Patent Description:
<CIT> Bl discloses an apparatus for use with a prosthetic heart valve. The apparatus includes a holder, to which the heart valve is releasably attached, and an elongated handle. The handle can be connected to the holder simply by pushing a distal end of the handle straight into a recess in the holder. After this has been done, the handle can be rotated about its longitudinal axis to transmit torque to the holder. Rotation of such a rotatable portion of the holder can be used to deflect portions of the valve radially inward. The handle can be released from the holder at any time, and it can similarly be reconnected to the holder at any time.

Referring to <FIG>, the human heart is generally separated into four pumping chambers, which pump blood through the body. Each chamber is provided with its own one-way exit valve. The left atrium receives oxygenated blood from the lungs and advances the oxygenated blood to the left ventricle through the mitral (or bicuspid) valve. The left ventricle collects the oxygenated blood from the left atrium and pushes it through the aortic valve to the aorta, where the oxygenated blood is then distributed to the rest of the body. Deoxygenated blood from the body is then collected at the right atrium and advanced to the right ventricle through the tricuspid valve. The right ventricle then advances the deoxygenated blood through the pulmonary valve and the pulmonary arteries to the lungs to again supply the blood with oxygen.

Each of the valves associated with the chambers of the heart are one-way valves that have leaflets to control the directional flow of the blood through the heart and to prevent backflow of the blood into other chambers or blood vessels that are upstream of the particular chamber. For example, as described above, the mitral valve controls the flow of oxygenated blood from the left atrium to the left ventricle, while preventing blood flow back into the left atrium. The valves are each supported by an annulus having a dense fibrous ring attached either directly or indirectly to the atrial or ventricular muscle fibers. When a valve become diseased or damaged, leakage or regurgitation may occur, where some of the blood travels back upstream through the diseased or damaged valve, and the efficiency and/or general functionality of the heart may be compromised.

Various surgical techniques can be performed to repair or replace a diseased or damaged valve. In some valve replacement procedures, the leaflets of the diseased or damaged native valve are at least partially removed to prepare the valve annulus for receiving the prosthetic replacement valve. <FIG> shows an example of one type of popular prosthetic replacement valve <NUM> that is a tissue-type bioprosthetic valve generally constructed with natural-tissue valve leaflets <NUM>, made for example, from porcine tissue or bovine pericardium, or from synthetic or semisynthetic material, that are mounted on a surrounding valve stent structure <NUM>. The shape and structure of the leaflets <NUM> is supported by a number of commissure posts <NUM> positioned circumferentially around the valve stent structure <NUM>. In these valves, a biocompatible cloth-covered suture or sewing ring <NUM> can also be provided on an inflow end of the stent structure <NUM> of the valve <NUM>, to facilitate easier attachment to the native valve annulus. Such prosthetic valves function much like natural human heart valves, where the leaflets coapt against one another to effect the one-way flow of blood.

When implanting a tissue type prosthetic valve as described above at a native valve annulus, a number of sutures may be involved in the attachment process, many of which may be pre-installed for providing a track on which the valve is advanced to and properly positioned at the implant site. Additional sutures may also be applied between the prosthetic valve and the heart walls after proper placement, to securely attach or hold the valve implant in place. Meanwhile, in some cases, the prosthetic valves are implanted through small access channels using one of various minimally invasive surgical procedures, where visibility at the implant site may be impeded or obstructed. In addition, depending on the direction of implantation, for example, with some mitral valve replacement procedures, commissure posts of the stent or frame, or other portions, of the prosthetic valve may be pointed distally and advanced on a blind side of the valve, thereby obstructing visibility of the posts or other portions during advancement and implantation.

Each of the above factors may lead to tangling of the sutures with the valve prosthesis, most commonly with the commissure posts of the frame, since the commissure posts provide a protrusion on which the sutures can easily loop around and tangle. This type of entanglement of sutures with prosthetic valves is referred to as "suture looping," which specifically refers to instances where a suture is inadvertently wrapped around one or more of the commissure post tips, where it can then migrate towards and damage the leaflets or interfere with proper leaflet coaptation or other valve operation when the sutures are tightened or secured, resulting in improper valve operation. In some cases, such tangling may not be apparent to the practitioner at the time of implantation, and will only be revealed some time later when valve operation is observed to be improper or other complications arise in the patient, in which case, it may be necessary to initiate another procedure to repair or replace the prosthetic valve.

In addition, many existing bioprosthetic valves are not amenable to implantation through a minimal size incision, such as in thoracotomy procedures. Such procedures can require a surgical valve and its holder to fit through incisions of approximately <NUM>-<NUM> in its narrowest direction or dimension.

Attempts have been made to resolve the issue of suture looping, some of which involve holders, which hold the prosthetic valves during delivery of the valves to the native valve annulus. In one example, a holder has a mechanism that urges the commissure posts of the prosthetic valve radially inwardly during delivery, such that the ends of the commissure posts are pointed inwards, to reduce the possibility of sutures catching against or looping around the commissure posts. After the valve prosthesis is delivered to the implant site, the holder is removed thereby releasing and expanding the commissure posts to their original positions. However, such holders may not be amenable to minimally invasive surgical techniques as the holder and valve combination may have a high or large profile, for example with the entire holder system positioned outside the valve, or the holder may not pull in the commissures enough to reduce the valve profile.

Meanwhile, Edwards Lifesciences has developed a valve holder system that can be used in mitral valve replacement procedures to protect the valve from suture looping during valve implantation. The system includes monofilament sutures that attach to both the holder and the commissures of the prosthetic valve, so that the sutures run over the outflow end of the valve between the ends of the commissures. When the holder is actuated, a central post extends distally through the prosthetic valve between the leaflets and pushes against the sutures that run across the middle of the valve between the commissures, pushing the sutures distally and causing an angled tent-like or "umbrella" effect on the sutures. The pressure on the sutures deflects the commissures slightly inwardly, while also forming angled surfaces or tracks with the sutures that slope outwardly from the central post to the commissure posts. These angled surfaces deflect any other sutures that might otherwise be looped over a commissure or leaflet away from the prosthetic valve. However, this system may not be very amenable to a minimally invasive surgical approach. The system does not pull in the commissures enough to reduce the valve profile, and the central post of the holder adds to the overall height of the valve once deployed, hindering minimally invasive surgical procedures.

In addition to the above, many of the newer holder designs also incorporate many additional parts that must be assembled by the practitioner or other end user, which may also lead to additional complications. Some holders incorporate various mechanisms and line connections, such that a number of additional steps must be taken by the practitioner to operate the holders correctly. Many of these holders have proven to be too complicated and/or prone to user error. For example, some holders may allow valves to be implanted without requiring that its mechanism be activated or deployed prior to delivery, for example, holders that allow delivery without deploying its mechanism to urge the commissure posts radially inward prior to insertion. Consequently, when practitioners use these holders improperly, suture looping still commonly occurs, while the implant process may also be further complicated by issues arising from user error. Further, some holders may require the practitioner to manually adjust the tightening of the holder to the prosthetic valves. Tightening too little can make the holder ineffective to prevent suture looping, while over-tightening can risk breaking one or more sutures of the system or damaging the valve.

Accordingly, a new replacement valve holder includes built-in mistake-proofing to ensure the anti-suture looping mechanism is engaged. In some embodiments, the new replacement valve holder can be designed to enable surgeons to implant the valve through minimal incisions, such as in thoracotomy procedures.

In one example, to fit through a minimal size incision, such as through an about <NUM>-<NUM> incision, a valve and holder combination can be collapsible in at least one direction. However, such holders and valves may not include a mechanism to actively collapse the valve into the reduced size configuration for delivery. Accordingly, an introducer according to other embodiments of the invention can be used with collapsible surgical valves and/or holders to introduce them into narrow surgical incisions, such as thoracotomies.

Features of the present disclosure provide for new holder systems and methods of using the holder systems, which reduce or eliminate the occurrence of suture looping or other damage to the prosthetic valves during implantation, for example, for mitral valve replacement using minimally invasive procedures or other procedures. Operation of the holders is also simplified, whereby the valves are prevented from being implanted prior to deployment of the holders, for example, via a removable activator dial, thereby reducing or eliminating mistakes caused by user error. According to embodiments, the dial cannot be removed until the system is activated, and while in place, the activator prevents the valve from being implanted. In some embodiments, the holder includes a removable handle that cannot be connected to the system until the removable activator dial is removed. The holders also provide for integrated alignment features or other safety features, such that over-deployment or under-deployment of the holders is prevented.

According to embodiments of the invention, holders for prosthetic valve delivery reduce or eliminate occurrences of suture looping and/or other damage to the valves when the valves are implanted, while the mechanisms for deploying these features are integrated into the holders in a way that reduces or eliminates mistakes in use and deployment.

In some embodiments, a mitral valve holder and handle system is provided that uses a ratchet mechanism to pull in the commissures of the valve towards the center of the valve, thereby eliminating the risk of suture looping. The holder has mistake-proofing features that prevent the physician from implanting the valve without engaging the system. In some embodiments, by flattening the profile of the valve, the holder system can allow implantation of the valve through a small or minimal incision. According to some embodiments, an introducer is provided to aid in implanting replacement valves through a minimal size incision, for example, by aiding in collapsing or otherwise reducing the profile of the valve and/or valve holder. The introducer can be used, for example, with mitral and/or aortic surgical valves. In some embodiments, such an introducer can be relatively short and only long enough to pass the valve past a patient's ribs. In other embodiments, the introducer can be relatively long and, for example, act as an atrial retractor, forming a channel all the way to the implant site in the case of a mitral valve.

Further features and advantages of the invention will become apparent from the description of embodiments using the accompanying drawings. In the drawings:.

Disclosed herein are various tools, such as valve holders and introducers, for assisting in the delivery and implantation of prosthetic heart valves, such as mitral heart valves, at an implant site. Disclosed are also methods for preparing the prosthetic heart valves for such procedures. Embodiments of the valve holders reduce occurrences of various complications that may arise during implantation, while remaining simple for end users to use. By providing these improved valve holders, damage to the prosthetic valves during surgical procedures can be reduced, and additional costs for extended or additional procedures and/or replacement valves can be avoided.

The valve holders disclosed herein are particularly useful for avoiding suture looping and other valve damage during advancement of the prosthetic valves to the implant sites, as well as during final suturing of the valves at the native valve annulus. In many existing mitral valve replacement procedures, commissure posts of the prosthetic valve point distally away from practitioners, and in the direction of valve advancement and may be more prone to suture looping or other entangling. For such procedures, valve holders according to embodiments of the invention can urge the commissure posts radially inwards toward a center of the valve to reduce or eliminate suture looping. The presented embodiments can also include features that prevent valve implantation until the valve holders are in the activated or deployed positions. The holders can also include alignment features that prevent over-deployment or under-deployment. In this fashion, the holders provide ease of use while minimizing or reducing user errors.

The disclosed mitral valve holder and handle system is specifically designed to address shortcomings in previous valve holders. The disclosed system prevents clinicians from forgetting to deploy the system by means of a mistake-proof dial. The dial itself cannot be removed until the system is activated, and while the dial is in place, the dial prevents the valve from being implanted by: (<NUM>) physically making the system too bulky for implantation; (<NUM>) preventing the valve from being rotated or pivoted relative to the handle to a proper orientation for implantation; and (<NUM>) obstructing access to the sewing ring, thereby making placing sutures in the valve difficult.

<FIG> show views of a valve holder <NUM> according to a first embodiment. <FIG> shows an exploded perspective view of the valve holder <NUM>, <FIG> shows a perspective view of the valve holder <NUM> in an assembled state, and <FIG> shows a cross-sectional view of the valve holder <NUM> in the assembled state.

The valve holder <NUM> includes a body <NUM>, a rotor <NUM>, a swiveling delivery mount <NUM>, a delivery handle <NUM>, and an activator dial <NUM>. As described in more detail below, a prosthetic heart valve can be attached to the body <NUM>. The rotor <NUM> is positioned in a bore of the body <NUM> and is adjustable using the dial <NUM> to deploy or activate the valve holder <NUM> to adjust the prosthetic valve to a delivery position or configuration. The delivery mount <NUM>, coupled to the delivery handle <NUM>, is attached to the body <NUM> for delivering the valve to the implant site. The prosthetic valve can include a Nitinol wireform exhibiting a large amount of flexibility.

The body <NUM> of the valve holder <NUM> is shown in greater detail in <FIG> and <FIG>. The body <NUM> includes a generally circular-shaped central hub <NUM> with a plurality of arms <NUM> extending from the central hub <NUM>. The arms <NUM> serve as routing points for connecting commissure posts of the prosthetic valve to the valve holder <NUM> via sutures or other flexible material. In the embodiment shown, the body <NUM> includes three arms <NUM>, but can include more or fewer arms <NUM> in other embodiments depending on the prosthetic valve the valve holder is intended to hold. The number of arms <NUM> generally corresponds to the number of commissure posts on the prosthetic valve. When three arms <NUM> are included in the body <NUM>, the arms <NUM> can extend from the body <NUM> at approximately <NUM> degrees relative to each other.

Each of the arms <NUM> includes one or more through holes or bores <NUM> for routing the sutures. As will be described more fully below, the sutures are used to deploy or activate the valve holder <NUM> and place the valve in a delivery position where the commissure posts are urged radially inwards toward a center of the valve to reduce or eliminate suture looping. The through holes <NUM> extend transverse through the arms <NUM>. The through holes <NUM> route the sutures across the top of the arms <NUM> to a region below the arms <NUM> where the sutures can connect to tips of the commissure posts, for example, by passing the sutures over and/or through other portions of the valve. Multiple through holes <NUM> can be provided. Through holes 117a, closer to the central hub <NUM>, can be used to fasten or tie off an end of the sutures to the body <NUM>, and to facilitate easier release of the valve from the valve holder <NUM>. Through holes 117b, located nearer free ends of the arms <NUM>, are used to route and position the sutures for connection to the commissure posts. In one embodiment, the sutures are routed through the arms <NUM> as follows. An end of the suture is fastened to the through hole 117a of the arms <NUM>, for example, via a knot. The suture is then routed across a length of the arms <NUM> towards and through hole 117b. The free ends of the sutures are then in position to connect to the commissure posts of the valve. In other embodiments, a different number of through holes <NUM> can be provided, and in some embodiments, only one through hole <NUM> is provided on each arm <NUM>. In addition, a surface of the arms <NUM> includes a recess or slot <NUM>. The sutures extend across the recesses <NUM> when extended between holes 117a and 117b, such that there is a clearance underneath the sutures in the region of the recesses <NUM> to provide space for cutting the sutures. Cutting the sutures at the region of the recess <NUM> will release the valve from the valve holder <NUM>. If the valve is in the delivery position, cutting the sutures will also allow the commissures to spring back to a normal or unbiased geometry by releasing the commissure posts. Each of the sutures connected to the arms <NUM> are cut to release the valve.

In order to have a good angle between the commissures of the valve, the sutures, and the holder <NUM> for transmitting force to pull in the commissures, the sutures are routed from the tip of a commissure to the opposite cusp area of the body <NUM>.

In the body <NUM>, a bore <NUM> is provided with an abutting surface 116a for receiving the rotor <NUM> therein. The abutting surface 116a serves as a stop for the rotor <NUM>. The bore <NUM> extends into a bottom portion <NUM> of the body <NUM> that is circular-shaped and can have a smaller outer diameter than the central hub <NUM>, for example, to provide clearance for a connected prosthetic valve. A through hole or bore <NUM> is positioned in the bottom portion <NUM> for coupling the rotor <NUM> to the body <NUM>. The bottom portion <NUM> additionally includes through holes or bores <NUM> for routing the sutures from the tips of the commissure posts to inside of the bore <NUM> for attachment to the rotor <NUM>. The number of through holes <NUM> generally corresponds to the number of arms <NUM>. The through holes <NUM> can be co-linear with a direction of extension of the arms <NUM> and can be located along a periphery of the bottom portion <NUM>. The through holes <NUM> can be located opposite to the position of the arms <NUM>.

As shown in <FIG>, when the body <NUM> is connected to the delivery mount <NUM> and delivery handle <NUM>, one of the arms 114a is aligned with the handle <NUM>, for example co-linear with the handle <NUM>, and two of the arms 114b extend away from the handle <NUM>. In a region adjacent a base of the arm 114a, the central hub <NUM> includes upwardly extending projections <NUM>. The projections <NUM> have a profile that matches an inner profile of the handle <NUM>. On a side of the body <NUM> opposite to the arm 114a, a tab <NUM> is provided for connecting the delivery mount <NUM> to the body <NUM>. Meanwhile, the arms 114b can be shaped to provide clearance for the delivery mount <NUM> and the delivery handle <NUM>. Similarly, an outer surface of the central hub <NUM> in a region adjacent the arms 114b can also have cutouts or other surface features to provide clearance for the delivery mount <NUM> and the delivery handle <NUM>.

While the central hub <NUM> and the bottom portion <NUM> are depicted as generally circular portions in the described embodiment, these portions can have different cross-sectional shapes in other embodiments.

<FIG> shows a perspective view of the rotor <NUM> of the valve holder <NUM>, and <FIG> shows a cross-sectional view of the rotor <NUM> attached to the body <NUM>. The rotor <NUM> is configured to be positioned inside of the bore <NUM> of the body <NUM> and is rotatable with respect to the body <NUM>. The rotor <NUM> is connectable to the sutures for adjusting the prosthetic valve to the delivery position using the activator dial <NUM>, as described further below. The rotor <NUM> includes a central portion <NUM> with a longitudinal axis and a plurality of outwardly extending flexible arms <NUM>. The flexible arms <NUM> are resilient such that the arms can be deflected inwards towards the central portion <NUM> and then released, causing the arms <NUM> to spring back into a relaxed shape when no longer deflected.

The rotor <NUM> is configured to be received in the bore <NUM> of the body <NUM>. The rotor <NUM> includes a coupling mount <NUM> on the central portion <NUM> to rotatably couple to the hole <NUM> in the bottom portion <NUM> of the body <NUM>. When coupled, the connection between the coupling mount <NUM> and the hole <NUM> permits rotation, but restricts translational movement of the rotor <NUM> relative to the body <NUM>. The coupling mount <NUM> is depicted as a protrusion that extends to a position below the body <NUM>, and may be snap fit into hole <NUM>. The coupling mount in other embodiments can be designed in any number of different ways, so long as the connection permits rotation and restricts translation of the rotor <NUM> relative to the body <NUM>. In some embodiments, the rotor <NUM> may be a monolithic part. In other embodiments, the rotor <NUM> may include separate components to connect to the body <NUM>, such as snap rings, pins, and/or nuts or other fasteners. The separate components may be positioned inside the body <NUM>, for example, placed in a slot in the bottom portion <NUM> of the body <NUM> (not illustrated). The separate components may additionally or alternatively be positioned outside of the body <NUM>, for example, surrounding a portion of the coupling mount <NUM>. Meanwhile, in other embodiments, the coupling mount <NUM> can, for example, have the form of a hole, which rotatably connects to a protrusion in the bottom portion <NUM> of the body <NUM>. In other embodiments, the delivery mount <NUM> and/or the sutures secure the rotor within the body.

As shown in <FIG>, end portions of the arms <NUM> have an engagement portion <NUM> in the form of teeth or pawls to engage a corresponding engagement portion <NUM> of an inner surface of the central hub <NUM>, in the form of a plurality of notches or grooves. The teeth <NUM> of the rotor <NUM> engage the notches <NUM> of the body <NUM> to provide a one-way ratcheting mechanism that allows the rotor <NUM> to rotate in one direction relative to the body <NUM>. The teeth <NUM> can have an asymmetric shape, such as a triangular shape, and the notches <NUM> can have a corresponding asymmetric cut out, such as a triangular cut-out, that permits the rotor <NUM> to rotate in only one direction relative to the orientation in <FIG> (e.g., clockwise as illustrated), but that prevents the rotor <NUM> from moving in a counter or opposite direction (e.g., counter-clockwise as illustrated). When the rotor <NUM> is rotated, the teeth <NUM> slide along an angular surface of the notches <NUM> such that the flexible arms <NUM> are compressed inwards and the teeth <NUM> disengage from their currently engaged notches <NUM>. When the rotor <NUM> is rotated sufficiently that the teeth <NUM> approach subsequent notches <NUM>, the resilient flexible arms <NUM> spring back into their original shape and engage the subsequent notches <NUM>. Due to the shape of the teeth <NUM> and the notches <NUM>, the rotor <NUM> is prevented from rotating in an opposite direction and back into the previously engaged notches <NUM>. The one-way ratcheting mechanism provides ease of use and prevents misuse of the rotor during operation. Meanwhile, while the engagement portions <NUM>, <NUM> in the disclosed embodiments are depicted as having a triangular shape, the engagement portions <NUM>, <NUM> in other embodiments can be designed in any number of different ways, so long as the connections allow for one-way rotational movement or pivoting of the rotor <NUM> relative to the body <NUM>. Further, in some embodiments, the engagement portions of the arms <NUM> of the rotor <NUM> can have the form of notches or grooves and the engagement portions of the body <NUM> can have the form of teeth or pawls with a shape that corresponds to the engagement portions of the arms.

Further, the rotor <NUM> includes a central opening <NUM> for connection to the activator dial <NUM>, as described in more detail below. The rotor <NUM> additionally includes one or more holes <NUM> projecting through a sidewall of the rotor <NUM> and into the central opening <NUM>. The holes <NUM> provide attachment points for connecting end regions of the sutures to the rotor <NUM>. After the sutures are routed through holes <NUM> in the bottom portion <NUM> of the body <NUM> as described above, end portions of the sutures can be connected to the rotor <NUM> via the holes <NUM>. When the sutures are connected to the rotor <NUM>, rotation of the rotor <NUM> will create tension in the suture lines and further cause the sutures to be pulled in the direction of the moving rotor <NUM>. Because the sutures are connected to the commissure posts of the prosthetic valve, this pulling force activates or deploys the valve holder <NUM> to adjust the prosthetic value to a collapsed or delivery position by transferring the force onto the commissure posts of the prosthetic valve. The commissure posts are thereby radially urged inwards toward a center of the prosthetic valve.

<FIG> shows a perspective view of the activator dial <NUM> of the valve holder <NUM>. The dial <NUM> is used by an operator or user to rotate the rotor <NUM> and adjust the valve holder <NUM> to the deployed configuration. The activator dial <NUM> can be assembled with the valve holder <NUM> prior to use in a surgical procedure in an operating room. In one embodiment, for example, the activator dial <NUM> can be preassembled with the valve holder <NUM> during an assembly process by the manufacturer of the valve holder <NUM>. Such an assembly step prior to use in surgical procedures can be done in order to aid in proper usage of the valve holder <NUM> and reduce the risk of inadvertent user errors.

The dial <NUM> includes a central shaft <NUM> having a central axis, and an enlarged gripping portion <NUM> extending therefrom. The central shaft <NUM> is sized and configured to be received in the central opening <NUM> of the rotor <NUM>. The central shaft or stem <NUM> includes alignment keyways <NUM> in the shape of longitudinally extending slots or recesses for coupling to the rotor <NUM>. The rotor <NUM> includes corresponding alignment keys <NUM> in the shape of longitudinally extending protrusions positioned inside the central opening <NUM> to mate to alignment keys <NUM> of the activator dial <NUM>. The mating of the alignment features <NUM>, <NUM> enables the rotor <NUM> to rotate together with the dial <NUM> when the gripping portion <NUM> of the activator dial <NUM> is turned. In various embodiments, the dial <NUM> can be turned either manually (for example, by the hands of an operator) or automatically via a motor or other means. Meanwhile, while three mating alignment features <NUM>, <NUM> are respectively shown, the number of mating alignment features <NUM>, <NUM> can be different in various embodiments. In one embodiment, for example, a single mating alignment feature <NUM>, <NUM> can be used.

<FIG> show views of the delivery mount <NUM> and delivery handle <NUM> of the holder <NUM>. The delivery mount <NUM> and handle <NUM> are used to deliver the valve to the implant site and place the valve into a proper configuration for implantation. The delivery mount <NUM> is configured to be positioned on an upper surface of the body <NUM> (e.g., against central hub <NUM>) and has a generally circular shape that corresponds to the shape of the body <NUM>. On an outer edge of the delivery mount <NUM> opposite to the handle <NUM>, the delivery mount includes one or more tabs <NUM> configured to be aligned with tab <NUM> of the body <NUM>. The tabs <NUM>, <NUM> are used to connect the delivery mount <NUM> to the body <NUM> via a single suture or other connector. To connect the tabs <NUM>, <NUM> by a single suture, the tabs <NUM>, <NUM> can include aligned through holes or bores to route the suture. By using a single suture to connect the delivery mount <NUM> to the body <NUM>, the delivery mount <NUM> and handle <NUM> can be quickly and easily removed from the body <NUM>.

The delivery mount <NUM> and handle <NUM> are used to move the holder <NUM> between a first configuration for delivery to the implant site, and a second configuration for final implantation. In the first configuration, the handle <NUM> extends away from the body <NUM> in a direction opposite the tabs <NUM> (<FIG>), <NUM>, such that the holder <NUM> and coupled valve have a low profile for insertion into the body. For example, in this first configuration, the holder <NUM> and coupled valve can have a slim cross-sectional profile that allows the assembly to be inserted past a patient's ribs. In the second configuration, the delivery mount <NUM>, while coupled to the body <NUM>, is rotated or swiveled relative to the handle <NUM> such that the handle <NUM> extends away from the prosthetic valve, for example in a direction that is substantially coaxial or parallel to a central axis of the prosthetic valve. In this second configuration, the prosthetic valve is in a configuration to be implanted in a heart of a human body (see, e.g., <FIG> and <FIG>).

To rotate between the first and second configurations, the delivery mount <NUM> is rotatably coupled to the delivery handle <NUM> via fasteners <NUM> (<FIG>). The delivery mount <NUM> can rotate relative to the handle <NUM> along an axis that extends between the fasteners <NUM>. To swivel the delivery mount <NUM> relative to the handle <NUM>, the holder <NUM> includes a pivoting connector or clevis <NUM> connected to an upper surface of the delivery mount <NUM> on a side opposite to the handle <NUM>. The pivoting connector <NUM> is connected to one end of a flexible tension cable, and the other end of the flexible tension cable is connected to a slide or rotation mechanism located on a grip of the handle <NUM> (not shown). The rotation of the valve relative to the handle <NUM> can therefore be controlled with the slide located on the handle <NUM> grip. The slide or rotation mechanism may include a thumb wheel or a lever. The slide or rotation mechanism can be actuated to place tension onto the tension cable, thereby pulling or pushing the pivoting connector <NUM> and rotating the delivery mount <NUM> and the connected valve from the first configuration to the second configuration. Meanwhile, as shown in <FIG>, when the activator dial <NUM> is connected to the valve holder <NUM>, the dial <NUM> blocks the delivery mount <NUM> and handle <NUM> from entering into the second configuration. As such, the dial <NUM> acts as a stop that prevents the holder <NUM> from moving into the second configuration until the holder <NUM> has been deployed by the dial <NUM> to adjust the valve to the collapsed or delivery position and the dial <NUM> has been removed from the holder <NUM>. Safety of procedures using the holder <NUM> is thereby enhanced, helping to reduce or eliminate misuse of the holder <NUM> during operation.

The delivery mount <NUM> additionally includes two alignment keyways 136a, 136b for use with the dial <NUM>. The alignment keyways 136a, 136b provide ease of use and prevent misuse of the holder <NUM> during deployment. The alignment keyways 136a, 136b provide alignment for the activator dial <NUM> and act as stops that limit rotation of the dial <NUM> and the rotor <NUM> relative to body <NUM>. To accomplish this, the alignment keyways 136a, 136b are sized and configured to receive a key or protrusion <NUM> (<FIG>) of the activator dial <NUM> therethrough when the dial <NUM> is coupled to the rotor <NUM>. More specifically, the key <NUM> is positioned on the central shaft or stem <NUM> of the activator dial <NUM> to interact with the keyways 136a, 136b of the mount <NUM>. When positioning the central shaft <NUM> of the activator dial <NUM> in the central opening <NUM> of the rotor <NUM>, the key <NUM> must be placed in keyway 136a in order to fully seat the activator dial <NUM> and to allow the activator dial <NUM> to rotate. In use, the rotor <NUM> can only be rotated in one direction, for example, the clockwise direction, as described above.

As described above, the activator dial <NUM> can be preassembled with the valve holder <NUM> prior to use in surgical procedures. To accomplish this, the central shaft <NUM> of the dial <NUM> is inserted into the rotor <NUM> with key <NUM> of the dial <NUM> inserted into keyway 136a of the delivery mount <NUM>. The dial <NUM> and rotor <NUM> are then rotated relative to the body <NUM> such that teeth <NUM> and notches <NUM> become engaged, thus locking the dial <NUM> into the valve holder <NUM>. In this configuration, the dial <NUM> is preassembled with the valve holder <NUM> for later use in surgical procedures. Because the engagement of the teeth <NUM> and notches <NUM> provide a one-way ratcheting mechanism, the activator dial <NUM> cannot be rotated counter-clockwise to be removed from through keyway <NUM>. The engagement of the teeth <NUM> and notches <NUM> may be heard or felt by a "click" between the mating components as the rotor <NUM> is rotated. The teeth <NUM> and notches <NUM> can be identified as being engaged when the dial <NUM> and rotor <NUM> are rotated by at least one "click.

In use, the key <NUM> is inserted in keyway 136a, either before or during surgical procedures. Following insertion of the key <NUM> into keyway <NUM>, the dial <NUM> can be rotated clockwise, during surgical procedures, until the key <NUM> is lined up with keyway 136b, at which point no further rotation is possible and the dial <NUM> can be removed. The key <NUM> and keyway 136b do not align until the dial <NUM> is rotated to the point of fully engaging the system. At the position of keyway 136b, the activator dial <NUM> cannot be rotated counter-clockwise by virtue of the one-way ratcheting mechanism of the rotor <NUM> and body <NUM>. Further, when the key <NUM> is inserted in keyway 136a, the activator dial <NUM> also cannot be rotated in the counter-clockwise direction. Lastly, a portion of the delivery mount <NUM> between the keyways 136a, 136b can be slightly thickened to form an additional stop for the key <NUM> to prevent over-rotation of the dial <NUM>. Accordingly, the keyways 136a, 136b limit the amount of rotation of the activator dial <NUM> to less than one full turn.

The keyways 136a, 136b enhance the safety of the holder <NUM> by eliminating over-tightening or under-tightening of the valve. Safety of procedures using the holder <NUM> is enhanced because the keyways <NUM>, 136b can only be used in one way. Safety is also enhanced because the dial <NUM> can be preassembled with the holder <NUM> prior to use in surgical procedures. Meanwhile, once the dial <NUM> is assembled with the holder <NUM>, the activator dial <NUM> can only be removed from the holder <NUM> when the key <NUM> reaches keyway 136b, requiring adjustment of the holder <NUM> into the second configuration before the dial can be removed.

When the activator dial <NUM> is removed, the holder <NUM> can have a low profile for implantation through minimally invasive incisions. In one embodiment, the height of the holder with an attached valve is between about <NUM>-<NUM> when the holder <NUM> is in a deployed position and the commissures of the valve are pulled down and radially inward. In some embodiments, the valve and holder combination may have a height of less than or equal to about <NUM>, so that the assembly would easily fit between most patient's ribs without spreading the ribs. This can be important, as spreading the ribs can result in more painful recovery for the patient. By comparison, the height of typical valves when deployed is about <NUM> or greater, not including the holder. In addition, a pivot point of the holder <NUM> to adjust the holder <NUM> into the second configuration may be only between about <NUM> to <NUM> above an inflow edge of the valve. In one embodiment, the pivot point may be only about <NUM> above the inflow edge of the valve. Further, most of the ratchet mechanism of the holder <NUM> sits within the boundaries of the valve itself.

A length of the handle <NUM> may be selected or optimized for use in minimally invasive procedures, such as thoracotomy procedures. The handle <NUM> may be made out of a malleable material, such as aluminum or Nitinol.

<FIG> shows a perspective view of the valve holder <NUM> with the delivery mount <NUM> in the second configuration. A single suture can connect the body <NUM> to the delivery mount <NUM> and handle <NUM> via the tabs <NUM>, <NUM>. Once the valve is parachuted or otherwise advanced to the native valve annulus, the handle <NUM> can be removed after cutting this single suture, which quickly releases the body <NUM> from the mount <NUM> and handle <NUM>. The body <NUM> stays attached to the valve at this point, and the mechanism that pulls in the commissures remains activated.

<FIG> show steps of using the holder <NUM> according to one embodiment. <FIG> shows a side view of the holder <NUM> and a prosthetic replacement valve to be implanted. The valve has not yet been coupled to the holder <NUM> and the activator dial <NUM> is also uncoupled from the holder <NUM>. In this configuration, the valve can be attached to the holder <NUM> via three sutures that connect the commissure posts of the valve to the body <NUM> and the rotor <NUM>. As described above, one end of each of the sutures is connected to respective arms <NUM> of the body <NUM> and passed through respective ones of the commissure posts. Opposite ends of each of the sutures are routed through respective holes <NUM> of the body <NUM> and holes <NUM> in the rotor <NUM>. When initially connected, the holder <NUM> is in an undeployed state and the commissure posts of the valve are in an expanded or unbiased position, as shown in <FIG>.

In the state shown in <FIG>, the activator dial <NUM> is coupled to the holder <NUM> to adjust the configuration of the holder <NUM>. To couple the dial <NUM> to the holder <NUM>, the central shaft <NUM> of the activator dial <NUM> is placed inside the central opening <NUM> of the rotor <NUM> with key <NUM> of the dial <NUM> aligned and inserted through keyway 136a of the delivery mount <NUM>. Proper use of the dial <NUM> is facilitated by the keyways 136a, 136b which minimize or prevent misuse of the holder <NUM>. For example, the keyways 136a, 136b enable the dial <NUM> to be preassembled with the holder <NUM> prior to use in surgical procedures, as described above. In another example, should the dial <NUM> with the key <NUM> be aligned and inserted into keyway 136b, instead of keyway 136a, the activator dial <NUM> will not rotate due to the one-way ratcheting mechanism of the body <NUM> and the rotor <NUM>.

From the configuration shown in <FIG>, the activator dial <NUM> can then be rotated in the clockwise direction, for example, for almost one full rotation until the key <NUM> is aligned with keyway 136b. As the activator dial <NUM> is rotated, the holder <NUM> is moved into a deployed state whereby the commissure posts of the valve are pulled down and inwards towards the center of the holder <NUM>, as shown in <FIG>. In this state, the valve is ready for insertion into a body, but the activator dial <NUM> remains connected to the holder <NUM> and prevents insertion of the valve into a small or minimally invasive incision due to the dial's <NUM> large size. While the activator dial <NUM> is connected, the dial <NUM> also prevents the handle <NUM> from being rotated to move the holder <NUM> into the second configuration for final implantation.

From the configuration shown in <FIG>, the activator dial <NUM> can then be removed from the holder <NUM> when key <NUM> is aligned with keyway 136b. Once the activator dial <NUM> is removed, the low profile of the combined valve and holder <NUM> allow the assembly to be inserted into a patent and moved past a patient's ribs. Once past the patient's ribs, the slide or rotation mechanism on the handle <NUM> can be actuated to rotate or pivot the holder <NUM> from the first configuration to the second configuration.

<FIG> shows the holder <NUM> in the second configuration, with an outflow end of the valve facing away from the handle <NUM>. In this configuration, the assembly is in position and ready to be implanted at a native heart valve of a patient. In a later step during use of the holder <NUM>, the operator can remove the delivery mount <NUM> and handle <NUM> from the holder <NUM> by cutting or untying the suture that connects tabs <NUM> and <NUM>. In yet a later step during use of the holder <NUM>, the operator can remove the valve from the holder <NUM> by cutting or untying the three sutures that connect to commissure posts to the holder <NUM>. The three sutures may be cut in the region of the recesses <NUM> of the arms <NUM> of the body <NUM>.

<FIG> show views of a valve holder <NUM> according to another embodiment. <FIG> shows an exploded perspective view of the valve holder <NUM>, <FIG> shows a perspective view of the valve holder <NUM> in an assembled state, and <FIG> shows a cross-sectional view of the valve holder <NUM> in the assembled state. Similar to the first embodiment, the valve holder <NUM> of the second embodiment includes a body <NUM>, a rotor <NUM>, a delivery mount <NUM>, a delivery handle <NUM>, and an activator dial <NUM>. The valve holder <NUM> of the second embodiment differs from the valve holder of the first embodiment in the design of the body <NUM>, the delivery mount <NUM>, and also in the connection of the valve to the body <NUM>.

The body <NUM> of this embodiment does not include the arms <NUM> of the first body, which were used for suture routing. Instead, the body <NUM> is shaped as a round or circular member with a suture mount <NUM> located at a periphery of the body <NUM> on a side opposite to the handle <NUM>. The suture mount <NUM> is used as a single point to release the valve from the holder <NUM>. For example, in embodiments where three sutures are used to attach to the commissure posts on the prosthetic valve (see <FIG>), each of the sutures is routed through the suture mount <NUM>. Similar to the first embodiment, the rotor <NUM> can be rotated by the activator dial <NUM> to deploy the prosthetic valve and cause the commissure posts to be urged down and radially inwards toward a center of the prosthetic valve.

In addition, in one embodiment, a single suture line can be used to connect the prosthetic valve to the holder <NUM> to simplify release of the valve. In such an embodiment, one end of the suture is connected to the rotor <NUM> via one or more holes <NUM> that extend through a sidewall of the rotor <NUM> and into a central opening <NUM> of the rotor <NUM>. The suture is then routed from the hole <NUM>, through a first commissure post, and then over the suture mount <NUM> of the body <NUM>. The suture is then routed through a second commissure post and is again looped around the suture mount <NUM>. Finally, the suture is routed through a third commissure post and again back to the suture mount <NUM>, and is then tied off at the suture mount <NUM>. When finished, the single suture connects all three commissure posts to the suture mount <NUM> and also to the rotor <NUM>.

Meanwhile, the delivery mount <NUM> of the second embodiment differs from the first embodiment by the inclusion of a guard <NUM>. The guard <NUM> is located at a periphery of the delivery mount <NUM> at a side opposite to the handle <NUM>. The guard <NUM> is used to connect the delivery mount <NUM> to the body <NUM>. The body <NUM> includes two through holes <NUM> (<FIG>) that extend vertically through the body <NUM>. When the body <NUM> and delivery mount <NUM> are connected, the through holes <NUM> of the body <NUM> are adjacent to the guard <NUM>. A single suture can be used to connect the body <NUM> to the delivery mount <NUM> via holes <NUM> and the guard <NUM>. To that end, the guard <NUM> includes notches <NUM> for ease of routing the single suture. This suture can be cut or untied to quickly release the body <NUM> from the mount <NUM> and handle <NUM>.

Further, the guard <NUM> provides an additional safety feature against inadvertent or premature release of the valve from the holder <NUM>. When the delivery mount <NUM> is coupled to the holder <NUM>, the guard <NUM> is aligned with the suture mount <NUM> of the body <NUM>, and is positioned over an upper surface of the suture mount <NUM> to cover the suture mount <NUM>. The guard <NUM> blocks access to the suture connecting the valve to the holder <NUM>, to prevent or make difficult any inadvertent or unintended cutting or breaking of the suture that would cause the holder <NUM> to be released from the valve while the delivery mount <NUM> remains coupled to the holder <NUM>. Therefore, while the delivery mount <NUM> is connected to the body <NUM>, a connected valve is restricted from being prematurely or inadvertently removed. When the delivery mount <NUM> is removed, the suture mount <NUM> is revealed and the suture can then be cut or untied to release the valve.

Assembly of the holder <NUM> according to one embodiment is as follows. First, the rotor <NUM> is received in the body <NUM> similar to the first embodiment. Next, one or more sutures are used to connect the holder <NUM> to the prosthetic valve. One end of the one or more sutures is connected to the rotor <NUM>, and may be connected to a hole <NUM> extending through the sidewall of the rotor <NUM>, as described above. The other end of the one or more sutures is routed through the commissure posts of the valve and connected to the suture mount <NUM> of the body <NUM>. Next, the delivery mount <NUM> and handle <NUM> are coupled to the body <NUM>. The delivery mount <NUM> is connected to the body <NUM> on a side opposite to the valve. The delivery mount <NUM> is positioned such that fasteners <NUM> and portions <NUM>, <NUM> of the delivery mount <NUM> and handle <NUM>, respectively, are received in slots <NUM> in the body <NUM>. The delivery mount <NUM> is then coupled to the body <NUM> using one or more sutures via holes <NUM> in the body and the guard <NUM>. When all of the described features are assembled, the valve is in position to be deployed using the activator dial <NUM>, similarly as discussed with respect to the first embodiment. Additionally, once the activator dial <NUM> is removed, a slide or rotation mechanism on the handle <NUM> can be actuated to rotate the valve from a first configuration for insertion into a patient and into a second configuration for final implantation, also similarly as described with respect to the first embodiment. In other embodiments, the assembly sequence can be varied to achieve the same or similar assembled combinations.

<FIG> show views of a valve holder <NUM> according to an embodiment of the invention. <FIG> shows an exploded perspective view of the valve holder <NUM>, <FIG> shows a perspective view of an underside of a guide <NUM> of the valve holder <NUM>, <FIG> shows a perspective view of an activator dial <NUM> of the valve holder <NUM>, <FIG> shows a perspective view of the valve holder <NUM> in an assembled state, and <FIG> shows a cross-sectional view of the valve holder <NUM> in the assembled state.

The valve holder <NUM> of the embodiment of the invention allows the use of an inexpensive, reusable handle system, with a mitral valve holder that is activated or deployed to reduce or eliminate the occurrence of suture looping. As in the first and second embodiments, the valve holder <NUM> of the embodiment of the invention includes integrated alignment features or other safety features, such that over-deployment or under-deployment of the valve holder <NUM> is prevented or avoided. The valve holder <NUM> of the embodiment of the invention differs from the valve holders <NUM>, <NUM> of the first and second embodiments, for example, in that the embodiment of the invention removes the swiveling functions of the delivery mounts <NUM>, <NUM> and delivery handles <NUM>, <NUM> of the first and second embodiments. Instead, the valve holder <NUM> can be attached and implanted via an inexpensive, reusable handle. Thereby, the valve holder <NUM> of the embodiment of the invention can require fewer components than the first and second embodiments, a simpler assembly of the valve holder <NUM>, and may provide a lower cost system.

The valve holder <NUM> of the embodiment of the invention includes a body <NUM>, a rotor <NUM>, a guide <NUM>, a delivery latch <NUM>, and an activator or activator dial <NUM>. Similar to the first and second embodiments, a prosthetic heart valve can be attached to the body <NUM> of the valve holder <NUM> (see <FIG>, <FIG>, and <FIG>). The rotor <NUM> is positioned in a bore of the body <NUM> and is adjustable using the dial <NUM> to deploy or activate the valve holder <NUM> for adjusting the prosthetic valve to a delivery position, as in the first and second embodiments. In the delivery position, the commissure posts of the prosthetic valve are urged downward and radially inwards toward a center of the valve to reduce or eliminate suture looping. As described in further detail below, the valve holder <NUM> includes an alignment keyway <NUM> for limiting rotation of the dial <NUM> and the rotor <NUM> relative to the body <NUM>. This is to prevent over-deployment or under-deployment of the valve. The alignment keyway <NUM> is provided on a guide <NUM>, which is attached to the body <NUM>. Unlike the first and second embodiments, the embodiment of the invention does not include a swiveling delivery mount coupled to a delivery handle. Instead, the delivery latch <NUM> is attached to the body <NUM>, and is used to connect to a delivery handle <NUM> (see <FIG> and <FIG>).

The body <NUM> and rotor <NUM> can be the same components or similar components as the body <NUM> and rotor <NUM> of the second embodiment. In particular, the body <NUM> and rotor <NUM> can be attached to the prosthetic valve using the same suture routing as described above with respect to the first and second embodiments. That is, three sutures can be used to attach the valve holder <NUM> to the commissure posts on the prosthetic valve as described above, and in some embodiments, a single suture line can be used to connect the prosthetic valve to the holder <NUM>, also as described above. In addition, the body <NUM> includes a suture mount <NUM>, which is the same or similar to the suture mount <NUM> of the second embodiment, and can provide a single access point to release the valve from the holder.

Meanwhile, the body <NUM>, rotor <NUM>, and dial <NUM> include the one-way ratcheting mechanism of the first and second embodiments to move the holder <NUM> into the deployed state by pulling the commissures of the prosthetic valve down and radially inward towards the center of the valve, and the description thereof will not be repeated, As described above with respect to the first and second embodiments, a central shaft or stem <NUM> of the dial <NUM> can be inserted into and connected to the rotor <NUM>, such that turning the dial <NUM> rotates the rotor <NUM>. Also as described above with respect to the first and second embodiments, holes in the rotor <NUM> (e.g., in sidewalls of the rotor <NUM>) can provide attachment points for connecting and routing sutures. In some embodiments, the central shaft <NUM> is hollow and has an internal cavity (see <FIG>), for example, to provide clearance for the sutures connected to inside of the rotor <NUM>. The central shaft <NUM> can be inserted into the rotor <NUM> such that a bottom surface of the central shaft <NUM> is positioned adjacent or near a correspondence horizontal surface of the rotor <NUM>. In such embodiments, a lower portion of the central shaft <NUM> can include openings (e.g., notches) <NUM> to aid with suture routing (see <FIG>). The openings <NUM> can extend through the walls of the central shaft <NUM> and exposes the holes in the rotor <NUM> used to connect to the sutures.

Similar to the delivery mounts <NUM>, <NUM> of the first and second embodiments, the guide <NUM> provides ease of use and prevents misuse of the holder <NUM> during deployment. As shown in <FIG>, the guide <NUM> is positioned above the rotor <NUM> such that the dial <NUM> must pass through a central opening <NUM> of the guide <NUM> before the dial <NUM> can be connected to the rotor <NUM>. The guide <NUM> includes a keyway <NUM> and a wall <NUM>, which provide alignment for the activator dial <NUM> via a key or protrusion <NUM> on the central shaft <NUM> of the dial <NUM> (see <FIG> and <FIG>). The keyway <NUM> and the wall <NUM> of the guide <NUM> act as a stop that limits rotation of the dial <NUM> and the rotor <NUM> relative to body <NUM>.

As shown in <FIG>. , in some embodiments, the key <NUM> of the dial <NUM> may be positioned on a flexible arm <NUM> of the central shaft <NUM>. The flexible arm <NUM> may be spaced apart from the remainder of the central shaft <NUM> by gaps <NUM> on either side of the flexible arm <NUM> such that the flexible arm <NUM> is movable (e.g., bendable) relative to the remainder of the central shaft <NUM>. The flexible arm <NUM> may be bent inwards relative to the remainder of the central shaft <NUM> and towards a cavity <NUM> of the dial <NUM>. The flexible arm <NUM> may be resilient such that the flexible arm <NUM> may be bent by the application of a force and return to its original shape when the force is removed. The flexible arm <NUM> may be connected to an upper portion <NUM> of the dial <NUM>.

In some embodiments, the dial <NUM> may be used in conjunction with the guide <NUM> to place the valve holder <NUM> in a deployed configuration as follows. The central shaft <NUM> of the dial <NUM> may be inserted into the central opening <NUM> of the guide <NUM> in an orientation such that the key <NUM> of the dial <NUM> is aligned with (e.g., rotationally aligned with) a portion of the guide <NUM>. In some embodiments, the key <NUM> may be rotationally aligned with a marker <NUM> of the guide <NUM>. The key <NUM> of the dial <NUM> extends from dial <NUM> with a length that is greater than the diameter of the central opening <NUM> of the guide <NUM>. As such, upon insertion of the central shaft <NUM> into the guide <NUM>, a lower surface 337b of the key <NUM> will contact an upper surface <NUM> of the guide <NUM>. Due to the flexibility of the flexible arm <NUM> of the dial <NUM>, contact between the key <NUM> of the dial <NUM> and the upper surface <NUM> of the guide <NUM> causes the flexible arm <NUM> to bend inwards into the cavity <NUM> such that the key <NUM> may pass through the central opening of the guide <NUM>. The lower surface 337b of the key <NUM> has an oblique or slanted shape (e.g., via a chamfer or fillet) relative to the upper surface <NUM> of the guide <NUM> to facilitate inward bending of the flexible arm <NUM> (see <FIG>). Once the key <NUM> passes the central opening <NUM> of the guide <NUM>, the flexible arm <NUM> returns to its original (e.g., unbent) shape. An upper surface 337a of the key <NUM> has a flat shape that matches an underside surface <NUM> of the guide <NUM> to prevent or hinder the flexible arm <NUM> from bending once the key <NUM> passes the central opening <NUM> of the guide <NUM> (see <FIG>). This is to retain the dial <NUM> in the guide <NUM> and prevent inadvertent or unintended removal of the dial <NUM> before deployment of the valve holder <NUM> is complete.

Once the key <NUM> passes the central opening <NUM> of the guide <NUM> and the dial <NUM> is connected to the rotor <NUM>, the dial <NUM> may be rotated to cause the rotor <NUM> to rotate and deploy the valve, similarly described above with respect to the previous embodiments. The rotor <NUM> has a one-way ratcheting mechanism such that the dial <NUM> may only be rotated in one direction (e.g., clockwise relative to the orientation shown in <FIG> and <FIG>), and the dial <NUM> is prevented from being rotating in an opposite direction. The underside of the guide <NUM> has a channel or groove <NUM> to facilitate rotation of the dial <NUM> relative to guide <NUM>, which provides clearance for the key <NUM> of the dial <NUM> during rotation. The channel <NUM> has a shape that encompasses a partial circumference of the guide <NUM>. That is, the channel <NUM> has a circumference that is less than <NUM> degrees such that the activator dial <NUM> is restricted to less than one full rotation in use. The guide <NUM> additional has a wall <NUM> to prevent over-deployment or over-tightening of the valve. The wall <NUM> acts as a stop against the key <NUM> to limit further rotation of the dial <NUM> when the key <NUM> is rotated in the channel <NUM>. The wall <NUM> is adjacent the keyway <NUM> of the guide <NUM> such that when the dial <NUM> has been fully rotated in the channel <NUM>, the dial <NUM> may be removed by removing the key <NUM> upwards through the keyway <NUM>. The keyway <NUM> is sized to permit the key <NUM> of the dial <NUM> to fit therethrough. Upon removal of the dial <NUM>, the valve holder <NUM> is in the fully deployed configuration. In addition, the keyway <NUM> and the one-way ratcheting mechanism prevent under-deployment of the valve. The dial <NUM> is prevented or hindered from being removed from the guide <NUM> until the key <NUM> is aligned with the keyway <NUM>.

As shown in <FIG>, the guide <NUM> is positioned in a bore <NUM> of the body <NUM>, and is coaxial with a central axis of the body <NUM> and the rotor <NUM>. In some embodiments, the guide <NUM> is positioned in the body <NUM> such that an upper surface <NUM> of the guide <NUM> is flush with or recessed relative to an upper surface <NUM> of the body <NUM>. The guide <NUM> includes a generally circular-shaped central hub <NUM> with the central opening <NUM>, and a plurality of arms <NUM> extending from the central hub <NUM>. In some embodiments, the central hub <NUM> may have other shapes (e.g., triangular, square, rectangular, irregularly shaped, or otherwise shaped). As described above, the central opening <NUM> of the guide <NUM> is sized to permit the central shaft <NUM> of the activator dial to extend therethrough in order for the dial <NUM> to engage with the rotor <NUM> for deployment of the valve holder <NUM>. In some embodiments, the guide <NUM> may include the marker <NUM> for identifying a connection orientation of the guide <NUM> relative to the body <NUM>. The marker <NUM> may be aligned with one of the arms <NUM>.

The arms <NUM> of the guide <NUM> are used to connect the guide <NUM> to the body <NUM>. In the embodiment shown in <FIG>, the guide <NUM> includes three arms <NUM>, but can include more or fewer arms <NUM> in other embodiments. When three arms <NUM> are included in the guide <NUM>, the arms <NUM> can extend from the guide <NUM> at approximately <NUM> degrees relative to each other. The body <NUM> includes a plurality of openings or channels <NUM> to connect the guide <NUM> to the body <NUM>. The openings <NUM> of the body <NUM> can extend through the body <NUM> from the upper surface of the body <NUM> to a lower surface <NUM> of the body <NUM>. The arms <NUM> of the guide <NUM> contain connection elements <NUM> that are designed to connect to the body <NUM> when the arms <NUM> are inserted into the openings <NUM> of the body <NUM>. In some embodiments, the connection elements <NUM> of the guide <NUM> may include flat surfaces that mate with (e.g., abut) the lower surface <NUM> of the body <NUM>. The arms <NUM> of the guide <NUM> may be resilient. In some embodiments, the arms <NUM> may connect to the body <NUM> via a snap fit, press fit, or other connection. In some embodiments, the guide <NUM> may be connected to the body <NUM> via a threaded engagement, and/or via pins or other fasteners or connection types.

The delivery latch <NUM> is positioned on the guide <NUM>, as shown in <FIG>, and is coaxial with the central axis of the body <NUM>, the rotor <NUM>, and the guide <NUM>. In some embodiments, the delivery latch <NUM> is positioned on the upper surface <NUM> of the guide <NUM>.

The delivery latch <NUM> includes a central opening <NUM> that extends therethrough. The central opening <NUM> is designed to receive the dial <NUM>, which as described above, is used to deploy or activate the valve holder <NUM> to adjust the prosthetic valve to the delivery position. In particular, the delivery latch <NUM> enables the stem of <NUM> of the dial <NUM> to be inserted into the latch <NUM>, inserted into the guide <NUM>, and connected to the rotor <NUM> for deploying the valve holder <NUM>. When the dial <NUM> is removed from the latch <NUM>, the central opening <NUM> of the delivery latch <NUM> is designed to receive and connect to the delivery handle <NUM> for implantation of the prosthetic valve. However, while the dial <NUM> is positioned inside the delivery latch <NUM>, the dial <NUM> prevents the handle <NUM> from being inserted into delivery latch <NUM>. Thereby, the dial <NUM> acts as a feature that prevents implantation until the dial <NUM> has been removed from the valve holder <NUM>. Safety of procedures using the valve holder <NUM> are thereby enhanced, helping to reduce or eliminate misuse of the holder <NUM> during operation.

The central opening <NUM> of the delivery latch <NUM> is sized to permit the stem <NUM> and key <NUM> of the dial <NUM> to be inserted into the opening <NUM> and pass through the latch <NUM>, so that the stem <NUM> engages the ratchet mechanism of the body <NUM> and rotor <NUM>, and so that the key <NUM> of the dial <NUM> engages the guide <NUM> as described above. In some embodiments, the central opening <NUM> includes a generally circular cross section. In some embodiments, the central opening <NUM> includes a generally circular cross section with a notch <NUM> for guiding the key <NUM> of the dial <NUM> through the delivery latch <NUM> at a particular rotational orientation, as shown in <FIG>, <FIG>, and <FIG>.

The central opening <NUM> of the delivery latch <NUM> includes an engagement portion <NUM> to mate with a corresponding engagement feature <NUM> of the handle <NUM>. The handle <NUM> is configured to be inserted into the central opening <NUM> of the latch <NUM> and removably coupled to the latch <NUM> for implantation. In some embodiments, the engagement portion <NUM> of the latch <NUM> and the engagement feature <NUM> of the handle <NUM> include mating threads 334a, 338a. In such an embodiment, the opening <NUM> of the latch <NUM> can include a non-threaded lead-in portion <NUM> located adjacent the threads 334a. When the handle <NUM> is inserted into the central opening <NUM> of the latch <NUM>, the threads 338a of the handle <NUM> may first reach the non-threaded portion <NUM> of the latch <NUM> before reaching the threads 334a of the latch <NUM>. The non-threaded portion <NUM> helps prevent potential cross threading and particle generation by ensuring axial alignment of the threads 338a of the handle <NUM> and threads 334a of the latch <NUM>. The threads 338a of the handle <NUM> are provided on an end or tip of the handle <NUM>. In some embodiments, the threads 338a are made of a single piece and are crimped onto a nitinol shaft of the handle <NUM>.

In some embodiments, an inner diameter between the threads 334a in the central opening <NUM> is sized such that the stem <NUM> and key <NUM> of the dial can pass therethrough. In embodiments containing the notch <NUM> in the central opening <NUM>, the notch <NUM> can extend through the threads 334a of the latch <NUM> for guiding the key <NUM> of the dial <NUM> through the delivery latch <NUM>. In such embodiments, the inner diameter between the threads 334a in the central opening <NUM> may be sized such that only the stem <NUM> of the dial <NUM> can pass through the threads, but not the key <NUM> (i.e., the key <NUM> fits through the notch <NUM> instead of the inner diameter between the threads 334a). This allows for a diameter of the stem <NUM> of the dial <NUM> to be smaller and the threads 338a of the handle <NUM> to be smaller. In some embodiments, the mating threads 334a, 338a have, for example, from a #<NUM>-<NUM> thread to a <NUM>/<NUM>"-<NUM> thread, or an M4 × <NUM> thread to an M12 × <NUM> thread.

Meanwhile, the delivery latch <NUM> includes a guard <NUM> that is the same or similar to the guard <NUM> of the delivery mount <NUM> of the second embodiment. The guard <NUM> is located at a periphery of the delivery latch <NUM>. Opposite to the guard are protrusions <NUM> for engaging horizontal openings <NUM> on the body <NUM>. The guard <NUM> and protrusions <NUM> are used to connect the delivery latch <NUM> to the body <NUM>. The guard <NUM> allows a single suture to connect the delivery latch <NUM> to the body <NUM>, as described above for the delivery mount <NUM>. Further, the guard <NUM> provides an additional safety feature against inadvertent or premature release of the valve from the holder <NUM>. When the delivery latch <NUM> is coupled to the holder <NUM>, the guard <NUM> is aligned with the suture mount <NUM> of the body <NUM>, and is positioned over and covers the suture mount <NUM>, thereby preventing or reducing inadvertent or unintended cutting or breaking of the sutures connecting the holder <NUM> to the valve. When the delivery latch <NUM> is removed, the suture mount <NUM> is revealed and the suture or sutures connecting the valve holder <NUM> to the valve can then be cut or untied to release the valve.

Assembly of the holder <NUM> according to some embodiments is as follows. First, the rotor <NUM> is received in the body <NUM> similar to the second embodiment. Next, the guide <NUM> is coupled to the body <NUM> in position over the rotor <NUM>. In particular, the arms <NUM> of the guide <NUM> are inserted into the openings <NUM> of the body <NUM>. Next, one or more sutures are used to connect the holder <NUM> to the prosthetic valve, as described above with respect to the second embodiment. In some embodiments, the holder <NUM> may be connected to the prosthetic valve before the guide <NUM> is coupled to the body <NUM>. Next the delivery latch <NUM> is coupled to the body <NUM> in position over the guide <NUM>. The delivery latch <NUM> is coupled to the body <NUM> using one or more sutures, the guard <NUM>, and the protrusions <NUM>. When all of the described features are assembled, the valve holder <NUM> is in position to be deployed using the activator dial <NUM>, similarly as discussed with respect to the first and second embodiments. In particular, the activator dial <NUM> is inserted into the central opening <NUM> of the latch <NUM>, passed through the latch <NUM> and the guide <NUM>, and connected to the rotor <NUM>. The activator dial <NUM> is rotated to deploy the valve holder <NUM>, and is then removed from the holder <NUM>. Once the activator dial <NUM> is removed, the handle <NUM> can be inserted into and connected to the latch <NUM> for insertion and implantation of the attached valve into a patient. In other embodiments, the assembly sequence can be varied to achieve the same or similar assembled combinations.

Meanwhile, various different features from the different embodiments discussed above can also be combined into a single modified valve holder. In addition, various other modifications or alternative configurations can also be made to the valve holder according to the above described embodiments.

The presented embodiments also include an introducer which aids in delivering valve holders in minimally invasive surgical procedures. The introducer can be used with collapsible surgical valves to introduce the valves into a narrow surgical incision, such as a thoracotomy. The introducer can be used, for example, for delivering a prosthetic mitral valve to the mitral position. The introducer has a funnel-like shape for passing a collapsible heart valve from outside the body to inside the body through a narrow opening, such as the space between two ribs. In thoracotomy procedures, an incision is introduced into the chest cavity through the chest wall. In intercostal approaches, the incision is made between adjacent ribs to minimize cuts through bone, nerves, and muscle. In a typical thoracotomy procedure, the distance between the ribs, without spreading the ribs, is from about <NUM> to about <NUM>. Parallel to the ribs, the incision can be longer as needed, for example, approximately <NUM> or greater. Collapsible valve holders can have a small size that is particularly suited to fit in the small gap between the ribs in thoracotomy procedures.

<FIG> show views of an introducer <NUM> for introducing a valve and holder into a human body according to another embodiment. The introducer <NUM> provides a simple alternative approach for implanting collapsible heart valves connected to flexible holders through a minimal size incision, such as in a thoracotomy procedure. Due to the small gap between human ribs, the introducer <NUM> is used as an aid for inserting valves mounted on alternative flexible holders past the ribs and into the chest cavity during a thoracotomy or other minimally invasive procedures.

The introducer <NUM> has a hollow, funnel-like shape for receiving flexible holders with mounted valves, with a central axis of the valves pointed in a direction of insertion, for example, with an outflow end of the valve pointed or directed towards the introducer <NUM>. The introducer <NUM> has a first, proximal end <NUM>, and a second, distal end <NUM>. The distal end <NUM> of the introducer faces towards the incision, while the proximal end <NUM> faces away from the incision and towards the operator of the holder. The proximal end <NUM> has a circular cross-sectional shape corresponding to the circular shape of the prosthetic heart valves. In use, the proximal end <NUM> is located outside of the incision. In one embodiment, the cross-section of the proximal end <NUM> is <NUM> in diameter. The distal end <NUM> has an oval cross-sectional shape corresponding to a size and shape of a surgical opening between ribs in a thoracotomy procedure. In one embodiment, the major diameter of the cross section of the distal end <NUM> is about <NUM> in diameter and the minor diameter of the cross section is from about <NUM> to about <NUM> in diameter. Between the proximal and distal ends <NUM>, <NUM>, the introducer <NUM> includes a smooth transition zone or region <NUM> connecting the ends <NUM>, <NUM>. The transition region <NUM> may have a smooth, continuous inner profile between the ends <NUM>, <NUM>, which is substantially free from corners.

The introducer <NUM> can be made very inexpensively as a disposable item that is supplied with a valve. For example, the introducer <NUM> can be made of or include polypropylene, or any other suitable material having a low coefficient of friction. The introducer <NUM> can be a molded part. Meanwhile, the valve to be implanted can be made of a Nitinol wireform band exhibiting a large degree of elasticity. In one embodiment, the valve exhibits superelastic properties.

In use, the introducer <NUM> is first introduced into an incision in the chest cavity with the distal end <NUM> positioned between two ribs. The valve, connected to a flexible holder, is inserted into the proximal end <NUM> of the introducer <NUM>. The valve is then pushed towards the smaller, distal end <NUM> of the introducer <NUM>, where the valve elastically deforms to squeeze through the smaller cross-sectional shape. The valve can take on the oval shape of the introducer or another generally collapsed shape as it is pushed through. Once the valve clears the distal end <NUM> of the introducer <NUM>, the valve regains its undeformed shape (e.g., a circular shape). In this way, the deformation of the valve and holder is passive, being imposed or dictated by the shape of the introducer rather than by a mechanism on the holder itself. The advantage of this configuration is that the holder can be a very inexpensive molded component.

In one embodiment, a length of the introducer <NUM> is sufficient to introduce the valve into an internal surface of the chest wall past the rib cage. In such an embodiment, a length of the introducer from the proximal end <NUM> to the distal end <NUM> may be up to about <NUM> long. In other embodiments, a length of the introducer can be made longer. In one embodiment, the distal end <NUM> could be extended many more centimeters so that it would extend, for example, into the left atrium of the heart, for a mitral valve replacement, to act as an atrial retractor. Meanwhile, the proximal end <NUM> of the introducer <NUM> can remain positioned outside of the incision in the chest cavity. This would provide a tunnel from the outside of the body all the way to the site of implantation at the annulus.

In alternative embodiments, the introducer <NUM> can include various additional features, for example, a slit in a wall of the introducer <NUM> can be provided to give clearance for sutures passing through a side of the introducer during surgical procedures. In addition, lighting, such as light emitting diodes ("LEDs") and/or at least one optical fiber, can be added to the introducer, along with a power supply, such as batteries, to power the lighting. LED lighting can be inexpensively added to the introducer with a built-in battery. The lighting can be particularly useful with the extended version of the introducer. The lighting can provide excellent illumination at the site of implantation and reduce the need for additional external lighting.

For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved.

For example, operations described sequentially can in some cases be rearranged or performed concurrently. The actual operations that correspond to these terms can vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

Claim 1:
A valve holder (<NUM>) for holding and implanting a prosthetic heart valve comprising a frame and a plurality of flexible leaflets, the valve holder (<NUM>) comprising:
a body (<NUM>) for holding the prosthetic heart valve, the body (<NUM>) having a top surface (<NUM>), a bottom surface (<NUM>), and a central axis extending between the top and bottom surfaces (<NUM>, <NUM>);
a rotor (<NUM>) positioned in the body (<NUM>), wherein when the prosthetic heart valve is coupled to the body (<NUM>), the rotor (<NUM>) is rotatable around the central axis of the body (<NUM>) to adjust the prosthetic heart valve to a delivery position;
a latch (<NUM>) having an opening (<NUM>) couplable with a handle (<NUM>), and through which an activator (<NUM>) is couplable to the rotor (<NUM>) for rotating the rotor (<NUM>) around the central axis of the body (<NUM>), and
a guide (<NUM>) attached to the body (<NUM>), wherein an alignment keyway (<NUM>) having a shape corresponding to a shape of a key (<NUM>) of the activator (<NUM>) is provided on the guide (<NUM>), wherein the alignment keyway (<NUM>) is for limiting rotation of the dial (<NUM>) and the rotor (<NUM>) relative to the body (<NUM>) and for permitting the key (<NUM>) to pass therethrough when disconnecting the activator (<NUM>) from the rotor (<NUM>), wherein the activator (<NUM>) is only disconnectable from the rotor (<NUM>) when the key (<NUM>) is rotationally aligned with the keyway (<NUM>).