US20130338698A1

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Publication number: US20130338698A1
Application number: US13/909,575
Authority: US
Inventors: Aiden Flanagan
Original assignee: Scimed Life Systems Inc
Current assignee: Boston Scientific Scimed Inc
Priority date: 2012-06-19
Filing date: 2013-06-04
Publication date: 2013-12-19
Also published as: US20170143487A1; WO2013191892A2; WO2013191892A3; US10583006B2

Abstract

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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Patent Provisional Application No. 61/661,599, filed Jun. 19, 2012, the entire contents of which are hereby incorporated herein by reference.

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.

The art referred to and/or described above is not intended to constitute an admission that any patent, publication or other information referred to herein is “prior art” with respect to this invention. In addition, this section should not be construed to mean that a search has been made or that no other pertinent information as defined in 37 C.F.R. §1.56(a) exists.

All US patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety.

Without limiting the scope of the invention a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below.

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.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

FIG. 1 is a perspective view of a valvuloplasty device in a deployed configuration.

FIG. 2 is a cross-sectional view of the valvuloplasty device ofFIG. 1 in the deployed configuration.

FIG. 3 is a cross-sectional view of the valvuloplasty device ofFIG. 1 in a delivery configuration in a delivery device.

FIG. 4 is a cross-sectional view of the valvuloplasty device ofFIG. 1.

FIGS. 5A-5C are cross-sectional views of the valvuloplasty device ofFIG. 1 in the delivery configuration, the partially deployed configuration, and the deployed configuration. For simplicity details regarding the thickness of the inner and outer walls of the balloon are omitted fromFIGS. 5A-5B.

FIGS. 6A-6B are cross-sectional views of a valvuloplastv device in the delivery configuration and in the deployed configuration.

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.

For the purposes of this disclosure, like reference numerals in the figures shall refer to like features unless otherwise indicated.

FIGS. 1-6B show avalvuloplasty device20 that comprises ananchor22, anexpansion member24, and has a longitudinal axis. As can be seen from the figures, the anchor has aproximal end30, adistal end32, and a longitudinal length extending from theproximal end30 to thedistal end32. Theanchor22 also has anouter surface25 and aninner surface26 that defines alumen28. In at least one embodiment, theanchor22 is tubular. In some embodiments, theanchor22 defines a valve region which is a part of thelumen28 where a replacement valve is positioned during a transcatheter aortic valve implantation method which is discussed below in greater detail. In at least one embodiment, theanchor22 is 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. Theanchor22 can be self-expanding, balloon expandable, or hybrid self-expanding and balloon expandable.

In some embodiments, theexpansion member24 is aballoon24a,as shown for example inFIGS. 1-5C. In at least one embodiment, theballoon24ahas anouter wall34 and aninner wall36, and aninterior lumen50 defined by theouter wall34 and theinner wall36. In some embodiments, theinterior lumen50 is an inflation lumen. As can be seen from the figures, theballoon24ais an annular balloon. Theinner wall36 defines a balloon lumen. In some embodiments, the balloon lumen has a diameter greater than a diameter of theanchor22 so that theanchor22 can be positioned within the balloon lumen. In at least one embodiment, as shown more clearly inFIG. 2,balloon24ahas two

waist portions

72,74 and a central portion76 extending between the two

waist portions

72,74. As used herein, a “waist portion” is the portion of theballoon24awhere theouter wall34 and theinner wall36 are joined to one another. In one embodiment, theballoon24ais a compliant balloon. In another embodiment, theballoon24ais a semi-compliant balloon. In yet another embodiment, theballoon24ais a non-compliant balloon. In at least one embodiment, theballoon24ahas a plurality ofspines38 positioned about the circumference of theinner wall36 of theballoon24a.In some embodiments, thespines38 are formed on the interior surface of theinner wall36 of theballoon24a,as shown for example inFIG. 4. In at least one embodiment, the spines are coextruded with theinner wall36 of theballoon24a.In some embodiments, thespines38 comprise a first material and at least theinner wall36 of theballoon24ais 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, thespines38 extend longitudinally from theproximal waist portion74 to thedistal waist portion72 of theballoon24a.

In at least one embodiment, theballoon24ais affixed at or substantially near thedistal end32 of theanchor22. As used herein “affixed” indicates a permanent attachment. In some embodiments, theinner wall36 of theballoon24ais affixed to theanchor22. In at least one embodiment, theballoon24ais directly affixed to theouter surface25 of theanchor22 at thedistal end32 of the anchor (shown for example inFIG. 2). In at least one embodiment, theballoon24ais only affixed to theanchor22 at a distal end of theballoon24a(shown for example inFIG. 2). Because theballoon24ais only affixed to one end of theanchor22, theproximal end30 of theanchor22 is free to move longitudinally relative to thedistal end32 of theanchor22.

In some embodiments, such as shown inFIG. 2, only thedistal waist portion72 is directly affixed to theouter surface25 of theanchor22. Thedistal waist portion72 is affixed to theouter surface25 of theanchor22 with adhesive, a suture, or other suitable attachment means. In at least one embodiment, the entire circumference of thedistal waist portion72 is affixed to theouter surface25 of theanchor22. In one embodiment, thedistal waist portion72 may 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, theproximal waist portion74 is not directly affixed to theanchor22. In at least one embodiment, both thedistal waist portion72 and theproximal waist portion74 are affixed to theouter surface25 of theanchor22.

In other embodiments, theexpansion member24 is asleeve24b,as shown for example inFIGS. 6A-B. As shown inFIG. 6A, thesleeve24bis tubular with aproximal end84 and adistal end86. In at least one embodiment, thesleeve24bis affixed to theanchor22 at at least one location. In some embodiments, both ends84,86 of thesleeve24bare affixed to theanchor22. In at least one embodiment, thesleeve24bis affixed to theanchor22 at a plurality of locations along the longitudinal length of the thick sleeve. In at least one embodiment thesleeve24bhas a greater thickness than the thickness of theanchor22. In some embodiments, thesleeve24bis at least twice as thick as the as the wall of theanchor22. Thus, thesleeve24bcan be described as a thick sleeve.

In some embodiments, thesleeve24bcomprises compliant material, semi-compliant material, and combinations thereof Suitable means by which thesleeve24bis affixed to theanchor22 include 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 theanchor22.

As discussed below in greater detail, theanchor22 has a delivery state and a deployed state; theexpansion member24 has 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, and6A show theanchor22 in the delivery state andFIGS. 2,5B-C, and6B show theanchor22 in the deployed state. In at least one embodiment, theanchor22 in the deployed state has a high radial force. In at least one embodiment, when theanchor22 is in the delivery state, theanchor22 has 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 and5A-B show theballoon24ain the delivery state andFIGS. 2 and 5C show theballoon24ain the deployed state. In at least one embodiment, theballoon24ahas a plurality of folds78, as shown for example inFIGS. 5B-C. In some embodiments, both theouter wall34 and theinner wall36 form the folds. Thus, when thevalvuloplasty device20 is in the delivery configuration, there is some space between the unattached portions of theinner wall36 of theballoon24aand theouter surface25 of theanchor22. In at least one embodiment, theballoon24ahas three folds78 when theballoon24ais in the delivery state. In one embodiment, the diameter of theballoon24ain the deployed state is greater than the diameter of theballoon24ain the delivery state. In some embodiments, theballoon24ais inflatable and is uninflated in the delivery state and inflated in the deployed state. In other embodiments, theballoon24acomprises an electroactive polymer.

As shown inFIGS. 1-3, theballoon24aextends axially over only a portion of theanchor22 when theanchor22 is in either the delivery state or the deployed state. In at least one embodiment, theballoon24aextends longitudinally over at least a portion of the valve region of theanchor22. In at least one embodiment, theballoon24aand theanchor22 are coterminous in one of the delivery state and the deployed state of theanchor22. 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, theballoon24aand theanchor22 have the same longitudinal length in one of the delivery state of theanchor22 and the deployed state of theanchor22.

In at least one embodiment, theballoon24ain the deployed state has a constant cross-section in the central portion76 (not shown). In some embodiments, theballoon24ahas a variable cross-section in the central portion76, where the central portion76 tapers towards the

waist portions

72,74, as shown for example inFIG. 2. In some embodiments, the taper to theproximal waist portion74 is steeper, at an greater angle relative to the longitudinal axis of thevavluloplasty device20, than the taper to thedistal waist portion72, as shown for example inFIG. 2.

FIGS. 3 and 5A show thevalvuloplasty device20 comprising ananchor22 and aballoon24ain the delivery configuration wherein both theanchor22 and theballoon24aare in the delivery state.FIG. 5B shows the valvuloplasty device in the partially deployed configuration wherein one of theanchor22 or theballoon24ais in the deployed state and the other is in the delivery state.FIGS. 2 and 5C show the valvuloplasty device in the expanded configuration wherein both theanchor22 and theballoon24aare in the deployed state. In at least one embodiment, as can be seen inFIGS. 5A-B, theballoon24ahas a plurality of folds78 when thevalvuloplasty device20 is in the delivery configuration and when thevalvuloplasty device20 is in the partially deployed configuration.

In at least one embodiment, thevalvuloplasty device20 in a delivery configuration is carried by adelivery device60.FIG. 3 shows an example of adelivery device60. In at least one embodiment, thedelivery device60 has atubular sheath62.

In some embodiments, thedelivery device60 further comprises aninner member64. In one embodiment, theinner member64 is tubular and defines a guidewire lumen. In some embodiments, theinner member64 may have an expansion balloon mounted thereon for expansion of theanchor22. In at least one embodiment, thesheath62 has a flared distal end66, which can assist in retrieving the valvuloplasty device from the deployment location without theballoon24abeing pushed distally over itself.

In at least one embodiment, theanchor22 self-expands by withdrawing thesheath62 proximally to expose theanchor22. In at least one embodiment, theanchor22 is expanded by inflating the expansion balloon mounted on theinner member64 has an expansion balloon mounted thereon. In at least one embodiment, theanchor22 is longitudinally compressed by using an arrangement of locking mechanisms attached to theanchor22, 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, theanchor22 is 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 theinner member64.

FIGS. 2 and 5C shows thevalvuloplasty device20 ofFIG. 1 in a deployed configuration. In at least one embodiment, expansion of theballoon24aoccurs after expansion of theanchor22. In some embodiments, theballoon24ais inflatable and expanded by transmitting inflation media into theinterior lumen50 of theballoon24a.In at least one embodiment, the inflation media is transmitted to theballoon24aby adetachable inflation mechanism40, which is in fluid communication with a fluid source and theinterior lumen50 of theballoon24a.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, thedetachable inflation mechanism40 extends from a proximal end of theballoon24aalong the outer surface of theanchor22 to a proximal end of adelivery 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, avalvuloplasty device20 comprising ananchor22 and asleeve24bhas a delivery configuration wherein both theanchor22 and thesleeve24bare in the delivery state, as shown for example inFIG. 6A and a deployed configuration wherein both theanchor22 and thesleeve24bare in the deployed state, as shown for example inFIG. 6B. As can be seen inFIG. 6A, thesleeve24bhas a smoothouter surface80 and a smoothinner surface82 when thesleeve24bis in the delivery state. As can be seen inFIG. 6B, when thesleeve24bis in the deployed state both theouter surface80 and theinner surface82 have large corrugations with a plurality of troughs and peaks. In at least one embodiment, thesleeve24bextends axially over only a portion of theanchor22 when theanchor22 is in either the delivery state or the deployed state. In at least one embodiment, thesleeve24band theanchor22 are coterminous in one of the delivery state and the deployed state of the anchor (not shown). In at least one embodiment, thesleeve24bis in the delivery state when theanchor22 is in the delivery state and thesleeve24bis in the deployed state when theanchor22 is in the deployed state. In some embodiments, thesleeve24bhas a first longitudinal length when thevalvuloplasty device20 is in the delivery configuration and a second longitudinal length less than the first longitudinal length when thevalvuloplasty device20 is in the deployed configuration.

In at least one embodiment, when theanchor22 is foreshortened or longitudinally compressed to the deployed state, as discussed above, thesleeve24bforeshortens 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 aregaps87 between theinner surface82 of thesleeve24band the outer surface of theanchor22 when thesleeve24bis in the expanded state. As can be seen, thegaps87 are between the inner surface of a peak and the outer surface of theanchor22. In at least one embodiment, the corrugations extend from theproximal end84 to thedistal end86 of thesleeve24b.

In some embodiments, the troughs of the plurality of corrugations are the portions of thesleeve24bthat are affixed to theanchor22 and the peaks of the plurality of corrugations are the portions of thesleeve24bthat are unaffixed to theanchor22. In other words, the attachment locations of thesleeve24bto theanchor22 form the troughs of the plurality of corrugations. In at least one embodiment, thesleeve24bextends a maximum distance from theouter surface25 of theanchor22 that is greater when thesleeve24bis in the expanded state than when thesleeve24bis in the delivery state. In at least one embodiment, a sleeve with corrugations mimics a balloon. In at least one embodiment, thedelivery device60 includes acontrol mechanism90 releasably engaged to thevalvuloplasty device20. In some embodiments, thecontrol mechanism90 is engaged to theanchor22, as shown for example inFIG. 2. In some embodiments, thecontrol mechanism90 allows an operator to retrieve thevalvuloplasty device20 from the bodily lumen or to change the position of thevalvuloplasty device20 within the bodily lumen. Thus, themechanism90 can also be considered a retrieval mechanism. Theretrieval mechanism90 in one embodiment comprises at least one suture line or wire woven through an opening extending between theouter surface25 and theinner surface26 of theanchor22. In some embodiments, proximally withdrawing thecontrol mechanism90 longitudinally lengthens the anchor. Thus, thecontrol mechanism90 can be used to move thevalvuloplasty device20 from the deployed configuration to the delivery configuration.

In at least one embodiment, when thevalvuloplasty device20 is in the deployed configuration at the deployment location, the radial forces caused theballoon24a,orsleeve24b,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, thelumen28, of theanchor22 acts as a single perfusion channel for blood to pass through thevavuloplasty device20. In at least one embodiment, thelumen28 is much larger than the channels of the perfusion balloons that are typically used in balloon aortic valvuloplasty. For example, in at least one embodiment, thelumen28 of theanchor22 has an effective orifice area greater than 1 mm²In 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 thevalvuloplasty device20 without the use of pacing.

In at least one embodiment, thevalvuloplasty device20 is used for valvuloplasty where thevalvuloplasty device20 is 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, thevalvuloplasty device20 is used for valve implantation. In some embodiments, the valve implantation method is a transcatheter aortic valve implantation method. Thus, in some embodiments, thevalvuloplasty device20 is used as part of a system including a replacement heart valve. In some embodiments, theballoon24ais compliant so that when inflated, theballoon24afills out gaps between the native valve and the aortic wall to prevent paravalvular leaks. In other embodiments, thesleeve24bin the deployed state fills out gaps between the native valve and the aortic wall to prevent paravalvular leaks.

Using thevalvuloplasty devices20 described 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 thevalvuloplasty device20 to a desired deployment location in the vascular system;

- i) wherein the desired deployment location is a native heart valve;
- ii) wherein thevalvuloplasty device20 comprises ananchor22 and aballoon24a;
- iii) wherein thevalvuloplasty device20 comprises ananchor22 and asleeve24b;

2) expanding theanchor22 from 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 thesleeve24bforeshortens and has a plurality of corrugations when the anchor is expanded;

3) expanding theballoon24afrom 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 thevalvuloplasty device20 from the vascular system;

- wherein the step of removing may include one or more of the following steps:
- i) deflating theballoon24aby removing the inflation media from theinterior lumen50 through theinflation mechanism40;
- ii) lengthening the anchor;
  - a) wherein the anchor is lengthened by a control mechanism comprising at least one suture line or wire woven through an opening extending between theouter surface25 and theinner surface26 of theanchor22;
- ii) resheathing thevalvuloplasty device20 with thesheath62 of thedelivery device60, and removing thedelivery device60 with thevalvuloplasty device20 positioned within;
  - a) wherein thesheath62 has a flared distal end.

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

4) removing thedetachable inflation mechanism40 from thevalvuloplasty device20; and

5) placing a replacement valve withinlumen28 of the anchor22 (not shown);

6) expanding the replacement valve.

Suitable inflation media to inflate theballoon24afor the implantation method include hardenable and non-hardenable media since theballoon24ain 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 deploysvalvuloplasty device20 and 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 thelumen28 of theanchor22.

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, theanchor22 is a stent, a graft, or a stent-graft. As discussed above, theanchor22 may 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 theanchor22 disclosed herein. In at least one embodiment, theanchor22 is a braided stent. In some embodiments, theanchor22 has a plurality of openings extending from theouter surface25 to theinner surface26.

Theanchor22 may 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.

Theanchor22 may 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 theanchor22 may be provided with shape memory effect properties or superelastic properties, as is known in the art. Ananchor22 made 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. Ananchor22 made 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 theballoon24aand thesleeve24b.

Other suitable materials for thesleeve24binclude, 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 thevalvuloplasty device20, thedelivery 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 thevalvuloplasty device20 is at least partially radiopaque. For example, in at least one embodiment, thevalvuloplasty device20 includes at least one area, band, coating, or member that is detectable by imaging modalities.

In some embodiments the at least a portion of thevalvuloplasty device20 is 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.

1. A valvuloplasty device comprising:

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 valuvloplasty device of statement1, wherein the anchor is a stent.

3. The valvuloplasty device of statement2, wherein the stent is a braided stent.

4. The valvuloplasty device of statements1-3, wherein the anchor is self-expandable.

5. The valvuloplasty device of statements1-4 wherein the anchor comprises a shape memory alloy with superelasticity.

6. The valvuloplasty device of statements1-5, wherein the expansion member is affixed to at least one location on the outer surface of the expandable anchor.

7. The valvuloplasty device of statements1-6, wherein the distal end of expansion member is affixed to the distal end of the anchor.

8. The valvuloplasty device of statements1-7, wherein the proximal end of the expansion member is unaffixed to the anchor.

9. The valvuloplasty device of statements1-8, wherein the expansion member extends axially over at least a portion of the expandable anchor.

10. The valvuloplasty device of statements1-9, 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 statements1-10, 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 statements1-7 and9-11, 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 statements1-7 and9-12, the sleeve having a first thickness, the anchor having a second thickness less than the first thickness.

14. The valvuloplasty device of statements1-10, 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 statements1-10 and14, the balloon being either a compliant balloon, a semi-compliant balloon, or a non-compliant balloon.

16. The valvuloplasty device of statements1-10 and14-15, 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 statements1-10 and14-16, wherein only the distal waist portion of the balloon is affixed to the anchor.

18. The valvuloplasty device of statements1-10 and14-17, the balloon further comprising a plurality of spines positioned about the circumference of the inner wall of the balloon.

19. The valvuloplasty device of statement18, 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 statement19, the first material being stiffer than the second material.

21. The valvuloplasty device of statements18-20, each spine extending from the proximal waist portion to the distal waist portion of the balloon.

22. The valvuloplasty device of statements1-10 and14-21, 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 statements1-10 and14-22, wherein the balloon has a plurality of folds when the expandable anchor is in the delivery state.

24. The valvuloplasty device of statements1-23, wherein the anchor lumen has an effective orifice area greater than1 mm²when the anchor is in the deployed state.

25. The valvuloplasty device of statements1-24, 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 statements1-25, 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 statements1-26 further comprising a replacement valve positioned within the lumen of the anchor.

28. The valvuloplasty device of statements1-27 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 ofstatement28, wherein the outer sheath has a flared distal end.

30. The valvuloplasty device of statements28-29, the delivery device further comprising an inner member, the inner member positioned within the lumen of the anchor.

31. The valvuloplasty device of statements28-30, further comprising an inflation mechanism detachably connected to the balloon of the valvuloplasty device.

32. The valvuloplasty device of statement31, 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 statements31-32, the balloon further comprising a valve, the inflation mechanism detachably connected to the valve.

34. The valvuloplasty device of statements28-33, further comprising a control mechanism, the control mechanism releasably engaged to the valvuloplasty device.

35. The valvuloplasty device ofstatement34, the control mechanism comprising at least one suture line or wire.

36. The valvuloplasty device of statement35, 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 statements34-36, wherein the control mechanism is configured to longitudinally lengthen the anchor.

38. The valvuloplasty device of statements1-37 used for a valvuloplasty method or a valve implantation method.

39. The valvuloplasty device ofstatement38, 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 statement39, wherein deploying the anchor includes withdrawing the sheath of the delivery device.

41. The valvuloplasty device of statements39-40, wherein the longitudinal length of the anchor decreases during deploying.

42. The valvuloplasty device of statements39-41, 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 statements39-41, 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 statement43, wherein the balloon is expanded after the anchor is deployed.

45. The valvuloplasty device of statements43-44, wherein the balloon is inflatable and is expanded by inflation media by a detachable inflation mechanism.

46. The valvuloplasty device of statements39-45, wherein the valvuloplasty method further comprises:

- removing the valvuloplasty device from the deployment location.

47. The valvuloplasty device of statement46, wherein removing the valvuloplasty device comprises deflating the balloon.

48. The valvuloplasty device of statements46-47 wherein removing the valvuloplasty device comprises lengthening the anchor.

49. The valvuloplasty device of statements48, wherein the anchor is lengthened by a control mechanism.

50. The valvuloplasty device of statements46-49, wherein removing the valvuloplasty device comprises withdrawing the valvuloplasty device within the outer sheath of the delivery device.

51. The valvuloplasty device of statements39-50, wherein the outer sheath of the delivery device has a flared distal end.

52. The valvuloplasty device of statements39-45, wherein the transcatheter aortic valve implantation method further comprises:

- removing the detachable inflation mechanism from the balloon.

53. The valvuloplasty device of statement52, further comprising placing a replacement valve within the lumen of the anchor

The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. All these alternatives and variations are intended to be included within the scope of the claims where the term “comprising” means “including, but not limited to”. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the claims.

Further, the particular features presented in the dependent claims can be combined with each other in other manners within the scope of the invention such that the invention should be recognized as also specifically directed to other embodiments having any other possible combination of the features of the dependent claims. For instance, for purposes of claim publication, any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly from originally filed claim1 should be alternatively taken as depending from all previous claims). In jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claim below (e.g. originally filed claim3 may be taken as alternatively dependent from originally filed claim2; originally filed claim4 may be taken as alternatively dependent on originally filed claim2, or on originally filed claim3; originally filed claim6 may be taken as alternatively dependent from originally filed claim5; etc.).

This completes the description of the preferred and alternate embodiments of the invention. Those skilled in the art may recognize other equivalents to the specific embodiment described herein which equivalents are intended to be encompassed by the claims attached hereto.