# Patent

## Title
Delivery systems and methods of implantation for prosthetic heart valves

## Abstract

A delivery system for delivering an implantable stented device to a lumen of a patient, the delivery system including an elongated body having a proximal end and a distal end, a driver mechanism positioned at the proximal end of the elongated body, an elongated threaded rod located axially distal to the driver mechanism, and a sheath including an elongated tubular portion having a hollow interior portion with a first diameter that is sized for compression and retention of the implantable stented device in a compressed configuration for delivery to a body lumen.

## Background
CROSS-REFERENCE TO RELATED APPLICATION
The present application claims priority to U.S. Provisional Application No. 61/062,207, filed Jan. 24, 2008, and titled “Delivery Systems and Methods of Implantation for Prosthetic Heart Valves”, the entire contents of which is incorporated herein by reference in its entirety.


TECHNICAL FIELD
The present invention relates to prosthetic heart valves. More particularly, it relates to devices, methods, and delivery systems for percutaneously implanting prosthetic heart valves.
BACKGROUND
Diseased or otherwise deficient heart valves can be repaired or replaced using a variety of different types of heart valve surgeries. Typical heart valve surgeries involve an open-heart surgical procedure that is conducted under general anesthesia, during which the heart is stopped while blood flow is controlled by a heart-lung bypass machine. This type of valve surgery is highly invasive and exposes the patient to a number of potentially serious risks, such as infection, stroke, renal failure, and adverse effects associated with use of the heart-lung machine, for example.
Recently, there has been increasing interest in minimally invasive and percutaneous replacement of cardiac valves. Such surgical techniques involve making a very small opening in the skin of the patient into which a valve assembly is inserted in the body and delivered to the heart via a delivery device similar to a catheter. This technique is often preferable to more invasive forms of surgery, such as the open-heart surgical procedure described above. In the context of pulmonary valve replacement, U.S. Patent Application Publication Nos. 2003/0199971 A1 and 2003/0199963 A1, both filed by Tower, et al., describe a valved segment of bovine jugular vein, mounted within an expandable stent, for use as a replacement pulmonary valve. The replacement valve is mounted on a balloon catheter and delivered percutaneously via the vascular system to the location of the failed pulmonary valve and expanded by the balloon to compress the valve leaflets against the right ventricular outflow tract, anchoring and sealing the replacement valve. As described in the articles: “Percutaneous Insertion of the Pulmonary Valve”, Bonhoeffer, et al., Journal of the American College of Cardiology 2002; 39: 1664-1669 and “Transcatheter Replacement of a Bovine Valve in Pulmonary Position”, Bonhoeffer, et al., Circulation 2000; 102: 813-816, the replacement pulmonary valve may be implanted to replace native pulmonary valves or prosthetic pulmonary valves located in valved conduits.
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, the 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. In other words, the replacement valves may include a valved vein segment that is mounted in some manner within an expandable stent to make a stented valve. In order to prepare such a valve for percutaneous implantation, the stented valve can be initially provided in an expanded or uncrimped condition, then crimped or compressed around the balloon portion of a catheter until it is as close to the diameter of the catheter as possible.
Other percutaneously-delivered prosthetic heart valves and systems for delivering them have been suggested, such as by Bonhoeffer, P. et al., “Transcatheter Implantation of a Bovine Valve in Pulmonary Position.” Circulation, 2002; 102:813-816, and by Cribier, A. et al. “Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis.” Circulation, 2002; 106:3006-3008, the disclosures of which are incorporated herein by reference. These heart valves and delivery techniques rely at least partially upon a frictional type of engagement between the expanded support structure and the native tissue to maintain a position of the delivered prosthesis, although the stents can also become at least partially embedded in the surrounding tissue in response to the radial force provided by the stent and balloons that are sometimes used to expand the stent. Thus, with these transcatheter techniques, conventional sewing of the prosthetic heart valve to the patient's native tissue is not necessary. Similarly, in an article by Bonhoeffer, P. et al. titled “Percutaneous Insertion of the Pulmonary Valve.” J Am Coll Cardiol, 2002; 39:1664-1669, the disclosure of which is incorporated herein by reference, percutaneous delivery of a biological valve is described. The valve is sutured to an expandable stent within a previously implanted valved or non-valved conduit, or a previously implanted valve. Again, radial expansion of the secondary valve stent is used for placing and maintaining the replacement valve.
Although there have been advances in percutaneous valve replacement techniques and devices, there is a continued desire to provide different delivery systems for delivering cardiac valves to an implantation site in a minimally invasive and percutaneous manner. There is also a continued desire to be able to reposition and/or retract the valves once they have been deployed or partially deployed in order to ensure optimal placement of the valves within the patient. In addition, there is a desire to provide a valve and corresponding delivery system that allow for full or partial repositionability and/or retractability of the valve once it is positioned in the patient.
SUMMARY
The delivery systems of the invention can be used to deliver replacement valves to the heart of a patient. These replacement heart valves may be configured to provide complimentary features that promote optimal placement of the replacement heart valve in a native heart valve, such as the aortic valve, mitral valve, pulmonic valve, and/or tricuspid valve. In some embodiments, the replacement heart valves of the invention are highly amenable to transvascular delivery using an antegrade transapical approach (either with or without cardiopulmonary bypass and either with or without rapid pacing) or retrograde transarterial approach (either with or without rapid pacing). The methodology associated with the present invention can be repeated multiple times, such that several prosthetic heart valves of the present invention can be mounted on top of or within one another, if necessary or desired.
The replacement heart valves each include a stent to which a valve structure is attached. The stents of the invention include a wide variety of structures and features that can be used alone or in combination with features of other stents of the invention. In particular, these stents provide a number of different docking and/or anchoring structures that are conducive to percutaneous delivery thereof. Many of the structures are thus compressible to a relatively small diameter for percutaneous delivery to the heart of the patient, and then are expandable either via removal of external compressive forces (e.g., self-expanding stents). The devices delivered by the delivery systems described herein can be used to deliver stents, valved stents, or other interventional devices such as ASD (atrial septal defect) closure devices, VSD (ventricular septal defect) closure devices, or PFO (patent foramen ovale) occluders.
Methods for insertion of the replacement heart valves of the invention include delivery systems that can maintain the stent structures in their compressed state during their insertion and allow or cause the stent structures to expand once they are in their desired location. In addition, delivery methods of the invention can include features that allow the stents to be retrieved for removal or relocation thereof after they have been deployed or partially deployed from the stent delivery systems. The methods may include implantation of the stent structures using either an antegrade or retrograde approach. Further, in many of the delivery approaches of the invention, the stent structure is rotatable in vivo to allow the stent structure to be positioned in a desired orientation.



BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be further explained with reference to the appended Figures, wherein like structure is referred to by like numerals throughout the several views, and wherein:
FIG. 1 is a front view of one embodiment of a delivery system of the invention;
FIG. 2 is a front view of another embodiment of a delivery system of the invention with its sheath in a closed position;
FIG. 3 is a front view of the delivery system of FIG. 2, with its sheath partially retracted to expose and partially expand a stent;
FIG. 4 is a front view of the delivery system of FIG. 3, with a distal end of the stent released from a distal tip of the delivery system;
FIG. 5 is a front view of the delivery system of FIG. 4 with its hook driver in a stent-releasing position;
FIG. 6 is an enlarged front view of a portion of the delivery system and stent of FIG. 5;
FIG. 7 is a front view of the delivery system of FIG. 5, with the stent released or deployed from the delivery system;
FIG. 8 is an enlarged front view of a portion of the delivery system and deployed stent of FIG. 7;
FIG. 9 is another front view of the delivery system of FIG. 7; and
FIG. 10 is a front view of the delivery system of FIG. 9, with the sheath positioned at the distal end of the system and enclosing the tips of the wires that had been engaged with the stent.



DETAILED DESCRIPTION
As referred to herein, the prosthetic heart valves used in accordance with the various devices and methods may include a wide variety of different configurations, such as a prosthetic heart valve that has tissue leaflets or a synthetic heart valve that has polymeric, metallic, or tissue-engineered leaflets. In this way, the heart valves can be specifically configured for replacing any heart valve. That is, while much of the description herein refers to replacement of aortic valves, the prosthetic heart valves of the invention can also generally be used for replacement of native mitral, pulmonic, or tricuspid valves, for use as a venous valve, or to replace a failed bioprosthesis, such as in the area of an aortic valve or mitral valve, for example.
Although each of the valves used with the delivery devices and methods described herein would typically include leaflets attached within an interior area of a stent, the leaflets are not shown in the illustrated embodiments for clarity purposes. In general, the stents described herein include a support structure comprising a number of strut or wire portions arranged relative to each other to provide a desired compressibility and strength to the heart valve. Other details on particular configurations of the stents of the invention are also described below; however, in general terms, stents of the invention are generally tubular support structures, and leaflets will be secured to the support structure. The leaflets can be formed from a variety of materials, such as autologous tissue, xenograph material, or synthetics as are known in the art. The leaflets may be provided as a homogenous, biological valve structure, such as a porcine, bovine, or equine valve. Alternatively, the leaflets can be provided independent of one another (e.g., bovine or equine pericardial leaflets) and subsequently assembled to the support structure of the stent. In another alternative, the stent and leaflets can be fabricated at the same time, such as may be accomplished using high strength nano-manufactured NiTi films produced at Advanced Bio Prosthetic Surfaces (ABPS) of San Antonio, Tex., for example. The support structures are generally configured to accommodate three leaflets; however, the replacement prosthetic heart valves can incorporate more or less than three leaflets.
In more general terms, the combination of a support structure with one or more leaflets for a replacement heart valve that is delivered by the delivery systems of the invention can assume a variety of other configurations that differ from those shown and described, including any known prosthetic heart valve design. In certain embodiments of the invention, the support structure with leaflets can be any known expandable prosthetic heart valve configuration, whether balloon expandable, self-expanding, or unfurling (as described, for example, in U.S. Pat. Nos. 3,671,979; 4,056,854; 4,994,077; 5,332,402; 5,370,685; 5,397,351; 5,554,185; 5,855,601; and 6,168,614; U.S. Patent Application Publication No. 2004/0034411; Bonhoeffer P., et al., “Percutaneous Insertion of the Pulmonary Valve”, Pediatric Cardiology, 2002; 39:1664-1669; Anderson H R, et al., “Transluminal Implantation of Artificial Heart Valves”, EUR Heart J., 1992; 13:704-708; Anderson, J. R., et al., “Transluminal Catheter Implantation of New Expandable Artificial Cardiac Valve”, EUR Heart J., 1990, 11: (Suppl) 224a; Hilbert S. L., “Evaluation of Explanted Polyurethane Trileaflet Cardiac Valve Prosthesis”, J Thorac Cardiovascular Surgery, 1989; 94:419-29; Block P C, “Clinical and Hemodyamic Follow-Up After Percutaneous Aortic Valvuloplasty in the Elderly”, The American Journal of Cardiology, Vol. 62, Oct. 1, 1998; Boudjemline, Y., “Steps Toward Percutaneous Aortic Valve Replacement”, Circulation, 2002; 105:775-558; Bonhoeffer, P., “Transcatheter Implantation of a Bovine Valve in Pulmonary Position, a Lamb Study”, Circulation, 2000:102:813-816; Boudjemline, Y., “Percutaneous Implantation of a Valve in the Descending Aorta In Lambs”, EUR Heart J, 2002; 23:1045-1049; Kulkinski, D., “Future Horizons in Surgical Aortic Valve Replacement: Lessons Learned During the Early Stages of Developing a Transluminal Implantation Technique”, ASAIO J, 2004; 50:364-68; the teachings of which are all incorporated herein by reference).
Orientation and positioning of the stents of the invention may be accomplished either by self-orientation of the stents (such as by interference between features of the stent and a previously implanted stent or valve structure) or by manual orientation of the stent to align its features with anatomical or previous bioprosthetic features, such as can be accomplished using fluoroscopic visualization techniques, for example. For example, when aligning the stents of the invention with native anatomical structures, they should be aligned so as to not block the coronary arteries, and native mitral or tricuspid valves should be aligned relative to the anterior leaflet and/or the trigones/commissures.
Some embodiments of the support structures of the stents described herein can be a series of wires or wire segments arranged so that they are capable of transitioning from a collapsed state to an expanded state. The stents may further include a number of individual wires formed of a metal or other material. These wires are arranged in such a way that a support structure allows for folding or compressing to a contracted state in which its internal diameter is greatly reduced from its internal diameter in an expanded state. The delivery systems used for such a stent should be provided with degrees of rotational and axial orientation capabilities in order to properly position the new stent at its desired location.
The wires of the support structure of the stents can be formed from a shape memory material such as a nickel titanium alloy (e.g., Nitinol). With this material, the support structure is self-expandable from a contracted state to an expanded state, such as by the application of heat, energy, and the like, or by the removal of external forces (e.g., compressive forces). This support structure can also be repeatedly compressed and re-expanded multiple times without damaging the structure of the stent. In addition, the support structure of such an embodiment may be laser cut from a single piece of material or may be assembled from a number of different components. For these types of stent structures, one example of a delivery system that can be used includes a catheter with a retractable sheath that covers the stent until it is to be deployed, at which point the sheath can be retracted to allow the stent to expand. Further details of such embodiments are discussed below.
Referring now to the Figures, wherein the components are labeled with like numerals throughout the several Figures, and initially to FIG. 1, one embodiment of a stent delivery system 10 is illustrated. This system 10 includes a proximal end 12 and a distal end 14. Proximal end 12 includes a tip knob 16, a hook driver 18, and a stop 20, all of which are used in controlling the delivery and deployment of a stent 30 at the generally distal end 14 of the delivery system 10. The distal end 14 of the delivery system 10 includes a tip 22, which is shown adjacent to the stent 30. The delivery system further includes a threaded rod 24 and a sheath 26. The sheath 26 generally includes an elongated tubular portion 28 that has a hollow interior portion with a first diameter that is sized for compression and retention of the stent 30 within its interior area prior to deployment of the stent 30.
The sheath 26 further includes a handle portion 32 that is proximal to the elongated portion 28. The handle portion 32 is designed to be held and manipulated by the user for controlling the longitudinal movement of the sheath 26. The handle portion 32 further includes an internal threaded mechanism that engages with the threaded rod 24 to provide incremental linear movement of the sheath 26 along the length of the delivery system 10. That is, the sheath 26 is moveable toward either the proximal end 12 or distal end 14 by rotating the handle portion 32 about the longitudinal axis of the delivery system, thereby moving the inner threaded mechanism along the helical screw of the threaded rod 24. The sheath 26 may or may not rotate with the handle portion 32. The handle portion 32 further includes a push-button 34 that releases the inner threaded portion of the sheath from its engagement with the threaded rod 24 so that the sheath 26 can slide relatively freely along the length of the threaded rod 24. Thus, the sheath 26 also has the capability of being quickly advanced or retracted when its inner threaded mechanism is released from the threaded rod 24, while also having the capability of being advanced and retracted more slowly and accurately by rotating the handle portion 32 along the threaded rod 24.
The exemplary stent 30 is made of a series of wires that are compressible and expandable through the application and removal of external forces, and may include a series of Nitinol wires that are approximately 0.010-0.015 inches in cross-section. That is, the stent 30 in this embodiment is a self-expanding stent. As shown in FIG. 1, the stent 30 is captured at a first end 36 by the tip 22 and is captured at a second end 38 by the sheath 26. This configuration of the delivery system 10 enables independent release of the first and second ends 36, 38 of the stent of the stent 30 from the system. In this way, both ends of the stent 30 can be controlled during the deployment thereof to be sure that it is properly positioned within the target anatomy prior to fully releasing the stent 30 from the delivery system 10. The mechanical stop 20 is located at the proximal end of the threaded rod 24 to control the distance that the sheath 26 can be moved toward the proximal end 12 during the process of unsheathing the stent 30.
Another exemplary delivery system 100 and process of deploying a stent 130 is illustrated in FIGS. 2-10. This method can be used for apical delivery of a stent to an aorta, or it can be used for other delivery approaches, such as for transarterial retrograde delivery. The delivery system 100 provides the capability for loading of a stent 130 onto the system, at least partially deploying the stent, then retracting the stent back into the delivery system and relocating it, if desired.
In particular, FIG. 2 illustrates a delivery system 100 including a distal tip 122 adjacent to a sheath 126 in which a stent is enclosed. The stent 130 of this embodiment is illustrated as being engaged with multiple wires or elements having angled end portions or protrusions, although it is understood that the stent could be attached to the delivery system using an alternate attachment configuration. In the embodiment of FIG. 2 and as is more clearly shown in the enlarged view of FIG. 6, the delivery system includes multiple elements 150 extending from the distal end of the sheath 126. The number of elements 150 is preferably the same as the number of crowns at a proximal end 136 of the stent 130, although the number of elements 150 can be different from the number of crowns. Each of the elements 150 includes an angled wire tip or protrusion 152 that extends at an angle from its respective element 150. The angle between the protrusion or tip 152 and its respective element 150 can be approximately 90 degrees, although it can be any angle that provides for secure engagement between the elements 150 and the stent 130 in the manner described below. Alternatively, a suture or wire without an angled tip or protrusion 152 could be used to securely engage the stent to the delivery system 100, or an attachment end could contain multiple protrusions that fit to the stent. In another alternative, the stent itself can include a structure for engagement with a delivery system. In any case, it is important that the geometry of the stent and/or any type of stent engaging elements provide for both secure capture of the stent and easy stent release from the delivery system, when desired.
Referring specifically to FIG. 6, the elements 150 with an angled wire tip or protrusion 152 are shown in an enlarged view. In this configuration, a sleeve 170 is positioned over the relatively straight portion of wire or element 150, but retracted relative to its angled wire tip 152. When the element 150 is engaged with the stent crown, the sleeve 170 can be slid toward the stent crown until it encases both the end of the stent crown and the angled wire tip or protrusion 152, thereby providing a more secure attachment of the components relative to each other. The sleeve 170 is preferably made of a relatively flexible material that can deform and expand as it slides over the stent crown and angled wire tip 152. This sleeve 170 helps to prevent disengagement of each angled wire tip 152 from its respective stent crown.
The delivery system 100 further includes driver mechanisms at its proximal end 112, including a sheath push-button 134, a counter-rotation knob 140, a hook driver 142, and a tip thumb knob 116. A threaded rod 124 is positioned between the counter-rotation knob 140 and the sheath push-button 134 when the delivery system is at this step of the process. The delivery system 100 can then be used to position the stent 130 in its target location in the patient.
For an antegrade approach (e.g., a transapical approach), once the delivery system 100 has been located within the patient so that the stent and/or valve is in its desired position, such as within the aortic valve, the sheath 126 is pulled back toward the proximal end 112 of the delivery system, as shown in FIG. 3, until it exposes the inflow (proximal) end of the stent 130. This removal of the compressive force provided by the sheath allows the stent 130 to then expand radially. Alternatively, in a transarterial retrograde delivery approach, the inflow or distal end of the stent 130 can remain compressed while the middle, or middle and proximal end, of the stent, along with other features such as petals, for example, are radially expanded. Any minor positional adjustments, if necessary, can be made at this point. However, if it is determined that the stent 130 is far enough from the desired position that major repositioning is necessary, the sheath 126 can be moved back toward the distal end 114 of the delivery system 100 until the entire stent 130 is again enclosed within the sheath 126. The delivery system 100 can then be repositioned until it is in its desired location. The delivery system 100 may also include a stop on its handle or some other portion of its structure that requires a positive action by the user to prevent inadvertent release of the stent 130 from the delivery system 100.
FIG. 4 illustrates the step of deploying the outflow (distal) end of the stent 130. In this step, the tip thumb knob 116 near the proximal end 112 is pressed to deploy the outflow end of the stent 130 so that it is free from the distal tip portion 122. When using an alternative transarterial retrograde approach, this mechanism can instead be used to radially expand the inflow end of the stent 130 after the middle portion of the stent 130, along with any other features provided on the stent such as petals, are radially expanded.
As shown in FIGS. 5 and 6, the hook driver 142 can be translated distally to release the stent 130 from the sleeves 170 that covered the angled wire tips 152 and their corresponding stent crowns. This is accomplished by driving the hooks or angled wire tips 152 forward. The sheath 126 is then driven toward the stent 130 to move the wire tips 152 toward the central axis of the delivery system 100 and toward the central axis of the stent 130, thereby allowing the inflow (proximal) end of the stent 130 to fully release from delivery system 100, as shown in FIGS. 7-9.
In an alternative embodiment, in order to deploy a stent when it is properly positioned in a lumen of the patient, the sheath can be pulled back to expose the stent and the wires engaged with the crowns of the stent. The stent can be released by pulling the wires back toward the central axis of the device to disengage them from the stent crowns. The process of pulling the wires toward the central axis can be accomplished in a number of ways, such as by rotating the sheath over coarse threads or pushing a sheath push-button to slide it to pull the wires toward the central axis and away from the stent. However, a number of different mechanisms can be used to accomplish this movement of the wires relative to the stent crowns. One example of an alternative mechanism for releasing the stent from the delivery system is to pull sleeves back from their respective angled wire tips or protrusions.
The hook driver 142 is then translated proximally to pull the angled wire tips 152 of the wires 150 into the same sleeves 170 that are also used to secure the angled wire tips 152 to the stent crowns. In this way, the angled wire tips 152 are protected from getting caught on the sheath 126 when the sheath 126 is driven toward the outflow end of the delivery system 100 to cover or “re-sheath” the wires 150 prior to removing the system 100 from the patient, as shown in FIG. 10. If the stent 130 includes crowns that are not all generally in the same plane (e.g., some crowns are further from one of the ends of the stent than other crowns), the delivery system 100 may include wires that have different lengths in order to capture all of the stent crowns. Thus, the delivery system provides both the function of withdrawing the sheath 126 and withdrawing the sleeves 170, when desired in the stent delivery process.
It is noted that in the above procedure, the stent can be retracted back into the sheath at any point in the process until the wires are disengaged from the stent. This may be useful for repositioning of the stent if it is determined that the stent has been improperly positioned relative to the patient's anatomy. In this case, the steps described above can be repeated until the desired positioning of the stent in the patient's anatomy is achieved.
With this system described above, full or partial blood flow through the valve can advantageously be maintained during the period when the stented valve is being deployed into the patient but is not yet released from its delivery system. This feature can help to prevent complications that may occur when blood flow is stopped or blocked during valve implantation with some other known delivery systems. In addition, it is possible for the clinician to thereby evaluate the opening and closing of leaflets, examine for any paravalvular leakage and evaluate coronary flow and proper positioning of the valve within the target anatomy before final release of the stented valve.
The delivery systems described above can be modified to additionally or alternatively deliver a balloon-expandable stent to the target site of the patient. Delivering balloon-expandable stents to the implantation location can be performed percutaneously. In general terms, this includes providing a transcatheter assembly, including a delivery catheter, a balloon catheter, and a guide wire. Some delivery catheters of this type are known in the art, and define a lumen within which the balloon catheter is received. The balloon catheter, in turn, defines a lumen within which the guide wire is slideably disposed. Further, the balloon catheter includes a balloon that is fluidly connected to an inflation source. For a balloon-expandable stent, the transcatheter assembly is appropriately sized for a desired percutaneous approach to the implantation location. For example, the transcatheter assembly can be sized for delivery to the heart valve via an opening at a carotid artery, a jugular vein, a sub-clavian artery or vein, femoral artery or vein, or the like. Essentially, any percutaneous intercostal or vascular penetration can be made to facilitate use of the transcatheter assembly.
Prior to delivery, the stent is mounted over the balloon in a contracted state to be as small as possible without causing permanent deformation of the stent structure. As compared to the expanded state, the support structure is compressed onto itself and the balloon, thus defining a decreased inner diameter as compared to an inner diameter in the expanded state. While this description is related to the delivery of a balloon-expandable stent, the same basic procedures can also be applicable to a self-expanding stent, where the delivery system would not include a balloon, but would preferably include a sheath or some other type of configuration for maintaining the stent in a compressed condition until its deployment.
With the stent mounted to the balloon, the transcatheter assembly is delivered through a percutaneous opening (not shown) in the patient via the delivery catheter. The implantation location is located by inserting the guide wire into the patient, which guide wire extends from a distal end of the delivery catheter, with the balloon catheter otherwise retracted within the delivery catheter. The balloon catheter is then advanced distally from the delivery catheter along the guide wire, with the balloon and stent positioned relative to the implantation location. In an alternative embodiment, the stent is delivered to an implantation location via a minimally invasive surgical incision (i.e., non-percutaneously). In another alternative embodiment, the stent is delivered via open heart/chest surgery. In one embodiment of the stents of the invention, the stent includes a radiopaque, echogenic, or MRI visible material to facilitate visual confirmation of proper placement of the stent. Alternatively, other known surgical visual aids can be incorporated into the stent. The techniques described relative to placement of the stent within the heart can be used both to monitor and correct the placement of the stent in a longitudinal direction relative to the length of the anatomical structure in which it is positioned.
Once the stent is properly positioned, the balloon catheter is operated to inflate the balloon, thus transitioning the stent to an expanded state. Alternatively, where the support structure is formed of a shape memory material, the stent can self-expand to its expanded state.
One or more markers on the valve, along with a corresponding imaging system (e.g., echo, MRI, etc.) can be used with the various repositionable delivery systems described herein in order to verify the proper placement of the valve prior to releasing it from the delivery system. A number of factors can be considered, alone or in combination, to verify that the valve is properly placed in an implantation site, where some exemplary factors are as follows: (1) lack of paravalvular leakage around the replacement valve, which can be advantageously examined while blood is flowing through the valve since these delivery systems allow for flow through and around the valve; (2) optimal rotational orientation of the replacement valve relative to the coronary arteries; (3) the presence of coronary flow with the replacement valve in place; (4) correct longitudinal alignment of the replacement valve annulus with respect to the native patient anatomy; (5) verification that the position of the sinus region of the replacement valve does not interfere with native coronary flow; (6) verification that the sealing skirt is aligned with anatomical features to minimize paravalvular leakage; (7) verification that the replacement valve does not induce arrhythmias prior to final release; and (8) verification that the replacement valve does not interfere with function of an adjacent valve, such as the mitral valve.
The present invention has now been described with reference to several embodiments thereof. The foregoing detailed description and examples have been given for clarity of understanding only. No unnecessary limitations are to be understood therefrom. It will be apparent to those skilled in the art that many changes can be made in the embodiments described without departing from the scope of the invention. Thus, the scope of the present invention should not be limited to the structures described herein.

## Claims

1. A delivery system for delivering an implantable stented device to a lumen of a patient, the delivery system comprising:
an elongated body comprising a proximal end and a distal end comprising a tip;
a plurality of stent engagement elements, wherein each stent engagement element includes an elongated wire and an angled wire tip for engagement with the implantable stented device;
a plurality of sleeves, wherein each sleeve surrounds a respective stent engagement element, wherein the plurality of sleeves and stent engagement elements include a first position wherein each sleeve surrounds a respective one of the angled wire tip and a portion of the implantable stented device and a second position wherein each sleeve is spaced proximally of the respective angled wire tip;
a driver mechanism positioned at the proximal end of the elongated body to axially translate the plurality of stent engagement elements from the first position to the second position, wherein the driver mechanism is axially translatable toward and away from the distal end of the elongated body;
an elongated threaded rod located axially distal to the driver mechanism; and
a sheath, at least a portion of which surrounds a portion of the elongated threaded rod, comprising an elongated tubular portion having a hollow interior portion with a first diameter that is sized for compression and retention of the implantable stented device in a compressed configuration for delivery to a body lumen, wherein with the stent engagement elements and the sleeves in the second position, the sheath is configured such that advancement of the sheath distally causes the angled wire tips to move towards a central longitudinal axis of the delivery system to disengage the angled wire tips from the implantable stented device.

2. The delivery system of claim 1, wherein the sheath further comprises a handle portion positioned axially proximal to the elongated tubular portion, wherein axial movement of the sheath is controllable with the handle portion.

3. The delivery system of claim 2, wherein the handle portion further comprises an internal threaded mechanism that is threadingly engageable with the threaded rod to provide incremental axial motion of the sheath relative to the proximal and distal ends of the elongated body.

4. The delivery system of claim 3, wherein the handle portion further comprises a control feature for releasing the inner threaded mechanism of the handle portion from its threaded engagement with the threaded rod to allow the sheath to slide axially along the elongated threaded rod.

5. The delivery system of claim 4, wherein the control feature comprises a push-button.

6. The delivery system of claim 3, wherein the handle portion further comprises a control feature for alternatively releasing the inner threaded mechanism of the handle portion from its threaded engagement with the threaded rod and engaging the threaded mechanism of the handle portion with the threaded rod.

7. The delivery system of claim 2, wherein the handle portion is rotatable about a longitudinal axis of the delivery system for axial movement of the sheath relative to the proximal and distal ends of the elongated body.

8. The delivery system of claim 7, wherein the sheath is rotatable with the handle portion.

9. The delivery system of claim 7, wherein the sheath is independently rotatable relative to the handle portion.

10. The delivery system of claim 1, wherein the tip of the distal end of the elongated body comprises a hollow interior portion for compression and retention of a distal end of a stented device.

11. The delivery system of claim 10, further comprising a tip controller at the proximal end of the elongated body for deployment of a distal end of a stented device.

12. The delivery system of claim 1, further comprising a stop mechanism at the proximal end of the elongated body for controlling the axial movement of the sheath in a proximal direction relative to the elongated body.

13. The delivery system of claim 1 in combination with a self-expanding stented device.

14. The combination of claim 13, wherein the stented device comprises a central lumen and a valve positioned within the central lumen.

15. The combination of claim 13, wherein the stented device comprises a replacement prosthetic heart valve.

16. A delivery system for delivering an implantable stented device to a lumen of a patient, the delivery system comprising:
an elongated body comprising a proximal end and a distal end comprising a tip;
a driver mechanism positioned at the proximal end of the elongated body;
an elongated threaded rod located axially distal to the driver mechanism;
a sheath comprising an elongated tubular portion having a hollow interior portion that is sized for compression and retention of the implantable stented device in a compressed configuration for delivery to a body lumen;
a plurality of stent engagement mechanisms, each of which is axially translatable from a distal end of the sheath by the driver mechanism and each of which includes a first portion and a second portion that extends outwardly at an angle from the first portion so that a distal end of the second portion is outwardly projecting from the first portion of its respective stent engagement mechanism, wherein the second portion of each engagement mechanism is engageable with a proximal end of a stented device; and
a plurality of sleeves surrounding the stent engagement mechanisms;
wherein movement of the driver mechanism in a proximal direction and a distal direction causes movement of the stent engagement mechanisms between a stent engagement position wherein each sleeve surrounds the second portion of a respective one of the stent engagement mechanisms and a portion of the implantable stent device and a stent deployment position wherein the second portion of each stent engagement mechanism is spaced axially distal of each respective sleeve, respectively,
wherein with the stent engagement mechanisms in the stent deployment position, movement of the sheath distally causes the stent engagement mechanisms to move toward a central axis of the elongated body such that the second portions of the stent engagement mechanisms disengage from the implantable stented device.

17. The delivery system of claim 16, wherein the second portion of each of the stent engagement mechanisms extends at an approximate 90 degree angle from the first portion of its respective stent engagement mechanism.