A valvuloplasty device comprises an expandable anchor and an expansion member mounted about an outer surface of the expandable anchor. The expansion member is either an annular balloon or a sleeve. The valvuloplasty device can be used for valvuloplasty and for valve implantation.

BACKGROUND OF THE INVENTION

Failing heart valves can become calcified and stenotic. Valvuloplasty is a procedure that can break calcification and open up heart valves. With the advent of percutaneous transcatheter heart valve replacement, the importance of valvuloplasty devices and procedures may increase, since a valvuloplasty procedure may be required to facilitate the proper placement and/or expansion of a percutaneously delivered valve. Typically the stenosed aortic valve would need to be opened using a procedure such as a balloon aortic valvuloplasty, prior to insertion of a catheter device and deployment of the replacement heart valve. A balloon opens the valve leaflets wider by a crushing action and cracks calcium deposits, making the leaflets more flexible.

During balloon aortic valvuloplasty, the aortic valve is blocked and a large pressure is created by the left ventricle during systole, and there are several drawbacks to prior art balloon-based valvuloplasty devices as a result of the pressure gradient between the aorta and the ventricle. Rapid pacing of the heart in order to lower the pressure gradient, but such rapid pacing of the heart has risks for the patient. Another problem associated with prior art balloon-based valvuloplasty devices is the tendency of the valvuloplasty balloon to slip out of the stenotic area during the valvuloplasty procedure. Such slippage may, for example, arise as a result of the pressures exerted on the device by blood ejected from the beating heart, or as a function of how the valvuloplasty device inflates.

In view of the drawbacks associated with previously known methods and apparatus for performing valvuloplasty, it would be desirable to provide a device that expands the valve area to remove the stenosis without creating a significant pressure gradient and without requiring pacing of the heart.

BRIEF SUMMARY OF THE INVENTION

The valvuloplasty devices described herein are deployed to treat bodily lumens affected by stenosis. In one application, the valvuloplasty devices described herein are used to treat a stenosis in the area of a heart valve. The valvuloplasty devices include an expandable anchor and an expansion member. Methods of using the valvuloplasty devices for valvuloplasty and replacement valve implantation are described herein.

These and other embodiments which characterize the invention are pointed out with particularity in the claims annexed hereto and forming a part hereof. However, for further understanding of the invention reference can be made to the drawings which form a further part hereof and the accompanying descriptive matter, in which there is illustrated and described embodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION

While a valvuloplasty device as described herein may be embodied in many different forms, there are described in detail herein specific preferred embodiments of the valvuloplasty device. This description is an exemplification of the principles of the valvuloplasty device, and use thereof, and is not intended to limit the valvuloplasty device to the particular embodiments illustrated.

FIGS. 1-6Bshow a valvuloplasty device20that comprises an anchor22, an expansion member24, and has a longitudinal axis. As can be seen from the figures, the anchor has a proximal end30, a distal end32, and a longitudinal length extending from the proximal end30to the distal end32. The anchor22also has an outer surface25and an inner surface26that defines a lumen28. In at least one embodiment, the anchor22is tubular. In some embodiments, the anchor22defines a valve region which is a part of the lumen28where a replacement valve is positioned during a transcatheter aortic valve implantation method which is discussed below in greater detail. In at least one embodiment, the anchor22is expandable. As used herein “expandable” refers to an increase in diameter from the delivery state and “diameter” is the distance of a straight line extending between two points and does not indicate a particular shape. The anchor22can be self-expanding, balloon expandable, or hybrid self-expanding and balloon expandable.

In some embodiments, the expansion member24is a balloon24a, as shown for example inFIGS. 1-5C. In at least one embodiment, the balloon24ahas an outer wall34and an inner wall36, and an interior lumen50defined by the outer wall34and the inner wall36. In some embodiments, the interior lumen50is an inflation lumen. As can be seen from the figures, the balloon24ais an annular balloon. The inner wall36defines a balloon lumen. In some embodiments, the balloon lumen has a diameter greater than a diameter of the anchor22so that the anchor22can be positioned within the balloon lumen. In at least one embodiment, as shown more clearly inFIG. 2, balloon24ahas two waist portions72,74and a central portion76extending between the two waist portions72,74. As used herein, a “waist portion” is the portion of the balloon24awhere the outer wall34and the inner wall36are joined to one another. In one embodiment, the balloon24ais a compliant balloon. In another embodiment, the balloon24ais a semi-compliant balloon. In yet another embodiment, the balloon24ais a non-compliant balloon. In at least one embodiment, the balloon24ahas a plurality of spines38positioned about the circumference of the inner wall36of the balloon24a. In some embodiments, the spines38are formed on the interior surface of the inner wall36of the balloon24a, as shown for example inFIG. 4. In at least one embodiment, the spines are coextruded with the inner wall36of the balloon24a. In some embodiments, the spines38comprise a first material and at least the inner wall36of the balloon24ais made of a second material, different then the first material. In one embodiment, the first material is stiffer than the second material. In at least one embodiment, the spines38extend longitudinally from the proximal waist portion74to the distal waist portion72of the balloon24a.

In at least one embodiment, the balloon24ais affixed at or substantially near the distal end32of the anchor22. As used herein “affixed” indicates a permanent attachment. In some embodiments, the inner wall36of the balloon24ais affixed to the anchor22. In at least one embodiment, the balloon24ais directly affixed to the outer surface25of the anchor22at the distal end32of the anchor (shown for example inFIG. 2). In at least one embodiment, the balloon24ais only affixed to the anchor22at a distal end of the balloon24a(shown for example inFIG. 2). Because the balloon24ais only affixed to one end of the anchor22, the proximal end30of the anchor22is free to move longitudinally relative to the distal end32of the anchor22.

In some embodiments, such as shown inFIG. 2, only the distal waist portion72is directly affixed to the outer surface25of the anchor22. The distal waist portion72is affixed to the outer surface25of the anchor22with adhesive, a suture, or other suitable attachment means. In at least one embodiment, the entire circumference of the distal waist portion72is affixed to the outer surface25of the anchor22. In one embodiment, the distal waist portion72may also be directly affixed to a locking member attached to the anchor, such as those locking members described in U.S. Patent Publication Nos. 2005/0137686, 2005/0143809, and 2010/0280495, the entireties of each are incorporated by reference herein. As shown inFIG. 2, the proximal waist portion74is not directly affixed to the anchor22. In at least one embodiment, both the distal waist portion72and the proximal waist portion74are affixed to the outer surface25of the anchor22.

In other embodiments, the expansion member24is a sleeve24b, as shown for example inFIGS. 6A-B. As shown inFIG. 6A, the sleeve24bis tubular with a proximal end84and a distal end86. In at least one embodiment, the sleeve24bis affixed to the anchor22at at least one location. In some embodiments, both ends84,86of the sleeve24bare affixed to the anchor22. In at least one embodiment, the sleeve24bis affixed to the anchor22at a plurality of locations along the longitudinal length of the thick sleeve. In at least one embodiment the sleeve24bhas a greater thickness than the thickness of the anchor22. In some embodiments, the sleeve24bis at least twice as thick as the as the wall of the anchor22. Thus, the sleeve24bcan be described as a thick sleeve.

In some embodiments, the sleeve24bcomprises compliant material, semi-compliant material, and combinations thereof Suitable means by which the sleeve24bis affixed to the anchor22include sutures, adhesives such as glue, or molding, spraying, or dip coating the material for the thick sleeve onto the anchor so that the thick sleeve material encloses or wraps around the wires of the anchor22.

As discussed below in greater detail, the anchor22has a delivery state and a deployed state; the expansion member24has a delivery state and a deployed state; and the valvuloplasty device has a delivery configuration, a partially deployed configuration, and a deployed configuration.

FIGS. 3, 5A, and 6Ashow the anchor22in the delivery state andFIGS. 2, 5B-C, and6B show the anchor22in the deployed state. In at least one embodiment, the anchor22in the deployed state has a high radial force. In at least one embodiment, when the anchor22is in the delivery state, the anchor22has a first longitudinal length and a first diameter and when the anchor is in the deployed state, the anchor has a second longitudinal length and a second diameter. In some embodiments, the second diameter is greater than the first diameter. In other embodiments, the first longitudinal length is greater than the second longitudinal length. In these embodiments, the anchor can be described as being longitudinally compressed or foreshortened. In yet another embodiment, the second diameter is greater than the first diameter and the first longitudinal length is greater than the second longitudinal length.FIGS. 3 and 5A-B show the balloon24ain the delivery state andFIGS. 2 and 5Cshow the balloon24ain the deployed state. In at least one embodiment, the balloon24ahas a plurality of folds78, as shown for example inFIGS. 5B-C. In some embodiments, both the outer wall34and the inner wall36form the folds. Thus, when the valvuloplasty device20is in the delivery configuration, there is some space between the unattached portions of the inner wall36of the balloon24aand the outer surface25of the anchor22. In at least one embodiment, the balloon24ahas three folds78when the balloon24ais in the delivery state. In one embodiment, the diameter of the balloon24ain the deployed state is greater than the diameter of the balloon24ain the delivery state. In some embodiments, the balloon24ais inflatable and is uninflated in the delivery state and inflated in the deployed state. In other embodiments, the balloon24acomprises an electroactive polymer.

As shown inFIGS. 1-3, the balloon24aextends axially over only a portion of the anchor22when the anchor22is in either the delivery state or the deployed state. In at least one embodiment, the balloon24aextends longitudinally over at least a portion of the valve region of the anchor22. In at least one embodiment, the balloon24aand the anchor22are coterminous in one of the delivery state and the deployed state of the anchor22. As used herein “coterminous” means that, with regard to two elements of the valvuloplasty device, the proximal ends of the two elements are radially aligned with one another and the distal ends of two elements are radially aligned with one another. Thus, two elements that are coterminus have the same longitudinal length. In this case, the balloon24aand the anchor22have the same longitudinal length in one of the delivery state of the anchor22and the deployed state of the anchor22.

In at least one embodiment, the balloon24ain the deployed state has a constant cross-section in the central portion76(not shown). In some embodiments, the balloon24ahas a variable cross-section in the central portion76, where the central portion76tapers towards the waist portions72,74, as shown for example inFIG. 2. In some embodiments, the taper to the proximal waist portion74is steeper, at an greater angle relative to the longitudinal axis of the valvuloplasty device20, than the taper to the distal waist portion72, as shown for example inFIG. 2.

FIGS. 3 and 5Ashow the valvuloplasty device20comprising an anchor22and a balloon24ain the delivery configuration wherein both the anchor22and the balloon24aare in the delivery state.FIG. 5Bshows the valvuloplasty device in the partially deployed configuration wherein one of the anchor22or the balloon24ais in the deployed state and the other is in the delivery state.FIGS. 2 and 5Cshow the valvuloplasty device in the expanded configuration wherein both the anchor22and the balloon24aare in the deployed state. In at least one embodiment, as can be seen inFIGS. 5A-B, the balloon24ahas a plurality of folds78when the valvuloplasty device20is in the delivery configuration and when the valvuloplasty device20is in the partially deployed configuration.

In at least one embodiment, the valvuloplasty device20in a delivery configuration is carried by a delivery device60.FIG. 3shows an example of a delivery device60. In at least one embodiment, the delivery device60has a tubular sheath62.

In some embodiments, the delivery device60further comprises an inner member64. In one embodiment, the inner member64is tubular and defines a guidewire lumen. In some embodiments, the inner member64may have an expansion balloon mounted thereon for expansion of the anchor22. In at least one embodiment, the sheath62has a flared distal end66, which can assist in retrieving the valvuloplasty device from the deployment location without the balloon24abeing pushed distally over itself.

In at least one embodiment, the anchor22self-expands by withdrawing the sheath62proximally to expose the anchor22. In at least one embodiment, the anchor22is expanded by inflating the expansion balloon mounted on the inner member64has an expansion balloon mounted thereon. In at least one embodiment, the anchor22is longitudinally compressed by using an arrangement of locking mechanisms attached to the anchor22, as discussed in U.S. Patent Publication Nos. 2005/0137686, 2005/0143809, and 2010/0280495, the entireties of each are incorporated by reference herein. In at least one embodiment, the anchor22is longitudinally compressed by using an arrangement of control wires or sutures attached to the distal end and tines attached to the proximal end. The tines act in the opposite direction to the control wires attached at the distal end, thereby foreshortening the anchor. In one embodiment, the tines can be a part of the anchor that is attached to the center of the inner member64.

FIGS. 2 and 5Cshows the valvuloplasty device20ofFIG. 1in a deployed configuration. In at least one embodiment, expansion of the balloon24aoccurs after expansion of the anchor22. In some embodiments, the balloon24ais inflatable and expanded by transmitting inflation media into the interior lumen50of the balloon24a. In at least one embodiment, the inflation media is transmitted to the balloon24aby a detachable inflation mechanism40, which is in fluid communication with a fluid source and the interior lumen50of the balloon24a. In some embodiments, the detachable inflation mechanism is detachably connected to a valve in the balloon's outer wall (not shown). When the inflation mechanism is detached from the balloon, the valve prevents fluid from escaping the inflation lumen. In some embodiments, the detachable inflation mechanism40extends from a proximal end of the balloon24aalong the outer surface of the anchor22to a proximal end of a delivery device60. In other embodiments, the detachable inflation mechanism extends from a distal end of the balloon through the distal end of the anchor and through the lumen of the anchor to a proximal end of a delivery device60(not shown).

In at least one embodiment, a valvuloplasty device20comprising an anchor22and a sleeve24bhas a delivery configuration wherein both the anchor22and the sleeve24bare in the delivery state, as shown for example inFIG. 6Aand a deployed configuration wherein both the anchor22and the sleeve24bare in the deployed state, as shown for example inFIG. 6B. As can be seen inFIG. 6A, the sleeve24bhas a smooth outer surface80and a smooth inner surface82when the sleeve24bis in the delivery state. As can be seen inFIG. 6B, when the sleeve24bis in the deployed state both the outer surface80and the inner surface82have large corrugations with a plurality of troughs and peaks. In at least one embodiment, the sleeve24bextends axially over only a portion of the anchor22when the anchor22is in either the delivery state or the deployed state. In at least one embodiment, the sleeve24band the anchor22are coterminous in one of the delivery state and the deployed state of the anchor (not shown). In at least one embodiment, the sleeve24bis in the delivery state when the anchor22is in the delivery state and the sleeve24bis in the deployed state when the anchor22is in the deployed state. In some embodiments, the sleeve24bhas a first longitudinal length when the valvuloplasty device20is in the delivery configuration and a second longitudinal length less than the first longitudinal length when the valvuloplasty device20is in the deployed configuration.

In at least one embodiment, when the anchor22is foreshortened or longitudinally compressed to the deployed state, as discussed above, the sleeve24bforeshortens and has a plurality of peaks and troughs that form large ripples, waves, or corrugations, as shown inFIG. 6B. For simplicity, corrugations will be used hereinafter. In some embodiments, there are gaps87between the inner surface82of the sleeve24band the outer surface of the anchor22when the sleeve24bis in the expanded state. As can be seen, the gaps87are between the inner surface of a peak and the outer surface of the anchor22. In at least one embodiment, the corrugations extend from the proximal end84to the distal end86of the sleeve24b.

In some embodiments, the troughs of the plurality of corrugations are the portions of the sleeve24bthat are affixed to the anchor22and the peaks of the plurality of corrugations are the portions of the sleeve24bthat are unaffixed to the anchor22. In other words, the attachment locations of the sleeve24bto the anchor22form the troughs of the plurality of corrugations. In at least one embodiment, the sleeve24bextends a maximum distance from the outer surface25of the anchor22that is greater when the sleeve24bis in the expanded state than when the sleeve24bis in the delivery state. In at least one embodiment, a sleeve with corrugations mimics a balloon. In at least one embodiment, the delivery device60includes a control mechanism90releasably engaged to the valvuloplasty device20. In some embodiments, the control mechanism90is engaged to the anchor22, as shown for example inFIG. 2. In some embodiments, the control mechanism90allows an operator to retrieve the valvuloplasty device20from the bodily lumen or to change the position of the valvuloplasty device20within the bodily lumen. Thus, the mechanism90can also be considered a retrieval mechanism. The retrieval mechanism90in one embodiment comprises at least one suture line or wire woven through an opening extending between the outer surface25and the inner surface26of the anchor22. In some embodiments, proximally withdrawing the control mechanism90longitudinally lengthens the anchor. Thus, the control mechanism90can be used to move the valvuloplasty device20from the deployed configuration to the delivery configuration.

In at least one embodiment, when the valvuloplasty device20is in the deployed configuration at the deployment location, the radial forces caused the balloon24a, or sleeve24b, in the deployed state assist in expanding the patient's native valve, such as by opening the valve leaflets wider and cracking mineral deposits to make the valve leaflets more flexible. Additionally, in at least one embodiment, the lumen28, of the anchor22acts as a single perfusion channel for blood to pass through the valvuloplasty device20. In at least one embodiment, the lumen28is much larger than the channels of the perfusion balloons that are typically used in balloon aortic valvuloplasty. For example, in at least one embodiment, the lumen28of the anchor22has an effective orifice area greater than 1 mm.sup.2 In some embodiments, the large single perfusion channel greatly reduces the pressure gradient between the ventricle and the aorta during valvuloplasty relative to the pressure gradient of prior art balloon aortic valvuloplasty. In some embodiments, this reduced pressure gradient prevents movement of the balloon and/or allows deployment of the valvuloplasty device20without the use of pacing.

In at least one embodiment, the valvuloplasty device20is used for valvuloplasty where the valvuloplasty device20is used to increase the valve area prior to the subsequent deployment of a replacement valve. In some embodiments, the valvuloplasty method is a balloon aortic valvuloplasty method. Suitable inflation media to inflate the balloon for a valvuloplasty method includes media that can be removed from the annular balloon in order to deflate the balloon.

In at least one embodiment, the valvuloplasty device20is used for valve implantation. In some embodiments, the valve implantation method is a transcatheter aortic valve implantation method. Thus, in some embodiments, the valvuloplasty device20is used as part of a system including a replacement heart valve. In some embodiments, the balloon24ais compliant so that when inflated, the balloon24afills out gaps between the native valve and the aortic wall to prevent paravalvular leaks. In other embodiments, the sleeve24bin the deployed state fills out gaps between the native valve and the aortic wall to prevent paravalvular leaks.

Using the valvuloplasty devices20described herein, a valvuloplasty method such as BAV, and an implantation method such as TAVI, each include at least some of the following steps:

1) advancing the valvuloplasty device20to a desired deployment location in the vascular system;

i) wherein the desired deployment location is a native heart valve;

2) expanding the anchor22from a delivery state to a deployed state;

i) wherein the sheath of the delivery device is withdrawn and the anchor self expands;

ii) wherein a balloon of the delivery device expands the anchor;

iii) wherein the longitudinal length of the anchor decreases during expansion;

iv) wherein the sleeve24bforeshortens and has a plurality of corrugations when the anchor is expanded;

3) expanding the balloon24afrom a delivery state to a deployed state;

i) wherein the balloon is expanded after the anchor is in the deployed state;

ii) wherein the balloon is inflatable and is expanded by the introduction of inflation media into the interior lumen.

The valvuloplasty method further includes at least some of the following steps:

4) removing the valvuloplasty device20from the vascular system;

wherein the step of removing may include one or more of the following steps:

i) deflating the balloon24aby removing the inflation media from the interior lumen50through the inflation mechanism40;

a) wherein the anchor is lengthened by a control mechanism comprising at least one suture line or wire woven through an opening extending between the outer surface25and the inner surface26of the anchor22;

ii) resheathing the valvuloplasty device20with the sheath62of the delivery device60, and removing the delivery device60with the valvuloplasty device20positioned within;

a) wherein the sheath62has a flared distal end.

The implantation method further includes at least some of the following steps:

4) removing the detachable inflation mechanism40from the valvuloplasty device20; and

5) placing a replacement valve within lumen28of the anchor22(not shown);

6) expanding the replacement valve.

Suitable inflation media to inflate the balloon24afor the implantation method include hardenable and non-hardenable media since the balloon24ain this method is implanted in the bodily lumen and thus does not need to be deflated.

In some embodiments of the implantation methods discussed above, a single delivery device deploys valvuloplasty device20and the replacement valve. In other embodiments of the implantation methods discussed above, one delivery device deploys the valvuloplasty device and another delivery device deploys the replacement valve. In at least one embodiment, the valvuloplasty device is expanded from the delivery configuration to the deployed configuration before the replacement valve is positioned within the lumen28of the anchor22.

In some embodiments, the replacement valve for the implantation methods such as TAVI, disclosed herein includes leaflets that may comprise bovine tissue, synthetic tissue, silicone, polymer or other materials having suitable and/or similar properties of the leaflets of a native valve. Features of the replacement valve that may be incorporated into this and other embodiments can be found at least in U.S. Pat. Nos. 7,329,279, 7,381,219, 7,445,631, 7,748,389, 7,780,725, 7,824,442, 7,824,443; U.S. Patent Publication Nos. 2005/0112355, 2005/0137686, 2005/0137687, 2005/0137688, 2005/0137689, 2005/0137691, 2005/0137692, 2005/0137694, 2005/0137695, 2005/0137696, 2005/0137697, 2005/0137701, 2005/0143809, 2006/0058872, 2006/0173524, 2006/0253191, 2007/0010876, 2007/0024452, 2007/0112355, 2007/0118214, 2007/0162107, 2007/0203503, 2008/0125859, 2008/0234814, 2009/0076598, 2009/0054969, 2009/0264997, 2010/0121434, 2010/0280495; and WO Publication Nos. 2005/062980, 2005/065585, 2006/009690, 2007/053243, 2007/058847, each which are incorporated by reference herein in their entireties.

In some embodiments, the anchor22is a stent, a graft, or a stent-graft. As discussed above, the anchor22may be created by methods including cutting or etching a design from a tubular stock, from a flat sheet which is cut or etched and which is subsequently rolled, or from one or more interwoven wires or braids. Any other suitable technique which is known in the art or which is subsequently developed may also be used to manufacture the anchor22disclosed herein. In at least one embodiment, the anchor22is a braided stent. In some embodiments, the anchor22has a plurality of openings extending from the outer surface25to the inner surface26.

The anchor22may be made from any suitable non-biodegradabale biocompatible material(s) including one or more polymers, one or more metals or combinations of polymer(s) and metal(s). Polymers that may be used include polyester, polyamide, polyoxymethylene, polyurethane, silicone, polycarbonate, various copolymers such as but not limited to polyetherester, polyetheramide, and combinations thereof. Examples of suitable metals include, but are not limited to, stainless steel, titanium, tantalum, platinum, tungsten, gold and alloys of any of the above-mentioned metals. Examples of suitable alloys include platinum-iridium alloys, cobalt-chromium alloys including Elgiloy and Phynox, MP35N alloy and nickel-titanium alloys, for example, Nitinol.

The anchor22may be made of shape memory materials, such as Nitinol, or may be made of materials which are plastically deformable. In the case of shape memory alloys, the shape memory alloy forming the anchor22may be provided with shape memory effect properties or superelastic properties, as is known in the art. An anchor22made of a shape memory alloy with shape memory effect properties restores itself to its memorized shape upon being heated to a transition temperature and having any restraints removed therefrom. An anchor22made of a shape memory alloy with superelastic properties reverts to a prior configuration upon removal of a load. Non-limiting examples of compliant material include, but are not limited to, nylon and polyamines.

Non-limiting examples of non-compliant materials include, but are not limited to, polyethylene terephthalates, polyacrylenesulfide, and copolyesters.

Non-limiting examples of semi-compliant materials include, but are not limited to, ethylene-vinyl acetate, polyvinyl chloride (PVC), olefin copolymers or homopolymers, polyethylenes, polyurethanes, crosslinked low density polyethylenes (PETs), highly irradiated linear low density polyethylene (LDPE), acrylonitrile polymers and copolymers, acrylonitrile blends and ionomer resins. Other suitable materials may also be used for the balloon24aand the sleeve24b.

Other suitable materials for the sleeve24binclude, but are not limited to, Poly(Styrene-Isobutylene-Styrene) Tri-block polymer (SIBS), polyurethane, an elastic polymer, woven fabric, a multi-walled membrane of polymer, and combinations thereof

In some embodiments the valvuloplasty device20, the delivery device60, or other portion of the assembly may include one or more areas, bands, coatings, members, etc. that is (are) detectable by imaging modalities such as X-Ray, MRI, ultrasound, etc. In some embodiments at least a portion of the valvuloplasty device20is at least partially radiopaque. For example, in at least one embodiment, the valvuloplasty device20includes at least one area, band, coating, or member that is detectable by imaging modalities.

In some embodiments the at least a portion of the valvuloplasty device20is configured to include one or more mechanisms for the delivery of a therapeutic agent. Often the agent will be in the form of a coating or other layer (or layers) of material placed on a surface region of the valve, which is adapted to be released at the site of the valve's implantation or areas adjacent thereto.

The following numbered statements describe the valvuloplasty device discussed above.

an expandable anchor having a proximal end, a distal end, an outer surface extending between the proximal end and the distal end, and an inner surface extending between the proximal end and the distal end, the inner surface defining a lumen; and an expansion member selected from the group consisting of:

an annular expandable balloon having an inner surface and an outer surface, the annular balloon disposed about the outer surface of the expandable anchor such that the inner surface of the balloon directly contacts the outer surface of the expandable anchor; and

a sleeve disposed about the outer surface of the expandable anchor.

2. The valvuloplasty device of statement 1, wherein the anchor is a stent.

3. The valvuloplasty device of statement 2, wherein the stent is a braided stent.

4. The valvuloplasty device of statements 1-3, wherein the anchor is self-expandable.

5. The valvuloplasty device of statements 1-4 wherein the anchor comprises a shape memory alloy with superelasticity.

6. The valvuloplasty device of statements 1-5, wherein the expansion member is affixed to at least one location on the outer surface of the expandable anchor.

7. The valvuloplasty device of statements 1-6, wherein the distal end of expansion member is affixed to the distal end of the anchor.

8. The valvuloplasty device of statements 1-7, wherein the proximal end of the expansion member is unaffixed to the anchor.

9. The valvuloplasty device of statements 1-8, wherein the expansion member extends axially over at least a portion of the expandable anchor.

10. The valvuloplasty device of statements 1-9, wherein the valvuloplasty device has:

a delivery configuration wherein the expandable anchor is in a delivery state and the expansion member is in a delivery state;

a deployed configuration, wherein the expandable anchor is in an deployed state and the expansion member is in the deployed state.

11. The valvuloplasty device of statements 1-10, wherein the expansion member is the sleeve, the sleeve in the delivery state having a smooth outer surface and a smooth inner surface, and the sleeve in the deployed state having a corrugated outer surface and a corrugated inner surface.

12. The valvuloplasty device of statements 1-7 and 9-11, wherein the sleeve has a plurality of attachment locations where the sleeve is affixed to the anchor, wherein when the sleeve is in the deployed state the plurality of attachments locations form troughs of the plurality of corrugations.

13. The valvuloplasty device of statements 1-7 and 9-12, the sleeve having a first thickness, the anchor having a second thickness less than the first thickness.

14. The valvuloplasty device of statements 1-10, wherein the expansion member is the balloon, the balloon being inflatable, the balloon in the delivery state being uninflated, the balloon in the deployed state being inflated.

15. The valvuloplasty device of statements 1-10 and 14, the balloon being either a compliant balloon, a semi-compliant balloon, or a non-compliant balloon.

16. The valvuloplasty device of statements 1-10 and 14-15, the balloon further comprising:

an outer wall forming the outer surface of the balloon;

an inner wall forming the inner surface of the balloon;

a proximal waist portion; and

a distal waist portion;

wherein the outer wall and the inner wall are affixed to one another to form the proximal waist portion and the distal waist portion, the outer and inner walls defining a balloon inflation lumen.

17. The valvuloplasty device of statements 1-10 and 14-16, wherein only the distal waist portion of the balloon is affixed to the anchor.

18. The valvuloplasty device of statements 1-10 and 14-17, the balloon further comprising a plurality of spines positioned about the circumference of the inner wall of the balloon.

19. The valvuloplasty device of statement 18, the plurality of spines being made of a first material, the inner wall being made of a second material different than the first material.

20. The valvuloplasty device of statement 19, the first material being stiffer than the second material.

21. The valvuloplasty device of statements 18-20, each spine extending from the proximal waist portion to the distal waist portion of the balloon.

22. The valvuloplasty device of statements 1-10 and 14-21, the valvuloplasty device further having a partially deployed configuration wherein the expandable anchor is in the deployed state and the balloon is in the delivery state.

23. The valvuloplasty device of statements 1-10 and 14-22, wherein the balloon has a plurality of folds when the expandable anchor is in the delivery state.

24. The valvuloplasty device of statements 1-23, wherein the anchor lumen has an effective orifice area greater than 1 mm.sup.2 when the anchor is in the deployed state.

25. The valvuloplasty device of statements 1-24, wherein when deployed at the site of a native heart valve, the anchor lumen reduces the pressure gradient between the ventricle and aorta which provides for the deployment of the valvuloplasty device without pacing.

26. The valvuloplasty device of statements 1-25, wherein the anchor has a first longitudinal length in the delivery state and a second longitudinal length in the deployed state, wherein the second longitudinal length is greater than the first longitudinal length.

27. The valvuloplasty device of statements 1-26 further comprising a replacement valve positioned within the lumen of the anchor.

28. The valvuloplasty device of statements 1-27 in combination with a delivery device, the delivery device comprising an outer sheath, the outer sheath defining a sheath lumen, the valvuloplasty device positioned within the sheath lumen.

29. The valvuloplasty device of statement 28, wherein the outer sheath has a flared distal end.

30. The valvuloplasty device of statements 28-29, the delivery device further comprising an inner member, the inner member positioned within the lumen of the anchor.

31. The valvuloplasty device of statements 28-30, further comprising an inflation mechanism detachably connected to the balloon of the valvuloplasty device.

32. The valvuloplasty device of statement 31, the inflation mechanism defining an inflation lumen in fluid communication with a balloon inflation lumen and with a fluid source.

33. The valvuloplasty device of statements 31-32, the balloon further comprising a valve, the inflation mechanism detachably connected to the valve.

34. The valvuloplasty device of statements 28-33, further comprising a control mechanism, the control mechanism releasably engaged to the valvuloplasty device.

35. The valvuloplasty device of statement 34, the control mechanism comprising at least one suture line or wire.

36. The valvuloplasty device of statement 35, wherein the at least one suture line or wire is woven through an opening extending between the outer surface and the inner surface of the anchor.

37. The valvuloplasty device of statements 34-36, wherein the control mechanism is configured to longitudinally lengthen the anchor.

38. The valvuloplasty device of statements 1-37 used for a valvuloplasty method or a valve implantation method.

39. The valvuloplasty device of statement 38, wherein the valvuloplasty and the valve implantation method each include the following steps:

advancing the delivery device with the valvuloplasty device to a desired deployment location in the vascular system; and

deploying the anchor of the valvuloplasty device.

40. The valvuloplasty device of statement 39, wherein deploying the anchor includes withdrawing the sheath of the delivery device.

41. The valvuloplasty device of statements 39-40, wherein the longitudinal length of the anchor decreases during deploying.

42. The valvuloplasty device of statements 39-41, wherein the valvuloplasty device comprises the sleeve, wherein when the anchor is in the deployed state, the sleeve is in the deployed state and has a plurality of corrugations.

43. The valvuloplasty device of statements 39-41, wherein the valvuloplasty device comprises the balloon, wherein the balloon aortic valvuloplasty and the transcatheter aortic valve implantation method further includes expanding the balloon from the delivery state to the deployed state.

44. The valvuloplasty device of statement 43, wherein the balloon is expanded after the anchor is deployed.

45. The valvuloplasty device of statements 43-44, wherein the balloon is inflatable and is expanded by inflation media by a detachable inflation mechanism.

46. The valvuloplasty device of statements 39-45, wherein the valvuloplasty method further comprises:

removing the valvuloplasty device from the deployment location.

47. The valvuloplasty device of statement 46, wherein removing the valvuloplasty device comprises deflating the balloon.

48. The valvuloplasty device of statements 46-47 wherein removing the valvuloplasty device comprises lengthening the anchor.

49. The valvuloplasty device of statements 48, wherein the anchor is lengthened by a control mechanism.

50. The valvuloplasty device of statements 46-49, wherein removing the valvuloplasty device comprises withdrawing the valvuloplasty device within the outer sheath of the delivery device.

51. The valvuloplasty device of statements 39-50, wherein the outer sheath of the delivery device has a flared distal end.

52. The valvuloplasty device of statements 39-45, wherein the transcatheter aortic valve implantation method further comprises:

removing the detachable inflation mechanism from the balloon.

53. The valvuloplasty device of statement 52, further comprising placing a replacement valve within the lumen of the anchor