# Patent

## Title
Transcatheter valve structure and methods for valve delivery

## Abstract

A valved stent including a stent structure having a generally tubular body portion with an interior area, a first end, a second end, and a longitudinal axis; a valve structure including a plurality of leaflets and positioned within the interior area of the stent structure; and an invertible structure extending from one of the first and second ends of the stent structure. The invertible structure can be rotatable relative to the end of the stent structure from which it extends.

## Background
TECHNICAL FIELD
The present invention relates to the implantation of transcatheter valves. More particularly, it relates to transcatheter valve structures, delivery systems, and methods of 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. One general type of heart valve surgery involves an open-heart surgical procedure that is conducted under general anesthesia, during which the heart is stopped and 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 potential risks, such as infection, stroke, renal failure, and adverse effects associated with use of the heart-lung machine, for example.
Due to the drawbacks of open-heart surgical procedures, there has been an increased interest in minimally invasive and percutaneous replacement of cardiac valves. Such surgical techniques involve making a relatively small opening in the skin of the patient, thereby providing access to the vascular system. A valve assembly may then be inserted into the patient 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.
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. These leaflet-like structures can be used with heart valve bioprostheses, which involves using a natural valve material (e.g., a porcine valve) to make a heart valve. More specifically, these bioprosthetic replacement valves include a valved segment that is mounted in some manner within an expandable stent or frame structure 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 as close to the diameter of the catheter as possible. When it is desired to expand the stent, such as when the stent is at its desired implantation location, the balloon is inflated to provide a certain outward radial force to achieve a particular stent expansion. In other percutaneous implantation systems, the stent 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. With either of these types of percutaneous stent delivery systems, conventional sewing of the prosthetic heart valve to the patient's native tissue is typically not necessary.
Although there have been advances in percutaneous valve replacement techniques and devices, there is a continued desire to provide different stent or frame structures and 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 control the inflow side of a valve during the implantation process to control the accuracy of placement within the body.
SUMMARY
In one aspect of the invention, a delivery system is provided that can be used in a number of areas of a patient's anatomy, with one particular exemplary placement involving transfemoral delivery of a new or replacement aortic valve to the native aortic valve area of a patient. With the present invention, the physician can more clearly determine the final location of a valve before it is completely deployed within a patient. In this way, the location of the valve can be adjusted to optimize valve placement within the patient.
It is noted that in the implantation of devices using other available systems, once an implantable device is attached to a delivery catheter, it can sometimes be difficult to detach it from the catheter without leaving behind any components that are not necessary for the functioning of the implanted device. In contrast, the implantable devices of the invention overcome this issue by using an invertible structure that is attached to the inflow circumference of the replacement valve. The invertible structure provides for secure attachment to the delivery system, easy detachment from the delivery system with certain manipulation of the delivery system and stent, and also extra structural integrity to the implanted valve or device once it has been deployed. In addition, the devices of the invention include an edge that can be controlled by attaching it directly to the delivery catheter (e.g., the inflow edge of the device).
In one aspect of the invention, when an implantable device or valve is loaded onto a catheter or delivery system, an invertible structure of the device is located closest to the distal tip of the delivery system and the valve and its scaffold, frame, or stent are located proximal to the invertible structure. At this point, the invertible structure can be considered to be in an inverted state. When the device is deployed, the invertible structure moves to a state in which it is no longer inverted, and is instead located or positioned inside the valve scaffold. In this way, it can provide additional radial force and better skirt apposition for the deployed valve.
In one aspect of the invention, an invertible structure is attached to the inflow end of an endoluminally delivered heart valve, although it is understood that it can also be used with other devices that are delivered using endoluminal and/or transcatheter delivery methods. At least a portion of the invertible structure can be considered to be inverted relative to the valve and then attached to the tip of a catheter or other delivery system structure, such as with a sprocket or spindle mechanism. The inflow end of the valve is held down in the tip area of the catheter, thereby allowing the device to be accurately positioned within the heart. The invertible structure can then be slowly deployed, which allows for complete apposition of the heart valve structure before being released. When released, the invertible structure will revert to a non-inverted position in which it will rest against or within the valve structure. One advantage of this additional structure is that it provides a portion of the stent that has an additional layer, which can allow the overall structure to provide additional radial force to the surrounding organ in which it is implanted.
In another aspect of the invention, an invertible structure is attached to one end of a stented transcatheter heart valve in such a way that it provides additional length to the stented valve during the delivery and deployment processes, yet the overall length of the stented valve does not increase after it is deployed. This is due to the fact that the invertible structure rotates or flips to be adjacent to the stent structure after it is deployed such that it does not increase the overall length of the structure.



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 a distal portion of a delivery system with an attached stent or frame structure in accordance with the invention, with a sheath of the delivery system partially retracted relative to the stent;
FIG. 2 is a front view of the stent and distal portion of the delivery system of FIG. 1, with the sheath further retracted;
FIG. 3 is a perspective view of the stent and distal portion of the delivery system of FIGS. 1 and 2, showing a capture mechanism or invertible structure of the system as it is beginning to be released;
FIG. 4 is a perspective view of the stent and distal portion of the delivery system of FIGS. 1-3, showing the invertible structure in a position in which it is further released from the delivery system;
FIG. 5 is a front view of the distal portion of the delivery system and stent of FIGS. 1-4, showing the invertible structure just before it is completely released from the delivery system, wherein the invertible structure is at approximately 90 degrees relative to the longitudinal axis of the delivery system;
FIG. 6 is a perspective view of the delivery system and stent of FIGS. 1-5, showing the invertible structure in its released position relative to the stent to which it is attached;
FIG. 7 is a schematic front view of a stent and distal portion of a delivery system, with the stent in its compressed condition;
FIG. 8 is a schematic front view of the delivery system and stent of FIG. 7, with the stent in a partially deployed condition;
FIG. 9 is a schematic front view of the delivery system and stent of FIGS. 7 and 8, with the stent in a further deployed condition;
FIG. 10 is a schematic front view of the delivery system and stent of FIGS. 7-9, with the stent in its fully deployed condition;
FIG. 11 is a schematic front view of a portion of a stent and attached invertible structure, in accordance with the invention; and
FIG. 12 is a schematic front view of the stent and invertible structure of FIG. 11, with the invertible structure in a non-inverted position relative to the stent structure.



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 having tissue leaflets or a synthetic heart valve having polymeric, metallic, or tissue-engineered leaflets, and can be specifically configured for replacing any heart valve. Further, while portions of the description herein refer 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. The present invention is not limited in use to heart valve replacement devices and systems, however, but can be used for a wide variety of vascular devices and systems, such as can be used with stent grafts, stents, vena cava filters, occluders, and the like.
In general, one embodiment of the stents or stent frames described herein includes support structures that comprise 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 features of the stents or stent frames used in accordance with the invention are also described below; however, in general terms, the stents or stent frames described herein are generally tubular support structures having an internal area in which leaflets are secured. 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 as independent structures from each other (e.g., bovine or equine pericardial leaflets) and subsequently assembled to the support structure of the stent frame to provide a valve structure. In another alternative, the stent frame and leaflets can be fabricated at the same time, such as may be accomplished using high strength nano-manufactured NiTi films of the type produced at Advanced Bio Prosthetic Surfaces, Ltd. (ABPS) of San Antonio, Tex., for example. The support structures are often configured to accommodate three leaflets, although it is contemplated that replacement prosthetic heart valves of the types described herein can incorporate more or less than three leaflets.
Orientation and positioning of stent frames relative to the delivery systems of the invention may be accomplished either by self-orientation of the stent frames (such as by interference between features of the stent frame and a previously implanted stent frame or valve structure) or by manual orientation of the stent frame 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 stent frames 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 stent frames 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. In some embodiments, a number of individual wires comprising the support structure can be 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 smaller than its internal diameter when it is in an expanded state. In its collapsed state, such a support structure with attached valves can be mounted on a delivery system. The support structure is configured so that it can be changed to its expanded state when desired, such as by the relative movement of one or more sheaths relative to the length of the stent frame. The delivery systems used for such stent frames should be provided with degrees of rotational and axial orientation capabilities in order to properly position the stent frame at its desired location.
The wires of the support structure of the stent frames in embodiments of the invention can be formed from a shape memory material such as a nickel titanium alloy (e.g., Nitinol), for one example. With this material, the support structure will be 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 compressed and re-expanded multiple times without damaging the structure of the stent frame. 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 frame structures, one example of a delivery system that can be used includes a catheter with a retractable sheath that covers the stent frame until it is to be deployed, at which point the sheath can be retracted to allow the stent frame to expand. However, it is contemplated that the materials from which the stents are made consist of structures that are expandable with the application of an external force, such as balloon expandable stent structures, for example.
Referring now to the Figures, wherein the components are labeled with like numerals throughout the several Figures, and initially to FIGS. 1 and 2, the distal end of one embodiment of a stent delivery system 10 is illustrated. Delivery system 10 includes a distal tip 12 from which a central longitudinal shaft 20 extends, a capturing collar 14, and a sheath 16. As shown in FIG. 1, a valved stent 18 is compressed and loaded onto the delivery system 10, and the sheath 16 is partially withdrawn in a proximal direction (i.e., to the left, in this figure) relative to the distal tip 12. It is noted that when this delivery system 10 is initially being introduced to deliver the valved stent 18 to a desired implantation location, the sheath 16 can be located close enough to the distal tip 12 that it covers all or most of the valved stent 18. The sheath 16 can optionally be positioned to also cover or partially cover the capturing collar 14 so that it protects more of the delivery system during the insertion process, such as by positioning the distal end of the sheath 16 adjacent to the proximal end of the distal tip 12. The sheath 16 can be positioned in this way during the process of delivering the stent to a location within the patient and until the valved stent 18 is properly located within the patient's anatomy. Thus, the configuration of the components of the delivery system 10 relative to the stent 18 shown in FIG. 1 represents one embodiment of the situation immediately after the valved stent 18 is in its desired location and the process of releasing the stent by retracting the sheath 16 has just started, and FIG. 2 represents one embodiment of the condition of the stent 18 as the sheath 16 is further retracted from the stent.
The valved stent 18 generally comprises a stent frame 22 with a valve attached within its internal area, where the figures illustrate a representative tissue or valve material 24, which illustrates an exemplary volume of material that can be used for a valve and sealing skirt. The valve can be made of any of a number of materials and can be configured in a number of different ways, such as by using the materials and/or configurations described above to manufacture prosthetic valves, or as made using other techniques and materials. As shown in this embodiment, the portion of the stent frame 22 in which the valve is located includes a wire structure arranged as rows of relatively sinusoidal or zigzag shapes positioned adjacent to each other. In particular, the “peaks” of one row of wire structure are arranged to meet the “valleys” of an adjacent row of wire structure. The valve can be located at any desired position along the length of the stent that will coincide with a desired location of the valve within the patient's anatomy.
Once the valved stent 18 is in its approximate desired position within the patient, the sheath 16 is pulled away from the distal tip 12 (i.e., in a proximal direction), as is illustrated in FIG. 2, to unsheath the distal end of the stent 18. The material used for the stent 18 in this embodiment is a shape-memory material, such that removal of the compressive force provided by the sheath 16 will allow the stent 18 to diametrically expand relative to the shaft 20 adjacent to its distal end. However, the proximal end of the stent frame will still be contained in its compressed state within the sheath 16 at this point in the stent frame delivery process. In addition, the distal end of the stent frame 22 is partially constrained from radial expansion by an invertible structure 28 that is attached to a portion of the delivery system, as described below. In this embodiment, the invertible structure 28 is permanently or semi-permanently attached at one end to the sealing skirt by sutures and temporarily attached to a structure of the delivery system on the other end. The invertible structure 28 generally comprises a ring of material that is arranged in a sinusoidal or zigzag shape around its circumference. The peaks and valleys of the structure 28 around its circumference may have the same or different sizes, shapes, and the like as other peaks and valleys of that structure. A first end of the structure 28 is partially constrained within the inner diameter of the capturing collar 14, while a second end of the structure 28 is attached to the valved stent 18 via sutures. It is noted that the term “invertible structure” is used herein to describe the portion of the stent that is generally configured to be an extension from one end of the stent and that can rotate, turn, or flip about that end of the stent to extend generally along a portion of that stent. Alternatively, this structure may be referred to as “eversible,” or capable of turning inside out relative to the structure of the stent.
Referring now to FIGS. 3-6, one exemplary process of releasing the invertible structure 28 relative to the valved stent 18 and the delivery system 10 is illustrated. To initiate this process, the collar 14 is held stationary while a sprocket type member 30 (see FIG. 6) is retracted. The member 30 is attached to a tube that rides over another tube that is in turn attached to the distal tip 12 and collar 14. In this way, the member 30 can be moved independently relative to the collar 14. In FIG. 3, the invertible structure 28 is just beginning to be released from the capturing collar 14, and it is in its inverted state relative to the stent 18. FIG. 4 illustrates the invertible structure 28 as it is further released from the capturing collar 14. FIG. 5 shows the invertible structure 28 oriented at approximately 90 degrees to the distal end of the stent frame 22, which is the position in which it will be located immediately prior to it being released from the delivery system. Finally, FIG. 6 shows the invertible structure 28 after it is released from the delivery system 10, but before the delivery system is removed from the area of the stent. After this release, the invertible structure 28 is oriented in its opposite or non-inverted position, where it is positioned within the distal end of the stent frame 22. This structure 28 provides additional structural integrity to the distal end of the stent frame 22 due to the “dual layer” type of structure in this area.
It is further noted that the delivery system 10 includes sprocket-type member 30, as mentioned above, which is visible in FIG. 6. This member 30 is used for loading and holding the invertible structure 28 during delivery of the stent 18 and is also used for controllably releasing the stent 18 from the delivery system 10. In this embodiment, the V-shaped structures of the stent can be placed over the extending portions of the member 30 so that when the stent is compressed, the stent can be contained between the member 30 and the collar 14. It is understood, however, that other methods and devices can be used to maintain the invertible structure in its desired pre-release condition until it desired to release the stent from the delivery system.
Although much of the discussion herein is directed to heart valves that are compressible and expandable for use in transcatheter valve delivery operations, the heart valve structures of the invention can also be used with more invasive forms of surgery, such as open-heart surgery. In such cases, the stent structure is not necessarily compressible and expandable, but may still include an invertible structure at one or both ends that provides a second stent layer that is adjacent to the stent frame. This layer can provide extra structural integrity to the stent, for example.
It is further noted that the invertible structure may be made of one or more materials that are the same or different from one or more materials from which the stent is made. Also, in order to provide a final structure with certain desired performance characteristics (e.g., flexibility, strength, and the like), an invertible structure may be made of the same material as the stent to which it is attached, but the thickness, shape, or other material properties may be different between the invertible structure and the stent.
FIGS. 7-12 schematically illustrate an embodiment of the invention that is similar to that discussed above relative to FIGS. 1-6. In particular, these figures illustrate a distal end of a delivery system 50 that includes a distal tip 52, a spindle 60 (e.g., a sprocket-type member), and a sheath 54. As shown in FIG. 7, a stented transcatheter valve 56 (which includes a stent frame with a valve attached within its interior area) is compressed and loaded onto the delivery system 50, and the sheath 54 is used to compress and cover the valve 56. An invertible structure 58 extends from the distal end of the valve 56 and toward the distal end 52 of the delivery system, and this invertible structure 58 is also held within the sheath 54. A spindle or other holding mechanism 60 holds the invertible structure 58 relative to the distal tip 52, and the spindle 60 is located within a capturing collar 62 at this point in the delivery process.
Once the valve 56 is in its approximate desired position, the sheath 54 is pulled away from the distal tip 52 (i.e., in a proximal direction), as is illustrated in FIG. 8, until the distal end of the valve 56 is unsheathed. When the material used for the stent of the valve 56 in this embodiment is a shape-memory material, removal of the compressive force provided by the sheath 54 will allow the valve 56 to diametrically expand. However, a proximal end of the valve 56 can still be contained in its compressed state within the sheath 54 at this point in the valve delivery process. In addition, the distal end of the valve is at least partially constrained from radial expansion by an invertible structure 58, which is attached to a sealing skirt (optional) with a suture or any other configuration that does not restrict the ability of the invertible structure 58 to flip or rotate relative to the stent. The invertible structure 58 may comprise a ring of material that is arranged in a sinusoidal or zigzag shape around its circumference. The peaks and valleys of the structure 58 around its circumference may have the same or different sizes, shapes, and the like as other peaks and valleys of the structure. A first end of the structure 58 is partially constrained within the inner diameter of the capturing collar 62 via the spindle or holding mechanism 60, while a second end of the structure 58 is attached to the valve 56.
Referring now to FIGS. 9 and 10, the release of the invertible structure 58 relative to the valve 56 and the delivery system 50 is illustrated. In particular, FIG. 9 shows the invertible structure 58 as it is in the process of being released from the capturing collar 62. The invertible structure 58 is in its inverted state relative to the valve 56. FIG. 10 illustrates the invertible structure 58 after it is released from the delivery system 50. After this release, the invertible structure 58 will reorient to its non-inverted position, where it is positioned within the distal end of the valve 56. This structure 58 will provide additional structural integrity to the distal end of the valve 56. FIGS. 11 and 12 illustrate additional views of the invertible structure 58 in its inverted and non-inverted positions relative to the distal end of the valve 56, respectively.
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, but only by the structures described by the language of the claims and the equivalents of those structures.

## Claims

1. A valved stent comprising:
a stent structure comprising a generally tubular body portion, an interior area, a first end, and a second end;
a valve comprising a plurality of leaflets and attached to the stent structure and disposed entirely within the interior area of the stent structure in a delivery configuration; and
an invertible structure having a first end coupled to the stent structure such that the invertible structure extends from the stent structure in the delivery configuration,
wherein the invertible structure is pivotable relative to the stent structure from the delivery configuration to an implanted configuration,
wherein the invertible structure extends beyond the stent structure in the delivery configuration, and
wherein the invertible structure folds inwardly towards the interior area of the stent structure and is positioned directly adjacent to an interior wall of the stent structure in the implanted configuration.

2. The valved stent of claim 1, wherein the invertible structure is pivotable relative to the first end of the stent structure, and
wherein the valve is positioned adjacent to the invertible structure.

3. The valved stent of claim 1, wherein the invertible structure further comprises a third configuration between the delivery configuration and implanted configuration, wherein the invertible structure is generally perpendicular to the stent structure when in the third configuration.

4. The valved stent of claim 1, further comprising at least one intermediate invertible structure pivotably attached to the stent structure within the interior area and between the first and second ends.

5. The valved stent of claim 1, further comprising a sealing skirt extending around at least a portion of the circumference of the tubular body at one of the first and second ends of the stent structure.

6. The valved stent of claim 1, wherein a length of the invertible structure is less than a length of the stent structure.

7. The valved stent of claim 1, wherein the invertible structure comprises at least one wire having multiple peaks and valleys positioned around a circumference of one of the first and second ends of the stent structure.

8. The valved stent of claim 1, wherein the invertible structure provides outward radial force against the interior area of the stent structure when the invertible structure is in the implanted configuration.

9. The valved stent of claim 1, wherein at least one of the stent structure and invertible structure comprise a shape memory material.

10. The valved stent of claim 1, wherein a second end of the invertible structure is configured to attach to a delivery system.

11. The valved stent of claim 1, further comprising an intermediate material attached to the stent structure, wherein the first end of the invertible structure is attached to the intermediate material.