Patent Description:
Medical devices, such as stents and prosthetic valve devices, can be introduced into a lumen of a body vessel via percutaneous catheterization techniques. These medical devices may be expandable from a first cross-sectional dimension that allows for percutaneous device delivery to a second cross-sectional dimension at a treatment site. In the expanded state, the medical device has a larger cross-sectional dimension than the catheter used to deliver the medical device. Accordingly, a crimping device is typically used to crimp (i.e., reduce) a cross-sectional dimension of the medical device so that the medical device can be loaded into the catheter and advanced to a treatment location in the body. At the treatment location, the medical device can be removed from the catheter and expanded (e.g., via self-expansion, balloon catheter expansion, or mechanical expansion means) to provide a treatment function.

Prosthetic heart valve devices (e.g., prosthetic mitral valve devices) can have a large cross-sectional dimension in the expanded state relative to other medical devices (e.g., stents) delivered via percutaneous catheterization techniques. For example, some prosthetic mitral valves can have an expanded cross sectional dimension of <NUM> (<NUM>. <NUM> inches) or more. It is often desirable to package and store prosthetic heart valve devices in their expanded state until just before implantation into the patient. For example, prosthetic heart valve devices can be stored in a sterile solution up until the time the prosthetic heart valve device is ready to be loaded into a delivery system for implantation. Therefore, it is often desirable to crimp prosthetic heart valve devices in the operating room and only a few minutes before a procedure to implant the prosthetic heart valve device. Such procedures preclude pre-crimping by the manufacturer, and benefit from crimping devices that are highly portable and readily available as a sterile system.

<CIT> relates to a transapical delivery device. <CIT> relates to a prosthetic valve crimping device.

The invention is directed to a crimping device according to claim <NUM>. A method for reducing a size of a medical device for loading into a delivery capsule is outlined in claim <NUM>.

Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure. Furthermore, components can be shown as transparent in certain views for clarity of illustration only and not to indicate that the illustrated component is necessarily transparent. The headings provided herein are for convenience only.

The present technology is generally directed to systems including crimping devices for reducing the size of prosthetic heart valve devices and other medical devices. The term "crimp" (e.g., used in relation to a crimping device or a crimping method) can refer to devices and methods that compact or compress a medical device to a smaller size. Specific details of several embodiments of the present technology are described herein with reference to <FIG>. Although many of the embodiments are described with respect to devices, systems, and methods for crimping, loading, and delivering prosthetic heart valve devices to a native mitral valve, other applications and other embodiments in addition to those described herein are within the scope of the present technology. For example, at least some embodiments of the present technology may be useful for delivering prosthetics to other native valves, such as the tricuspid valve or the aortic valve. It should be noted that other embodiments in addition to those disclosed herein are within the scope of the present technology. Further, embodiments of the present technology can have different configurations, components, and/or procedures than those shown or described herein. Moreover, a person of ordinary skill in the art will understand that embodiments of the present technology can have configurations, components, and/or procedures in addition to those shown or described herein and that these and other embodiments can be without several of the configurations, components, and/or procedures shown or described herein without deviating from the present technology.

With regard to the terms "distal" and "proximal" within this description, unless otherwise specified, the terms can reference relative positions of portions of a prosthetic valve device and/or an associated delivery device with reference to an operator and/or a location in the vasculature or heart. For example, in referring to a delivery catheter suitable to deliver and position various prosthetic valve devices described herein, "proximal" can refer to a position closer to the operator of the device or an incision into the vasculature, and "distal" can refer to a position that is more distant from the operator of the device or further from the incision along the vasculature (e.g., the end of the catheter).

<FIG> shows an embodiment of a crimping and loading system <NUM> ("system <NUM>") for reducing the size of a medical device in accordance with the present technology. In particular, the system <NUM> can be used to crimp or compact the medical device to enable the medical device to be loaded into a delivery system for percutaneously delivering the medical device to a patient. In some embodiments, the medical device can be a prosthetic heart valve device. More particularly, the medical device can be a mitral valve device for implantation into a native mitral valve and the delivery system can be a delivery system for delivering the mitral valve device to the native mitral valve, such as one or more of the mitral valve devices and/or delivery systems disclosed in (<NUM>) International Patent Application No. <CIT>, (<NUM>) International Patent Application No. <CIT>, (<NUM>) International Patent Application No. <CIT>, (<NUM>) International Patent Application No. <CIT>, (<NUM>) <CIT>, and (<NUM>) <CIT>.

As shown in <FIG>, the system <NUM> includes a crimping device <NUM>, a medical device holder <NUM> ("holder <NUM>"), a tray <NUM>, and a stand <NUM>. The crimping device <NUM> includes a plurality of blades (not visible; described in further detail below) that define a channel <NUM> configured to receive a medical device in an expanded state, and an actuating member <NUM> operably coupled to the blades. The actuating member <NUM> can be manipulated by a user to vary or reduce a cross-sectional dimension (e.g., a diameter) of the channel <NUM> and, thereby, reduce the outer dimension of the medical device positioned within the channel <NUM>. In some embodiments, the holder <NUM> is releasably coupled to the medical device, and then detachably coupled to an entry side <NUM> of the crimping device <NUM> such that the holder <NUM> positions the medical device appropriately within the channel <NUM> of the crimping device <NUM> before and/or during crimping.

As shown in <FIG>, the crimping device <NUM> can be positioned at least partially within a reservoir <NUM> in the tray <NUM> In some embodiments, the tray <NUM> includes a plurality of flanges <NUM> that project into the reservoir <NUM> and define a recess <NUM> that is sized and shaped to retain the crimping device <NUM> such that the channel <NUM> is positioned within the reservoir <NUM>. In other embodiments, the tray <NUM> can include different or additional features for retaining and appropriately positioning the crimping device <NUM> within the tray <NUM>, such as fasteners, interlocking surfaces, and/or other suitable retention features. The reservoir <NUM> can hold a liquid (e.g., chilled saline) that submerges the channel <NUM> when the crimping device <NUM> is positioned within the recess <NUM>. As further shown in <FIG>, the tray <NUM> can also include an aperture <NUM> for receiving a portion of a delivery system <NUM> therethrough and to facilitate loading the crimped medical device into the delivery system <NUM>. For example, an elongated catheter body <NUM> and/or delivery capsule <NUM> of the delivery system <NUM> can be inserted through the aperture <NUM> and positioned adjacent to the channel <NUM> on an exit side <NUM> of the crimping device <NUM>. In some embodiments, the tray <NUM> can further include one or more sealing members (not shown) positioned within the aperture <NUM> to at least partially seal liquid within the reservoir <NUM> when the delivery system is moved into and out of the reservoir <NUM>. The stand <NUM> can be positioned to support a portion of the catheter body <NUM> and/or align the delivery system <NUM> with the aperture <NUM> of the tray <NUM>. In other embodiments, the system <NUM> can include additional components or some of the features may be omitted.

In operation, the crimping device <NUM> is positioned within the recess <NUM> of the tray <NUM>. A medical device, such as a prosthetic heart valve device, is releasably attached to the holder <NUM> while the medical device is in its expanded state (e.g., an unconstrained state), and then the holder <NUM> is attached to the entry side <NUM> of the crimping device <NUM> such that the medical device extends into the channel <NUM>. In some embodiments, the holder <NUM> is attached to the entry side <NUM> of the crimping device <NUM> before the crimping device <NUM> is positioned within the recess <NUM> of the tray <NUM>. In some embodiments, the medical device can be packaged with and pre-attached to the holder <NUM>. In some embodiments, the holder <NUM> is omitted, and the medical device can be placed in the channel <NUM> by itself and/or releasably attached to another portion of the crimping device <NUM> to retain the medical device in the channel <NUM>. Before or after the medical device is positioned in the channel <NUM>, the reservoir <NUM> of the tray <NUM> can be filled with a liquid (e.g., chilled saline) such that the channel <NUM> of the crimping device <NUM> and the medical device positioned therein are submerged in the liquid. Submerging the medical device can keep the medical device chilled as the crimping device <NUM> acts on the medical device to reduce the outer dimension of the medical device.

When the system <NUM> is used to facilitate loading of the device into the delivery system <NUM>, a distal portion of the catheter body <NUM> can be positioned through the aperture <NUM> such that the delivery capsule <NUM> at the distal end of the catheter body <NUM> is positioned at the exit side <NUM> of the crimping device <NUM> adjacent the channel <NUM>. In some embodiments, a distal nose cone of the delivery capsule <NUM> and an elongated central shaft attached thereto are inserted at least partly through the channel <NUM> and the unconstrained medical device (e.g., toward the entry side <NUM> of the crimping device <NUM> beyond a distal end of the medical device). The stand <NUM> can be positioned to support the catheter body <NUM> and/or other portions of the delivery system <NUM> outside of the tray <NUM>, and to align the delivery system <NUM> with the aperture <NUM> of the tray <NUM> and the channel <NUM> of the crimping device <NUM>.

Once the delivery system <NUM> and the medical device are properly positioned with respect to the crimping device <NUM>, a user can manipulate the actuating member <NUM> of the crimping device <NUM> to reduce the cross-sectional dimension of the channel <NUM>, and thereby reduce the outer dimension of the medical device (i.e., "crimp" the medical device). In some embodiments, the medical device is crimped to accommodate sizing of the delivery capsule <NUM> for implanting the medical device using a minimally invasive procedure. In some embodiments, reducing the cross-sectional dimension of the channel <NUM> disengages the holder <NUM> from the medical device such that the medical device is no longer attached to the holder <NUM> to allow for subsequent removal of the medical device from the channel <NUM> (e.g., via the exit side <NUM> or the entry side <NUM> of the crimping device <NUM>).

Once the medical device has been crimped, the medical device can be loaded into the delivery system <NUM> for subsequent delivery to a patient. For example, a portion of the delivery system <NUM> can be configured to engage the medical device and pull the crimped medical device into the delivery capsule <NUM> and/or the catheter body <NUM>. In some embodiments, a piston device of the delivery system <NUM> engages with features of the medical device, and is then retracted to pull the medical device into the delivery capsule <NUM>. In some embodiments, the channel <NUM> of the crimping device <NUM> has a generally funnel-like shape in which the diameter of the channel <NUM> decreases along an axis from the entry side <NUM> to the exit side <NUM> (i.e., away from the holder <NUM> and toward the delivery capsule <NUM>. In such embodiments, pulling the medical device into the delivery capsule <NUM> can further crimp a portion of the medical device as the medical device is pulled from a wider-diameter portion of the channel <NUM> and through a narrower-diameter portion of the channel <NUM>. In some embodiments, the medical device is pulled into the delivery system <NUM> while submerged in the liquid within the reservoir <NUM>. This is expected to inhibit air pockets or air bubbles from forming in the delivery system <NUM> as the medical device is loaded. Once the medical device is loaded in the delivery system <NUM>, the delivery system <NUM> can be withdrawn from the tray <NUM> and subsequently used to implant the medical device in a patient. In some embodiments, the system <NUM> is configured to be a completely disposable system. Accordingly, the various components of the system <NUM>, including the crimping device <NUM>, can be disposed of (as compared to being cleaned for subsequent re-use) after the medical device is loaded into the delivery system. By making the system <NUM> disposable, the system <NUM> can be provided as a new, sterile environment prior to each procedure.

<FIG> are isometric views of the crimping device <NUM> of <FIG> illustrating the crimping device <NUM> in a first position with the channel <NUM> having a first cross-sectional dimension (<FIG>) and in a second position with the channel <NUM> having a second cross-sectional dimension (<FIG>). <FIG> is an isometric partially exploded view of the crimping device <NUM> of <FIG> (i.e., showing the crimping device <NUM> in the first position). In some embodiments, the first and second cross-sectional dimensions are a maximum and a minimum cross-sectional dimension, respectively. The crimping device <NUM> includes a frame <NUM>, a plurality of movable blades <NUM> arranged circumferentially within the frame <NUM> to define the channel <NUM> having a central axis <NUM> extending therethrough.

Referring to <FIG>, the frame <NUM> can include a first plate <NUM> having a plurality of first slots <NUM> extending through portions of the first plate <NUM>, and a second plate <NUM> having a plurality of second slots <NUM> extending through portions of the second plate <NUM> (collectively referred to as "plates <NUM>, <NUM>"). The crimping device <NUM> further includes a first movable member <NUM> and a second movable member <NUM> (collectively "movable members <NUM>, <NUM>") that are movable (e.g., rotatable) with respect to the first and second plates <NUM> and <NUM>. For example, the movable members <NUM>, <NUM> can be configured to rotate about the central axis <NUM> of the channel <NUM>. The first movable member <NUM> is positioned between the blades <NUM> and the first plate <NUM>, and the first movable member <NUM> includes a plurality of third slots <NUM> extending through portions of the first movable member <NUM>. Similarly, the second movable member <NUM> is positioned between the blades <NUM> and the second plate <NUM>, and the second movable member <NUM> includes a plurality of fourth slots <NUM> extending through portions of the second movable member <NUM>. Portions of the first slots <NUM> can be aligned with portions of the third slots <NUM>, and portions of the second slots <NUM> can be aligned with portions of the fourth slots <NUM>. In some embodiments, the first and second slots <NUM> and <NUM> (collectively referred to as "slots <NUM>, <NUM>") and the third and fourth slots <NUM> and <NUM> (collectively referred to as "slots <NUM>, <NUM>") are reflectively symmetric about a plane extending perpendicularly to the central axis <NUM> of the channel <NUM>.

Each blade <NUM> can include a pin <NUM> that projects from a portion of the blade <NUM> spaced apart from the central axis <NUM> (e.g., an outer portion of the blade <NUM>). At the exit side <NUM> of the crimping device <NUM>, each pin <NUM> extends through one of the first slots <NUM> of the first plate <NUM> and a corresponding one of the third slots <NUM> of the first movable member <NUM>, and at the entry side <NUM> of the crimping device <NUM> each pin <NUM> extends through one of the second slots <NUM> and a corresponding one of the fourth slots <NUM> of the second movable member <NUM>. Accordingly, the quantity of slots <NUM>, <NUM>, <NUM>, <NUM> on each of the plates <NUM>, <NUM> and the movable members <NUM>, <NUM> can correspond to the quantity of blades <NUM>. In operation, a user can manipulate the actuating member <NUM> to rotate, slide, or otherwise move the first and second movable members <NUM> and <NUM> relative to the first and second plates <NUM> and <NUM>. This drives the pins <NUM> along paths defined by corresponding slots <NUM>, <NUM>, <NUM>, <NUM>, thereby driving the blades <NUM> radially inward to decrease the cross-sectional dimension of the channel <NUM> (<FIG>). The radially inward movement of the blades <NUM> acts on an outer surface of a medical device (e.g., a prosthetic heart valve device) positioned within the channel <NUM> and, thereby, reduces the outer cross-sectional dimension (e.g., diameter) of the medical device to fit within a delivery capsule (e.g., the delivery capsule <NUM> of <FIG>). In some embodiments, the second plate <NUM> and the second movable member <NUM> are omitted such that the relative movement of the first plate <NUM> and the first movable member <NUM> alone drive the inward motion of the blades <NUM>.

The plates <NUM>, <NUM> can have a generally rectangular shape such that the frame <NUM> has a generally rectangular cross-section. In other embodiments, the plates <NUM>, <NUM> can have other shapes such as, for example, circular, hexagonal, polygonal, etc., and can have different shapes from one another. For example, when the plates <NUM>, <NUM> have a circular shape, the frame <NUM> can include a stabilizing base region. In some embodiments, the plates <NUM>, <NUM> can be internal components positioned within an outer housing that defines the frame <NUM>. The frame <NUM> can have a shape configured to fit snugly within the recess <NUM> (<FIG>) of the tray <NUM>. The actuating member <NUM> can be positioned on an upper surface <NUM> (<FIG>) of the frame <NUM> such that it is accessibly to a user during a crimping procedure. In other embodiments, the actuating member <NUM> may be positioned elsewhere on the frame <NUM>, or may be an electric motor instead of a manual actuator. As shown in <FIG>, the plates <NUM>, <NUM> are stationary relative to the movable members <NUM>, <NUM>. In some embodiments, the first plate <NUM> is movable relative to the first movable member <NUM> and/or the second plate <NUM> is movable relative to the second movable member <NUM> to drive the blades <NUM> radially inward. For example, manipulating the actuating member <NUM> can rotate the first plate <NUM> in an opposite direction as the first movable member <NUM>.

The first and second slots <NUM> and <NUM> can each define a straight path extending radially away from the central axis of the channel <NUM>. As shown in <FIG>, each plate <NUM>, <NUM> can include twelve slots <NUM>, <NUM> spaced at equal intervals around the central axis <NUM> of the channel <NUM>. However, in some embodiments, each plate <NUM>, <NUM> can include fewer than or more than twelve slots (e.g., six slots, eight slots, fourteen slots) depending on the quantity of blades <NUM>, and/or the slots <NUM>, <NUM> can be arranged in other configurations and can have different shapes. For example, one or more of the slots <NUM>, <NUM> can define a generally arcuate or other path. As illustrated in <FIG>, the second slots <NUM> can have generally similar features to the first slots <NUM>. In other embodiments, the second slots <NUM> can have a different number and/or have a different configuration, shape, etc. from the first slots <NUM>.

The third slots <NUM> on the first movable member <NUM> can each define an arcuate or angled path having a first end 163a and a second end 163b spaced radially closer to the central axis of the channel <NUM> than the first end 163a. In some embodiments, the first movable member <NUM> includes twelve arcuate slots <NUM> spaced apart from each other at equal intervals around the central axis <NUM> of the channel <NUM>. In other embodiments, the plurality of third slots <NUM> can include fewer than or more than twelve slots (e.g., eight slots) depending on the quantity of blades <NUM>, and can be arranged in other configurations and can have different shapes. For example, the third slots <NUM> can define a generally straight path, or could have a concave portion that faces radially outward from the central axis of the channel <NUM>. Although partly obscured in <FIG>, the fourth slots <NUM> can have generally similar features to the third slots <NUM>. In some embodiments, the slots <NUM>, <NUM> are reflectively symmetric about a plane extending perpendicularly to the central axis <NUM> of the channel <NUM>. In other embodiments, the slots <NUM>, <NUM> can each comprise a different number of slots, and/or have different configurations, shapes, etc. from one another. Moreover, as shown in <FIG>, the slots <NUM>, <NUM> can be longer than the slots <NUM>, <NUM> in the plates <NUM>, <NUM>. In some embodiments, the slots <NUM>, <NUM> extend radially the same or a substantially similar distance as the slots <NUM>, <NUM>.

The first through fourth slots <NUM><NUM>, <NUM>, <NUM> define a path of movement for the pins <NUM>. For example, the first and second slots <NUM> and <NUM> can be sized and shaped to maintain the position of the individual blades <NUM> relative to each other, and the third and fourth slots <NUM> and <NUM> can be sized and shaped to drive the blades <NUM> radially inward or outward. Accordingly, movement of the pins <NUM> along the slot paths causes the blades <NUM> to slide relative to each other and to move radially inward or outward. For example, movement of the first movable member <NUM> relative to the first plate <NUM> drives the pins <NUM> along the path defined by the third slots <NUM> of the first movable member <NUM> and constrained by the path of the first slots <NUM> of the first plate <NUM>. Similarly, movement of the second movable member <NUM> relative to the second plate <NUM> drives the pins <NUM> along the path defined by the fourth slots <NUM> of the second movable member <NUM> and constrained by the path of the second slots <NUM> of the second plate <NUM>. When the pins <NUM> are in an initial or first pin position (<FIG>), the blades <NUM> are arranged such that the channel <NUM> has a maximum cross-sectional dimension (e.g., diameter), and the pins <NUM> are positioned at a radially outer end 123a (<FIG>) of the first slots <NUM> and a radially outer end 162a (<FIG>) of the third slots <NUM>. When the pins <NUM> are in a final or second pin position (<FIG>), the pins <NUM> are positioned at a radially inner end 123b (<FIG>) of the first slots <NUM> and a radially inner end 162b (<FIG>) of the third slots <NUM>, and the channel <NUM> has a minimum cross-sectional dimension. Accordingly, the pins <NUM> can move between the first and second pin positions to reduce and expand the cross-sectional dimension of the channel <NUM>. In other embodiments, the pins <NUM> can be positioned at different locations (e.g., positioned at an intermediate location) along the first slots <NUM> when in the first and/or second pin configuration. When the medical device is positioned within the channel <NUM>, driving the pins <NUM> radially inward can reduce a cross-sectional dimension (e.g., diameter) of the medical device. In some embodiments, such as embodiments including twelve blades <NUM>, the blades <NUM> are configured to reduce an outer diameter of a prosthetic heart valve device from about <NUM> (<NUM> inches) to <NUM> (<NUM> inch) or less. For example, the blades <NUM> can be configured to completely close the channel <NUM> in the second pin position (i.e., a cross-sectional dimension of the channel <NUM> is zero). As another example, in embodiments including eight blades <NUM>, the blades <NUM> can be arranged such that the channel <NUM> has a maximum outer diameter of about <NUM> (<NUM> inches) and can reduce the diameter of the channel <NUM> to <NUM> (<NUM> inch) or less. The maximum and minimum cross-sectional dimensions of the channel <NUM> can depend on the quantity of blades <NUM>, the size and shape of the blades <NUM>, the locations of the pins <NUM> on the blades <NUM>, and/or the travel path of the blades <NUM> as defined by the slots <NUM>, <NUM>, <NUM>, <NUM>.

As shown in <FIG>, the second plate <NUM> includes a plurality of first connective features <NUM> and a plurality of second connective features <NUM> The first connective features <NUM> can be holes, flanged surfaces, and/or other attachment mechanisms configured to releasably couple the medical device holder <NUM> (<FIG>) to the second plate <NUM> of the frame <NUM>. The second connective features <NUM> are configured to provide an attachment mechanism for forming the frame <NUM> (e.g., connecting the first plate <NUM> to the second plate <NUM>). As shown, the second connective features <NUM> can be hooks or fasteners shaped to mate with corresponding holes <NUM> on the first plate <NUM>. In some embodiments, the second connective features <NUM> permit the frame <NUM> of the crimping device <NUM> to be taken apart to, for example, permit cleaning of the individual components within the frame (e.g., the blades <NUM> and movable members <NUM>, <NUM>). In some embodiments, the first and second plates <NUM> and <NUM> can be fixedly attached to each other via bonding, welding, and/or other attachment methods.

As further shown in <FIG>, the crimping device <NUM> can also include an actuator device <NUM> operably coupled to the first and second movable members <NUM> and <NUM>, and configured to move the first and second movable members <NUM>, <NUM> relative to the first and second plates <NUM> and <NUM>. In some embodiments, as shown in <FIG>, the actuator device <NUM> includes the actuating member <NUM> coupled to a threaded shaft <NUM> and a connector <NUM> having a threaded shaft <NUM> extending therethrough. The connector <NUM> couples to portions of the first and second movable members <NUM>, <NUM>. Turning the actuating member <NUM> rotates the threaded shaft <NUM> about a longitudinal axis of the threaded shaft <NUM>, which in turn moves the connector <NUM> along the length of the threaded shaft <NUM>. Movement of the connector <NUM> moves the first and second movable members <NUM>, <NUM>, thereby driving the pins <NUM> inward or outward along the paths defined by the slots <NUM>, <NUM>, <NUM>, <NUM> of the plates <NUM>, <NUM> and the movable members <NUM>, <NUM>. For example, a user can turn the actuating member <NUM> in a first direction to cause the connector <NUM> to move downwards (i.e., towards the bottom of the page) in order to rotate the first and second movable members <NUM>, <NUM> clockwise about the central axis <NUM> of the channel <NUM>. Clockwise rotation of the first and second movable members <NUM>, <NUM> can drive the pins <NUM> inward along the combined paths of the first and third slots <NUM>, <NUM> and second and fourth slots <NUM>, <NUM> to reduce the cross-sectional dimension of the channel <NUM>. Turning the actuating member <NUM> in the opposite direction can rotate the movable members <NUM>, <NUM> in the counterclockwise direction to drive the pins <NUM> outward along the combined paths of the first and third slots <NUM>, <NUM> and second and fourth slots <NUM>, <NUM> to increase the cross-sectional dimension of the channel <NUM>. In some embodiments, the actuator device <NUM> can be configured to rotate the blades <NUM> in the opposite directions to effectuate device compression. The actuator device <NUM> illustrated in <FIG> provides for continuous (e.g., rather than stepwise) compression of a medical device placed within the channel <NUM> of the crimping device <NUM>, and can have a relatively smaller footprint as compared to other types of actuators.

In some embodiments, the actuator device <NUM> can comprise a different mechanism to drive movement of the movable members <NUM>, <NUM>, and/or the actuator device <NUM> can be coupled to the movable members <NUM>, <NUM> in a different manner. For example, in some embodiments, the actuator device <NUM> can comprise a lever coupled to the movable members <NUM>, <NUM>. In other embodiments, the movable members <NUM>, <NUM> can be configured to slide (i.e., rather than rotate) relative to the plates <NUM>, <NUM>. In such embodiments, the actuator device <NUM> may comprise a handle or other gripping mechanism for sliding the movable members <NUM>, <NUM>. In still other embodiments, the actuator device <NUM> may include an electric motor configured to move the movable members <NUM>, <NUM>.

<FIG> is an isometric view of one of the blades <NUM> of the crimping device <NUM> (<FIG>). Each blade <NUM> can include a first end portion 141a, a second end portion 141b, a first side 143a, and a second side 143b. The pin <NUM> of each blade <NUM> can include a first pin portion 142a projecting from the first side 143a of the blade <NUM> (e.g., toward the entry side <NUM> of the crimping device <NUM> of <FIG>), and a second pin portion 142b projecting from the second side 143b of the blade <NUM> (e.g., toward the exist side <NUM> of the crimping device <NUM> of <FIG>). The first pin portion 142a and the second pin portion 142b (collectively referred to as "pin portions 142a, 142b") can be a single component (e.g., a single shaft) extending through and/or integrally formed with the blade <NUM>, or the pin portions 142a, 142b can be separate pin components that project from either side of the blade <NUM>. In some embodiments, some or all of the blades <NUM> can include only the first pin portion 142a or only the second pin portion 142b. As shown in <FIG>, the pin portions 142a, 142b project from the second end portion 141b of the blade <NUM>. When the blade <NUM> is positioned within the crimping device <NUM>, the second end portion 141b is spaced apart from and radially farther from the central axis <NUM> of the channel <NUM> than the first end portion 141a. Accordingly, the pin portions 142a, 142b project from a radially outer portion of the blade <NUM>. Compared to a blade with a pin positioned at a central or more radially inward position of the blade, this radially outward positioning of the pin <NUM> requires less actuation (i.e., the pin <NUM> need not be driven as far) to produce an equal amount of inward movement of the blade <NUM>. As a result, the overall size of the crimping device <NUM> is reduced while still maintaining a sufficiently large crimping range (e.g., the range between a minimum and maximum cross-sectional dimension of the channel <NUM>) to accommodate the sizing of a medical device in an expanded state and the sizing of a delivery system (e.g., a delivery capsule).

As further shown in <FIG>, the blade <NUM> includes an inner surface 146a and an outer surface 146b. In general, the inner and outer surfaces 146a and 146b are configured to enable adjacent blades <NUM> to slide relative to one another and to define a shape of the channel <NUM> of the crimping device <NUM>. More specifically, the inner surface 146a can be generally sloped along an axis extending between the first and second sides 143a and 143b of the blade <NUM> (e.g., along the central axis <NUM> of the channel <NUM> shown in <FIG>). The outer surface 146b can have a portion that is generally shaped to match the shape of the inner surface 146a of an adjacent blade <NUM>, and is configured to slide against the inner surface 146a of an adjacent blade <NUM> as the pin portions 142a, 142b are actuated (e.g., driven radially inward or outward along the slots <NUM>, <NUM> and slots <NUM>, <NUM>).

A portion of the inner surfaces 146a (e.g., a portion not covered by the outer surface 146b of an adjacent blade <NUM>) of the blades <NUM> collectively define the channel <NUM> of the crimping device <NUM>. When the blades <NUM> with a sloped inner surface 146a are arranged circumferentially, the channel <NUM> can have a generally funnel-like shape (e.g., as shown in <FIG>). That is, the channel <NUM> can have a larger cross-sectional dimension closer to the second sides 143b of the blades <NUM> (e.g., proximate to the second plate <NUM> at the entry side <NUM> of the crimping device <NUM>) than the first sides 143a of the blades <NUM> (e.g., proximate the first plate <NUM> at the exit side <NUM> of the crimping device). In other embodiments, the inner and outer surfaces 146a, 146b of the blade <NUM> can have other shapes or arrangements. For example, the inner surfaces 146a of each blade can have a wedge-like shape such that the channel <NUM> has a constant cross-sectional dimension along the central axis of the channel <NUM>. In yet other embodiments, the blades <NUM> can generally have any other shape or configuration so as to form a channel <NUM> with a varying cross-sectional dimension along the central axis <NUM> of the channel <NUM>. In some embodiments, the inner and/or outer surfaces 146a, 146b of the blade <NUM> can include one or more grooves, slots, holes, etc. These features can reduce the weight of the blade <NUM> to thereby increase the portability of the crimping device <NUM>, without affecting the function or strength of the crimping device <NUM>.

In some embodiments of the present technology, the crimping device <NUM> can omit one or more of the components described above with reference to <FIG>. For example, the crimping device <NUM> can include only one of the movable members <NUM>, <NUM>, and each blade <NUM> may include only one of the pin portions 142a or 142b to drive the blades <NUM> inward to reduce the size of a medical device. However, redundancy of the two movable members <NUM>, <NUM> and the two plates <NUM>, <NUM> at the first and second sides <NUM> and <NUM> of the crimping device <NUM> effectively supports each blade <NUM> at both the first and second side 143a, 143b of the blade <NUM>. Including two movable members <NUM>, <NUM> can also decrease the amount of force required to actuate the blades <NUM>, and can facilitate at least substantially equal distribution of the actuating force across the blades <NUM> between the first and second sides 143a, 143b. In some embodiments, the crimping device <NUM> can include fewer than twelve blades (e.g., four blades, five blades, six blades, eight blades) or more than twelve blades (e.g., sixteen blades, twenty blades), and the quantity of slots <NUM>, <NUM>, <NUM>, <NUM> of the movable members <NUM>, <NUM> and the plates <NUM>, <NUM> can be modified to correspond to the number of blades <NUM>.

Each of the components described above with reference to <FIG> can be made from the same or different materials, such as metals, polymers, plastic, composites, combinations thereof, and/or other materials. The components of the crimping device <NUM> can be manufactured using suitable processes, such as, for example, three-dimensional printing, injection molding, and/or other processes for supporting and compressing a medical device during a crimping procedure. In some embodiments, each component is made from a suitable plastic or polymer such that the system is completely disposable and able to be manufactured at a relatively low cost. In some embodiments, some of the components illustrated herein as individual components can be integrally formed together or otherwise combined.

In use, the crimping device <NUM> can provide a compact, yet efficient mechanism for reducing the size of a prosthetic heart valve device or other medical device. The slots <NUM>, <NUM> of the plates <NUM>, <NUM> and the slots <NUM>, <NUM> of the movable members <NUM>, <NUM> define paths for the pins <NUM> that slide the blades <NUM> radially inward relative to each other to reduce the diameter of the channel <NUM>. This radially inward force is continuous along the surfaces of the blades <NUM> contacting the medical device within the channel <NUM>, and therefore provides continuous compression of the medical device. As such, the continuous compression allows the user to pause or terminate the crimping procedure at any time (i.e., not just at the maximum and minimum diameters of the channel <NUM>). Further, the funnel-like shape of the channel <NUM> provided by the blade shape allows portions of the medical device to be compressed more than other portions during inward movement of the blades. For example, a larger portion of the medical device may be positioned in the larger portion of the channel <NUM> (e.g., toward the entry side <NUM> of the crimping device <NUM>) and not undergo as much compression as the portion of the medical device positioned in the smaller portion of the channel <NUM> (e.g., toward the exit side <NUM> of the crimping device <NUM>). This can inhibit the compressive crimping forces from moving the medical device laterally toward the entry side <NUM> of the crimping device <NUM> and help retain the medical device within the channel <NUM> during crimping. In addition, the position of the pins <NUM> on the outer portions of the blades <NUM> reduces the length of the pin travel path necessary for inward movement of the blades <NUM> to achieve the desired crimping range. For example, the pins <NUM> can travel a distance of <NUM> mm (<NUM> inch) to reduce the channel diameter from about <NUM> (<NUM> inches) to <NUM> (<NUM> inch) or less. Thus, the arrangement of the pins <NUM>, the blades <NUM>, the movable members <NUM>, <NUM>, and the plates <NUM>, <NUM>, in conjunction with the actuator device <NUM>, allows the crimping device <NUM> to have a compact size that can easily be moved by a clinician to and from a sterile field, while still providing for a large crimping range suitable for reducing the size of prosthetic heart valves to allow for percutaneous delivery of the device.

<FIG> is an isometric view showing the medical device holder <NUM> ("holder <NUM>") configured in accordance with an embodiment of the present technology and coupled to an exemplary medical device <NUM>. In some embodiments as shown in <FIG>, the medical device <NUM> is a valve support for use with a prosthetic heart valve device. The holder <NUM> includes a base <NUM> having a first side 203a, a second side 203b, and an opening <NUM> extending therebetween. The base <NUM> can include a plurality of connectors <NUM> on the second side 203b and configured to removably couple the holder <NUM> to the crimping device <NUM> (e.g., to the connective features <NUM> of the second plate <NUM> of <FIG>). As shown in <FIG>, the base <NUM> can have a generally annular shape including a radially outer surface 209a and a radially inner surface 209b, both extending between the first and second sides 203a, 203b. The outer surface 209a can include a plurality of grooves <NUM> and/or ridges to make the holder <NUM> easy to grip and manipulate, even while submerged during the crimping process. The holder <NUM> further includes a plurality of first fingers <NUM> and a plurality of second fingers <NUM> (collectively "fingers <NUM>, <NUM>") projecting from the base <NUM> and arranged circumferentially around a central axis extending through the opening <NUM> of the base <NUM>. The fingers <NUM>, <NUM> are configured to engage at least a portion of the medical device <NUM> to hold the medical device <NUM> within the channel <NUM> of the crimping device <NUM> (<FIG>) during at least an initial portion of a crimping procedure.

As shown in <FIG>, the first fingers <NUM> can be spaced around the central axis of the opening <NUM> to engage the medical device <NUM> at more than one point around a circumference of the medical device <NUM>. The first fingers <NUM> include a first portion 206a extending radially inward from the inner surface 209b of the base <NUM> toward the central axis of the opening <NUM>, a second portion 206b extending from the first portion 206a and away from the second side 203b of the base <NUM>, a third portion 206c extending from the second portion 206b and radially inward toward the central axis of the opening <NUM>, and a fourth portion 206d configured to engage the medical device <NUM>. The fourth portion 206d can include an index feature 206e shaped to engage a portion of the medical device <NUM>. For example, as shown in <FIG>, the medical device <NUM> can be a stent-device including a frame <NUM> comprising a plurality of frame cells <NUM>. Each frame cell <NUM> can have a hexagonal shape and comprise a pair of first struts <NUM>, a pair of second struts <NUM>, and a pair of third struts <NUM>. Each of the first struts <NUM> can extend from an end of the second struts <NUM>, and pairs of the first struts <NUM> can be connected together to form V-struts <NUM>. At least some of the V-struts <NUM> at an end portion of the frame <NUM> can define an apex <NUM>. As shown, the index features 206e can have a generally V-like shape to engage (e.g., mate with) an individual V-strut <NUM> of the medical device <NUM>. In other embodiments, the medical device <NUM> and/or the first fingers <NUM> can have other suitable shapes that enable the first fingers <NUM> to engage a portion of the medical device <NUM>. For example, the medical device <NUM> may be a stent device having frame cells <NUM> with a rectangular, sinusoidal, triangular, polygonal, or other shape, and the index features 206e can have a corresponding shape and arrangement that mates with or fits within a portion of the frame cells <NUM>. In some embodiments, the first fingers <NUM> are configured to engage with the atrial end of a valve support of a prosthetic mitral valve device and/or other atrial portions of the prosthetic mitral valve device. In some embodiments, the first fingers <NUM> are configured to engage with the ventricular side of the valve support and/or other ventricular portions of the prosthetic mitral valve device.

In some embodiments, the first fingers <NUM> are flexible such that they bend radially inward or outward in response to external forces applied to the first fingers <NUM>. For example, when the holder <NUM> is not attached to the medical device <NUM>, the fourth portions 206d of the first fingers <NUM> can be positioned a distance away from the central axis of the opening <NUM> that is slightly greater than a cross-sectional dimension of the medical device <NUM>. To attach the medical device <NUM>, the first fingers <NUM> can be bent radially inward until the fourth portions 206d of the first fingers <NUM> are within the medical device <NUM>, and then released. Accordingly, the index features 206e of the first fingers <NUM> can press against (e.g., the first fingers <NUM> are slightly radially biased outward against) a radially interior side of the medical device <NUM> to hold or grip the medical device <NUM>. The index features 206e can prevent the medical device <NUM> from slipping off of the holder <NUM> when no other forces are applied to the first fingers <NUM>. When the holder <NUM> is attached to the crimping device <NUM> (<FIG>), the blades <NUM> can press down on the first fingers <NUM> as the channel <NUM> decreases in size, thereby causing the first fingers <NUM> to flex inwardly and release the medical device <NUM> from the holder <NUM> for subsequent loading into the delivery system <NUM> (<FIG>).

The second fingers <NUM> can each include a first portion 208a extending radially inward from the inner surface 209b of the base <NUM> toward the central axis of the opening <NUM>, a second portion 208b extending from the first portion 208a and away from the second side 203b of the base <NUM>, and a third portion 206c extending from the second portion 208b and radially inward toward the central axis of the opening <NUM>. Notably, the first portion 208a of each second finger <NUM> is longer than the first portion 206a of each first finger <NUM>. The second portions 206b of the first fingers <NUM> are therefore positioned radially farther from the central axis of the opening <NUM> than the second portions 208b of the second fingers <NUM>. As shown, the third portions 208c of the second fingers <NUM> can be shaped and positioned to receive the apexes <NUM> of the medical device <NUM>. The second fingers <NUM> can therefore provide additional support for holding the medical device <NUM> in place. In some embodiments, the holder <NUM> can include fingers <NUM>, <NUM> with other shapes, arrangements, quantities, etc., suitable for holding the medical device <NUM> in place. For example, the holder <NUM> may comprise more or less than the twelve fingers <NUM>, <NUM> shown in <FIG> (e.g., more or less than three first fingers <NUM> and more or less than nine second fingers <NUM>). In some embodiments, the holder <NUM> includes only the first fingers <NUM> or only the second fingers <NUM>.

<FIG> are an isometric view and a cross-sectional side view, respectively, illustrating the holder <NUM> of <FIG> coupled to the crimping device <NUM> shown in <FIG>. For ease of illustration, the medical device <NUM> is not shown in <FIG>. Referring first to <FIG>, the holder <NUM> can be removably coupled to the entry side <NUM> of the crimping device <NUM> via the second plate <NUM> of the frame <NUM>. More specifically, the connectors <NUM> (shown in <FIG>) of the holder <NUM> can connect to the first connective features <NUM> disposed on the frame <NUM>. In some embodiments, the connectors <NUM> are at least one of hooks, fasteners, clips, locking features, etc. that engage (e.g., mate with) the first connective features <NUM> to removably secure the holder <NUM> to the crimping device <NUM>. In some embodiments, the connectors <NUM> are inserted into the connective features <NUM>, and the holder <NUM> is rotated to secure the holder <NUM> in place. Once secured, the central axis of the opening <NUM> of the holder <NUM> can be generally aligned with the central axis <NUM> of the channel <NUM> of the crimping device <NUM>. By aligning the central axes of the crimping device <NUM> and holder <NUM>, the medical device <NUM> can be evenly spaced with respect to the blades <NUM> within the channel <NUM> before the medical device <NUM> is crimped to facilitate generally symmetric radial compression of the medical device <NUM>.

As shown in <FIG>, the fingers <NUM>, <NUM> of the holder <NUM> can project at least partly into the channel <NUM> of the crimping device <NUM>. Accordingly, the fingers <NUM>, <NUM> of the holder <NUM> can hold the medical device <NUM> (<FIG>) in a position that is fully within the channel <NUM>. <FIG> further shows an embodiment in which the channel <NUM> has a generally funnel-like shape in which a cross-sectional dimension (e.g., diameter) of the channel <NUM> decreases along the central axis <NUM> moving from the entry side <NUM> of the crimping device <NUM> to the exit side <NUM> of the crimping device <NUM>.

Referring to <FIG> together, to crimp the medical device <NUM>, the actuating member <NUM> is manipulated as described above to reduce the diameter of the channel <NUM>. As the diameter of the channel <NUM> decreases, portions of the blades <NUM> can contact portions of the first fingers <NUM> and/or portions of the second fingers <NUM> that are within the channel <NUM>. Specifically, the blades <NUM> first contact the second portions 206b of the first fingers <NUM> because they are positioned radially farther from the central axis of the channel <NUM> than the second portions 208b (<FIG>) of the second fingers <NUM>. As the diameter of the channel <NUM> is further decreased, the blades <NUM> exert an inward force against the second fingers <NUM> that bends the fingers <NUM> radially inward and causes the fourth portions 206d of the first fingers <NUM> to disengage from the medical device <NUM>. The blades <NUM> do not contact the first fingers <NUM> until after contacting the second fingers <NUM> because the second portions 208b of the second fingers <NUM> are positioned radially closer to the central axis <NUM> of the channel <NUM> than the second portions 206b of the first fingers <NUM>. Therefore, after the first fingers <NUM> disengage from the medical device <NUM>, the third portions 208c of the second fingers <NUM> can still engage and support a portion of the medical device <NUM> (e.g., the apexes <NUM>). In some embodiments, the second fingers <NUM> can inhibit the medical device <NUM> from moving laterally (e.g., translation between the opposing plates <NUM>, <NUM>) while the medical device <NUM> is crimped. For example, the second fingers <NUM> can counteract the tendency of the medical device <NUM> to move laterally toward the entry side <NUM> of the crimping device <NUM> as a result of non-uniform compression of the medical device <NUM> caused by the funnel-like shape of the channel <NUM>.

In some embodiments, the diameter of the channel <NUM> can be decreased to a small enough diameter to disengage the holder <NUM> from the medical device <NUM> (e.g., disengage the first fingers <NUM>), but maintain a large diameter such that the fingers <NUM>, <NUM> positioned within the medical device <NUM> do not interfere with the crimping of the medical device <NUM>. For example, the holder <NUM> and the crimping device <NUM> can be configured such that the holder <NUM>: (i) holds (e.g., is engaged with and grips) the medical device <NUM> when the channel <NUM> of the crimping device <NUM> has a maximum diameter (e.g., the first position shown <FIG>), and (ii) is disengaged from the medical device <NUM> when the channel <NUM> of the crimping device <NUM> has a minimum diameter (e.g., the second position shown <FIG>). In some embodiments, the holder <NUM> can be removed from the crimping device <NUM> after the holder <NUM> disengages from the medical device <NUM>. In such embodiments, the diameter of the channel <NUM> can then be further decreased to further crimp the medical device <NUM>.

<FIG> is a top view of the tray <NUM> of the crimping and loading system <NUM> of <FIG> configured in accordance with embodiments the present technology. The tray <NUM> can be formed using a thermoforming process and/or other suitable tray forming processes. As shown, the interior walls of the tray <NUM> define the reservoir <NUM> for holding a liquid (e.g., chilled saline). The reservoir <NUM> can include a first portion <NUM>, a second portion <NUM>, and a third portion <NUM>. The first portion <NUM> can be sized and shaped to receive the crimping device <NUM> (<FIG>) with the entry side <NUM> or the exit side <NUM> facing down against a bottom surface of the tray <NUM> prior to use (e.g., during storage and/or shipping). The second portion <NUM> of the reservoir <NUM> is defined by the flanges <NUM> of the tray <NUM> and includes the recess <NUM> that is configured to retain the crimping device <NUM> (<FIG>) in a stable upright position during the crimping procedure. In some embodiments, the tray <NUM> includes a slot for introducing the liquid into the reservoir <NUM>. The slot can be configured to allow liquid to enter the reservoir <NUM> in a non-turbulent manner, which is expected to inhibit air bubbles from forming in portions of the tray <NUM> or the crimping device <NUM>. For example, in some mbodiments, the slot provides a liquid flow path into the first portion <NUM> of the reservoir <NUM>.

The third portion <NUM> of the reservoir <NUM> can be positioned at the exit side <NUM> of the crimping device <NUM> (e.g., as shown in <FIG>), and can provide a region in which the crimped medical device can be loaded into a delivery system (e.g., the delivery system of <FIG>). In some embodiments, the third portion <NUM> of the reservoir <NUM> can also provide an area to visualize the channel <NUM> of the crimping device <NUM> and/or portions of the delivery system positioned adjacent the crimping device <NUM> (<FIG>) during device loading. For example, the tray <NUM> can include slanted sidewalls (identified individually as a first slanted sidewall 317a and a second slanted sidewall 317b; referred to collectively as "slanted sidewalls <NUM>") on which one or more mirrors can be placed to provide alternate views of the crimping device <NUM> (<FIG>) and/or the delivery system. In some embodiments, the tray <NUM> has a generally flat lower surface in the third portion <NUM> with a mirror disposed on the lower surface to provide for visualization during device loading. The third portion <NUM> of the reservoir <NUM> can also be shaped to receive the stand <NUM> (<FIG>) so that that the stand <NUM> can be positioned in the third portion <NUM> prior to use (e.g., during storage and/or shipping). Accordingly, in some embodiments, each component of the system <NUM> (<FIG>) can be securely positioned within dedicated portions of the tray <NUM> for shipping and storage. The system <NUM> (<FIG>) can therefore be provided to a physician in a streamlined and sterile manner.

As further shown in <FIG>, the walls of the tray <NUM> further includes the aperture <NUM> for receiving a portion of a delivery system (e.g., the delivery system <NUM> of <FIG>) therethrough, and one or more grooves (identified individually as a first groove 319a and a second groove 319b; referred to collectively as "grooves <NUM>") positioned on either side the aperture <NUM>. The grooves <NUM> can be configured to receive a dam member (not pictured) for sealing the reservoir <NUM> and preventing liquid from escaping through the aperture <NUM>. In some embodiments, a portion of a suitable delivery system can puncture the dam members positioned within the grooves <NUM> in order to position the portion of the delivery system adjacent the crimping device <NUM> (<FIG>). In some embodiments, the tray <NUM> can include valve and/or sealing device that is positioned on a sidewall of the tray <NUM> (e.g., in the aperture <NUM> or other hole) and in fluid communication with the reservoir <NUM>. The valve and/or sealing device can fluidically seal liquid in the reservoir <NUM> before, during, and/or after a delivery system (e.g., the delivery system <NUM> of <FIG>) has been moved therethrough. For example, a valve (e.g., a cross-slit valve, a one-way check valve, etc.) can be housed within a grommet (e.g., a molded silicone grommet) that is positioned in the hole in the sidewall of the tray <NUM> to at least partially prevent liquid from leaking from the reservoir <NUM> when the delivery system is moved into and out of the valve member. In other embodiments, the tray <NUM> can include other configurations of valves and/or sealing devices to seal liquid within the reservoir <NUM>, while still allowing access to the reservoir <NUM> from a sidewall of the tray <NUM> for device loading or adjustment.

Although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.

Moreover, unless the word "or" is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of "or" in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list.

Claim 1:
A crimping device (<NUM>) comprising:
a stationary plate (<NUM>) having a plurality of first slots (<NUM>);
a movable member (<NUM>) having a plurality of second slots (<NUM>), wherein the individual second slots are aligned with a portion of the corresponding individual first slots;
a plurality of movable blades (<NUM>) arranged circumferentially to form a channel (<NUM>) having a central axis extending therethrough, wherein
each blade has a first end portion (141a) and a second end portion (141b), and wherein the second end portion is radially farther from the central axis than the first end portion,
each blade includes a pin (<NUM>) projecting from the second end portion of the blade, and
each pin extends through one of the first slots and a corresponding one of the second slots; and
an actuator device (<NUM>) operably coupled to the movable member and configured to move the movable member relative to the stationary plate, wherein movement of the movable member drives the plurality of pins along a path defined by the first and second slots such that the plurality of blades move radially inward to decrease a diameter of the channel, and wherein the radial inward movement of the blades is configured to reduce a diameter of a medical device positioned within the channel to accommodate sizing of a delivery capsule for implanting the medical device using a minimally invasive procedure.