Patent Description:
The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require replacement of the native valve with an artificial valve. There are a number of known artificial valves and a number of known methods of implanting these artificial valves in humans.

Various surgical techniques may be used to repair a diseased or damaged valve. In a valve replacement operation, the damaged leaflets are excised and the annulus sculpted to receive a replacement valve. Due to aortic stenosis and other heart valve diseases, thousands of patients undergo surgery each year wherein the defective native heart valve is replaced by a prosthetic valve, either bioprosthetic or mechanical. Another less drastic method for treating defective valves is through repair or reconstruction, which is typically used on minimally calcified valves. The problem with surgical therapy is the significant insult it imposes on these chronically ill patients with high morbidity and mortality rates associated with surgical repair.

When the valve is replaced, surgical implantation of the prosthetic valve typically requires an open-chest surgery during which the heart is stopped and patient placed on cardiopulmonary bypass (a so-called "heart-lung machine"). In one common surgical procedure, the diseased native valve leaflets are excised and a prosthetic valve is sutured to the surrounding tissue at the valve annulus. Because of the trauma associated with the procedure and the attendant duration of extracorporeal blood circulation, some patients do not survive the surgical procedure or die shortly thereafter. It is well known that the risk to the patient increases with the amount of time required on extracorporeal circulation. Due to these risks, a substantial number of patients with defective valves are deemed inoperable because their condition is too frail to withstand the procedure. By some estimates, more than <NUM>% of the subjects suffering from aortic stenosis who are older than <NUM> years cannot be operated on for aortic valve replacement.

Because of the drawbacks associated with conventional open-heart surgery, percutaneous and minimally-invasive surgical approaches are garnering intense attention. In one technique, a prosthetic valve is configured to be implanted in a much less invasive procedure by way of catheterization. For instance, <CIT> and <CIT>, describe collapsible transcatheter heart valves that can be percutaneously introduced in a compressed state on a catheter and expanded in the desired position by balloon inflation or by utilization of a self-expanding frame or stent.

An important design parameter of a transcatheter heart valve is the diameter of the folded or crimped profile. The diameter of the crimped profile is important because it directly influences the physician's ability to advance the valve through the femoral artery or vein. More particularly, a smaller profile allows for treatment of a wider population of patients, with enhanced safety.

<CIT> discloses a two-stage or component-based valve prosthesis that can be implanted during a surgical procedure. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be connected to the support structure. The support structure has the form of a stent that is expanded at the site of a native valve. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state.

Moreover, International patent application <CIT> discloses a valve prosthesis device suitable for implantation in body ducts. The device comprises a support stent, comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet. The support stent is provided with a plurality of longitudinally rigid support beams of fixed length.

<CIT> discloses, inter alia, systems for minimally invasive replacement of a valve. The system includes a collapsible valve and anchoring structure. The valve assembly comprises a valve and anchoring structure for the valve, dimensioned to fit substantially within the valve sinus.

The present disclosure is directed toward new and non-obvious apparatuses relating to prosthetic valves, such as heart valves.

Independent device claim <NUM> defines the implantable prosthetic heart valve according to the present invention. Advantageous further embodiments of the invention defined in claim <NUM> are the subject of dependent claims <NUM> to <NUM>. A system comprising a balloon catheter and the implantable prosthetic valve according to claims <NUM> to <NUM> is defined in independent claim <NUM>.

In one representative embodiment, an implantable prosthetic valve as defined in claim <NUM>, comprises a radially collapsible and expandable frame, or stent, and a leaflet structure comprising a plurality of leaflets. The leaflet structure can have a scalloped lower edge portion that is positioned inside of and secured to the frame. The valve can further include an annular skirt member, which can be disposed between the frame and the leaflet structure such that the scalloped lower edge portion can be attached to an inner surface of the skirt member. Each leaflet can have an upper edge, a curved lower edge and two side flaps extending between respective ends of the upper edge and the lower edge, wherein each side flap is secured to an adjacent side flap of another leaflet to form commissures of the leaflet structure. Each commissure can be attached to one of the commissure attachment posts, and a reinforcing bar can be positioned against each side flap for reinforcing the attachments between the commissures and the commissure attachment posts.

The frame can comprise a plurality of angularly spaced, axial struts that are interconnected by a plurality of rows of circumferential struts. Each row of circumferential struts desirably includes struts arranged in a zig-zag or saw-tooth pattern extending around the circumference of the frame.

At least one row, and preferably all rows, of circumferential struts include pairs of circumferential struts extending between two axial struts. Each strut of the pair has one end connected to a respective axial strut and another end interconnected to an adjacent end of the other strut of the same pair by a crown portion such that a gap exists between the adjacent ends of the struts. The angle between the struts of each pair desirably is between about <NUM> and <NUM> degrees, with about <NUM> degrees being a specific example. The frame desirably is made of a nickel-cobalt based alloy, such as a nickel cobalt chromium molybdenum alloy (e.g., MP35N™).

The valve further includes an annular cover member disposed on and covering the cells of at least a portion of the frame. The cover member desirably comprises an elastomer, such as silicon, that can expand and stretch when the valve is expanded from a crimped state to an expanded state.

The cover member may be a thin sleeve of silicon that surrounds at least a portion of the frame. Alternatively, the cover member may be formed by dipping at least a portion of the frame in silicon or another suitable elastomer in liquefied form.

In addition, a method being not part of the present invention, is disclosed for crimping an implantable prosthetic valve having a frame and leaflets supported by the frame. The method comprises placing the valve in the crimping aperture of a crimping device such that a compressible material is disposed between the crimping jaws of the crimping device and the frame of the valve. Pressure is applied against the compressible material and the valve with the crimping jaws to radially crimp the valve to a smaller profile and compress the compressible material against the valve such that the compressible material extends into open cells of the frame and pushes the leaflets away from the inside of the frame.

The foregoing and other features and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

<FIG> illustrate an implantable prosthetic valve <NUM>, according to one embodiment. Valve <NUM> in the illustrated embodiment generally comprises a frame, or stent, <NUM>, a leaflet structure <NUM> supported by the frame, and a skirt <NUM> secured to the outer surface of the leaflet structure. Valve <NUM> typically is implanted in the annulus of the native aortic valve but also can be adapted to be implanted in other native valves of the heart or in various other ducts or orifices of the body. Valve <NUM> has a "lower" end <NUM> and an "upper" end <NUM>. In the context of the present application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow", respectively. Thus, for example, the lower end <NUM> of the valve is its inflow end and the upper end <NUM> of the valve is its outflow end.

Valve <NUM> and frame <NUM> are configured to be radially collapsible to a collapsed or crimped state for introduction into the body on a delivery catheter and radially expandable to an expanded state for implanting the valve at a desired location in the body (e.g., the native aortic valve). Frame <NUM> can be made of a plastically-expandable material that permits crimping of the valve to a smaller profile for delivery and expansion of the valve using an expansion device such as the balloon of a balloon catheter. Exemplary plastically-expandable materials that can be used to form the frame are described below. Alternatively, valve <NUM> can be a so-called self-expanding valve wherein the frame is made of a self-expanding material such as Nitinol. A self-expanding valve can be crimped to a smaller profile and held in the crimped state with a restraining device such as a sheath covering the valve. When the valve is positioned at or near the target site, the restraining device is removed to allow the valve to self-expand to its expanded, functional size.

Referring also to <FIG> (which shows the frame alone for purposes of illustration), frame <NUM> is an annular, stent-like structure having a plurality of angularly spaced, vertically extending, commissure attachment posts, or struts, <NUM>. Posts <NUM> can be interconnected via a lower row 36a of circumferentially extending struts <NUM> and first and second upper rows 36b, 36c, respectively, of circumferentially extending struts <NUM> and <NUM>, respectively. The struts in each row desirably are arranged in a zig-zag or generally saw-tooth like pattern extending in the direction of the circumference of the frame as shown. Adjacent struts in the same row can be interconnected to one another as shown in <FIG> and <FIG> to form an angle A, which desirably is between about <NUM> and <NUM> degrees, with about <NUM> degrees being a specific example. The selection of angle A between approximately <NUM> and <NUM> degrees optimizes the radial strength of frame <NUM> when expanded yet still permits the frame <NUM> to be evenly crimped and then expanded in the manner described below.

In the illustrated embodiment, pairs of adjacent circumferential struts in the same row are connected to each other by a respective, generally U-shaped crown structure, or crown portion, <NUM>. Crown structures <NUM> each include a horizontal portion extending between and connecting the adjacent ends of the struts such that a gap <NUM> is defined between the adjacent ends and the crown structure connects the adjacent ends at a location offset from the strut's natural point of intersection. Crown structures <NUM> significantly reduce residual strains on the frame <NUM> at the location of struts <NUM>, <NUM>, <NUM> during crimping and expanding of the frame <NUM> in the manner described below. Each pair of struts <NUM> connected at a common crown structure <NUM> forms a cell with an adjacent pair of struts <NUM> in the row above. Each cell can be connected to an adjacent cell at a node <NUM>. Each node <NUM> can be interconnected with the lower row of struts by a respective vertical (axial) strut <NUM> that is connected to and extends between a respective node <NUM> and a location on the lower row of struts <NUM> where two struts are connected at their ends opposite crown structures <NUM>.

In certain embodiments, lower struts <NUM> have a greater thickness or diameter than upper struts <NUM>, <NUM>. In one implementation, for example, lower struts <NUM> have a thickness T (<FIG>) of about <NUM> and upper struts <NUM>, <NUM> have a thickness T of about <NUM>. Because there is only one row of lower struts <NUM> and two rows of upper struts <NUM>, <NUM> in the illustrated configuration, enlargement of lower struts <NUM> with respect to upper struts <NUM>, <NUM> enhances the radial strength of the frame at the lower area of the frame and allows for more uniform expansion of the frame.

<FIG> shows a flattened view of a <NUM>-degree segment of frame <NUM> shown in <FIG>, the segment comprising a portion of the frame extending between two posts <NUM>, As shown, the frame segment has three columns <NUM> and three rows 36a, 36b, 36c of struts per segment. Each column <NUM> is defined by the adjoining pairs of struts <NUM>, <NUM>, <NUM> extending between two axially extending struts <NUM>, <NUM>. Frame <NUM> desirably is comprised of three <NUM>-degree segments, with each segment being bounded by two posts <NUM>. Accordingly, frame <NUM> in the illustrated embodiment includes <NUM> total columns per frame.

The number of columns and rows desirably is minimized to reduce the overall crimp profile of the valve, as further discussed below. The arrangement of <FIG> and <FIG> typically is used for valves that are less than about <NUM> in diameter, and are most suitable for valves that are about <NUM>-<NUM> in diameter. In working examples of valves comprising frame <NUM>, a <NUM>-mm valve can be crimped to a diameter of about <NUM> (<NUM> Fr), a <NUM>-mm valve can be crimped to a diameter of about <NUM> (<NUM> Fr) and a <NUM>-mm valve can be crimped to a diameter of about <NUM> (<NUM> Fr). For valves that are about <NUM> and larger in diameter, it may be desirable to add another row and column of struts.

For example, <FIG> and <FIG> show an alternative frame <NUM> that is similar to frame <NUM> except that frame <NUM> has four rows of struts (a lowermost, first row 52a of struts <NUM>, a second row 52b of struts <NUM>, a third row 52c of struts <NUM>, and an uppermost row 52d of struts <NUM>) instead of three rows of struts, as well as four columns <NUM> of struts for each <NUM>-degree frame segment instead of three columns of struts. <FIG> shows a flattened view of a <NUM>-degree segment of frame <NUM> shown in <FIG>. Frame <NUM> in the illustrated embodiment includes three such <NUM>-degree segments, providing <NUM> total columns <NUM> of struts for the frame.

Struts <NUM> of the third row desirably are facing in the opposite direction of the struts <NUM> of the fourth row (i.e., the apexes or crown portions are facing in the opposite direction), to help avoid buckling of the vertical posts of the frame during crimping and expansion of the valve. Struts <NUM> of the second row can be arranged so as to be facing in the same direction as the struts <NUM> of the first row as shown (i.e., the apexes or crown portions are facing in the same direction). Alternatively, struts <NUM> of the second row can be facing in the opposing direction from struts <NUM> of the first row so as to form square cells, like the cells formed by the struts <NUM>, <NUM> of the third and fourth rows, respectively. Frame <NUM> can also include axially extending struts <NUM> connected to and extending between the ends of each strut <NUM>, <NUM>, <NUM>, <NUM> aligned in a column <NUM> that are not connected to a post <NUM>. As noted above, frame <NUM> is most suitable for valves <NUM> and larger in diameter (when expanded to its functional size). In a working example of a valve incorporating frame <NUM>, a <NUM>-mm valve can be crimped to a diameter of about <NUM> (<NUM> Fr).

Suitable plastically-expandable materials that can be used to form the frame include, without limitation, stainless steel, a nickel based alloy (e.g., a nickel-cobalt-chromium alloy), polymers, or combinations thereof. In particular embodiments, frame <NUM> is made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-<NUM>). MP35N™/UNS R30035 comprises <NUM>% nickel, <NUM>% cobalt, <NUM>% chromium, and <NUM>% molybdenum, by weight. It has been found that the use of MP35N to form frame <NUM> provides superior structural results over stainless steel. In particular, when MP35N is used as the frame material, less material is needed to achieve the same or better performance in radial and crush force resistance, fatigue resistances, and corrosion resistance. Moreover, since less material is required, the crimped profile of the frame can be reduced, thereby providing a lower profile valve assembly for percutaneous delivery to the treatment location in the body.

Referring again to <FIG>, skirt <NUM> can be formed, for example, of polyethylene terephthalate (PET) ribbon. The thickness of the skirt can vary, but is desirably less than <NUM> (<NUM> mil), and desirably less than <NUM> (<NUM> mil), and even more desirably about <NUM> (<NUM> mil). Skirt <NUM> can be secured to the inside of frame <NUM> via Lenzing sutures <NUM>, as shown in <FIG>. Leaflet structure <NUM> can be attached to the skirt via a thin PET reinforcing strip <NUM> (or sleeve), discussed below, which enables a secure suturing and protects the pericardial tissue of the leaflet structure from tears. Leaflet structure <NUM> can be sandwiched between skirt <NUM> and the thin PET strip <NUM> as shown. Suture <NUM>, which secures the PET strip and the leaflet structure <NUM> to skirt <NUM> can be any suitable suture, such as an Ethibond suture. Suture <NUM> desirably tracks the curvature of the bottom edge of leaflet structure <NUM>, as described in more detail below. Leaflet structure <NUM> can be formed of bovine pericardial tissue, biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in <CIT>.

Leaflet structure <NUM> can comprise three leaflets <NUM>, which can be arranged to collapse in a tricuspid arrangement, as best shown in <FIG> and <FIG>. The lower edge of leaflet structure <NUM> desirably has an undulating, curved scalloped shape (suture line <NUM> shown in <FIG> tracks the scalloped shape of the leaflet structure). By forming the leaflets with this scalloped geometry, stresses on the leaflets are reduced, which in turn improves durability of the valve. Moreover, by virtue of the scalloped shape, folds and ripples at the belly of each leaflet (the central region of each leaflet), which can cause early calcification in those areas, can be eliminated or at least minimized. The scalloped geometry also reduces the amount of tissue material used to form leaflet structure, thereby allowing a smaller, more even crimped profile at the inflow end of the valve.

Leaflets <NUM> can be secured to one another at their adjacent sides to form commissures <NUM> of the leaflet structure (the edges where the leaflets come together). Leaflet structure <NUM> can be secured to frame <NUM> using suitable techniques and mechanisms. For example, as best shown in <FIG>, commissures <NUM> of the leaflet structure desirably are aligned with the support posts <NUM> and secured thereto using sutures. The point of attachment of the leaflets to the posts <NUM> can be reinforced with bars <NUM> (<FIG> ), which desirably are made of a relatively rigid material (compared to the leaflets), such as stainless steel.

<FIG> shows a single leaflet <NUM>, which has a curved lower edge <NUM> and two flaps <NUM> extending between the upper edge and curved lower edge of the leaflet. The curved lower edge <NUM> forms a single scallop. When secured to two other leaflets to form leaflet structure <NUM>, the curved lower edges of the leaflets collectively form the scalloped shaped lower edge portion of the leaflet structure (as best shown in <FIG>). As further shown in <FIG>, two reinforcing bars <NUM> can be secured to the leaflet adjacent to flaps <NUM> (e.g., using sutures). The flaps can then be folded over bars <NUM> and secured in the folded position using sutures. If desired, as shown in <FIG>, each bar <NUM> can be placed in a protective sleeve <NUM> (e.g., a PET sleeve) before being secured to a leaflet.

As shown in <FIG>, the lower curved edge <NUM> of the leaflet can be reinforced for later securement to the skirt <NUM>, such as by securing a reinforcing strip <NUM> along the curved lower edge between flaps <NUM> on the side of the leaflet opposite bars <NUM>. Three such leaflets <NUM> can be prepared in the same manner and then connected to each other at their flaps <NUM> in a tricuspid arrangement to form leaflet structure <NUM>, as shown in <FIG>. The reinforcing strips <NUM> on the leaflets collectively define a ribbon or sleeve that extends along the lower edge portion of the inside surface of the leaflet structure.

As noted above, leaflet structure <NUM> can be secured to frame <NUM> with skirt <NUM>. Skirt <NUM> desirably comprises a tough, tear resistant material such as PET, although various other synthetic or natural materials can be used. Skirt <NUM> can be much thinner than traditional skirts. In one embodiment, for example, skirt <NUM> is a PET skirt having a thickness of about <NUM> at its edges and about <NUM> at its center. The thinner skirt can provide for better crimping performances while still providing good perivalvular sealing.

<FIG> shows a flattened view of the skirt before the opposite ends are secured to each other to form the annular shape shown in <FIG>. As shown, the upper edge of skirt <NUM> desirably has an undulated shape that generally follows the shape of the second row of struts <NUM> of the frame. In this manner, the upper edge of skirt <NUM> can be tightly secured to struts <NUM> with sutures <NUM> (as best shown in <FIG>). Skirt <NUM> can also be formed with slits <NUM> to facilitate attachment of the skirt to the frame. Slits <NUM> are aligned with crown structures <NUM> of struts <NUM> when the skirt is secured to the frame. Slits <NUM> are dimensioned so as to allow an upper edge portion of skirt to be partially wrapped around struts <NUM> and reduce stresses in the skirt during the attachment procedure. For example, in the illustrated embodiment, skirt <NUM> is placed on the inside of frame <NUM> and an upper edge portion of the skirt is wrapped around the upper surfaces of struts <NUM> and secured in place with sutures <NUM>. Wrapping the upper edge portion of the skirt around struts <NUM> in this manner provides for a stronger and more durable attachment of the skirt to the frame. Although not shown, the lower edge of the skirt can be shaped to conform generally to the contour of the lowermost row of struts <NUM> to improve the flow of blood past the inflow end of the valve.

As further shown in <FIG>, various suture lines can be added to the skirt to facilitate attachment of the skirt to the leaflet structure and to the frame. For example, a scalloped shaped suture line <NUM> can be used as a guide to suture the lower edge of the leaflet structure at the proper location against the inner surface of the skirt using suture <NUM> (as best shown in <FIG>). Another scalloped shaped suture line <NUM> (<FIG>) can be used as a guide to suture the leaflet structure to the skirt using sutures <NUM> (<FIG>). Reinforcing strips <NUM> secured to the lower edge of the leaflets reinforces the leaflets along suture line <NUM> and protects against tearing of the leaflets. <FIG> shows a leaflet assembly comprised of skirt <NUM> and leaflet structure <NUM> secured to the skirt. The leaflet assembly can then be secured to frame <NUM> in the manner described below. In alternative embodiments, the skirt, without the leaflet structure, can be connected to the frame first, and then the leaflet structure can be connected to the skirt.

<FIG> shows a top view of the valve assembly attached to frame <NUM>. Leaflets <NUM> are shown in a generally closed position. As shown, the commissures of the leaflets are aligned with posts <NUM> of the frame. The leaflets can be secured to the frame using sutures extending through flaps <NUM> of the leaflets, openings <NUM> in bars <NUM>, and openings <NUM> in posts <NUM>, effectively securing flaps <NUM> to posts <NUM>. As noted above, bars <NUM> reinforce the flaps at the area of connection with posts and protect against tearing of the leaflets.

As shown in <FIG>, bars <NUM> desirably are aligned perpendicular and as straight as possible with respect to posts <NUM> of the frame, such that bars <NUM> and post <NUM> at each commissure form a "T" shape. The width of bars <NUM> and the attachment of the commissures via the bars provides a clearance between the deflectable portions of the leaflets <NUM> (the portions not secured by sutures to the frame) and the frame, while the edge radius (thickness) of bars <NUM> serves as a flex hinge for the leaflets <NUM> during valve opening and closing, thereby increasing the space between the leaflets and the frame. By increasing the space between the moving portions of the leaflets and frame and by having the leaflets flex against an edge radius of bars <NUM>, contact between the moving portions of the leaflets (especially the outflow edges of the leaflets) and the frame can be avoided during working cycles, which in turn improves the durability of the valve assembly. This configuration also enhances perfusion through the coronary sinuses.

<FIG> depicts a side view of a valve I <NUM> crimped on a balloon delivery catheter <NUM>. The valve is crimped onto balloon <NUM> of balloon catheter <NUM>. It is desirable to protect leaflet structure <NUM> of the valve from damage during crimping to ensure durability of the leaflet structure and at the same time, it is desirable to reduce as much as possible the crimped profile size of the valve. During the crimping procedure the tissue of the leaflet structure (e.g., bovine pericardial tissue or other suitable tissue) is pressed against against the inner surface of the metal frame and portions of the tissue can protrude into the open cells of the frame between the struts and can be pinched due to the scissor-like motion of the struts of the frame. If the valve is severely crimped to achieve a small crimping size, this scissor-like motion can result in cuts and rupture of the tissue leaflets.

Skirt <NUM>, described above, can protect against damage to the leaflet structure during crimping to a certain degree. However, the skirt's main purpose is structural and it does not in certain embodiments cover the entire frame. Therefore, in such embodiments, the skirt may not fully protect the leaflet structure during crimping and as such, the frame can still cause damage to the leaflet structure.

<FIG> show an embodiment of a crimping apparatus for atraumatic crimping of a valve onto a balloon in a manner that further protects against damage to the leaflets. The crimping apparatus (also referred to as a crimper), indicated generally at <NUM>, has an aperture <NUM> sized to receive a valve in an expanded state. <FIG> shows aperture <NUM> in a fully open or dilated state with a valve <NUM> positioned inside aperture <NUM>. Crimping apparatus <NUM> has a plurality of crimper jaws <NUM> (<NUM> in the illustrated embodiment) which are configured to move radially inwardly to radially compress (crimp) the valve to a smaller profile around the balloon of a balloon catheter.

A deformable material is positioned between the outside of the frame and the crimping jaws <NUM>. In the illustrated embodiment, the deformable material comprises a protective sleeve, or covering, <NUM> that is placed around the valve so that it covers the outer surface of the frame of the valve and prevents the hard surface of the crimping jaws from directly contacting the frame of the valve. The sleeve <NUM> desirably is sized to fully cover the outer surface of the frame. Sleeve <NUM> desirably is made of a soft, flexible and compressible material. The sleeve can be formed from generally available materials, including, but not limited to, natural or synthetic sponge (e.g., polyurethane sponge), a foamed material made of a suitable polymer such as polyurethane or polyethylene, or any of various suitable elastomeric materials, such as polyurethane, silicon, polyolefins or a variety of hydrogels, to name a few.

The sleeve is desirably stored in a wet environment (e.g., immersed in saline) prior to use. After placing sleeve <NUM> around the valve, the valve and the sleeve are placed into crimping apparatus <NUM> as shown in <FIG>. Balloon <NUM> of a balloon catheter can then be positioned within the leaflets <NUM> of the valve (<FIG> shows crimper jaws <NUM> surrounding sleeve <NUM>, which in turn surrounds frame <NUM> and leaflet structure <NUM> of valve <NUM>. Balloon <NUM> typically is placed at the center of the valve so that the valve can be evenly expanded during implantation of the valve within the body.

As seen in <FIG>, during crimping, the sponge-like material of protective sleeve <NUM> protrudes into the open cells of frame <NUM> and occupies this space, thereby preventing leaflet structure <NUM> from entering this space and being pinched or otherwise damaged. After crimping is completed, the valve with the protective sleeve is removed from the crimping apparatus. Sleeve <NUM> can then be gently peeled away from the frame. Because the protective sleeve presses the leaflet structure inwardly and away from the frame during crimping, the valve can be crimped to a small profile without damaging the leaflet structure.

<FIG> illustrate an advantage that can be gained by using protective sleeve <NUM>. <FIG> shows a prosthetic valve that was crimped without using the protective sleeve. Dotted line <NUM> identifies an area of the valve where leaflet structure <NUM> has been pressed between struts of a frame <NUM>, which can damage the leaflet structure as discussed above.

In contrast, <FIG> shows a prosthetic valve that was crimped using protective sleeve <NUM>. In this example, leaflet structure <NUM> was pressed inwardly and away from the inside of frame <NUM> and, therefore, the leaflet structure was not pinched or squeezed between the struts of the frame.

Accordingly, since the leaflet structure is pushed away from the frame when the protective sleeve is used, the leaflet structure is less likely to be pinched or cut during the crimping process. Also, when using a protective sleeve, a very ordered structure of balloon-leaflets-frame (from inward to outward) can be achieved. When no such protective sleeve is utilized, some portion of the balloon, leaflets, and frame are much more likely to overlap after the crimping procedure and the resulting structure is less predictable and uniform.

In addition to the foam or sponge-type protective sleeve described above, other types of sleeves or protective layers of deformable material can be used to protect the leaflets against damage during crimping of a valve. In one implementation, for example, a layer (e.g., rectangular slices) of deformable material (e.g., sponge, rubber, silicon, polyurethane, etc.) can be disposed on each crimping jaw <NUM> so as to form a sleeve around the valve upon crimping. Alternatively, deformable packets filled with a flowable, deformable material, such as a gel or gas, can be disposed on each crimping jaw for contacting the valve upon crimping. In addition, the deformable material (e.g., sleeve <NUM>) can be covered with a thin PET cloth, among many other fabric materials or other suitable materials, to prevent particles of the deformable materials from migrating to the valve during crimping.

The skirt of a prosthetic valve serves several functions. In particular embodiments, for example, the skirt functions to seal and prevent (or decrease) perivalvular leakage, to anchor the leaflet structure to the frame, and to protect the leaflets against damage caused by contact with the frame during crimping and during working cycles of the valve. The skirt used with the prosthetic valve discussed above has been described as being a fabric, such as a PET cloth. PET or other fabrics are substantially non-elastic (i.e., substantially non-stretchable and non-compressible). As such, the skirt in certain implementations limits the smallest achievable crimping diameter of the valve and can wrinkle after expansion from the crimped diameter.

In alternative embodiments, such as discussed below, a prosthetic valve can be provided with a skirt that is made of a stretchable and/or compressible material, such as silicon. Due to the compressibility of such a skirt, the valve can be crimped to a relatively smaller diameter as compared to a valve having a non-compressible skirt. Furthermore, such a skirt can recover its original, smooth surfaces with little or no wrinkling after expansion from the crimped state.

<FIG> shows an embodiment of a frame <NUM> that has an elastic "over-tube" skirt or sleeve <NUM> that extends completely around and covers at least a portion of the outside of the frame. In particular embodiments, skirt <NUM> is made of silicon, which can undergo large deformations while maintaining its elasticity. Such a silicon skirt can be a thin sleeve that covers a portion of frame <NUM> from the outside. In the illustrated embodiment, the height of the skirt is less than the overall height of frame <NUM>, however, the skirt can vary in height and need not be the height shown in <FIG>. For example, the height of the skirt can be the same as or greater than that of the frame so as to completely cover the outside of the frame. In an alternative embodiment, the skirt <NUM> can be mounted to the inside of the frame using, for example, sutures or an adhesive. When mounted inside of the frame, the skirt can protect the leaflets from abrasion against the inside of the frame. Other materials that can be used to form the skirt or sleeve include, but are not limited to, PTFE, ePTFE, polyurethane, polyolefins, hydrogels, biological materials (e.g., pericardium or biological polymers such as collagen, gelatin, or hyaluronic acid derivatives) or combinations thereof.

In another embodiment, the entire frame or a portion thereof can be dipped in liquefied material (e.g., liquid silicon or any of the materials described above for forming the sleeve <NUM> that can be liquefied for dip coating the frame) in order to encapsulate the entire frame (or at least that portion that is dipped) in silicon. <FIG> is a side view of a frame <NUM> that has been dipped in silicon to form a continuous cylindrical silicon covering <NUM> encapsulating the struts of the frame and filling the spaces between the struts. <FIG> shows the covering <NUM> before it is trimmed to remove excess material extending beyond the ends of the frame. Although less desirable, the frame can be dipped such that the silicon encapsulates the struts of the frame but does not fill the open spaces between the struts of the frame.

<FIG> shows an embodiment of a prosthetic valve <NUM> comprising a frame <NUM> and a leaflet structure <NUM> mounted to the inside of the frame (e.g., using sutures as shown). Frame <NUM> has a skirt in the form of silicon covering <NUM> that is formed, for example, by dipping the frame into liquid silicon. <FIG> shows valve <NUM> in its expanded state. In <FIG>, valve <NUM> has been crimped to a smaller profile. During crimping, coating <NUM>, which extends across and fills the open cells between the struts of the frame, is effective to push leaflet structure <NUM> inward and away from the frame, thereby protecting the leaflet structure from pinching or tearing. <FIG> shows valve <NUM> after being expanded by a balloon of a balloon catheter.

In order to test the durability and stretch resistance of the silicon used, several uniaxial tests were conducted. In particular, silicon strips of about 5x50 mm (with a thickness of about <NUM>) were tested in a uniaxial tester. <FIG> show graphs of the results of the uniaxial testing of silicon strips. In addition, tears were deliberately introduced into silicon strips at a middle of the strips and at the edge of the strips while the strips were stretched on a uniaxial tester. The tears were introduced by making holes in the silicon strips with a needle. <FIG> show graphs of the results of the uniaxial testing of silicon strips with deliberately introduced tears.

It was found that ultimate tensile stretch for a thin layer of silicon was over <NUM>% and that samples that had tears that were deliberately introduced continued to show notable strength. Accordingly, the elasticity of silicon permits silicon dipped frames to be crimped to very low profiles and expanded back out to larger profiles without significant damage to the silicon layer. In addition, the silicon material can increase friction between the frame and the native annulus where the prosthetic valve is implanted, resulting in better anchoring and preventing/reducing perivalvular leaks.

A silicon skirt can be mounted on a frame by various means, including by using a mandrel. Also, it may be desirable to use a silicon skirt in combination with a cloth or fabric skirt. For example, it may be desirable to place a silicon skirt on the outside of a cloth or fabric skirt that is surrounding at least a portion of a frame.

Alternatively or additionally, a silicon skirt could also be placed on the inside of the frame and attached to the frame so that it offers the leaflets improved protecting during working cycles. Alternatively, instead of silicon, the skirt can be made of an auxetic and/or swelling material, such as synthetic or natural hydrogels. An auxetic material is one that expands laterally while stretched longitudinally, which means that this material has a negative Poisson ration. If the frame is covered with an auxetic material it can expand radially while being stretched circumferentially when the valve is expanded from its crimped state. Such expansion can improve the fit of the valve at the native valve annulus, thereby preventing or reducing perivalvular leakage.

Claim 1:
An implantable prosthetic heart valve (<NUM>) configured to be radially collapsible to a collapsed or crimped state for introduction into the body on a balloon delivery catheter (<NUM>) and radially expandable using a balloon (<NUM>) of the balloon delivery catheter (<NUM>) to an expanded state for implanting the prosthetic heart valve (<NUM>) at a native aortic valve, the prosthetic heart valve (<NUM>) comprising:
a radially collapsible and expandable annular frame (<NUM>), the frame (<NUM>) having a plurality of angularly spaced axial struts (<NUM>, <NUM>) that are interconnected via a lower row (36a) of circumferentially extending struts (<NUM>) and first and second upper rows (36b, 36c) of circumferentially extending struts (<NUM>, <NUM>), wherein the second upper row (36c) is the uppermost row;
wherein at least one row of circumferential struts (<NUM>, <NUM>, <NUM>) include pairs of circumferential struts (<NUM>) extending between two axial struts (<NUM>, <NUM>), wherein each strut (<NUM>) of the pair has one end connected to a respective axial strut (<NUM>, <NUM>) and another end interconnected to an adjacent end of the other strut (<NUM>) of the same pair by a crown portion (<NUM>) such that a gap (<NUM>) exists between the adjacent ends of the struts (<NUM>);
a leaflet structure (<NUM>) supported by the frame (<NUM>); and
an annular inner skirt (<NUM>) positioned inside of and secured to the frame (<NUM>), wherein an upper edge portion of the skirt (<NUM>) is wrapped around upper surfaces of the first upper row (36b) of circumferentially extending struts (<NUM>) and secured in place with sutures (<NUM>).