Loading system for an implantable prosthesis and related loading method

Disclosed herein is a loading system (1) for implantable prostheses, specifically heart valve prostheses. The loading system (1) may be pre-mounted in a storage container (J) filled with a preservation solution with the prosthesis attached thereto, and may provide one or more deployment elements of a delivery instrument as receivers (4, 33) for the loading of the prosthesis (2).

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a national stage application of PCT/IB2018/053648 filed May 23, 2018, which is herein incorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure refers to implantable prostheses loading systems and methods, and in particular, to implantable prostheses loading systems for heart valve prostheses including a radially contractible armature and a heart valve prosthesis carried by the armature.

BACKGROUND

In the fields of heart valve surgery and interventional cardiology, easy handling of implantable prostheses such as vascular prostheses and heart valve prostheses, and the reduction of the time required to perform a surgical intervention and procedure are main topics of the medical and technological research in the field.

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

Loading an implantable heart valve prosthesis onto a delivery instrument may present a number of 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 major challenges for the practitioner when loading a heart valve prosthesis onto a delivery instrument, is the handling of the prosthesis from the storage facility (typically a so-called “jar” filled with a sterile solution for preservation) to the delivery instrument. Various current solutions require either multiple handling devices or even manual manipulation of the valve, which are both indeed undesirable under the prospect of an easy and flawless valve loading onto the delivery instrument.

SUMMARY

In embodiments, the challenges described above may be achieved by providing a system which renders loading of implantable heart valve prostheses onto a delivery instrument easier, safer, faster and more accurate in comparison to known systems.

In a first example, a loading system for a heart valve prosthesis including a radially contractible armature and a prosthetic heart valve coupled to said armature, said armature having at least one radially contractible annular portion, the loading system comprising:

a gripper that is axially operable along a longitudinal axis of the loading system from a first axial position to a second axial position, wherein in the first axial position the gripper engages the heart valve prosthesis with the armature in a radially expanded condition;

a first receiver for the heart valve prosthesis, the first receiver configured for holding at least a first portion of the heart valve prosthesis in a radially contracted condition upon engagement of the first receiver by the heart valve prosthesis, and wherein the gripper is axially displaceable relative to the first receiver; and

a first funnel shaped element surrounding the first receiver, the first funnel shaped element having a first diameter and a second diameter, the second diameter being smaller than the first diameter and being arranged axially closer to the first receiver than the first diameter, and wherein the gripper is axially displaceable relative to the first funnel shaped element,

wherein in a transition from the first axial position to the second axial position the gripper is configured to displace the heart valve prosthesis axially through the first funnel shaped element from the first diameter to the second diameter, so as to provide a radial contraction of the armature of the heart valve prosthesis and a fitting of said at least a first portion into said first receiver in a radially contracted condition upon reaching the second axial position.

A second example according to the first example, including a tubular member which is axially fixed relative to said gripper, the tubular member including a holder to which the first receiver is mated.

A third example according to the second example, wherein the gripper includes a stud encased by said tubular member and a gripping portion at one end of the stud, the tubular member further including a drive member engaging the stud to provide an axial displacement thereof upon operation of the drive member, the gripping portion engaging coupling elements of the at least a first portion of the heart valve prosthesis in the first axial position.

A fourth example according to the third example, wherein the stud is threaded, and wherein the drive member is a threaded rotary drive member engaging the thread of the stud.

A fifth example according to the second example or the third example, wherein said stud is a hollow stud and includes an axial slot, wherein the holder extends axially along and coaxially to the longitudinal axis and within the tubular member, wherein the hollow stud is slidably fitted around the holder, and wherein the axial slot accommodates a bridge member connecting the holder to the tubular member.

A sixth example according to any of the previous claims, wherein the gripper includes a gripping portion comprising a plurality of resilient finger members, the resilient finger members engaging the heart valve prosthesis radially outwardly of the same, and being radially displaceable from a radially divaricated condition to a radially collapsed condition upon an axial displacement of the gripper relative to the first funnel shaped element from the first axial position to the second axial position, thereby providing the radial contraction of the armature of the heart valve prosthesis.

A seventh example according to the sixth example, wherein each resilient finger is associated to a guide blade, each guide blade including a longitudinal through slot configured to accommodate the resilient finger during a displacement of the same from the radially divaricated to the radially collapsed condition, thereby keeping the same aligned along a longitudinal direction.

An eighth example according to any of the previous claims, wherein the first funnel shaped element is detachably coupled to the first receiver.

A ninth example according to any of the previous claims, comprising a delivery instrument for the heart valve prosthesis, the delivery instrument including a shaft, a hub coupled to said shaft, and a second receiver which is axially slidable relative to the hub from a third axial position to a fourth axial position,

the hub of the delivery instrument is configured for coupling with the first receiver;

the second receiver includes a second funnel shaped element coupled thereto, the second funnel shaped element having a third diameter and a fourth diameter, the fourth diameter being smaller than the third diameter and being axially closer to the second receiver than the third diameter, the third diameter being presented with the heart valve prosthesis coupled to the gripper; and

in an axial displacement of the second receiver from the third axial position to the fourth axial position the second funnel shaped element moves relative to the heart valve prosthesis so that a second portion of the armature negotiates a lumen narrowing from the third diameter to the fourth diameter, and fits into the second receiver in a radially contracted condition.

A tenth example according to the ninth example, wherein the second funnel shaped element is detachably coupled to the second receiver.

An eleventh example according to the second example or the tenth example, wherein the first receiver is detachably coupled to the holder.

A twelfth example according to the first example, wherein the receiver, the gripper, and the heart valve prosthesis attached thereto are stored in a jar filled with a preservation solution, the first funnel shaped element being pre-mounted on the first receiver.

A thirteenth example according to the first or the twelfth example, wherein the loading system further includes a heart valve prosthesis including a radially contractible armature and a prosthetic heart valve carried by said armature, said armature having at least one radially contractible annular portion, wherein in the first axial position the gripper engages the heart valve prosthesis with the armature in a radially expanded condition.

A fourteenth example of a method of loading a prosthetic heart valve onto a delivery instrument using the loading system according to any of the previous examples, the method including:

displacing the gripper from the first axial position to the second axial position to fit the at least one portion of the heart valve prosthesis into the first receiver in a radially collapsed condition;

decoupling the first funnel shaped element from the loading system;

coupling the first receiver to the hub of the delivery instrument;

displacing the second receiver from the third axial position to the fourth axial position to fit the second portion of the heart valve prosthesis into the second receiver in a radially collapsed condition;

decoupling the second funnel shaped element from the delivery instrument;

decoupling the first receiver from the holder, while maintaining the first receiver attached to the hub of the delivery instrument.

A fifteenth example according to the fourteenth example, wherein decoupling the first receiver from the holder comprises axially displacing the gripper, with the at least a portion of the prosthesis loaded into the first receiver, back towards the first axial position to release the gripper from the prosthesis.

A sixteenth example according to the fifteenth example, wherein in the second axial position the resilient fingers are located axially outside of the first receiver and held in a radially contracted condition by the tubular member, wherein axially displacing the gripper back towards the first axial position releases the resilient fingers from the radial contraction action of the tubular member, thereby releasing the resilient fingers from coupling elements of the at least a first portion of the heart valve prosthesis with a radially outward motion thereof relative to the coupling elements.

A seventeenth example of a method of loading a prosthetic heart valve onto a delivery instrument using the loading system according to any of examples first to thirteenth, the method including:

displacing the gripper from the first axial position to the second axial position to fit the heart valve prosthesis into the first receiver in a radially collapsed condition;

decoupling the first funnel shaped element from the loading system,

detaching the first receiver and coupling the same to a delivery instrument.

An eighteenth example according to the seventeenth example, wherein the first receiver includes an annular portion extended in length as a delivery sheath, and axially slidable relative to a hub, the annular portion extended in length being configured to cover the axial extension of the prosthesis.

A nineteenth example according to the eighteenth example, wherein the annular portion is intended to mate with actuation member of the delivery instrument for axial displacement thereof, and the hub is intended to mate with a static portion of a shaft of the delivery instrument.

DETAILED DESCRIPTION

Reference number1inFIG.1designates a loading system for a heart valve prosthesis, according to embodiments of this disclosure.

a heart valve prosthesis2including a radially contractible armature and a prosthetic heart valve coupled to the armature, wherein the armature has at least one radially contractible annular portion;

a gripper3that is axially operable along a longitudinal axis X1of the loading system1from a first axial position to a second axial position, wherein in the first axial position the gripper3engages the heart valve prosthesis2with the armature in a radially expanded condition;

a first receiver4for the heart valve prosthesis2, the first receiver4being configured for holding a first portion, preferably the radially contractible annular portion, of the heart valve prosthesis2in a radially contracted condition upon engagement of the first receiver by the heart valve prosthesis, and wherein the gripper3is axially displaceable relative to the first receiver4; and

a first funnel shaped element5surrounding the first receiver4, the first funnel shaped element5having a first diameter D1and a second diameter D2, the second diameter being smaller than the first diameter and being arranged axially closer to the first receiver4than the first diameter D1, and wherein the gripper3is axially displaceable relative to the first funnel shaped element5.

With reference toFIGS.2B and3A, in some embodiments, the loading system1includes a tubular member6which may define at least partly an outer shell for the gripper (or part thereof), as well as an attachment for a drive member of the gripper. The tubular member6is axially fixed relative to the gripper, and the gripper axially moves relative thereto.

The tubular member6can include a holder7that extends longitudinally along the axis X1and coaxially thereto. The holder7is configured as a coupling seat for the first receiver4. In some embodiments, such as shown in the figures, the holder7is a tubular member surrounded by the tubular member6that is suspended within the tubular member6by bridging formations8radially extending from a hub9coaxial to the axis X1. In some embodiments, a single bridging formation extending across the inner walls of the tubular member is provided, without the hub9.

In embodiments, the gripper3includes a stud10(FIGS.3A and3C) encased by the tubular member6and a gripping portion14at one end of the stud10. In the first axial position shown inFIG.3A, the gripping portion14is arranged essentially at an axial location corresponding to the first funnel shaped element5.

In embodiments, a drive member12engages the stud10to provide an axial displacement thereof upon operation of the drive member. In some embodiments, the drive member12is a rotary knob that engages the tubular member6at one end thereof opposite the end at which the gripping portion is arranged. Engagement may occur, as shown inFIG.3A, by way of engagement of resilient formations13—cantilevered to the main body of the rotary knob12—into an annular groove G provided on the outer surface of the tubular member6.

In embodiments, the rotary knob12includes an inner thread15that engages an outer thread16on the outer surface of the stud, so that a rotary operation of the rotary knob results in an axial motion of the stud, and the gripper as a whole, along the axis X1.

Alternatively, in some embodiments, another sort of cam mechanism may be provided between the drive member12and the gripper3, for example a cam-pin engagement with the cam track provided on either of the drive member12and the stud10, and the pin(s)/cam follower(s) provided on the other of the two.

With reference toFIGS.3A and3C, in embodiments such as that depicted in the figures, the stud10is a hollow stud and includes an axial slot17that separates two semi-cylindrical axial portions18that may carry the thread16on the outer surface thereof (or the cam track/cam follower where appropriate). The axial slot17ends at an annular portion19wherein the two axial extensions18merge.

This design of the stud10allows the compenetration between the same and the holder7when the gripper3is inserted axially into the tubular member6. Specifically, the hollow stud10is slidably fitted around the holder7, thereby accommodating the same therein and between the axial extensions18, while the axial slot17accommodates the bridging formations (or in general a bridge member) connecting the holder7to the tubular member6.

With reference toFIG.3D, in embodiments such as per the figure the gripping portion14includes a plurality of resilient finger members20in a number that may depend on specific features of the heart valve prosthesis2that is coupled to the gripping portion. In some embodiments, which are suitable for engagement of an aortic valve prosthesis such as that visible in the subsequentFIG.4A, the resilient fingers20are in the number of three, spaced 120 degrees apart. Each of the fingers20is radially displaceable from a radially divaricated condition (visible inFIG.3Aand inFIG.3D) to a radially collapsed condition upon an axial displacement of the gripper3relative to the first funnel shaped element5from the first axial position to the second axial position. The resilient fingers20engage the heart valve prosthesis2radially outwardly of the same, and to this end they may be provided with inwardly pointing gripping ends21. In some embodiments, as visible in figures, the fingers20are provided as separate wire like members that engage corresponding axial seats19G on the annular portion19of the stud10. In other embodiments, the fingers20come in one piece, for example as wire like extension from a common ring that is snap fit or otherwise engaged into a seat on the stud10. Either way, in embodiments, the fingers20are mounted so to be cantilevered relative to the stud10, so to exploit the inherent resiliency thereof to make for a return motion to the radially divaricated condition. In other embodiments, the resiliency of the fingers may be provided by a bias mechanism such as leaf springs or a rolled leaf springs cooperating with the fingers (which may be hinged instead of cantilevered).

In embodiments, each resilient finger20is associated to a guide blade22, each guide blade being provided as an extension stemming from a ring member23which is fastened to the stud10, particularly to the annular portion19.

The guide blades22are positioned with the ring member23radially inwardly of the resilient finger set, and each include a longitudinal through slot24configured to accommodate the respective resilient finger20during a displacement of the same from the radially divaricated to the radially collapsed condition, thereby keeping the same aligned along a longitudinal direction. In embodiments, each resilient finger20runs axially parallel to the slot24and outside thereof, then bends radially outwardly to divert from axial orientation, further bends radially inwardly to regain axial orientation, then bends again—in one embodiment approximately 90 degrees—radially inwardly to weave through the tip of the respective blade22, particularly through an opening22W at the tip of the blade22, to protrude radially inwardly of the gripping portion14and of the blades22.

This arrangement is generally achieved when the gripping portion14is assembled into the loading system1, with a certain degree of radial constraint applied to the fingers20.

In embodiments, the resilient fingers20are shaped so to exhibit, when radially unconstrained, a generally flared pattern wherein no engagement is provided between the tips21and the openings22W. This is intended to facilitate attachment of the valve when pre-assembling the loading system upon manufacturing thereof, as well as—as will be detailed further on—to allow smooth release of the loaded valve when needed.

It may also be noted that in embodiments wherein the axial length prior to the first bend away from the axis is such as to allow the finger20to enter the slot24from the outside thereof (see, purely for exemplary purposes,FIG.3A), only to exit the slot24when bending radially outwardly as described above.

Due to the fingers20generally having—in embodiments—a marked elongation compared to the cross section thereof, a risk exists that the same get eventually twisted or otherwise distorted when subject to a radial collapsing action, which is undesired. Therefore, the slots24are configured to accommodate the fingers20by a variable extent during radial contraction, so that the resilient fingers will contact two separate axial locations within the slot24to counter distortion or other twisting phenomena.

In embodiments, a locking ring25may be provided surrounding the ring member23, to secure connect the resilient fingers20to the blades22. The locking ring25is then fitted, e.g. force fitted, onto the annular portion19, wherein force fitting also involves sandwiching the resilient fingers and the ring member (in this order from outside in) between the locking ring25and the annular portion19.

With reference toFIG.3E, the first receiver4includes ring26connected by spoke like formations27to an axially protruding hub28, wherein the hub28is configured to mate with the holder7at an end thereof opposite to that where the hub9is located. Additionally, the receiver4may be provided with an axial extension29of the hub28, which extends to an opposite direction relative to the protrusion of the hub28, and that is configured for mating with an additional component of the loading system1that, in some embodiments, is used to provide a cooperative loading of the heart valve prosthesis2.

The spoke like formations27are provided in the same number as that of the fingers20, as the spoke like formations27allow a compenetration between the gripping portion14and the receiver4as visible inFIG.3A. Specifically, in embodiments, each finger20-blade22pair traverses the receiver4between two adjacent spoke like formations27. Owing to this arrangement, the gripping portion14is enabled to axially displace relative to the receiver4along the axis X1.

Referring again toFIGS.2A and3Athe first funnel shaped element5is removably coupled to the loading system1, and specifically it is removably coupled to the receiver4, in turn mated to the holder7. In embodiments, removable coupling is provided by the funnel shaped element5comprising two halves5A,5C hinged to one another and locked into a funnel shape by a snap fit closure5C.

With reference toFIGS.4A and4B, the prosthesis2and the armature thereof are respectively depicted therein. The heart valve prosthesis2includes an armature102for anchorage of the valve prosthesis at an implantation site. The armature102defines a lumen for the passage of the blood flow and has a longitudinal axis X2.

The prosthesis2also includes a set of prosthetic valve leaflets104supported by the armature102and 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 leaflets104co-operate with one another and block the flow of blood through the prosthesis1in the direction opposite the first direction. This is commonly referred to as leaflet coaptation.

The prosthetic leaflets104may be in any number compatible with operation as 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 leaflets104(e.g. for an aortic valve prosthesis). In some embodiments, the set may include four leaflets104.

The armature102includes an annular part106, and a pattern of arched struts108carried by the annular part106. The annular part106has 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 armature102. The cuff may be sewn or stitched to the annular part106. The annular part106with the sewing cuff attached thereto provides an inflow portion of the heart valve prosthesis2.

As described, depending on the technique used to manufacture the valvular sleeve, wherein the cuff SC may be integral with the set of prosthetic valve leaflets104.

The annular part106, and particularly the sealing cuff SC are provided with coupling elements2C intended to be engaged by the resilient fingers20(they may be engaged by the radially protruding tips21, where provided) the way exemplified inFIG.3A. In some embodiments, the coupling elements2C may be provided as loop elements attached to the sealing cuff, and preferably provided by a thread or yarn that is weaved through the sealing cuff SC. In some embodiments, the coupling elements2C may be provided integrally with the armature102circumferentially aligned with the support posts118, albeit axially past the annular part106at the inflow portion (i.e. the coupling elements2C protrude axially away from the annular part106) as visible inFIG.4B.

The pattern of arched struts108includes proximal ends110connected to the annular part106, and distal ends112spaced axially from the proximal ends110and arranged at an end of the armature102opposite the annular part106. In embodiments, the distal ends112coincide with distal ends of the armature102, and in some embodiments where the distal end of the armature102coincides with a distal end of the prosthesis100as a whole, the distal ends112coincide with a distal end of the prosthesis as well.

a plurality of sets114of anchoring formations116configured to protrude radially outwardly of the annular part106, each set114being supported by at least one of the annular part106and a corresponding arched strut108; and

a plurality of support posts118, each supported by adjacent arched struts108, wherein the sets114of anchoring formations116alternate with the support posts118around the longitudinal axis X1. In various embodiments the support posts118are cantilevered to adjacent arched struts108and are configured as fixing locations for the prosthetic valve, specifically for the pleat formations PF at the commissural points of the valve.

Each arched strut108extends from a first proximal end110, to a distal end112, then to a second proximal end110in a valley-peak-valley sequence, wherein valleys are located at the proximal ends110, and peaks are located at the distal ends112. In embodiments the pattern of arched struts includes three adjacent and preferably identical arched struts108(such as in the figures).

The pattern of arched struts108includes distal portions120located at the distal ends112, and inter-strut portions122located at the proximal ends110.

The distal portions120may be shaped 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 portions120provide 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 portions120are provided as closed-loop structures such as eyes or eyelets. The pattern of arched struts108, and particularly the distal ends with the distal portion120thereof provide an outflow portion of the prosthesis2.

In embodiments, the inter-strut portions122are essentially V-shaped and are defined by the roots of the adjacent arched struts departing from the same proximal end110. In some embodiments, the inter strut portions122may exhibit a Y-shape such as, for instance, that shown in the figure wherein each inter-strut portion122extends through the mesh of the annular part106. Alternatively, they may exhibit a U-shape. In embodiments, the mesh of the annular part106is 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 portion122is thus integrally formed at a selected connection point between two adjacent rhomboidal strut clusters, and, in some embodiments, extends no further than the proximal end of the armature102.

The support posts118are angularly arranged at an inter-strut location, i.e. a circumferential location arranged at an area where an inter-strut portion122(as well as—accordingly—a proximal end110shared by two adjacent arched struts108) is provided. The support posts are provided as cantilevered to both the adjacent arched struts8intervening at an inter-strut portion122via a first and a second cantilever struts124,126, each connected to a corresponding one of said adjacent arched struts8as shown in the figures. The cantilever struts124,126merge into each corresponding post118starting from locations on respective arched strut108approximately halfway through the portion of the arched strut108extending from a proximal end110to a distal end112. The connection points at which the Y-shaped inter-strut portion122is formed may be chosen so that the same portions are evenly spaced (angular-wise) around the axis X1. The same applies to the support posts118, which may be arranged to be evenly spaced (angular-wise) around the axis X1.

In embodiments, the armature102comprises three arched struts108, three posts118spaced 120° around the axis X1, and three sets114, so that the sequence around the axis X1is post118—set114—post118—set114—post118—set114(in this sense, even the struts108and the sets114do follow a 120 degree-like distribution). In embodiments, the three sets114include each a pair of anchoring formations116, wherein each set114(and accordingly each anchoring formation116) extends bridge-wise between the annular part106and the corresponding arched strut108.

Further details of the prosthesis2are disclosed in PCT application no. PCT/IB2018/053640 filed on even date herewith and in the name of the same Applicant, the disclosure of which is hereby incorporated by reference herein.

With reference toFIG.5A, reference number30designates a delivery instrument that in embodiments forms part of the loading system1of this disclosure.

The delivery instrument30is configured to be used with the prosthesis2or in general it is an instrument configured to be used with any prosthesis intended to be loaded by way of the loading system1.

In embodiments as shown herein, the delivery instrument including a shaft31, a hub32carried by the shaft31, and a second receiver33which is axially slidable relative to the hub32from a third axial position III to a fourth axial position IV. In embodiments, the second receiver33is a sheath member slidable over the hub32, and exhibiting a variable degree of overlap relative thereto.

To this end, the delivery instrument30, in embodiments, includes a rotary drive member34that is configured to impart a linear axial motion to the receiver33along the axis X1. In other embodiments, the rotary drive member34may be replaced by a linear drive member.

A handle35may be conveniently provided at one end of the shaft31to allow for easier manipulation of the instrument30. In some embodiments, the rotary drive member34(or linear drive member where applicable) is provided on the handle35.

Pursuant to aspects of this disclosure, the hub32of the delivery instrument30is configured for coupling with the first receiver4: to this end, a coupling member36(e.g. a threaded member or else a mating pin) may be provided at a free end of the hub32to dock with the receiver4, particularly with the axial extension29of the hub28, and secure thereto.

In embodiments, such as those shown herein, the second receiver33includes a second funnel shaped element37coupled thereto, the second funnel shaped element37having a third diameter D3and a fourth diameter D4, the fourth diameter D4being smaller than the third diameter D3and being axially closer to the second receiver33than the third diameter D3(FIG.5B). The funnel shaped element37is detachably coupled to the receiver33, in a way similar to the funnel shaped element4. For example, the funnel shaped element37may be provided as including two halves that can be separated or opened upon undoing a locking feature or mechanism thereof, or else the funnel shaped element37may be provided as a one-piece element that interference fits with the receiver33, while allowing for a detachment from the same.

With reference toFIGS.6A to10, as well as cross support fromFIGS.1to5B, operation of the loading system1in embodiments disclosed herein will now be detailed.

With reference toFIG.6A, in embodiments, the loading system1comes as a pre-mounted kit including the funnel shaped element5, and wherein the gripper3is in the first axial position I along the axis X1and engages the heart valve prosthesis2essentially in a radially unconstrained condition due to the engagement of the coupling elements2C. The coupling element2C are traversed by the resilient fingers20, and especially by the tips21thereof, and are accordingly each secured between a finger20and the respective blade22the finger20runs through.

The heart valve prosthesis, in some embodiments, is preferentially mounted to be slightly pre-loaded axial wise (seeFIGS.1and6A), for example by having the inflow portion with the annular part106and the sealing cuff SC abutting on the funnel shaped element5, that is likewise pre-mounted on the loading system1. The condition referred to corresponds to that visible inFIG.3Awith the heart valve prosthesis2in phantom line. In embodiments, the portion of the prosthesis2disclosed inFIGS.4A and4Bthat is coupled to the gripper3is an inflow portion associated to annular part106of the armature102(at the sealing cuff SC), which includes the coupling elements2C.

In some embodiments, the loading system1with the prosthesis2pre-mounted therein may be provided stored in a jar J (FIG.1) filled with a sterile preservation solution and closed by a cap.

A centering flange or disc DS may additionally be fitted onto the tubular member6to provide radial centering and axial support within the jar J.

Once the loading system is extracted from the jar J—FIG.6A—or anyway grabbed by the practitioner, loading of the heart valve prosthesis2may begin. In embodiments, this is done by operating the drive member12, for example—in case of a rotary drive member as shown in the figures—by rotating the same around the axis X1to provide an axial displacement of the gripper3from the first axial position I to the second axial position II.FIG.6Billustrate a detail of the gripping portion holding the valve prosthesis2just out form the jar J, with the resilient fingers20engaging the coupling elements2C.

Purely by reference, the description that follows will be rendered assuming clockwise rotation as the driving action that brings the gripper3from the first to the second axial position, and accordingly counterclockwise rotation as the action that brings the gripper3from the second axial position to the first axial position. Clearly, this is purely a disclosure assumption: the loading systems can operate whatever association is made, i.e. it operates just the same with clockwise and counterclockwise directions swapped.

Rotation of the drive member12in the clockwise direction translates the stud10and the gripping portion14axially towards the second position II, while the receiver4remains steady and mated to the holder7. This creates a relative axial motion between the heart valve prosthesis and the funnel shaped element5, and specifically the heart valve prosthesis2is dragged axially along the axis X1from the first axial position I to the second axial position II, thereby negotiating the disparate diameters from D1to D2. Negotiating the disparate diameters from D1to D2accordingly results in a radial contraction of the armature102of the heart valve prosthesis2.

Operation of the drive member12proceeds until the radially collapsed portion of the armature of the heart valve prosthesis2, which in the sequence depicted in the figures is the inflow portion associated to the sealing cuff SC whereat the coupling elements2C are provided, slides into the receiver4, thereby getting loaded into the annular portion26of the same.

In this regard, the compenetration between the fingers20and the spoke like formations27also allows for a relative motion between the groups of fingers20and related blades22and the receiver4, also accommodating the radial collapse of the fingers20. In fact, during transition from the first axial position I to the second axial position II the fingers20are radially collapsed as well due to the interaction with the funnel shaped element5. The provision of guide blades22—that move integrally with the gripper3—prevents undesired twists or rotations of the fingers20, as described.

As visible inFIG.3A, in embodiments, the diameter D2may be conveniently provided as identical or anyway closely matching the inner diameter of the receiver4, particularly the inner diameter of the annular portion26. This facilitates the transition of the (inflow) portion of the heart valve prosthesis2from the funnel shaped element5to the receiver4, thereby allowing for a smoother loading of the same into the receiver4.

The resulting condition, reached at the second axial position II, is shown inFIG.7. Specifically, following loading of the inflow portion of the heart valve prosthesis2into the receiver, the funnel shaped element5is detached from the loading system, for example by opening the two halves5A,5B.

In the above regard, it is significant to note that when the gripper reaches the second axial position II, the resilient fingers20are located axially outside of the receiver4. This is clearly visible inFIG.7in that it is the annular part106(with the sealing cuff on the outside thereof) that is sitting into the receiver4, surrounded and held collapsed by the annular member26.

In other words, following displacement of the fingers20through the inter-spoke areas of the receiver4(i.e. the areas between adjacent spoke like formations27), the fingers20end up with sitting past the annular portion26(towards position II) with the coupling elements2C still engaged thereby. The prosthesis2cannot migrate any further owing to the shape of the receiver4, i.e. the very spoke like formations27that allow the fingers20to move past the receiver provide an axial stop to the prosthesis2. In embodiments, the final position may feature the fingers20engaged with slightly tensioned coupling formations2C that protrude axially away from the annular portion26while the inflow portion of the prosthesis2is firmly held into (and by) the receiver4. In this condition, the fingers20are actually held in a radially collapsed condition by the inner walls of the tubular member6as the same fingers end up with being actually accommodated therein when the stud10is axially retracted to bring the gripper3in the second axial position II.

Next—FIG.8—the delivery instrument30with the funnel shaped element37pre-mounted thereon is mated to the receiver4, which in embodiments may occur by engagement of the coupling extension36with the axial extension29of the receiver4, for example by a threaded connection or a snap fit connection.

Mating is effected such that the third diameter D3of the funnel shaped element37is presented with the heart valve prosthesis2, still held by the gripper3.

At this stage, the armature of the heart valve prosthesis2not constrained by the receiver, which in embodiments corresponds to the outflow portion at which the distal ends of the arched struts108are located, is still free from radial contraction.

When the funnel shaped member37is presented with the valve prosthesis2, the distal ends of the arched struts108might be even slightly flared outwards due to the contraction of the inflow portion by the first receiver4, while the outflow portion is substantially unconstrained in itself.

In embodiments as shown herein, loading of the outflow portion of the prosthesis102occurs at the delivery instrument30, and specifically the outflow portion of the prosthesis102is intended to be loaded into the second receiver33.

To accomplish this, in embodiments, an axial displacement of the second receiver33from the third axial position III to the fourth axial position IV is provided—either by way of the drive member34or by a direct axial displacement of the receiver33—so that the second funnel shaped element37moves axially relative to the heart valve prosthesis102.

In embodiments, the delivery instrument may envisage an override mechanism that allows for an axial displacement of the receiver33independently of the drive member34to provide for a fast advance of the receiver33towards the third axial position. An example of such an override mechanism can be found, e.g. in European Patent no. EP 2 250 975 B1 in the name of the same Applicant, which is hereby incorporated by reference herein. The advanced position of the receiver33achieved thanks to the override mechanism above may be maintained in embodiments by way of a spacer clip CL that fits between the (advanced) receiver33and the handle35.

Accordingly, the outflow portion of the prosthesis102negotiates the disparate diameters from D3to D4, that is, it negotiates a lumen narrowing from the third diameter D3to the fourth diameter D4. Radial contraction of the distal ends of the arched struts108—and the outflow portion too in the process—is therefore provided, so that the outflow portion comes to fit into the second receiver33in a radially contracted condition (FIG.9)

Similar to the funnel shaped element5, the funnel shaped element37may then be detached from the delivery instrument30(FIG.9already shows the loading system1with the funnel shaped member37detached) for example by opening the two halves thereof. This may be considered a preferred solution in that owing to the delivery instrument being mated to the receiver4, axially removing the funnel shaped element37at this stage may turn out to hinder the subsequent stages of the loading method.

With reference again toFIG.9, it may be noted therefore that once the two funnel shaped members are removed, the first one when the gripper is in the second axial position II, the second one when the second receiver is in the fourth axial position IV, the result is that of the first receiver4and the second receiver33providing deployment elements of the delivery instrument. More in detail, in embodiments, the first receiver4may provide an inflow deployment element intended to hold the inflow portion of the prosthesis2(here, essentially the annular portion106of the armature with the sealing cuff SC) in a radially contracted condition and release the same on site when later operated, while the second receiver33may provide an outflow deployment element intended to hold the outflow portion of the prosthesis2(here, essentially the distal end of the prosthesis at the distal end portions120of the arched struts108) and release the same on site when later operated.

In order for the delivery instrument to be later used as indicated above, the receiver4is to be detached from the holder7while remaining mated to the hub32. To do this, in embodiments, the gripper3is to be first released from the heart valve prosthesis2.

This is achieved, in embodiments, by operating the drive member12counterclockwise, or more in general in a direction opposite to that which results in displacement of the gripper to the second axial position II. This operation of the drive member12advances the gripping portion14with the resilient fingers20axially towards position I, and ultimately away from the tubular member6. While the fingers20gradually exit the tubular member6, the radial contracting action exerted thereon by the tubular member is released as well (this, also by virtue of the flared pattern of the resilient fingers20), thus allowing the same to get back to the radially divaricated condition they exhibit at the beginning of the loading operation, and even past that to a more divaricated arrangement which corresponds to the unconstrained condition mentioned in the foregoing. That is, the resilient fingers are allowed to expand back to an unconstrained condition wherein they also release engagement with the blades22at least at the openings22W thereof, so that the prosthesis2is allowed to smoothly become free of the gripping portion14.

The same release is not extended to the inflow portion of the heart valve prosthesis2, as the same is kept radially contracted by the annular portion26of the receiver4.

As the gripper3constrains the prosthesis2radially outwardly thereof via the fingers20, the latter in turn do not have any stop or otherwise constraint feature that holds them in engagement with the coupling elements2C when the fingers20are subject to a radially outward motion relative to the prosthesis2.

Accordingly, while the prosthesis2remains within the receiver4, the fingers20are biased back to/towards the divaricated condition which allows them to simply slip away from engagement with the coupling elements2C in a radially outward direction (see rotation θ20inFIG.9), thereby releasing the inflow portion of the prosthesis2from the gripper3.

Next, the receiver4may be safely decoupled from the holder7, while remaining stably attached to the hub32(FIG.10). Accordingly, at the end of the loading method carried out by the loading system1, in embodiments the result is that of a delivery instrument30featuring two deployment elements, one provided by the receiver33, the other provided by the receiver4that was formerly part of another device, wherein both deployment elements can be controlled by the instrument30. The inflow portion of the prosthesis2is held radially collapsed by the receiver4, while the outflow portion is held radially collapsed by the receiver33. The portion of the armature in between the inflow and outflow portion is instead left free of radial contraction by the deployment elements, in a way similar to the subject of European Patent no. EP 2 238 947 B1 in the name of the same Applicant, which is hereby incorporated by reference herein.

By way of summary, in embodiments, a method is defined of loading a prosthetic heart valve onto a delivery instrument by means of a loading system1including the delivery instrument30as well, the method including:

displacing the gripper3from the first axial position I to the second axial position II to fit the at least one portion (e.g. the inflow portion) of the heart valve prosthesis2into the first receiver4in a radially collapsed condition;

decoupling the first funnel shaped element5from the loading system1;

coupling the first receiver4to the hub32of the delivery instrument30;

displacing the second receiver33from the third axial position III to the fourth axial position IV to fit the second portion (e.g. the outflow portion) of the heart valve prosthesis2into the second receiver33in a radially collapsed condition;

decoupling the second funnel shaped element37from the delivery instrument; and

decoupling the first receiver4from the holder7, while maintaining the same attached to the hub32of the delivery instrument30.

While the ideas and principles of the disclosure remain the same, the details of construction and the embodiments may widely vary with respect to what has been described and illustrated purely by way of example, without departing from the scope of the present disclosure.

For example, in embodiments the receiver4may be sized and dimensioned to cover the entire axial extension of the prosthesis to be implanted, so that the second receiver33may not be necessary. In these embodiments, therefore, the loading system1may only include the gripper3with the prosthesis2attached thereto, the related actuation facilities (i.e. the tubular member6with the drive member12, for instance), the first receiver dimensioned as above, and the first funnel shaped element5. In some embodiments, displacement of the gripper3from the first axial position I to the second axial position II results in the loading of the entire prosthesis into the receiver4. Detachment of the gripper3from the prosthesis may occur just as disclosed above, but the full-length receiver4can be coupled to a delivery instrument later, as the delivery instrument is no longer required to complete the loading action.

In some embodiments the receiver4may be provided with an annular portion extended in length as a delivery sheath, which may be intended to cover the axial length of the prosthesis2, and which may be axially slidable relative to the hub28. Accordingly, the hub28and the annular portion26may have two separate coupling interfaces with the delivery instrument: one for the hub, intended to mate with a static portion of the shaft of the delivery instrument, the other for the sheath26, intended to mate with an actuation member of the delivery instrument for axial displacement thereof.

Additionally, in embodiments disclosed herein the inflow portion of the prosthesis2is referred to pre-mounted on the gripper and later sitting in the receiver4, while the outflow portion of the prosthesis is referred to as coupling sitting into the second receiver33, in other embodiments they may be arranged the other way around, i.e. with the inflow portion sitting in the receiver33, and the outflow portion pre-mounted on the gripper and later sitting in the receiver4. In this regard, when the distal portions120of the arched struts108are provided with a hairpin shape, the same may provide a natural engagement site for the gripper3, and specifically for the resilient fingers20.

In any case, loading of the prosthesis onto a receiver element to be later used as part of a delivery instrument can be performed smoothly and efficiently, and most of all with a device that may come ready out of the jar wherein the prosthesis2is stored, thereby greatly simplifying the manipulation of heart valve prosthesis from the jar to the delivery instrument.

While the ideas and principles of the disclosure remain the same, the details of construction and the embodiments may widely vary with respect to what has been described and illustrated purely by way of example, without departing from the scope of the present disclosure.