Patent Description:
The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require replacement of the native valve with an artificial valve. There are a number of known artificial valves and a number of known methods of implanting these artificial valves in humans. Because of the drawbacks associated with conventional open-heart surgery, percutaneous and minimally-invasive surgical approaches are garnering intense attention. In one technique, a prosthetic valve is configured to be implanted in a much less invasive procedure by way of catheterization. For example, collapsible transcatheter prosthetic heart valves can be crimped to a compressed state and percutaneously introduced in the compressed state on a catheter and expanded to a functional size at the desired position by balloon inflation or by utilization of a self-expanding frame or stent.

A prosthetic valve for use in such a procedure can include a radially collapsible and expandable frame to which leaflets of the prosthetic valve can be coupled. The leaflets typically are made of biological materials such as pericardium valves or harvested valves. For improved function after deployment, it is often desirable to package and store such valves in the open (i.e., expanded) diameter inside a preserving solution up until the time the valve is mounted on a delivery device for implantation. Using this procedure, it may be necessary to crimp the valve in the operation room a few minutes before implantation, therefore precluding pre-crimping by the manufacturer. Thus many crimping devices are now shipped as a disposable accessory along with the valve and delivery system, thus increasing the importance of portability of such crimping devices.

Generally, conventional crimping devices operate by one of two methods. In one method, a stent is driven through a cone-like surface, which compresses the stent to a smaller diameter. For example, a static conical tube can be passed over a stent, thereby reducing its diameter. This method typically is used for crimping prosthetic valves having self-expanding metal frames (e.g., frames made of Nitinol), which are easily deformable. Self-expandable prosthetic valves typically are pushed from the conical tube of the crimping device into a sheath of a delivery apparatus, which retains the prosthetic valve in a radially compressed state. The second crimping method uses crimping jaws to create a cylinder-like surface that can change diameter. This method typically is used for crimping prosthetic valves having plastically-expandable frames (e.g., frames made of stainless steel or cobalt chromium alloys).

Self-expandable prosthetic valves typically have multiple connection features extending from the frame that form a releasable connection with the distal end of the delivery apparatus. Once the prosthetic valve has been deployed from the sheath inside the patient's body, the physician can release the connection between the delivery apparatus and the connection features of the prosthetic valve. A challenge in crimping self-expandable prosthetic valves involves the ability of the physician to easily and quickly crimp and load a prosthetic valve into a sheath of a delivery apparatus while aligning and connecting the connection features of the prosthetic with mating connection features of the delivery apparatus. There thus remains a need for an improved crimping device that addresses these and other disadvantages in the prior art.

<CIT> discloses a method and apparatus for compressing a stent to a compressed condition and/or for loading a stent for a delivery catheter.

The invention relates to a crimping device as defined by claim <NUM>. An exemplary embodiment of a crimping device for crimping a radially expandable and compressible prosthetic valve can include a housing configured to receive a prosthetic valve in a radially expanded state. The housing member can include a funnel segment and an outlet in communication with the funnel segment. The crimping device can further include an actuator rotatably coupled to the housing, wherein rotation of the actuator relative to the housing causes the prosthetic valve to move axially through the funnel segment such that at least a portion of the prosthetic valve compresses radially by engagement with the funnel segment and exits the crimping device via the outlet. Rotation of the actuator can cause the actuator to move axially over the housing.

Some embodiments of the crimping device can further comprise a pusher member configured to abut the prosthetic valve within the housing, wherein rotation of the actuator causes axial movement of the pusher member relative to the housing, thereby pushing the prosthetic valve through the housing. The pusher member can comprise an internal cavity, the internal cavity comprising a plurality of ribs configured to contact the prosthetic valve during radial compression. Additionally and/or alternatively, the pusher member can include an annular groove configured to receive an end portion of the prosthetic valve. The pusher member can be rotatably coupled to the actuator such that the actuator is rotatable relative to the pusher member. The pusher member can comprise releasable locking features for releasable engagement with the actuator.

In some embodiments of the crimping device, the housing can comprise two or more housing components that form a generally cylindrical shape when assembled to form the housing. A retaining member can be configured to releasably retain the two or more housing components together.

Additionally and/or alternatively, an exemplary crimping device for crimping a radially expandable and compressible prosthetic valve can comprise a housing having an outlet, the housing member configured to receive a prosthetic valve in a radially expanded state, and a pusher member that is axially movable relative to the housing, wherein the pusher member is configured to abut an end of the prosthetic valve and axial movement of the pusher member relative to the housing causes radial compression of the prosthetic valve and axial movement of the prosthetic valve through the outlet in a radially compressed, delivery configuration. The crimping device can further comprise an actuator that is rotatable relative to the housing and the pusher member to cause axial movement of the pusher member relative to the housing.

In some embodiments, an internal surface of the housing can include a plurality of ribs configured to receive a prosthetic valve in a radially expanded state. Additionally and/or alternatively, the pusher member can further include a plurality of fins disposed between the plurality of ribs and configured to slidingly engage the plurality of ribs during axial movement of the pusher member. The housing member can further comprise a tapered internal wall that terminates at the outlet. The internal wall can cause radial compression of the prosthetic valve during axial movement of the pusher member relative to the housing. In some embodiments, the pusher member can be rotatably coupled to the actuator such that the actuator is rotatable relative to the pusher member.

An exemplary method for crimping a prosthetic valve can comprise rotating an actuator of a crimping device relative to a housing of the crimping device, wherein the housing includes a funnel in communication with an outlet of the crimping device, and slidingly engaging the prosthetic valve with the funnel such that at least a portion of the prosthetic valve compresses radially and exits the crimping device via the outlet. In some embodiments, the method can further comprise advancing the prosthetic valve out of an outlet of the crimping device and into a sheath of a delivery apparatus.

In some embodiments, the funnel can comprise a plurality of ribs extending radially inward toward a longitudinal axis of the crimping device and the method for crimping can further comprise aligning at least a portion of a frame of the prosthetic valve within the plurality of ribs. The housing can comprise two or more housing components, wherein each housing component comprises a portion of the funnel. In some embodiments the method can further comprise assembling the two or more housing components and placing the housing co-axially around a delivery apparatus prior to crimping of the prosthetic valve. Additionally and/or alternatively, the method can comprise disassembling the two or more housing components and removing them from the delivery apparatus.

For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language.

As used herein, the terms "a", "an", and "at least one" encompass one or more of the specified element. That is, if two of a particular element are present, one of these elements is also present and thus "an" element is present. The terms "a plurality of" and "plural" mean two or more of the specified element.

As used herein, the term "and/or" used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase "A, B, and/or C" means "A", "B,", "C", "A and B", "A and C", "B and C", or "A, B, and C.

As used herein, the term "coupled" generally means physically coupled or linked and does not exclude the presence of intermediate elements between the coupled items absent specific contrary language.

<FIG> shows an exemplary system for crimping a prosthetic valve and other crimpable, implantable medical devices, such as stents, grafts, etc. The illustrated system comprises a crimping device <NUM> and a radially expandable and compressible prosthetic valve <NUM>, shown positioned within the crimping device <NUM>. The crimping device <NUM> is configured to reduce the diameter of the prosthetic valve <NUM> from a fully expanded configuration to a radially compressed, delivery configuration for delivery into a patient. The prosthetic valve <NUM> is shown schematically in <FIG> for purposes of illustration. <FIG> is a more detailed illustration of an exemplary prosthetic valve that can be used with any of the crimping devices disclosed herein.

The exemplary system shown in <FIG> can further comprise a delivery apparatus <NUM> or a portion thereof. The delivery apparatus can comprise an inner shaft or catheter <NUM> and an outer sheath <NUM>, which is sized to retain the prosthetic valve <NUM> in the radially compressed configuration for delivery into a patient. The prosthetic valve <NUM> can comprise any radially collapsible and expandable prosthetic valve, such as a prosthetic heart valve. The prosthetic valve <NUM> can be radially collapsible and expandable between an expanded configuration and a delivery configuration. The prosthetic valve <NUM> can be self-expandable or plastically expandable. A self-expandable valve can have a frame formed from a self-expanding metal (e.g., Nitinol). A plastically expandable valve can have a frame formed from a plastically deformable metal (e.g., stainless steel or cobalt chromium alloy).

After the prosthetic valve <NUM> is crimped onto the delivery apparatus <NUM> in the delivery configuration, the prosthetic valve <NUM> can be removed from the crimping device <NUM>. In some embodiments, the prosthetic valve <NUM> and the delivery apparatus <NUM> can be advanced through an outlet of the crimping device <NUM> such that the crimping device <NUM> remains positioned around a portion of the delivery apparatus <NUM> that is distal to the prosthetic valve <NUM>. In other embodiments, the crimping device <NUM> or components thereof can be configured to separate into pieces or open, such as like a clam shell, such that the crimping device <NUM> can be removed laterally from the delivery apparatus <NUM> and prosthetic valve <NUM>, as further describe below. After the prosthetic valve <NUM> is removed from the crimping device <NUM>, the prosthetic valve <NUM> and the delivery apparatus <NUM> can be introduced into a patient.

As shown in <FIG>, portions of the crimping device <NUM> can be removably coupled to each other, for example via a threaded engagement. For example, the crimping device <NUM> in the illustrated embodiment comprise a housing <NUM> threadably coupled to an actuator <NUM> in the form of a rotatable knob. The crimping device <NUM> can further comprise a pusher member or valve holder <NUM> (also referred to as a pedestal member <NUM>) axially movable with respect to the housing member <NUM>.

<FIG> show the generally rigid housing <NUM> within which the prosthetic valve <NUM> can be positioned. The housing <NUM> in the illustrated embodiment comprises an assembly comprising first and second separable housing component 19a and 19b, respectively. Each housing component 19a, 19b can include an externally threaded portion <NUM> comprising external threads on an outer surface of the housing component adjacent a distal end <NUM>, an outlet <NUM> at a proximal end <NUM>, and an internal funnel segment <NUM>. The funnel <NUM> segment of each housing component 19a, 19b comprises an internal tapered wall <NUM> that terminates at the outlet <NUM>. For example, each funnel segment <NUM> can taper from a first, greater diameter adjacent an intermediate portion <NUM> of the housing component 19a, 19b to a second, smaller diameter adjacent the outlet <NUM>. The diameter of the outlet <NUM> can be approximately the desired diameter of the prosthetic valve <NUM> in the radially compressed, delivery configuration. In some embodiments, the outlet <NUM> can be flush with an outer rim portion <NUM> at the proximal end <NUM> but in other embodiments the outlet <NUM> can be recessed with respect to or extend beyond the rim portion <NUM>.

Each housing component 19a, 19b can comprise a half cylinder. When placed together, the housing components 19a, 19b form a generally cylindrical or tubular shape. The housing components 19a, 19b can include mating features that assist the user in assembling the housing components 19a, 19b. In the illustrated embodiment, for example, the first housing component 19a has diametrically opposed recesses <NUM> formed in the longitudinal edges of the first housing component 19a (<FIG>), while the second housing component 19b has diametrically opposed protrusions <NUM> formed in the longitudinal edges of the second housing component 19b (<FIG>). The recesses <NUM> are sized to receive corresponding protrusions <NUM> when the housing components 19a, 19b are placed together.

In the assembled stated, the external threads <NUM> of the housing components 19a, 19b are aligned with each other to form continuous threads that extend around the outer surface of the housing assembly <NUM>. The external threads of the housing assembly <NUM> are configured to mate with internal threads <NUM> of the actuator <NUM> to produce relative axial motion between the actuator <NUM> and the housing assembly <NUM> upon rotation of the actuator <NUM> relative to the housing assembly <NUM>, as further described below.

The first and second housing components 19a, 19b can be held or locked together in the assembled state while a prosthetic valve is being crimped and then separated from each other to facilitate removal of the crimping device <NUM> from the delivery apparatus <NUM> after the prosthetic valve is loaded onto the delivery apparatus. For example, as shown in <FIG> and <FIG>, the crimping device <NUM> can further comprise a retaining member <NUM> (also referred to as a retaining ring) configured to encircle the housing components 19a, 19b, for example at their proximal ends <NUM>, and releasably lock or retain the housing components 19a, 19b together. The retaining member <NUM> can include a gripping interface <NUM> for easy gripping and use by a user. The gripping interface <NUM> can include, for example, a plurality of circumferentially spaced ribs <NUM>.

The retaining member <NUM> can include an internal annular surface <NUM> that can be sized to slide over and form a frictional fit with the proximal end portions of the housing components 19a, 19b, such that retaining member can hold the housing components 19a, 19b together during use but can be easily removed from the housing components 19a, 19b by a user when it is desired to disassemble the housing assembly <NUM> and remove it from the delivery apparatus <NUM>. The retaining member <NUM> can include one or more notches <NUM>, such as two diametrically opposed notches <NUM> as shown in <FIG>. The notches <NUM> can be configured to receive corresponding protrusions <NUM> extending from the outer surfaces of the housing components 19a, 19b to assist in retaining the retaining member <NUM> in place during use. <FIG> shows a protrusion <NUM> extending from the outer cylindrical surface of first housing component 19a. The second housing component 19b can include an identical protrusion <NUM> located diametrically opposed to the one on the first housing component 19a.

In certain embodiments, other techniques or mechanisms can be used to secure the retaining member <NUM> on the housing components 19a, 19b. For example, the notches <NUM> or other portions of the retaining member <NUM> can be configured to form a snap-fit connection with corresponding portions of the housing components 19a, 19b. Alternatively, the retaining member <NUM> can be have a threaded portion (e.g., internal threads) that engage corresponding threads (e.g., external threads) on the housing components 19a, 19b.

In alternative embodiments, the housing components 19a, 19b can include releasable, mating locking features that are configured engage each other and retain the housing components 19a, 19b in their assembled state without the use of a separate retaining member <NUM>. For example, the first housing component 19a can have features that form a releasable snap-fit connection with corresponding mating features of the second housing component 19b.

In alternative embodiments, the housing assembly <NUM> can comprise a single cylindrical housing component or member rather than multiple, separable components. In such alternative embodiments, the retaining member <NUM> would not be required. In still alternative embodiments, the housing assembly <NUM> can comprise more than two housing components, for example, three, four, or more separable housing components that can be assembled into a cylindrical form.

As noted above, the crimping device <NUM> can further comprise an actuator <NUM> and a valve holder <NUM>. The engagement of the inner threads <NUM> of the actuator <NUM> with the external threads <NUM> of the housing assembly <NUM> is such that rotation of the actuator <NUM> in one direction relative to the housing assembly <NUM> causes the actuator <NUM> to move proximally relative to the housing assembly <NUM> in the direction indicated by arrow <NUM> in <FIG>. Rotation of the actuator <NUM> in the opposite direction causes the actuator <NUM> to move distally relative to the housing assembly <NUM> in the direction indicated by arrow <NUM> in <FIG>.

As used herein, the term "proximal" or "proximally" means closer to or in a direction toward the user using the delivery apparatus <NUM>. Thus, the proximal direction indicated by arrow <NUM> is toward a handle (not shown) of the delivery apparatus <NUM> and the user. As used herein, the term "distal" or "distally" means farther or in a direction away from the user using the delivery apparatus <NUM>. Thus, the distal direction indicated by arrow <NUM> extends away from the handle of the delivery apparatus <NUM> and the user.

In the illustrated embodiment, the crimping device <NUM> is arranged on the delivery apparatus <NUM> at a location distal to the sheath <NUM> and such that the actuator <NUM> defines the distal end of the crimping device <NUM> and the retaining member <NUM> defines the proximal end of the crimping device <NUM>. However, it should be understood that the crimping device <NUM> can be placed on the delivery apparatus <NUM> in a reverse position at a location proximal to a proximal opening of a sheath with the actuator <NUM> defining a proximal end of the crimping device <NUM> and the retaining member <NUM> defining the distal end of the crimping device <NUM>. Thus, it can be appreciated that the terms "proximal" and "distal" when used to describe components of the crimping device and their operation, these terms are used as a matter of convenience and not require a certain orientation of the crimping device relative to the delivery apparatus or the user.

As best shown in <FIG>, the valve holder <NUM> can be generally cylindrical and sized to fit within an axially extending bore <NUM> of the housing assembly <NUM>. The valve holder <NUM> is configured to hold at least a portion of the prosthetic valve <NUM> and push the prosthetic valve <NUM> axially through the bore <NUM> and the funnel segment <NUM> to effect crimping of the prosthetic valve <NUM>. As shown, the valve holder <NUM> can comprise an internal annular recess <NUM> that is configured to engage, abut, or receive a first end portion <NUM> of the prosthetic valve <NUM>. The annular recess <NUM> can include an annular lip <NUM> configured to hold the first end portion <NUM> of the prosthetic valve <NUM> within the recess <NUM>.

The annular recess <NUM> can be in communication with a larger internal cavity or bore <NUM> formed within a proximal end portion <NUM> of the valve holder <NUM>. The wall of the cavity <NUM> is formed with a plurality of circumferentially spaced ribs <NUM> that extend longitudinally along and radially inwardly from the inner surface of the cavity <NUM>. The ribs <NUM> can help support the prosthetic valve <NUM> such that there is less axial deformation of the prosthetic valve <NUM> during radial compression of the prosthetic valve <NUM>. The ribs <NUM> can further assist in the proper placement of the prosthetic valve <NUM> in the crimping device <NUM>. The number of plurality of ribs <NUM> can vary depending on the type and/or size of prosthetic valve to be crimped.

As further shown in <FIG> and <FIG>, a distal end portion <NUM> of the valve holder <NUM> can have an axially extending bore <NUM> that is in communication with the cavity <NUM> within the proximal end portion <NUM> of the valve holder. In this manner, the bore <NUM> and the cavity <NUM> form an axially extending passageway or lumen extending completely through the valve holder <NUM> to permit the delivery catheter <NUM> to be inserted through the valve holder <NUM>.

The valve holder <NUM> can be rotatably coupled to the actuator <NUM> so as to permit rotation of the actuator <NUM> relative to the valve holder <NUM> and effect axial movement of the actuator <NUM> and the valve holder <NUM> relative to the housing assembly <NUM> upon rotation of the actuator. To such ends, the distal end portion <NUM> of the valve holder <NUM> can be formed with one or more releasable locking features <NUM> (e.g., two diametrically opposed locking features <NUM> in the illustrated embodiment) configured to releasably engage the actuator <NUM>. For example, as best shown in <FIG>, each locking feature <NUM> can comprise a deflectable lip <NUM> and a notch or groove <NUM> that is sized to receive an inwardly turned annular ledge <NUM> of the actuator <NUM>. The lips <NUM> can be deflected inwardly when pressed against the ledge <NUM>, which allows the ledge <NUM> to slide into the grooves <NUM>, thereby forming a snap-fit connection between the ledge <NUM> and the locking features <NUM>.

The grooves <NUM> can be slightly oversized relative to the ledge <NUM> to permit rotation of the ledge <NUM> within the grooves <NUM> upon rotation of the actuator <NUM> relative to the valve holder <NUM>. Due to the threaded engagement of the actuator <NUM> and the housing assembly <NUM>, rotation of the actuator <NUM> is effective to cause relative axial movement between the actuator <NUM> and the housing assembly <NUM>. The ledge <NUM> in engagement with the grooves <NUM> transfers axial movement of the actuator <NUM> to the valve holder <NUM> such that axial movement of the actuator <NUM> is effective to move the valve holder <NUM> axially relative to the housing assembly <NUM> in the same direction. The valve holder <NUM> in turn pushes the prosthetic valve <NUM> axially though the housing assembly <NUM>. Thus, rotation of the actuator <NUM> relative to the housing assembly <NUM> can urge the valve holder <NUM> against the first end <NUM> of the prosthetic valve <NUM> thereby forcing the prosthetic valve <NUM> against the tapered walls <NUM> of the funnel <NUM>, thereby causing the prosthetic valve <NUM> to radially compress as it is pushed through the funnel <NUM> and outwardly through the outlet opening <NUM>.

If desired, the actuator <NUM> can be removed from the valve holder <NUM> by pressing the lips <NUM> of the locking features inwardly past the radial innermost edge of the ledge <NUM>, which allows the actuator <NUM> to be slid axially away from and out of engagement with the distal end portion <NUM> of the valve holder <NUM>. In other embodiments, the actuator <NUM> need not be removable from the valve holder <NUM> and instead can be permanently coupled to the valve holder <NUM> but otherwise allows for relative rotation of the actuator <NUM> and the valve holder <NUM> as previously described above.

As shown in <FIG>, the valve holder <NUM> can have one or more longitudinally extending, external ribs or protrusions <NUM> (two diametrically opposed ribs <NUM> in the illustrated embodiment). The external ribs <NUM> are sized to be received in respective longitudinal slots <NUM> in each housing component 19a, 19b (see <FIG>). Although only the slot <NUM> of the first housing component 19a is shown in <FIG>, the second housing component 19b has an identical slot <NUM> diametrically opposed to the one in the first housing component 19a. The engagement of the ribs <NUM> within the slots <NUM> can be used to align the valve holder <NUM> within the housing assembly <NUM> and prevents any rotation of the valve holder <NUM> relative to the actuator <NUM> and the housing assembly <NUM> upon rotation of the actuator <NUM>.

The threaded engagement of the actuator <NUM> and the housing assembly <NUM> can allow a user to precisely control the advancement of the prosthetic valve <NUM> out of the crimping device <NUM> and/or radial compression of the prosthetic valve <NUM>. The crimping device <NUM> further allows for a one-person operation of the crimping device <NUM> and a repeatable, predictable procedure for crimping and loading a prosthetic valve <NUM>. Some embodiments of the prosthetic valve <NUM> can include connection features that form a releasable connection with mating features of the delivery apparatus <NUM> (the connection features are located at the end of the prosthetic valve opposite the end in engagement with the valve holder <NUM>) (e.g., see connecting arms <NUM> of prosthetic valve <NUM>, described in further detail below). The connection features of the prosthetic valve have to be radially compressed while maintaining rotational alignment with the mating features of the delivery apparatus. The crimping device <NUM> allows a single operator to control crimping of the prosthetic valve while maintaining the rotational alignment of the connection features of the prosthetic valve with the mating features of the delivery apparatus. As the prosthetic valve is advanced out of the outlet <NUM> of the crimping device <NUM>, the operator can connect the connection features of the prosthetic valve to the mating features of the delivery apparatus.

In the embodiment shown in <FIG>, for example, the prosthetic valve <NUM> can be advanced through the outlet <NUM> of the crimping device <NUM> and into the sheath <NUM> of the delivery apparatus <NUM>. The sheath <NUM> can be a tubular structure configured to contain the prosthetic valve <NUM> in the delivery configuration. The crimping device <NUM> can then be removed from the delivery apparatus <NUM> by sliding it distally off the inner shaft <NUM> (in the direction of arrow <NUM>).

In some embodiments, the delivery apparatus <NUM> can include a nose cone or tip portion at the distal end of the inner shaft <NUM>, which can prevent removal of the crimping device <NUM> by sliding it distally off the inner shaft <NUM>. In such cases, the crimping device <NUM> can be disassembled by rotating the actuator <NUM> in the opposite direction to cause the actuator <NUM> to move distally relative to the housing assembly <NUM> (in the direction of arrow <NUM>) until the actuator <NUM> is disengaged and removed from the housing assembly <NUM>. The retaining member <NUM> can be slid off of the proximal end of the housing assembly <NUM>, which then allows the first and second housing components 19a, 19b to be separated laterally away from each other and the delivery apparatus <NUM>. The valve holder <NUM> desirably has a large enough lumen to be slid off the delivery apparatus <NUM>, such as by sliding the valve holder <NUM> distally relative to the inner shaft <NUM> until it is removed from the distal end of the delivery apparatus.

The delivery apparatus <NUM> can then be inserted into the vasculature of a patient and used to deliver the prosthetic valve <NUM> percutaneously to the desired implantation location using conventional techniques. The distal end of the delivery apparatus <NUM> can be inserted into another device, such as an introducer sheath, which has been already inserted into a patient, to facilitate insertion of the delivery apparatus <NUM> into the patient.

In some embodiments, a system comprising a crimping device <NUM>, a delivery apparatus <NUM>, and a prosthetic valve <NUM> can be packaged and shipped from the manufacturer to the end user with the prosthetic valve <NUM> pre-loaded inside of the fully assembled crimping device <NUM> coaxially mounted on the delivery apparatus. In some embodiments, the system can further comprise a sterile package enclosing the crimping device <NUM> mounted on the distal end portion of the delivery apparatus, the prosthetic valve <NUM> pre-loaded in the crimping device, and the entire the delivery apparatus <NUM> or just the distal end portion of the delivery apparatus on which the crimping device and the prosthetic valve are mounted. In other embodiments, the system can further comprise another device, such as an introducer sheath, to assist in inserting the delivery apparatus <NUM> into a patient once the prosthetic valve has been loaded into the sheath <NUM>.

In some embodiments, the prosthetic valve <NUM> can be in a partially crimped configuration prior to being assembled within the crimping device <NUM>. For example, the prosthetic valve <NUM> can be pre-crimped to the partially crimped configuration using another crimping instrument, prior to being assembled into crimping device <NUM>. In the partially crimped configuration, the prosthetic valve <NUM> has an outer diameter that is between that of the expanded configuration and that of the delivery configuration. In some embodiments, the prosthetic valve <NUM> can have an outer diameter in the partially crimped configuration that is closer to the outer diameter in the delivery configuration than to the outer diameter in the expanded configuration. For example, the prosthetic valve <NUM> in the partially crimped configuration can be crimped about <NUM>% of the way from the expanded configuration to the delivery configuration. The crimping device <NUM> can also be configured to crimp the prosthetic valve <NUM> to the delivery configuration from the expanded configuration without first pre-crimping the prosthetic valve <NUM> to an intermediate partially crimped configuration.

<FIG> shows an alternative embodiment of a crimping device <NUM> comprising a housing, a valve holder or pusher member <NUM> and an actuator or knob <NUM>. The housing can comprise a unitary, generally cylindrical structure. Alternatively, the housing can comprise or two or more separable housing components as described above. For example, the housing can include a first housing component <NUM> and a second housing component (not shown). When assembled together, the first housing component <NUM> and the second housing component can form a generally cylindrical or tubular shape. Both the first and the second housing components can include releasable, mating locking features that are configured to engage each other and retain the housing components in their assembled state. For example, each housing component can include one or more fins <NUM> extending from the proximal end of the housing component (shown on the first housing component <NUM> in <FIG>), for example two such fins <NUM> on diametrically opposed sides of an outlet <NUM>. One of the fins <NUM> on the first housing component <NUM> can include a threaded hole <NUM> and the other fin <NUM> can include a non-threaded hole <NUM>. The non-threaded <NUM> hole may have a larger diameter of the threaded hole <NUM>. The threaded hole <NUM> can be configured to align up with a non-threaded hole on a fin of the second housing component and the non-threaded hole <NUM> can be configured to align with a threaded hole on a fin of the second housing component (not shown). A threaded screw or knob (not shown) can be passed through first a non-threaded hole and then through the threaded hole of the first and second housing components to join and releasably retain the first and second housing components together.

<FIG> show an alternative embodiment of a crimping device <NUM> comprising a housing <NUM>, a valve holder or pusher member <NUM> and a rotatable actuator or knob <NUM>. <FIG> is an exploded view of the crimping device <NUM>. <FIG> is a cross-sectional, assembled view of the crimping device <NUM>. The housing <NUM> can have a generally cylindrical shape having an externally threaded portion <NUM> along a distal end portion <NUM> and a funnel segment <NUM> along a proximal end portion <NUM> in communication with an outlet opening <NUM>. In the illustrated embodiment, the housing <NUM> comprises a unitary, generally cylindrical structure. However, in other embodiments, the housing can comprise an assembly of a plurality of separable housing components, as described above in connection with the crimping device <NUM>.

The funnel segment <NUM> comprises a conical or funnel shaped wall <NUM> that is tapered from a first, greater diameter adjacent an intermediate portion <NUM> of the housing <NUM> to a second, smaller diameter at the outlet <NUM>. The housing <NUM> can further comprise internal tapered wall <NUM> extending from the distal end portion <NUM> of the housing <NUM> to approximately adjacent the distal end of the funnel segment <NUM>. The internal tapered wall <NUM> tapers from a first larger diameter to a second, smaller diameter moving in a direction from the distal end portion <NUM> to the proximal end portion <NUM>. In the illustrated embodiment, the wall <NUM> is tapered at a smaller angle relative to a longitudinal axis A of the crimping device than the funnel segment, which is tapered at a steeper angle relative to the longitudinal axis A. In other embodiments, the wall <NUM> can be tapered at the same angle as the funnel segment <NUM>, or at a greater angle than the funnel segment <NUM>.

The wall <NUM> includes a plurality of circumferentially spaced ribs <NUM> extending longitudinally along a portion or the entire length of the wall <NUM> and radially inwardly extending toward the longitudinal axis A. The width of the ribs (the width being the dimension extending from the wall <NUM> toward the longitudinal axis A) can increase along their length from a smaller width adjacent the distal end portion <NUM> to a greater width adjacent the proximal end portion <NUM>. The ribs <NUM> function to prevent or at least minimize axial deformation of a prosthetic valve <NUM> (see <FIG>) during radial compression and/or assist in alignment of the connection features of the prosthetic valve with mating features of the delivery apparatus.

In particular embodiments, the ribs <NUM> can also begin to radial compress a prosthetic valve <NUM> from the fully expanded diameter to a partially crimped diameter before it enters the funnel segment <NUM> where it is then crimped from the partially crimped diameter to the fully crimped diameter for loading into a delivery apparatus. Thus, in this manner, the housing <NUM> can have two crimping sections that can crimp the prosthetic valve at different rates due to the different tapering angles of the two sections. In the illustrated embodiment, for example, the wall <NUM> and the ribs <NUM> are tapered at a smaller angle relative to the longitudinal axis A than is the funnel segment <NUM>, in which case the first crimping section (defined by the ribs <NUM>) initially crimps the prosthetic valve a first amount and then is further crimped by the second crimping section (defined by the funnel segment <NUM>) a second amount greater than the first amount.

As best shown in <FIG>, the pusher member <NUM> can comprise a generally cylindrical or tubular main body <NUM>, an annular ledge <NUM> at the proximal end of the main body, and a plurality of circumferentially spaced, radially extending fins <NUM> extending from the ledge <NUM>. The fins <NUM> can be configured to be slidably disposed between the ribs <NUM> of the housing <NUM> such that as the pusher member <NUM> moves axially with respect to the housing <NUM>, the fins <NUM> slide between the ribs <NUM>. Each of the fins <NUM> can have the shape of an angular segment that flares or widens in width extending in a radial direction away from the annular ledge <NUM> so as to generally correspond to the shape of the spaces between the ribs <NUM>, as best shown in <FIG>. The annular ledge <NUM> is configured to abut an adjacent end <NUM> of the prosthetic valve <NUM> when pushing the prosthetic valve through the housing <NUM>.

In alternative embodiments, the pusher member <NUM> can have an annular recess (similar to the recess <NUM> of the valve holder <NUM>) or a similar feature that is configured to hold or retain an end portion of a prosthetic valve as it is pushed through the housing <NUM>.

The actuator <NUM> can have internal threads <NUM> configured to engage the external threads <NUM> of the housing <NUM> such that rotation of the actuator <NUM> causes the actuator <NUM> to move axially along the length of the housing <NUM>. The actuator <NUM> can surround the pusher member <NUM> and can be coupled to the pusher member <NUM> such that axial movement of the actuator <NUM> (through rotation of the actuator <NUM> relative to the pusher member <NUM> and the housing <NUM>) causes corresponding axial movement of the pusher member <NUM> through the housing <NUM>. For example, the main body of the pusher member <NUM> can be formed with resilient locking features <NUM> configured to form a snap fit connection with an inwardly turned radial ledge <NUM> of the actuator <NUM>.

The crimping device <NUM> can be used to crimp a prosthetic valve <NUM> in the manner described above in connection with the crimping device <NUM>. Briefly, the prosthetic valve <NUM> can be inserted into the housing <NUM>. The pusher member <NUM> (which can be preassembled to the actuator <NUM>) is inserted into the housing <NUM> so as to engage an adjacent end <NUM> of the prosthetic valve <NUM> while the actuator <NUM> is screwed onto the outside of the housing <NUM>. Although not shown, the housing <NUM>, the prosthetic valve <NUM>, the pusher member <NUM>, and the actuator <NUM> can be positioned co-axially around the shaft of a delivery apparatus. As the actuator <NUM> is rotated relative to the housing <NUM>, the actuator <NUM> moves axially along the housing <NUM>, pushing the pusher member <NUM> through the housing <NUM>, which in turn pushes the prosthetic valve <NUM> through the housing <NUM>. As prosthetic valve <NUM> is pushed through the tapered wall segment <NUM> and the funnel segment <NUM>, the prosthetic valve is radially compressed and pushed outwardly through the outlet <NUM>. In particular embodiments, the prosthetic valve <NUM> can be pushed directly from the crimping device <NUM> into a sheath of a delivery apparatus (not shown).

<FIG> is a side elevation view of an exemplary prosthetic valve <NUM> that can be crimped using any of the crimping devices disclosed herein. The prosthetic valve <NUM> comprises a radially expandable and compressible metal frame <NUM> supporting a plurality of leaflets <NUM> inside of the frame. The prosthetic valve <NUM> can also include a sealing member <NUM> (e.g., a fabric skirt) secured on the outside of the frame <NUM> and configured to create a seal against a native valve annulus. In certain embodiments, the prosthetic valve <NUM> is self-expandable with the frame <NUM> being formed from a self-expanding metal (e.g., Nitinol).

The frame <NUM> can comprise a main body <NUM> and a first set of anchors <NUM> and a second set of anchors <NUM> extending toward each other from opposing portions of the main body <NUM>. In particular embodiments, the prosthetic valve <NUM> is a prosthetic mitral valve and the anchors <NUM> are configured to help anchor the prosthetic valve <NUM> in the left atrium and the anchors <NUM> are configured to help anchor the prosthetic valve <NUM> in the left ventricle. The end of the frame <NUM> opposite the anchors <NUM> can include a plurality of connecting arms <NUM> having enlarged end portions <NUM>. The end portions <NUM> are configured to engage mating features of a delivery apparatus to form a releasable connection between the prosthetic valve and the delivery apparatus.

As noted above, the plurality of ribs <NUM> can aid in the alignment of the prosthetic valve <NUM>. For example, the prosthetic valve <NUM> can be aligned within the crimping device such that one or both of the first and second set of anchors <NUM> and <NUM> are disposed between the plurality of ribs (as shown in <FIG> with respect to the second set of anchors <NUM>), thereby ensuring that the enlarged end portions <NUM> are positioned for engagement with the mating features of the delivery apparatus to form a releasable connection between the prosthetic valve and the delivery apparatus. As the prosthetic valve is pushed out of the outlet <NUM>, the second set of anchors <NUM> can be radially compressed against the main body <NUM> of the frame <NUM> of the prosthetic valve <NUM>. In alternative embodiments, the leading end <NUM> (<FIG>) of the funnel segment <NUM> can be adapted to cause the anchors <NUM> to bend away from the main body <NUM> into a substantially straightened configuration extending <NUM> degrees from the main body <NUM> as the prosthetic valve <NUM> moves through the funnel segment <NUM>.

<FIG> shows the distal end portion of an exemplary delivery apparatus <NUM> that can be used to deliver and implant the prosthetic valve <NUM> in a patient's body. Any of the crimping devices disclosed herein can be used to crimp the prosthetic valve <NUM> and load it onto the delivery apparatus <NUM>. As shown, the delivery apparatus <NUM> generally comprises an outer sheath <NUM>, a first shaft <NUM> extending coaxially through the sheath <NUM>, and a second shaft <NUM> extending coaxially through the first shaft <NUM>. A nose cone <NUM> can be attached to the distal end portion of the second shaft <NUM>. Although not shown, the proximal end portions of the sheath <NUM>, the first shaft <NUM>, and the second shaft <NUM> can be coupled to a handle and each of these components can be moveable axially relative to each other.

A valve-retaining member <NUM> can be connected to the distal end portion of the first shaft <NUM> and can include a plurality of circumferentially spaced slots <NUM> sized to receive the connecting arms <NUM> of the prosthetic valve <NUM>. During the crimping process, the valve-retaining member <NUM> initially can be outside of the sheath <NUM>. As the prosthetic valve <NUM> is initially pushed out of the outlet <NUM> of the crimping device <NUM>, the connecting arms <NUM> can be placed within respective slots <NUM> of the valve-retaining member <NUM>. The enlarged end portions <NUM> can be positioned within an annular slot <NUM> proximal to slots <NUM> to prevent axial separation of the prosthetic valve from the valve-retaining member.

As the prosthetic valve is further advanced from the crimping device, the sheath <NUM> can be advanced distally over the valve-retaining member <NUM> and the prosthetic valve <NUM> so that the prosthetic valve can be delivered and implanted in a patient's body using the delivery apparatus <NUM>. After the delivery apparatus <NUM> is inserted into a patient's vasculature and the distal end portion is positioned at or adjacent the desired implantation site (e.g., the native mitral valve), the sheath <NUM> can be retracted proximally to deploy the prosthetic valve <NUM> from the sheath <NUM>, allowing the prosthetic valve to expand under its own resiliency. When the sheath <NUM> is retracted proximally beyond the valve-retaining member <NUM>, the connecting arms <NUM> can expand radially away from their engagement with the slots <NUM>, thereby de-coupling the prosthetic valve from the delivery apparatus.

Claim 1:
A crimping device (<NUM>, <NUM>, <NUM>) for crimping a radially expandable and compressible prosthetic valve (<NUM>, <NUM>, <NUM>), the crimping device (<NUM>, <NUM>, <NUM>) comprising:
a housing (<NUM>, <NUM>) having an outlet (<NUM>, <NUM>) and an internal surface, the internal surface having a plurality circumferentially spaced ribs (<NUM>) extending longitudinally along at least a portion of an inner wall (<NUM>) of the housing (<NUM>, <NUM>) and radially inwardly from the internal surface, said plurality of ribs (<NUM>) configured to receive a prosthetic valve (<NUM>, <NUM>, <NUM>) in a radially expanded state;
a pusher member (<NUM>, <NUM>, <NUM>) that is axially movable relative to the housing (<NUM>, <NUM>), wherein the pusher member (<NUM>, <NUM>, <NUM>) is configured to abut an end of the prosthetic valve (<NUM>, <NUM>, <NUM>) and axial movement of the pusher member (<NUM>, <NUM>, <NUM>) relative to the housing (<NUM>, <NUM>) causes radial compression of the prosthetic valve (<NUM>, <NUM>, <NUM>) and axial movement of the prosthetic valve (<NUM>, <NUM>, <NUM>) through the outlet in a radially compressed, delivery configuration; and
an actuator (<NUM>) that is rotatable relative to the housing (<NUM>, <NUM>) and the pusher member (<NUM>, <NUM>, <NUM>) to cause axial movement of the pusher member (<NUM>, <NUM>, <NUM>) relative to the housing (<NUM>, <NUM>).