a central passage and a central axis, a secondary passage formed between an inner surface of the frame and an outer surface of an inner rib closer to the central passage, a proximal alignment arm extending proximally from a proximal end of the frame, and a skirt coupled to the inner rib and the proximal alignment arm;

rotationally orienting the stent assembly such that the secondary channel is generally circumferentially aligned with an ostium of a coronary artery; and

deploying the stent assembly from the radially compressed delivery configuration to a radially expanded deployed configuration at the location within the aorta such that the proximal alignment arm extends into an aortic sinus below the ostium of the coronary artery and a coronary channel is formed between an outer surface of the skirt at the inner ribs and an inner surface of aorta, and a coronary pocket is formed between the outer surface of the skirt at the proximal alignment arm and an inner surface of the aortic sinus.

22. The method ofclaim 21, further comprising the steps of:

delivering a valve component in a radially compressed delivery configuration to a location within a native aortic valve; and

deploying the valve component such that the valve component expands from the radially compressed delivery configuration to a radially expanded deployed configuration.

23. The method ofclaim 21, wherein the secondary passage comprises two secondary passages, and wherein the step of rotationally orienting the stent assembly comprises circumferentially aligning one of the secondary passages with the ostium of the left coronary artery and circumferentially aligning the other of the secondary passages with the right coronary artery.

24. A valve assembly having a radially compressed delivery configuration and a radially expanded deployed configuration, the valve assembly comprising:

a generally tubular frame having a first end and a second end, the frame defining a central passage and a central axis:

a prosthetic valve coupled to the frame;

a coronary orifice extending between an inner surface and an outer surface of the frame; and

a coronary arm having a generally tubular structure, the coronary arm defining a longitudinal passage with a longitudinal axis, a first end of the coronary arm coupled to the coronary orifice, the coronary arm having a longitudinally collapsed delivery configuration wherein a second end of the coronary arm is adjacent the first end, and a longitudinally extended deployed configuration wherein the second end is spaced from the first end.

25. The valve assembly ofclaim 24, wherein the valve assembly is configured to be deployed at a native aortic valve.

26. The valve assembly ofclaim 25, wherein the longitudinal axis of the coronary arm extends generally transverse to the central axis of the frame.

27. The valve assembly ofclaim 25, wherein the coronary arm comprises two coronary arms.

28. The valve assembly ofclaim 27, wherein the second end of each coronary arm is configured to align with an ostium of a respective coronary artery.

29. The valve assembly ofclaim 28, wherein the valve assembly is configured such that when the valve assembly is in the radially expanded deployed configuration and the coronary arms are in the longitudinally expanded deployed configuration, the central passage of the frame is in fluid communication with the longitudinal passage of each of the coronary arms, and the longitudinal passage of each of the coronary arms is in fluid communication with the respective coronary artery.

30. A method of implanting a valve assembly at a location of a native valve comprising the steps of:

advancing the valve assembly in a radially compressed delivery configuration to the location of the native valve, wherein the valve assembly includes a generally tubular frame having a first end and a second end, the frame defining a central passage and a central axis, a prosthetic valve coupled to the frame, a coronary orifice extending between an inner surface and an outer surface of the frame, and a coronary arm having a generally tubular structure, a first end of the coronary arm coupled to the coronary orifice of the frame and a second end of the coronary arm disposed adjacent to the first end with the coronary arm in a longitudinally collapsed delivery configuration;

rotationally orienting the valve assembly such that the coronary arm is aligned with an ostium of a coronary artery;

deploying the valve assembly such that the frame expands from the radially compressed delivery configuration to a radially expanded deployed configuration with the frame engaging an inner surface of the native valve and the aortic sinuses;

deploying the coronary arm from the longitudinally compressed delivery configuration to a longitudinally extended deployed configuration such that the second end of the coronary arm is extended away from the first end and the second end is disposed within the coronary artery.

31. The method ofclaim 30, wherein the valve assembly includes two coronary arms, and wherein the step of rotationally orienting the valve assembly comprises aligning one of the two coronary arms with the left coronary artery and the other of the two coronary arms with the right coronary artery.

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