apparatus and method for compressing stent valves

专利摘要:
METHOD AND APPLIANCE FOR COMPRESSING / LOADING STENT VALVES. The present invention relates to an apparatus (40) for compressing a transcatheter cardiac stent valve (10) comprising: a hollow channel (42) having an inner surface (50) molded to progressively compress the stent valve in response the longitudinal advance of the stent valve into the channel; an actuator (46) screwed into the outside of the channel to generate a longitudinal actuating force in response to rotation; a booster (44) having members (56) that protrude through the slits (58) in the channel wall to transmit the driving force to the stent valve into the channel; and a removable channel extension (48) connectable to the outlet (54) to provide a generally cylindrical retaining hole (66).
公开号:BR112013028002B1
申请号:R112013028002-6
申请日:2012-05-03
公开日:2021-02-02
发明作者:Jacques Essinger；Stéphane Delaloye；Jean-Luc Hefti；Luc Mantanus；Michael Paris
申请人:Symetis Sa；
IPC主号:

专利说明:

[0001] The present invention relates to the field of stents for the introduction of transcatheter, and in particular to a method and apparatus for compressing a stent for a compressed condition and / or for loading a stent for an introduction catheter. In some non-limiting aspects, the stent is a stent valve, for example, a cardiac stent valve. The invention was designed to address problems encountered with stent valves, but the invention may also be applicable to compress other types of stents for the introduction of transcatheter.
[0002] Document WO-A-2009/053497 describes cardiac stent valve and associated methods and systems for introducing the stent valve through minimally invasive surgery. The stent valves are compressible to a compressed state suitable to be accommodated at the introduction tip of the introduction catheter. In the compressed state, the small size enables the catheter that carries the stent valve to be introduced through minimally invasive surgery. As a result of the release at the desired implantation site, the stent valve expands to an operational size.
[0003] Additional examples of stent valves, introduction catheters, and / or techniques for compressing stent valves for introduction, are described in: US-2009/0171432, WO 2008/035337 and WO 2009/116041.
[0004] The task of compressing the stent valve into (or ready for) the delivery catheter is complicated due to the stent valve being delicate and vulnerable to damage. Damage can result from over-compression, or a non-uniform distribution of tension, or bending, or non-circularity during compression, or from cutting or abrasion of the valve component tissue. A deformed or damaged stent valve may malfunction, or have a shortened operating life, or it may be difficult or even impossible to implant correctly. Complications are exacerbated in the case of a type of self-expanding stent valve due to a self-expanding stent valve having a strong restoring force when compressed, and requiring the application of a large compressive force to compress the stent valve to its compressed condition. Large forces are difficult to apply to a delicate stent valve. A self-expanding stent valve may also have more than one tendency to deform undesirably into a non-circular shape unless the shape is carefully controlled during compression. Additional considerations refer to the quantity and volume of accessory equipment that needs to be used in an operating room merely to prepare or load a stent valve into an introduction catheter.
[0005] It remains challenging to provide a technique for compressing a stent valve, which is relatively easy and intuitive to use, inexpensive to implement, using a device that is not too bulky and can be sterilized conveniently, and also avoids the problems discussed above.
[0006] The present invention was designed with these problems in mind. It may be a non-limiting objective to address and / or mitigate at least one of the above problems.
[0007] Certain aspects of the invention are defined in the claims.
[0008] In general, an additional aspect of the invention provides an apparatus for use to compress a stent (preferably a stent valve) to a desired size for mounting on an introduction catheter. The apparatus may comprise one or more of: a hollow channel (which may optionally, additionally or alternatively be referred to as a hollow channel member or hollow channel body) that has an inner surface molded to progressively compress the stent in response to longitudinal advancement from the stent into the hollow canal; and a booster to apply a longitudinal driving force to the stent to advance the stent into the hollow channel.
[0009] Optionally, the device can be configured to have one or any combination of two or more of the following characteristics, which are all optional: (a) the device additionally comprises an actuator to generate a driving force, in which the impeller is configured to transmit the driving force from the driver to the stent to advance the stent into the channel. The actuator can be mounted externally to or in the channel, for example, externally radially or externally radially. The driver may comprise a rotating member externally around the longitudinal geometric axis of the channel, and a threaded and / or helical guide to generate longitudinal movement in response to rotation. For example, the actuator can be attached screwed to the outside of the channel. In some embodiments, the channel has (i) a generally cylindrical outer part that carries a thread for the driver, and / or (ii) a generally non-cylindrical inner part for compacting the stent valve. The generally non-cylindrical inner part may optionally comprise a substantially round cross-sectional shape which progressively reduces in diameter along one or more regions of the longitudinal geometric axis. (b) the hollow channel may comprise at least one slot through a wall thereof, and the pusher may comprise a sliding part in the slot and projecting through it to enclose a stent within the channel. The slot can be substantially linear and / or extend longitudinally. Optionally the channel comprises two slots, or optionally the channel comprises three slots, or optionally the channel comprises four slots, or optionally the channel comprises five slots, or optionally the channel comprises six slits, or optionally more. The pusher may comprise a corresponding quantity of said parts, one for each slot. Additionally or alternatively, the hollow channel can comprise a member that has at least one slot that extends within it. For example, the slit can extend for at least 50% of the axial length of the member, optionally at least 55%, optionally at least 60%, optionally at least 65%, optionally at least 70%, optionally at least 75%, optionally at least 80%, optionally at least 85%, optionally at least 90%, optionally at least 95%. Alternatively, the hollow channel can comprise a plurality of members assembled (or mountable) together to define the shape of the hollow channel collectively. In any case, the slits can optionally be opened at at least one end of the channel, to allow the booster to be separated from the channel by sliding out of the open ends of the slits.
[00010] Optionally, the hollow channel comprises a plurality of slits, and the pusher comprises (i) a plurality of said sliding parts in the slits, and (ii) a part that fits on the outside, for example, radially on the outside , of the channel (for example, radially outside the circumferential periphery of the channel). The part that adjusts from the outside can interconnect, radially from the outside of the channel, the sliding parts in the slits. For example, the part that fits on the outer side can connect the outer ends radially of the sliding parts in the slots. (c) The booster can be configured to apply the longitudinal actuating force to at least one (optionally two, or optionally three, or optionally four, or optionally more) circumferential positions around the circumference of the stent. This can enable the actuation force to be applied to one or more specific circumferential positions in which the stent (eg, stent valve) is relatively robust and / or is less vulnerable to damage or deformation. For example, one or more circumferential positions to which force can be applied can be substantially aligned with supports or commissural posts of a stent valve. Alternatively, the one or more circumferential positions to which the force can be applied may be substantially unaligned to the stent valve brackets or commissural posts. (d) The booster can be configured to apply the longitudinal actuating force to at least one (optionally two, or optionally three, or optionally four, or optionally more) longitudinal position along the axial length of the stent. This can enable the driving force to be applied to one or more specific longitudinal positions in which the stent is relatively robust and / or is less vulnerable to damage or deformation. For example, one or more longitudinal positions to which force can be applied may correspond to supports or commissural posts of a stent valve. Additionally or alternatively, each of the one or more longitudinal positions can correspond to a depression in the profile or structure of the stent (for example, a depression defined at a vertex junction between two supports). (e) The booster can be configured to apply the longitudinal actuating force to at least one (optionally two, or optionally three, or optionally four, or optionally more) specific positions that are intermediate to the ends of the stent. This can enable a "push" force to be applied with less risk of flexing the stent axially. Additionally or alternatively, it can enable a "traction" force to be applied without depending on or interfering with the ends of the stent. The stent may comprise one or more fasteners at one end of the stent. This provision does not interfere or complicate the fitting by the fastening elements. Additionally or alternatively, each of the positions can correspond to a depression or concavity in the profile or structure of the stent (for example, a depression defined at a vertex junction between two supports). Optionally, the at least one position can be: away from both opposite ends of the stent by at least 5 mm, preferably at least 10 mm; and / or away from both opposite ends of the stent by at least 10% of a maximum length of the stent valve, preferably at least 15%. (f) The pusher may comprise a ring that extends around the outside of the channel, and one or more members that extend or protrude into the ring. The limbs may be blade-like and / or finger-like and / or pin-like and / or lightning-like. The ring can be slidable longitudinally around the outside of the channel.
[00011] Each member can extend through a respective slot in the channel wall to extend towards the interior of the channel. Each member can be slid in the respective slot. The inner ends of the members may be substantially free, or the inner ends may be coupled together, for example, each meeting at a common point (eg, center) or coupled through an inner ring. (g) The part or surface of the booster configured to fit with the stent (for example, each member described above, if used) may extend in a generally radial direction with respect to the geometric axis of the channel and / or the plane of the ring (if used). Alternatively, the part or surface of the pusher configured to fit with the stent can be tilted with respect to the radial and / or plane direction of the ring. In one form, the part is tilted in a direction towards an outlet end and / or narrower (for example, internally narrower) of the channel. The angle of inclination (for example, towards the exit / narrower end) can be approximately 5 ° (or more), approximately 10 ° (or more), approximately 15 ° (or more), or approximately 20 ° (or more). The angle of inclination can be between approximately any two of the above values, for example, between approximately 5 ° and approximately 15 °. Inclination can reduce the risk of the stent flexing under axial compression loads. The inclination may tend to propel the stent modestly in a radial outward rather than radially inward direction. Modest outward radial thrust is counteracted by contact with the inner surface of the channel, in order to enable the shape of the stent to be controlled to prevent flexion. (h) The inner surface of the hollow channel can be substantially fixed and / or immobile, at least in a radial direction. Compression of the stent valve can be achieved at least predominantly (and preferably entirely) as a result of longitudinal displacement of the stent valve into the channel, without substantial radial movement of the inner surface of the channel. (i) The inner surface of the hollow channel can comprise at least one non-cylindrical part, for example, having a diameter that progressively reduces along the longitudinal geometric axis of the channel in a direction towards an outlet. Additionally or alternatively, the channel may comprise at least a generally cylindrical part. In the illustrated embodiments, the interior surface comprises at least two non-cylindrical parts. The part of the inner surface adjacent to the entrance to the channel can generally be cylindrical. The portion of the inner surface adjacent to the outlet of the channel may generally be non-cylindrical. (j) The apparatus may additionally comprise a loading tube (which may optionally, additionally or alternatively be referred to as a channel extension or an outlet extension) for or usable at the outlet and / or narrow end (for example, internally more channel). The loading tube can be removably connectable to the channel, or it can be associated with the channel by holding it in place with your hands, or it can be insertable at the outlet of the channel. When the extension is separated (for example, removed) from the channel, this may allow the end of the stent to be seen at the outlet / narrow end of the channel to load over, or engage with, an introducing catheter. After loading / fitting the end of the stent to an introduction catheter, the extension can be positioned, inserted or repositioned (for example, fixed or refixed) with respect to the channel. In some embodiments, the loading tube has a hole. In some embodiments, the hole may have substantially the same diameter as the outlet end of the channel. In other embodiments, the bore and / or the outside diameter of the loading tube may be slightly smaller than the diameter at the outlet of the channel.
[00012] In some embodiments, the loading tube can be connected by a fixture that supports the longitudinal load between the channel and the extension. For example, the fixture can be a threaded fixture. In other embodiments, the loading tube may be at least partially insertable into the channel at or through the outlet. (k) The longitudinal length of the hollow channel may be longer than the stent valve so that, in use, the stent valve is contained entirely within the channel when it is being advanced. (l) in use, the stent valve can be passed entirely through the hollow channel from an inlet at one end to an outlet at the opposite end. (m) The stent valve can be advanced first through the flow inlet end into the hollow channel. The flow inlet end may be a first end to emerge from an outlet of the hollow channel. Alternatively, the stent valve can be advanced first through the flow outlet end into the hollow channel. The flow outlet end may be a first end to emerge from an outlet of the hollow channel.
[00013] In a further aspect, the invention provides an apparatus for compressing a transcatheter cardiac stent valve, which comprises one or more of:
[00014] a hollow channel that has an inner surface molded to progressively compress the stent valve in response to the longitudinal advance of the stent valve into the channel; a plugged or pluggable actuator screwed to the outside of the channel to generate a longitudinal actuating force in response to rotation; a booster that has members that protrude through slits in the channel wall to transmit the driving force to the stent valve inside the channel; and a removable channel extension pluggable at the outlet to provide a generally cylindrical retaining hole.
[00015] In a further aspect, the invention provides an apparatus for compressing a transcatheter cardiac stent valve, wherein the apparatus comprises:
[00016] a hollow channel that has an inner surface molded to progressively compress the stent valve in response to the longitudinal advance of the stent into the hollow channel, wherein the hollow channel comprises at least one slot through a wall thereof; and a booster comprising a part that fits on the outside of the circumferential periphery of the hollow channel and a sliding part in the slot and protrudes through it to enclose the stent valve within the hollow channel, to apply to the stent valve a longitudinal actuation force on the outside of the hollow channel.
[00017] In a further aspect, the invention provides an apparatus comprising:
[00018] a transcatheter cardiac stent valve that has opposite first and second ends;
[00019] a hollow channel that has an inner surface molded to progressively compress the stent valve in response to the longitudinal advance of the stent into the hollow channel; and
[00020] a booster to wrap the stent valve within the hollow channel, to apply to the stent valve a longitudinal actuation force on the outside of the hollow channel, where the booster is configured to wrap the stent valve in at least one intermediate position to the first and second opposite ends of the stent valve.
[00021] In a further aspect, the invention provides an apparatus for compressing a transcatheter cardiac stent valve, comprising:
[00022] a hollow channel that has an inner surface molded to progressively compress the stent valve in response to the longitudinal advance of the stent valve into the hollow channel; and
[00023] an actuator coupled to the hollow channel by a thread, and configured to generate, in response to the rotation of the actuator, a longitudinal actuation force to advance the stent valve.
[00024] In a further aspect, the invention provides an apparatus for compressing a transcatheter cardiac stent valve, comprising:
[00025] a hollow channel that has an inlet and an outlet, the inlet that has a larger bore than the outlet, in which the hollow channel additionally has an inner surface molded to progressively compress the stent valve in response to the longitudinal advance of the stent valve into the hollow channel, the inner surface of which comprises at least one selected from: (i) at least one generally cylindrical surface and at least one generally non-cylindrical surface; (ii) a plurality of generally non-cylindrical surfaces. In a further aspect, the invention provides an apparatus for compressing a transcatheter cardiac stent valve, which comprises:
[00026] a hollow channel that has an inner surface molded to progressively compress the stent valve in response to the longitudinal advance of the stent valve into the hollow channel; and a pusher to apply a longitudinal actuating force to a stent valve into the channel, wherein the pusher comprises a ring from which a plurality of members extends, wherein the members generally extend into the ring, and are inclined with respect to the plane of the ring.
[00027] In a further aspect, the invention provides a method for compressing a transcatheter cardiac stent valve, which comprises in any order the steps of: (a) providing a hollow channel that has an inlet and an outlet, in which the channel the hollow additionally has an inner surface molded to progressively compress a stent valve in response to the longitudinal advance of the stent valve into the channel; (b) insert a stent valve at the entrance to the channel; and (c) applying a longitudinal actuation force to the radially external side of the channel to advance the stent valve into the channel towards the outlet.
[00028] In a further aspect, the invention provides a method for compressing a transcatheter cardiac stent valve, which comprises in any order the steps of: (a) providing a hollow channel that has an inlet and an outlet, in which the channel the hollow additionally has an inner surface molded to progressively compress a stent valve in response to the longitudinal advance of the stent valve into the channel; (b) insert a stent valve at the entrance to the channel; and (c) rotating an actuator relative to the hollow channel, to generate through a thread, a longitudinal actuation force to advance the stent valve into the channel towards the outlet.
[00029] In a further aspect, the invention provides a method for compressing a transcatheter cardiac stent valve, comprising in any order the steps of: (a) providing a hollow channel that has an inlet and an outlet, in which the inlet it has a larger bore than the outlet, in which the hollow channel additionally has an inner surface molded to progressively compress a stent valve in response to the longitudinal advance of the stent valve into the hollow channel; (b) providing a loading tube for the hollow channel; (c) positioning the loading tube over at least part of an introduction catheter; (d) insert a stent valve at the entrance to the channel; (e) applying a thrust force to the stent valve to advance the stent valve into the channel towards the outlet until part of the stent valve emerges at the outlet; (f) coupling the part of the stent valve at the outlet to a stent support of the introduction catheter; (g) transfer a delivery catheter containment sheath to capture it within the part of the coupled stent valve to the stent holder; (h) moving the loading tube in the introduction catheter to couple the loading tube to the hollow channel and / or inserting the loading tube at the outlet of the channel; and (i) applying an additional boost to the stent valve to further advance the stent valve towards the outlet of the hollow channel.
[00030] In a further aspect, the invention provides a method for compressing a transcatheter cardiac stent valve, in which the method comprises in any order the steps of: (a) providing a hollow channel that has an inlet and an outlet, in that the inlet has a larger bore than the outlet, wherein the hollow channel additionally has an inner surface molded to progressively compress a stent valve in response to the longitudinal advance of the stent valve into the hollow channel; (b) insert the stent valve into the channel entrance; and (c) applying to the stent valve in at least one intermediate position to the opposite ends of the stent valve, a longitudinal actuating force to advance the stent valve into the channel towards the outlet.
[00031] In a further aspect, the invention provides an apparatus comprising:
[00032] an introduction catheter for introducing a stent valve to an implantation site within the body, where the introduction catheter has at least one translatable sheath in a containment region to receive the stent valve in a compressed form as result of a loading operation to compress and load the stent valve with respect to the delivery catheter; packaging to contain the introduction catheter before use, where the packaging includes a base that has an impermeable vat, where the vat has an adequate depth used to hold the liquid into which the catheter's containment region can be immersed during the loading operation.
[00033] In a further aspect, the invention provides a method for preparing a stent valve and an introduction catheter for use, wherein the method comprises: (a) providing a closed package containing the introduction catheter, in which the package includes a base that supports the introduction catheter in a storage position, in which the base has an impermeable tub; (b) opening the closed package; (c) introducing liquid into the base tank; (d) loading the stent valve into a containment region of the introducing catheter while at least the containment region is immersed in the liquid in the vat.
[00034] Features and advantages of the invention in its various aspects include one or more of: (i) relatively easy and intuitive to use (ii) inexpensive to implement, (iii) uses a device that can be sterilized conveniently, (iv) avoids interfering with a binding region at one end of the stent, (v) prevents flexion of the stent, (vi) provides precise control of the shape of the stent during compression, (v) facilitates loading of the stent into an introducing catheter, (vi) enables compression of at least a significant part of the stent to be achieved without exerting pressure on the fitting with a support of the introduction catheter stent, (vii) can easily be performed by a single operator, and / or (viii) reduction in number of auxiliary equipment in an operating room, enabling loading / compression in place on the device packaging.
[00035] Although several features and ideas of the invention are described above and defined in the appended claims, additional features and advantages will be evident from the non-limiting description of detailed modalities below. Protection is claimed for any original feature or idea described in this document and / or illustrated in the drawings whether emphasis has been placed on it or not.
[00036] Non-limiting modalities of the invention are now described by way of example only, with reference to the attached drawings, in which:
[00037] Fig. 1 is a schematic view of an example of a stent valve and an introduction catheter for it.
[00038] Fig. 2 is a schematic side view of the stent component of the stent valve of Fig. 1.
[00039] Fig. 3 is an exploded schematic cross-sectional view of an apparatus for compressing the stent valve for loading into the delivery catheter.
[00040] Fig. 4 is a schematic perspective view of the hollow channel of the apparatus of Fig. 3;
[00041] Fig. 5 is a schematic perspective view of the booster of the apparatus of Fig. 3;
[00042] Fig. 6 is a schematic guide for an example of using the device; and
[00043] Fig. 7 is a schematic side view of the impeller involving the stent valve to apply a driving force to it (other components are omitted in Fig. 7 to avoid obscuring the view);
[00044] Fig. 8 is a schematic side view of the package for an introduction catheter, the package shown with a cap separated from a base;
[00045] Fig. 9 is a schematic section similar to Fig. 8;
[00046] Fig. 10 is a schematic section along line A-A in Fig. 8;
[00047] Fig. 11 is a schematic section along line B-B of Fig. 8;
[00048] Fig. 12 is a schematic section along the line D-D of Fig. 8;
[00049] Fig. 13 is a plan view of the base of the packaging of Fig. 8; and
[00050] Fig. 14 is a plan view of the base similar to Fig. 13 but indicating the placement of an insertion catheter in place.
[00051] Before describing the compression device in detail, an example of a stent (stent valve) is first described so that the characteristics and functions of the compression device can be fully evaluated.
[00052] Figs. 1 and 2 illustrate an example of a stent in the form of a stent valve 10. The stent valve 10 can be a cardiac stent valve, for example, an aortic stent valve. The stent valve 10 can be configured to implant a transcatheter in the body, for example, allowing the use of minimally invasive techniques. The stent valve 10 can be configured to implant a transcatheter aortic valve ("TAVI"). Although a particular stent valve geometry 10 is illustrated by way of example, it will be appreciated that the invention is not limited to any specific stent valve geometries. The geometry example is used in this document because it allows the advantages of the invention to be emphasized.
[00053] The stent valve 10 can be transformable between an expanded state (as shown in Fig. 1), and a compressed state indicated by the dashed line 10 '. The expanded state can roughly correspond to an operational state of the stent valve after implantation. The stent valve 10 may not reach the fully expanded state in the implantation, in which tolerance for size mismatch and / or slight compression is allowed to maintain an external elastic action for a friction fit in the native anatomy. The compressed state 10 'can correspond to an introduction state to be accommodated by an introduction catheter 12 and / or for introduction into the anatomy for the desired implantation site.
[00054] The stent valve 10 can be of a self-expanding type that is propelled elastically towards the expanded state, and is compressible to the compressed state 10 'by the application of suitable radial compressive forces. The stent valve 10 remains in its compressed state while contained. When the containment is removed, the stent valve 10 itself expands to the expanded state. Alternatively, the stent valve 10 may 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.
[00055] Stent valve 10 may comprise a stent component 14 and a valve component 16. The stent component 14 may provide an anchoring function to anchor the stent valve to native anatomy and / or a support function for support the valve component 16. The stent component 14 can be of any material or suitable materials. The component of stent 14 may be metal. Examples of materials include shape-memory and / or superelastic alloys (eg, nitinol), stainless steel, or cobalt and chromium alloy. In the illustrated form, the component of stent 14 is self-expanding and is of memory-shaped / superelastic alloy (for example, nitinol). However, the component of stent 14 can also be substantially non-self-expanding.
[00056] The stent component 14 can have any desired profile to anchor and / or align the stent valve 10 with respect to native anatomy at the desired implantation site. In some embodiments, the stent component 14 can generally be cylindrical in shape, or comprise one or more generally cylindrical part or parts which are on a generally cylindrical surface (e.g., 20c and 22a). In addition or alternatively, the stent component 14 may be generally non-cylindrical in shape or comprise one or more parts or parts generally non-cylindrical that lie on a non-cylindrical surface (e.g., 20a, 20b, and 24). Additionally or alternatively, the stent component 14 may comprise one or more anchor projections, and / or one or more stabilization parts.
[00057] In the illustrated form, the stent component 14 optionally comprises an anchoring part 20 defined, for example, by a lower crown 20a and an upper crown 20b that define a groove and / or waist 20c between them. The anchoring part 20 may have a first compressive strength, and may comprise a cellular structure.
[00058] The stent component 14 optionally (additionally) comprises a valve support part 22 which comprises, for example, a plurality (for example, three) support commissural posts 22a. The commissural support posts 22a can be arranged in a primitive circle diameter less than one end of at least one of the crowns 20a and 20b. The commissural support posts 22a can be arranged in a primitive circle diameter corresponding to the waist 20c. The commissural support posts 22a can partially overlap at least one of the crowns 20 and 22 in the axial direction, and extend axially beyond that respective crown. The commissural support posts 22a may be similar to the structure. The commissural support posts 22a may have a shape that follows, at least approximately, a peripheral contour of the valve, at least in the region of the periphery of the valve adjacent to the commissural support posts.
[00059] The stent component 14 optionally (additionally) comprises a stabilization or alignment part 24 defined, for example, by a plurality (for example, three) wings or arcs 24a. The arches 24a can extend from the tips of the commissural support posts 22a, to define a vaulted structure over them. The alignment part 24 may have greater flexibility than the anchoring part 20 and / or the valve supporting function 22. The alignment part 24 may have a second compressive strength which is less than the first compressive strength of the anchoring part 20. The alignment part 24 may be less rigid (for example, radially) than the anchoring part 20 and / or the valve support part 22.
[00060] The stent component 14 optionally comprises (additionally) a fixation part 26 for securing the stent component 14 to a stent receiver 28 of the introduction catheter 12. In the illustrated embodiment, the stent receiver 28 can be a support stent and will be referenced as such hereinafter, although other types of receivers can be used to receive and / or accommodate at least part of the stent valve 10 as desired. The fixation part 26 can comprise one or more geometric openings, or one or more projections or other projections, to form a forced fit (for example, interlocked) with a complementary part of the stent support 28. The fixation part 26 can be arranged at or adjacent to at least one end of the stent component 14. In the present embodiment, the fixation part 26 is defined by a plurality (for example, three) of cell extensions of the lower crown 20a.
[00061] The valve component 16 can be of any suitable natural and / or synthetic material (s). For example, valve component 16 may comprise extracted porcine and / or bovine and / or natural pericardium valve material. The valve component 16 can comprise a plurality of leaflets arranged to collapse or compact to a closed position to obstruct flow in one direction passing through, or flex away to an open position to allow flow in the opposite direction. The valve component 16 can be accommodated in the valve support part 22 and / or at least partially within the anchoring part 20. The stent valve 10 (for example, the valve component 16) can additionally comprise an internal skirt and / or an outer skirt that covers at least partially a respective internal or external surface part of the stent component 14. For example, the skirt (s) can cover at least a part of the anchoring part 20 and / or at least a part of the valve support part 22.
[00062] Still with reference to Fig. 1, the introduction catheter 12 can only, by way of example, comprise at least one sheath 30 in a region of containment of the introduction catheter 12, to accommodate a stent valve 10. The hair at least one sheath 30 can be configured to cover at least part of the stent valve 10 in its compressed state 10 ', to restrict the stent valve 10 against expansion. The at least one sheath 30 is translatable along the longitudinal geometric axis of the catheter to cover or selectively expose the respective region of the stent valve 10, in response to actuation by a control at a cable end 32 of the introduction catheter 12. The support of stent 28 can prevent, or at least reduce, any tendency of stent valve 10 to move axially during translation of sheath 30, and / or prevent, or at least reduce, any tendency of stent valve 10 to loosen the sheath 30 when only a small part of the stent valve 10 is covered by the sheath 30. The stent holder 28 can be transported in a central tube 36 (or a set of several tubes), for example, to receive a guide wire. A loading tip 34 can be removably mounted on the most distal end of tube 36. Other models of delivery catheters 12 can be used, for example, without a sheath 30 and / or without a stent holder 28. The example of introduction catheter 12 is used in this document because it allows the advantages of the invention to be emphasized.
[00063] The maximum external diameter of the stent valve 10 in its expanded state can be from approximately 25mm to approximately 35mm. In contrast, the maximum outside diameter of the stent valve in its condition compressed 10 'by the introducing catheter can be significantly smaller, for example, by approximately 10mm or less. The radial force required to compress the stent valve can be considerable, for example, at least 50N, or at least 75N, or at least 100N. In some embodiments, the radial force is between approximately 100N and 120N.
[00064] With reference to Figs. 3 to 7, apparatus 40 is illustrated by compressing the stent valve 10 to its compressed state 10 '. Apparatus 40 is also configured to facilitate loading the stent valve 10 into the delivery catheter 12 as part of the compression process.
[00065] The apparatus 40 may comprise one or any combination of two or more of the following components: a hollow channel (or hollow channel member or hollow channel body) 42; a booster 44; a driver 46; a loading tube (or channel extension) 48. Some or all of the components 42 to 48 can be disassembled from each other, and assembled while using the apparatus 40.
[00066] The hollow channel 42 may have an inner surface 50 molded to progressively compress the stent valve 10 in response to the longitudinal advance of the stent valve 10 into the channel 42 from an inlet 52 at one end to an outlet 54 at the opposite end. The inner surface 50 can generally be rounded in the cross section, in order to maintain the rounded shape of the stent valve 10 during compression. The inner surface 50 may comprise one or more non-cylindrical parts 50b and 50d, for example, which have a diameter that progressively reduces (e.g., converges) along the longitudinal geometric axis of channel 42 in a direction towards outlet 54. This shape can be referred to as a funnel shape. The funnel can be straight-sided or with a concave or convex profile. The inner surface 50 may additionally comprise one or more generally cylindrical parts 50a and 50c. The inner surface 50 can be coated to reduce friction between the surface 50 and the stent valve 10, for example, with a coating based on hydrophobic silicone.
[00067] In the illustrated embodiment, a generally cylindrical part 50a is provided adjacent to inlet 52 of channel 42. The cylindrical part 50a can facilitate the initial insertion of stent valve 10 into channel 42 without substantial compression (and in the case of a self-expanding stent, without any tendency of the stent valve for an elastic return out of inlet 52). Additionally or alternatively, a generally non-cylindrical part 50d (for example, in the form of a funnel) may be provided adjacent to outlet 54 of channel 42. The non-cylindrical part 50d may promote a converging shape (for example, tapered conical) at the end of the stent valve 10 when emerging at outlet 54, to facilitate fitting the stent valve 10 with the stent support 28 of the introduction catheter 12 during loading.
[00068] The outlet 54 of the channel 42 can be optionally formed with an annular step fitting 54a to receive the tip of a sheath 30 of the introduction catheter 12, to facilitate loading in sheath 30. The fitting 54a can have an internal diameter that substantially corresponds to the outer diameter of the end (e.g., distal) of the sheath 30 to be received inside.
[00069] The wall (s) of channel 42 can generally be stationary or fixed, at least in a radial direction. Compression of the stent valve 10 is achieved by advancing the stent valve 10 into the channel 42, so that the stent valve 10 supports against the inner surface 50 and is forced to compress in order to advance along it and / or through it.
[00070] Booster 44 can be configured to apply a longitudinal actuation force generated from the outside of channel 42, to stent valve 10 within channel 42, in order to advance stent valve 10 into channel 42. Booster 44 can be configured to apply longitudinal driving force from the radially outer side of channel 42 to stent valve 10 in order to advance stent valve 10 into channel 42. Booster 44 may comprise one or more more parts (for example, members) 56 that slide into the respective slots 58 on the wall of channel 42, and project from the outside of channel 42 through slits 58 into the interior of channel 42. The parts (members) 56 are configured to engage parts of the stent valve 10 to advance the stent valve 10 when the booster 44 is actuated to translate longitudinally.
[00071] Applying the actuation force using this booster 44 can allow the actuation force to be applied to the stent valve in one or more positions that are intermediate to the opposite ends of the stent. This can allow a "push" force to be applied with less risk of bending to the part of the stent under the axial compression load. Additionally or alternatively, this may allow a force ("pull" or "push") to be applied without interfering with the ends of the stent, nor depending on or using the fixation part 26.
[00072] Alternatively, the booster 44 can allow the actuation force to be applied at one end of the stent valve 10, still solves the problem of how to advance a stent valve (i) through a hollow channel that is larger than the stent valve and / or (ii) applying a bias force to a part of the stent valve that it itself compresses.
[00073] Additionally or alternatively, applying the driving force using this booster 44 may allow the driving force to be applied in one or more positions (radial and / or longitudinal) in which the stent is relatively robust and / or is less vulnerable damage or deformation.
[00074] In the present example, the actuation force is intended to be applied to the commissural support posts 22a (see Figs. 2 and 7). The driving force "F" can be applied at the junctions between the support commissural posts 22a and the alignment arcs 24a connected to each respective post 22a. The driving force can be applied in the hollow 38 (also referred to as a depression or concavity) between two adjacent arches 24a. Using this technique, the booster 44 can make contact with the stent valve 10 in a position that is (i) free of the valve component and the skirt (s), in order to avoid damage to them, and / or (ii) free of the cellular structure of the anchoring part 20 which is packed densely during compression. The commissural support posts 22a can provide robust support for receiving the driving force, stronger, for example, than the stabilizing part 24.
[00075] The parts (members) 56 can have any suitable shape and configuration desired to surround the stent valve 10. In the illustrated form, each member part 56 is generally rectangular and / or planar in the shape of the cross section. The portion of the member 56 may have a blade shape. The shape of the cross section can provide a relatively thin and / or flat surface in contact with the stent valve 10. The shape of the cross section can define a first dimension in contact with the stent valve 10 that is less than one dimension of the shape that is generally transversal to the first dimension.
[00076] This shape or shapes can (m) reduce any tendency of the member 56 to make space in the stent valve 10, while still providing adequate torsion resistance for the member 56 with torsion resistance suitable for transmitting the driving force through the strut to the stent valve 10 through slots 58.
[00077] In the form illustrated in the drawings, the members 56 extend inward in a generally radial direction (for example, perpendicular to the longitudinal geometric axis of channel 42). Alternatively, each member part 56 can be tilted relative to the radial direction. The angle of inclination can be approximately 5 ° or more, optionally approximately 10 ° or more, optionally approximately 15 ° or more or optionally approximately 20 ° or more. Additionally or alternatively, the angle of inclination may not be more than approximately 30 °, optionally not more than approximately 25 °, optionally not more than approximately 20 °, optionally not more than approximately 15 °, optionally no more than approximately 10 °. The limb parts 56 can be tilted in one direction towards the outlet 54 of channel 42 when the booster 44 is mounted thereon (so that the inner ends of the limb parts 56 incline towards the outlet 54, as indicated by the arrow 56a in Fig. 3). This arrangement can prevent, or at least reduce, any tendency for the stent valve to curve inward during compression. Instead, the tilt propels the stent valve modestly outward toward surface 50, the presence of surface 50 obstructing outward bending. In other embodiments, a different angle of inclination and / or a different direction of inclination may be used. In still other embodiments, the members 56 may extend inwardly in a substantially radial direction.
[00078] In the illustrated form, the radially internal tips or ends of the member parts 56 are free and define a gap between them. The clearance allows a distal part of the delivery catheter 12 to be accommodated when the stent valve 10 is loaded into the delivery catheter 12 as part of the compression process. In other forms, the inner ends of the member parts 56 can be coupled together.
[00079] Booster 44 optionally may additionally comprise a ring 60 which carries member parts 56, and / or from which member parts 56 extend. The ring 60 can fit around the outer side of the channel 42, and be sliding longitudinally along at least a part of the length of the channel (for example, sliding along at least a part corresponding to the length of the slits 58). Slots 58 can be opened at at least one end of channel 42 (for example, inlet 52) to allow the booster to be disengaged from channel 42 to introduce a stent valve 10 into the inlet.
[00080] Channel 42 can be made substantially as a single member that has slits 58 formed in it (as illustrated in the preferred embodiment). Alternatively, channel 42 may comprise a plurality of component parts that are assembled together to collectively define the shape of the channel.
[00081] In some embodiments, the booster 44 can be operated directly with the hands, but in the preferred embodiments, the compactor 46 can provide additional convenience and control to generate and apply (for example, homogeneously) a driving force for the booster 44 .
[00082] Actuator 46 can be movable with respect to channel 42 and be coupled (or attachable) to channel 42 to generate the actuation force in response to the relative movement applied to actuator 46. Actuator 46 can be external to channel 42. For example, the driver 46 may comprise a rotating member 62 rotated by hand or using a suitable tool. The rotating member 62 can be rotatable about the longitudinal geometric axis of channel 42. The rotating member 62 can be coupled (or attachable) to channel 42 by means of a thread 64 and / or a helical guide, in order to generate displacement longitudinal in response to the rotation of the rotating member 62. Actuator 46 (for example, the rotating member) directly or indirectly meets against pusher 44 (for example, against the ring), to apply the actuation force to it when the rotating member 62 is rotated. The parts (members) 56 transmit the driving force to the stent valve 10 to advance the stent valve 10 into the channel 42.
[00083] In the illustrated form, the channel 42 has a generally cylindrical outer part that carries the thread 64 to the rotating member 62. The rotating member 62 can be unscrewed and removed from the thread 64, for example, at the inlet 52 of the channel 42. This unscrewing / disassembly allows the removal of the booster 44 for insertion of the stent valve in the inlet 52 of the channel 42, and subsequent readjustment of the booster 44 and the rotating member 62.
[00084] The loading tube (or channel extension) 48, if provided, may comprise a hole 66. Hole 66 may correspond in diameter to the outer diameter of the sheath 30 of the introduction catheter and / or to the diameter of the fitting 54a. In the illustrated form, the loading tube 48 further comprises a tab 68 which carries a fixture 70 to removably fix the extension 48 to the channel 42 with the hole 66 substantially aligned with the outlet of the channel 54. The fixation 70 can be a thread female to screw the thread 64 of channel 42 into place, for example, at the outlet end of channel 42. In other embodiments, a different fixation 70 can be used to removably fix the loading tube 48 to channel 42. In addition in other embodiments, no fixation can be used, and the loading tube 48 can instead be held in place when desired by hand, or by some other external support. In still other embodiments, the loading tube can be dimensioned to be at least partially insertable at the outlet of channel 42.
[00085] The loading tube 48, if provided, can simplify the coordination between the introduction catheter 12 and the channel 42. The loading tube 48 can reinforce the sheath 30 and / or allow the compression of at least part of the valve of stent 10 into the loading tube 48 prior to the capture of that part of the stent valve by the sheath. Optionally, the loading tube 48 can be slid over the sheath 30. The loading tube 48 can be slid back (away from the channel 42) to facilitate the loading fit between the fixing part 26 and the stent holder 28. Thereafter, the loading tube can be slid forward (towards channel 42) to reinforce sheath 30 and / or to allow compression of stent valve 10 into extension 48 without having to continuously adjust sheath 30 to collect the progressive compression of the stent valve 10.
[00086] The above components can be made of any suitable material or materials, including metal and / or plastic and / or ceramic. By way of example only, channel 42, driver 46, and loading tube 48 may be plastic; and / or the ring 60 of the booster 44 may be of metal; and / or the members 56 of the booster 44 may be plastic (for example, to avoid metal - metal contact with the stent component 14). In other forms, the members 56 can be of metal or ceramic, or optionally be coated or carry a plastic cover. Alternatively, ring 60 and members 56 of booster 44 may be of plastic, for example, integrally molded together.
[00087] The loading tube 48 and / or the channel 42 can optionally be transparent or translucent to allow the operator to see the status of the stent valve 10 during compression, and to assist in the loading and handling of the introducing catheter 12. An example of the compression and / or loading process is now described by way of example only with respect to Fig. 6, in which relative directions of movement of components can be indicated by the sequence of arrows.
[00088] In step 100, the loading tube 48, if provided, can be slid over sheath 30 while separated from channel 42. The loading tube 48 can be slid back towards the end of the cable (32) so that the loading tube 48 do not cover stent support 28. Sheath 30 can also be moved back to expose stent support 28.
[00089] Still in step 100, before inserting the stent valve 10 into channel 42, driver 46 can be unscrewed and separated from channel 42. Booster 44 can be slid out of the open ends of slots 58 at inlet 52. Thereafter, the stent valve 10 can be inserted by hand into port 52. The stent valve 10 can be inserted with the end that includes the clamping portion 26 first. In the present example, the end inserted first includes the anchoring part 20 and / or the lower crown 20a thereof. The stent valve 10 is rotationally oriented so that the part (s) of the stent valve 10 to which the actuation force is to be applied by the booster, are substantially aligned (or at least approximately) in register with the slots 58. In the present example, these parts correspond to the commissural support posts 22a. The part of the generally cylindrical inner surface 50a at inlet 52 enables the stent valve 10 to be inserted relatively easily, without substantial compression initially.
[00090] In step 102, the booster 44 can be repositioned at the inlet 52, so that the ring 60 fits on the outside of the channel 42, and the members 56 are received in the slots 58 and involve the tips of the commissural support posts 22a (illustrated in Fig. 7). In step 104, the driver 46 can be positioned over the ring 60 of the booster 44 at the inlet 52, and rotated to engage by screw to the thread 64, and retain the stent valve 10 and the booster 44 relative to the channel 42.
[00091] After that (still in step 104), the continuous rotation of the driver 46 relative to channel 42 generates a longitudinal actuation force that is applied to the stent valve 10 through the booster 44, to advance the stent valve 10 in the direction at outlet 54. When the stent valve 10 advances, contact with the non-cylindrical part (s) 50b and 50d of the inner surface 50 compresses the stent valve 10 progressively towards the compressed state. When the stent valve 10 approaches outlet 54, the clamping portion 26 may emerge first at outlet end 54.
[00092] In step 106, the distal end of the delivery catheter can be inserted into the outlet end 54 (if not already in position, as explained below), until the stent 28 support engages and / or matches the exposed part of the fixation 26. The ability to see the exposed part of fixation 26 projecting from the outlet end 54 of the channel facilitates the task of fitting fixation part 26 with stent support 28. The delivery of the non-cylindrical part 50d of the inner surface 50 at outlet 54 encourages the fixation part 26 that protrudes from outlet 54 to adopt a convergent shape, to also facilitate fitting with the stent holder 28. In some cases the distal end of the introducing catheter can be introduced at the outlet end 54 at an earlier stage, so that it is already in place ready to receive the fastening part 26, or it can be introduced once the fastening part 26 begins to reach the outlet end 54 The before emerging from it.
[00093] In step 108, the sheath 30 can be moved distally in order to cover the fixing part 26 fixed to the stent support 28, and to thereby capture the end of the stent valve 10.
[00094] Thereafter, the additional steps of the compression and / or loading process may depend on whether the loading tube 48 is used. If the loading tube 48 is not used, the process can progress incrementally throughout the rotation stage of the driver 46 (step 112) to advance the stent valve 10 a short distance, followed each time by the corresponding (distal) translation of the sheath 30 towards outlet 54 (step 114) to progressively capture the newly exposed part of the stent valve at the outlet. Each time, the sheath 30 can be moved until it comes into contact within the socket 54a.
[00095] Alternatively, if the loading tube 48 is used, in step 110 the loading tube 48 can be slid along the sheath to contact the outlet end 54 of channel 42. The loading tube 48 can be fixed to channel 42 (for example, using fixture 70), or held in place with your hands. The loading tube 48 can provide reinforcement or containment to prevent or reduce any need to further transfer sheath 30 throughout the step when stent valve 10 additionally emerges at outlet end 54 of channel 42. Instead, at step 112 , the driver 46 can be rotated to advance the stent valve 10 towards full compression, without additionally shifting the sheath 30. Sheath 30 can remain merely covering the fixing part 26 attached to the stent holder 28. Sheath 30 can move away from outlet 54, while everything else remains contained within the loading tube 48. The loading tube 48 can temporarily hold the compressed stent valve 10 in a compressed cylindrical or almost cylindrical state. Once the pusher 44 has reached a final position at the end of the slits 58 near the outlet 54, in step 114 the sheath 30 can be moved again towards the outlet end 54 of channel 42 in order to capture, within the sheath, the part of the stent valve 10 contained by the loading tube 48. It can be judged that the amount of additional compression required for the stent valve to pass through hole 66 of the loading tube 48 and into the sheath 30 is relatively small, and can be easily be carried out by translating the sheath 30 into the loading tube 48. The loading tube 48 surrounding the sheath 30 can reinforce the sheath 30 in case reinforcement is required.
[00096] Using any technique, the stent valve 10 achieves a substantially compressed state in which at least a majority of the anchoring part 20 (and optionally at least a part of the valve support part 22) is / are compressed (s) and loaded (s) into the sheath 30. The stabilizing part 24 of the stent valve 10 can remain inside the channel 42. In step 116, the apparatus 40 is disengaged from the introduction catheter 12 and the stent valve 10 by sliding the apparatus 40 distally from the introduction catheter 12. At least a part of the stabilizing part 24 of the stent valve 10 that may not have previously left the hollow channel 24 may tend to re-expand due to that part 24 not being contained by the sheath 30. However , the stabilization part 24 is relatively flexible in a radial direction, and can then be compressed easily without the need for the hollow channel 42, as explained below.
[00097] The final stages of the loading process (not shown in Fig. 6, as these are not directly related to the apparatus 40) may include one or more of: (i) removing the loading tip 34 from the introduction catheter 12 and replace with an implantation tip; and (ii) transfer the sheath 30 more distally to compress the stabilization part 24. The sheath 30 can be translated to contact the introduction tip, to close the distal region of the introduction catheter 12 ready for use for implantation.
[00098] Figs. 8 to 14 illustrate packaging examples 120 in which the introduction catheter 12 can be stored, transported, and delivered to a location where the introduction catheter 12 is to be used. The position of the introduction catheter 12 is illustrated in Fig. 14. The package 120 optionally also contains the apparatus 40 (in Figs. 9, 10, 13 and 14) for compressing and / or loading a stent valve 10. The apparatus 40 it may be, or comprise, any of the characteristics of the modalities described above.
[00099] The package 120 generally comprises a base 122 and a cover (e.g., lid) 124 to cover the base 122 to close the package 120. The base 122 comprises a bowl 126 for receiving, at least partially, the delivery catheter 12. In the illustrated embodiment, the bowl 126 is dimensioned to be able to accommodate the substantially whole introduction catheter 12.
[000100] The characteristic of this modality may be that the bowl 126 is generally impermeable, and is usable to hold a liquid within which the stent valve 10 and / or a containment region 12a of the introduction catheter 12 is immersed during an operation to compress and / or load the stent valve 10 with respect to the introduction catheter 12. Optionally, an additional feature may be that the same bowl 126 is used to maintain the introduction catheter 12 in (i) a storage position in the package 120 in which the introducing catheter 12 is initially supplied, and (ii) a loading position for loading the stent valve 10 into the introducing catheter 12. Optionally, the storage position and the loading position can be substantially the same. In at least one of the positions (or in both positions, when appropriate), the delivery catheter 12 can be substantially parallel to a plane of the base, and / or substantially horizontal when in use to load a stent valve. Having the introduction catheter 12 substantially parallel to the base plane can enable the height of the package to be kept desirably small. Having the introduction catheter 12 substantially parallel to the base plane and / or substantially horizontal in use during the loading of a stent valve, can (i) enable the amount of liquid necessary to fill the vat to be kept desirably small, and / or (ii) reduce the amount of air that can inevitably be trapped inside the delivery catheter during the loading operation. The trapped air must be removed prior to insertion of the catheter into the patient's body, and reducing the amount of air likely to be trapped during loading can facilitate the obligation of this subsequent "de-aeration" step.
[000101] The bowl 126 can have a uniform depth, or it can have a depth that varies along its length. At least in a region 126a into which the stent valve 10 is compressed and / or loaded, or the containment region 12a of the introduction catheter 12 is accommodated, the bowl 126 has a depth greater than the transverse dimension of the valve stent 10 and / or loading device 40. For example, the depth in region 126a can be: at least 1 cm; at least 2cm; at least 3cm; at least 4cm; at least 5cm; at least 6cm; at least 7cm; at least 8cm; at least 9cm; at least 10cm; at least 11cm; at least 12cm; at least 13cm; at least 14cm; at least 15cm.
[000102] The bowl 126 can have a uniform width, or it can have a width that varies along its length.
[000103] In some embodiments, the bowl 126 includes one or more first surface parts 128 that together define a fitting that fits a shape of parts of the introducing catheter 12 to support the catheter against substantial movement. Additionally or alternatively, the bowl 126 includes one or more second surface parts 130 which together define the spaces 130a adjacent to the parts 12b of the introduction catheter which are intended to be secured or accessed manually to manipulate the catheter and / or transfer the sheath. Additionally or alternatively, the bowl 126 includes one or more surface parts 130 that define a clearance for the region 126a. In some embodiments, the bowl 126 includes one or more first surface parts 128 and one or more second surface parts 130, so that the second surface parts 130 allow manual access to manipulate the sheath while the introduction catheter 12 is in the position defined by the first surface parts 128.
[000104] The base of the bowl 126 can be generally flat (optionally with rounded corners) and / or at least parts of the base of the bowl 126 can be shaped to support or retain the introducing catheter and / or the loading apparatus from below.
[000105] The liquid capacity of bowl 126 can be chosen by the project. In some embodiments, the liquid capacity may be such that (optionally with the introduction catheter 12 and / or the loading device 40 in place inside the bowl 126) the quantity of liquid for the bowl 126 can be one or more selected from of: no more than 4 liters; no more than 3.5 liters; no more than 3.25 liters; no more than 3 liters; at least 1 liter; at least 2 liters. For example, the amount of liquid can be measured when both the introducing catheter 12 and the loading apparatus 40 are positioned inside the bowl 126.
[000106] The lid 124 optionally comprises one or more projections 132, such as one or more vertices, which depend on the lid 124 and match the bowl 126 and / or involve (i) the introduction catheter 12 and / or (ii) the loading device 40, to retain the introducing catheter / loading device trapped inside the bowl. The projections 132 may have a profile 134, such as a concave shape, configured to retain the surface of the introducing catheter / loading device.
[000107] The charging apparatus 40 may optionally be contained within a separate compartment of bowl 126, or it may be contained in a region 136 of bowl 126 reserved for it. As explained above, the loading apparatus 40 may be restricted in place by the lid 124 (or a projection 132 of the lid).
[000108] Base 122 may additionally comprise one or more compartments other than bowl 126, for containing accessories.
[000109] The base 122 and / or the cover 124 can be of any suitable material or materials, for example, plastic. The base 122 and / or the cap 124 can be formed by any suitable technique, for example, blow molding or injection molding.
[000110] Examples of steps for using package 120 may include, in any order, one or more of the following: (a) providing package 120, in closed form, containing the introduction catheter 12 and / or the loading apparatus; (b) opening the package 120 (for example, removing the lid 124); (c) introducing liquid into bowl 126; and (d) loading a stent valve within a containment region 12a of the introducing catheter 12 while at least the stent valve and / or the containment region 12a are immersed in the liquid in the bowl. For example, apparatus 40 can be positioned on the tip of the introduction catheter 12, and manipulated into region 126a of bowl 126.
[000111] The liquid can, for example, be saline. The liquid can be colder than your body temperature. For example, the liquid can be approximately room temperature.
[000112] Step (d) can be performed with the introduction catheter 12 substantially horizontal.
[000113] The method may additionally include a step of removing trapped air from the introduction catheter 12 after the loading operation (e.g., a "de-aeration" step). As explained above, performing step (d) with the substantially horizontal delivery catheter can reduce the amount of air trapped during the loading operation.
[000114] Step (d) can include the steps described above in relation to Fig. 6 of the drawings.
[000115] The above description is merely illustrative of preferred embodiments of the invention and does not limit the scope of protection. Many equivalents, modifications and improvements can be used within the scope of the invention.

权利要求:
Claims (16)
[0001]
1. Apparatus (40) for compressing a transcatheter cardiac stent valve (10) characterized by the fact that it comprises: a hollow channel (42) that has a wall that is stationary or fixed in a radial direction, and an interior surface (50 ) shaped to progressively compress the stent valve in response to the longitudinal advance of the stent valve into the hollow channel; and a driver (46) coupled to the hollow channel (42) by a threaded connection (64), and configured to generate in response to the rotation of the driver, a longitudinal drive force to advance the stent valve.
[0002]
2. Apparatus (40) according to claim 1, characterized by the fact that the actuator (46) is rotatable about the longitudinal geometric axis of the hollow channel (42).
[0003]
Apparatus (40) according to claim 1 or 2, characterized by the fact that the hollow channel (42) has an inlet (52) and an outlet (54), in which the inlet has a larger bore diameter than the outlet, and the apparatus further comprising a loading tube (48) usable in, or at least partially insertable into, the loading tube having a hole for receiving (i) at least a part of a sheath of a introduction catheter to be loaded with the stent valve; and / or (ii) at least a part of the stent valve.
[0004]
Apparatus (40) according to any one of claims 1 to 3, characterized in that it additionally comprises an impeller (44) for applying the longitudinal actuating force of the actuator (46) to a stent valve within the channel hollow (42).
[0005]
Apparatus (40) according to claim 4, characterized in that the hollow channel (42) comprises at least one slot (58) through a wall thereof; wherein the booster (44) comprises a part (60) that fits on the outside of the circumferential periphery of the hollow channel and a sliding part (56) that protrudes through it to engage the stent valve within the channel hollow, to apply a longitudinal actuation force to the stent valve from the booster (44).
[0006]
Apparatus (40) according to claim 5, characterized by the fact that the hollow channel (42) comprises a plurality of said slots (58), and in which the pusher (44) comprises a corresponding number of parts ( 56) sliding through the slits and projecting through it to engage the stent valve within the channel.
[0007]
7. Apparatus (40) according to claim 6, characterized by the fact that the part (60) of the impeller that adjusts on the outer side of the circumferential periphery of the hollow channel, radially interconnects the outer side of the hollow channel, the parts (56) which are sliding in the slits (58).
[0008]
Apparatus (40) according to claim 2 or 3, characterized in that the part of the impeller external to the hollow channel comprises a ring (60), and in which the sliding parts in the slots comprise respective members (56) that extend into the ring.
[0009]
Apparatus (40) according to claim 8, characterized in that the members (56) are inclined in relation to the plane of the ring.
[0010]
Apparatus (40) according to any one of claims 5 to 9, characterized in that the part (56) of the sliding pusher in the slot is shaped like a blade having a thin front edge or edge that advances inwards of the slot, and a long edge or surface that slides against the edge of the slot.
[0011]
Apparatus (40) according to any one of claims 5 to 10, characterized in that the impeller is configured to apply a longitudinal actuation force to the stent valve radially from the outside of the hollow channel.
[0012]
Apparatus (40) according to any one of claims 5 to 11, characterized by the fact that the part (60) of the impeller (44) which fits on the outside of the circumferential periphery of the hollow channel is dimensioned in a way that said part (60) remains on the outer side of the circumferential periphery at least along the entire length of the slot (58).
[0013]
13. Apparatus according to claim 12, characterized by the fact that the part (60) of the impeller (44) that fits on the outside of the circumferential periphery of the hollow channel has a dimension in a circumferential direction that is greater than a circumferential width of the slot (58).
[0014]
14. Apparatus applicable to a kit, characterized by the fact that the kit comprises: an apparatus (40) as defined in any of the preceding claims; an introduction catheter for introducing a stent valve to an implantation site within the body, the introduction catheter having at least one translatable sheath in a containment region to receive the stent valve in a compressed manner as a result of an operation loading to compress and load the stent valve with respect to the introduction catheter; and packaging to contain the introduction catheter before use, the packaging including a base that has an impermeable vat, the vat having a depth suitable for use to hold liquid into which the catheter's containment region can be immersed during the delivery operation. loading.
[0015]
Apparatus according to claim 14, characterized by the fact that the base further comprises a region for storing the apparatus for compressing a stent valve during the loading operation, said region optionally being inside the vat.
[0016]
16. Method for compressing a transcatheter cardiac stent valve (10) characterized by the fact that it comprises in any order the steps of: (a) providing a hollow channel (42) having a wall that is stationary or fixed in a radial direction, an inlet (52) and an outlet (54), and an inner surface (50) shaped to progressively compress a stent valve in response to the longitudinal advance of the stent valve into the channel; (b) insert a stent valve (10) at the entrance to the channel; and (c) rotating an actuator relative to the hollow channel to generate, through a thread, a longitudinal actuation force to advance the stent valve into the channel towards the outlet.

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法律状态:
2018-03-27| B15K| Others concerning applications: alteration of classification|Ipc: A61F 2/24 (2006.01), A61F 2/00 (2006.01), A61F 2/9 |

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2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-10-01| B15K| Others concerning applications: alteration of classification|Free format text: AS CLASSIFICACOES ANTERIORES ERAM: A61F 2/24 , A61F 2/00 , A61F 2/95 , A61F 2/958 Ipc: A61F 2/00 (1985.01), A61F 2/24 (1985.01), A61F 2/9 |

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2019-10-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-12-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-02-02| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 03/05/2012, OBSERVADAS AS CONDICOES LEGAIS. |

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2022-03-03| B21F| Lapse acc. art. 78, item iv - on non-payment of the annual fees in time|Free format text: REFERENTE A 10A ANUIDADE. |

优先权:

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申请号 | 申请日 | 专利标题

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EP11164926A|EP2520251A1|2011-05-05|2011-05-05|Method and Apparatus for Compressing Stent-Valves|

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EP11164926.5|2011-05-05|

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PCT/EP2012/058085|WO2012150290A1|2011-05-05|2012-05-03|Method and apparatus for compressing/loading stent-valves|

---