Apparatus and methods for a prosthetic mitral valve holder

A holder for a prosthetic heart valve includes a base having an annular portion defining an aperture, and a spool rotatably mated with the base. The spool has a platform and a head extending in a longitudinal direction from the platform. The holder further includes a button housing having an aperture sized and shaped to receive the head of the spool, and a button inserted in the button housing. The button housing is detachably coupled to the spool in an assembled condition. The button is movable relative to the button housing to move the button housing from a condition locked to the spool to a condition removable from the spool.

FIELD OF THE INVENTION

The present invention relates to prosthetic heart valves, and more particularly to apparatus for use in holding such valves prior to and during implantation of the valve in a patient.

BACKGROUND

Prosthetic heart valves are used for replacing diseased and/or deficient valves in a patient's heart. For example, a patient's mitral and/or aortic valves may need to be replaced by such prostheses. One illustrative type of prosthetic heart valve includes animal tissue that has been treated to make it suitable for long-term use in a patient's body. Prior to implantation, such tissue valves may need to be stored in a liquid that preserves the tissue and keeps it flexible. During the implantation procedure, the prosthetic tissue valve is removed from the storage liquid, rinsed extensively to remove any vestige of that liquid, and then implanted in the patient, typically in an “open heart” surgical procedure. In addition, during the implantation procedure, it may be desirable to temporarily modify the shape of the prosthetic tissue valve in certain respects in order to facilitate getting the valve into place in the patient with good visualization and with good access for suturing the valve to native tissue of the patient. For example, this temporary shape modification may include deflecting free end portions of the commissure posts of the prosthetic tissue valve radially inward. This shape modification is preferably done just prior to the implantation procedure to avoid any part of the valve taking an undesirable “set” during prolonged deformation.

The above aspects of prosthetic tissue valve handling may be aided by associating the valve with a so-called holder. This association may include a suture connection between the valve and the holder. The holder can be used to hold the valve in its storage liquid. When it is desired to use (implant) the valve, a handle can be removably attached to the holder to remove the holder and valve from the storage liquid and to hold those components during the above-described rinsing. Upon rinsing and/or sterilizing the holder and the prosthetic heart valve assembly, it can be difficult to access many surfaces of the components of a fully assembled holder and valve when there is little to no space between the components to access and clean the interior surfaces of the assembly. Attachment of the handle to the holder (or subsequent manipulation of the handle relative to the holder) may also be used to cause the above-described temporary deformation of the valve. The handle may also be used to place the holder and valve in the patient. The handle may be removed from the holder during suturing of the valve into the patient; however, visibility of the prosthetic valve may be decreased while suturing the valve to the patient due to the bulky parts of the holder left behind. The holder may be decoupled from the prosthetic valve by cutting each individual suture attaching the holder to the prosthetic valve in different locations.

From the foregoing it will be seen that efficient, easy, and reliable handle and holder attaching and detaching as well as effective cleaning of the valve and holder are highly desirable. Improvements to this aspect (and related aspects) of prosthetic heart valve apparatus are therefore sought. Among other advantages, the present disclosure may address one or more of these needs.

BRIEF SUMMARY

According to a first aspect of the disclosure, a holder for a prosthetic heart valve includes a base, a spool, a button housing and a button. The base may have an annular portion defining an aperture. The spool may include a platform and a head extending in a longitudinal direction from the platform, and may be rotatably mated with the base. The button housing may have an aperture sized and shaped to receive the head of the spool, and may be detachably coupled to the spool in an assembled condition. The button may be inserted into the button housing. The button may have a button aperture sized and shaped to receive the head of the spool.

According to another aspect of the disclosure, a kit for a prosthetic heat valve assembly may include a prosthetic heart valve, a prosthetic heart valve holder, and a handle. The prosthetic heart valve may have a frame extending circumferentially about a longitudinal axis and surrounding a central opening, a plurality of leaflets disposed in the central opening and affixed to the frame, each adjacent pair of leaflets together defining a commissure, and a sewing cuff affixed to the frame and extending circumferentially about an exterior of the frame. The prosthetic heart valve holder may include a base, a spool, and a button housing. The base may have an annular portion defining an aperture. The spool may be rotatably connectable to the base, and may include a platform and a head extending from the platform. The button housing may have an aperture sized and shaped to receive the head of the spool, and may be detachably couplable to the spool. The handle may be connectable to the button housing of the prosthetic heart valve holder, and may be releasable from the prosthetic heart valve assembly in combination with the button housing.

According to another aspect of the disclosure, a method of implanting a prosthetic heart valve in a patient may include coupling a handle to a first portion of a prosthetic heart valve assembly by rotating the handle relative to the prosthetic heart valve assembly, the prosthetic heart valve assembly including a prosthetic heart valve and a holder coupled to the prosthetic heart valve by a plurality of sutures, the prosthetic heart valve having a frame, a plurality of leaflets joined to the frame, and a sewing cuff surrounding the frame, and the holder including the first portion of the prosthetic heart valve assembly that is releasable from a remainder of the prosthetic heart valve assembly; further rotating the handle relative to the prosthetic heart valve assembly to deflect the frame of the prosthetic heart valve; positioning the prosthetic heart valve in a native heart valve annulus of the patient; decoupling the handle and the first portion of the prosthetic heart valve assembly from the remainder of the prosthetic heart valve assembly; suturing the sewing cuff of the prosthetic heart valve to the native heart valve annulus; cutting the plurality of sutures at a single location to decouple the holder from the prosthetic heart valve; and removing the holder from the patient.

DETAILED DESCRIPTION

As used herein in connection with devices for delivering a prosthetic heart valve or other medical device into a patient, the terms “proximal” and “distal” are to be taken as relative to the user of the delivery devices (e.g., a surgeon). “Proximal” is to be understood as relatively close to the user, and “distal” is to be understood as relatively farther away from the user. Also as used herein, the terms “generally,” “substantially,” “approximately,” and “about” are intended to mean that slight deviations from absolute are included within the scope of the term so modified.

When used to indicate relative locations within the prosthetic heart valve, the terms “longitudinal” and “vertical” are to be taken as the direction of the axis extending between the inflow end and the outflow end of the stent of the heart valve, along the direction of intended blood flow; and the term “flow direction” is to be taken as the direction from the inflow end to the outflow end of the stent of the heart valve along the direction of intended blood flow. In the prosthetic heart valve and holder assembly described herein, the inflow end of the valve is the proximal end of the valve and the outflow end is the distal end of the valve when the valve is oriented for implantation. A handle of the valve holder, as described below, is positioned at the proximal end of the holder to be grasped by a user, and a base of the valve holder is positioned at the distal end of the holder when the holder is oriented for implantation. When used to indicate relative locations within the prosthetic heart valve assembly, the term “circumferential” is to be taken as the direction of rotation about the longitudinal axis of the heart valve frame.

As described herein, “prosthetic heart valve assembly” is used to refer to a prosthetic heart valve coupled to a prosthetic heart valve holder.FIG.1illustrates a prosthetic heart valve assembly100including valve holder105holding a prosthetic heart valve10. As shown, a handle180may represent a proximal end of prosthetic heart valve assembly100, the handle being configured to be grasped by a user (e.g., a surgeon), and prosthetic heart valve10may represent a distal end of the assembly. Prosthetic heart valve10is designed to replace a native valve of a patient, such as the pulmonary, mitral, tricuspid, or aortic valve. Prosthetic heart valve10may be implanted in a patient whose heart has been stopped, via a thoracotomy or open-heart surgery, for example. Prosthetic heart valve10may have a rigid frame (e.g., made of titanium or polymer) encapsulated by a cover20made, for example, from polyester fabric or tissue. A sewing cuff15at an inflow end of cover20may encapsulate a flexible ring (e.g., made of silicone) extending circumferentially about the exterior of the rigid frame in a closed curve shape (e.g., a circle). Alternatively, sewing cuff15may be replaced with a braided suture, for example, on a prosthetic aortic or mitral valve. Prosthetic heart valve10may have three leaflets22(e.g., made of bovine pericardial tissue or porcine cusps) that coapt in a central area of the prosthetic heart valve. Prosthetic heart valve10may be configured to be sewn into the native mitral annulus of the patient after removal of the patient's native mitral valve leaflets, with sewing cuff15positioned adjacent the native mitral annulus of the patient, and suturing may be used to stitch the sewing cuff to the native mitral annulus. The user may place the suturing circumferentially about sewing cuff15between the sewing cuff and the native mitral annulus, using a single or multiple continuous sutures, mattress sutures or a plurality of interrupted sutures. For example, three sutures may be used in an embodiment including multiple continuous sutures, each of the three sutures extending around part of the circumference of sewing cuff15.

The components of valve holder105are more clearly illustrated inFIG.2, and include a base110, a plug120, a suture holding component such as a spool130, a button housing140, a spring142and a button144. Valve holder105may be made of a rigid plastic material such as Ultem® or polysulfone, for example. It is contemplated that different components of valve holder105may be made of different materials.

Base110is shown inFIGS.2and3according to an embodiment of the disclosure. Base110includes annular portion112extending circumferentially about longitudinal axis X. An interior lip114extends radially inward from the distal end of annular portion (i.e., lower on the page) and defines an aperture111through base110. Interior lip114forms an annular platform for spool130to contact and rest on when the spool is coupled to base110. A plurality of interior ridges116are located circumferentially around the interior proximal end of annular portion112(i.e., higher on the page). Ridges116are sized and shaped to engage with spool130when the spool is coupled to base110. Ridges116may allow for rotation of spool130relative to base110about longitudinal axis X in a first direction (e.g., clockwise), while preventing rotation of the spool relative to the base in a second direction opposite the first direction (e.g., counterclockwise). Ridges116may be part of a ratcheting mechanism used to deflect stent posts of valve10medially, as described further below. Base110further includes a first leg118a, a second leg118band a third leg118ccoupled to annular portion112. Each leg118a-chas an upper leg portion119a,119b,119c, respectively, extending substantially parallel to longitudinal axis X, and a lower leg portion117a,117b,117c, respectively, extending radially outward and in a distal (i.e., downward) direction from the upper leg portion to a terminal end. The terminal ends of lower leg portions117a-cinclude downward facing surfaces121a,121b,121c(121cis not shown), respectively, lying in a plane perpendicular to longitudinal axis X such that each leg118a-cmay rest stably on a surface, particularly another flat surface perpendicular to the longitudinal axis (e.g., a table).

Each lower leg portion117a-cfurther includes a pair of apertures proximate to the terminal end for securing sutures to valve holder105, as is discussed further below. That is, first lower leg portion117aincludes suture anchors122a-1and122a-2, second lower leg portion117bincludes suture anchors122b-1and122b-2, and third lower leg portion117cincludes suture anchors122c-1and122c-2, as shown inFIGS.3and8. Further included on base110are tabs, each having an eyelet through which suture may be passed. For example, a first tab124amay be positioned at the intersection of upper leg portion119aand the exterior surface of annular portion112. Tab124aincludes an eyelet125amost clearly shown inFIG.8. A second tab124bpositioned at the intersection of upper leg portion119band the exterior surface of annular portion112includes an eyelet125b, and a third tab124cpositioned at the intersection of upper leg portion119cand the exterior surface of annular portion112includes an eyelet125c.

FIG.4illustrates spool130according to an embodiment of the disclosure, the spool being configured to mate at least with base110. Spool130includes a platform131surrounding longitudinal axis X and a head132protruding generally proximally from the center of the platform along the longitudinal axis. Head132tapers as the head extends proximally from platform131and may have a generally hexagonal transverse cross-section. Head132includes an enlarged recess in one side of the heading from its base to a position spaced from the proximal tip, forming an overhang132a, and the head defines an aperture127size and shaped to receive handle180, as will be discussed below in greater detail. An enlarged notch133in the perimeter of platform131provides an area that facilitates the cutting of sutures attaching valve10to valve holder105. A proximal face of platform131has a partial impression134located substantially on a first side of head132and extending approximately halfway around a perimeter of the head. Opposite impression134, platform131further includes a ramp135on its proximal face that extends from the base of head132in a radially outward and slightly distal (downward) direction, such that the surface of the ramp tapers relative to the surrounding platform face as the ramp extends outward. Impression134and ramp135, together with an aperture136centrally located in platform131, provide gaps and spaces between spool130and button housing140when valve holder105is in an assembled configuration. Gaps and spaces between components of valve holder105promote sterilization by allowing a chemical sterilant to penetrate a greater surface area of the valve holder. The gaps and spaces, such as aperture136, further limit or prevent the formation of air bubbles when, for example, valve holder105is submerged in a pool of liquid to be cleaned and/or sterilized.

A plurality of apertures and indentation and/or recesses may be provided in various locations on or near the perimeter of platform131for receiving sutures that may be used to secure valve holder105to prosthetic heart valve10. For example, the illustrated embodiment includes suture apertures138a,138band138c, as well as suture recesses139aand139b. Spool130may include additional apertures and/or recesses that are not visible inFIG.4, such as suture anchor151shown inFIG.8.

Spool130may further include a stability component such as rib137, as shown inFIGS.5A-5B. Rib137is an elongate protrusion extending from a side of head132. In the illustrated embodiment, rib137extends from the side of head132opposite the overhang formed by the proximal (upper) portion of the head, however, it is contemplated that the rib may extend from any side of the head. Rib137may protrude from head132generally in a radially outward direction, and the elongation of rib137may extend generally in the proximal-distal direction, however, any shape is contemplated for the rib. The addition of rib137may improve the stability of valve holder105when button housing140is assembled to spool130, as will be described in more detail below.

FIGS.7-8illustrate spool130, base110and plug120(not shown) coupled to one another in the assembled configuration, forming a base assembly108.FIG.8further illustrates the sutures that couple spool130and base110to prosthetic heart valve10in the assembled configuration. Valve holder105may include a plurality of sutures extending through and/or around spool130. In the embodiment illustrated inFIG.9, spool130includes a first length of suture152, a second length of suture154and a third length of suture156. Each length of suture152,154,156is coupled (e.g., tied) to suture anchor151located on platform131of spool130. Suture anchor151is illustrated as an aperture extending through platform131, however, the suture anchor may be any useful means for tying a suture to the platform, such as a protrusion having an eyelet. Each length of suture152,154,156extends from suture anchor151to second suture aperture138b, passing over notch133. Passing each length of suture152,154,156over notch133enables the user to cut all three sutures in one location and potentially with the use of a single cut.

Each length of suture152,154,156may extend in a different direction from second suture aperture138bto couple to different locations of base110and form a stable attachment. In the illustrated embodiment, first length of suture152may extend from second suture aperture138b, through eyelet125bin tab124band from there toward the terminal end of second leg118bto anchor to suture anchors122b-1,122b-2. First length of suture152may pass distally (downwardly) through a first suture anchor122b-1of second leg118band through a portion of prosthetic heart valve10, and then proximally (upwardly) through the portion of the prosthetic heart valve to couple to a second suture anchor122b-2, as shown inFIG.9.

Second length of suture154may extend from second suture aperture138bthrough first suture recess139aand from there to first suture aperture138a. After passing through first suture aperture138a, second length of suture154may extend through eyelet125ain tab124aand toward the terminal end of first leg118ato anchor to suture anchors122a-1,122a-2. Second length of suture154may couple to first leg118ain a substantially similar manner as first length of suture152. That is, the second length of suture may pass distally through a first suture anchor122a-1of first leg118aand through a portion of prosthetic heart valve10, and then proximally through the portion of the prosthetic heart valve to couple to a second suture anchor122a-2of the first leg.

Third length of suture156may extend distally through second suture aperture138b,and proximally through second suture aperture138a. Third length of suture156may then pass through second suture recess139band third suture aperture138c, through eyelet125cin tab124c, and then toward the terminal end of third leg118c. Third length of suture156may couple to leg118cin a substantially similar manner as first and second lengths of suture152,154couple to their respective legs. More particularly, the third length of suture may pass distally through a first suture anchor122c-1of third leg118cand through a portion of prosthetic heart valve10, and then proximally through the portion of the prosthetic heart valve to couple to a second suture anchor122c-2of the third leg.

FIG.10shows an enlarged view of button housing140according to an embodiment of the disclosure. Button housing140includes a receiver141, which is generally rectangular and configured to receive button144. Receiver141is at least partially enclosed on all sides except one, on which the receiver defines a slot143. Button144may be inserted into receiver141through slot143, as shown inFIG.11. Receiver141has a longitudinal aperture146extending along longitudinal axis X and located generally in the center of the receiver. Button housing140further includes a hollow stem145extending distally from receiver141along longitudinal axis X. Stem145defines a lumen which may be aligned with aperture146of receiver141. As shown inFIG.2, button144includes a frame162coupled to an actuator portion164. An aperture165substantially in the center of frame162may be hexagonal in shape, although any shape that corresponds to the apertures of other components of valve holder105is contemplated. Frame162includes a tab166extending from a position on the frame opposite actuator portion164. Tab166is configured to receive spring142when valve holder105is in an assembled configuration and button144is inserted into button housing140. That is, one side of spring142may abut frame162surrounding tab166, and the opposite side of the spring may abut the interior of button housing140when valve holder105is assembled. Spring142may be at least partially compressed in the assembled configuration, and therefore applying a biasing force upon button144in the direction out from slot143. The bias of spring142may cause aperture165of button144to be out of concentric alignment with aperture146of receiver141. When valve holder105is being assembled, button housing140may be positioned over spool130such that head132is inserted into aperture146of receiver141, and the taper of head132may push button144transversely so that the apertures become aligned, further compressing spring142. As button housing140is moved distally along head132, frame162of button144will distally pass overhang132aand reach the enlarged recess in the head, allowing spring142to push the button transversely beneath the overhang to lock the button housing to the head. In other words, the proximal face of frame162of button144may abut the distal face of overhang132a, thereby placing the button in a locked condition and preventing the decoupling of button housing140from spool130when the button is at rest in the assembled configuration.

When button housing140is coupled to spool130in the assembled configuration, rib137may engage with the button housing to promote the stability of valve holder105by reinforcing head132to counteract bending moments applied to the valve holder and prevent the button housing from slipping off and/or detaching from the head of the spool. For example,FIG.6illustrates valve holder105in a condition with a bending moment applied to button housing140relative to spool130. Rib137may assist in maintaining the coupling of button housing140to spool130in such a condition. The addition of rib137may improve the stability of valve holder105without increasing the size and/or radial thickness of head132of spool130around the entire perimeter of the head, allowing for the existence of various gaps and spaces within the valve holder to promote sterilization as described above.

FIG.12illustrates an enlarged view of plug120. Plug120has a base171and walls extending proximally from the base. A first pair of walls172aare connected to one another along a linear joint173a, with each wall extending from the linear joint at an angle transverse to the other wall. A second pair of walls172bare connected to one another along a linear joint (not shown, but substantially similar to linear joint173a), the second pair of walls forming a mirror image opposite the first pair of walls172a. Plug120further includes coupling components, such as latches174, which oppose each other and extend from base171between and on both sides of first and second pairs of walls172aand172b. Walls172a,172band latches174collectively define a substantially hexagonal interior space of plug120, the distal end of the space being closed by base171and the proximal end being open. Latches174have a lip which connects plug120to spool130such that the plug and the spool may be rotated together about longitudinal axis X relative to base110when valve holder105is in the assembled configuration.

Valve holder105may be used in combination with a handle such as handle180shown inFIG.13Aaccording to an embodiment of the disclosure. Handle180may be coupled to the assembled valve holder105to manipulate and/or position prosthetic heart valve assembly100and to modify the configuration of prosthetic heart valve10, e.g., deflect the stent posts of the valve medially (i.e., radially inward). Handle180includes an elongate proximal grip portion182, an elongate intermediate shaft portion184and a distal end portion186. Grip portion182may be made of plastic and may be shaped to facilitate comfortable and secure holding in one hand of the user. Shaft portion184may be made of metal, which may be malleable if it is desired to enable the user to bend the handle laterally if needed. Distal portion186includes a generally cylindrical body188and a threaded tip187having diameter smaller than the cylindrical body, as more clearly shown inFIG.13B. The smaller diameter of threaded tip187creates a surface at the end of body188coupled to the threaded tip that may mate with a corresponding surface of valve holder105when assembled thereto. A pair of opposing flat surfaces189on body188provide for an appropriately sized wrench or other instrument to engage distal portion186for tightening handle180to, or loosening the handle from, valve holder105.

In a process for assembling valve holder105and mounting it to prosthetic heart valve10, base110and spool130may be coupled to one another by positioning plug120in aperture111from one side of the base and coupling it to the spool on the other side of the base. As described above, plug120may be coupled to spool130such that they are fixed relative to one another, but may be rotated in unison relative to base110. Base assembly108(i.e., base110, spool130and plug120) may then be coupled to prosthetic heart valve10by the suturing process described above. An assembled button housing140(i.e., including button144and spring142positioned therein, as shown inFIG.11) may then be snapped in place on spool130by inserting head132of the spool into aperture146of receiver141pushing the components toward one another until frame162of button144is captured in the recess of the head as described more fully above. Head132may have a transverse shape (e.g., hexagonal or the like) corresponding to that of aperture165of button144and to that of aperture146of receiver141such that button housing140fits securely over spool130. The above-described assembly may then be inserted into a storage unit, such as a jar with a lid liner and a cap sealed to the jar, for safe and clean storage and transportation of prosthetic heart valve assembly100.

When prosthetic heart valve assembly100is ready for use, a user may open the jar and assemble handle180to the proximal end of valve holder105, as shown inFIG.1. Handle180may be coupled to valve holder105by rotating the handle in a clockwise direction about longitudinal axis X to threadedly engage the threaded distal tip187of distal end portion186with the corresponding threaded portion of button housing140located within the lumen of hollow stem145. Rotation may continue until the distal tip187of handle180reaches a distal end of the corresponding threaded portion in button housing140. Handle180may then be further rotated (e.g., further in the clockwise direction) to engage a ratcheting mechanism in which button housing140, spool130and plug120rotate relative to base110, wherein protrusions on the outer perimeter of spool130or plug120engage ridges116in the annular portion112of base110to prevent counter-rotation. Due to the positioning of lengths of suture152,154,156described above, rotation of spool130may tighten the sutures, causing them to deflect stent posts of valve10medially (e.g., radially inward) to promote ease of annulus seating for a user to suture sewing cuff15of prosthetic heart valve10to the native valve annulus. Prior to implanting prosthetic heart valve assembly100, additional sutures may be coupled at a first end to the patient's native annulus, and at a second end to sewing cuff15of prosthetic heart valve10, such that the valve assembly may travel along the sutures and parachute down into position within the native valve annulus, as shown, for example, inFIG.14. The user may grasp valve holder105anywhere along the assembly, particularly along handle180, to translate prosthetic heart valve assembly100along the sutures and manipulate the valve into the desired position within the native valve annulus.

Once prosthetic heart valve10is properly positioned in the native valve annulus, valve holder105may be removed, e.g., in steps or phases. The user may actuate (e.g., press) button144to an unlocked configuration by applying a force to actuator portion164of the button with a finger, a tool or the like. The force may be applied toward button housing140such that button144translates deeper into the button housing, overcoming the biasing force of spring142. At this position, aperture165of button144may align with the overhang132aportion of head132of spool130, which may allow button housing140and handle180to be decoupled and removed from the spool, leaving only base assembly108and prosthetic heart valve10in the native valve annulus. Removal of handle180and button housing140may improve the visibility of sewing cuff15and the native annulus for a surgeon, thus promoting the ease and effectiveness of securing sewing cuff15of valve10to the native annulus with sutures. When valve10has been sutured to the native valve annulus, first length of suture152, second length of suture154and third length of suture156may each be cut, either one at a time or simultaneously within the notch133of spool130. A single cutting region may promote the ease and efficiency of the procedure for removing base assembly108. Because each length of suture is coupled to valve holder105at both ends, cutting the lengths of suture will separate each length of suture into two strands, each strand having a first free end and a second end anchored to the valve holder. Therefore, after the sutures have been cut, lengths of suture152,154,156decouple and are removed from the valve as base assembly108is removed, leaving behind the implanted prosthetic heart valve.

To summarize the foregoing, the present disclosure describes a holder for a prosthetic heart valve including a base having an annular portion defining an aperture; a spool including a platform and a head extending in a longitudinal direction from the platform, the spool being rotatably mated with the base; a button housing having an aperture sized and shaped to receive the head of the spool, the button housing being detachably coupled to the spool in an assembled condition; and a button inserted into the button housing, the button having a button aperture sized and shaped to receive the head of the spool; and/orthe head of the spool may have a hexagonal transverse cross-section, and the button aperture may have a hexagonal shape corresponding to the transverse cross-section; and/orthe head of the spool may include an interference surface extending transverse to the longitudinal direction, and the button in a locked condition may contact the interference surface to secure the button housing to the spool; and/orthe button may be movable in a direction transverse to the longitudinal direction to an unlocked condition in which the button does not contact the interference surface; and/orthe button housing may be removable from the head of the spool in the unlocked condition; and/orthe button housing in the assembled condition may confront a face of the platform of the spool, and the face of the platform may include a partial impression forming a space between the spool and the button housing; and/orthe button housing in the assembled condition may confront a face of the platform of the spool, and the face of the platform may include a ramp forming an open space between the spool and the button housing; and/orthe ramp may have a thickness that decreases as the ramp extends radially outward from the head of the spool to an outer edge of the platform; and/orthe platform may have an aperture aligned in the longitudinal direction with the head of the spool; and/orthe platform may include a notch on an outer edge of the platform, and the holder may further include a plurality of suture lengths extending across the notch; and/orthe head of the spool may have an outer surface and a rib projecting radially outward from the outer surface; and/orthe rib may be oriented in the longitudinal direction; and/orthe button housing may include a hollow stem defining a lumen with a threaded surface on the interior of the hollow stem.

The present disclosure further describes a kit for a prosthetic heart valve assembly including a prosthetic heart valve having a frame extending circumferentially about a longitudinal axis and surrounding a central opening, a plurality of valve leaflets disposed in the central opening and affixed to the frame, each adjacent pair of the leaflets together defining a commissure, and a sewing cuff affixed to the frame and extending circumferentially about an exterior of the frame; a prosthetic heart valve holder including a base having an annular portion defining an aperture, a spool rotatably connectable to the base, the spool including a platform and a head extending from the platform, and a button housing having an aperture sized and shaped to receive the head of the spool, the button housing being detachably couplable to the spool; and a handle connectable to the button housing of the prosthetic heart valve holder, the handle being releasable from the prosthetic heart valve assembly in combination with the button housing; and/orthe handle may have a distal threaded tip and the button housing may have a threaded portion for threaded engagement with the distal threaded tip; and/orthe kit may further include three lengths of suture coupling the prosthetic heart valve to the prosthetic heart valve holder, the three lengths of suture extending together from a suture anchor on the platform across a notch in an outer edge of the platform to a suture aperture in the platform.

The present disclosure further describes a method of implanting a prosthetic heart valve in a patient including coupling a handle to a first portion of a prosthetic heart valve assembly by rotating the handle relative to the prosthetic heart valve assembly, the prosthetic heart valve assembly including a prosthetic heart valve and a holder coupled to the prosthetic heart valve by a plurality of sutures, the prosthetic heart valve having a frame, a plurality of leaflets joined to the frame, and a sewing cuff surrounding the frame, and the holder including the first portion of the prosthetic heart valve assembly that is releasable from a remainder of the prosthetic heart valve assembly; further rotating the handle relative to the prosthetic heart valve assembly to deflect the frame of the prosthetic heart valve; positioning the prosthetic heart valve in a native heart valve annulus of the patient; decoupling the handle and the first portion of the prosthetic heart valve assembly from the remainder of the prosthetic heart valve assembly; suturing the sewing cuff of the prosthetic heart valve to the native heart valve annulus; cutting the plurality of sutures at a single location to decouple the holder from the prosthetic heart valve; and removing the holder from the patient; and/orthe decoupling step may occur prior to the suturing step; and/orthe cutting step may include cutting the plurality of sutures with a single cut; and/orthe first portion of the prosthetic heart valve assembly may have a locked condition in which the first portion of the prosthetic heart valve assembly is not removable from the remainder of the prosthetic heart valve assembly and an unlocked condition in which the first portion of the prosthetic heart valve assembly is removable from the remainder of the prosthetic heart valve assembly, and the decoupling step may include actuating a button to move the first portion of the prosthetic heart valve assembly from the locked condition to the unlocked condition.