Compressing / filling cardiovascular implants

Abstract

An instrument (10) for compressing a cardiovascular implant (40), optionally a prosthetic heart valve, into a reduced size sufficient for transcatheter implantation, the instrument comprising: a funnel (20) having an inner surface defining a constricted channel (21) configured to compress the implant in response to longitudinal translation of the implant within the channel, the channel has an axis (A) extending from an inlet (21a) to an outlet (21b); and at least one, optionally a plurality of longitudinal cantilevered elements (32; 32a, 32b) configured to be inserted into the channel via the inlet to support an implant (40) from inside during compression, at least one cantilevered element having a tip biased toward a position spaced from the axis of the channel, the tip being deflectable toward the axis of the channel to accommodate constriction of the channel. When the implant is translated longitudinally within the channel, the cantilevered element biases the implant (40) outwardly against at least a portion of the inner surface of the funnel to prevent inward buckling during compression of the implant having a non-circular profile.

Description

Technical Field

[0001] The present invention relates to the field of cardiovascular implants, and more particularly to devices, uses and methods for compressing and / or loading implants into delivery catheters for transcatheter implantation. For example, the implants may be cardiac implants and / or artificial valve implants (e.g., artificial heart valves). Background Art

[0002] Diseased, damaged, or malformed heart valves often require heart valve replacement. For example, in cases of valvular regurgitation, the damaged valve cannot close effectively. Replacement prosthetic heart valves are usually placed by a surgeon or other qualified physician during open-heart surgery or through less invasive methods such as transcatheter intervention. Transcatheter implantation can be very beneficial and more effective because it allows the implant to be delivered without the use of a heart-lung bypass machine. In this case, the physician inserts a catheter through an access point and introduces the valve implant in a compressed state to the delivery site for implantation.

[0003] Although pre-compressed valve implants have been proposed, the most common technique is to compress the implant from normal size shortly before intervention to reduce the risk of damage to the implant due to prolonged compression. Compression of the implant is usually accomplished by using a crimper, which reduces the circumference of the vascular stent, allowing delivery via minimally invasive techniques.

[0004] However, compressing implants, especially valve implants, is a complex task. Implants are fragile and can break, deform, tear or become damaged if crimped incorrectly. In some cases, the implant may still be usable but will need to be re-crimped, which in turn can result in a fragile device or reduced operating efficiency. In other cases, damage caused by incorrect compression renders the implant unusable and requires replacement with a new one. The second implant may not be immediately available, and preparing the second implant will result in delays. Using a second implant will inevitably increase the cost of the procedure. The difficulty of compressing the implant is further exacerbated if the implant is of a non-circular design. Non-circular implants may experience higher and uneven stress concentrations during crimping, increasing the risk of deformation (e.g., buckling) or other damage to the implant. The implant must also be loaded into the delivery catheter in its compressed state, which can also be challenging when the implant is of the self-expanding type. The implant must remain sterile, and sterile gloves must be worn when handling the implant and crimper. This can affect the operator's dexterity, making the operation even more inconvenient.

[0005] A further consideration involves the number of personnel, especially trained operators, required to perform each crimping procedure and to load the implant into the catheter. Multiple operators are often required to perform the necessary step-by-step procedures and maneuvers. However, the more operators that need to be relied upon, the greater the potential for contamination and accidents due to human error.

[0006] It may be a non-limiting objective to solve and / or alleviate at least one of the above-mentioned problems, and / or to enhance a transcatheter delivery system as described above. Summary of the invention

[0007] Broadly speaking, one aspect of the invention provides an apparatus for compressing a cardiovascular implant into a small size for transcatheter implantation. The apparatus may include a funnel having an inner surface defining a narrowed channel configured to compress the implant in response to longitudinal translation of the implant within the channel. The apparatus is configured to compress an implant having a non-circular profile into a circular shape.

[0008] As used throughout the text, the term "non-circular profile" refers to an implant having (i) a generally non-circular form and / or (ii) one or more non-circular features. For example, the non-circular form can include a D-shaped cross-section (e.g., a tubular portion of the implant, described below). The non-circular feature can include a locally protruding anchor, optionally used in conjunction with a D-shaped cross-section of the tubular portion of the implant. The implant can have a non-circular profile in a non-compressed and / or pre-compressed configuration, and / or in an operational implant configuration.

[0009] Furthermore, as used herein, the term "compression" refers to reducing the size of an implant at least in the circumferential direction of the implant, regardless of whether the axial length of the implant increases or decreases. Depending on the design of the implant, the implant may become longer when compressed in the circumferential direction. However, by circumferential compression, the implant can be implanted using a small diameter catheter, thereby delivering the implant in a compressed form.

[0010] In addition, as described herein and in all aspects below, the cardiovascular implant can optionally be a cardiac implant, optionally an artificial heart valve. The artificial heart valve can optionally be an artificial atrioventricular valve, such as a mitral valve, and / or optionally a self-expanding artificial heart valve. Another cardiovascular implant particularly contemplated is an implantable filter for filtering blood.

[0011] In addition to or in lieu of the first aspect, a second aspect of the invention provides an apparatus for compressing a cardiovascular implant into a reduced size sufficient for transcatheter implantation. The apparatus includes a funnel having an inner surface defining a narrowed channel configured to compress the implant in response to longitudinal translation of the implant within the channel. The apparatus also includes a biasing device for biasing the implant outwardly against at least a portion of the inner surface of the funnel when the implant is longitudinally translated within the channel. Optionally, the biasing prevents inward bending during compression of an implant having a non-circular profile.

[0012] The biasing means may help prevent the implant from buckling during compression by biasing the implant against the inner surface of the passageway, thereby significantly reducing the risk of inadvertent deformation of the implant during the compression phase.

[0013] In some embodiments, the biasing device may include at least one cantilevered biasing element extending longitudinally relative to the channel and configured to bias at least a portion of the inner surface of the channel outwardly. Additionally or alternatively, the cantilevered element may be configured to be deflectable and / or bend inwardly to accommodate a narrowing of the channel.

[0014] In other words, the cantilevered element can be configured to conform to the channel as the implant is advanced longitudinally within the channel.The cantilevered element serves to cause the implant to at least partially lie flush with the inner surface of the funnel, thereby preventing the implant from buckling inwardly when compressed.

[0015] In some embodiments, the biasing device may include at least two cantilevered elements; the cantilevered elements may have the same length and / or different lengths.

[0016] Additionally or alternatively to any of the above, the biasing element of the biasing device may optionally be a finger extending from the hub.The finger may extend longitudinally from the hub.

[0017] Having at least two cantilevered biasing elements / fingers serves to at least partially urge the implant against the inner surface of the funnel at multiple locations around its entire cross-section, thereby increasing resistance to unwanted inward bending.

[0018] In some embodiments, the apparatus may include an actuating mechanism; operation of the actuating mechanism (e.g., manual operation) may produce longitudinal movement of the biasing device relative to the funnel. Alternatively, the actuating mechanism may include a threaded element that produces longitudinal movement by rotation of a rotatable actuating member. The actuating mechanism may thus be used to gradually advance the biasing device longitudinally.

[0019] In certain embodiments, the apparatus may include a moving member for advancing an implant in passage, the moving member being driven by the movement of an actuator. The moving member may be attached directly or indirectly or may be attached to the implant, thereby allowing the implant to move along the narrowed passage when the moving member is enabled by an actuating mechanism. For example, the moving member may be a traction device that is directly or indirectly engaged or may be engaged to the implant, for pulling the implant through a funnel. In one form, the moving member includes an axle that is configured to be engaged to a connector that is pre-attached to an implant, for example, by being pre-attached to one or more tethers or arms of the implant.

[0020] Here, operation of the actuation mechanism (eg, manual operation) drives the moving member, thereby advancing the implant in the channel. This can achieve controlled compression of the implant as the implant is advanced longitudinally in the channel.

[0021] In some embodiments, the apparatus may include an actuating mechanism configured to cause the biasing device and the moving member to move longitudinally simultaneously within at least a portion of the range of motion of the biasing device and / or the moving member. Optionally, the actuating mechanism may cause a longitudinal displacement of the biasing device together with a longitudinal displacement of the moving member within at least a portion of the range of motion of the biasing device and / or the moving member.

[0022] The simultaneous longitudinal movement of the biasing means and the moving member ensures that they advance in unison with one another, which facilitates controlled compression of the implant and continued support of the implant from within as it moves.

[0023] As a supplement or alternative to any of the above aspects, and as a supplement or alternative to any of the above features, a third aspect of the present invention provides an apparatus for compressing a cardiovascular implant into a small size for transcatheter implantation. The apparatus comprises a funnel having an inner surface defining a narrowed passage, the narrowed passage being configured to compress the implant in response to the longitudinal translation of the implant in the passage, the passage having an axis extending from an inlet to an outlet. The apparatus also comprises at least one (optionally a plurality of) longitudinal cantilevered elements configured to be inserted into the passage via the inlet. The at least one cantilevered element has a top biased toward a position spaced apart from the passage axis, the cantilevered element and / or the top having elasticity to allow bending and / or deflection toward the passage axis when the cantilevered element advances in the narrowed passage.

[0024] At least one cantilevered element can be configured to bias the implant outwardly into contact with an inner surface of the funnel, optionally inhibiting bending of the (eg, non-circular) implant.

[0025] Additionally or alternatively, the at least one cantilevered element may be configured to guide collapse of a valve component of the prosthetic heart valve implant during compression of the prosthetic heart valve implant.

[0026] When multiple cantilever elements are provided, two or more elements may have substantially the same length, and / or two or more elements may have substantially different lengths. For example, different lengths may be suitable for cooperating with a valve component of an artificial heart valve implant to guide the folding of the valve component.

[0027] In addition to or in lieu of any of the above aspects, and optionally using any of the above features, a fourth aspect of the present invention provides a method for compressing a cardiovascular implant to a smaller size for transcatheter delivery. The method may optionally use an apparatus according to any of the above aspects. The method comprises:

[0028] longitudinally translating an implant within a funnel having an inner surface defining a constricted channel such that the constricted channel compresses the implant in response to the longitudinal translation; and

[0029] During at least a portion of the translating step, at least a region of the implant is supported radially inwardly to prevent buckling of the region during compression.

[0030] The supporting step may include using a biasing means to bias the implant outwardly against at least a portion of the inner surface of the funnel as the implant translates longitudinally within the passage. The biasing means may include at least one (optionally a plurality) longitudinal cantilevered elements.

[0031] In addition to or in lieu of any of the above aspects, and optionally using any of the above features, a fifth aspect of the present invention provides a method of compressing a cardiovascular implant to a smaller size for transcatheter delivery. The method may optionally use an apparatus according to any of the first to third aspects. The method comprises:

[0032] longitudinally translating an implant within a funnel having an inner surface defining a constricted channel such that the constricted channel compresses the implant in response to the longitudinal translation; and

[0033] During at least a portion of the translating step, at least a region of the implant is supported radially inwardly by at least one (optionally a plurality) longitudinal cantilevered elements.

[0034] The method of any of the above aspects may also include inserting a biasing device and / or at least one cantilevered element into or through one end (e.g., an inlet end) of the funnel and / or channel.

[0035] The method of any of the above aspects may further comprise translating the biasing device and / or the at least one cantilevered element longitudinally within the channel. The translating step may cause the biasing device and / or the at least one cantilevered element to deflect and / or bend toward the axis of the channel as the biasing device and / or the at least one cantilevered element translates along the channel.

[0036] The biasing device and / or at least one cantilevered element may move simultaneously with the movement of the implant within at least a portion of the implant's range of motion, and optionally substantially synchronously with the implant within at least a portion of the implant's range of motion. This may provide continuous support for the implant during compression.

[0037] The method of any of the above aspects may also include manually operating an actuating mechanism to translate the implant and the biasing device and / or at least one cantilevered element, optionally at least partially simultaneously and / or in unison, as described above. The step of manually operating the actuating mechanism may include rotating a rotary actuating member of the actuating mechanism to drive translation of: the implant (e.g., via a moving member); and / or the biasing device; and / or at least one cantilevered element. The step of rotating the rotary actuating member may include rotating the rotary actuating member approximately around an axis of rotation approximately coaxial and / or parallel to the longitudinal axis of the funnel.

[0038] In addition to or in lieu of any of the above aspects, and in addition to or in lieu of any of the above features, a sixth aspect of the present invention provides an apparatus for compressing a cardiovascular implant into a small size for transcatheter implantation. The apparatus includes a funnel having an inner surface defining a narrowed channel, the narrowed channel being configured to compress the implant in response to longitudinal translation of the implant within the channel. The narrowed channel includes a cross-section that varies in shape and size from one end of the funnel to the other end and / or along at least a portion of the length of the channel. The shape of the channel can vary between a non-circular channel shape and a circular channel shape to compress an implant having a non-circular profile into a circular shape.

[0039] In any of the above aspects, the narrowed channel of the device allows the implant to enter the compressed state from the deployed state. The change in channel shape from a non-circular or out-of-circular cross-section to a generally circular cross-section can help the implant adopt a generally circular compressed form, which is typically the form adopted when introduced using a catheter. It is often necessary for a non-circular implant to adopt a circular form when compressed to fit within a catheter and be delivered to a patient.

[0040] The narrowed channel of the device may include a cross-section that gradually changes in size and shape over at least a portion of the length of the channel for compressing an implant having non-circular and / or out-of-round features into a circular shape.

[0041] The gradual change in the channel cross section gradually changes its shape and size as the implant is advanced longitudinally. This allows for a gradual adjustment of the implant structure, avoiding unnecessary stress on the implant and reducing the risk of damage.

[0042] In some embodiments, a portion of the channel can have a D-shaped cross-section, including a curved region (e.g., a rounded portion representing a "D") connected to a smaller curved region (e.g., a flat portion representing a "D"). The smaller curved region can optionally include a curved region or a straight region. Optionally, the D-shaped cross-section can have one or more peripheral protrusions. The D-shaped cross-section can provide a channel suitable for implant types that have a D-shaped morphology in their expanded state, such as certain types of mitral valve implants. Thus, an implant having a D-shape can better control the shape when compressed than compressing a D-shaped implant using a purely round funnel channel, which is inherently less suitable for the shape of the implant.

[0043] Additionally or alternatively, in some embodiments, the inner surface of the funnel defining the narrowed passage may include one or more longitudinal internal grooves. The advantage of the grooves is that the passage shape can be adapted to implants with non-circular features, such as protrusions extending outwardly from a tubular implant. The position of at least one groove may be roughly aligned with the position of such a protrusion.

[0044] In certain embodiments, at least one groove, optionally multiple grooves, optionally each groove is expanded in the circumferential direction at the first end of the groove. Expanding can correspond to the gradual circumferential widening at the first end of the longitudinal groove. For example, the first end can correspond to the wide end and / or the entrance end of the funnel. In one example, the groove has a sidewall away from each other at the first end of the groove. Expanding can be roughly linear, or curvilinear or roughly curved (e.g., convex or concave). When the implant enters the passage, the circumferential expansion can help the projection of the implant to be correctly guided into the groove, thereby allowing correction of any slight rotational misalignment, and providing positional tolerance without the need to carry out unnecessary circumferential widening of the groove along most of its length.

[0045] In certain embodiments, the implant may have an anchoring system comprising a plurality of projections at different circumferential positions of the periphery of the implant. The funnel may have a groove less than the number of projections so that not all projections are contained in the corresponding grooves. For example, the funnel may have a groove corresponding only to a projection folded into the wall of the implant to overlap with the implant wall. For example, such a projection may be folded into a window frame provided in the tubular portion of the implant wall.

[0046] In certain embodiments, the depth of at least one groove changes along at least a portion of the length of the passage. Alternatively, the depth can gradually change along at least a portion of the length of the passage. Alternatively, the depth of the groove can shallower toward the outlet of the passage. This groove configuration can be configured to compress or inwardly fold the projection of the implant when the implant advances longitudinally in the passage.

[0047] In addition to or in lieu of any of the above aspects, and optionally using any of the above features, a seventh aspect of the invention provides a method of compressing a cardiovascular implant to a smaller size for transcatheter delivery. The method may optionally use an apparatus according to the sixth aspect or any other aspect. The method comprises:

[0048] longitudinally translating an implant within the funnel, the funnel having an inner surface defining a constricted channel such that the constricted channel compresses the implant in response to the longitudinal translation,

[0049] Wherein the translating step includes causing the implant to change its cross-sectional size and shape through a passageway that changes size and shape along at least a portion of the funnel.

[0050] The translation step may include translating the implant so that at least one anchoring system protrusion of the implant enters a longitudinal groove of the funnel. Alternatively, the protrusion may enter the groove through a mouth of the groove that tapers circumferentially to gradually guide the protrusion into the groove. Additionally or alternatively, the translation step may include translating the implant so that at least one other anchoring system protrusion of the implant does not enter a corresponding groove of the funnel. The number of grooves may be less than the number of protrusions.

[0051] In addition to the above or alternatively, the translation step can include translating implant from the region where the inner channel has a roughly non-circular cross-sectional shape to the region where the inner channel has a roughly circular cross-sectional shape. For example, the non-circular cross-sectional shape can be a D-shape, including a curved region (such as a circular portion representing "D") that is connected to a smaller curved region (such as a flat portion representing "D"). The smaller curved region can optionally include a curved region or a straight region. Alternatively, a D-shaped cross section can have one or more peripheral projections.

[0052] In addition to or in lieu of any of the above aspects, and in addition to or in lieu of any of the above features, a fifth aspect of the invention provides an apparatus for compressing a cardiovascular implant into a small size for transcatheter implantation, comprising a funnel having an inner surface defining a narrowed channel, the narrowed channel being configured to compress the implant in response to longitudinal translation of the implant in the channel, the channel having an axis extending from an inlet end to an outlet end. The apparatus may also include a first member and a second member, which may be longitudinally translated relative to the channel, and optionally at least partially translated relative to each other. The apparatus may also include an actuating mechanism for achieving longitudinal movement of the first element from (and / or at, and / or via) the inlet end of the channel, and for achieving longitudinal movement of the second element from (and / or at, and / or via) the outlet end of the channel.

[0053] The first member may correspond to the above-mentioned biasing device, for example. The second member may correspond to the above-mentioned moving member, for example.

[0054] The actuation mechanism may be configured to move the first and second members simultaneously, at least within a portion of the range of motion of one or both members. Alternatively, the actuation mechanism may be configured to move the first and second members in unison with each other, at least within a portion of the range of motion of one or both members.

[0055] Such an actuation mechanism may provide a single actuator capable of causing movement of multiple components relative to the compression passage, and may facilitate operation of the device by, for example, a single operator.

[0056] In addition to or as an alternative to any of the above aspects, and in addition to or as an alternative to any of the above features, an eighth aspect of the present invention provides a support that carries (or is used to carry) a cardiovascular implant in an implant packaging form, which implant can be compressed into a compressed form for transcatheter implantation, optionally using a compression device as defined in any of the above aspects.

[0057] The support at least partially surrounds at least a portion of the cardiovascular implant such that the implant is at least partially located within the support. The support includes an engagement profile configured to cooperate with an anchor of the implant to bend the anchor from a deployed configuration to a non-deployed configuration when the implant translates out of the support at least in a first relative motion direction. For example, in the deployed configuration, the anchor may protrude laterally relative to the tubular portion of the implant. In the non-deployed configuration, the anchor may no longer protrude laterally, and / or it may have a more streamlined shape at least laterally.

[0058] By such an arrangement, the support can serve multiple purposes. First, the support can carry the implant in a packaged form prior to use, for example, in a sterile bottle or other packaging. Second, it can be used to assist in compressing the implant to a compressed form by bending the implant's anchor to a non-deployed form when the implant's anchor is removed from the support. This bending operation then does not need to be performed separately by a compression instrument.

[0059] In some embodiments, the support can also be used to transfer the implant from its packaging to a compression device to compress the implant, optionally a compression device according to any of the foregoing aspects. For example, the device may include a funnel having an inner surface defining a narrowed channel, the narrowed channel configured to compress the implant in response to longitudinal translation of the implant within the channel. The support can be positioned near or at the entrance of the compressor to bend the anchor when the implant translates from the support into the funnel.

[0060] In some embodiments, the engagement profile may bend the anchor by at least 90°, optionally at least 120°, optionally at least 150°, optionally at least 170°, optionally about 180°.

[0061] The engagement contour may comprise a contoured front face forming a positive fit with an anchor of the implant and, in particular, a channel-shaped rear contour for accommodating the anchor of the implant.

[0062] At least one anchor may be adapted to be placed in a ventricle. The anchor may be adapted to engage a heart valve from the ventricle. The anchor may be arranged on a longitudinal end of the implant, which is adapted to be placed in a ventricle, in particular in the left ventricle, on an opposite side of a longitudinal end of the implant, which is adapted to be placed in an atrium, in particular in the left atrium.

[0063] In use, the anchor may be adapted to interact with cardiovascular tissue by at least partially surrounding the leaflets of a heart valve, in particular the tips of the leaflets.

[0064] This allows an optimal mounting of the implant to the valve annulus, in particular the mitral valve annulus, by fixing the native leaflets using at least one anchor. Furthermore, by such a design of the anchors, the risk of outflow tract obstruction, in particular of the left ventricular outflow tract (LVOT) obstruction, can be minimized. The movement of the leaflets relative to the anchors can be limited by encircling the leaflets. The implant can be mounted in a delivery catheter, the anchor for placement within the ventricle being arranged on the distal or proximal longitudinal end of the implant. This allows the implant to be used, for example, for transapical retrograde surgical valve replacement or transseptal antegrade valve replacement, in particular mitral valve replacement.

[0065] In some embodiments, the implant includes a plurality of anchors, and the stent includes a plurality of engagement profiles configured to flex at least some of the plurality of anchors.

[0066] The implant may comprise two anchors of different configurations.At least one anchor may be arranged at a longitudinal end of the implant, in particular at a longitudinal end of the tubular portion of the implant.

[0067] Additionally or alternatively, the implant may comprise at least one anchor arranged between the longitudinal ends of the implant, in particular on a middle portion of the tubular portion of the implant.The first anchor and the second anchor may be spaced apart from each other in the longitudinal direction of the implant.

[0068] At least one first anchor and at least one second anchor may have different angular orientations relative to each other. If the implant comprises two first and second anchors of different structures, for example formed by side and end projections, at least one first anchor, for example an end projection, may be bent by the engagement profile by at least 90°, optionally at least 120°, optionally at least 150°, optionally at least 170°, optionally about 180°. At least one second anchor, for example formed by a side projection, may be bent by the stent to a lesser extent than the first anchor, in particular less than 100°, optionally less than 90°, optionally less than 80°.

[0069] The anchors, in particular the second anchor, may be adapted to be folded into a window frame formed by the tubular portion of the implant.

[0070] This allows designing the tubular portion of the implant in a way that overlapping parts of the tubular portion of the implant (e.g. parts of the frame) are avoided, internal stresses can be minimized and the foldability of the implant in its undeployed configuration can be optimized. The implant can be suitable for mounting a single leaflet, in particular a pericardial single leaflet. The device can further include a single leaflet. The single leaflet can have an asymmetrical symmetry, in particular an asymmetrical symmetry suitable for forming a joining area of ​​the tubular portion directly adjacent to the implant.

[0071] Furthermore, the implant may have a D-shape, including a curved region and a less curved connection region. The coaptation region of the single leaflet may be arranged in the more curved region of the D-shape.

[0072] In addition to or as an alternative to any of the above aspects, and in addition to or as an alternative to any of the above features, a ninth aspect of the invention provides a use of a stent for a cardiovascular implant, the cardiac implant being compressible from an expanded configuration to a compressed configuration for transcatheter implantation, the cardiac implant having at least one anchor movable between a deployed shape in the expanded configuration of the implant and a non-deployed shape in the compressed configuration of the implant, the stent having at least one engagement profile for contacting at least one anchor of the implant. The use comprises:

[0073] (i) prior to use, at least partially surrounding at least a portion of a cardiovascular implant in a packaged form with a stent, such that the implant is at least partially located within the stent; and

[0074] (ii) When the cardiac implant is translated out of the stent to be compressed to the compressed configuration, the stent facilitates compression of the implant by at least partially bending the anchor from the deployed shape to the non-deployed shape through contact between the engagement profile and the anchor.

[0075] The use may also include using the stent to support a cardiac implant at an insertion position relative to (eg, an inlet thereof) a compression device including a compression funnel for compressing the implant by longitudinally translating the implant out of the stent and through the funnel.

[0076] In addition to or as an alternative to any of the above aspects, and in addition to or as an alternative to any of the above features, a tenth aspect of the present invention provides a process or method, comprising:

[0077] providing a cardiovascular implant in a packaged configuration mounted to a stent, the implant having an anchor for interacting with cardiovascular tissue in use, and the stent at least partially constraining the implant such that the implant is at least partially located within the stent; and

[0078] The implant is translated out of the stent, the translating step comprising causing an engagement profile of the stent to interact with the anchor to bend the anchor from a deployed shape to a non-deployed shape as the implant is translated out of the stent.

[0079] In addition or as an alternative to any of the above aspects, and in addition or as an alternative to any of the above features, an eleventh aspect of the present invention provides an apparatus comprising:

[0080] (i) a cardiovascular implant in a packaged form, the implant being compressible into a compressed form to facilitate transcatheter implantation; and

[0081] (ii) a puller to which the implant is coupled by at least one tether extending along a plurality of reciprocating segments and / or pairs of segments between the puller and the implant to resist longitudinal sliding of the tether relative to the puller.

[0082] Each reciprocating cable segment includes a pair of individual cable segments, for example, back and forth between the puller and the implant.

[0083] The puller can be used to pull the implant into and / or through a compression device (e.g., a funnel) via a tether. Preventing longitudinal slippage of the tether relative to the puller allows for stable control of the relative spacing from the puller to the implant around the perimeter of the implant and / or the puller without providing a separate tether for each rope segment. Implant stability is important to prevent the implant from being decentered and / or affecting the distribution of tension on the implant, both of which can be detrimental to the crimping grip.

[0084] For example, the puller may include a hub including a plurality of holes through which the tether is passed. The tether may include an anchoring loop to anchor at least one end of the reciprocating rope segment of the tether relative to at least one hole to prevent longitudinal sliding.

[0085] In some embodiments, the puller includes at least one component having at least one (optionally multiple) cutting gaps, at which at least one tether is located to facilitate cutting of at least one tether to release the implant from the puller. The gap can optionally take the form of a groove in the surface of the puller. For example, a technician can insert a scalpel into the gap to cut the tether at that point. Providing one or more cutting gaps in the puller helps to cut at a controlled position that is farthest from the implant and the technician is least likely to accidentally damage the implant with a scalpel. It also avoids the technician having to cut the stroke at some other imprecise and more dangerous position closer to the implant.

[0086] The cutting gap may be arranged such that by cutting the tether within the gap, the tether will separate into segments. These segments may remain connected to the hub. This arrangement may avoid the risk of loose segments of tether material being left on the implant, which material may become foreign body fragments that may cause problems for the patient if accidentally implanted.

[0087] In some embodiments, there may be eight reciprocating rope segments and four cutting gaps. The tether portion is cut in the cutting gaps.

[0088] In some embodiments, the tether may extend along a path comprising the following sequence:

[0089] a first set of at least one reciprocating cord segment between the puller and the implant;

[0090] a segment extending across the cutting gap; and

[0091] A second set of at least one reciprocating cord segments between the puller and the implant.

[0092] Optionally, a first group of at least one reciprocating rope segment is anchored to the puller at a first end position longitudinally away from the segment in the tether. Additionally or alternatively, a second group of at least one reciprocating rope segment is anchored to the puller at a second end position longitudinally away from the segment in the tether. Such an arrangement enables the first end and / or the second end to remain anchored to the puller when the segment is severed at the cutting gap.

[0093] In some embodiments, the puller includes a hub having a plurality of apertures through which at least one tether extends, and a cover at least partially covering the hub.

[0094] At least one tether may include a single tether that defines all of the multiple rope segments between the puller and the implant, or at least one tether may include multiple tethers, for example, each tether extending around a corresponding portion of the periphery of the puller and / or implant. The four tethers may each extend around a corresponding quarter (approximately) of the circumference.

[0095] In any of the above cases, the plurality of tethers may be substantially independent of one another. Alternatively, the plurality of tethers may be connected by one or more connections or joints.

[0096] In addition to or as an alternative to any of the above aspects, and in addition to or as an alternative to any of the above features, a twelfth aspect of the present invention provides a method or process, comprising:

[0097] connecting the cardiovascular implant to the puller by at least one tether extending along a plurality of reciprocating segments and / or pairs of segments between the puller and the implant to resist longitudinal sliding of the tether relative to the puller; and

[0098] Encapsulating cardiovascular implants and pullers.

[0099] In particular, the method process may optionally have any of the features of the above eleventh aspect.

[0100] In addition to or in lieu of any of the above aspects, and in addition to or in lieu of any of the above features, the thirteenth aspect of the present invention provides an expansion limiter for a delivery catheter (or an expansion limiter for a delivery catheter) for assisting in loading a self-expanding cardiovascular implant onto a delivery catheter.

[0101] The delivery catheter includes one or more or all of the following: a receiving area for accommodating a cardiovascular implant in a compressed form; and / or a sheath that can longitudinally translate relative to the receiving area, for selectively covering the implant to confine the implant in a compressed form, or selectively exposing the implant to allow expansion for implantation; and / or an implant retainer in the receiving area, for matingly engaging with at least one attachment element of the implant.

[0102] The expansion limiter includes a tubular member configured to be mounted on at least a portion of the sheath, the tubular member including a hole for receiving the sheath and terminating at a mouth at one end, the expansion limiter also including at least one protrusion adjacent to the mouth, and a manipulator for moving the protrusion, the protrusion protruding radially inward relative to the surface of the hole and movable relative to the tubular member by the manipulator in a circumferential direction. The at least one protrusion may be a single protrusion, or a plurality of protrusions distributed in a circumferential direction (e.g., two diametrically opposed protrusions). The "protrusion" mentioned herein may apply to a plurality of protrusions as appropriate.

[0103] Such an expansion limiter can provide multiple functions during loading. First, the protrusion can provide a locking function to temporarily lock the attachment element of the implant to the implant holder until the sheath of the delivery catheter begins to advance over the implant and restrain the implant. The manipulator can be operated to move the protrusion circumferentially to the locking position. Second, the tubular member around the sheath can reinforce the sheath to reduce the risk of the sheath bending when the sheath is pushed to close the sheath on the implant.

[0104] In more detail, the expansion limiter can be used to temporarily maintain the operational engagement of the attachment element of the implant with the implant holder of the delivery catheter, and prevent disengagement even when not covered by the sheath. Before the closed sheath, the self-expanding properties of the implant make it difficult to maintain the engagement of the attachment element with the implant holder, especially for a single person to perform the filling, because when the sheath is opened, the implant will self-bias to expand and disengage from the engagement with the implant holder. When the protrusion of the limiter is in the unlocked position, the attachment element can easily engage with the implant holder, and then the protrusion moves to the locked position. The expansion limiter can overcome the self-expanding bias and prevent the attachment element from being operationally engaged with the implant holder. This provides a stable and reliable engagement without further user interaction. The reinforcement provided by the tubular member reduces the risk of bending when the sheath is translated on the self-expanding implant. The translationally closed sheath can directly or indirectly convert the attachment element from being constrained by the protrusion to being constrained by the sheath without disengaging the implant holder. This technology can simplify the filling operation without increasing the load burden on the sheath and is conducive to the single-person filling delivery catheter.

[0105] In some embodiments, at least one projection projects radially inwardly to a position substantially aligned with an inner surface of the sheath.

[0106] In some embodiments, the protrusion extends axially beyond the mouth, the protrusion defining a castellated structure, such as a circumference.

[0107] In some embodiments, the manipulator comprises a ring carrying a projection. Movement of the ring relative to the tube in a circumferential direction moves the projection carried by the ring. Execution of the rotational movement is simple and unambiguous for the operator.

[0108] In some embodiments, the diameter of the hole in the tubular member is substantially the same as the outer diameter of the sheath, for example, to provide a substantial degree of reinforcement to the sheath.

[0109] In some embodiments, the protrusion can move between a first position that does not overlap with a predetermined area of ​​the implant holder and / or does not overlap with an attachment element of the implant and a second position that at least partially overlaps with a predetermined area of ​​the implant holder and / or at least partially overlaps with an attachment element of the implant.

[0110] The expansion limiter can be configured to translate axially as at least a portion of the sheath translates.

[0111] In some embodiments, the apparatus further comprises a transfer tube for constraining the implant in a compressed state for loading into a delivery catheter, the transfer tube having a periphery with a circumferential groove for keyed engagement with the protrusion.

[0112] In addition to or in lieu of any of the above aspects, and in addition to or in lieu of any of the above features, a closely related fourteenth aspect of the invention provides a method of loading a self-expanding cardiovascular implant into a delivery catheter, the delivery catheter comprising a receiving area for receiving the cardiovascular implant in a compressed configuration, and / or a sheath longitudinally translatable relative to the receiving area for selectively covering the implant to confine the implant in a compressed configuration or selectively exposing the implant to allow expansion for implantation, and / or an implant retainer in the receiving area for cooperative engagement with at least one attachment element of the implant. The loading method may comprise:

[0113] providing an expansion limiter at the mouth of the sheath, at least a portion of the limiter extending outside the mouth of the sheath and including a mount selectively movable relative to the sheath by manipulating the limiter;

[0114] removably engaging an attachment element of the implant with the implant holder while the sheath is in a first position substantially uncovering the implant holder;

[0115] manipulating the expansion limiter so that the seat moves to a blocking position, thereby limiting engagement of the attachment element with the implant holder; and

[0116] The sheath is translated to at least partially close the sheath on the implant, the step of translating the sheath comprising directly or indirectly disengaging at least a seat of the expansion limiter from engagement with the attachment element as the sheath translates on the attachment element, such that the attachment element transitions from being constrained by the seat to being constrained by the sheath without disengaging from the implant retainer.

[0117] In all of the above aspects, the invention may be defined independently of an implant or in combination with an implant.

[0118] Another aspect of the invention provides a combination of a cardiovascular implant and a device according to any aspect described herein, and optionally including any of the features described above. For example, the implant and the device may be provided as a kit, and / or used together.

[0119] In any of the above aspects, the implant optionally has a non-circular shape and / or one or more out-of-round features.

[0120] Additionally or alternatively, in any of the above aspects, the implant has a plurality of protrusions, such as protruding anchors. At least one protrusion may correspond to at least one internal longitudinal groove of the funnel. Optionally, the plurality of protrusions may correspond to a plurality of internal longitudinal grooves of the funnel.

[0121] Certain exemplary embodiments of the present invention have been described above, defined in the appended claims, and shown in the accompanying drawings. The embodiments are intended to illustrate the present invention only and should not be construed as limiting the scope of the present invention. Other embodiments of the present invention and improvements to the embodiments will become apparent from the following non-limiting example descriptions. Any novel features or ideas disclosed herein and / or in the accompanying drawings are protected by the claims, whether or not emphasized. BRIEF DESCRIPTION OF THE DRAWINGS

[0122] Figure 1 is a schematic cross-sectional view of a first embodiment of a compression device for compressing a cardiovascular implant, which is in an initial state before compression.

[0123] Figure 2 is similar to Figure 1 Schematic cross-sectional view of a device with the biasing device removed.

[0124] Figure 3 is similar to Figure 1 Schematic cross-section of a , but in a partially compressed state.

[0125] Figure 4 yes Figure 1 A schematic perspective view of a biasing device of an apparatus.

[0126] Figure 5 yes Figure 2 Schematic side view of the device.

[0127] Figure 6 yes Figure 2 Schematic end view of the instrument entrance.

[0128] Figure 7 yes Figure 3 Schematic end view of the funnel of the instrument in the shown state.

[0129] Figure 8 is a schematic top view of a prosthetic heart valve implant in a fully expanded configuration;

[0130] Fig. 9 yes Figure 8 Schematic side view of the implant.

[0131] Fig.10 is similar to Figure 8 Schematic top view of the implant, but with the implant in a compressed configuration.

[0132] Fig.11 is similar to Fig. 9 Schematic side view of the implant, but with the implant in a compressed configuration.

[0133] Fig.12is a schematic perspective view of a second embodiment in the form of an implant holder carrying an implant in a stored configuration.

[0134] Fig.13 is a schematic bottom perspective view of an implant holder carrying an implant in a storage configuration.

[0135] Fig.14 is a schematic perspective view showing the interaction between the compressor and the support.

[0136] Fig.15 is a schematic side view of a third embodiment in the form of a puller attached to an implant by a tether.

[0137] Fig.16 is similar to Fig.15 Schematic side view of , but showing the cover of the puller slightly moved away from the hub.

[0138] Fig.17 yes Fig.16 A schematic perspective view of a hub member alone.

[0139] Fig.18 is the tether relative to Fig.16 and 17 Schematic diagram of a reciprocating rope segment defined by a hub member.

[0140] Fig.19 is a schematic perspective view illustrating a fourth embodiment in the form of an expansion limiter for assisting in loading an implant onto a delivery catheter.

[0141] Fig. 20 is a schematic side cross-sectional view showing an expansion limiter installed around a sheath of a delivery catheter.

[0142] Fig.21 It is shown Fig. 20 Zoomed in detail. DETAILED DESCRIPTION

[0143] In the drawings, the same reference numerals are used to denote corresponding features regardless of whether they are described in detail or not.

[0144] Figures 1 to 7 An apparatus 10 for compressing a cardiovascular implant 40 to a compressed state 40' for transcatheter implantation is shown. The apparatus may generally include or use at least one or any combination of the following apparatuses: a funnel 20; a narrowed channel 21 defined by the funnel 20; a channel 21 that changes from a cross-section 21a to a cross-section 21b; a biasing device 30; a moving member 15 for pulling the implant 40 through the apparatus; and an actuating mechanism 14 for driving movement of different components of the apparatus.

[0145] refer to Figure 8-11, an implant 40 is shown as an example in the form of a self-expanding prosthetic mitral valve. Only the self-expanding frame of the implant is shown to avoid obscuring the lines. Figure 8 and Fig. 9 Depict the state of the implant in its fully expanded configuration, wherein the implant is initially in this state, and in use, the implant will self-expand toward this state when implanted. In this expanded configuration, the implant 40 presents a non-circular profile. The implant has a substantially D-shaped cross-sectional shape to fit the mitral valve anatomy. The flat or less curved region 42a can correspond to the anterior region of the natural mitral valve anatomy, while the more curved region 42b can correspond to the posterior region. The implant 40 also includes an anchoring system, which includes at least one protrusion 41, optionally multiple protrusions 41, for example, six protrusions in the illustrated form. The protrusions can be used to anchor the implant 40 relative to the natural anatomical tissue. In the illustrated form, the protrusions include at least one side protrusion 41a (four in the illustrated example) and / or at least one end protrusion 41b (two in the illustrated example). In the expanded configuration of the implant, each side protrusion 41a extends outward from a window frame 43 formed in the tubular portion of the implant frame. Each end projection 41b is folded upon itself to define a jaw-like anchor relative to the tubular portion.

[0146] Fig.10 and 11 The implant is depicted as it is compressed by the device 10 to a compressed configuration. The device 10 compresses the implant from a non-circular profile to a generally circular profile. The window frame 43 allows the side protrusions 41a to fold inwardly to coincide with the tubular portion. The window frame 43 is a generally incompressible portion of the frame that does not change significantly in size when the stent is compressed circumferentially. The frame may exhibit stress concentrations that are generally non-uniform around the circumference during compression, for example, due to its original non-circular profile and / or the presence of incompressible windows or other frame elements that have different resistance to circumferential compression. Fig.11 As best shown, the end projection 41b may be bent at an angle of at least 90°, optionally at least 120°, optionally at least 150°, optionally at least 170°, optionally about 180° to form a generally straight extension extending out of the end of the tubular portion.

[0147] The implant 40 also includes a valve assembly ( Figure 8-11 ), which is used to form a one-way flow regulating valve.

[0148] Reference again Figure 1-7The funnel 20 of the compression device 10 has an inner surface defining a narrowed channel 21 for compressing the implant 40 from its initial expanded state to a compressed state 40' in response to longitudinal translation of the implant 40 within the channel 21. The channel 21 may have an axis A extending from an inlet 21a to an outlet 21b.

[0149] The cross-sectional size and / or shape of the passage 21 changes from at or near the entrance 21a (having a non-circular or out-of-round cross section 23) to at or near the exit 21b (having a smaller and generally circular cross section 23'). The cross section of the passage 21 can change gradually so that the size and shape of the implant changes as the implant is advanced longitudinally within the passage. The passage 21 changes from a non-circular or out-of-round cross section 23 to a generally circular cross section 23', allowing the implant 40 to be gradually and controllably compressed from a non-circular or out-of-round shape to a generally circular shape that is compatible with transcatheter delivery within a patient's body.

[0150] In the illustrated example, the channel 21 has a cross section at its entrance that includes a curved region connected to a smaller curved region; the smaller curved region optionally has a curved region or a straight region. In other words, the channel 21 can provide a cross section similar to a D-shape (optionally with one or more shaped protrusions on the periphery, as described below).

[0151] This non-circular or out-of-round profile of the passage 21 (at least at the entrance) allows the device to be used in conjunction with cardiovascular implants having similar profiles, such as shown in Figures 8 and 9. Thus, a D-shaped implant can be compressed more controlled than using a purely circular funnel passage with an unformed implant shape.

[0152] The inner surface of the funnel 20 also has at least one longitudinal groove 22 ( Figure 6 and 7 ), in this example, there are four such grooves 22. At least one groove 22 extends from the entrance 21a of the channel 21 to the exit 21b, and its depth varies as it extends longitudinally along the inner surface of the funnel 20. The groove 22 may gradually become shallower as it extends toward the channel exit. At the channel entrance, the groove may be visible as one or a bulge formed around the circumference.

[0153] The presence of at least one groove 22 facilitates compression of the tubular implant comprising one or more external protrusions 41 (particularly the side protrusions 41a in this example). Figure 7 The position of each circumferential groove 22 is generally aligned with the position of the corresponding protrusion 41a of the implant 40 so as to receive the protrusion when the implant is introduced into the channel entrance. During compression, the groove 22 helps control the protrusion to fold inwardly to abut against or enter the implant wall, thereby reducing the risk of fracture or damage to the implant 40.

[0154] A biasing device 30 is also provided to bias at least one or more regions of the implant 40 outwardly from the inside of the implant 40 against at least a portion of the inner surface of the funnel 20, thereby reducing the risk of the implant 40 bending inwardly during the compression phase. The biasing device 30 can support one or more regions from the inside during the compression phase. The compression phase can correspond to any moment when the implant 40 is longitudinally advanced in the channel 21. One or more regions optionally correspond to regions of the vascular support (e.g., window frame regions) that are not significantly compressed in the circumferential direction, and / or support inwardly folded protrusions, and / or have relatively high resistance to circumferential compression. These regions may be prone to bending inwardly when the entire implant is forcibly compressed.

[0155] The biasing device 30 includes one or more cantilever biasing elements 32, which extend longitudinally relative to the channel 21 and are inserted into the channel 21 through the entrance 21a when in use to help keep at least a portion of the implant flush with the channel surface. At least two or more cantilever elements 32 can have the same length 32a as each other, or can have different lengths 32b from each other. The cantilever element 32 or each cantilever element 32 can be finger-shaped and extend longitudinally from the hub 31. Providing at least two or more cantilever elements 32 helps to make the implant 40 at least partially flush with the inner surface of the funnel 20 at multiple locations throughout its periphery, thereby increasing resistance to unwanted inward bending.

[0156] The cantilever element 32 can deflect inwardly (e.g., bendable) 32' to accommodate changes in the profile of the passage 21 as the biasing device 30 is advanced longitudinally; alternatively, the biasing device 30 can translate within the passage 21 or translate with the implant. The cantilever element 32 can deflect or have a deflectable tip that can accommodate changes in the profile of the passage 21. Additionally or alternatively, the cantilever element 32 can be biased outwardly 32' to force the implant 40 against the inner surface of the funnel 20.

[0157] The biasing device 30 may also be configured and / or mounted to advance longitudinally relative to the funnel 20, and optionally, the longitudinal movement of the biasing device 30 may be simultaneous or coincident with the advancement of the implant 40 within the passage 21. The advancement of the biasing device 30 within the passage 21 causes the cantilevered element 32 to deflect at least partially inwardly while supporting the implant 40 and pressing the implant 40 against at least a portion of the inner surface of the funnel 20. The cantilevered element 32 may be configured to guide the folding of the valve component of the implant during compression. The valve component may be made of biological tissue or other biocompatible materials. Guiding the folding of the valve component may reduce the risk of tearing, permanent creases or other damage that may be caused by random folding, which may otherwise shorten the working life of the valve component.

[0158] The instrument 10 may further include a moving member 15 for advancing the implant 40 longitudinally within the channel by pulling the implant 40. The moving member 15 includes, for example, a threaded tube or shaft having a top structure 15a that is connected to the implant 40 by a puller 80 and one or more tethers 82 (e.g. Figure 7 ) is joined to the flared end implant 40. Figures 15 to 18 The embodiments of the puller 80 and the tether 82 are described in detail. The pull-translator 15 generates a force through the tether to move the implant longitudinally while also causing the flared end to be pulled inwardly to a smaller circumference.

[0159] The apparatus 10 may also include an actuating mechanism 14 on a structure 11 that is coupled to or combined with the funnel 20 for driving a first element (e.g., biasing device 30) to move longitudinally from (or at or via) an inlet 21a of the passage 21a, and for causing a second element (e.g., moving member 15) to move longitudinally from (or at or via) an outlet 21b of the passage 21. The movement may be caused to cause simultaneous movement of the two elements, optionally together, within at least a portion of the range of motion of each element. The two elements may translate longitudinally relative to the passage 21, and may optionally translate at least partially relative to each other.

[0160] The actuating mechanism 14 may include a manual rotation member 14a, which is operably engaged to at least one of the carriages 12, 13, which are in turn engaged to the biasing device 30 and the moving member 15. One or more threads, racks and pinions or other couplings convert the manual rotation into longitudinal carriage movement. In the direction shown in the figure, the moving member 15 moves to the left and moves out of the outlet 21b, while the biasing device 30 also moves to the left from the entrance end 21a of the passage 21. In the illustrated embodiment, two carriages 12, 13 are used to achieve more refined control of the movement of each carriage. The first carriage 13 includes a first connecting ring 13a, and the hub 31 of the biasing device 30 can be attached to the first connecting ring 13a by, for example, a snap connection 33. The second carriage 12 includes a second connecting ring 12a, which carries a rotatable adjuster 16, and the moving member 15 is threadedly connected to the adjuster 16. The adjuster 16 allows for additional adjustment of the longitudinal position of the moving member 15 or additional pulling of the moving member 15 in response to rotation of the adjuster 16 .

[0161] Therefore, the actuating mechanism 14 is easy for one person to operate, so that the moving member 15 and the biasing device 30 can move in coordination, which is very beneficial for achieving optimal compression of the implant. The convenience of one person operation helps to greatly reduce the labor intensity of the compression process.

[0162] The device 10 also provides a transfer tube 17 removably placed at the outlet end 21b of the passage 21 for receiving the compressed implant 40' emerging from the passage 21 in a compressed state. The transfer tube 17 can hold the implant 40 in its compressed form for transfer to a delivery catheter for filling.

[0163] Figure 12-14 A second embodiment is shown involving a multifunctional implant holder 70 for supporting the implant 40 during storage and for assisting in handling the implant 40 when transferring the implant 40 to an instrument for compressing the implant. Figure 15-18 A third embodiment is shown, involving a puller 80 coupled to an implant 40 via one or more tethers 82. The second and third embodiments are shown separately, but are described together below, because these embodiments can be used independently or in combination. The second and / or third embodiments can optionally be used with the first embodiment described above.

[0164] refer to Figure 12-14 , before use, the implant 14 is stored in a completely (or nearly completely) expanded state, such as stored in a sterile package, such as a bottle (not shown). The support 70 is generally annular and at least partially surrounds the implant 14 that is at least partially located in the support 70. The support includes at least one engagement profile 72 (two profiles 72 in the illustrated embodiment), which is aligned with the corresponding end protrusions 41b, and the protrusions 41b engage around the engagement profile 72 to keep the implant 40 firmly connected to the support 70. Each engagement profile 72 includes a profiled front end face 72a to achieve a shape fit with the implant 40, and a channel-shaped rear profile 72b for accommodating the end protrusions 41b. The support 70 also optionally further includes one or more side braces 74 for stabilizing the implant 40 in the support 70.

[0165] refer to Figure 15-18 , also prior to use, the implant 14 is pre-attached to the puller 80 by at least one tether 82, which defines a plurality of reciprocating rope segments between the puller 80 and an aperture of the implant 40, such as the apex aperture of the flared atrial end of a heart valve stent. The puller 80 includes a hub 84 and an optional cover plate 86 mountable to the hub 84. The hub 84 includes a plurality of apertures 88 through which the tethers 82 extend. In the illustrated example, the apertures 88 are in the form of axial apertures. The apertures 88 are arranged in a circle around the periphery of the hub 84. Fig.18 In the schematic diagram of FIG. , the axial hole is reduced to a simple schematic hole.

[0166] refer to Fig.18, the tether 82 is threaded in a predetermined manner to prevent or hinder longitudinal sliding of the tether 82 relative to the puller 80. During compression of the implant 40, the puller is used to apply traction to one end of the implant 40 to pull the implant 40 into and / or through the compression device. Preventing the tether 82 from sliding relative to the hole 88 can better control the alignment of the implant 40 with the puller axis and ensure that the traction force is evenly applied around the implant 40. These features are beneficial for controlling the compression of the implant, especially in the case of non-circular morphologies or protruding anchors.

[0167] Longitudinal sliding of the tether 82 is impeded by the path of the tether 82 including at least one, and optionally a plurality of, anchor loops 90 relative to certain apertures. Fig.18 The path of the tether is depicted, from "start" to "end" in the order of the path segments indicated by arrows 1-11, relative to the four holes 88 (labeled 1-4) defined in FIG. Fig.17 The tether 82 is connected from above ( Fig.17 and 18 ) extends through the first hole 1, along the lower path segment 2 to the second hole 2, through the hole 2, and along the upper third path segment 3 back to the first hole 1. The tether 82 passes through the first hole 1 again, extends on the rope segment 4 to the apex of the implant, and returns to the puller on the rope segment 5, and passes through the second hole 2 again. Rope segments 4 and 5 define a reciprocating rope segment between the puller 80 and the implant 40. Path segments 2 and 3 define an anchor loop 90 between the first and second holes 1 and 2 by tightly wrapping to prevent longitudinal sliding. After passing through the second hole 2, the tether extends toward the next pair of holes 3 and 4 to repeat the same path sequence.

[0168] If desired, longitudinal sliding may also be prevented by clamping contact with the cover plate 86, although in other embodiments, the cover plate 86 may be used only to cover and protect the tether 82 (as described below) without being in clamping contact with the tether 82.

[0169] The puller 80 also includes one or more (four in the present embodiment) cutting gaps 92 where the tether 82 is located so that the tether can be cut at a precise location when it is desired to release the puller 80 from the implant (e.g., after compression). The gaps 92 are provided in the form of axial grooves in the hub 84 and in the form of axial slots in the cover plate 86, which align with the grooves in the hub 84 when the cover plate 86 is assembled to the hub 84. The cutting gaps 92 are sized to enable the tether 82 to be cut within the gaps 92 by inserting the edge of a scalpel into the gaps 92. The cover plate 86 protects the tether 82 from accidental cutting damage on either side of the predetermined cutting gap 92.

[0170] like Fig.18As shown, the tether 82 includes a path segment 6 that extends through a cutting gap 92 between adjacent pairs of holes 88. When the tether 82 is cut at path segment 6, the tether separates into different tether segments. Path segments 5 and 7 are free to be pulled out of the hub 84, thereby allowing the implant 40 to be released. The tether 82 remains attached to the hub 84 because the anchor ring 90 (path segments 2 and 3; and path segments 9 and 10) prevents the tether 82 from easily sliding out at these end locations.

[0171] At least one tether 82 may include a single string defining all of the multiple rope segments between the puller 80 and the implant 40, or multiple tethers may be used, for example, each tether extending around a corresponding portion of the periphery of the puller and / or the implant. In the illustrated embodiment, sixteen holes 88 support eight reciprocating rope segments of the tether 82 between the puller 80 and the implant 40. The holes are divided into four groups. Four cutting gaps 92 are arranged between adjacent hole groups 92. Four tethers 82, or two tethers, or a single tether may be used alternatively.

[0172] When it is necessary to compress the implant 40 for insertion into the delivery catheter, the implant 40 can be transferred to a compression device (e.g., the device 10 of the first embodiment) optionally using the support 70. Fig.14 , the support 70 is introduced into the insertion position, for example relative to the entrance end 21a of the channel 21, wherein the end protrusion 41b faces away from the instrument 10. The moving member 15 is engaged to the end of the implant closest to the channel 21 for pulling the implant 40 into the channel 21. For example, the moving member 15 is coupled to the above-mentioned puller 80.

[0173] When implant 40 is pulled and translated from rest 70 into channel 21 (e.g., Fig.14 72 cooperates with the end projection 41b to cause the end projection 41b to bend toward its undeployed configuration (as indicated by arrow 76), wherein the projection 41b forms a straight extension pointing away from the rest of the implant 40. The use of the support 70 to automatically bend the projection 41b into a straight (or nearly straight) position means that this operation does not need to be performed separately by compressing the funnel and does not complicate the engagement between the implant 40 and the funnel 21. The engagement profile 72 can bend the projection by at least 90°, optionally at least 120°, optionally at least 150°, optionally at least 170°, optionally about 180°.

[0174] The biasing device 30 may be introduced into the interior of the implant 40 prior to removal of the rest, or introduced into the interior of the implant 40 after the implant 40 is substantially located within the passage 21 .

[0175] Once the implant 40 is loaded into the transfer tube 17, the puller 80 can be released from the implant 40 by cutting the tether 82 at the cutting gap 92 of the puller 80. One of the rope segments of each reciprocating rope segment is released while the other rope segment holds the tether on the puller 80, thereby preventing any tether fragments from remaining attached to the implant 40.

[0176] Figures 19 to 21 A fourth embodiment is shown which relates to an expansion limiter 58 for assisting in loading the compression implant 40 into the delivery catheter 50. The fourth embodiment may optionally be used with the first and / or second and / or third embodiments described above, but may particularly be used with the first embodiment.

[0177] refer to Fig.19 , a transfer tube 17 is shown for transferring the compressed implant 40 from the compression device 10 to the implant receiving area of ​​the delivery catheter 50. The delivery catheter includes a sheath 54 that can be longitudinally translated relative to the receiving area, and is used to selectively cover the implant 40 to confine the implant 40 in a compressed state, or selectively expose the implant 40 to allow it to expand for implantation.

[0178] The implant holder 56 in the receiving area releasably engages at least one attachment element of the implant 40 to axially restrict the implant in its desired position. In this example, the attachment element is formed by one or two end protrusions 41b when axially extended in the compressed configuration. The implant holder 56 has a top profile (paddle-shaped end profile) for receiving and matingly engaging the protrusions 41b.

[0179] Overall reference Figure 19-21 , an expansion limiter 58 is disposed or positioned on the catheter to assist in loading the implant into the delivery catheter. The expansion limiter 58 comprises a tubular member 100 having an aperture sized to receive the sheath 54 while achieving a tight fit around the exterior of the sheath 54. The tubular member 100 reinforces the sheath 54 to provide additional column strength during loading and to reduce the risk of sheath bending when the sheath is translated to cover the implant.

[0180] The expansion limiter 58 also includes a manipulator ring 60 located at the mouth of the tubular member, from which extends at least one protrusion 62, and in the illustrated example, two. The protrusion 62 (or each protrusion 62) extends radially inward to a position substantially aligned with the inner surface of the sheath 54 so as to provide a continuous constraint to the implant between the sheath 54 and the protrusion 62. The protrusion 62 (or each protrusion 62) also extends axially beyond the ring 60 to define a circumferential castellated structure. The ring 60 can be rotated, or at least circumferentially movable about the axis of the tubular member 100, so that the protrusion 62 is in a blocked position (along the axis of the tubular member 100) relative to the attachment element and / or the retainer. Fig.19 Counterclockwise in the direction of the arrow) and non-blocking position (in the Fig.19 clockwise rotation).

[0181] like Fig.21 As shown, in this example, the tubular member 100 can be made of two parts connected together, for example, a tubular body portion 100a and a mouth portion 100b, the mouth portion 100b is shaped and sized as a support hub, and the manipulator ring 60 is installed around the support hub. This structure can also facilitate the assembly of the ring 60 to the tubular member 100 in a fixed and rotatable manner.

[0182] In use, if not already installed to the catheter 50, the expansion limiter 58 is slid over the sheath 54 of the delivery catheter in preparation for loading the implant. After compressing the implant (e.g., using the above-described instrument 10), the implant 40 is transferred to the delivery catheter 50 using the transfer tube 17. The transfer tube 17 is slightly shorter than the implant 40, or has an end groove 17a, exposing the attachment element (the top of the end protrusion 41b). With the ring 60 arranged in a non-blocking position and the sheath in an open state, the attachment element can be manually engaged with the implant retainer 56. The person performing this task may need to slightly squeeze the attachment element radially inward to offset the natural self-expansion tendency of the implant 40. In the non-blocking position, the expansion limiter 58 allows easy finger and visual contact to properly engage the attachment element with the retainer 56.

[0183] Thereafter, the ring 60 is manually rotated to move the projection 62 circumferentially to its blocking position (along the Fig.19 ), wherein the projection 62 at least partially overlaps the attachment element and / or engagement profile of the holder 56. The projection 62 overcomes the self-expansion bias of the implant at the attachment element and prevents the attachment element from operating in engagement with the implant holder 56. This provides a stable and reliable engagement without further interaction by the user, thereby freeing the user's hands to perform other tasks and / or avoiding the need for additional operator presence.

[0184] The delivery catheter 50 is operated to translate and close the sheath 54 in the direction of the sheath arrow 52, ​​and the attachment element is transformed from being constrained by the protrusion 62 to being constrained by the advancing sheath 54 without being disengaged from the implant holder 56. This technology can simplify the loading operation and facilitate single-person loading of the delivery catheter. When the sheath 54 translates and closes, the tubular member 100 provides support and reinforcement around the sheath to prevent bending when subjected to column loads at the sheath 54. In addition, when the sheath 54 translates and closes, the expansion limiter 58 can be gradually displaced, such as directly by advancing the sheath and / or indirectly by contact between the advancement portion 102 of the delivery catheter that moves the sheath 54. The axial displacement of the expansion limiter 58 causes the protrusion 62 to move away from overlapping with the implant holder 56 and / or the implant attachment element. In turn, displacement of the limiter 58 also displaces the transfer tube 17, allowing the implant 40 to gradually transition from being constrained by the transfer tube 17 to being constrained by the sheath without requiring further manual intervention by the user at the mouth of the sheath 54. Thereafter, the expansion limiter 58, and in particular the tubular member 100 retained about the sheath 54, can be removed by sliding off the sheath, optionally simultaneously with the transfer tube 17 if it is still engaged with the delivery catheter.

[0185] It should be understood that the foregoing description illustrates only preferred embodiments of the invention and that numerous modifications and equivalents may be used within the scope and / or principles of the invention.

Claims

1. An apparatus (10) for compressing a cardiovascular implant (40), optionally a prosthetic heart valve, into a reduced size sufficient for transcatheter implantation, comprising: a funnel (20) having an inner surface defining a constricted channel (21) configured to compress the implant in response to longitudinal translation of the implant within the channel; as well as Means (30) for biasing an implant (40) outwardly against at least a portion of an inner surface of the funnel as the implant translates longitudinally within a passage, optionally for preventing inward buckling during compression of an implant having a non-circular profile.

2. An apparatus according to claim 1, wherein the biasing device (30) includes at least one cantilevered biasing element (32) extending generally longitudinally relative to the channel (21) and configured to (i) bias outwardly toward at least a portion of the inner surface of the funnel, and / or (ii) be deflected inwardly to accommodate insertion into a narrowed channel.

3. An apparatus according to claim 2, wherein the biasing device (30) comprises at least two cantilevered biasing elements (832; 32a, 32b), said elements having the same and / or different lengths.

4. A device (10) for compressing a cardiovascular implant (40), optionally an artificial heart valve, into a size small enough for transcatheter implantation, the device optionally being a device according to claim 1, 2 or 3, and comprising: a funnel (20) having an inner surface defining a constricted channel (21) configured to compress the implant in response to longitudinal translation of the implant within the channel, the channel having an axis (A) extending from an inlet (21a) to an outlet (21b); as well as At least one, and optionally a plurality of, longitudinal cantilevered elements (32; 32a, 32b) configured to be inserted into the passage via the entry port to internally support the implant (40) during compression, the at least one cantilevered element having a top end biased toward a position spaced apart from the axis of the passage, the top end being deflectable toward the axis of the passage to accommodate narrowing of the passage.

5. An instrument according to claim 3 or 4, wherein the cantilevered element (32; 32a, 32b) is a finger extending from the hub (31).

6. The instrument according to claim 1, wherein the instrument (10) is configured to compress an implant having a non-circular contour into a circular shape.

7. The apparatus according to any of the preceding claims further comprises an actuating mechanism (74) for causing the biasing device (30) and / or the cantilevered element (32; 32a, 32b) to move longitudinally relative to the funnel (20), optionally wherein the actuating mechanism comprises a threaded element for generating the longitudinal movement by rotation of a rotatable actuating member.

8. The device according to claim 7, further comprising a moving member (15) for advancing the implant in the channel, the moving member (15) being driven by the actuating mechanism (74).

9. The apparatus of claim 8, wherein the actuating mechanism (74) is configured to cause the biasing device (30) and the moving member (15) to move longitudinally simultaneously during at least a portion of the range of motion of the biasing device and / or the moving member.

10. An apparatus according to claim 9, wherein the actuating mechanism (74) is constructed so that the longitudinal displacement of the biasing device (30) is consistent with the longitudinal displacement of the moving member (15) during at least a portion of the movement range of the biasing device and / or the moving member.

11. An apparatus according to any of the preceding claims, wherein the narrowing channel (21) has a cross-section of varying size and shape from one end (21a) of the funnel to the other end (21b), the shape varying between a non-circular channel shape and a circular channel shape for compressing an implant having a non-circular profile into a circular shape.

12. An assembly of a device according to any of the preceding claims and a cardiovascular implant (40), optionally wherein the cardiovascular implant is an artificial heart valve.

13. A method of compressing a cardiovascular implant (40), optionally a prosthetic heart valve, to a smaller size for transcatheter delivery, optionally using an apparatus according to any one of claims 1 to 11, the method comprising: longitudinally translating an implant (40) within a funnel (20) having an inner surface defining a constricted channel (21) such that the constricted channel compresses the implant in response to the longitudinal translation; as well as During at least a portion of the translating step, at least a region of the implant is supported radially inwardly to prevent buckling of the region during compression.

14. A method of compressing a cardiovascular implant (40) to a reduced size sufficient for transcatheter delivery, the method optionally being a method according to claim 13 and / or the method optionally using an apparatus according to any one of claims 1 to 11, the method comprising: longitudinally translating an implant (40) within a funnel (20) having an inner surface defining a constricted channel (21) such that the constricted channel compresses the implant in response to the longitudinal translation; as well as During at least a portion of the translating step, at least one region of the implant is supported radially from the inside by at least one, optionally a plurality of, longitudinal cantilevered elements (32; 32a, 32b).

15. A method according to claim 13 or 14, further comprising translating the biasing means (30) and / or the cantilevered element (32; 32a, 32b) relative to the funnel (20).

16. The assembly of claim 12, or the method of any one of claims 13 to 15, wherein the cardiovascular implant (40) has a non-circular profile in its non-compressed state.

17. An apparatus (10) for compressing a cardiovascular implant (40), optionally a prosthetic heart valve, into a reduced size sufficient for transcatheter implantation, comprising: A funnel (20) having an inner surface defining a constricted channel (21) configured to compress an implant in response to longitudinal translation of the implant within the channel, the constricted channel (21) comprising a cross-section of varying shape and size along at least a portion of the length of the channel, the shape of the channel varying between a non-circular channel shape (23) and a circular channel shape (23') to compress an implant having a non-circular profile into a circular shape.

18. The apparatus according to claim 17, wherein the narrowed channel (21) comprises a cross-section whose size and shape gradually change over at least a part of the length of the channel.

19. Apparatus according to claim 17 or 18, wherein the narrowed channel (21) comprises a cross section whose shape and size vary from one end of the funnel to the other.

20. An apparatus according to any one of claims 17 to 19, wherein a portion (23) of the channel (21) has a cross-sectional shape comprising a D-shape comprising a curved area and a less curved connecting area, the D-shape optionally comprising one or more peripheral protrusions.

21. Device according to any one of claims 17 to 20, wherein the inner surface of the funnel defining the narrowed channel (21) comprises one or more longitudinal internal grooves (22) for accommodating one or more protrusions of the implant.

22. Apparatus according to claim 21, wherein the recess (22) has a circumferential flare at its first end.

23. An apparatus according to claim 22, wherein the implant (40) includes an anchoring system having a plurality of protrusions (41a, 41b) at different circumferential positions around the periphery of the implant, and wherein the funnel has a smaller number of grooves (22) than the number of protrusions (41a, 41b) so that not all protrusions are accommodated in corresponding grooves (22).

24. An apparatus according to claim 21, 22 or 23, wherein the depth of at least one groove (22) varies along at least a portion of the length of the channel, optionally wherein the depth varies gradually along at least a portion of the length of the channel.

25. Apparatus according to claim 24, wherein the depth becomes shallower towards the outlet (21b) of the channel (22).

26. An apparatus according to any one of claims 17 to 25, further comprising a device (30) for biasing the implant outwardly against at least a portion of the inner surface of the funnel as the implant translates longitudinally within the channel, optionally to prevent inward bending during compression of an implant having a non-circular profile.

27. The apparatus according to any one of claims 17 to 26 further comprises an actuating mechanism (14) for generating longitudinal movement of the biasing device (30) and / or the cantilevered element relative to the funnel, optionally wherein the actuating mechanism comprises a threaded element for generating the longitudinal movement by rotation of a rotatable actuating member.

28. An assembly of a device (10) according to any one of claims 17 to 27 and a cardiovascular implant (40), optionally wherein the cardiovascular implant is an artificial heart valve.

29. A method of compressing a cardiovascular implant (40), optionally a prosthetic heart valve, to a reduced size sufficient for transcatheter delivery, the method optionally using an apparatus (10) according to any one of claims 17 to 27, the method comprising: An implant (40) is longitudinally translated within a funnel (20) having an inner surface defining a constricted channel (21) such that the constricted channel compresses the implant in response to the longitudinal translation, The translating step includes causing the implant (40) to change its cross-sectional size and shape by changing the size and shape of the passageway (21) along at least a portion of the funnel.

30. The method of claim 29, wherein the translating step comprises translating the implant from a region (23) of the interior passage having a generally non-circular cross-sectional shape to a region (23') of the interior passage having a generally circular cross-sectional shape.

31. A method according to claim 29 or 30, wherein the method comprises compressing an implant (40) having a non-circular profile into a circular shape.

32. An apparatus comprising: A cardiovascular implant (40) in a packaged configuration having an anchor (41b) for interacting with cardiovascular tissue in use and the implant being compressible to a compressed configuration for transcatheter implantation; as well as A support (70) to which the implant is removably mounted, the support at least partially surrounding the implant so that the implant is at least partially located within the support, the support including an engagement profile (72) configured to cooperate with the anchor (41b) to bend the anchor from a deployed shape to a non-deployed shape when the implant (40) translates out of the support (70) in at least a first direction of relative movement.

33. The apparatus of claim 32, wherein in the deployed configuration the anchor (41b) projects laterally relative to the tubular portion of the implant, and wherein in the non-deployed configuration the anchor (41b) has a more streamlined shape relative to the tubular portion.

34. An instrument according to claim 32 or 33, wherein the engagement profile (72) is configured to bend the anchor (41b) to an angle selected from one or more of the following: at least 90°; at least 120°; at least 150°; at least 160°; at least 170°; at least 180°.

35. The apparatus of claim 32, 33 or 34, wherein the implant (40) comprises first and second anchors (41b), and wherein the support comprises first and second engagement profiles (72) for cooperating with the first and second anchors.

36. The apparatus according to any one of claims 24 to 35 further comprises a compressor (10) for compressing an implant into a compressed form for transcatheter implantation, the compressor comprising a funnel (20) having an inner surface defining a narrowed channel (21), the narrowed channel being configured to compress the implant in response to longitudinal translation of the implant within the channel, the support being positionable near or at the entrance of the funnel (20) and being configured to cause the anchor (41b) to bend when the implant translates from the support (70) into the funnel (20).

37. A use of a support (70) for a cardiovascular implant (40), the cardiac implant (40) being compressible from an expanded configuration to a compressed configuration for transcatheter implantation, the cardiac implant (40) having at least one anchor (41b) movable between a deployed shape of the expanded configuration of the implant and a non-deployed shape of the compressed configuration of the implant, the support (70) having at least one engagement profile (72) for contacting the at least one anchor (41b) of the implant, the use comprising: (i) prior to use, at least partially restraining at least a portion of a cardiovascular implant (40) in a packaged configuration using a holder (70) such that the implant is at least partially located within the holder; and (ii) when the cardiac implant translates out of the support to compress into the compressed configuration, the support (70) is used to at least partially bend the anchor (41b) from the deployed shape to the non-deployed shape through contact between the engagement profile (72) and the anchor (41b), thereby facilitating compression of the implant.

38. The use according to claim 37 further comprises the use of a support (70) to support the cardiac implant (40) at the insertion position of the compression device (10), the compression device (10) comprising a compression funnel (20) for compressing the implant (40) by longitudinally translating the implant out of the support (70) and through the funnel (20).

39. Use according to claim 37 or 38, wherein at least partially bending the anchor using the rest (70) comprises bending the anchor using the engagement profile (72) by at least 90°, optionally at least 120°, optionally at least 150°, optionally at least 170°, optionally about 180°.

40. The use according to claim 37, 38 or 39, wherein the implant (40) comprises a plurality of anchors (41a, 41b), the support (70) comprises a plurality of engagement profiles (72), and wherein at least partially bending the anchors using the support comprises bending at least some of the plurality of anchors using the support.

41. A method comprising: A cardiovascular implant (40) is provided in a packaged form in which the implant is mounted to a holder (70), the implant having an anchor (41b) for interacting with cardiovascular tissue in use, and the holder (70) at least partially constrains the implant so that the implant is at least partially located within the holder; The implant (40) is translated out of the yoke (70), the translating step comprising causing the engagement profile (72) of the yoke to interact with the anchor (41b) as the implant is translated out of the yoke, thereby bending the anchor (41b) from a deployed shape to a non-deployed shape.

42. The method according to claim 41 further includes a step of positioning a support at an insertion position of the compressor (10) before translation for compressing the implant into a compressed form for transcatheter implantation, wherein the translation step includes translating the implant out of the support and into a portion of the compressor (10).

43. A method according to claim 42, wherein the compressor (10) includes a funnel (20) having an inner surface defining a narrowed channel (21), and wherein the translating step further includes longitudinally translating the implant within the channel (21) to compress the implant in response to the longitudinal translation.

44. An apparatus according to any one of claims 32 to 36, comprising: (i) Cardiovascular implants in packaged form, which can be compressed into a compressed form for transcatheter implantation; as well as (ii) a puller to which the implant is connected by at least one tether extending along a plurality of reciprocating segments and / or pairs of segments between the puller and the implant to resist longitudinal sliding of the tether relative to the puller.

45. A method according to claim 41, comprising: connecting the cardiovascular implant to the puller via at least one tether extending along a plurality of reciprocating segments and / or pairs of segments between the puller and the implant to resist longitudinal sliding of the tether relative to the puller; and Packaging of cardiovascular implants and pullers.

46. ​​A method according to claim 45 or an apparatus according to claim 44, wherein the puller includes a hub member, the hub member includes a plurality of holes through which a tether is passed, and the tether includes an anchoring loop for anchoring at least one end of a reciprocating rope segment of the tether relative to at least one hole, thereby hindering longitudinal sliding.

47. A method according to claim 45 or any of its dependent claims, or an apparatus according to claim 44 or any of its dependent claims, wherein the puller comprises at least one component having at least one and optionally a plurality of cutting gaps, wherein the at least one tether is located at the cutting gap to facilitate cutting of the at least one tether at the gap, thereby releasing the implant from the puller, and the at least one gap optionally has the form of a narrow groove in the surface of the puller.

48. A method according to claim 47 or an apparatus according to claim 44, wherein the cutting gap is arranged such that by cutting the tether within the gap the tether separates into sections which remain attached to the hub.

49. A method according to claim 47 or 48, or an apparatus according to claim 44, wherein the tether extends along a path which in turn comprises: a first set of at least one reciprocating cord segment between the puller and the implant; a segment extending across the cutting gap; as well as A second set of at least one reciprocating cord segment between the puller and the implant.

50. An apparatus comprising: A delivery catheter (50) for delivering a self-expanding cardiovascular implant (40) via catheter to a target site for implantation, the delivery catheter comprising: a receiving area for receiving the cardiovascular implant in a compressed state; a sheath (54) that can be longitudinally translated relative to the receiving area for selectively covering the implant to confine the implant in a compressed state or selectively expose the implant to allow it to expand for implantation; and an implant retainer (56) in the receiving area for cooperative engagement with at least one attachment element of the implant; and An expansion limiter (58) is used to assist in loading an implant into a delivery catheter, the expansion limiter comprising a tubular member (100) comprising a hole for receiving a sheath (54) and terminating at one end at a mouth, the expansion limiter also comprising at least one protrusion (62) adjacent to the mouth, and a manipulator (60) for moving the protrusion, the protrusion (62) protruding radially inward relative to the surface of the hole and being movable by the manipulator (60) in a circumferential direction relative to the tubular member (100).

51. The apparatus of claim 50, wherein the at least one projection (62) projects radially inwardly to a position substantially aligned with an inner surface of the sheath (54).

52. An instrument according to claim 50 or 51, wherein the projection (62) extends axially beyond the mouth.

53. An apparatus according to any one of claims 50 to 52, wherein the manipulator (60) comprises a ring carrying a projection (62), the ring being configured so that movement of the ring relative to the tube in a circumferential direction causes movement of the projection (62) carried by the ring.

54. The apparatus according to any one of claims 50 to 53, wherein the diameter of the hole in the tubular member (100) is substantially the same as the outer diameter of the sheath (54).

55. An instrument according to any one of claims 50 to 54, wherein the protrusion (62) can move between a first position in which it does not overlap with a predetermined area of ​​the implant holder (56) and / or does not overlap with an attachment element of the implant, and a second position in which it at least partially overlaps with a predetermined area of ​​the implant holder (56) and / or at least partially overlaps with an attachment element of the implant.

56. The apparatus according to any one of claims 50 to 55, wherein the expansion limiter (58) is configured to translate axially with translation of at least a portion of the sheath (54).

57. The device according to any one of claims 50 to 56 also includes a compressed form for confining the implant in a transfer tube (17) for loading into a delivery catheter, the transfer tube (17) having an outer edge with a circumferential groove (17a) for keying engagement with the protrusion (62).

58. An instrument according to any one of claims 50 to 57, comprising at least two of said projections (62), optionally comprising exactly two of said projections.

59. A method of loading a self-expanding cardiovascular implant (40) into a delivery catheter (50), the delivery catheter (50) comprising: a receiving region for receiving the cardiovascular implant in a compressed configuration; a sheath (54) that is longitudinally translatable relative to the receiving region for selectively covering the implant to confine the implant in a compressed configuration or selectively exposing the implant to allow expansion thereof for implantation; and an implant retainer (56) in the receiving area for mating engagement with at least one attachment element (41b) of the implant; Filling methods include: providing an expansion limiter (58) at the mouth of the sheath, the expansion limiter comprising a tubular member (100) including a bore for receiving the sheath (54) and terminating at one end at the mouth, the expansion limiter further comprising at least one protrusion (62) adjacent the mouth, and a manipulator (60) for moving the protrusion relative to the tubular member; removably engaging the attachment element (41b) of the implant with the implant holder (56) while the sheath (54) is in a first position substantially uncovering the implant holder; manipulating the expansion limiter (58) to move the projection (62) to a blocking position, thereby limiting engagement of the attachment element (41b) with the implant holder (56); and The sheath (54) is translated to at least partially close the sheath on the implant, the step of translating the sheath comprising directly or indirectly moving at least one protrusion (62) of the expansion limiter (58) away from engagement with the attachment element as the sheath translates on the attachment element, such that the attachment element transitions from being constrained by the support (62) to being constrained by the sheath (54) without disengaging from the implant retainer.

60. A method according to claim 50, wherein the manipulator includes a ring (60) capable of moving in a circumferential direction around the axis of the sheath, and the step of manipulating the limiter includes circumferentially moving the ring (60) to move the protrusion (62) from a first rotational position that does not overlap with the attachment element to a second rotational position that at least partially overlaps with the attachment element.

61. The method according to claim 59 or 60 also includes a step of introducing the implant (40) into the delivery catheter (50), wherein the implant (40) is in at least a partially compressed state constrained by the support tube (17) and not covering the attachment element (41b), and the introduction step is performed at least before the detachable engagement step, wherein the step of translating the sheath also directly or indirectly replaces the support tube (17).

62. The method according to any one of claims 59 to 61, wherein the step of translating the sheath (54) comprises translating a tubular member (100) fitted around the sheath (54).

63. An expansion limiter (58) for use in an instrument as described in any one of claims 50 to 58 and / or in a method as described in any one of claims 59 to 62, the expansion limiter (58) comprising a tubular member (100) comprising a hole for receiving a sheath and terminating at one end at a mouth, the expansion limiter further comprising at least one protrusion (62) adjacent to the mouth, and a manipulator (60) for moving the protrusion, the protrusion (62) protruding radially inward relative to the surface of the hole and being movable circumferentially relative to the tubular member (100) by the manipulator (60).

64. Apparatus according to any one of claims 50 to 58, or a method according to any one of claims 59 to 62, wherein the implant (40) is a cardiac stent-valve, optionally a mitral stent-valve.

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