Crimping devices for prosthetic heart valves

A crimping device includes a housing and a crimping band. The housing has a lumen for receiving a prosthetic valve. The crimping band is adjustably coupled to the housing and has a first end portion, a second end portion, and a loop. The loop of the crimping band is disposed within the lumen and move between first and second configurations. In the first configuration, the loop has a first diameter and is configured such that the prosthetic valve in a radially expanded configuration can be positioned radially within the loop. In the second configuration, the loop has a second diameter and is configured to apply a radial force on the prosthetic valve to move the prosthetic valve to a radially compressed configuration. The loop of the crimping band is configured to contact less than half of an axial length of the prosthetic valve.

FIELD

This disclosure relates generally to prosthetic heart valves, and more specifically to crimping devices for prosthetic heart valves.

BACKGROUND

The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient's vasculature (e.g., through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size. There are various types of expandable prosthetic heart valves, including balloon expandable, self-expandable, and mechanically expandable.

A mechanically expandable prosthetic heart valve can comprise a frame with a plurality of struts that are pivotably connected together. The pivotably-connected struts of the frame can be moved between a radially expanded configuration and a radially compressed configuration by actuating a mechanical actuator that is coupled to the frame.

Due to the unique configuration of mechanically expandable prosthetic heart valves, there is a need for devices and methods configured specifically for mechanically expandable prosthetic heart valves.

SUMMARY

Disclosed herein are devices and methods configured specifically for mechanically expandable prosthetic devices, including prosthetic heart valves and stents. In particular, this disclosure describes various devices and methods configured for crimping mechanically expandable prostheses. The disclosed crimping devices and methods can provide advantages over prior crimping devices and methods, as further described below.

In one representative embodiment, a crimping device comprises a housing and a crimping band. The housing has a lumen configured to receive a prosthetic heart valve. The crimping band is adjustably coupled to the housing and comprises a first end portion, a second end portion, and a loop. The loop of the crimping band is disposed within the lumen of the housing and can be moved between a first configuration and a second configuration. In the first configuration, the loop of the crimping band has a first diameter and is configured such that the prosthetic heart valve in a radially expanded configuration can be positioned radially within the loop. In the second configuration, the loop of the crimping band has a second diameter and is configured to apply a radial force on the prosthetic heart valve to move the prosthetic heart valve from the radially expanded configuration to a radially compressed configuration. The loop of the crimping band is configured to contact less than one half of an axial length of the prosthetic heart valve.

In some embodiments, the loop of the crimping band is configured to contact less than one fourth of the axial length of the prosthetic heart valve.

In some embodiments, the loop of the crimping band is configured to contact less than one eighth of the axial length of the prosthetic heart valve.

In some embodiments, the first end portion of the crimping band is fixed relative to the housing, and the second end portion of the crimping band is movable relative to the housing to move the loop of the crimping band between the first configuration and the second configuration.

In some embodiments, the first and second end portions of the crimping band are movable relative to the housing to move the loop of the crimping band between the first configuration and the second configuration.

In some embodiments, the housing comprises a band opening extending from the lumen of the housing to an outer surface of the housing, wherein in the band opening is configured such that the crimping band can extend therethrough.

In some embodiments, the band opening of the housing comprises an actuation portion and a locking portion. The crimping band can move relative to the housing when the crimping band is radially aligned with the actuation portion of the band opening, and the housing restricts relative movement between the crimping band and the housing when the crimping band is radially aligned with the locking portion of the band opening.

In some embodiments, the crimping device further comprises a locking mechanism coupled to the housing and configured to restrict relative movement between the crimping band and the housing.

In some embodiments, the locking mechanism is disposed adjacent to the band opening of the housing.

In some embodiments, the locking mechanism comprises a plurality of jaws, and the jaws are movable between on open configuration spaced from the crimping band and a closed configuration contacting the crimping band.

In some embodiments, the jaws comprise mating features configured to retain the jaws in the closed configuration.

In some embodiments, the mating features of the jaws comprise interlocking tabs that extend from the jaws.

In some embodiments, the crimping band comprises an indicator configured to signify to a user that the prosthetic heart valve is fully radially compressed.

In some embodiments, the crimping device further comprises one or more stopper elements extending outwardly from the crimping band, and the stopper elements are configured to restrict relative movement between the crimping band and the housing.

In some embodiments, the crimping band has only one loop.

In another representative embodiment, a crimping device for a mechanically expandable prosthetic heart valve comprises a housing and a crimping band. The housing comprises a base and a main body. The main body extends from the base and comprises a lumen configured to receive a mechanically expandable prosthetic heart valve. The main body further comprising a first opening and a second opening. The first opening and the second opening are spaced apart and extend from an inner surface of the main body that defines the lumen to an outer surface of the main body. The crimping band comprises a first end portion, a second end portion, and only a single loop disposed between the first and second end portions. The loop of the crimping band comprises a width that is less than an axial length of the mechanically expandable prosthetic heart valve.

In some embodiments, the crimping band is a flexible polymeric band.

In some embodiments, the crimping band is a flexible suture.

In some embodiments, the crimping band is a flexible wire.

In another representative embodiment, a method of crimping an implantable device is provided. The method comprises positioning the implantable device within an loop of a crimping band with the implantable device in a radially expanded state. The method further comprises tensioning the crimping band such that a diameter of the loop decreases, contacts a first portion of the implantable device, and moves the implantable device to a radially compressed configuration. The crimping band is configured to apply a radially compressive force to the implantable device when the crimping band is tensioned. The first portion of the implantable device comprises less than one half of an axial length of the implantable device.

In some embodiments, the method further comprises advancing a capsule of a delivery apparatus over a second portion of the implantable device while crimping band is tensioned. The second portion comprises less than one half of an axial length of the implantable device.

In some embodiments, the method further comprises slackening the crimping band and advancing the capsule of the delivery apparatus over the first portion of the implantable device and a third portion of the implantable device. The first portion, the second portion, and the third portion of the implantable device together comprise the axial length of the implantable device.

The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.

DETAILED DESCRIPTION

General Considerations

As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

EXEMPLARY EMBODIMENTS

Disclosed herein are devices and methods configured specifically for mechanically expandable prosthetic heart valves, though the disclosed devices and methods may in some instances be used with other types of prosthetic heart valves (e.g., balloon expandable and/or self-expandable prosthetic heart valves) or other prostheses (e.g., stents). In particular, this disclosure describes various devices and methods configured for radially compressing (“crimping”) mechanically expandable prosthetic heart valves.

The disclosed devices and methods are configured to take advantage of and/or utilize crimping behavior of certain valves, such as mechanically expandable prosthetic heart valves, which can uniformly collapse/crimp as a result of local crimping force applied to the prosthetic heart valve. In other words, the devices and methods disclosed herein can be particularly advantageous for crimping a prosthetic heart valve in which collapsing a section of the valve results in the collapsing of the entire prosthetic heart valve.

Accordingly, the disclosed crimping devices and methods can provide advantages over prior crimping devices and methods, particularly when used with mechanically expandable prosthetic heart valves. For example, the disclosed crimping devices are quick and easy to use. The disclosed crimping devices are also simple, safe, and less expensive to produce than typical crimping devices because they have relatively fewer moving parts/mechanisms. Additional features and advantages are described below.

FIG.1shows a crimping device100, according to one embodiment. The crimping device100can comprise two main components: a housing102and a crimping band104. In some embodiments, the crimping device100can also include a locking mechanism106. The housing102can be configured to support the crimping band104and/or the locking mechanism106. The crimping band104can form a loop108and can be moved relative to the housing102and the locking mechanism106to adjust the size of the loop108, in a lasso-like manner. The locking mechanism106can selectively secure the crimping band104relative to the housing102, and thereby secure the loop108at a desired configuration. As such, the crimping device100can, for example, be used to radially compress or crimp a mechanically expandable prosthetic heart valve from a radially expanded configuration (e.g., a functional configuration) to a radially compressed configuration (e.g., a delivery configuration), as shown inFIGS.5-12. Additional details regarding the crimping device100and methods of using the crimping device100to crimp a prosthetic heart valve are provided below.

Referring again toFIG.1, the housing102of the crimping device100can comprise a base110and a main body112. The base110of the housing102can be configured to support and/or stabilize the crimping device100. The main body112extend from the base110and can be configured to support the crimping band104and to receive a prosthetic heart valve.

The base110of the housing102can, in some instances, be configured to engage a table or bench. In some embodiments, the base110can comprise one or more mounting features configured such that the housing102can be mounted to a table. For example, the mounting features can include openings, slots, etc. configured to receive fasteners (e.g., bolts, screws, etc.), which can coupled the housing102to the table. In some embodiments, one or more surfaces of the base110can comprise friction elements (e.g., polymeric pads and/or coatings) configured to enhance frictional engagement between the base110and a surface on which the base110is disposed (e.g., a table).

The main body112of the housing102can comprise a lumen114configured to receive a prosthetic heart valve and/or a delivery apparatus (see, e.g.,FIG.6). The main body112can also comprise one or more openings configured for receiving the crimping band104. For example, in the illustrated embodiment, the main body112comprises a first opening116and a second opening118. The first and second openings116,118can extend from an outer surface120of the main body112to the inner surface122of the main body112, which defines the lumen114.

The first and second openings116,118in the main body112can be spaced circumferentially around the lumen114relative to each other. For example, in some embodiments, the first and second openings116,118are directly opposite each other relative to the main body112(e.g., 180 degree apart). In other embodiments, the first and second openings116,118can be spaced circumferentially relative to each other by about 90-180 degrees. In certain embodiments, the first and second openings116,118can be spaced circumferentially relative to each other by about 135-180 degrees.

Although not shown, in some embodiments, the main body112can also comprise a groove or recess formed in the inner surface122. The groove can be configured to at least partially receive the loop108of the crimping band104to selectively retain the loop of the crimping band104against the inner surface122of the main body112(e.g., when positioning a prosthetic heart valve within the lumen114).

In the illustrated embodiment, the outer surface120of the main body112comprises a generally U-shape such that the main body112comprises a generally annular shape. In other embodiments, the outer surface120of the main body112can comprise various other shapes (e.g., rectangular, triangular, etc.)

The housing102can be formed of various materials such as polymers, metals, composites, etc.

Referring toFIG.2, the crimping band104of the crimping device100can comprise a first end portion124and a second end portion126. As mentioned above, the crimping band104can be arranged to form the loop108between the first and second end portions124,126. In some instances, the crimping band104have only one loop. In other instances, the crimping band104can comprise a plurality of loops (e.g., 2-5). In some embodiments, the loop108can formed by coiling the crimping band104in a helical manner. In other embodiments, the loop108can be formed by tying a knot (e.g., an overhand knot) in the crimping band104.

Referring toFIG.1, the crimping band104can be coupled to the housing102such that the first end portion124of the crimping band104extends through the first opening116of the housing102, the loop108of the crimping band104is disposed within the lumen114of the housing102, and the second end portion126of the crimping band104extends through the second opening118of the housing102. The crimping band104can be tensioned or slackened to adjust the diameter of the loop108.

The crimping band104and the first and second openings116,118of the housing102can be configured such that the crimping band104can be moved relative to the first and second openings116,118of the housing102. As such, the diameter of the loop108of the crimping band104can be adjusted by tensioning or slackening the crimping band104. In some embodiments, both the first and second end portions124,126of the crimping band104can be moved relative to the housing102. In such embodiments, the crimping band104can be tensioned by moving both the first and second end portions124,126away from each other (e.g., by pulling on the end portions). In other embodiments, one end portion (e.g., the first end portion124) of the crimping band104can remain stationary relative to the housing102, and the other end portion (e.g., the second end portion126) of the crimping band104can be moved relative to the housing102, as shown in the illustrated embodiment. In such embodiments, the crimping band104can be tensioned by moving the free end of the crimping band away from the stationary end of the crimping band104.

The tension of the crimping band104can be adjusted manually and/or automatically. For example, in some embodiments, the crimping band104can be tensioned and/or slacked by manually tensioning/slackening the crimping band104by hand. In other embodiments, the crimping band104can be adjusted automatically, such as by coupling the crimping band104(and/or a spool) to an electric motor. In such embodiments, the crimping device100can further comprise one or more actuators (e.g., buttons, switches, etc.) configured to actuate the electric motor.

In some embodiments, an end portion of the crimping band104can be secured relative to the housing102. For example, an end portion of the crimping band104can be secured to the housing102with adhesive and/or fasteners. As another example, an end portion of the crimping band104can be integrally formed with (e.g., co-molded) with the housing102. As yet another example, the crimping band104can have a stopper element disposed thereon and/or coupled thereto configured to restrict movement between the crimping band104and the housing102. In the illustrated embodiment, the crimping band104has a stopper element128disposed on the first end portion124of the crimping band104. The stopper element128can be larger than the first opening116of the housing102so that the first end portion124of the crimping band104cannot “pull through” the first opening124when tension is applied to the crimping band104(e.g., when the second end portion126of the crimping band104is pulled away from the housing102.

In the illustrated embodiment, the stopper element128comprises a flange that is integrally formed with and extends radially outwardly from the main portion of the crimping band104. In other embodiments, the stopper element can be a knot that is formed in the crimping band104. In yet other embodiments, the stopper element can be a ferrule, cap, and/or other member that is coupled (e.g., clamped) to the end portion of the crimping band104.

In the illustrated embodiment, the crimping band104has a generally circular cross-sectional profile taken in a plane perpendicular a longitudinal axis of the crimping band104. In other embodiments, the crimping band104can have various other cross-sectional profiles (e.g., rectangular, ovular, etc.).

Referring toFIG.1, the locking mechanism106of the crimping device100can be coupled to the housing102. Turning toFIGS.3-4, the locking mechanism106can be moved between an unlocked configuration (FIG.3) and a locked configuration (FIG.4) to selectively restrict relative movement between the crimping band104and the locking mechanism106(and the housing102). As such, the locking mechanism106can be used to selectively retain the crimping band104in a desired configuration (e.g., a particular diameter and/or a tensioned/slackened state).

The locking mechanism106can comprise a pair of jaws130. The jaws130of the locking mechanism106can be pivotably coupled together such that the jaws130can be moved between an open state (e.g.,FIG.3) and a closed state (e.g.,FIG.4). In the open state, the jaws130of the locking mechanism106are spaced apart from the crimping band104such that the crimping band104can be moved relative to the jaws130and the housing102. Therefore, with the jaws130in the open state, the second end portion126of the crimping band104can be moved relative to the locking mechanism106and the housing102to adjust the diameter of the loop108of the crimping band104. In the closed state, the jaws130of the locking mechanism106engage the second end portion126of the crimping band104and thereby restrict relative movement between the crimping band104, the locking mechanism106, and the housing102such that the diameter of the loop108of the crimping band104is fixed.

In some embodiments, the jaws130of the locking mechanism106can have mating features132. The mating features132can be configured to engage one another so that the jaws can be releasably secured in the closed state, as shown inFIG.4. For example, the mating features132of the jaws130can include tabs that are configured to overlap and engage with one another (e.g., similar to the locking features of a hemostat).

In some embodiments, one or more of the jaws130of the locking mechanism106can comprise a recess configured to receive at a portion of the crimping band104. The recess can be configured to improve the frictional engagement between the jaws130and the crimping band104by increasing the surface area of the jaws that contacts the crimping band104. In certain embodiments, the recess can comprise a semi-circular cross-sectional profile taken in a plane perpendicular to the longitudinal axis of the crimping band104.

In lieu of or in addition to the recess, the jaws130of the locking mechanism106can comprise one or more friction increasing elements or coatings. For example, the jaws130can comprise projections (e.g., ribs) and/or texturing (e.g., non-smooth) configured to increase frictional engagement between the jaws130and the crimping band104. Additionally or alternatively, the jaws130can comprise a coating that increases frictional engagement between the jaws130and the crimping band104.

In the illustrated embodiment, the crimping device100comprises only one locking mechanism106, which is disposed adjacent to the second opening118of the housing102and configured to engage the second end portion126of the crimping band104. In other embodiments, the locking mechanism106can be disposed adjacent to the first opening116. In yet other embodiments, the crimping device100can comprise more than one (e.g., two) locking mechanisms. For example, the crimping device can comprise a locking mechanism disposed adjacent to each opening of the housing and configured to engage a respective end portion of the crimping band.

The crimping device100can be used, for example, to crimp a prosthetic heart valve from a radially expanded configuration to a radially compressed configuration. The prosthetic heart valve can be releasably coupled to a delivery apparatus configured for implanting the prosthetic heart valve. For example,FIGS.5-12depict the crimping device100being used with a delivery assembly200, which comprises a prosthetic heart valve202and a delivery apparatus204. The crimping device100can be used to radially compress the prosthetic heart valve202and to retain the prosthetic heart valve202in the radially compressed state while the prosthetic heart valve202is loaded into a capsule206of the delivery apparatus204. Additional details of an exemplary crimping procedure and the delivery assembly200are provided below.

Referring toFIG.5, the prosthetic heart valve202of the delivery assembly200can comprise a frame208and a valve structure (not shown for purposes of illustration). The frame208of the prosthetic heart valve202can have a plurality of struts that are pivotably coupled together. As such, the frame208of the prosthetic heart valve202can be moved between a radially expanded and axially foreshortened configuration (e.g.,FIG.5) and a radially compressed and axially elongate configuration (e.g.,FIG.7) by applying forces (e.g., radial and/or axial) to the prosthetic heart valve202. The prosthetic heart valve202may be referred to as a mechanically expandable prosthetic heart valve.

Since the struts of the frame of the prosthetic heart valve202can pivot relative to each other, the force needed to radially compress the prosthetic heart valve202(and/or other mechanically expandable prosthetic heart valves) is relatively less than the force required to radially compress typical self-expanding and balloon expandable prosthetic heart valves.

Although not shown, the prosthetic heart valve202can also comprise one or more mechanical actuators configured to apply forces to the frame208and/or to lock the frame208in a desired configuration. Additional details regarding exemplary mechanically expandable prosthetic valves can be found, for example, in U.S. Pat. No. 10,603,165, U.S. Publication Nos. 2018/0311039, 2018/0344456, and 2019/0060057, and International Publication No. WO 2020/081893, which are incorporated by reference herein.

Referring still toFIG.5, the delivery apparatus204of the delivery assembly200can comprise a first shaft210(which can also be referred to as “the outer shaft210”), a second shaft212(which can also be referred to as “the inner shaft212), and a nosecone214. The outer shaft210can comprise the capsule206(which can also be referred to as “a sheath”) disposed at the distal end portion of the outer shaft210and configured to receive and retain a radially compressed prosthetic heart valve therein. The inner shaft212can extend through the outer shaft210. The nosecone214can be coupled to a distal end portion of the inner shaft212. The inner and outer shafts210,212, can be moved relative to each other. Although not shown, the delivery apparatus204can comprise one or more other components, including one or more additional shafts configured for releasably coupling the prosthetic heart valve202to the delivery apparatus204and/or one or more handles coupled to the shafts210,212. Further details regarding delivery apparatus and coupling a prosthetic heart valve to a delivery apparatus can be found, for example, in U.S. Pat. No. 10,603,165 and U.S. Publication Nos. 2018/0311039 and 2019/0060057.

To prepare the delivery apparatus204to receive the prosthetic heart valve202, the inner shaft212of the delivery apparatus204can be positioned relative to the outer shaft210such that the nosecone214is disposed distal to the distal end of the capsule206, as shown inFIG.5. The prosthetic heart valve202can be positioned over the nosecone214and the inner shaft212such that the prosthetic heart valve202is axially disposed between the nosecone214and the distal end of the capsule206.

Although not shown, the prosthetic heart valve can be releasably coupled to the delivery apparatus. This can be accomplished, for example, by releasably coupling an actuation shaft of the delivery apparatus to one or more actuators of the prosthetic heart valve.

Referring toFIG.6, the delivery assembly200be positioned relative to the crimping device100such that the nosecone214and the distal end of the inner shaft212extend through the lumen114(FIG.5) of the crimping device100and the prosthetic heart valve202is disposed within the lumen114of the crimping device100.

As shown inFIG.6, the crimping device100can be configured such that the crimping band104axially overlaps and contacts only a portion of the axial length of the prosthetic heart valve202. As used herein, the axial length of the prosthetic heart valve is the length of the frame of the prosthetic heart valve as measured from the inflow end of the frame to the outflow end of the frame when the frame is in a fully expanded, functional configuration. In some embodiments, the crimping band104can axially overlap and contact less than one half of the axial length of the prosthetic heart valve202. In certain embodiments, the crimping band104can axially overlap and contact less than one fourth of the axial length of the prosthetic heart valve202. In particular embodiments, the crimping band104can axially and contact with less than one eighth of the axial length of the prosthetic heart valve202. This is significantly different than typical crimping devices, which have crimping elements (e.g., jaws) configured to axially overlap and contact the entire (or at least most of the) length of the prosthetic heart valve. The crimping band104of the crimping device100can be relatively narrow because the crimping device100is configured to take advantage of the low crimping forces needed to compress the mechanically expandable prosthetic heart valve202, and thus can compress the entire prosthetic heart valve by contacting only a relatively small portion of the prosthetic heart valve.

With the prosthetic heart valve disposed within the crimping device100, the prosthetic heart valve202can be radially compressed by tensioning the crimping band104, as shown inFIG.7. This can be accomplished by pulling the second end portion126of the crimping band104away from the housing102. As a result, the loop108of the crimping band104radially contracts and applies a radially compressive force to a portion of the frame208of the prosthetic heart valve202, which causes the struts of the frame208to pivot relative to each other, which causes the entire frame208to radially compress due to the pivoting connections between the struts of the frame208.

Also, due to the pivoting struts of the prosthetic heart valve202, the amount of force needed to compress the prosthetic heart valve202is relatively low. Accordingly, a user can supply the force necessary to radially compress the prosthetic heart valve202by simply grasping the second end portion126of the crimping band104with their hand and pulling the crimping band104away from the housing102(e.g., in the direction of arrow134). Thus, the crimping device100can be relatively simple and easy to use compared to typical crimping devices, which can require complex mechanisms and/or require the user to apply large forces to radially compress a prosthetic heart valve.

In some embodiments, the crimping device100can comprise one or more indicators configured to provide a user with information about or a status of the crimping of the prosthetic heart valve. An indicator can, for example, be configured to signify to a user that the prosthetic heart valve is fully radially compressed. As shown inFIG.7, the crimping band104comprises an indicator136. The indicator136can be markings, coloration, symbols, and/or any other type of visual indicia.

The indicator136can be positioned relative to the crimping band104such that the indicator136is disposed within the housing102(e.g., adjacent the inner surface122of the housing102) when the loop108of the crimping band104(and thus the prosthetic heart valve) is in the radially expanded configuration (e.g.,FIG.6) and such that the indicator136is disposed outside of the housing102(e.g., adjacent the locking mechanism106) when the loop108of the crimping band104(and thus the prosthetic heart valve) is in a pre-determined radially compressed configuration (e.g.,FIG.7). In this manner, the indicator136can inform the user that the prosthetic heart valve is fully crimped, which can in help prevent the prosthetic heart valve from being over crimped.

Additionally or alternatively, the crimping device100can comprise a stopper element (not shown) coupled to the crimping band. The stopper element can be configured to allow relative movement between the crimping band104and the housing102to a pre-determined point and to restrict relative movement between the crimping band104and the housing102beyond the pre-determined point. The stopper element can be radially larger than the second opening118of the housing102. As such, the stopper element can be disposed within the lumen114of the housing102when the loop108of the crimping band104is in radially expanded configuration (e.g.,FIG.6). As the crimping band104is tensioned and the loop108contracts, the stopper element can move toward the second opening118of the housing102. When the crimping band104reaches the pre-determined point, the stopper element can contact the inner surface122of the housing102adjacent to the second opening118and thereby prevent the crimping band104from moving further relative to the housing102. In some embodiments, the stopper element can be a knot or other radial projection that is an integral part of the crimping band. In other embodiments, the stopper element can a separate element (e.g., a ferrule or a cable stop) that is coupled to the crimping band104.

In lieu of or in addition to the indicator136and/or the stopper element, the crimping device100can further comprise a force control mechanism. The force control mechanism can be configured to limit and/or indicate the force applied to the crimping band104. For example, as shown inFIG.8, the crimping device100can comprise a spring load gauge138(which can also be referred to as “a spring scale”) coupled to the second end portion126of the crimping band104. The spring load gauge138can provide a readout of the amount of force applied to the crimping band104(e.g., in pounds and/or newtons). In other embodiments, a force control mechanism can take the form of a crimping band that is formed of an elastic material configured to elongate (i.e., elastically deform) once the force on the crimping band reaches a certain magnitude. In such embodiments, the user could pull on the crimping band104until the crimping band104begins to elongate, at which point the user would know the prosthetic heart valve was fully crimped and thus stop pulling on the crimping band104.

In embodiments comprising an electric motor configured to adjust the tension of the crimping band104, the crimping device100can comprise one or more force (e.g., torque) limiting mechanisms configured to limit the force that the crimping band can apply to a prosthetic heart valve. For example, the crimping device100can comprise a slip clutch and/or electronic circuitry configured to limit the electrical current to the motor.

Once the prosthetic heart valve is crimped to a desired radially compressed configuration, the locking mechanism can be used to retain the prosthetic heart valve202in the crimped configuration. The locking mechanism106can be actuated by moving the jaws130of the locking mechanism106into contact with the crimping band104, as shown inFIG.9. As such, the jaws130can restrict relative movement between the crimping band104and the housing102. This retains the loop108of the crimping band104in contact with the prosthetic heart valve202, and thereby retains the prosthetic heart valve202in the radially compressed configuration.

When in the radially compressed configuration, the prosthetic heart valve202can be loaded into the capsule206of the delivery apparatus204. This can be accomplished by moving the outer shaft210of the delivery apparatus204axially relative to the prosthetic heart valve202such that the capsule206extends radially over the proximal end portion of the prosthetic heart valve202, as shown inFIG.10. The outer shaft210can be moved axially relative to the prosthetic heart valve202until the distal end of the capsule206is disposed adjacent to the crimping band104.

Even though the capsule206is disposed over only a portion of the prosthetic heart valve202, the capsule206of the delivery apparatus204can then be used to retain the prosthetic heart valve202in the radially compressed configuration while the prosthetic heart valve202is released from the crimping device100. To release the prosthetic heart valve202, the locking mechanism106can be unlocked by opening the jaws130, and the crimping band104can be radially expanded so as to be radially spaced from the prosthetic heart valve202, as shown inFIG.11.

As shown inFIG.12, the capsule206of the delivery apparatus204can then be moved axially relative to the prosthetic heart valve202so that the capsule206extends over the entire prosthetic heart valve202. The shafts210,212can be moved relative to each other such that the nosecone214and the capsule206contact each other, and the delivery assembly200can be withdrawn from the lumen114of the crimping device100.

The delivery assembly200can then be inserted into a patient's vasculature, and the delivery apparatus204can be used to deliver the prosthetic heart valve202to a desired implantation location (e.g., a native aortic annulus).

FIGS.13-14show a crimping device300, according to another embodiment. Generally speaking, the crimping device300is similar to the crimping device100in that the crimping device300comprises a housing302and a crimping band304with an adjustable loop306that function similar to the housing102, the crimping band104, and the loop108of the crimping device100, respectively. The crimping device300differs from the crimping device100in several ways. For example, the crimping band304of the crimping device300is configured such that both end portions308of the crimping band304can be moved relative to the housing302; whereas, the crimping band104is configured such that only the second end portion126of the crimping band104can be moved relative to the housing102(e.g., during normal operation). The crimping band304also comprises a plurality of stopper elements310disposed along its length; whereas the crimping band104has a substantially uniform diameter along its length. Also, as shown inFIGS.15-17, the crimping device300comprises a locking mechanism that is integrally formed in the housing302; whereas the crimping device has a separate locking mechanism106that is coupled to the housing102. Additional details regarding the crimping device300and its components are provided below.

Referring toFIGS.13-14, the housing302of the crimping device300comprises a base312and a main body314. The main body314includes a lumen316configured such that a delivery assembly can be inserted therethrough (see, e.g.,FIGS.6-7). The main body314also includes band openings318extending from an interior surface320(which defines the lumen316) of the main body314to an exterior surface322of the main body314. The band openings318can be circumferentially spaced apart from each other and configured to receive the crimping band304.

It should be noted that the loop306of the crimping band304is shown as having a circular shape for purposes of illustration; however, when a prosthetic heart valve is not disposed within the loop306and the crimping band304is tensioned, the loop306would disappear (or become knotted) and the crimping band304would be substantially flat.

Turning now toFIG.15, each band opening318can comprise an actuation portion324, a locking portion326, and a connection portion328disposed between the actuation portion324and the locking portion326. The actuation portion324can be larger (e.g., radially) than the locking portion326and the connection portion328. In some embodiments, the locking portion326can be larger than the connection portion328. In other embodiments, the locking portion326and the connection portion328can be the same size.

As shown inFIG.16, the actuation portion324of the band opening318can be configured such that the stopper elements310of the crimping band304can pass therethrough. Thus, the crimping band304can be aligned with the actuation portions324of the band openings318when the crimping band304is being moved relative to the housing302.

As shown inFIG.17, the locking portion326and the connection portion328of the band opening318can be configured such that the main portion of the crimping band304(i.e., the portion(s) between the stopper elements310) can pass therethrough and such that the stopper elements310of the crimping band304cannot pass therethrough. Thus, once the crimping band is adjust relative to the housing302to a desired diameter by moving the crimping band304through the actuation portions324of the band openings318, the crimping band304can be moved from the actuation portions324of the band openings318, through the connection portions328of the band openings318, and into the locking portions326of the band openings318. In this “locked” configuration, the stopper elements310of the crimping band304can engage the exterior surface322of the housing302adjacent to the band openings318, and thereby restrict relative movement between the crimping band304and the housing302.

In some embodiments, the stopper elements can be evenly spaced relative to each other. In other embodiments, the stopper elements can be non-evenly spaced. For example, the stopper elements disposed towards the ends of the crimping band can be spaced further apart from adjacent stopper elements than the stopper elements that are disposed on the middle portion of the crimping band.

The stopper elements310of the crimping band304can extend radially outwardly from the main portion of the crimping band304. For example, in the illustrated embodiment, the stopper elements310have a frustoconical shape that extends radially outwardly from the crimping band304. In certain embodiments, as shown, the smaller radial portion of each stopper element can be disposed closer to an adjacent end portion than the larger radial portion. This configuration allows the crimping band304to move relatively more easily in one direction than the other. Specifically, the “directional” configuration allows the crimping band304can pass more easily through the band openings318when moving from the interior surface320to the exterior surface322of the housing302than when moving from the from the exterior surface322to the interior surface320of the housing302. In some instances, the stopper elements310can be configured such that the end portions308of the crimping band304can move away from the housing302when the crimping band304is aligned with the locking portions326of band openings318(e.g., when tensioning the crimping band) and such that the end portions308cannot move toward the housing302when the crimping band304is aligned with the locking portions326of band openings318(e.g., when slackening the crimping band). In other words, the diameter of the loop306of the crimping band304can be reduced but cannot be expanded when the stopper elements310are aligned with the locking portions326of the band openings318.

In other embodiments, the stopper elements can comprise various other shapes. For example, the stopper elements can comprise tabs or legs that project outwardly, such as in a T-shape or V-shape taken in a plane parallel to the longitudinal axis of the crimping band. In some such embodiments, the band openings can comprise a rectangular cross-sectional profile, which allows the stopper elements of the crimping band to pass through the band openings when the stopper elements of the crimping band are in a first orientation (e.g., vertical) that aligns the tabs with the major axis of the rectangular opening, and which restricts movement of the stopper elements of the crimping band relative to the housing when the stopper elements of the crimping band are in a second orientation (e.g., horizontal) that aligns the tabs with the minor axis of the rectangle such that the tabs contact the exterior surface of the housing. In this manner, the crimping band can be moved between the locked and unlocked states by rotating (e.g., twisting) the crimping band (e.g., by 90 degrees) relative to the housing.

The crimping device300can be used to crimp a mechanically expandable prosthetic heart valve (e.g., the prosthetic heart valve202). A radially expanded prosthetic heart valve and an end portion of a delivery apparatus can be inserted into the lumen316of the housing302when the loop306of the crimping band304is in the radially expanded configuration (e.g.,FIG.13). The diameter of the loop306of the crimping band304can then be reduced by aligning the end portions308of the crimping band304with the actuation portions324of the band openings318of the housing302(see, e.g.,FIG.16) and moving the end portions308of the crimping band304away from the housing302. This results in the loop306of the crimping band contacting the prosthetic heart valve and applying a radially inward force on the prosthetic heart valve.

The prosthetic heart valve can be retained in the radially compressed state by moving the crimping band304relative to the housing302from the actuation portions324of the band openings318, through the connection portions328of the band openings318, and into the locking portions326of the band openings318, as shown inFIG.17. As such, the stopper elements310of the crimping band304contact the exterior surface322of the housing302and thereby restricts relative movement (e.g., at least slackening) between the crimping band304and the housing302.

The prosthetic heart valve can be partially loaded into a capsule of a delivery apparatus. The capsule of the delivery apparatus can retain the prosthetic heart valve in the radially compressed configuration, and the crimping device300can be released from the prosthetic heart valve. To release the prosthetic heart valve, the crimping band304can be moved relative to the housing302so that the stopper elements310radially align with the actuation portions324of the band openings318. The crimping band304can be slackened such that the diameter of the loop306of the crimping band304increases. The prosthetic heart valve and the delivery apparatus can be retracted from within the loop306and the capsule of the delivery apparatus can be advanced over the rest of the prosthetic heart valve, or vice versa.

The crimping devices described herein are quick and simple to use and less expensive to produce compared to typical crimping devices that often have complicated mechanisms.

It should be noted that, although the disclosed crimping devices described as primarily for use with prosthetic heart valves, the disclosed crimping devices can also be used with other implantable devices (e.g., stents).

The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, one or more features of the crimping device100can be combined with the one or more features of the crimping device300. In particular, the crimping band304can be used with the crimping device100in lieu of the crimping band104.

In view of the many possible embodiments to which the principles of the disclosure may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.