Patent Description:
In the fields of heart valve surgery and interventional cardiology, easy handling of medical devices and the reduction of time required to perform surgical interventions and procedures are topics of interest for medical and technological research.

With reference to the implantation of expandable heart valve prostheses, such as for example sutureless valve prostheses, current practice provides that a heart valve prosthesis should be stored in a sterile environment in order to maintain its integrity and in order to prevent air from being trapped in the structure of the prosthesis.

Also, such prostheses may need to be crimped i.e. radially collapsed and coupled to a delivery instrument to be delivered to an implantation site, for example in a minimally invasive or percutaneous procedure.

Crimping an implantable medical device can present many important issues. While many crimping devices with different features have been devised to facilitate the crimping operation, such a step may remain rather delicate and complex to perform.

One of the challenges for the practitioner when crimping a heart valve prosthesis onto a delivery instrument, lies in achieving a desired position, in particular a desired angular position, of the implantable device on the crimping device. In various prior art devices, the delivery instruments are provided with angular indicia (for example markers which are intended to identify the commissures of an aortic or tricuspid valve) intended to aid the practitioner in correctly positioning the prosthesis at the implantation site.

Another challenge for the practitioner when implanting a heart valve prosthesis is the handling of the prosthesis from the storage facility (typically a so-called "jar" filled with a sterile solution for preservation) to the crimping instrument. Various current solutions require either multiple handling devices or even manual manipulation of the valve, which are both undesirable under the prospect of an easy and flawless valve positioning procedure.

<CIT> discloses a kit for manipulating implantable medical device such as heart valve prosthesis, has holder element that is configured to support implantable medical device, and is extended axially towards tubular structure of medical device.

The present invention relates to a holder for a heart valve prosthesis as defined in claim <NUM>. Embodiments of the invention are recited in the dependent claims.

A first example of a holder for a heart valve prosthesis comprising a radially contractible armature and a prosthetic valve carried by said armature. The holder including an annular member having a longitudinal axis and comprising a plurality of supporting formations, said supporting formations protruding radially inwardly of said annular member, and a locking member configured for coupling with said annular member. Where, each supporting formation includes a coupling profile configured for engaging the armature of a heart valve prosthesis, the coupling profile being configured to prevent the displacement of the armature along said longitudinal axis and being configured to prevent rotation of the armature around the longitudinal axis, while leaving the armature unconstrained in a radially inward direction. The locking member is configured to removably mate with the annular member to provide a radial constraint to the armature in a radially inward direction at the supporting formations.

A second example according to the first example, wherein the annular member defines a lumen, the supporting formations protruding inwardly of said lumen.

A third example according to the first example, wherein the annular member includes an angular reference member configured for a sliding coupling with a fixed rectilinear guide, the angular reference member having a predetermined position relative to the supporting formations.

A fourth example according to the third example, wherein the angular reference member is provided on the periphery of said annular member and is configured as a slider member of a prismatic guide.

A fifth example according to the first example, wherein each coupling profile is a coupling interface for an arched strut comprising a cylindrical wall, and an arched track provided on the cylindrical wall and configured for receiving an arched strut, each coupling interface facing radially inwardly of said annular member. Where, at least one of said supporting formations includes a guide member for guiding said locking member upon mating to the annular member.

A sixth example according to the fifth example, wherein said guide member is configured for guiding said locking member in a direction parallel to said longitudinal axis.

A seventh example according to the fifth example, wherein said arched track includes a tooth protruding from the cylindrical wall and radially inwardly of the annular member, and a pair of arched protrusions arranged on opposite sides of said tooth.

An eighth example according to the seventh example, wherein said arched protrusions are spaced from one another in correspondence of said tooth.

A ninth example according to any of the previous examples, wherein said locking member is a hub member configured for mating to the annular member coaxially to the longitudinal axis thereof and including a cylindrical portion configured to settle among the supporting formations when the locking member is mated to the annular member.

A tenth example according to the ninth example, wherein the locking member further includes a guide portion, particularly provided on a rim, configured for slidably coupling with the guide members of the supporting formations.

An eleventh example according to the tenth example, wherein the guide portion is further configured to abut on an axial end portion of the supporting formations.

A twelfth example according to any of the previous examples, further including a heart valve prosthesis having a radially contractible armature and a prosthetic heart valve carried by said armature. The armature including an annular part, and a pattern of arched struts carried by said annular part. Said pattern of arched struts having proximal ends connected to said annular part, and distal ends spaced axially from the proximal ends and opposite said annular part (<NUM>). Where, distal portions of the arched struts engage corresponding coupling profiles of the supporting formations.

A thirteenth example according to the twelfth example, wherein the distal portions of the arched struts are received in the arched tracks of the coupling profiles.

A fourteenth example of a holder for a heart valve prosthesis comprising a radially contractible armature and a prosthetic valve carried by said armature, the holder (<NUM>) including:.

A fifteenth example according to the fourteenth example, wherein each coupling feature provides a coupling interface for an arched strut comprising:.

A sixteenth example according to the fourteenth example, wherein at least one of said supporting formations includes a guide member for guiding said locking member upon mating to the annular member.

A seventeenth example according to the fourteenth example, wherein said locking member is a hub member configured for mating to the annular member coaxially to the longitudinal axis thereof and including a cylindrical portion configured to settle among the supporting formations when the locking member is mated to the annular member.

An eighteenth example according to the fourteenth example, wherein the annular member includes an angular reference member configured for a sliding coupling with a fixed rectilinear guide, the angular reference member having a predetermined position relative to the supporting formations.

A nineteenth example of a prosthetic heart valve storage kit including:.

A twentieth example of a crimping kit comprising:.

A twenty-first example of a method of crimping a heart valve prosthesis comprising a radially contractible armature and a prosthetic valve carried by said armature, the method comprising:.

While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosure.

Various embodiments will now be described with reference to the attached figures, provided purely by way of non-limiting example, and wherein:.

While the disclosure is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the disclosure to the particular embodiments described. On the contrary, the disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure as defined by the appended claims.

With reference to <FIG>, reference number <NUM> designates a holder for a heart valve prosthesis according to various embodiments herein. The holder <NUM> may be used for supporting an implantable medical device such as a heart valve prosthesis including a radially contractible armature and a prosthetic valve carried by the armature. An exemplary heart valve prosthesis is disclosed, e.g., in PCT application no. <CIT> filed on even date herewith and in the name of the same Applicant.

In embodiments, the holder <NUM> includes an annular member <NUM> having a longitudinal axis X1 (which also corresponds to the holder axis) and comprising a plurality of supporting formations <NUM>, the supporting formations <NUM> protruding radially inwardly of the annular member <NUM>, and a locking member <NUM> configured for coupling with the annular member <NUM>.

Each supporting formation <NUM> includes a coupling feature configured for engaging the armature of a heart valve prosthesis supported by the holder <NUM>, wherein the coupling feature is configured to limit the displacement of the armature along the longitudinal axis X1 while leaving the armature unconstrained in a radially inward direction. The locking member <NUM> is configured to removably mate with the annular member <NUM> to provide a radial constraint to the armature in a radially inward direction at the supporting formations <NUM>.

In embodiments, the locking member <NUM> removably couples to the annular member <NUM>, wherein coupling occurs through an axial sliding of the locking member <NUM> along the axis X1 and into the supporting formations <NUM>, so that the locking member <NUM> is located among the supporting formations <NUM> and at least partially overlaps the same when mated to the annular member <NUM>.

With reference to <FIG>, in embodiments the annular member <NUM> includes a peripheral rim <NUM> wherefrom the supporting formations <NUM> protrude radially inwardly in a spoke-like fashion. The peripheral rim <NUM> defines a lumen <NUM> for the prosthesis, wherein the supporting formations <NUM> protrude into the lumen <NUM>.

The number and location of the supporting formations <NUM> may generally depend on the specific features of the heart valve prosthesis to be coupled to the holder <NUM>. In embodiments shown in the figures, the supporting formations are in the number of three with even angular offset (<NUM> degrees), bearing witness to the holder <NUM> being configured for coupling to the armature of an aortic heart valve prosthesis.

Embodiments of such a prosthesis are visible in <FIG> associated to reference number <NUM>. The heart valve prosthesis <NUM> includes an armature <NUM> for anchorage of the valve prosthesis at an implantation site. The armature <NUM> defines a lumen for the passage of the blood flow and has a longitudinal axis X1.

The prosthesis <NUM> also includes a set of prosthetic valve leaflets <NUM> supported by the armature <NUM> and configured to move, under the action of blood flow, which has a main flow direction roughly corresponding to that of the axis X1, in a radially divaricated condition to enable the flow of blood through the lumen in a first direction, and in a radially contracted condition, in which the valve leaflets <NUM> co-operate with one another and block the flow of blood through the prosthesis <NUM> in the direction opposite the first direction. This is commonly referred to as leaflet coaptation.

The prosthetic leaflets <NUM> may be in any number compatible with operation as a replacement heart valve. In some embodiments, the set includes a pair of leaflets. In some embodiments, such as that shown in the figures, the set includes three prosthetic valve leaflets <NUM> (e.g. for an aortic valve prosthesis). In other embodiments, the set may include four leaflets <NUM>.

The armature <NUM> includes an annular part <NUM>, and a pattern of arched struts <NUM> carried by the annular part <NUM>. The annular part <NUM> has a structure which can expand from a radially contracted condition, associated to delivery of the prosthesis to implantation site, to a radially expanded condition wherein the prosthesis is withheld at the implantation site. In embodiments, the annular part may have a mesh structure including an annular pattern of multiple strut clusters (cells) having polygonal shape (hexagonal, rhomboidal, etc.).

In embodiments, the annular part is covered by a cuff such as the sealing cuff SC to provide sealing at the implantation site, the cuff being arranged outside of the lumen of the armature <NUM>. Advantageously, the cuff may be sewn or stitched to the annular part <NUM>.

As said, depending on the technique used to manufacture the valvular sleeve, wherein the cuff SC may be integral with the set of prosthetic valve leaflets <NUM>.

The pattern of arched struts <NUM> includes proximal ends <NUM> connected to the annular part <NUM>, and distal ends <NUM> spaced axially from the proximal ends <NUM> and arranged at an end of the armature <NUM> opposite the annular part <NUM>. In embodiments, the distal ends <NUM> coincide with distal ends of the armature <NUM>, and in embodiments where the distal end of the armature <NUM> coincides with a distal end of the prosthesis <NUM> as a whole, the distal ends <NUM> coincide with a distal end of the prosthesis as well.

The armature <NUM> further includes a plurality of sets <NUM> of anchoring formations <NUM> configured to protrude radially outwardly of the annular part <NUM>, each set <NUM> being supported by at least one of the annular part <NUM> and a corresponding arched strut <NUM>, and a plurality of support posts <NUM>, each supported by adjacent arched struts <NUM>. Wherein the sets <NUM> of anchoring formations <NUM> alternate with the support posts <NUM> around the longitudinal axis X1. In embodiments the support posts <NUM> are cantilevered to adjacent arched struts <NUM> and are configured as fixing locations for the prosthetic valve, specifically for the pleat formations PF at the commissural points of the valve.

Each arched strut <NUM> extends from a first proximal end <NUM>, to a distal end <NUM>, then to a second proximal end <NUM> in a valley-peak-valley sequence, wherein valleys are located at the proximal ends <NUM>, and peaks are located at the distal ends <NUM>. In embodiments the pattern of arched struts includes three adjacent and preferably identical arched struts <NUM> (such as in the figures).

The pattern of arched struts <NUM> includes distal portions <NUM> located at the distal ends <NUM>, and inter-strut portions <NUM> located at the proximal ends <NUM>. The distal portions <NUM> may be shaped so as to provide a marked local variation in the shape of the strut, for example by exhibiting a C-shape as shown in the figure. The distal portions <NUM> may provide coupling locations for other devices such as a valve holder or a hub of a carrier portion of a delivery catheter. In other embodiments, the distal portions <NUM> may be provided as closed-loop structures such as eyes or eyelets.

In embodiments, the inter-strut portions <NUM> are essentially V-shaped and are defined by the roots of the adjacent arched struts departing from the same proximal end <NUM>. In embodiments, the inter strut portions <NUM> may exhibit a Y-shape such as, for instance, that shown in the figure wherein each inter-strut portion <NUM> extends through the mesh of the annular part <NUM>. Alternatively, a U-shape may be envisaged for the inter-strut portions <NUM>. In embodiments, the mesh of the annular part <NUM> is provided as a sequence of rhomboidal strut clusters (cells) sequentially connected to each other at endpoints of a diagonal line (typically the shortest diagonal) and exhibiting accordingly an identical circular pattern of free ends on opposite sides of a circumference extending through the sequence of the connection points. The Y-shaped inter-strut portion <NUM> is thus integrally formed at a selected connection point between two adjacent rhomboidal strut clusters, and may extend no further than the proximal end of the armature <NUM>.

The support posts <NUM> are angularly arranged at an inter-strut location, i.e. a circumferential location arranged at an area where an inter-strut portion <NUM> (as well as a proximal end <NUM> shared by two adjacent arched struts <NUM>) is provided. The support posts may be provided as cantilevered to both the adjacent arched struts <NUM> intervening at an inter-strut portion <NUM> via a first and a second cantilever struts <NUM>, <NUM>, each connected to a corresponding one of said adjacent arched struts <NUM> as shown in the figures. The cantilever struts <NUM>, <NUM> merge into each corresponding post <NUM> starting from locations on respective arched strut <NUM> approximately halfway through the portion of the arched strut <NUM> extending from a proximal end <NUM> to a distal end <NUM>. The connection points at which the Y-shaped or U-shaped inter-strut portion <NUM> is formed may be chosen so that the same portions are evenly spaced (angular-wise) around the axis X1. The same applies to the support posts <NUM>, which may be arranged so as to be evenly spaced (angular-wise) around the axis X1.

In embodiments shown in the figure, the armature <NUM> comprises three arched struts <NUM>, three posts <NUM> spaced <NUM>° around the axis X1, and three sets <NUM>, so that the sequence around the axis X1 is post <NUM> - set <NUM> - post <NUM> - set <NUM> - post <NUM> - set <NUM> (in this sense, even the struts <NUM> and the sets <NUM> do follow a <NUM> degree-like distribution). In embodiments the three sets <NUM> include each a pair of anchoring formations <NUM>, wherein each set <NUM> (and accordingly each anchoring formation <NUM>) extends bridge-wise between the annular part <NUM> and the corresponding arched strut <NUM>.

With reference again to <FIG>, in embodiments, each supporting formation includes a radial tab member <NUM> and a circumferential tab member <NUM> which is arranged at a radially inward end of the tab member <NUM>. In such embodiments, the circumferential tab member <NUM> may be generally orthogonal to the tab member <NUM>. In embodiments, the circumferential tab member <NUM> carries the coupling feature of the supporting formation <NUM>, wherein the coupling feature is generally indicated as <NUM> in the figures. In embodiments, the coupling feature <NUM> may be a coupling profile. Owing to the location on the tabs <NUM>, each coupling profile or feature faces radially inwardly of the annular member <NUM>. In embodiments, the coupling profile <NUM> is a recessed profile and is configured for receiving a portion - such as a strut - of the armature of the prosthesis to at least partially secure the prosthesis to the holder.

In embodiments, each coupling profile <NUM> is a coupling interface comprising a cylindrical wall <NUM>, which may be a radially innermost wall of the tab <NUM>, an arched track <NUM> (<FIG>) provided on the cylindrical wall <NUM> and configured for receiving an arched strut <NUM> of the prosthesis <NUM>, particularly a distal portion <NUM> thereof. In embodiments, the arched track <NUM> may receive any arched strut of a valve armature, and not necessarily those in the prosthesis <NUM>. In embodiemnts, the arched track <NUM> is a recessed track.

The arched track (<FIG>) may include a tooth <NUM> protruding from the cylindrical wall <NUM> radially inwardly of the annular member <NUM> (i.e. protruding into the lumen <NUM>), and a pair of arched protrusions <NUM>, <NUM> arranged on opposite sides of the tooth <NUM> and likewise protruding radially inwardly of the annular member <NUM>.

In embodiments, the arched protrusions <NUM>, <NUM> are spaced from one another in correspondence of the tooth <NUM> so as to provide a gap <NUM> therebetween. The gap <NUM> may serve as an additional coupling location to the arched track <NUM>, especially when the arched strut of the prosthesis armature exhibits a hairpin-like shape that is able to penetrate (in a snap-fit fashion) through the interspace <NUM>.

It should be noted, however, that depending on specific coupling requirements the coupling profiles may be provided as reliefs instead of recesses. In these embodiments, the reliefs couple with matching features of the armature of the heart valve prosthesis radially outwardly of the same. The mesh of radially contractible/expandable annular portion of the armature maybe an example of such matching features.

With combined reference to <FIG>, <FIG> and <FIG>, in embodiments the prosthesis <NUM> (this applies to any prosthesis having a contractible armature featuring arched struts including arched or looped portions of the armature mesh) is coupled to the holder <NUM> so that the arched struts <NUM> - and particularly the distal portions <NUM> thereof - are received in the arched track <NUM> astride of the tooth <NUM>. As a result, the axial displacement of the armature <NUM> is limited or substantially prevented, any rotational movement around the axis X1 is likewise prevented (thus providing a predetermined angular orientation of the prosthesis <NUM> relative to the holder <NUM>), while radial displacement inwardly of the annular member <NUM> (i.e. inwardly of the lumen <NUM>) remains fully allowed, as no radial constraint is provided by the supporting formations <NUM> relative to contraction of the armature <NUM>. The locking member <NUM> is then inserted axially into the lumen <NUM> so as to settle among the supporting formations <NUM> with the armature of the prosthesis <NUM> located between the supporting formations <NUM> and the locking member <NUM>.

In embodiments at least one - and preferably all - of the supporting formations includes a guide member for guiding the locking member <NUM> upon coupling to the annular member <NUM>. These guide members may be provided, in embodiments such as that depicted in the figures, by the very radial tabs <NUM> which can act as rectilinear guides for the locking member <NUM>, which may be provided with a correspondingly mating profile to the tabs <NUM>. In other embodiments the guide member may be a member separate from the supporting formations, especially in those embodiments wherein the guide members are grouped in a pattern located on the rim <NUM> of the annular member <NUM> in a position angularly offset from the pattern of supporting formations <NUM>.

Whatever the embodiments, the guide members on the annular element are configured for guiding the locking member <NUM> in a direction parallel to the longitudinal axis X1.

In embodiments (<FIG>) the locking member <NUM> is provided as a hub member configured for mating to the annular member <NUM> coaxially to the longitudinal axis X1 thereof and including a cylindrical portion <NUM> configured to settle among the supporting formations <NUM> to provide a radial constraint to the armature of the prosthesis <NUM>, particularly a radial constraint inwardly of the annular member <NUM>. In embodiments, the locking member <NUM> provides a radial locking action against contraction of the prosthesis: being the latter axially and rotationally locked by the supporting formations <NUM>, and likewise radially locked by the same formations relative to the expansion of the armature <NUM>, the sole degree of freedom not taken away by the annular member <NUM> consists of the radial contraction of the armature <NUM>. In this sense, the positioning of the locking member <NUM> with the hub portion <NUM> among the supporting formations <NUM> takes away this last degree of freedom as the armature gets sandwiched between the supporting formations and the hub portion of the locking member <NUM>.

In embodiments the locking member <NUM> may further include a guide portion, particularly provided on a rim <NUM>, which configured for slidably coupling with the guide members of the supporting formations <NUM>, particularly with the tabs <NUM> the rim <NUM> may include in one embodiments a plurality of notches configured for mating with the radial tabs <NUM> to provide a sliding coupling therewith.

Additionally, in embodiments the rim <NUM> is configured to abut on an axial end portion of the supporting formations <NUM>, particularly onto the tabs <NUM>, to limit the penetration of the locking member <NUM> among the formations <NUM> and correctly position the locking member relative to the same.

In embodiments, the annular member <NUM> includes an angular reference member <NUM> configured for a sliding coupling with a fixed rectilinear guide. The angular reference member <NUM> has a predetermined angular position relative to the supporting formations <NUM>, which in turn have an arrangement specific to the structure of the prosthesis they carry (hence a predetermined angular position relative to the prosthesis itself, as per the foregoing description). In this way the angular reference member <NUM> is univocally representative of the angular orientation of the prosthesis around the axis X1.

In embodiments, the angular reference member <NUM> is provided on the periphery of the annular member <NUM>, particularly as apportion of the rim <NUM>, and is configured as a slider member of a prismatic guide. In such embodiments, the angular reference member <NUM> includes two side radial tabs <NUM>, <NUM> and a cylindrical wall <NUM> located between the tabs <NUM>, <NUM>. In other embodiments, the angular reference members - while maintaining the slider features - may be provided as a triangular or otherwise polygonal notch on the rim <NUM>.

With reference to <FIG>, in embodiments the holder <NUM> may be part of a storage kit S for a heart valve prosthesis <NUM> comprising a radially contractible armature (such as the armature <NUM>) and a prosthetic valve carried by said armature.

In embodiments the storage kit S comprises the holder <NUM> and the prosthesis <NUM> coupled to the holder <NUM>, i.e. coupled to the supporting formations <NUM> so to be axially and rotationally locked by the annular member <NUM>, and furthermore radially locked both by the annular member <NUM> and the locking member <NUM>.

In embodiments the storage kit S further comprises a container J (so called "jar") filled with a preservation solution and closed by a cap C with the interposition of a seal SL.

The holder <NUM> with the prosthesis <NUM> attached thereto is arranged in the container J with the heart valve prosthesis <NUM> immersed in the preservation solution. In embodiments the interior of the container J is provided with axial ribs R configured to engage notches on the periphery of the rim <NUM> to guide the holder into the container J and held it against rotation, as well as to set the axial position of the holder within the container J.

With reference to <FIG>, reference number <NUM> designates a crimping kit according to various embodiments. In embodiments the crimping kit <NUM> includes a crimping instrument <NUM> with a crimping orifice <NUM> having a longitudinal axis X200, the crimping instrument being preferably mounted on a base member B, a rectilinear guide <NUM> oriented parallel to the longitudinal axis X200, the holder <NUM> with the heart valve prosthesis <NUM> coupled thereto.

Optionally, the crimping kit <NUM> may come provided with the holder <NUM> (with the attached prosthesis <NUM>) in the storage kit S, so to provide a stand-alone package that can be deployed in the operational theater when necessary.

The kit <NUM> may also include a support post <NUM> for the shaft of a delivery instrument which, during crimping and loading operations of the prosthesis <NUM>, is positioned coaxially to the axis X200 for loading of the prosthesis. The post <NUM> may be provided as a sliding element capable of a linear motion X204+/- in a direction parallel to the axis X200, to accommodate for different delivery instrument lengths.

The crimping kit <NUM> allows for a rapid, fail-safe crimping procedure of the prosthesis <NUM> based on the features of the holder <NUM>.

Once the kit <NUM> and the holder <NUM> with the prosthesis <NUM> attached thereto have been provided, the holder <NUM> may be grabbed by the practitioner (or by assistant medical personnel in the operational theater) and coupled to the rectilinear guide <NUM>. Specifically, the angular reference member <NUM> on the annular element <NUM> is mated with the rectilinear guide <NUM> so as to assemble a prismatic guide, wherein the angular reference member <NUM> (and the holder <NUM> as a whole, accordingly) acts as a slider, while the guide <NUM> acts as a guide member for the slider. The holder <NUM> is mated to the guide <NUM> so as to present the prosthesis <NUM> to the crimping orifice <NUM> of the crimping instrument <NUM>, while the holder <NUM> is located in a "trailing" position relative to the prosthesis.

The holder <NUM> with the prosthesis <NUM> attached thereto may be then advanced towards the crimping orifice <NUM> along the guide <NUM> (displacement X203 in <FIG>) so to insert the heart valve prosthesis <NUM> into the crimping orifice <NUM>, and set the armature <NUM> in a position that allows the same to be later contracted by crimping members of the instrument <NUM> (<FIG>), subject to removal of locking member <NUM>. The locking member <NUM> is still coupled to the annular member <NUM> to ensure that during the whole insertion of the heart valve prosthesis <NUM> into the crimping orifice <NUM>, the prosthesis does not experience undesired displacements that result in a misplacement thereof.

With the holder <NUM>, the prosthesis <NUM> maintains the positioning imparted thereto at the time of coupling of the same to the holder <NUM>. As already described, the supporting formations <NUM> with the coupling features or profiles <NUM> preventing the prosthesis <NUM> from axial translation, from rotation around the axis X1, as well as from radial outward expansion. In this way, the angular reference member <NUM> is univocally representative of the actual orientation of the prosthesis <NUM> around the axis X1. Once the holder <NUM> is mated to the guide <NUM>, the axes X1 and X200 line up and the angular position of the prosthesis <NUM> becomes fully defined relative to the crimping instrument <NUM> (and the crimping orifice <NUM>) as well. The angular reference member <NUM> thus eliminates any risk of angular misplacement of the prosthesis <NUM>, moreover in a way that only requires a very easy operation such as mating a slider to a guide. Additionally, the provision of the locking member <NUM> avoids any displacement of the valve prosthesis <NUM> during manipulation.

Once the prosthesis <NUM> is fully into the crimping orifice <NUM>, the prosthesis shall be cleared relative to the radial contraction. This is made, in various embodiments, by removal of the locking member <NUM> from the annular member <NUM> of the holder <NUM> (<FIG>, <FIG>), for example by axial sliding thereof away from the annular member (e.g. in a direction opposite that of X203). Other defeat mechanisms may of course be envisaged for the locking member <NUM>, for example the same may be provided as a variable diameter member, wherein the variation in diameter may be controlled via a push button on the locking member itself, in a way at least roughly similar to releasable joints with radially slidable studs or pins.

Removal of the locking member <NUM> thus removes the constraint that prevents the prosthesis <NUM> from being radially collapsed/contracted. Additionally, removal of the locking member <NUM> also clears the lumen <NUM> for insertion of the carrier portion of the delivery instrument, which at this point may be set on the post <NUM> and into the crimping orifice <NUM>.

In embodiments, the removal of the locking member <NUM> may advantageously be provided just prior to installation of the delivery instrument and subsequent crimping of the prosthesis to ensure maximum positional stability and loading of the prosthesis <NUM> onto the instrument, essentially to avoid any accidental misplacement of the prosthesis <NUM> relative to the crimping instrument <NUM> prior to the crimping and loading of the same onto the delivery instrument.

This is an additional safety feature of the holder <NUM>, which essentially allows the crimping orifice to be cleared for delivery instrument insertion and crimping only when the prosthesis is firmly and correctly set in place.

The prosthesis <NUM> is then crimped (e.g. by rotation of the handle of the crimping instrument <NUM> in the direction θ<NUM> in <FIG>) and loaded into the carrier portion of the delivery instrument. During crimping operation, the annular member <NUM> remains into the crimping orifice, as the same does not provide any hindrance to the crimping action, which is a radial contraction action. Instead, crimping of the heart valve prosthesis <NUM> results in a disengagement of the armature <NUM> from the supporting formations <NUM> due to a migration of the portion of the armature <NUM> received in the coupling feature or profile <NUM> radially inwardly and off the coupling profile itself (e.g. off the arched track <NUM>).

The annular member <NUM> may then optionally be removed from the crimping instrument <NUM>, e.g. by sliding it away from the crimping orifice <NUM> along the guide <NUM> in a direction opposite to X203, and over the delivery instrument shaft. Once the latter is lifted too away from the crimping orifice <NUM>, the annular element <NUM> may then be removed from the delivery instrument shaft.

Generally, however, the annular member <NUM> is left in place on the guide <NUM> and taken away after takeoff of the delivery instrument.

While in embodiments the most advantages in terms of fail safety and ease of crimping may be provided by combining the structure of the holder <NUM> (annular member + locking member) with the angular reference member <NUM>, in certain embodiments the angular reference member <NUM> and the guide <NUM> may be dispensed with, instead relying on more conventional angular positioning techniques, for example a mating notch/pin pair on the annular member <NUM> and the crimping instrument <NUM>. While still retaining all of the benefits in terms of positional stability of the prosthesis into the crimping orifice, these embodiments only perform slightly less efficiently in terms of angular positioning of the holder relative to the crimping instrument, requiring i.e. a minor manual alignment operation (e.g. a rotation until the mating notch/pin pair clicks into engagement) instead of coming already angularly positioned and ready to insert as with the holder <NUM> in the embodiments pictured by the figures.

Claim 1:
A holder (<NUM>) for a heart valve prosthesis (<NUM>) comprising a radially contractible armature (<NUM>) and a prosthetic valve carried by said armature (<NUM>), the holder (<NUM>) including:
an annular member (<NUM>) having a longitudinal axis (x1) and comprising a plurality of supporting formations (<NUM>); and
a locking member (<NUM>) configured for coupling with said annular member (<NUM>),
wherein:
each supporting formation (<NUM>) includes a coupling feature (<NUM>) configured for engaging the armature (<NUM>) of a heart valve prosthesis (<NUM>), so as to prevent the displacement of the armature (<NUM>) along said longitudinal axis and rotation of the armature (<NUM>) around the longitudinal axis (X1), and
the locking member (<NUM>) is configured to removably mate with the annular member (<NUM>) to provide a radial constraint to the armature in a radially inward direction at the supporting formations (<NUM>).