BR112013005863A2 - stent valve, delivery device and delivery method - Google Patents

Abstract

STENT VALVE, RELEASE APPARATUS AND RELEASE METHOD. The present invention relates to a delivery catheter (12) for a stent valve (10), the delivery catheter having a distal portion (14) insertable in an anatomy, the distal portion comprising an accommodation region (18) to accommodate a stent valve for delivery to anatomy, the delivery catheter further comprising at least one wrap (20, 22) that is translatable between a closed position to at least partially close the accommodation region and an open position to at least partially open the accommodation region.

Description

S . Invention Patent Descriptive Report for "STENT VALVE, RELEASE APPARATUS AND RELEASE METHOD". The non-limiting aspects of the present invention relate to implantation of transcatheter prosthetic stent valves within the anatomy, production methods and methods and devices for delivery. a stent valve for implantation at a desired implantation site.

In some non-limiting aspects, the invention is directed to cardiac stent valves and / or delivery to the heart.

Additionally or alternatively, some non-limiting aspects refer to valves 1 10 intended to be released via a transvascular access route. . Traditional approaches to aortic valve replacement require cutting a relatively large opening in the patient's sternum (sternotomy) or chest cavity (thoracotomy) in order to allow s. surgeon to access the patient's heart.

In addition, these approaches require the patient's heart to stop and a cardiopulmonary bypass (ie, use of a heart-lung bypass machine to oxygenate and circulate the patient's blood) . In recent years, efforts have been made to reduce aggression using a transcatheter procedure, that is, by releasing and implanting a prosthetic valve via a catheter inserted through a small skin incision, using a transvascular route or a transapical route for the valve implantation site.

The prosthetic valve is referred to as a stent valve or a stent-valve.

Although less invasive and arguably less complicated, transcatheter heart valve replacement devices and procedures still face several difficulties.

One issue is the unpredictability of the anatomical condition of the aortic valve, for example, in the presence of severe calcification.

Performing the deployment and controllable anchoring, consisting of a stent valve in variable conditions, with access only via a remote catheter, is a challenge.

An incorrectly positioned valve may fail to function or may damage the delicate heart tissue (which may result in the patient having to be fitted with a pacemaker) or may result in blood leakage at the interface between the valve

. stent la and native tissue. Another issue for transvascular release is difficulty in navigating, through a tortuous and often constricted vasculature, a release catheter large enough to accommodate a stent valve for implantation. The distal end of the release catheter is typically fixed in the 6-8mm diameter bands (18-24: French) to accommodate the stent valve. The design of a release catheter must meet the requirements for (i) atraumatic introduction, navigation and later withdrawals through the vasculature, and (ii) support, for example, for applying force along the catheter extension from the '10 proximal end for transverse advancement of the existing valve, and manipulate the distal end to remove the wrap and unfold the stent valve.These requirements often conflict, leading to complications - "promises in the design. For example, the softness and flexibility of the catheter x is desired for atraumaticity and ease of navigation, but reduces the capacity of the catheter to provide support for force applied from the proximal end remotely to the distal end.Additional complications refer to the desired small size of the release catheter, without affecting the reliability, accuracy or controllability of the stent valve deployment, and the cap the ability to remove the catheter following the deployment of a stent, for example, through an airtight adjustment introducer.

A particular type of stent valve having a geometry that compromises self-alignment and self-location even in a severely calcified native valve is described in World Patent —cooperation WO-A-2009/053497 and WO-A-2011/051043 . The stent component comprises a tapered lower anchoring crown that defines an inflow end, a tapered upper anchoring crown leaning outwardly in a direction opposite the lower crown to the efflux end, and stabilizing arches at the efflux end. As described, the stabilization arches are deployed first to align the stent valve, followed by the deployment of the upper crown and finally deployment of the lower crown. A transapical release device is described

. that it is easy and intuitive to unfold the stent valve according to the sequence above. It may be desirable to refine the stent valve and / or the delivery device for transvascular use.

Another issue is that it is sometimes necessary to rotate the stent around the release axis, such that the stent has a certain amount. rotational alignment with respect to native anatomy. Certain previously described stent designs have correct rotational alignment between native anatomy and the stent, in order to locate / function correctly. Other previously shown stent designs include openings or clearances that, when properly aligned with respect to local anatomy, - allow entrances to each coronary artery to be kept relatively clear. This benefits the flow of blood to the coronary arteries and / or - SS allows later treatment of the coronary arteries by allowing access and to implant the coronary stents, should this be desired for the patient to have a subsequent treatment. In the devices previously described, rotation is performed by applying a torsional force to the catheter from the end of the handle. proximal. Ideally, the distal end should rotate at a constant rate in response to torsional force. Although rotation is generally not a problem with a short catheter in a straight stroke, from the "handle" to the end that carries the stent (eg, transapical), it is much more problematic with a long catheter that extends in a relatively twisted and / or substantially curved path (eg, transvascular). Friction against arterial walls obstructs free rotation, distributing the torsion to the artery itself. When the handle end is rotated, the distal end tends to remain fixed. Torsional energy tends to form along the length of the catheter until the handle has been rotated sufficiently that the total energy exceeds the frictional resistance, after which the springs at the distal end free and rotate through a large angle. This makes the rotation adjustment relatively coarse, making fine adjustment extremely difficult. Thus, there is a need for a stent delivery system that allows for easy rotation and flexibility when releasing a stent through

“You see from a longer or curved route.

The present invention has been designed with all the aforementioned issues in mind. It may be desirable (although not essential) to address and / or mitigate at least one of the issues. Throughout this description, including the above description of the technique. relative, any and all publicly available documents described herein, including any of all US patents, are specifically incorporated by reference here in their entirety. The above description of the correlated technique is not intended in any way as an admission that any of the documents described herein, including pending US patent applications, are prior art for embodiments in accordance with the present invention. In addition, the description here of any disadvantages associated with the products, methods already and / or apparatus described, is not intended to limit the invention. In fact, aspects of the reported embodiments may include certain characteristics of the products, methods and / or apparatus described, without suffering from their described disadvantages. . Broadly speaking, an aspect of the present invention provides a "release" catheter for transvascular "release" of a stent valve to an implant site. The delivery catheter can be defined independently of the stent valve or as part of a system in combination with a stent valve. The invention may also comprise any one or a combination of two or more of the following characteristics, which will all be optional: (a) The delivery catheter may have a distal portion for insertion into the anatomy and a proximal portion, a region of accommodation in the distal portion to accommodate the stent valve in the compressed-for-release condition and a stem portion that extends from the accommodation region to the proximal portion (for example, to a control lever in the proximal portion). As defined, the stent valve can be radially compressive to a compressed state for release, and radially expandable to a functional state. The stent valve can comprise

- a plurality of valve leaflets and a stent component to support and / or house the valve leaflets.

The stent component may be self-expanding from the compressed state, or the stent component may be non-self-expanding (in which case, the delivery catheter may comprise a device for applying an expansion force to cause or force expansion) ). (b) The delivery catheter may comprise a first wrap to cover a first portion of the accommodation region and / or stent valve to contract a first portion of the compressed stent valve, and a second wrap to cover a second portion of the accommodation region and / or the stent valve to restrict a second portion of the compressed stent valve o The second wrap can be translatable in an already proximal direction so as not to cover the second portion The first wrap can be 15 translatable in one direction so as not to cover the first portion.

The use of such wraps moving in opposite directions can reduce the total distal i extension of the catheter when the wraps are opened (for example, compared to a catheter employing a simple distally movable wraps). The first and second wraps can be independently translatable.

The rod may have a smaller outside diameter than the first wrap and / or the second wrap.

The delivery catheter may further comprise a stent retainer in the accommodation region to retain the stent valve in a predetermined axial position during deployment.

The stent retainer can restrict the stent valve against substantial axial movement (for example, in both the distal and proximal directions). The stent retainer may have a profile that mates with a portion of the stent component.

For example, the conjugation may be such as to allow the self detachment of the stent component from the sentent retainer when the portion of the stent component that conjugates with the stent retainer is finally allowed to expand

- by removing a respective wrap. In some embodiments, the stent retainer is positioned to a distal end of the accommodation region and / or is configured to mate with a distal end portion of the accommodation region and / or is configured to mate with a distal end portion and / or end portion of. inflow of the stent component. Optionally, the stent retainer can be at least partially overlapped by the first wrap. Optionally, the stent retainer may not be overlapped by the first wrap. The second wrap can be longer than the first wrap. Such an arrangement can further reduce the distal extension of the release catheter when transferring the wraps to unfold the stent valve. The ratio of the length of the second wrap divided by the length of the first wrap can, for example, be at least 1.1 or at least 1.5 + or at least 2 or at least 2.5 or at least 3 or at least minus 3,5 or 7 15 at least 4 or at least 4,5 or at least 5. The first and second wraps can be configured in such a way that there is no overlap of the ends of the wraps one BR with another. By avoiding an overlap, you can avoid the excess diameter of the distal portion that must otherwise be taken by the wall of the envelope to overlap with each other. The first and second casings may have substantially the same internal and / or external diameter with each other.

In some embodiments, the first and second wraps may, in one configuration, substantially meet the end with the end. The delivery catheter can be used, when it contains the stent valve ready for introduction into a patient, in such a way that the wraps substantially join end to end, thus covering the extension of the stent valve almost completely.

Alternatively, if the wraps are able or not to be positioned to join end to end, in use when there is a stent valve ready for introduction into a patient, the ends of the wrap can be spaced from the other wrap in such a way. so that a portion of the stent valve is also not covered by a wrap. The

* the pitch between the wraps can, for example, be at least imm or at least 2mm or at least 3mm or at least 4mm or at least] Smm or at least 6mm. Additionally or alternatively, the spacing can be less than 10mm or less than 9mm or less than 8gmm or less than 7mm or less than 6.mm or less than 5mm. In a BR shape the spacing is between about 4mm and about 6.mm. The spacing 'may correspond (for example, approximately) to a region of the stent valve in which the inner and outer valves overlap and / or may reduce tension within the stent valve in the spacing region. In the accommodation region, the stent valve can be oriented - with the inlet end of the stent valve distal from the outflow end of the stent valve. The catheter may further comprise an interface member, having any of the associated characteristics described below. : 15 (c) The delivery catheter may comprise at least one wrap that is translatable from a restriction position to restrict at least a portion of the stent valve compressed in the accommodation region, to an open position where the respective portion of the stent valve is discovered for deployment from the accommodation region; and an interface member that is foldable to provide a guide surface to assist in removing the catheter to release the anatomy after the stent valve has been deployed. Optionally, the catheter can be withdrawn with the interface member in an unfolded state. Optionally, the interface member can be held captive in the deliberation catheter, for example, in the accommodation region.

The interface member can provide significant performance advantages. In some embodiments, the distal portion of the release catheter may include one or more surfaces or abrupt edges that are exposed when at least one wrap is translated open. Abrupt surfaces / edges can, for example, obstruct the removal of the catheter through an airtight fitting introducer if at least one wrap remains open. Closing at least one wrap can be pro-

. blemic if an open end of the wrap initially relies on the presence of the compressed stent valve for concentric relation with another part of the delivery catheter (eg concentricity of the first and second opposing wraps). In some embodiments, the interface member may provide a 'guide surface to cooperate with an exposed abrupt edge of a' stent retainer or other component of the distal portion that is exposed when at least one enclosure is opened, the surface of the guide defining an exposed profile less abrupt and / or more aerodynamic if the wrapper remains open. The more aerodynamic profile can allow the distal portion of the catheter. of release to be removed without substantial obstruction, even in and through an airtight adjustment introducer. oo In addition or alternatively, in some embodiments, the guide surface of the interface member may serve to: 7 15 (i) at least partially cover, and / or define a profile that accommodates the edge of the wrap at its open end , and / or '(ii) center of the open end of the envelope with respect to one: catheter axis. ] This function can allow easier closure of the enclosure if desired.

In some embodiments, the delivery catheter may comprise first and second wraps, at least one of which is transferable as mentioned above. The other wrap can also be transferable or can be substantially fixed. The wraps can have respective open ends that generally turn towards each other when (or each) wrap is in the closed position (whether or not the wraps contact each other at the ends).

In some embodiments, the interface member may be foldable to: (i) provide an interface on or between the open ends that generally turn towards each other, and / or (ii) align the open ends of the wraps to be

. substantially coincident and / or centered with respect to the catheter axis, and / or Ú (iii) define a bridge and / or a smooth profile between the open ends that face each other of the wraps. Whatever the role of the interface member, in some. In some embodiments, the interface member may be translatable along the catheter's axis, from an unfolded condition to an unfolded condition. For example, the interface member can initially be stowed inside one of the wraps in an unfolded condition and be translatable to or to the open end of the wrap for transition to its unfolded condition. In some embodiments, the interface member may be substantially freely translatable within a predetermined range of motion and be configured to move with or in response to movement of the wrap.

: 15 Additionally or alternatively, in some embodiments, the interface member (or at least a portion thereof) may be expandable.

Ú The transition from an unfolded condition to an unfolded condition may include expansion of the expandable portion. For example, the expandable portion can be self-expanding from a compressed state.

In some embodiments, the interface member can be both mobile and self-expanding. For example, the interface member can initially be arranged within one of the wraps in a compressed, unfolded condition. The wrap can restrict the interface member in a compressed condition. The relative movement between the wrap and the interface member can cause the interface member to transition to the open end of the wrap. When the interface member is no longer constrained by the wrap, the interface member can auto-expand to unfold. In expansion, the interface member may float or self-position on or near the open end of the envelope and / or an exposed edge of the stent retainer, in its unfolded condition.

(d) The delivery catheter may comprise a sleeve or skirt (or segments) of flexible material to fit between the outer surface

- a portion of the stent valve and an internal surface of a translatable release catheter wrap. The sleeve / skirt segments can also be referred to as petals or projections. The glove / skirt (or segments) can be made of flexible film or tablet material ("wafer"). The wrap can move relative to the sleeve / skirt (or segments). The sleeve / skirt (or segments) can optionally be mounted on a stent retainer of the release catheter. The sleeve / skirt (or segment) can optionally be made of "balloon material from a balloon catheter, for example, the valvuloplasty balloon catheter. Such material is strong, tear resistant and yet flexible.

The sleeve / skirt (or segments) can reduce the friction between the wrap and the stent valve, for example, making it easier to load the stent valve into the release catheter wrap. The sleeve / skirt (or - segments) can also avoid the funny wrap against an edge of an external skirt of the stent valve.

: 15 In some embodiments, the moon / skirt may comprise a section of sleeve having a closed loop shape at one end ie, it slides at an opposite end defining the segments that can independently flex outwards from each other .

(e) In another characteristic similar to (d), yet, the release catheter may comprise a stent retainer to couple the coupling with a stent valve when in a compressed state to axially restrict the stent valve against the axial movement in at least one direction, the stent retainer having a flexible material sleeve / skirt (or segments) attached to it.

In some embodiments, the sleeve / skirt (or segments) can be configured to overlap on an external surface portion of a stent valve that mates with the stent retainer.

In some embodiments, the stent retainer may comprise a radially recessed portion for receiving a portion of a stent valve. The sleeve / skirt (or segments) can cover the radially recessed portion, at least in one position of the sleeve / skirt (or segments).

* In some embodiments, the sleeve / skirt may comprise a section of sleeve having a closed loop shape at one end and slits at an opposite end defining segments that can flex externally, independently of each other. In some embodiments, the glove / skirt may overlap substantially. the entire axial extension of the stent retainer. In some embodiments, the glove / skirt (or segments) can be made of balloon material from a balloon catheter, for example, a valvuloplasty balloon catheter. Such material is strong, tear resistant, yet flexible. - (f) | The distal portion of the delivery catheter may comprise: at least one wrap that is translatable from a restricted position to restrict at least a portion of the compressed stent valves to an open position where the respective portion of the valve no stent, 15 is covered for deployment; and a stent retainer relative to which at least one wrap is transferred. The stent retainer can be configured to: cooperate with the stent valve to retain the stent valve in a pre-terminated axial position during the translation of the wrap. The delivery catheter may comprise a stem portion extending between the distal and proximal ends. The rod portion may comprise a first tube into which a second tube is fitted. One of the first and second tubes can be attached to the wrap and the other to the stent retainer. The first and second tubes can be relatively slideable to transmit relative movement from the end proximal to the distal end, for translation of the envelope relative to the stent retainer.

The second tube can be hollow to define a guide wire lumen for receiving (directly or indirectly) a guide wire. The second tube can comprise a polyamide material and a polyimide material. Polyamide and - polyimid can be superimposed on top of each other to define an integral tubular laminate having a radially internal layer and a radially external layer, for example, by coextrusion. In some

. tions, the radially inner layer may be polyimide and the radially outer layer polyamide. However, in other embodiments, the order 'could be reversed if desired. Polyimide has desirably high resistant modules, but it is expensive to manufacture in significant thickness. The addition of a polyamide layer can complement the physical properties of the polyimide, providing a thicker tube with high tension and column resistance, good flexibility and high modules. For example, polyimide "and the combination of polyamides can provide properties similar to much more expensive materials such as PEEK (polyether-ether-ketone) tubing that is sometimes used in a catheter delivery system. - The first tube may be made of plastics in which a braid is embedded. The plastic may, for example, be polyamide. The braid may, for example, be made of stainless steel filaments. (G) The rod portion may comprise tubes (hereinafter referred to as the first and third tubes) embedded within each other. The tubes can be made of plastics in which a respective braid is embedded. The braided U can be defined by a density or PPI ("peaks by pole-. gada ") and / or by a braiding angle. One braid (for example, for the radially outer side of these tubes) may have a lower density (for example PPI) than another braid (for example, for the side radially internal of these tubes.) The density can, for example, be at least twice, optionally at least 5 times, optionally at least 10 times the density of the other. In one form, the radially inner side of these tubes can have a PPI of between 5 and 10, for example, about 8. Added or alternatively, the radially outer side of these tubes can have a PPI between about 50 and 100 , for example, about 80.

A higher braid density can provide good column strength due to the amount of braid filament embedded in the tube. Good column strength can make it possible to transmit a compression force axially along the tube.

A lower braiding density and / or a braiding angle of about 45 degrees can provide good torque transmission over

- the extension of the respective tube. The combination of two different braid densities can provide better characteristics than an identical S braid in both tubes. (h) The stem portion may comprise at least three tubes fitted within each other and defining at least two spaces (for example generally annular, but subject to relative movement between the 'tubes) between them. The delivery catheter may further comprise a nozzle orifice for receiving a liquid to level both spaces. The same nozzle can communicate with both, the first and second spaces, to supply the liquid directly to both: first and second spaces. Alternatively, the nozzle orifice can communicate with one of the first and second delivery spaces - liquid to them and a communication channel can be provided for passing liquid from one space to the other. For example, the '15 communication channel can be an opening in the wall of one of the tubes. Such an arrangement can avoid the need to provide a different nozzle hole for each space to be leveled. This can also be simpli-. stay the squirt operation for an operator. () The delivery catheter can comprise first and second hollow flexible tubes extending between the distal and proximal portions of the catheter.

A first tube coupling can couple the first tube to a stent retainer tube on which a stent retainer is mounted. An end of the stent retaining tube can be received within the first tube in the coupling of the first tube. The second tube can be fitted into the first tube and can be moved relative to the first tube. The second tube can be coupled (directly or indirectly) to a wrap to apply a transaction force to the wrap. The second tube can provide a guide wire receiving lumen for receiving (directly or indirectly) a guide wire. The second tube may include a distal extension having an outside diameter smaller than a main portion of the second tube and communicating with it at an interface point. The distal extension of the second

. The tube can be fitted into the stent retainer tube and can be moved relative to the stent retainer tube (in response to the relative translational force being applied via the first and second tubes). The coupling of the first tube can be distal from the interface point of the second tube. The interface point of the second tube can be spaced axially from the coupling. of the first tube in the closed position of the wrap. The interface point of the 'second tube can move relatively to the coupling of the first' tube when the wrap is moved to the open position.: (1) The delivery catheter can comprise first and second flexible tubes extending between the distal portions and close to the catheter.

. A catheter handle portion may be operable to stretch and / or pre-stretch at least one of the flexible tubes, for example, before insertion into the body, and / or before reaching the desired implantation site, and / or before opening a wrap. Pre-stretching can prevent any tendency for the respective tube to elongate further when a manipulative force is applied through the neighboring tube.

Ú In some embodiments, the stretched tube can be coupled to a casing that moves distally from a closed position to restrict a portion of the stent valve to an open position to unfold the respective portion of the stent valve. The stretching of the tube can polarize the wrap in a proximal direction, in order to restrict the wrap against distal deformation when handling forces are applied through at least one other tube, for example, for translation to open a second wrap.

The use of tension or "pre-tension" can avoid any need for a locking mechanism or overlapping of the wrap or extension of the additional wrap which can otherwise be used to account for distal deformation. The use of tension can therefore provide a more compact and / or less complicated distal portion.

(k) The delivery catheter may further comprise a member (eg, interface member) attached to the catheter, and slidable with respect to the wrap. The limb can initially be stowed within the envelope.

+ voltório and can be moved from the envelope by the relative movement of the envelope (eg, between the envelope and the limb). The member may be self-expanding (or includes a self-expanding portion) in such a way that, once moved from the wrap, the member (or portion) self-expands to become oversize compared to the wrap. The surplus member may tend to remain at least partially outside the interior of the wrap. "(1) The delivery catheter may comprise a stent retainer to couple the engagement with a stent valve when in the compressed state, to restrict the stent valve against axial movement, the stent retainer comprising a body having a plurality of substantially radial projections to match the fastening elements - of a stent valve, each projection having at least one ramp surface extending partially around it to define the portions of the ramp surface circumferentially in one side of the projection and axially to one side of the projection, the ramp surface portions inclined externally away from the projections.

BR With such an arrangement, the portions of the ramp surface can assist in separating the stent valve fixing element from the stent retainer when the stent valve is completed in removing the wrap for expansion to the functional state. A small axial or rotational movement of the release system can cause the fasteners to advance on one of the portions of the ramp surface and be propelled radially away from the stent retainer, if the fastener could otherwise remain in proximity for projection .

In some embodiments, the stent retainer body has a portion defined by the rotating surface on which the radial recesses are provided. A respective projection can project into each recess. The radial extent of the projection can be accommodated totally or substantially within the recess. A respective ramp surface can define an axial side and opposite circumferential sides of the recess. The other axial side of the recess can be opened. The recess can open radially to

'out.

Such a stent retainer arrangement may have an external: generally smooth contour provided by the surface of revolution.

A smooth surface can, for example, facilitate the removal of the distal portion of the delivery catheter (including the stent retainer) through the valve of a stent valve. following the unfolding of said stent valve. (m) The delivery catheter may further comprise a% spherical joint located proximal to the stent accommodation region.

The spherical joint can be formed in an external tube in / or leading to the distal portion.

In such a delivery catheter, the proximal portion may include one. distal wrap (first) which is slidably configured to cover at least a portion of the distal end of the accommodation region and "'configured to slide distally to reveal the distal end of the accommodation region for the demountable (deformable) stent and a wrap - '15 proximal river (second) which is slidably configured to cover at least a portion of the proximal end of the accommodation region for' the detachable stent to slide proximally to the threshold of the proximal ends of the accommodation region for the dismountable stent .

In some embodiments, the distal wrap and the proximal wrap meet at the proximal end of the distal wrap and the distal end of the proximal wrap when they cover the distal and proximal ends of the detachable stent.

The spherical joint may be less than 5 cm proximal to the stent accommodation region of the catheter.

It may also be less than 2 cm proximal to the catheter stent accommodation region.

It may also be less than 1 cm from the catheter stent accommodation region.

It may also be between 1 and 2 cm proximal to the stent accommodation region of the catheter.

The ball joint of the cardiac stent delivery system can also be hollow.

Also, one or more inner tubular members can pass through the hollow portion of the spherical joint.

The spherical joint can also allow the outer and inner tubular members to bend, according to some embodiments, at least 20º or at least 30º or at least 40º

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In some embodiments, the spherical joint of the cardiac stent release catheter may also allow an axial force to be applied to the inner tubular member and the outer tubular member causing the envelope to be moved distally and / or the wrap. proximal to be moved proximally.

This movement of the distal wrap in a distal way and the Ú proximal wrap in a proximal way can reveal the dismountable stent in the "fixation region, for example.

In some embodiments, the spherical joint of the cardiac stent release catheter may also allow the outer * and inner tubular members to rotate in mutual relationship.

The outer and inner tubular members may be allowed to rotate with respect to one another. 'rotation or for unlimited rotations, for example. (n) The system can understand; '15 is an aortic stent valve comprising a stent component and a plurality of valve leaflets supported by the stent component', the stent component having an inflow end and an ex-. effluent tremendity and being self-expanding from a compressed state to release to a functional state in the implementation, the stent component comprising an efflux structure at or to the efflux end, a crown intervening at the ends flow and efflux, the crown having a free end intervenes at the flow and flow ends and is directed towards the flow end and the stent component still comprising a clamping section between the crown and the flow end , a delivery catheter having a distal portion for insertion into the anatomy and a proximal portion, a stent valve accommodation region in the distal portion to accommodate the stent valve in the compressed state for delivery, the distal portion comprising a first envelope - river to cover at least a portion of the clamping section to restrict the compressed clamping section and a second wrap to cover at least a portion of the arches and at least one po crown adjustment to restrict

. The compressed bows and crown.

The second wrap can be translatable in a 'proximal' direction to discover the crown and the efflux structure.

The first wrap can be translatable in a distal direction so as not to cover the securing section.

The use of such wraps moving in the opposite directions can prevent. prevent at least partial unfolding of the crown and efflux structure] without substantial distal extension of the catheter.

It can also reduce the total distal S extension of the catheter when the casings are opened (compared to a catheter employing a simple distally movable casing). The efflux section can comprise a plurality of arcs + at the efflux end each having an apex at the effluent end. -] The translation of the second wrap (for example, in a proximal direction) may not cover the crown for unfolding followed by not covering the efflux structure (for example arches) for unfolding.

Such a sequence is different from that described in world patents WO-A-i 2009/053497 and WO-A-2011/051043. Meanwhile, it has been appreciated that the 'unfolding of the efflux structure (for example, arches) after the crown is still highly effective in allowing the arches to function.

Notably, the efflux structure (for example arches) can be unfolded before removing the cover from the securing section for unfolding.

In some embodiments, the efflux structure (for example, arches) can be configured to align the stent valve with respect to an axis of the ascending aorta by contact with an as- | —Cending.

For example, the arches can be curved independently of each other.

The crown can be configured to engage and / or rest against existing leaflets from one side of the outflow.

The securing section can be configured to engage existing rings.

The unfolding of the efflux structure (eg, arches) before the clamping section can allow the self-alignment of the stent valve by the action of the efflux structure (eg arches), before the clamping section to unfold to anchor the stent valve to the existing valve rings.

* Other aspects of the invention refer to the methods of using the stent valve and / or delivery catheter using process steps corresponding to any of those described above.

Other aspects of the invention relate to a stent valve.

Optionally, the stent valve can be for use in a system like R described above and / or for use with a delivery catheter as described above.

The following definitions are therefore intended to be combined with "any of the aspects described above.

The stent valve can comprise a valve component and a plurality of leaflets supported by the valve component.

The stent valve can still be com-. meet any or a combination of two or more of the following characteristics, which are all optional: '(a) The stent component can be configured to be radically compressible in a compressed state and expandable to a functional state. .

The stent component may be self-expanding from the compressed state or the stent component may be non-self-expanding (in which case the delivery catheter may comprise a positive device for applying an expansion force (for example, example, from inside the stent valve) to cause the expansion.

Non-limiting sample materials for a self-expanding stent component include profile memory materials, especially metal alloys such as "nitinol". Non-limiting sample materials for a non-self-expanding stent component include profile memory materials and stainless steel.

The stent component may comprise commissural supports (eg posts) to support the valve leaflets.

The commissural supports can support the edges of the valve leaflets found on the commissural supports.

Commissural supports can be defined by a section of the stent component which is a section of the opposite end of the stent. Each commissural support can have opposite ends that each communicates with a respective stent section that is axially adjacent to the commissural support.

The commissural support optionally may not

. have a free end.

In addition or alternatively, the commissural supports can each have a slot to receive a projection of a leaflet. The commissural supports can also comprise a plurality of holes flanking one or both long sides of the slot. The holes can be confi. secured to receive suture thread. 'In addition or alternatively, each commissural support may NR comprise a post. Each commissural support can have a fork shape. The fork shape can include first and second legs that diverge from one end of the post.

- In some embodiments, the stent component may comprise a truss structure having at least one row of cells, a. Ú truss structure including a sequence of cells that repeats the circumferential direction, the sequence including apexes of the cell that define: a Ú 15 first apex node communicating at least with a first leg of a commissural fork support, at least one free apex extended 'by the fork commissural post, and at least one other apex of the knot with a crown element. First and second node apexes can additionally communicate with one or respective elements of a crown. As mentioned above, the commissural support can comprise a pole communicating at one end with the fork-shaped legs and communicating at the other end with an efflux section of the stent component (for example comprising stabilization costs).

The above forms of construction can provide a stent that is functional in supporting a valve component, yet can be compressed to a small size, (b) The stent valve (for example, stent component) can comprise at least one of (and preferably a plurality) fixing elements to cooperate with a stent retainer of the delivery catheter. Each fastener (or at least one of the fasteners) may comprise a U-shaped portion joining two

CNS. ?) PPA. "" "" Pn pNneN "ECO INN -. O" / I [AAE ”AÉÁ] ÁÁá": = ôI 21/70. Stent ras. The term U-shape is used here to include any form- including a generally arcuate apex, or if the sides are not] straight or curved, externally expanded, parallel or non-parallel In a deformed condition (eg, compressed) of the stent when received within the delivery catheter's accommodation region, the struts may be adjacent to each other in the fastener, such that the arc of the U-shaped portion extends around the first angle more than 180 degrees to define, for example, a closed or almost closed eye (for example, horseshoe shape) having an opening greater than the spacing of the struts The horseshoe shape of the eye opening and the adjacent space between the struts can together define a hole-like shape In an expanded (Not deformed) condition of the stent ”'when released from the release catheter, the scars can move apart and the arc in a U-shaped portion can '15 extend around a second angle that is less than the first angle, to at least partially open more eyelet. For example, the second angle can be about 180 degrees or less. In the expanded condition, the fixed element can define a substantially straight U shape on one side with an arcuate apex.

The delivery catheter may comprise a stent retainer provided within the accommodation region. The stent retainer may comprise: (i) One or more receivable projections within the eye. The projection can be dimensioned in such a way that, when the stent is in its collapsible condition, the projection is trapped inside the eye and unable to pass between the adjacent struts, and / or (ii) one or more recesses or interstices for accommodate the eye substantially within them, at least in the disassembled state of the stent.

The above forms can provide a compact, yet reliable, self-opening and / or self-releasing attachment between a stent valve and a delivery system.

CC. / L PA. 0 Bana aan AS P <29 º “" “º“ “í iZÀAQN“ ““ oe HAI! ” NUM .PES -! “* O 22/70 - (c) The stent valve can comprise at least two leaflets The leaflets may be pericardial tissue, more preferably porcine pericardium or bovine pericardium The porcine pericardium may provide a desirable tissue fineness Bovine pericardium may be slightly more personal but more durable.

. Each valve leaflet can include at least two projections. ] The projections can be used to support the leaflets related to the stent component. In some embodiments, the projections can be fixed directly on the commissural supports (for example, posts) of the stent component. The projections can be fixed in the fixation medium provided on the commissural support. For example, a projection can pass through a '] slit in a commissural support, from the inside of the stent component to the outside. of stent '15 can be folded to sit against the commissural support and / or sutured in the commissural support. Optionally, the respective projections of two adjacent leaflets that meet in the commissural support pass through' the same slot. be folded to sit against the outside of the commissural support without overlapping the other projection.The two projections are optionally not directly provided with each other.

Additionally or alternatively, the leaflets can be attached to an inner skirt. The leaflets can be attached to a portion of the inner skirt, the projections passing through the slits (for example, slits) in the inner skirt to the outside of the inner skirt. The internal skirts can have varied slack (scalloped), each one of such slack being extended by a respective leaflet. The inner skirt may have commissural or standing portions in which the slits (for example, slits) are provided.

In addition or alternatively, the material defining the inner skirt may include portions of integral extension that wrap at least around the commissural supports, to cover the commissural supports and / or to cover the leaflet projections attached to the commissural supports. The extension portions can be sutured on the commissural supports.

AAA 23/70 * In some embodiments, a combination of any two or all three arrangements above may be used.

For example, a pair of adjacent leaflet projections can pass through a slot in the inner skirt and through a slot in the commissural support.

The projections can be folded back in opposite directions and sutured to the outside of the. commissural support (optionally without the projections being sutured directly to each other). One or more extensions of the inner skirt on the commural support can be wrapped around the exterior of the commissural support to cover the projections and / or the commissural support.

The extension can be supported on the commissural support.

For example, sutures can pass through. through the same suture holes in the commissural support as those used to fix the projections.

The extensions can extend axially y It is beyond the projections, in such a way that the edges of the projections are covered and protected. ] 15 (d) The stent valve may comprise a stent component, a plurality of valve leaflet mounted within the stent component i, an inner skirt provided in the valve leaflets, the inner skirt extending at least partially within the stent component, and an outer skirt extending at least partially outside the stent component.

At least a portion of the stent component over which at least one of the skirts extends can comprise a truss structure having at least one row of a plurality of cells.

In some embodiments, the inner and outer skirts may partially overlap, at least with respect to the surface of at least one of the skirts.

Additionally or alternatively, the inner and outer skirts may not have any co-terminus.

In addition or alternatively, the outer skirt may extend further to an inflow end of the stent component than the inner skirt.

In addition or alternatively, the inner skirt may extend further to one end of the stent component than the outer skirt.

A function of the inner skirt may be to define a conduit inside the stent to channel blood to the valve leaflets and obstruct

- leakage of blood through the interstices of the stent component (for example, lattice interstices). A function of the outer skirt may be to 'provide a sealing surface outside the stent component for sealing with the surrounding tissue, for obstruct the leak at the interface with the surrounding tissue. 'Providing both skirts can be beneficial in terms of leakage obstruction. However, the presence of both skirts can significantly increase the thickness of the material loaded by the stent and thus increase the difficulty of compressing the stent valve to a desirably small size. By providing both skirts, with only partial overlap in an axial direction, the benefits of both skirts can be obtained, but with a reduced thickness profile in regions where only one skirt extends. The overlapping of the skirts may provide a better seal between the skirts than the skirts that were disposed: edge-to-edge inside and outside, respectively, of the stent component (for example, especially bearing in mind that the stent] must be substantially deformed by compression for release and re-expansion in implantation). The degree of overlap of the skirt in the axial direction can, for example, be at least Imm or at least 2mm or at least 3mm or at least 4mm or at least 5mm or at least 6mm or at least 7mm or at least 8mm. In addition or alternatively, the degree of skirt overlap in the axial direction can, for example, be less than 10mm or less than 9mm or less than 8mm or less than 7mm or less than 6mm or less than 5mm or less than 4mm. For example, the degree of skirt overlap in the axial direction can be about 4 - 6 & mm.

At least one of the skirts (optionally each skirt) can extend over an overlapping axial distance of at least Imm away from the overlapping region. The non-overlapping distance for / or each skirt - can, for example, be at least 2mm or at least 3mm or at least 4mm or at least 5mm or at least 6mm or at least 7mm or at least 8mm or at least 9mm or at least 10mm.

o If “AÔA“ “º“ ““ P “Pº” 9Pó ““ “Ô NO 25/70 - In some embodiments, the inflow end or edge of the stent component may have a zigzag shape defined by" a truss structure of at least one row of cells The zigzag shape can define an alternating sequence of free apexes (for example, at an inflow end) and connected apexes (eg. connected to the truss structure extending far from the inflow end to the efflux end). In some embodiments, the "inner" skirt may extend only to the connected apices. The outer skirt can overlap the inner skirt and extend more than the inner skirt, to a level corresponding to at least some of the free apexes.

* In some embodiments, the inner skirt may be attached to an inflow edge and / or an effluent edge of the valve leaflets. The inner skirt may extend towards the inflow end of the stent component. The outer skirt can only partially overlap the inner skirt '15 while remaining spaced from the uppermost edge of the inner skirt. The outer skirt can extend to (or optionally to) the inflow end of the stent component. The outer skirt can optionally not overlap (for example, directly or indirectly through the stent component) any portion of leaflets.

The inner skirt and / or the outer skirt can be of any suitable material such as pericardium tissue (for example, pig skin due to its fineness), PET, Dacron, etc. The internal and external skirts can optionally be made of the same material as each other.

Additional aspects of the invention are defined in the claims. Although certain aspects and ideas have been focused on above and / or in the claims, protection is claimed for any new features or ideas described here and / or illustrated in the independent emphasis drawings whether or not they have been placed on them.

The preferred embodiments of the invention are described below, by way of example only, with reference to the accompanying drawings, in which: Figure 1 is a schematic partial section view of a case.

7 release teter and stent valve; figure 2 is a schematic section showing the distal portion 7 of the partially open release catheter; figure 3 is a schematic section showing the distal portion of the fully open release catheter; . Figure 4 is a schematic section showing the distal 'portion of the delivery catheter in greater detail.

The axial scale (horizontal) is V compressed relative to the radial scale (vertical) to allow all elements to be shown in a simple view; figure 5 is a schematic perspective view showing a. distal portion of the release catheter fully open, unfolding the interface element; figure 6 is a schematic side view of the insulating interface element, shown in an unfolded condition; Figure 15 is a schematic perspective view showing the initial closure of the second wrap; Figure 8 is a schematic perspective view showing the. second wrap in its closed position; figure 9 is a schematic side view showing the first and second envelopes closed again with the interface element unfolded; Figures 10a - c are schematic sections showing, in an isolation example, the fixing elements of a stent valve for fixation in a stent retainer of the release catheter.

The fasteners are shown in an expanded condition of the stent valve; figure 11 is a schematic perspective view showing in isolation an example of a stent retainer for the delivery catheter; figure 12 is a schematic side view showing the engagement between the fixation element of figure 10a and the stent retainer of figure 11; figure 13 is a schematic side view showing the engagement between the fixing elements of figures 10a / 10b and a second example of stent retainer;

Figure 14 is a schematic perspective section showing petals on the stent retainer; 7 figure 15 is a schematic section similar to figure 14 illustrating a combined stent retainer and interface element; figure 16 is a schematic section illustrating a handle. with controls on the proximal end of the release catheter; and Figure 17 is a schematic side view illustrating an example of a stent valve; figure 18 is a schematic profile view illustrating the woven profile of the stent component of the stent valve of figure 17; . figure 19 is a schematic view showing a developed geometry of the stent component in a simple plane; - figure 20 is a schematic section showing a lining sleeve for the catheter; Figure 15 is a schematic section illustrating the interface member to streamline the stent retainer to allow ST withdrawal of the catheter through an introducer while opening. In figure 210, the en-. voltori are omitted to avoid clutter; figure 22 is a schematic perspective view of an existing insulation, as a single piece item having a geometry similar to figure 13; figure 23 is a schematic perspective view of the stent retainer of figure 22 with a wrap around it and mounted on the stent retainer support tube; and figure 24 is a schematic section showing a delivery catheter with a ball joint.

In the drawings, the same reference numbers are used to indicate the same or equivalent characteristics between different embodiments and examples. Unless otherwise described, the description of a feature in one embodiment or example, the same or equivalent feature in another embodiment or example may also apply. The features can also be switched between embodiments as desired.

Referring to figures 1 - 3, a stent valve 10 and a release catheter 12 are illustrated. The release catheter 12 may have a distal portion 14 for one end for insertion into a patient's anatomy and a proximal portion 16 for an opposite end of which. release catheter is handled in use by an operator. A barrel or stem portion 15 may extend between the distal and proximal portions. q As used here, the terms "distal" and "proximal" for the delivery catheter can refer to the relative position with respect to an operator. The distal portion 14 of the catheter 12 may comprise a region - of accommodation 18 to accommodate the stent valve 10 in a deformed shape to introduce into the anatomy. The stent valve 10 can be an AC cardiac stent valve. The release catheter 12 can be configured to allow the release of stent valves 10 to, and unfold at, Ú 15 a desired implantation site while the heat remains on heating, for example, using a minimally invasive and / or per procedure - S cutaneous. In some embodiments, catheter 12 can be configured for introduction into the anatomical vascular system, and for advancing along the vasculature system to the desired implantation site. For example, catheter 12 can be configured for insertion into the femoral artery and guided retrograde via the descending aorta, aortic arch and ascending aorta to the heart (sometimes called a transfemoral access). Catheter 12 can be at least 1m long to provide sufficient insertion length in anatomy. In other embodiments, catheter 12 can be inserted via the subclavian artery and retrograde to the heart (sometimes called the transsubclavian access). In other embodiments, catheter 12 can be inserted directly into a heart chamber such as a ventricle (eg, left ventricle) via a direct access route while the heart remains beating. For example, a direct access route can be through an open opening at the apex of the heart (sometimes called transapical access).

The size of the access opening in the anatomy may depend

7 of the outer diameter of the distal portion 14. The cylinder portion 15 may be slightly smaller than or of the same diameter as the distal portion 14 7 as desired. For minimally invasive surgery, it is desired that the anatomy access opening be as small as practical, bearing in mind the size to which the stent valve 10 can be deformed without. the risk of damage. An introducer 19, for example, a standard arterial introducer,] can optionally be used in the access opening for anatomy. The optional & introducer 19 can be 20 French or smaller, for example, 18 French or smaller. The distal portion 14 can be dimensioned for rainforest using such an introducer size 19.. The stent valve 10 can be expandable from a compressed or disintegrated condition to a functional condition and / or expanded, in order to anchor the stent valve 10 at the implantation site. For example, stent valve 10 can form a friction and / or interference adjusted '15 with respect to native anatomy. Various 10 stent valve shapes and geometry can be used to adjust the anatomy at the implantation site. S A generally cylindrical stent valve 10 is illustrated here for clarity,. however the invention is not limited to the cylindrical shape and can be especially advantageous with a non-cylindrical shaped stent valve 10. A more detailed example of a stent valve 10 is described later and all details of the release catheter 12 are explicitly applicable to the stent valve format described below.

The stent valve 10 can be self-expanding and / or can be configured to be expandable by expanding an expander (for example, a balloon not shown). Self-expanding 10 stent valves can be constructed of, or use profile memory material, for example, a profile memory metal alloy (such as nitinol). A self-expanding stent valve can be retained in its compressed state by being contracted within a 20/22 wrapper of release catheter 12. At least in the partial release of the 20/22 wrapper, the portion released from the stent valve 10 can be free to expand. Non-self-expanding stent valves 10 can also be made of

* profile or stainless steel or cobalt-chromium alloy., A non-self-expanding ode stent valve 10 can also be contained at least partially within a 20/22 wrap to protect the stent valve 10 and / or facilitate smooth introduction through anatomy.

The distal portion 14 of catheter 12 can comprise at least. a wrap 20 and / or 22 that is translatable between a closed position at least partially covering the accommodation region 18 and / or the stent valve 10 there and an opening position that at least partially opens or exposes the region housing 18 and / or the stent valve 10 there.

In the present example, catheter 12 comprises two wraps 20 and 22, both shown in their respective closed positions in figure 1 to at least partially (optionally, almost substantially in full) cover 7: the stent valves 10 in the region of accommodation 18. Wraps 20 and 22 can be moved in opposite directions to respective open positions.

A first (for example, more distal) one of the wraps 20 can be translatable in a distal direction (indicated by arrow 20a in figure 1) to an open position (figure 3). The first wrap 20 can also be referred to as the distal wrap.

A second (for example, closer) of the wraps 22 can be translatable in a proximal direction (indicated by the arrow 22a in figure 1) to an open position (figures 2 and 3). The second wrap 22 can also be referred to as a proximal wrap.

The use of first and second opposing wraps 20 and 22 can provide good versatility for releasing the stent valve 12 from the accommodation region.

For example, referring to figure 2 by translating the second wrap 22a or to its open position without translation by the first wrap 20, a portion 10a of stent valve 10 previously covered by the second wrap 22 can be released (at least partially) before a portion 10b of the stent valve 10 is covered by the first wrapper 20. The portion 10b can be released subsequently by translation of the first wrapper 20a or to its open position (figure 3). The length of the second wrap 22 can be greater than the length of the first wrap 20. For example, the ratio of the length of the second wrap divided by the ex-

- tension of the first wrap can be at least 1.1, optionally at least 1.2, optionally at least 1.3, optionally at least 1.4, optionally at least 1.5, optionally at least 1.6, optional - at least 1.7, optionally at least 1.8, optionally at least 1.9, optionally at least 2.0-, optionally 2.1, optional-. at least 2.2, optionally at least 2.3, optionally at Ú least 2.4, optionally at least 2.5, optionally at least 2.6, "optionally at least 2.7, optionally at least 2.8 , optionally at least 2.9, optionally at least 3, optionally at least 3.5, optionally at least 4 or optionally at least 4.5, or optionally at least 5. The use of a first wrap relatively short 20 can reduce the risk of trauma in use The first wrap -: 20 advances distally along a path that can be less controlled than the second wrap that benefits from a more controlled path 15 defined by path taken by the catheter's cylinder portion 15. For example, in the case of transvascular access (for example, transfemoral access), the first wrap 20 can advance to the heart's ventricle The use of a relatively short first wrap 20 can reduce the degree to which catheter 12 has in the ventricle and the risk that interferes with delicate tissue surfaces. In the case of direct access (for example, transapical access), the first envelope 20 can advance to the ascending aorta. The use of a relatively short first wrap 20 can reduce the degree to which the first wrap 20 has to penetrate the space of the ascending aorta, and the risk of interfering with the aorta wall.

One or both of the wraps 20 and 22 can optionally be made of plastics including the reinforcement to resist the radial expansion of the wrap. A suitable plastic is a polyether block amide (PEBA), for example, PEBAXº. The reinforcement can be provided by a helical coil built into the wrap. The helical coil can be made of metal, for example, stainless steel filament.

Wraps 20 and 22 can have the same internal and / or external diameter. Wraps 20 and 22 can be configured not to overlap

7 tion among themselves. By avoiding an overlap, you can avoid the excess diameter of the distal portion that should otherwise be caused by the surrounding walls overlapping each other.

Wraps 20 and 22 may be capable of positioning in detail that are substantially at the end of the end. Alternatively, wraps 20 and 22 can be configured in such a way that they always remain spaced from each other, q even in mutually closed positions of the first and second wraps 20 and 22. For example, the minimum spacing can be at least less Imm or at least 2mm or at least 3mm or at least 4mm or at least * 5mm or at least 6mm. Additionally or alternatively, the spacing can be less than 10mm, or less than 9mm or less: Í 8mm, or less than 7mm or less than 6.mm or less than 5mm. In one form, the spacing is between about 4mm and about 6.Gmm. i 15 During translations of wraps 20 and 22, a stent retainer 24 can hold stent valve 10 axially in position and / or restrict the stent valve 10 against axial movement. Stent retainer 24 is - shown purely schematically in figures 1 - 3 and is described in more detail below. The stent retainer 24 can prevent and / or obstruct any tendency of the stent valve 10 to be dragged by the translation of a wrap 20 or 22. In addition or alternatively, the stent retainer 24 can prevent and / or obstruct any tendency towards a self-expanding stent valve 10 to pop out of the catheter if only a small portion of stent valve 10 remains constrained by wrap 20 or 22. Stent retainer 24 can be positioned in accommodation region 18 in an appropriate position to engage stent valve 10 until final release of stent valve 10 from the accommodation region. In the illustrated example, a distal portion of the stent valve 10 can be intended to be released last and the stent retainer 24 can be positioned towards the distal end of the accommodation region 18. In the other embodiments, if the portion proximal to the stent valve 10 is intended to be released last, the stent retainer 24 could instead be positioned towards the end

The 33/70 - proximal activity of the accommodation region 18. Figure 4 illustrates an example construction of the distal portion 14 "of catheter 12 in greater detail. The cylinder portion 15 comprises a plurality of flexible tubes 26, 28 and 30 extending between the distal portion and the proximal portion 16. Tubes 26-30 can be fitted at least one inside the other and coupled to wraps 20 and 22 and to retainer 'stent 24. Wraps 20 and 22 can be moved by relative 1 translation of the respective tubes At least one, optionally two, optionally three, optionally more of the flexible tubes can be made of plastics, optionally with reinforcement.

. For example, at least one tube can comprise a combination of polyamide material and polyimide material. The polyamide and polyimide can be layered over each other to define an integral tubular laminate having a radially inner layer and a radially outer layer, for example, by coextrusion. In some embodiments, the radially inner layer may be polyimide and the radially outer layer, polyamide. However, in other embodiments,. the order could be reversed if desired. Polyimide has a high modulus and resistance, but it is expensive to manufacture in significant thickness. The addition of a polyamide layer can complement the physical properties of the polyimide, providing a thicker tube with high tension and column strength, good flexibility and high modules. For example, the combination of powder and polyamide can provide properties similar to much more expensive materials such as PEEK (polyether ether ketone) tubing that is sometimes used in catheter delivery systems. Additionally or alternatively, the reinforcement can be provided by a braid, for example, a metal braid, inside the plastics. Plastics can, for example, be a polyamide, and or the stainless steel strand braid. The reinforcement can, compared to a tube of the same plastics without the reinforcement: (i) increase the elasticity modules and still retain flexibility, and / or (ii) improve the resistance to twisting when the tube is flexed; and / or (iii) increase the capacity for transmission of

r that from the proximal portion to the distal portion. The respective different tubes may have different braids. The strands can be defined by a density or PPI ("peaks per inch and / or by a strand angle. For example, a lower density may mean that the winding angle is closer to the axial direction; a higher density. means that the winding angle is closer to the radial direction. 'A strand (for example, a tube more radially external) may have a lower density (for example, PPI) than another strand (for example, for a more radially internal tube.) The density can, for example, be at least twice, optionally at least 5 times, optionally at least 10 times, the density of the other. A higher density can provide greater resistance A lower density - 'and / or a braid angle closer to 45 degrees can provide greater torque transmission. The combination of two different braid densities can provide better characteristics than an identical braid in both the tubes. In some embodiments, a tube may have a strand: PPI between about 5 and about 10, for example, about 8. Additional or - alternatively, the other tube may have a strand PPI between about 50 and about 100, for example, about 80.

With reference to the specific structure in figure 4, a first tube 26 can be coupled to control the stent retainer 24. The first tube 26 can optionally comprise plastics with braided reinforcement, as described above. A coupling of the first tube 34 can couple the first tube 26 to a stent retainer support tube 32 on which the stent retainer 24 is mounted. For example, the stent retainer support tube 32 can be inserted at the end of the first tube 26 and / or attached to it, in the coupling of the first tube 34. The stent retainer support tube 32 can have a diameter smaller than the first tube

26. The stent retainer support tube 32 may be less flexible than the first tube 26. The stent retainer support tube 32 may, for example, be polyimide. The stent retainer support tube 32 can act as an extension of the first tube 26 adapted to pass in.

- the relatively confined space of the accommodation area 18. The reduced flexibility can compensate for a smaller diameter to provide adequate column strength along the axis of the stent retainer support tube 32. A second tube 28 can be coupled to control the first (distal) wrap 20. The second tube 28 can optionally comprise. provide a tubular laminate of a polyimide layer radially within a polyamide layer, including any of the details associated with the above described.

The second tube 28 can be fitted within the first tube 26 and can be moved relative to it.

The second tube 28 can include a distal extension 38 having a smaller outside diameter than the pore. main connection of the second tube and communicating with it at an interface point 36. The distal extension 38 can, for example, be an extension of the inner layer of polyimide without the outer polyamide.

The distal extension 38 can support (directly or indirectly) the first wrap 20. The '15 wrap 20 is mounted on the distal extension 38 by a tip member 40. The tip member 40 can have an atraumatic shape connected to help. advancing catheter 12 within the anatomy without trauma to the surrounding anatomy.

The tip member 40 may have a rear extension 42 around which the first wrap 20 is fixed immovably to the tip member 40. The smallest outer diameter of the distal extension 38 can be configured to pass within the smallest diameter of the stent retainer support tube 32. The distal extension 38 can move into the stent retainer support tube 32 and move within it when the second tube 28 moves into the first tube 26. To move the first wrap 20 to its open position, a translational force can be applied to the advancement of the second tube 28 distally relative to the first tube 26. The translational force and the movement is applied from the second tube 28 to the distal extension 38, which pulls the first wrap 20 distally (for example, the translation force and the movement being applied through the tip member). Concurrently, the stent retainer 24 can retain the stent valve 10 relatively stationary under the control of the first tube 26 and the stent retainer support tube 32 in which the stent retainer 24

. is assembled.

The optional diameter difference between the first tube 26 and the stent retainer support tube 32 can define a profile step or change in the coupling of the first tube 34. The difference in the optional diameter between the second tube 28 and the distal extension 38 can define a profile 'step or change at interface point 36. The outer diameter of the second tube 28 may be larger than the inner diameter of the stent retainer support tube f (for example, such that the second tube cannot move beyond the coupling of the first tube 34). In the closed position of the first wrap 20, the coupling of the first tube 34 and the interface point 36 can be spaced.

The interface point 36 can be proximal to the coupling of the first tube 34. The spacing can be at least - as large as the amount of linear translation of the first envelope 20 when the wrapper moves between its open and closed positions '15 da.

Spacing can allow interface point 36 to advance distally.

S The second tube 28 and the distal extension 38 can define a lumen 46 that extends through the catheter.

The lumen 46 can be a guide wire receiving lumen for receiving a guide wire (not shown) along the catheter 12 can be advanced into the anatomy to guide the distal portion 14 to the desired implantation site.

A third tube 30 can be coupled to control the second (proximal) wrap 22. The third tube 30 can optionally comprise plastics with braided reinforcement, as described above.

The first tube26 can be fitted with the third tube 30. The third tube can be translatable relative to the first tube 26 and / or the second tube 28. A coupling of the third tube 44 can couple the third tube 30 to the second envelope 22. The coupling of the third tube 44 can include a connected surface to define a smooth atraumatic transition between the external surfaces of the third tube 30 and the second wrap 22. The coupling of the third tube 44 can be integral with the second wrap 22 and can be a portion of the narrowed end thereof.

AO 2 ”a».-..— s. — .——— DDD tn COS O Ma OE o ES Oaa 37/70 - To move the second wrap 32 to its open position, a translational force (for example, tension) can be applied to retract the third tube 30 proximally relative to the first tube 26. The translational force and movement are applied from the third tube 30 to the second envelope 22, which pulls the second wrap 22 proximally.

Competitor-. In addition, the stent retainer 24 can hold the stent valve 10 relatively: stationary under the control of the first tube 26 and the stent retainer support tube 32 on which the stent retainer 24 is mounted.

As described above, the strands in the first and third tubes 26e30 can have different characteristics according to their respective. internal and external radial relationship.

The sequential order in which the first and second wraps. 'are transferred to their open position may depend on the design of the stent valve.

In at least some embodiments, the second wrap 22 can be translated before the first wrap 20. An unfolding sequence of the example is described below. Also, in some embodiments, at least one of the tubes - can be pre-stretched at least before opening the distal portion 14 to unfold a stent valve.

Pre-stretching the tube can compensate for any tendency of the catheter portion controlled by the tube to distort distally in response to forces applied during manipulation to open another catheter portion controlled by another tube.

For example, the second tube 28 can be pre-stretched from the proximal end in order to prevent the first wrap 20 from distally distorting when the second wrap 22 is pulled back while applying a holding force to the first tube 26, deformation of the first wrap 20 is undesirable since it may result in movement of the unfolding position or premature release of the stent.

Pre-stretching of the second tube 28 can keep the first wrap 20 tightly closed, thereby preventing pre-mature release.

When it is desired to open the first wrap 20 by applying a buoyant force through the second tube 28, the pre-tension is removed as part of the transition to apply a buoyant force.

THE

Va ———— i —.—— DD — D— MD A 38/70

7 pre-tension can be generated by the controls inside the handle as described below.

The amount of pre-tension can be sufficient to calculate the 'reaction force applied through the first tube when moving the third tube to move the second wrap proximally.

The amount of pre-tension appropriate for a specific delivery catheter embodiment

. ration can, for example, be empirically derivable. 'The above arrangements can provide a delivery catheter that q combines the desirable properties of compact size, good flexibility without twisting, good torque transmission, good column resistance and prevention of distal deformation of a wrap, all without using materials and -

. drugs that are prohibitively expensive.

When additional flexibility is desired, the invention also contemplates the inclusion of a spherical joint (not shown) that is close to the distal portion.

The spherical joint can be provided in the third tube or '15 in the connection portion between the third tube and the second wrap.

The spherical joint can be hollow to allow the first and second tubes to pass through it. . As can be seen generally in figures 1 - 4, the first and second wraps 20 and 22 can have open mouths or ends 20b, 22b, respectively, which can generally confront or overlap one another when (or each) the wraps 20, 22 is in the closed position or can remain slightly spaced. In the illustrated embodiments, both wraps 20 and 22 are translatable, however in some embodiments it is possible that only one of wraps 20 and 22 should be translatable

Prior to the release of the stent valve 10, the presence of a stent valve 10 within the accommodation region 18 may cause the wraps 20 and 22 to be generally aligned in register.

Even if the open ends 20b and 22b are spaced from each other or facing each other in overlap, the open ends 20b and 22b can still line up in register.

Such alignment can avoid any sharp edges in the external profile of the wraps and facilitate the insertion of the distal portion.

- such 14 in anatomy (optionally via introducer 19 and / or advancement through the vasculature). However, after the stent valve 10 has been released "from the accommodation region 18, if the operator wishes to close the wraps, there may be a tendency for the open ends 20b and 22b to no longer be aligned closely. Such misalignment may result in. an abrupt edge in a case of confronting or slightly spaced open ends and / or difficulty re-engaging open ends in case of trying to overlap the open ends. It may be desirable to avoid an abrupt edge, especially at the open end 20b of the first wrapper 20. When the catheter 12 is removed after releasing the stent valve 10, the open end 20b may interfere with native tissue in the return path or may make it difficult to extract the distal portion through. introducer 19, especially if the distal portion 14 is in an airtight fit within the introducer 19. During such withdrawal, the second wrap '15 22 can be smoothly guided to the introducer 19 through the ram surface 44 in the coupling of the third tube 44. However, a sharp edge in the open open tremendity 20b of the first wrap 20 can obstruct the smooth passage of the first wrap 20 for withdrawals through the introducer 19.

Alternatively, if catheter 12 is removed with one or both of the wraps 20 and 22 in an open condition, an exposed abrupt edge (eg end face 92 in figures 11-13) of the stent retainer 24 can make it difficult to extraction of the distal portion through an introducer 19, especially if the distal portion 14 is in a situation of hermetic adjustment within the introducer 19.

To address this, the distal portion 14 may comprise an interface member 50 (figures 4 to 9). The interface member 50 can be foldable to: (i) provide an interface at or between the generally confronting open ends 20b and 22b when (at least nearly) closed and / or (ii) align the open ends 20b and 22b to be substantially registered with each other and / or centered in relation to the catheter axis; and / or

(iii) define a bridge and / or smooth profile between the facing open ends 20b and 22b; and / or '(iv) providing an interface for the stent retainer 24 less abrupt than the exposed edge 92. In some embodiments, the interface member 50 can be. foldable as part of the sequence during or after the release of the stent valve 10. T In some embodiments, the interface member 50 can be translatable along the catheter axis, from an unfolded condition (figure 4) to an unfolded condition (Figures 5 to 9). For example, the interface member 50 can initially be stowed inside one of the envelopes (for example, the second wrap 22) in an unfolded condition and be translatable to or from the open end wrap (22) to transition to its unfolded condition.

By storing a member of] 15 movable interface 50 initially within the second wrap 22 you can avoid having to stretch the first wrap 20 unnecessarily to accommodate the interface member 50. As illustrated below, in some embodiments, the interface member 50 can be substantially freely translatable within a predetermined range of motion and be configured to move with or in response to movement of the envelope.

Interface member 50 can be referred to as a plug.

The interface member 50 can be slidable (for example, captively slidable) in one of the tubes 26, 28, 32, 28. In some embodiments, the interface member 50 or at least a portion thereof 52) can be expandable.

The transition from an unfolded condition (figure 4) to an unfolded condition (figures 5 to 9) can include expansion of the expandable portion 52. For example, the expandable portion 52 of the interface member can be radially expandable.

The expandable portion can be self-expanding from a compressed state.

In the illustrated embodiment, the interface member 50 can be either self-moving or self-expanding.

With reference to figure 4, the interface member 50 can initially be arranged within one of the wraps o a MA - a a A a a -. - —.———— p ——— O - - p ——— oa. 41/70 - (for example, the second wrap 22 as mentioned above) in a compressed unfolded condition.

Wrap 22 may restrict U interface member 50 in a compressed condition.

Interfacing member 50 can be accommodated at one end of the accommodation region18 where interface member 50 may not interfere with the valve. of stent 10. As part of the release of the stent valve 10 as explained above, the second wrap 22 can be retracted proximally.

However, the path of the interface member 50 in the proximal direction can be restricted, for example, by the step profile of the coupling of the first tube 34. The re-. pull of the second wrap 22 can therefore cause relative movement between the second wrap 22 and the interface member 50, resulting in the interface member 50 transitioning to the open end 22b of the wrap 22. When the interface member 50 cannot the more it is restricted 15 by the wrap 22, the interface member 50 (or the portion 52) can self-expand.

In expansion, interface member 50 can become so 'large to be received entirely again within envelope 22. BR interface member 50 can at least "float" partially captive in the catheter between stent retainer 24 and the second wrap 22. In some embodiments, it may be desired to re-wrap wraps 22 and 24 before removing catheter 12 from the body.

When the second wrap 22 is closed again after releasing the stent valve 10, the interface member 50 can at least partially autolocalize or "float" on the open end 22b.

The interface member 50 can be driven distally towards the stent retainer 24 and / or the open end 20b of the first wrap.

Optionally, interface member 50 can be propelled distally until its path is stopped by stent retainer 24 and / or the first wrap 20. For example, if the first wrap 20 is currently in its open position, the member interface 50 can advance until its path is stopped by stent retainer 24. Then, when the first wrap 20 is closed, the interface member 50 can cooperate with the open end 20b of the first wrap.

. 42/70 ”- thorium 20 as explained above. | Optionally, interface member 50 can be scaled | at one end or both ends, to be partially | insertable in a respective open end of a wrap even when the expandable portion 52 (for example, intermediate of the ends) is expanded and becomes too large with respect to the open ends of the wrap.

Such insertion may provide a pos-! Service and cooperation between (or each) wrapper and the interface member.

Tal | insertion can also provide a degree of high alignment or self-centering between (or each) envelope and the interface member.

If both - the ends of the plug are inserted into the respective wraps, the wraps can also self-align or self-center in registration with each other. In addition or alternatively, the expandable portion 52 of interface member 50 may have an annular bulging shape generally | flat or bulb.

The expandable portion may have surfaces generally re- | Ú donda or ramp at its opposite axial ends.

Such format or | BR formats can provide a smooth transition between interface member 50 and each open end 20b and 22b and / or a generally smooth profile or bridge between open ends 20b and 22b.

The shape may further increase the self-alignment or self-centering of the open ends 20b and 22b in registration with each other.

The expandable portion 52 can be dimensioned in such a way that, in the expanded state of the expandable portion 52, at least one of the open ends 20b and 22b will not pass entirely over the expandable portion.

For example, in the case of confronting the open ends 20b and 22b, optionally none of the open ends 20b and 22b can pass entirely over the expandable portion 52. In the case of the overlap of the open ends 20b and 22b, optionally one of the open ends can pass over the expandable portion 52. The ends of the interface member can generally be asymmetrical.

In the illustrated shapes, the proximal end 62 can be

+ formed like a cone. The cone shape can provide a mounting surface for an optional skirt 60 described below and or provide a fitting profile for fitting within the coupling of the third tube 44. The distal end 64 can be formed as a generally annular ring with - smooth edges, for example, rounded to guide the open end 20b: of the first wrap 20 when the first wrap 20 is closed over the same.

í With reference to figure 21, in some embodiments, instead of closing the wraps 20 and 22, it may be desired to remove the catheter 12 from the body while the distal portion 14 remains in an "open" condition, - For example, at at least the first wrap 20 may remain open, whether the second wrap 22 is "open" or at least partially closed. In such a case, the stent retainer 24 and the interface member 50 may remain exposed in the distal portion 14. The '15 50 interface member may tend to slide into the stent retainer 24, or as a result of movement through anatomy or when the distal portion reaches the site of an introducer that fits closely 19. The interface member. 50 can cooperate with stent retainer 24 to provide a more aerodynamic profile than abrupt edge 92. In particular, interface member 50 may comprise a conical surface 62 that defines a smooth ram profile that will slide over the edges of an introducer 19 to guide the stent retainer 24 into the introducer and / or through the hemostasis valve. The interface member 50 may comprise an enlarged oversize portion 52 that acts as a stop to prevent the interface member 50 from passing through the introducer until the interface member 50 comes into contact with or engages with the stent retainer 24 At that point, the continuous thrust to remove the catheter causes the enlarged portion 52 to disassemble slightly, allowing the interface member 50 and stent retainer 24 to pass smoothly through the introducer. The interface member 50 can - optionally be configured to form a snug interference adjusted on the end of the stent retainer 24 so that it remains in close contact with the stent retainer 24.

. The interface member 50 as described above can comprise any suitable materials, including one or more of: plastics, resiliently compressible plastics, metal and profile memory alloys (e.g., nitinol). In the illustrated form, the interface member 50 comprises a generally non-compressible core member 54 carrying. an outer cover 56 defining the expandable portion 52. The non-compressible core may, for example, be plastic. The outer cover 56 & may, for example, be of metal or profile memory alloy (e.g., nitinol) to provide a well-defined expanded shape. The expandable portion 52 may comprise segments defining a bulging or similar bulb. home to the cage.

In addition to or as an alternative to any or all of the structural features, the interface member 50 may optionally comprise a flexible sleeve or skirt 60. The sleeve or skirt 60 may optionally be constructed as plurality of petals or segments of material that may or may not overlap, and collectively behave as either a glove or skirt and all references here to a skirt are intended. which also refer to such petals or segments. The skirt 60 can be unfolded from a folded or deformed state to an expanded state. Skirt 60 may be substantially self-expanding. In the folded / deformed state, the skirt 60 can be retained and / or restrained within one of the wraps 20 and 22. In the expanded state once the skirt 60 has been released, the skirt 60 can be dimensioned to fit - outside the open ends 20b, 22b or at least one of the wraps 20, 22, respectively. In particular, skirt 60 can at least partially cover the open end 20b of the first wrapper 20. skirt 60 can be made of any suitable material, for example, flexible plastics. In one form, skirt 60 can be cut from a profiled balloon member, for example, as used on a balloon catheter. A balloon catheter can be used for valvuloplasty. Such a balloon can be molded into its expanded shape and a skirt 60 cut from such a balloon can be self-polarized to the expanded shape, but also be flexible and easily foldable.

- a deformed state. Such a balloon is also designed to be of fine material having atraumatic characteristics. In the illustrated example, the skirt 60 can be connected to be an integral part of the interface member 50. The skirt 60 can be connected to the proximal cone 62. The cone 62 can provide an appropriate divergent surface. to support the natural shape of skirt 60.] Rather than being slidable, the folding interface member q 50 and / or skirt 60 could be substantially stationary with respect to stent retainer 24. In an example described below, the interface member - folding c 50 and / or skirt 60 can be mounted on stent retainer 24. - Figures 10a-c illustrate different examples of stent valve element for engaging different examples of stent retainer 24, 'as illustrated in figures 11 -13 and 22. The stent valve can comprise at least one fastener 68, optionally two or three fasteners 68, optionally more. Generally, each fastener 68 can be defined by an apex 74 or 76, joining first and second S struts 70 and 72 that extend from one end of the stent valves. 10. Struts 70 and 72 can be members defining a trellis or stencil stencil structure 10. In the case of a truss, the cell associated with struts 70 and 72 can project axially beyond the neighboring cells of the truss.

In figure 10a, struts 70 and 72 can extend in a generally linear manner to meet at apex 74, defining a shape generally of V. In figures 10b and 10c, apex 76 is slightly different in that it incorporates a U shape between the ends of the struts 70 and 72. The U-shape can be straight-sided (for example, figure 10b) or it can have curved sides (for example, figure 10c).

With reference to figure 11, a two-piece stent retainer construction is described. However, it will be appreciated that the stent retainer can, if desired, be made as a one-piece item. An example construction of two stent retainer parts 24 can generally comprise first and second parts 78 and 80 mounted together. The first part

78 may comprise a cube 82 from which a plurality of projections 84 project. The second part 80 may comprise a housing having a hollow interior for fitting around at least a portion of the cube 82 from which the projections 84 project. and defining interstices 86 to accommodate locking projections 84 with a space or clearance 88 around them. . The casing can be forked to define the interstices. The edge 90 of each interstice 86 can optionally be rounded or chamfered. A two-part assembly can enable a complex stent retainer shape 24 to be formed reliably and cost effectively. It can also allow different materials to be used as appropriate (eg, the first part can be metal for strength, and the second part can be plastic). However, as already mentioned, the stent retainer 24 can ”] be formed as a unitary rather than a plurality of parts assembly. Ú 15 The projections 84 can be configured to fit inside the apex 74 or 76 of each fixture 68, when the stent valve 10 is in its disintegrated state. The engagement between the projection - 84 and the apex 74/76 captures the fixation element (and therefore, the stent valve 10) against axial movement, at least in an axial direction away from the stent 24.

Projection 84 can be referred to as a radial projection since it projects generally in a radial direction. In some embodiments, the projection or an edge thereof, can be tilted to the distal direction by an angle of, for example, no more than about 20 degrees, optionally no more than about 10 degrees, optionally no more that about 5 degrees.

In the example of figures 11 and 12, the projection 84 has an elongated blade or fin shape, suitable for adjustment inside the apex 74 (figure 10a). The use of a fin or blade can enable the projection 84 to have a desirably thin shape, while remaining strong (essentially in the elongated, axial direction). In addition to projection 84 by trapping stent valve 10 against distant axial movement

. of the stent retainer, the shape of the interstice 86 encompassing the apex 74, and / or engaging between a face of the end 92 of the stent retainer 24 and the apices' of the cell neighboring the stent can restrict the stent valve 10 against the axial movement in the opposite direction. The stent valve 10 can therefore be held in position until the expansion of the stent valve 10 can - disengage each fixing element 68 from the stent retainer 24. i In the case of a self-expanding stent valve 10, the % - clamping devices may disengage when the portion of the stent valve 10 from which the clamping elements 68 extend, is not covered by a wrap (for example, the first wrap 20). When expanding the valve. of stent 10, struts 70 and 72 move apart to open the V-shape of the apex 74. When the V-shape opens, this widens the interior of the el-. 'clamping element 68 to facilitate disengagement between the projection 84 and the apex' 74. The chamfered edge 90 of the interstice 86 also acts as a ramp surface to 'radially raise the struts 70 and 72 out of the gap 88 when the struts 70 and 72 expand circumferentially and are against the edge 90. In this case, the fasteners 68 can accidentally adhere within the interstice 86, the fasteners 68 can be released by slight rotation and / or axial displacement of the catheter, to promote more rotation against edge 90.

In the example of figures 13 and 22, the projections 84 are fingers or pins, suitable for adjustment inside the apex 76 (figures 10b / c). Each pin (figure 13) can be thicker than an equivalent strip (figure 12). In a disintegrated condition of the stent valve 10 (figure 13), the struts 70 and 72 can be intimately adjacent to each other in the fixing element 68, such that the arc of the U-shaped portion 76 extends around a first angle more than 180 degrees to define a closed or nearly closed eye having an opening greater than the spacing of the struts, to accommodate pin 84. The U shape can be referred to as a horse shoe U shape . The eye opening and the space between the struts together can define a keyhole shape. Alternatively, struts 70 and 72 can

- stay against each other on the fastening element 68 to close the eye. The arrangement can also restrict the fastening element 68 in both axial directions, merely by engaging the fastening element 68 and the projection 84. This can be advantageous in that it allows a chamfer surface to be used at the edge 90 of the interstice 86 and / or on the face of the end. 92 of the stent retainer. A beveled end face 92 may be desirable! to facilitate the removal of stent retainer 24 and first wrap 20 through stent valve 10 once implanted. In the expanded (or functional or non-disintegrated) condition of the stent valve 10, the struts 70 and 72 can move apart and the arch. apex in U-shape 76 can extend around a second angle that is less than the first angle, to at least partially open the -: eye. The second angle can be about 180 degrees or less. For example, the apex may be substantially U-shaped with a straight side. In] 15 a manner similar to that described above, opening of the apex 86 can facilitate disengagement from the projection 84. The beveled edge 90 of the interstice 86 also acts as a ramp surface to radially raise the struts' 70 and 72 out of gap 88 when struts 70 and 72 expand circumferentially and are against edge 90.

Figure 22 shows a stent retainer equivalent to figure 13, optionally for production as a single piece item. All stent retainers shown in figures 11 - 13 and 22 illustrate the provision of at least one ramp surface that extends partially around each projection, to define the ramp surface portions circumferentially on either side of the projection and axially (for example distally) to one side of the projection. The ramp surface portions are inclined externally away from the projections. The clearance around the projection is opened to another axial (proximal side) and / or opened radially outward. The radial height of the projection 84 can be accommodated entirely or at least substantially within the profile of the stent retainer body. The stent retainer body can be a revolution surface. A difference that can be noticed between one side of the example of the figures

and 0. "º -: -" 00Z-mDÀ) 23iii lr Co .DA2>?) a nr "nl AhAPAIA“ “ÚÂÔ“ CO "PO 49/70. 11 and 12 and on the other side of the examples in figures 13 and 22, is that in the last example, the ramp surface extends to the clearance or interstice floor around projection 84. The ramp surface can generally be tilted at an angle between about 20 and about 40 degrees, optional | finally around 30 or 35 degrees.

- With reference to figures 14 and 23, the stent retainer 24 can carry a skirt (or it can also be referred to as a glove) 94. The skirt 94% can optionally be constructed as a plurality of petals or segments of material that collectively hold like a glove or skirt and all references here to a glove / skirt are intended to refer to as well. as well as such petals or segments. Skirt 94 can be similar to skirt 60 described above and the same constitutional details can be used. Figure 23 illustrates a structure of the example in greater detail. The skirt 94 may comprise a generally tubular sleeve section 94a and a plurality 'of cuts or slits 94b defining joined petals or segments 94c. The pedals 94c can substantially cover the projections 84 and / or the radial recess around them. Slots 94b may allow petals 94c to fold. open or flex externally open. Slots 94b can generally be aligned with the projections 84 or the radial recesses around them. Such positioning of the slots 94b can ensure that the petals 94c do not obstruct the expansion and detachment of the stent valve fasteners. Bending outward from the petals can automatically lead slits 94b into the opening to allow fasteners to expand through the open slits.

The skirt 94 can work to facilitate the loading of the disintegrated stent valve 10, especially in the first wrap 20, before using the release catheter 12. The loading can be done first by opening the first wrap 20 (arrow 20a), folding back or open the skirt 94 (or its petals 94c), disintegrate the stent valve 10 in such a way that the fasteners 68 engage with the stent retainer 24 and then move the first wrap 20 in its closed position (arrow 20c ) covering the distal portion of the stent valve 10. Skirt 94 can return flat to

| 50/70 is to cover, at least partially, the fasteners 68. Covering the fasteners 68 can prevent the apex 74 or 76 from creating an a- 'rough edge that obstructs the closure of the first wrap 10, if the fastening element fixation 68 is not perfectly level with the surface of the stent retainer24. Covering the fasteners 68 can also prevent a .- of the fasteners from accidentally passing out of the open ends 20b of the first wrapper 20. It will be appreciated that when the * stent valve 10 comprises a plurality of fasteners 68, it can be difficult | easy to see if all fasteners 68 are perfectly engaged | 10 on stent retainer 24 during loading. Covering the elements of | - fixing 68 with skirt 94 can reduce your problem and can compensate to guide the open end 20b of the first wrap 20 along the fixing elements 68 even if it was not perfectly positioned. The skirt 94 can also protect the open end of the first gloves] 15 20 from aggressive friction at the edges of the external skirt material of the stent valve. 'Ú Skirt 94 on the stent retainer can also find use in. a release catheter 12 that has only a simple wrap (not shown).

In the arrangement of figure 14, skirt 94 can be distinguished from the optional skirt 60 of separate interface member 50. Figure 15 can illustrate an alternative arrangement in which a simple glove or skirts 94 can additionally perform the skirt function 60 as an interface element.

With reference to figure 15, following the release of the stent valve 10, asaia94 can be directed with its open end turning | distally, in order to cover the open end 29b of the first envelope 20. The skirt 94 can extend outside the first wrap 20. Within the terminology of an interface member, the skirt 94 can be in one - | unfolded when extending the first wrap to the outside

20. The second wrap 22 can be advanced distally to the first wrap 20. The second wrap 22 can optionally be advanced distally beyond its normal closed position.

. In addition to or alternatively to skirt 94, it will be appreciated that other foldable interface elements may be provided in / or form part of the stent retainer 24 or be mounted on the stent retainer support tube. This would illustrate another example of a foldable interface element that is not freely slidable within the accommodation region 18. i Figure 16 illustrates a handle 100 for the proximal portion 167 of the release catheter to control the portion distal 14 via tubes 26 - 30 extending between the proximal and distal potions of the release catheter. The tubes 26 can optionally be included or connected to the respective - rigid portions that extend through the handle 100. The handle 100 can comprise a fixed body 102 that if the Ú substantially extends the extension of the handle 110 and can be a slot | elongated 104 through which the control pins can slide, as' 15 described below. A fastener 106 can firmly couple the body 102 to the first tube 26, such that the body 102 can control the relative position Ú of the first tube 26. A handle of the wieldable "first tube" 108 can. be coupled to the body 102, for example, at the distal end of the handle

100.

The handle 100 may further comprise a "second tube" handle 110 having a helical guide 112 associated with it The helical guide 112 can optionally be formed into a separate component 112a which is coupled to rotate with the "second tube" handle "110. A slider 114 coupled to the second tube 28 may have a pin 116 that is | 25 tends through the slot 104 in engagement with the helical guide 112. The "second tube" handle 110 can be rotatable around the body 102. The rotation of the "second tube" handle rotates the helical guide 112, taking pin 116 and therefore the cursor 114 to move axially. The cursor 114 transmits the axial movement to transfer the second tube 28 relative to the first tube 26 to thereby transfer the first (distal) envelope 20 with respect to | to the stent retainer 24. The handle 100 may further comprise a "ter- |

. third tube "118 having a helical guide 120 associated therewith. Helical guide 120 can optionally be formed into a separate component '120a which is coupled to rotate with the" third tube "handle 118. A cursor 122 coupled to the third tube 30 can have a pin 124 that extends through the slot 104 in engagement with the helical guide 120, The - "third tube" handle can be rotatable around the body 102. The rotation of the "third handle" tube "118 (relative to body 102) rotates the helical guide 120, lifting pin 124 and therefore the cursor 122 to move axially. Curve 122 transmits axial movement to transfer the third relative tube 30 to the first tube 26, in this way to transfer the second (proximal) envelope 22 with respect to the stent retainer 24.

Optionally, handle 100 may comprise at least. a nozzle orifice 126 through which the liquid (for example saline) can be injected in order to release air from the spaces that are open to the anatomy. In particular, it may be desired to level the space between the first and second tubes and the space between the second and third tubes. In some embodiments, a simple or common nozzle orifice 126 can. be provided to level both spaces. A communication orifice or opening (the position of which is indicated schematically at 128 and referred to below by the same number) can be provided to allow the liquid in one space to enter the other. nozzle 126 can be configured to admit the liquid in the space between the first and second tubes. A communication port 128 is optionally positioned on the handle 100 or at least closer to the proximal portion of the catheter than to the distal portion, in order to level the spaces fully up to the distal portion. Providing a simple or common nozzle orifice 126 to level a plurality of spaces can be advantageous in simplifying the number of connections and operations that an operator has to perform when preparing the catheter for use. Alternatively, if it is desirable to have independent control over the leveling of each space, a plurality of nozzle holes 128 can be provided, each communicating individually with a respective space to be leveled.

. Handle 100 can be configured to apply pre-tension to one or more of the tubes, as described above. Various mechanisms for applying pre-tension are designed. The mechanism can be part of the "second tube" 110 handle or it can be a separate mechanism capable of application. In a simple, more effective and intuitive way, the .- "second tube" 110 handle can be rotatable to generate the pre-tension and can be lockable in the stretching position. The handle can be lockable using any appropriate latches such as a removable pin or a ratchet mechanism. In addition, handle 100 may include an indicator ring to indicate the amount of rotation of handle 110 to generate a desired amount of pre-tension. The indicator ring can be manually adjusted in such a way that a first marker is registered with a counter - marker on handle 110 when the first wrap is in a closed position with no pre-tension. Once adjusted, the indicator ring can indicate, by a second marker, the greater degree of rotation by which handle 110 must be rotated or moved to generate the pre-tension. The lock to lock the handle 110 in position and / or the adjustable indicator ring are ge-. usually shown schematically at 110a. However, it will be appreciated that the lock and indicator ring can be separated and / or placed in different positions on handle 100 as desired.

Figure 20 illustrates a liner sleeve 150 that can be used with catheter 12. The liner sleeve 150 can act as a friction reduction liner between catheter 12 and an introducer 19 (for example, a standard arterial introducer) through than the catheter is inserted into the body. The lining sleeve 150 can reduce friction in the catheter tubes, especially in the outer tube 30, allowing easier deployment of the stent 10. A standard arterial introducer includes a hemostasis valve 19a to prevent blood reflux and aspiration of air. The hemostasis valve 19a can be a multiflap valve in order to work with a wide range of different types and sizes of equipment that could be introduced into the artery. The aggressiveness of the hemostasis valve may tend to obstruct fine displacement of the tubes of the release catheter 12 to control the translation of the envelopes.

ee 39D2: =]> -)]) ““ Ió R ».ôaZÔOQ“ “» A?)) AND “cÓÔ! aU See I “me. ". o. 54/70 * rivers in the distal portion. The liner sleeve 150 provides a low-friction interface between the third tube 30 and the introducer 19. The liner sleeve 150 can be 'captive in catheter 12 and slid axially along the length of the catheter The lining sleeve 150 may include, at its proximal end, a stop 152 that limits the length of the entry into the introducer In addition or alternatively, the lining sleeve 150 may include a portion 154 for removable interference adjusted with socket 156 of handle 100. This allows the liner sleeve 150 to be stored connected to socket 156 of handle 100 and separate from handle 100 when you wish to advance the liner sleeve 150 to the operating position within an introducer 19. The iron sleeve 150 - can optionally additionally comprise a seal 158 to effect a substantially blood-tight seal between the liner sleeve 150 and the outer tube 30 of the catheter 12. The seal 158 can be configured - only for the size of the catheter 12 and thus can be substantially less aggressive than the introducer hemostasis seal 19a

19. For example, seal 158 can be formed by an O-ring. Sale 158 can optionally be provided on stop 152 or on the connector. 154, such that the seal 158 is not subjected to forces inside the introducer 19. Alternatively, the seal 158 can be positioned anywhere along the length of the liner sleeve 150.

When unfolded to the introducer, the liner sleeve 150 may not be fixed axially and / or rotationally with respect to the rest of the catheter 12, allowing the catheter to be handled without obstruction. In some embodiments, the length of the iron glove 150 that protrudes distally from the stop 152, may not be greater than about 30 cm, optionally not greater than about 25 cm, optionally not greater than about 20 cm cm, optionally not greater than about 15 cm, optionally not greater than about 10 cm.

Figure 24 illustrates a modification of the release catheter including a spherical joint (the terms spherical joint, spherical socket, spherical socket joint and spherical socket connection are all interchangeable) at least in one tubular member of the catheter . The spherical joint can

Cs NODE. “P“ ÔÓ: iesã j,; Ôàjcíúº "l. Õ + â0])] m" "”. Be s — a - ”” * ii ô0 55/70 'be provided just proximal to the accommodation region of stent (also referred to here as the stent retention region or compartment) of the catheter, in such a way that the spherical joint can provide a region of high flexibility just proximal to the stent retention compartment.

The spherical joint may be located within the Scm proximal to the stent retention compartment.

The jun-. The spherical shape can also be 0.1, 0.5, 1, 2, 3, 4 or 4.5 cm proximal to the stent retention compartment. The spherical joint can also be between 1 L and 2 cm proximal to the stent retention compartment.

The spherical joint can be provided in a tubular member of the catheter that moves axially with respect to the stent position.

That is, the tubular member, according to al-. In some embodiments, it can be moved in a proximal 22A or distal 20A direction (also as shown in figure 1) to release the stent.

In this case, the distance measurement above is defined to be when the tubular member is in a position corresponding to a closed position, for example: a more approximate position for that tubular member.

An example of this approximate position is shown in figure 24. In the a-] position, the wraps can be joined end to end or per-. remain spaced from each other.

The spherical joint can be provided on the external tubular member of the catheter assembly.

The spherical joint is preferably hollow or includes an opening to allow passage of one or more internal tubular members.

In some embodiments, there is a simple inner tubular member that passes through the outer tubular member.

This inner tubular member can be a guide wire receiving lumen.

A stent retainer can also be mounted on the inner tubular member.

There can also be at least two tubular members that pass through the outer tubular member.

These two or more inner tubular members can be arranged within each other.

There can also be three, four, five, six, seven, eight, nine or ten internal tubular members. Each of these can be fitted one inside the other.

In some embodiments, the spherical joint may allow the tubular members to be bent over a range of up to at least e MM. .õP PY PÉ éP) I "[Nʺ ii. ns" o "" "0" 1 There [1â1 +; " a. 56/70. 45º, compared to the catheter's straight axis at that point. The spherical joint may also allow the tubular members to be bent up to at least 40º compared to the straight catheter axis at that point. The spherical joint can also allow the bending of the tubular members up to at least 20º in comparison to the straight axis of the catheter at that point. THE . spherical joint can also allow curving of tubular members] up to at least 30º, compared to the catheter straight axis at that 1 point. The spherical joint also allows the tubular limbs to be bent up to at least 20º compared to the catheter's straight axis at that point. The spherical joint can also allow the members to bend - tubular through 20º, 21º, 22º, 23º, 24º, 25º, 26º, 27º, 28º, 29º, 31º, 32º, 33º, 34º.35º, 36º, 37º, 38º, 39º, 41º, 42º, 43º and 44º compared to the axis. catheter straight at that point. Such high flexibility would be difficult to achieve with a continuous bending member with an equivalent cross-sectional diameter, 15, without risk of twisting of the continuous member. In some embodiments, the spherical joints have a transverse external diameter (for example, measured in a direction from the cross section to the catheter axis) that is not greater than a diameter of at least one adjacent tubular member of the catheter. catheter set. This allows the ball joint to be accommodated without widening the profile of the size of the catheter assembly. The profile of the tubular member adjacent to the ball joint can blend smoothly into the profile of the ball joint to define a generally smooth continuous surface, even when the catheter assembly is flexed in the ball joint. If desired, the transverse outer diameter of the spherical joint can be greater than a diameter of both adjacent tubular members of the catheter assembly leading to the spherical joint.

In some embodiments, the transverse outer diameter of the spherical joint is not greater than a diameter of the larger tubular member of the catheter assembly. For example, for a catheter assembly insertable into the body using an 18 French size introducer, the maximum diameter of an external tubular member is approximately 6mm (not greater than 7mm). The transverse external diameter of the spherical joint must then be no and ss. >. 00 o. us "º“ “ce sm 57/70. larger than this maximum diameter. In some embodiments, the spherical joint extension (in an axial direction of the catheter assembly) can be increased to about two thirds of the transverse external diameter of the In some embodiments, the spherical joint can also allow an axial force to be applied along the extension of the tubular members, to propel forward (distally) or to stretch back (proximally). For example, the outer tubular member may comprise a wrap (for example, part of a proximal wrap) that at least partially surrounds the stent and the wrap can move axially forward or backward under axial force for change. from a closed state to an open state. The axial force can be applied through the ball joint. The ball joint can thus form part of a portion or subset of the catheter that moves axially with respect to the 15 position. stent in the catheter.

In some embodiments, the spherical joint may also allow for relative rotation between the two parts of the tubular members in one. the sides of the ball joint. The relative rotation can be limited to one lap or in some embodiments, the relative rotation can also be limited to two, three, four, five, six, seven, eight, nine or ten turns. Alternatively, it can be unlimited. One of the arrangements may allow the catheter stent retention compartment to be rotated, while the catheter's outer body remains stationary in the artery without rotation. The external body of the catheter can act as a plug into which the other tubular members rotate, without friction with respect to the artery wall. The torsion can be applied via other (one or more) tubular members loaded into the catheter and passing through the spherical joint to the distal section of the release device (at least distal from the spherical joint). Alternatively, a hydraulic or electronic actuator can generate rotary movement in the distal part (stent holding compartment) in response to an appropriate / electronic fluid signal provided via an electronic signal line or a fluid conduit.

and e ss. A »a Né” ÚÔ I) 73â? O “ÔÍI9”: - $ ÁAS JAÀÉÍÔ * 1t1o0 "" 'OO !! ") Ç7” º “Oô6); -aíú-aA-34 + -" O 58/70' Figure 24 shows an example of a stent delivery device with a spherical joint according to some embodiments Ú of the present invention. As shown, the spherical joint 1 is provided in the external tubular member 30 of the catheter, which is the tubular member to stretch the external envelope backwards (proximally 22 A for the catheter handle). proximal (second wrap) 22 covering (at least) a portion of the 'stent 10. To pull the proximal wrap back, an axial force is applied from a handle along the catheter extension and then through the ball joint for the outer wrap. The rotation is performed by applying a torsional force to the internal tubular members 26 and / or 28 inside the catheter. These rotate the stent from the inside. Stent retainer 30 transmits torsional force from the other internal tubular members to rotate the stent around the catheter axis. The friction between the stent and the external envelope also rotates the external envelope. The spherical joint allows the outer casing Ú 15 to act freely without torsion that is applied (or resisted) by the body of the catheter. Figure 1 also shows that the stent retainer can be located Ú distally 6A or proximally 6B. The stent retention compartment. it is composed of the proximal wrap 22 and the distal wrap 20. The distal wrap is fixed on the internal tubular members. When the tubular-resin limbs are extended distally, the distal envelope can also be pushed distally and out of the stent. Similarly, the proximal wrap can be pulled proximally, as described above. The innermost tubular member also forms a guide wire lumen 3 that extends through the center of the catheter.

The spherical joint and the portions of the tubular member coupled thereto may be of any suitable material, for example metal (for example stainless steel) or plastics (for example, nylon).

The socket part of the spherical joint can communicate with a staggered reduction region or even a local reduction of sectional area in the tubular member, in order to allow the spherical extension of the socket surface to be increased.

A relative aspect may be the provision of a discharge portion and Si N. PP PA; G = z. the * º “Q“! PO “u7TTISANCE ESÍI) I * O! MIOOOEWMÔWU“ ow: o0á! ÊAÔo 59/70. flexibility of the catheter adjacent to the stent retention compartment. High flexibility can be defined as having a resistance to flexion less than 50% of the tubular member on one side of the region of high flexibility. The region of high flexibility can also have a resistance of 10%, 15%, 20%, 25%, 30%, 25%, 40% or 45% of the tubular member in one of the la-. high flexibility region. The region of high flexibility can have an axial extension of less than 5 cm. The region of high flexibility can also have an axial extension of between 1 and 2m. An implementation for the high flexibility region may be using a spherical joint as above. Another may be to use a segment of highly flexible tubing attached to (or integral with) the catheter tubing.

The flex and rotate joint of a spherical joint can * even be separated into two separate connections, joints or couplings, as long as both of these are close to the catheter stent retention compartment S 15. The two couplings are generally no more than S5cm apart. The two couplings can also be between 1 and 2 cm apart. The bending connection can be positioned closer to the com-. stent retention partition to compensate for the stiffness of the adjacent stent, however the order could easily be reversed according to a particular implementation. It will be appreciated that including a ball joint in the outer tube can restrict the amount of torque transmissible through the outer tube. The construction of other internal tubes can optionally be modified to transmit the torque, for example, using the principles previously described.

Figures 17, 18 and 19 illustrate a detailed example of a stent valve 10 so that the release catheter 12 of any preceding embodiments can be eminently appropriate. The stent valve 10 can be of a self-expanding type that is resiliently polarized to the expanded and / or functional state, and is compressible to a compressed state by the application of appropriate radial compressive forces. The stent valve 10 remains in its compressed state while restricted

——, 8 .—— »—————> 295 AeAeÂúwúba aaa AA PP“ Mm om “om sto oe 60/70 - gido. When the restriction is removed, the stent valve 10 expands to the expanded and / or functional state. Alternatively, the stent valve Ú 10 can be of a non-self-expanding type that requires the application of an expansion force to transform the stent valve 10 from the compressed state 10 'to the expanded state.

. The stent valve 10 can comprise a stent component 134 supporting a plurality of valve leaflets 136. The leaflets 136 can collectively be referred to as a valve component, whether or not the leaflets 136 form an integral unit. The stent component 134 can provide an anchoring function to anchor the stent valve to native anatomy and / or a support function to support valve leaflets 136. Stent component 134 can be of any mate. appropriate materials or materials. The stent component 14 can be metal. Example materials include profile memory and / or superelastic alloys] 15 (eg nitinol), stainless steel or cobalt-chromium alloy. In the illustrated form, the stent component 134 is self-expanding and is of super elastic periliga memory (eg nitinol). However, the stent component 134 could also be substantially non-self-expanding. Stent component 134 may have any desired profile to anchor and / or align stent valve 10 with respect to native anatomy at the desired implantation site. In some embodiments, the stent component 134 may be generally cylindrical in shape or comprise one or more generally cylindrical portions or portions that rest on a generally cylindrical surface (for example 140c and 142a). In addition or alternatively, stent component 134 may be generally non-cylindrical in shape or comprise one or more generally non-cylindrical portions or portions that rest on a non-cylindrical surface (eg 140a, 140b and 144 ). Additionally or alternatively, the stent component 134 may comprise one or more anchor projections and / or one or more stabilization portions.

When viewed in one aspect, stent component 134 optionally has an inflow end and an efflux end,

| tionally self-expanding from a compressed state for release to a functional state on implantation, the stent component 134 i comprising an efflux structure, for example, in the form of a plu | arcing ratio 144a at the efflux end each having an apex at the efflux end, the stent component still comprising a crown] (e.g. upper crown) 140b between the inflow and e-flow ends, a crown 140b having a free end between the inflow and outflow ends and directed towards the outflow end and the stent component further comprising the clamping section (e.g., lower crown) 140a between the crown and the inflow end.

Additionally or alternatively, stent component 134 optionally comprises an anchoring portion 140 defined, for example, by a lower crown 140a and an upper crown (or other fixation section) 140b that together define a groove and / or belt 140c between them.

The anchoring portion 140 may have a first resistance to compression and may comprise a cellular lattice. - The stent component 134 optionally (further) comprises a valve support portion 142 comprising, for example, a plurality (e.g., three) commissural support posts 142a.

The commissural support posts 142a can be arranged in a diameter of the pass circle less than one end of at least one of the crowns 140a and 140b.

The commissural support posts 142a can be arranged in a circle diameter of the pass corresponding to the belt 140c.

The commissural support posts 142a can partially overlap at least one of the crowns 140 and 142 in the axial direction and extend axially beyond that respective crown.

The commissural support posts 142a may be similar to the frame.

The commissural support posts 142a can be shaped that follow at least approximately a peripheral contour of the valve, at least in the region of the periphery adjacent to the commissural support posts.

The stent component 134 optionally (yet) comprises

CN SiiPÍ .. Aa E TTÕS O ENSÔ);) ICOE! , -) 2OoO | [”- AC“ 62/70 - a stabilization or alignment portion 144 that can represent an efflux structure.

The portion 144 can be defined, for example, by a plurality (e.g. three) of fins or arcs 144a.

The arches 144a can extend from the tips of the commissural support posts 142a, to define an arched structure over it.

The alignment portion. 144 may have greater flexibility than the anchoring portion 1408 / or] the valve support portion 142. The alignment portion 144 may have. a second compressive strength which is less than the first compressive strength of the anchoring portion 140. The alignment portion 144 may be less rigid (for example radially) than the anchoring portion 140 and / or the support portion of valve 142. Stent component 134 optionally (still) comprises - a fixture 68 for securing stent component 134 to a stent retainer 24 of release catheter 12. In the present embodiment, the '15 portion of fixation 68 is defined by a plurality (for example, three) of cell extensions of the lower crown 140a and has a shape corresponding to one of the examples in figures 10a-c.

R The valve component or leaflets 136 may be of any suitable natural / and or synthetic material.

For example, the valve / booklet component 136 may comprise porcine and / or bovine pericardium and / or natural collection valve material.

The leaflets can be supported to co-fit or disassemble in a closed position to obstruct flow in a past direction, while flexing far to an open position to allow flow in an opposite direction.

The valve / leaflet component 130 may be accommodated in the valve support portion 142 and / or at least partially within the anchoring portion 140. The leaflets may have side projections.

Projections in adjacent pairs of leaflets can pass in pairs through slots in the support posts 142, be folded back and sutured on one side of the slot.

The support posts 142a may have suture hole lines on one side of the slot to accommodate the sutures.

Other suture holes can be provided above and / or below the tears.

If desired, the suture hole above the eee RA .à A. . The "o" ... mA 63/70 - slot (indicated in A in figure 19) and / or the suture hole below the slot, can be omitted to save space.

i The stent valve 10 (for example the valve component 136) can further comprise an inner skirt and / or an outer skirt by partially covering a portion of the inner or outer surface - of the stent component 14. For example, the skirt may cover at least a portion of the anchoring portion 140 and / or at least a portion of the | valve support portion 142. The skirt can be made of any suitable material, including PET and / or pericardium. The pericardium may be of the same material as the leaflets. In some embodiments, the inner and outer skirts may partially overlap each other in a region of overlapping skirt A in figure 17 and include the portions of non-overlap extending axially up and down, respectively in overlapping region A. The inner skirt can be advantageous in channeling blood: 15 to leaflets and preventing blood leakage through the interstices of the truss structure. The external skirt can be advantageous in preventing blood from leaking at the interface between the stent valve and surrounding tissue. . The provision of both skirts, however with only partial overlap, may enable the advantages of both to be obtained, but also reduce the total overlap of material (which would otherwise increase the material thickness of the stent valve making it the most difficult to compress the stent valves to a small size). The partial overlap however provides a reliable seal to be made between the inner and outer skirts.

In use, seen in general, at least a portion of the lower crown (or other securing section) 140a can be received and restricted by the first wrapper 20. At least a portion of stent component 134 not covered by the first wrapper 20 can be received and constricted by the second wrap 22. As explained above and described in more detail below, a method of releasing the stent valve 10 may include moving the second wrap 20 to an open position in order to fold the upper crown / crown 140b, followed by the support section 142 and

RP. çêCf "AÁSOO;!» 4IÁSÊES ars Bh) 21á ATI EO 64/70 * finally the arches 144a. For example, these elements can be deployed on one side of the aorta of a native and / or a failed valve. once the operator is satisfied with the position and / or function of the stent valve 10 within the native anatomy, the first wrap 10 can be moved to its open position in order to unfold the lower crown 1401. Simultaneously, the fasteners 68 can be released from the i 24 stent retainer.

c Such an unfolding sequence is different from that described in world patents WO-A-2009/053497 and WO —A-2011/051043. However, it has been appreciated that the unfolding of the arches 144a after the crown 140b is more highly effective in allowing the arcs to function. Notably, the bows can be unfolded before the cover is removed. fixing section 140 for unfolding. In some embodiments, the arches can be configured] 15 to align the stent valve with respect to an axis of the ascending aorta by contact with the wall of the ascending aorta. For example, the arches can be curved independently of each other. The crown can be configured. to engage and / or rest against existing leaflets from one side of the outflow. The clamping section can be configured to engage an existing valve ring.

Below, a detailed description of how the device described above can be used in an example will be presented. The description can be modified according to which the characteristics of the device can be implemented according to the current embodiment used. The order of individual steps can be changed as desired. The steps are grouped by topic. The order of the topics can be changed as desired. The order of the steps within each topic can be changed as desired. The following description can mainly focus on the previously described release catheter characteristics; additional steps not described here can be included as part of the procedure, as may be known to those skilled in the field of transcatheter stent valve implantation.

—————— € —— € ——wW "or:> NA = 2SÓÕôMôÊO ú ÔÔó âÚÂwLÂN» NÉÇÉ ;, The ““ ““ ““ ““ Pa ”PAP“ is. 65/70 - A: Loading the stent valve in the accommodation region: AT1: The first and second wraps 20 and 22 are each opened using controls 110 and 118 of the handle 100. The feet 94c of the skirt 94 are folded back to expose the 84 projections of the stent retentord.

R A2: Stent valve 10 is compressed in place in the accommodation regions. A conventional corrugator can be used. The stent valve is arranged with its end (for example, inflow end) with the fixing elements positioned distally in the accommodation region and in register with the projections 84. The lower fixation / crown section 140a they can be compressed first, such that the fasteners 68 are coupled with the projections 84. Using the handle 110, the first wrap 20 can be translated proximally to at least partially cover the lower fixing section / crown 140a and capture the valid-] 15 vulade stent for its fastening elements. During such translation, the feet 94 may open flat to lie between the inner surface of the first wrap 20 and a portion of the outer surface of the stent valve. Then, the remaining sections of the stent valve can be compressed (for example, the upper crown / crown 140b; the valve support section; eosarches) and the second wrap 22 is translated distally to at least partially cover the stent valve a from the arches to the upper cormorant 140b to restrict these sections of the compressed stent valve. As previously mentioned, in the closed positions of the first and second wraps, the ends of the wraps can be substantially in end-to-end mode or the wraps can remain spaced. B: Preparation of the release catheter for introduction into the body (following step A): B1: The release catheter can be squirted by the injection liquid (for example, saline) via at least one nozzle orifice

126. Optionally, plurality of spaces within the delivery catheter can be squirted by the injection liquid through a single orifice a a. . — Ú “2 UÕU U“ oº ““ .A “| ô P if l-s im 66/70: and / or common 126. B2: The first tube 26 can be pre-stretched by turning the knob 'from 110 to the second tube to further close the first wrap. The amount of pre-tension to apply can be indicated by manually adjusting the indicator ring in such a way that a first marker on the indicator ring. the aligner aligns with a counter-marker on the handle 100. The handle of the second tube 110 is further rotated by the indicated amount and a second marker on the ring to generate the pre-tension. The handle of the second tube 100 can optionally be locked in the pre-stretched position, in order to avoid sliding of the handle in use and to relax the pre-tension before the desired moment. C: Steps performed on the patient before implantation (following step A or B): C1: An arterial introducer 19 is placed to penetrate percutaneously an artery, for example, the femoral artery or subclavian artery. A guide wire is introduced through the introducer 19 and navigated through the vasculature to cross the valve to be replaced, for example, a BR aortic valve. C2: A balloon catheter can optionally be introduced through the introducer 19 and advanced along the guide wire to the valve to be replaced. Valvuloplasty can be performed to free valve leaflets in the case of a stenosed valve. The balloon catheter is then removed. D: Stent valve implantation (following steps A, B and CC) D1: The delivery catheter can be fed along the guide wire to the introducer 19, with the guide wire being received into the lumen of the first tube 26. The distal portion of the delivery catheter can be introduced through the introducer. Then, the delivery catheter can be progressively fed through the introducer, to advance the distal portion along the chia thread to the location of the valve to be replaced.

D2: At some stage, at least after the distal portion has passed

Through the introducer 19, the liner sleeve 150 can be detached from the handle 100 and slid distally along the catheter shaft and into the introducer 19 to provide reduced friction adjusted in the introducer. This can allow easier advancement of the catheter through the vasculature, and / or easier handling of the wraps in the following steps.

. D3: When the distal portion is approximately in position or slightly elevated in the ascending aorta, the operator can, if desired, 1 rotate the release catheter to rotationally align the stent valve with the native anatomy. Although the geometry of the stent valve itself can: not require such rotational alignment, some people skilled in the art may prefer the possibility of aligning the stent valve with the native valve, so that the stent valve can replicate the function of valid-. natural valve as closely as possible. As previously described, the combination of braided tubes 26 and 30 and / or the feature of braided '15 - third tube 30 allows good transmission of torque from handle 100 to the distal portion, despite the relatively long extension of the] catheter release. The rotational orientation of the stent valve can be observed using imaging equipment, for example, X-ray imaging equipment.

D4: With the distal portion still approximately in position or slightly high in the ascending aorta, the third tube 118 handle can be operated to move the second wrap 22 proximally and free the sections of the stent valve previously covered by the second wrap

22. This can include the upper crown / crown 140b, the arches 144a and any sections (e.g. support section 142) between them. The translation of the second wrap 22 may first release the upper crown / crown 140b, followed last by the arches 144a. If pre-tension is used in step B2, the pre-tension can polarize the first wrap proximally preventing any tendency for the first wrap to distally distort as a result of the reaction forces applied through the tubes during handling of the second wrap. It can be appreciated that although the pre-stretching step is described as part of the preparation in e ss Ui PP e) nú A es ". 68/70 - step B2, the application of pre-tension can be carried out later in any stage before D4, even after the catheter has been advanced to the single valve to be replaced. Performing the pre-stretching step later can, in some cases, improve the flexibility of the catheter for tracking along the guidewire.Additionally or alternatively, it can be appreciated that if the liner sleeve 150 is used in step D2, the liner sleeve 150 can reduce the frictional resistance against movement of the third tube 30 within the introducer 19, thereby making it the translation operation of the second | wrap 22 easier and smoother.

D5: The operator can gently propel the catheter until the unfolded upper crown / crown 140b is tapped against the existing leaflets of the valve to be replaced. In such a placement, the operator can feel resistance and effectively feel that the upper crown / crown 140b is correctly seated against the leaflets. In addition or alternatively, the '15 position can be monitored by the appropriate imaging equipment, such as X-ray imaging equipment. During: such manipulation of the catheter with the partially deployed stent valve,. the engagement between stent retainer 24 and fasteners 68 keeps the stent valve firmly anchored in the release catheter.

D6: When the operator is satisfied with the position of the upper cormorant 140b, the operator can operate the handle of the second tube 110 to translate the first wrap 20 distally in order to release the lower clamping / crown section 140a. If the second tube 110 handle is locked in position as part of the pre-stretch operation, the lock can be removed or disengaged to allow the pre-tension to be released and the second tube instead of applying a compression force to transfer the first wrap distally. As previously mentioned, the construction of the second tube provides good resistance of the column to transmit the compression force from the handle 110 to the first wrap 20.

D7: When removing the first wrap 20, the lower crown / clamping section 140a unfolds to anchor the stent valve in position. The fastening elements 68 expand radially to ee the "OAºôÔÚº PA" P "A ÔÔ") bô "" "" [ÓQ "ÚÚAA" Omimmmi E ni "nn aan Aa lil aa 9 5 96 tocoãO 69/70 - outside and can expand circumferentially, to automatically release from the projections 84 of the stent retainer 24. The ramp surfaces at least partially surrounding the projections 84 raise the expanding fasteners radially removed from the retainer. stent 24. Probably in the event that any fastener 68 can remain attached to the stent retainer 24, the ramp surfaces also provide a facility for releasing the fasteners by slight axial and / or rotation of the release catheter, which encourages the fixation element to meet a ramp surface.

D8: Following the release of the stent valve 10 from the accommodation region, a first step of removing the release catheter may be to remove the portion of the release catheter that is distal from the valve flaps 136, through the valve leaflets to the proximal side (for example, to the ascending aorta). Then, the delivery catheter can be: 15 removed with wraps 20 and 22 open or closed. It can be appreciated that: E: Removal of the release catheter, while open (after eta- BR pa D): E1: The release catheter can be removed without any other manipulation or translation to close the wraps 20 and 22. If the limb interface 50 has not already been deployed from the second wrap 22, the second wrap 22 may still be open (proximally) to release and unfold the interface member 50.

E2: The delivery catheter can be removed by stretching proximally through the introducer 19. The sleeve of the lining 150 if used, can remain in place in the introducer, when the stem is pulled through it or the sleeve of the lining 150 they can be manually removed or can be removed as a result of friction.

E3: When the distal portion of the release catheter approaches the inlet, the second wrap 22 can pass smoothly into the inlet, due to the aerodynamic shape of the coupling of the third tube

44. The interface member 50 can be moved distally to cover itself and A IT “)“ ni íTIQÚOIP! OOV] O:! L A CC =) OWPWA "70/70“ with stent retainer 24, also in virtue of the movement of the catheter in the blood flow or in contact between the interface member 50 and the end of the introducer 19. As previously explained, the interface member 50 has a shape that has an aerodynamic profile to guide the portion distal with the stent retainer 24, gently into the introducer.

The portion. The distal can thus be removed via the introducer even when the casings are open.

Interface member 50 remains unfolded during removal, F: Removal of the release catheter with closed wraps (after step E, and instead of step E): F1: If interface member 50 has not yet been unfolded of the second wrap 22, the second wrap 22 can also be moved open (proximally) to release and unfold the interlayer member 50. '15 F2: The first and second wrap can be moved to a closed state, with the first wrap being translated proximally and the second wrap being translated distally.

As previously explained, interface member 50 has a shape that can provide a bridge or interface between the ends of the two wraps. 20 to define a smooth profile without abrupt edges.

The distal portion can thus be removed smoothly through the introducer.

Interface member 50 remains deployed during withdrawal.

F3: The liner sleeve 150, if used, can remain in place in the introducer, when the stem is pulled through or the liner sleeve 150 can be manually removed or it can be self-removed as a result of friction.

It will be appreciated that the above description is merely illustrative of the aforementioned forms of the invention and that many modifications, equivalents and improvements can be used within the scope of the invention.

Claims (27)

1. Transcatheter aortic valve implantation system, comprising: an aortic stent valve (100) comprising a stent component (134) and valve cusps (136) supported by the stent component (134), the stent component ( 134) having an inflow end and an efflux end and being self-expanding from a compressed condition for release to an expanded functional condition, the stent component (134) comprising an efflux structure in the efflux end, a crown (140b ) between the inflow and outflow ends, the crown (140b) having a free end between the inflow and outflow ends and directed towards the outflow end, and the stent component (134) still comprising a securing section (140a ) between the crown (140b) and the inflow end; a delivery catheter (12) having a distal portion (14) insertable into the anatomy, the distal portion (14) comprising a stent valve accommodation region (18) to accommodate the stent valve (10) in the compressed condition for delivery , a first wrap (20) to cover at least a portion of the fastening section (140a) in the accommodation region (18) to restrict the compressed fastening section (140a) and a second wrap (22) to cover at least a portion of the efflux structure and at least a portion of the crown (140b) in the accommodation region (18) to restrict the efflux structure and the compressed crown (140b), characterized in that the second wrap (22) is translatable in a proximal direction to remove cover of the crown (140b) and the efflux structure for unfolding and the first wrap (20) being translatable in a distal direction to remove the cover of the fixing section (140a) for unfolding. The system of claim 1, characterized in that the efflux structure comprises a plurality of arches (144a) having apexes at the efflux end of the stent component. System according to claim 1 or 2, characterized by the fact that (i) a translation of the second wrap (22) unfolds the crown (140b) followed by the stabilization arcs to allow axial seating of the crown (140b) against cusps and generation of axial alignment forces through the arches contacting the ascending aorta, and (ii) a translation of the first wrap (20) unfolds the fixation section (140a) to anchor the stent valve (10). 4. System according to claim 1, 2 or 3, characterized by the fact that the stent valve (10) is configured in such a way that, when the first wrap (20) covers at least a portion of the fixing section (140a), and the second wrap (22) is translated proximally to remove the cover of the crown (140b) and the efflux structure, the stent component (134) defines a substantially dilated partially unfolded shape of the fixation section portion (140a) restricted by the first wrap (20) to the free end of the crown (140b), the enlarged shape allowing universal seating of the crown (140b) against the native cusps. System according to claim 4, characterized in that the substantially enlarged shape partially unfolded corresponds to the crown (140b) being partially unfolded in a smaller form than its fully unfolded shape. 6. System according to any of the preceding claims, characterized by the fact that in a condition in which the stent valve (10) is loaded in the accommodation region (18) and the system is ready for introduction into the anatomy, the first and second wraps (20, 22) are spaced apart from each other. System according to claim 6, characterized in that the stent valve further comprises an inner skirt covering a portion of an internal surface of the stent component (134), and an outer skirt covering a portion of an external surface of the stent component (134) stent (134), the inner skirts including a region of partial overlap and in which the space between first and second wraps (20, 22) spaced is recorded with at least a portion of the region of partial overlap of the inner and outer skirts. System according to any one of claims 1 to 7, characterized in that it is configured for transvascular delivery of the destent valve (10) to the heart. System according to any one of the preceding claims, characterized in that the delivery catheter (12) further comprises a stent retainer (24) in the accommodation region (18) for engagement coupled with a portion of the stent component (134) at one end of the stent valve (10), when in disintegrated condition, to restrict the stent valve (10) against substantial axial movement in the proximal and distal directions during deployment, the stent valve (10) configured to detach itself from the stent retainer (24) by the radial expansion portion of the stent component (134) for functional condition. System according to claim 9, characterized in that the stent retainer (24) is arranged closer to a distal end of the accommodation region (18) than to a proximal end. System according to any one of claims 1 to 10, characterized in that the first wrap (20) is shorter than the second wrap (22). System according to any one of claims 1 to 11, characterized by the fact that the first wrap (20) and the second wrap (22) are non-overlapping and / or have the same diameter between them. A system according to any one of claims 1 to 12, characterized in that the delivery catheter (12) comprises a portion of flexible rod (15) that extends between the distal portion (14) and a control handle (100) in a proximal portion (16) of the delivery catheter (12), the stem portion (15) comprising a plurality of flexible sliding tubes (26, 28, 30) fitted within each other to control the translation of the wraps (20, 22) in response to the operation of the control handle (100), where the control handle (100) it comprises an actuator to apply a pre-tension to at least one of the tubes (26, 28, 30) to polarize the first wrap (20) in a proximal direction. System according to any one of claims 1 to 14, characterized in that the delivery catheter (12) still comprises an interface member (50) in the accommodation region (18), the interface member (50) being foldable in the translation of at least one of the wraps (20, 22), the interface member (50) providing a guide surface to assist the removal of the release catheter (12) from the anatomy after the stent valve (10) is deployed. System according to claim 14, characterized in that the delivery catheter still comprises a stent retainer (24) in the accommodation region (18) and having a coupling profile coupled with a stent valve (10) when the valve stent (10) is accommodated within the accommodation region (18) and where the guide surface of the interface member (50), when unfolded, provides a more aerodynamic profile than the stent retainer (24) alone, to facilitate the withdrawal of the delivery catheter (12) with at least one wrap (20, 22) in the open position. 16. System according to claim 15, characterized in that the delivery catheter (12) is withdrawable through an 18 French arterial introducer (19), with at least one wrap (20, 22) in the open position. System according to claim 14, 15 or 16, characterized in that the interface member (50) is foldable to perform at least one of the following: (i) providing an interface at or between the open ends (20b, 22b) which generally turn from the wraps (20, 22) and / or (ii) align the open ends (20b, 22b) of the wraps (20, 22) to be substantially in register with each other and / or centered with respect to the catheter axis , and / or (iii) define a bridge of / or a smooth profile between the open ends (20b, 22b) which face each other of the wraps (20, 22). System according to claim 14, 15 or 17, characterized in that the interface member (50) is captive in the delivery catheter (12). System according to claim 14, 15, 17 or 18, characterized in that in the unfolded condition, the interface member (50) is received inside or a wrap (20, 22). A system according to claim 14, 15, 17, 18 or 19, characterized in that the interface member (50) is self-expanding from a compressed unfolded condition to an expanded unfolded condition. 21. System according to claim 14, 15, 17, 18, 19 or 20, characterized in that the interface member (50) is axially slidable within the accommodation region (18) when in the unfolded condition. 22. The system of claim 14, 15, 17, 18, 19, 20 or 21, characterized in that the interface member (50) comprises a conical or rounded end defining the guide surface. 23. System according to any one of claims 1 to 22, characterized in that the catheter (12) additionally comprises: a portion of flexible rod (15) extending proximally to the distal portion (14), the portion of rod (15) comprising at least one flexible tube (26, 28, 30) consisting of a tubular laminate of a first tubular layer radially within a second tubular layer, wherein one of the first and second layers is polyimide and the other first and second layer is polyamide. 24. System according to claim 23, characterized in that the first tubular layer is polyimide and the second tubular layer is polyamide. A system according to any one of claims 1 to 24, characterized in that the delivery catheter (50) further comprises a flexible rod portion (15) extending proximally to the distal portion (14), and comprising a plurality of tubes (26, 28, 30) of control fitted within each other and axially sliding relative to each other to manipulate the distal portion (14) to unfold a stent valve (10); and a sleeve (60) slidable on the stem portion (15) to advance to the introducer (19) to provide a separator between the introducer hemostasis valve and the stem portion (15), the sleeve (60) having an interior configured to allow substantially unobstructed sliding, in one direction, of the stem portion (15) with respect to the sleeve (60). 26. The system of claim 25, characterized in that the sleeve (60) comprises a sealing member to form a substantially blood-tight seal between an inner surface of the glove (60) and an outer surface of the stem portion (15) . 27. Delivery catheter as defined in claims 25 or 26, characterized in that the sleeve is slidably attached to the stem portion (15).