Patent Description:
Prosthetic heart valves can pose particular challenges for delivery and deployment within a heart. Valvular heart disease, and specifically, aortic and mitral valve disease is a significant health issue in the United States (US); annually approximately <NUM>,<NUM> valve replacements are conducted in the US. Traditional valve replacement surgery involving the orthotopic replacement of a heart valve, is considered an "open heart" surgical procedure. Briefly, the procedure necessitates surgical opening of the thorax, the initiation of extra- corporeal circulation with a heart-lung machine, stopping and opening the heart, excision and replacement of the diseased valve, and restarting of the heart. While valve replacement surgery typically carries a <NUM>-<NUM>% mortality risk in otherwise healthy persons, a significantly higher morbidity is associated to the procedure largely due to the necessity for extra- corporeal circulation. Further, open heart surgery is often poorly tolerated in elderly patients. Thus elimination of the extra-corporeal component of the procedure could result in reduction in morbidities and cost of valve replacement therapies could be significantly reduced.

While replacement of the aortic valve in a transcatheter manner is the subject of intense investigation, lesser attention has been focused on the mitral valve. This is in part reflective of the greater level of complexity associated to the native mitral valve apparatus, and thus, a greater level of difficulty with regards to inserting and anchoring the replacement prosthesis. Thus, a need exists for delivery devices and methods for transcatheter heart valve replacements. There is also a need for devices and methods for repositioning and/or retrieving deployed prosthetic heart valves.

<CIT> suggests catheter devices for delivery, repositioning and/or percutaneous retrieval of percutaneously implanted heart valves, including a medical device handle that provides an array of features helpful in conducting a percutaneous heart valve implantation procedure while variously enabling radial expansion or contraction and/or lateral positioning control over the heart valve during the medical procedure. Methods and systems for loading a stent are described in <CIT>.

Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve into a heart. In some embodiments, an apparatus includes a catheter assembly, a valve holding tube and a handle assembly. The valve holding tube is releasably couplable to a proximal end portion of the catheter assembly and to a distal end portion of the handle assembly. The handle assembly includes a housing and a delivery rod. The delivery rod is configured to be actuated to move distally relative to the housing to move a prosthetic heart valve disposed within the valve holding tube out of the valve holding tube and distally within a lumen of the elongate sheath of the catheter assembly. The catheter assembly is configured to be actuated to move proximally relative to the housing such that the prosthetic valve is disposed outside of the lumen of the elongate sheath.

Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic heart valve (e.g., a prosthetic mitral valve) into a heart. The embodiment of the present invention is defined by the appended claims. In some examples, a delivery device as described herein can be used to deploy and reposition a prosthetic heart valve. In some examples, a delivery device as described herein can include a two-stage controlled deployment mechanism for allowing accurate valve deployment. A delivery device as described herein can include a single 34Fr all-in-one system that can accommodate a variety of valve sizes. In some embodiments, a repositioning and retrieval device is described herein that can be used to reposition and /or retrieve a deployed prosthetic heart valve. The repositioning and retrieval device can include a two-stage controlled capture of a prosthetic valve implanted within a heart to reposition and/or remove/retrieve the prosthetic valve.

Although some examples are described herein with reference to a prosthetic mitral valve, it should be understood that the apparatus and methods described herein can be used to deploy, reposition and / or remove other any type of heart valve. For example, the apparatus and methods described herein can be used to deploy, reposition and / or remove a tricuspid heart valve, a pulmonary heart valve or an aortic heart valve. Further, the apparatus and methods described herein can be used from various delivery approaches to the heart, such as, for example, a transapical approach, transatrial, or a transventricular or transvascular approach (e. , transj ugular, transfemoral).

In some examples, a dilator device can be coupled to or incorporated within the delivery device. In some embodiments, the dilator device can include a balloon dilator member and be inserted through a port defined in, for example, the handle assembly or the catheter assembly of the delivery device. Such a dilator device is described below with reference to <FIG> and <FIG>. Use of a dilator device can help reduce the risk of damaging the prosthetic valve and/or the heart (e.g., the atrium).

As described herein, in some examples, a delivery device can include a handle assembly having one or more actuators, a delivery catheter assembly and a valve holding tube. The valve holding tube can be removably coupled to a distal end portion of the handle assembly and removably coupled to a hub of the delivery catheter assembly. In some embodiments, the valve holding tube can be coupled to the handle assembly, and the valve holding tube and handle assembly can be collectively and movably coupled to the delivery catheter. In some embodiments, the valve holding tube can be coupled to the catheter assembly prior to being coupled to the handle assembly. In some embodiments, during use, the valve holding tube is coupled to the handle assembly and to the catheter assembly prior to the catheter assembly being inserted into a heart. In some embodiments, the valve holding tube and handle assembly can be collectively and movably coupled to the delivery catheter assembly after the catheter assembly has been inserted into the heart. A dilator device is also described herein that can optionally be used during a procedure to deliver a prosthetic valve (e.g., prosthetic mitral valve) to the heart and can be received through a lumen of the delivery catheter. The delivery devices described herein can be used to deploy a prosthetic mitral valve into the heart in a controlled manner providing incremental movement of the prosthetic mitral valve within the delivery catheter and into the heart.

In some examples, an apparatus includes a catheter assembly, a valve holding tube and a handle assembly. The valve holding tube is releasably couplable to a proximal end portion of the catheter assembly and to a distal end portion of the handle assembly. The handle assembly includes a housing and a delivery rod. The delivery rod is configured to be actuated to move distally relative to the housing to move a prosthetic heart valve disposed within the valve holding tube out of the valve holding tube and distally within a lumen of the elongate sheath of the catheter assembly. The catheter assembly is configured to be actuated to move proximally relative to the housing such that the prosthetic valve is disposed outside of the lumen of the elongate sheath.

In some embodiments, an apparatus includes a loading funnel assembly configured to receive therein a prosthetic heart valve when the valve is in a non-collapsed or biased expanded configuration and a valve holding tube that defines an interior region that is configured to receive a prosthetic heart valve in a collapsed configuration. The valve holding tube has a first end portion configured to be releasably coupled to the loading funnel assembly and a second end portion. The apparatus further includes a handle assembly that includes a handle and a loading leadscrew. The loading leadscrew can be releasably coupled to the second end portion of the valve holding tube. The handle assembly further includes a tether retention mechanism and an actuator knob. The tether retention mechanism can secure a tether extending from a prosthetic heart valve disposed within the funnel assembly in a fixed positon relative to the handle assembly. The actuator knob is operatively coupled to the loading leadscrew and the handle such that relative movement between the handle and the loading leadscrew causes the prosthetic valve to be disposed within the valve holding tube.

In some examples, an apparatus includes a recapture device that can be used to remove or reposition a prosthetic heart valve deployed within a heart. The recapture device includes an outer sheath, an outer dilator, an inner dilator, and a handle assembly. The outer sheath defines a first lumen and the outer dilator defines a second lumen and is movably disposed at least partially within the first lumen of the outer sheath. The inner dilator is movably disposed at least partially within the second lumen of the outer dilator and includes a distal tip. The handle assembly includes an actuator operatively coupled to the inner dilator and operatively coupled to the outer dilator and a tether retention mechanism to secure to the handle assembly a tether extending from the prosthetic heart valve. The actuator includes a drive mechanism operatively coupled to a first spring coupled to the inner dilator and to a second spring coupled to the outer dilator. When the actuator is actuated, the inner dilator moves proximally relative to the outer dilator when the tether extending from the prosthetic heart valve is secured to the tether retention mechanism such that a first portion of the prosthetic heart valve is pulled to within the second lumen of the outer dilator and moved to a collapsed configuration. The outer dilator can be actuated sequentially after the inner dilator to move the outer dilator proximally relative to the outer sheath such that a second portion of the prosthetic heart valve, distal of the first portion of the prosthetic heart valve, is pulled within the first lumen of the outer sheath and moved to a collapsed configuration.

In some examples, a method of delivering a transcatheter mitral valve replacement to the mitral annulus of a heart includes deploying into the mitral annulus a transcatheter mitral valve prosthesis using a delivery device as described herein. The transcatheter mitral valve prosthesis can be made from an expandable metal stent body having valve leaflets disposed therein. The stent body can be covered with a synthetic material or stabilized pericardial tissue and the valve leaflets can be made from stabilized pericardial tissue. The expandable metal stent body can have an optional atrial cuff and the cuff can optionally have a covering made from a synthetic material and/or stabilized pericardial tissue. The transcatheter mitral valve prosthesis can be deployed via catheter in a compressed state and expanded upon ejection from the catheter. The mitral valve prosthesis (also referred to herein as "prosthetic mitral valve" or "prosthetic valve" or "prosthetic heart valve") may include one or more tethers coupled to a proximal end portion of the mitral valve prosthesis.

A distal end of the one or more tethers can be anchored, for example, in the left ventricle. The one or more tethers can be tightened and/or otherwise adjusted to a desired tension prior to fastening the one or more tethers to establish a fixed length and securing the tethers to, for example, an apex region of the heart. Prosthetic mitral valves that can be delivered with the devices and methods disclosed herein can include, for example, those disclosed in International Patent Application Serial Nos. <CIT> ("PCT application `<NUM>"), <CIT> ("PCT application `<NUM>"), <CIT> ("PCT application `<NUM>"), and<CIT> ("PCT application ` <NUM>").

In some examples, a surgical kit can include a delivery device as described herein and accessory components that can be used with the delivery device in a procedure to deliver a transcatheter prosthetic valve as described herein. The delivery device and the accessory components can be disposed within a sterile package. For example, in some examples, a kit can include a delivery device and a dilator device and/or a valve loading device as described herein. In some embodiments, a kit can also include a transcatheter valve (e.g., a prosthetic mitral valve) and/or an epicardial pad that can be used to secure the transcatheter valve in position within the heart. In some embodiments, a kit can include a retrieval and repositioning device as described herein.

As used herein, the words "proximal" and "distal" refer to a direction closer to and away from, respectively, an operator of, for example, a medical device. Thus, for example, the end of the medical device closest to the patient's body (e.g., contacting the patient's body or disposed within the patient's body) would be the distal end of the medical device, while the end opposite the distal end and closest to, for example, the user (or hand of the user) of the medical device, would be the proximal end of the medical device.

<FIG> is a cross-sectional illustration of the left ventricle LV and left atrium LA of a heart having a transcatheter prosthetic mitral valve PMV deployed therein and an epicardial anchor device EAD securing the prosthetic mitral valve PMV to the apex region of the heart. <FIG> illustrates the prosthetic mitral valve PMV seated into the native valve annulus NA and held there using an atrial cuff AC of the prosthetic mitral valve PMV, the radial tension from the native leaflets, and a ventricular tether T secured with attachment portions Tp to the prosthetic mitral valve PMV and to the epicardial anchor EAD. The apparatus and methods described herein can be used in conjunction with the various different types and embodiments of an epicardial anchor device, such as those described in pending International Patent Application No. <CIT> entitled "Epicardial Anchor Devices and Methods," ("PCT application `<NUM>").

<FIG> is a schematic illustration of a delivery device, according to an example. A delivery device <NUM> can be used to deliver and deploy a prosthetic heart valve within the heart, such as, for example, a prosthetic mitral valve. The delivery device <NUM> includes a catheter assembly <NUM>, a handle assembly <NUM> removably couplable to the catheter assembly <NUM>, and a valve holding tube <NUM> removably couplable to the handle assembly <NUM> and to the catheter assembly <NUM>.

The catheter assembly <NUM> includes a hub <NUM> and a delivery sheath <NUM>. The delivery sheath <NUM> defines a lumen (not shown in <FIG>) through which the valve holding tube <NUM> can be inserted to deliver a prosthetic valve (not shown in <FIG>) disposed within the valve holding tube <NUM> as described in more detail below. In some embodiments, the delivery sheath <NUM> can be for example, a 34Fr braided sheath. The hub <NUM> is disposed at a proximal end of the sheath <NUM> and defines an interior region through which the prosthetic valve is first introduced prior to insertion into the lumen of the sheath <NUM>. In use, the hub <NUM> remains outside the heart and can provide access to the lumen of the sheath when it is inserted into the heart. The hub <NUM> can also include a port (not shown in <FIG>) through which a device, such as a dilator device, can be introduced as described in more detail below.

The handle assembly <NUM> includes a housing <NUM>, a tether retention and mechanical retention coupler (also referred to herein as "retention mechanism") <NUM> coupled to the housing <NUM>, a delivery rod <NUM> extending distally from the housing <NUM>, a proximal actuator knob <NUM> (also referred to as "proximal actuator" or "first actuator") coupled to the housing <NUM>, and a distal actuator knob <NUM> (also referred to as "distal actuator" or "second actuator") coupled to the housing. The proximal actuator knob <NUM> can be operatively coupled to the delivery rod <NUM> and used to move or push distally within the delivery sheath <NUM>, a prosthetic heart valve that is pre-loaded into the valve holding tube <NUM> and coupled to the handle assembly <NUM> as described in more detail below. The distal actuator knob <NUM> can be operatively coupled to the delivery sheath <NUM> and used to actuate or move the delivery sheath <NUM> during deployment of the prosthetic valve into the heart. For example, the prosthetic valve can first be moved distally by the delivery rod <NUM> until it is positioned within a distal end portion of the delivery sheath <NUM>, and then to deploy the prosthetic valve within the heart, the delivery sheath <NUM> is moved proximally, disposing the prosthetic valve outside of the delivery sheath <NUM> and within the heart. The distal actuator <NUM> can provide a slow, controlled deployment of the prosthetic valve. In some embodiments, the delivery sheath <NUM> can also be actuated to recapture a prosthetic heart valve that has already been deployed within a heart such that the prosthetic valve can be repositioned or removed. For example, upon initial deployment of the valve within the heart, it may be desirable to reposition the valve. The delivery device <NUM> can be actuated to partially recapture a proximal portion of the valve to make adjustments to its positon. For example, the delivery sheath can be actuated to move distally to recapture a portion of the valve, then after the valve has been repositioned, the sheath can be actuated to move proximally again to release the valve. The delivery rod <NUM> can also be used to recapture a portion of the prosthetic valve. For example, the delivery rod <NUM> can define a lumen and can be actuated to move distally such that a portion of the prosthetic valve is recaptured within the lumen of the delivery rod <NUM>. Further details of the delivery and deployment of a prosthetic heart valve using the delivery device are provided below with reference to specific embodiments.

The valve holding tube <NUM> can contain or hold a prosthetic mitral valve (not shown in <FIG>) in a compressed configuration within an interior lumen of the valve holding tube <NUM>. As discussed with respect to <FIG>, in some embodiments, a valve loading device <NUM> can be used to load the prosthetic valve into the valve holding tube <NUM> such that the prosthetic valve is compressed in a controlled manner to a desired compressed size and shape. Such a valve loading device is also described in more detail below with reference to a specific embodiment (see, e.g., <FIG>). The valve holding tube <NUM> (with the prosthetic mitral valve therein) can be coupled to a distal end portion of the handle assembly <NUM>. For example, the valve holding tube <NUM> can be coupled to the handle assembly <NUM> such that a portion of the distal end portion of the delivery rod <NUM> of the handle assembly <NUM> can be received within an interior region of the valve holding tube <NUM>. In some embodiments, the valve holding tube <NUM> and the handle assembly <NUM> can include mating quick connect couplers to releasably couple the valve holding tube <NUM> to the handle assembly <NUM>. Prior to coupling the valve holding tube <NUM> to the delivery device <NUM>, a tether (not shown) coupled to the prosthetic valve (within the valve holding tube <NUM>) can be threaded through a lumen defined by the delivery rod <NUM> and extend proximally out of the handle assembly <NUM>.

The valve holding tube <NUM> can have various lengths to accommodate various different procedures to deliver the prosthetic heart valve to the heart. For example, in some embodiments, the valve holding tube <NUM> can have a length of between about <NUM> and <NUM>. In some embodiments, the sheath <NUM> can have a length of about <NUM> to about <NUM>. In some embodiments, the sheath <NUM> can have a length of about <NUM> to about <NUM>.

In some embodiments, the prosthetic heart valve (e.g., mitral valve) can be delivered apically, i.e. delivered through the apex of the left ventricle of the heart, using the delivery device <NUM> described herein. With such apical delivery, the delivery device <NUM> can access the heart and pericardial space by intercostal delivery. In this case, the sheath <NUM> can have a length of, for example, <NUM>-<NUM>.

In another delivery approach, the delivery device <NUM> can deliver the prosthetic heart valve using either an antegrade or retrograde delivery approach without requiring the use of a rigid tube system that is commonly used in such procedures. In another embodiment, the delivery device <NUM> can access the heart via a trans-septal approach. In either case, where a long distance must be travelled, the valve holding tube <NUM> can have a length of, for example, <NUM>-<NUM>.

The tether retention mechanism <NUM> can be coupled to a proximal end portion of the housing <NUM> and can be used to couple a tether(s) extending from a prosthetic valve to the handle assembly <NUM>. One or more tethers coupled to the prosthetic valve can extend through the handle assembly <NUM> and can also be inserted or threaded through the retention mechanism <NUM>. In some embodiments, the retention mechanism <NUM> includes a spring mechanism that can be used to secure the tether to the tether retention mechanism <NUM> and thus to the handle assembly <NUM>. The spring mechanism can be actuated to deflect the tether (e.g., bend Nitinol wire of tether) and apply a constant or substantially constant force (e.g., tension) on the tether during deployment. The spring mechanism can also allow for adjustment of the force applied to the prosthetic valve during removal of the delivery device after deployment of a prosthetic valve. The tension on the tether can be released to allow movement of the prosthetic valve, and then re-tensioned to secure the tether and prosthetic valve in the new position. In some embodiments, the tether retention mechanism <NUM> includes a tether pinning mechanism. In such an embodiment, a pinning member can be used to pierce the tether to secure the tether to the retention mechanism <NUM>.

The tether retention mechanism <NUM> can provide additional safety during a deployment procedure in that, with a compressed valve under great pressure, release from a catheter can launch the prosthetic valve, for example, a distance of many feet. However, with the retention mechanism <NUM> provided herein and the ability to provide a slow calibrated deployment, the user can control the deployment to prevent the valve from inadvertently being projected from the sheath <NUM>.

In one example use to deliver and deploy the prosthetic mitral valve within a heart, the sheath <NUM> of the catheter assembly <NUM> can be inserted through the epicardial surface of the patient's heart and extended through the left ventricle and to the left atrium of the heart such that the hub <NUM> is disposed on the outside of the heart near or in contact with the epicardial surface. In some embodiments, prior to introducing the sheath <NUM> into the heart, a guidewire (not shown) is extended into the heart and to the left atrium. The sheath <NUM> can then be threaded over the guidewire to be inserted into the heart. For example, the guidewire can be extended through the sheath <NUM> and out a port disposed on the hub <NUM>. In some embodiments, prior to inserting the sheath <NUM> into the heart, a dilator device (not shown in <FIG>) can be inserted through the port of the hub <NUM> and through the lumen of the sheath <NUM>, such that a tapered distal end portion of the dilator device extends outside a distal end of the sheath <NUM>. The tapered distal end of the dilator device can provide a lead-in for the sheath <NUM> and help open or enlarge the entry opening at the epicardial surface and through the mitral annulus. An example dilator device is described in <CIT> ("the `<NUM> application"). Other embodiments of a dilator device are described herein with reference to <FIG> and <FIG>. When the sheath <NUM> is placed at the desired position within the heart, the dilator device can be removed leaving the sheath <NUM> within the heart. Further details of a dilator device are described below.

As described above, the valve holding tube <NUM> (with a prosthetic valve disposed therein) can be coupled to a distal end portion of the handle assembly <NUM>. The tether extending from the valve can be threaded through the delivery rod <NUM> and extend out a proximal end of the handle assembly <NUM>. With the valve holding tube <NUM> coupled to the distal end portion of the handle assembly <NUM>, and the distal end portion of the delivery rod <NUM> disposed within the valve holding tube <NUM>, the valve holding tube <NUM> can be inserted into the hub <NUM> of the catheter assembly <NUM> and coupled to the hub <NUM>. In some embodiments, O-rings (not shown in <FIG>) on the valve holding tube <NUM> can maintain the position of the valve holding tube <NUM> within the hub <NUM>. For example, in some embodiments, the valve holding tube <NUM> and the hub <NUM> can include mating quick connect couplers that include O-rings, to releasably couple the valve holding tube <NUM> to the hub <NUM>.

With the valve holding tube <NUM> coupled to the catheter assembly, the proximal actuator knob <NUM> can then be actuated (e.g., rotated) to move the delivery rod <NUM> distally such that a distal end of the delivery rod <NUM> pushes the prosthetic valve out of the valve holding tube <NUM> and into a distal end portion of the delivery sheath <NUM>. As the delivery rod <NUM> moves distally, the delivery rod <NUM> moves relative to the housing <NUM> of the handle assembly <NUM>, and the valve holding tube <NUM> remains stationary relative to the housing <NUM>, allowing the delivery rod <NUM> to push the prosthetic valve out of the valve holding tube <NUM> and into the delivery sheath <NUM>. The tether can then be secured to the retention mechanism <NUM>, securing the valve to the housing <NUM>. The distal actuator knob <NUM> can then be actuated to retract or move proximally the delivery sheath <NUM> (and the valve holding tube <NUM> coupled thereto via the hub <NUM>) relative to the housing <NUM> such that the prosthetic valve is left disposed outside of the delivery sheath <NUM> and within the left atrium of the heart or within the annulus of the native mitral valve. After the prosthetic valve has been deployed, the prosthetic valve can be maneuvered and repositioned as needed and then the tether can be released from the retention mechanism <NUM>. The tether can then be secured to an epicardial surface of the heart with, for example, an epicardial pad (e.g., EAD in <FIG>) as described above.

In an alternative example procedure, rather than first inserting the catheter assembly <NUM> into the heart, and then coupling the valve holding tube <NUM> and handle assembly <NUM> thereto, the valve holding tube <NUM> can be coupled to both the handle assembly <NUM> and to the catheter assembly <NUM> prior to the catheter assembly <NUM> being inserted into the heart. In such a procedure, the same steps described above can be employed for inserting the catheter assembly <NUM> into the heart, such as, for example, inserting the catheter assembly <NUM> over a guidewire and/or using a dilator device as described above. The delivery device <NUM> can then be actuated in the same manner as described above to first move the prosthetic valve distally within the delivery sheath <NUM> and then move the delivery sheath <NUM> proximally to dispose the prosthetic valve in the heart.

<FIG> is a schematic illustration of a valve loading device <NUM>. The valve loading device <NUM> includes a funnel assembly <NUM>, a loading handle assembly <NUM> and the valve holding tube <NUM> described above. Prior to coupling the valve holding tube <NUM> to the handle assembly <NUM> and catheter assembly <NUM>, a prosthetic valve (also referred to herein as "valve") is loaded into the valve holding tube <NUM> using the valve loading device <NUM>. The valve is first placed within the funnel assembly <NUM> to move the valve from a biased expanded configuration to a collapsed configuration. The funnel assembly <NUM> includes an outer funnel <NUM> and an inner funnel or centering cone <NUM>. The valve is placed within the outer funnel <NUM> and then the inner funnel is coupled to the outer funnel <NUM> sandwiching the valve therebetween and collapsing the valve to a desired shape and configuration in a controlled manner. The valve holding tube <NUM> can be releasably coupled to the funnel assembly <NUM> and to the loading handle assembly <NUM> via quick connect couplers in a similar manner as how the valve holding tube <NUM> is coupled to the handle assembly <NUM> and catheter assembly <NUM> described above.

The loading handle assembly <NUM> includes a handle <NUM> (also referred to as "main loading knob" or "actuator"), a retention mechanism <NUM> for securing a tether coupled to the valve, and a loading leadscrew <NUM> operatively coupled to the handle <NUM>. With the valve holding tube <NUM> coupled to the funnel assembly <NUM> and to the loading handle assembly <NUM>, and with the tether extending from the valve secured to the retention mechanism <NUM>, the valve loading device <NUM> can be actuated to move the valve from a first position in which it is disposed within the funnel assembly to a second position in which the valve is disposed within the valve holding tube <NUM>. More specifically, the handle <NUM> can be rotated, which in turn moves the leadscrew relative to the handle <NUM>, which in turn moves the valve holding tube <NUM> and funnel assembly <NUM> away from the handle <NUM>. Because the valve is in a fixed positon (i.e., is stationary) relative to the handle <NUM> during actuation (through the securement of the tether to the retention mechanism <NUM>), the funnel assembly <NUM> is moved away from the handle, and the valve holding tube <NUM> is moved over the valve, disposing the valve within an interior region of the valve holding tube <NUM>. Details regarding the various components and operation of the valve loading device <NUM> are described below with respect to <FIG> and valve loading device <NUM>.

<FIG> illustrate a delivery device according to one example. A delivery device <NUM> includes a catheter assembly <NUM>, a handle assembly <NUM> removably couplable to the catheter assembly <NUM> and a valve holding tube <NUM> removably couplable to the handle assembly <NUM> and the catheter assembly <NUM>. The delivery device <NUM> can include the same or similar components and features, and can function the same as or similar to the delivery device <NUM> described above. The delivery device <NUM> can be used to deliver and deploy a prosthetic heart valve within the heart, such as, for example, a prosthetic mitral valve (not shown) as described above for the previous embodiment.

The catheter assembly <NUM> includes a hub <NUM> and a delivery sheath <NUM>. The delivery sheath <NUM> defines a lumen <NUM> (<FIG>) into which a prosthetic valve (not shown) pre-disposed within an interior region of the valve holding tube <NUM> can be moved during delivery of the prosthetic valve. The hub <NUM> is disposed at a proximal end of the sheath <NUM> and defines an interior region through which the prosthetic valve is first introduced prior to insertion into the lumen of the sheath <NUM>. In use, the hub <NUM> remains outside the heart and can provide access to the lumen of the sheath <NUM> when it is inserted into the heart. The hub <NUM> also includes a port <NUM> through which, various devices, such as for example, a dilator device (not shown) can be inserted and used during the delivery of a prosthetic heart valve as described in more detail with respect to the example of <FIG>. Other examples of a dilator device are described below with respect to <FIG>, which can be used with the delivery device <NUM>. The port <NUM> can also be used to receive a guidewire therethrough. For example, a guidewire can be threaded through a distal end of the delivery sheath <NUM>, into the interior of the hub <NUM>, and out through the port <NUM>.

The handle assembly <NUM> includes a housing <NUM>, a tether retention mechanism <NUM> coupled to the housing <NUM>, a delivery rod <NUM> coupled to the housing <NUM>, a proximal actuator knob <NUM> (also referred to as "first actuator" or "proximal actuator") coupled to the housing <NUM>, and a distal actuator knob <NUM> (also referred to as "second actuator" or "distal actuator") coupled to the housing <NUM>. A deployment travel window <NUM> is disposed on the housing <NUM> and can be used to view the progress of the delivery of the prosthetic valve. For example, the delivery rod <NUM> can include markings that are visible through the deployment travel window. The markings can be, for example, labeled with numbers or letters, or can be color coded. The markings can indicate the progress or distance the valve has traveled distally during deployment of the valve. Markings can also be included that indicate the movement proximally of the delivery sheath during deployment of the valve.

The proximal actuator knob <NUM> can be used to move or push distally within the delivery sheath <NUM>, a prosthetic heart valve (not shown) that is pre-loaded into the valve holding tube <NUM> and coupled to the handle assembly <NUM>. For example, the proximal actuator knob <NUM> can be operatively coupled to the delivery rod <NUM> and can be used to move the delivery rod <NUM> distally within the delivery sheath <NUM> relative to the housing <NUM> such that the delivery rod <NUM> engages the prosthetic heart valve and moves (e.g., pushes) the prosthetic heart valve distally within the delivery sheath <NUM> until the prosthetic heart valve is disposed within a distal end portion of the delivery sheath <NUM>. In this embodiment, the proximal actuator <NUM> is rotated, which in turn causes the rod <NUM> to move relative to the housing <NUM>. When deploying a valve, the valve holding tube <NUM> is secured in a fixed relation to the housing <NUM>, and thus, does not move relative to the housing <NUM> when the rod <NUM> is actuated. This allows the rod <NUM> to push the valve distally out of the valve holding tube <NUM> and into the hub <NUM> and then within a distal end portion of the delivery sheath <NUM>. With the valve disposed within a distal end of the delivery sheath <NUM>, the tether can be secured to the housing <NUM> via the retention mechanism <NUM>.

The distal actuator knob <NUM> can be operatively coupled to the delivery sheath <NUM> and used to actuate or move the delivery sheath <NUM> during deployment of the prosthetic valve into the heart. In this example, as shown in <FIG>, the distal actuator knob <NUM> is coupled to a leadscrew <NUM>, which in turn is coupled to the valve holding tube <NUM>. Thus, when the valve holding tube <NUM> is coupled to the hub <NUM>, the leadscrew <NUM> can be actuated to move the valve holding tube <NUM> and the catheter assembly <NUM> relative to the housing. For example, as described above, with the prosthetic valve disposed within the delivery sheath <NUM>, to deploy the prosthetic valve into the heart, the delivery sheath <NUM> is moved proximally relative to the housing <NUM> (by actuating the distal actuator knob <NUM>) disposing the prosthetic valve outside of the delivery sheath <NUM> and within the heart.

The delivery sheath <NUM> can also be actuated to partially recapture a prosthetic heart valve that has already been deployed within a heart such that the prosthetic valve can be repositioned. For example, after the prosthetic valve has been deployed as described above, if it is determined that the prosthetic valve should be repositioned, the actuator knob <NUM> can be actuated in an opposite direction to move the leadscrew <NUM> distally, causing the delivery sheath <NUM> to move distally back over a proximal portion of the prosthetic valve. The delivery device <NUM> can then be maneuvered to position the prosthetic valve in a desired location, and then the actuator knob <NUM> can be actuated to move the delivery sheath <NUM> proximally, again releasing the prosthetic valve from the delivery sheath <NUM>. Further, as described previously, the delivery rod <NUM> can be actuated by the actuator knob <NUM> to move distally to recapture a portion of the prosthetic valve within the lumen of the delivery rod <NUM>.

As described above for the previous example, the valve holding tube <NUM> (see, e.g., <FIG>) can contain or hold a prosthetic mitral valve (not shown) in a compressed configuration within an interior lumen of the valve holding tube <NUM>. As described above for <FIG>, and described below with respect to <FIG>, a valve loading device can be used to pre-load the prosthetic valve into the valve holding tube <NUM> such that the prosthetic valve is compressed in a controlled manner to a desired compressed size and shape. The valve holding tube <NUM> (with the prosthetic mitral valve therein) can be removably coupled to a distal end portion of the handle assembly <NUM> and removably coupled to the hub <NUM> of the catheter assembly <NUM>.

For example, as shown, for example, in <FIG>, the valve holding tube <NUM> can include a first quick connect coupler <NUM> (a female connector in this example) and a second quick connect coupler <NUM> (a male connector in this embodiment). The first quick connector <NUM> can be matingly coupled to a quick connect coupler <NUM> (a male connector in this embodiment) disposed at the distal end portion of the handle assembly <NUM>. Similarly, the second quick connect coupler <NUM> of the valve holding tube <NUM> can be matingly coupled to a quick connect coupler <NUM> (a female connector in this embodiment) disposed on the hub <NUM> of the catheter assembly <NUM>. The quick connect couplers can include O-rings to maintain the position of the valve holding tube <NUM> to the handle assembly <NUM> and to the catheter assembly <NUM>. The quick connect couplers can be a variety of different types of suitable couplers/connectors. For example, the quick connect couplers can be a bayonet connector or ¼ turn connector. It should be understood that in alternative examples, the male and female couplers can be reversed (e.g., coupler <NUM> of valve holding tube <NUM> can be a male coupler that can be matingly coupled to a female coupler <NUM> of the handle assembly). With the valve holding tube <NUM> coupled to the handle assembly, a distal end portion of the delivery rod <NUM> of the handle assembly <NUM> can be received within an interior region of the valve holding tube <NUM>. Prior to coupling the valve holding tube <NUM> to the delivery rod <NUM>, a tether (not shown) coupled to the prosthetic valve (within the valve holding tube <NUM>) can be threaded through a lumen defined by the delivery rod <NUM> and extend proximally out of the handle assembly <NUM>.

The valve holding tube <NUM> can be configured the same as or similar to, and function the same as or similar to the valve holding tube <NUM> described above. For example, the valve holding tube <NUM> can have various lengths to accommodate various different procedures to deliver the prosthetic heart valve to the heart. The retention mechanism <NUM> can be coupled to a proximal end portion of the housing <NUM>. In this embodiment, the retention mechanism <NUM> includes a tether pinning member that can be configured to pierce through the tether and secure the tether to the retention mechanism <NUM>.

In use to deliver and deploy a prosthetic mitral valve within a heart, the valve holding tube <NUM> can be coupled to the handle assembly <NUM> and to the catheter assembly <NUM> via the quick connect couplers described above. For example, the valve holding tube <NUM> can be inserted into the hub <NUM> of the catheter assembly <NUM> and the quick connect couplers <NUM> and <NUM> can maintain the position of the valve holding tube <NUM> within the hub <NUM>. Similarly, the quick connect couplers <NUM> and <NUM> can maintain the position of the valve holding tube <NUM> relative to the handle assembly <NUM>. The delivery sheath <NUM> of the catheter assembly <NUM> can be inserted through the epicardial surface of the patient's heart and extended through the left ventricle and to the left atrium of the heart such that the hub <NUM> is disposed on the outside of the heart near or in contact with the epicardial surface. As described above, in some embodiments, prior to introducing the sheath <NUM> into the heart, a guidewire is extended into the heart and to the left atrium. The sheath <NUM> can then be threaded over the guidewire to be inserted into the heart. In some embodiments, prior to inserting the sheath <NUM> into the heart, a dilator device (not shown) (see, e.g., dilator device <NUM> in <FIG>, and dilator devices <NUM> and <NUM> described below) can be used as described above to provide a tapered distal insertion tip for insertion of the delivery device <NUM> into the heart of a patient. As described above for delivery device <NUM>, in an alternative procedure, the catheter assembly <NUM> can first be inserted into the heart, prior to the valve holding tube <NUM> being coupled thereto.

<FIG> illustrates the assembled delivery device <NUM> in a ready to use position (e.g., the valve holding tube <NUM> is coupled to the housing <NUM> and catheter assembly <NUM> with a prosthetic valve loaded therein). The proximal actuator knob <NUM> can then be actuated (e.g., rotated) to move the delivery rod <NUM> distally (in the direction of Arrow A in <FIG> and <FIG>) and push the prosthetic valve out of the valve holding tube <NUM> and into a distal end portion of the delivery sheath <NUM>, as described above. <FIG> illustrates the delivery handle <NUM> without the catheter assembly <NUM> and valve holding tube <NUM> for illustrative purposes to show the delivery rod <NUM> actuated distally to push the prosthetic valve out of the valve holding tube <NUM>. As the delivery rod <NUM> moves distally, the valve holding tube <NUM> remains stationary or fixed relative to the housing <NUM>, allowing the delivery rod <NUM> to push the prosthetic valve out of the valve holding tube <NUM> and into the delivery sheath <NUM> until the valve holding tube <NUM> is disposed at a distal end portion of the delivery sheath <NUM>. The tether can be secured to the retention mechanism <NUM>, and the distal actuator knob <NUM> can then be actuated to retract or move proximally the delivery sheath <NUM> relative to the housing <NUM> such that the prosthetic valve is left disposed outside of the delivery sheath <NUM> and within the left atrium of the heart. More specifically, as described above, the distal actuator <NUM> is operatively coupled to the leadscrew <NUM>, which is coupled to the valve holding tube <NUM>. Thus, because the valve holding tube <NUM> is also coupled to the delivery sheath <NUM>, the delivery sheath <NUM> is also moved proximally (the direction of arrow B in <FIG> and <FIG>) relative to the housing <NUM>. <FIG> illustrates the delivery sheath <NUM> partially retracted (moved proximally), and the valve holding tube <NUM> coupled thereto is shown partially disposed within the housing <NUM>. <FIG> illustrates the delivery sheath <NUM> fully retracted, the hub <NUM> partially disposed within the housing <NUM>, and the valve holding tube <NUM> disposed entirely within the housing <NUM>. After the prosthetic valve has been deployed, with the tether coupled to the retention mechanism <NUM>, the prosthetic valve can be maneuvered and repositioned as needed and then the tether can be released from the retention mechanism <NUM>. The tether can then be secured to an epicardial surface of the heart with, for example, an epicardial pad (e.g., EAD in <FIG>) as described above.

Further, prior to securing the tether, as described above, if upon initial deployment of the prosthetic valve it is determined that the valve should be repositioned, the delivery device <NUM> can be actuated to partially recapture a proximal portion of the valve to make adjustments to its position. For example, the delivery sheath <NUM> can be actuated to move distally to recapture a portion of the valve, then after the valve has been repositioned, the sheath <NUM> can be actuated to move proximally again to release the valve. Alternatively, the delivery rod <NUM> can also be used to recapture a portion of the prosthetic valve. For example, the delivery rod <NUM> can be actuated to move distally such that a portion of the prosthetic valve is recaptured within the lumen of the delivery rod <NUM>. The valve can then be repositioned and then the delivery rod <NUM> can be actuated to move proximally to release the valve.

<FIG> illustrates a delivery device according to another example. A delivery device <NUM> includes a catheter assembly <NUM>, a handle assembly <NUM> removably couplable to the catheter assembly <NUM> and a valve holding tube (not shown) removably couplable to the handle assembly <NUM> and the catheter assembly <NUM>. In this embodiment, the valve holding tube is disposed within an interior of a housing <NUM> of the handle assembly <NUM> and the catheter assembly <NUM>. The delivery device <NUM> can include the same or similar components and features, and can function the same as or similar to the delivery device <NUM> and/or the delivery device <NUM> described above. The delivery device <NUM> can be used to deliver and deploy a prosthetic heart valve within the heart, such as, for example, a prosthetic mitral valve (not shown) as described above for the previous embodiment.

The catheter assembly <NUM> includes a hub <NUM> and a delivery sheath <NUM>. The delivery sheath <NUM> defines a lumen (not shown) into which a prosthetic valve disposed within the valve holding tube can be moved during delivery of the prosthetic valve as described above for previous embodiments.

The handle assembly <NUM> includes the housing <NUM>, a delivery rod (not shown) coupled to the housing <NUM>, a proximal actuator knob <NUM> coupled to the housing <NUM>, and a distal actuator knob <NUM> coupled to the housing <NUM>. A deployment travel window <NUM> is disposed on the housing <NUM> and can be used to view the progress of the delivery of a prosthetic heart valve visible through the deployment travel window <NUM>. The proximal actuator knob <NUM> can be used to move or push distally the prosthetic heart valve (not shown) that is loaded into the handle assembly <NUM> via the valve holding tube (not shown). The distal actuator knob <NUM> can be used to actuate or move the delivery sheath <NUM> during deployment of the prosthetic valve into the heart. For example, the prosthetic valve can be moved distally until it is positioned within a distal end portion of the lumen of the delivery sheath <NUM>. To deploy the prosthetic valve, the delivery sheath <NUM> is moved proximally disposing the prosthetic valve outside of the delivery sheath <NUM> and within the heart. The delivery sheath <NUM> can also be actuated to recapture a prosthetic heart valve that has been deployed within a heart such that the prosthetic valve can be repositioned as described above for delivery devices <NUM> and <NUM>. Although not shown in <FIG> and <FIG>, the housing <NUM> can also include a spring tether retention and mechanical retention coupler (also referred to herein as "retention mechanism") coupled to the housing <NUM> as described above for previous embodiments.

As described above, the valve holding tube can contain or hold a prosthetic mitral valve in a compressed configuration within an interior lumen of the valve holding tube. The valve holding tube (with the prosthetic mitral valve therein) can be coupled to a distal end portion of the handle assembly <NUM> and coupled to the hub <NUM> of the catheter assembly <NUM>. As described above for previous embodiments, when coupled to the handle assembly <NUM>, a portion of the distal end portion of the delivery rod can be received within an interior region of the valve holding tube. Prior to coupling the valve holding tube to the delivery rod, a tether (not shown) coupled to the prosthetic valve (within the valve holding tube) can be threaded through a lumen defined by the delivery rod and extend proximally out of the handle assembly <NUM>.

In this example, a dilator device <NUM> is illustrated that can be used with the delivery device <NUM> during deployment of a prosthetic valve. The dilator device <NUM> can include a tapered distal end that can provide a lead-in for the sheath <NUM> and help open or enlarge the entry opening at the epicardial surface and through the mitral annulus. The dilator device <NUM> includes an expandable dilator balloon member <NUM> (also referred to herein as "balloon member"). The balloon member <NUM> is coupled to a balloon manifold <NUM> via an elongate inflation tube that extends through the delivery sheath <NUM> and out through a port <NUM> defined by the hub <NUM>. The balloon member <NUM> has a tapered distal tip portion to provide a lead-in during insertion of the catheter assembly <NUM> into the heart. The balloon manifold <NUM> can be coupled to an inflation medium and used to inflate and deflate the balloon member <NUM>. The port <NUM> is disposed on the hub <NUM> distally of the prosthetic valve. In other words, when the valve holding tube (containing the prosthetic valve) is coupled to the catheter assembly <NUM>, the prosthetic valve is disposed proximally of where the balloon shaft exits the port <NUM>. <FIG> also illustrates a shipping mandrel <NUM> that can be inserted through a lumen of the dilator device <NUM> and includes an elongate member <NUM>. The elongate member <NUM> can be inserted through the balloon manifold <NUM>, through a lumen defined by the dilator device <NUM>, until a distal end is disposed outside a distal end of the balloon member <NUM>. The shipping mandrel <NUM> can be used to maintain the alignment of the various components of the dilator device <NUM> and reduce or eliminate the possibility of components collapsing prior to use of the dilator device <NUM>. The shipping mandrel <NUM> can be removed prior to insertion of the delivery device <NUM> into a patient's body.

In use to deliver and deploy a prosthetic mitral valve within a heart, with the dilator device <NUM>, catheter assembly <NUM>, handle assembly <NUM> and valve holding tube (not shown) coupled together, and with the balloon member <NUM> inflated, the delivery sheath <NUM> can be inserted through the epicardial surface of the patient's heart and extended through the left ventricle and into the left atrium of the heart such that the hub <NUM> is disposed on the outside of the heart near or in contact with the epicardial surface. When the delivery sheath <NUM> is positioned in a desired location, the balloon member <NUM> can be deflated and removed through the port <NUM>.

The proximal actuator knob <NUM> can then be actuated (e.g., rotated) to move the delivery rod distally and push the prosthetic valve out of the valve holding tube and into a distal end portion of the delivery sheath <NUM> in a similar manner as described above for previous embodiments. The distal actuator knob <NUM> can then be actuated to retract or move proximally the delivery sheath <NUM> such that the prosthetic valve is left disposed outside of the delivery sheath <NUM> and within the left atrium of the heart.

<FIG> illustrate a recapture device according to an example. A recapture device <NUM> can be used to capture a prosthetic valve that is deployed within a heart such that the prosthetic valve can be repositioned and/or retrieved/removed. The recapture device <NUM> includes an outer sheath <NUM> operatively coupled to a handle assembly <NUM>, an outer dilator <NUM> disposed within a lumen of the outer sheath <NUM>, and an inner dilator <NUM> movably disposed within a lumen of the outer dilator <NUM> and operatively coupled to the handle assembly <NUM>. The recapture device <NUM> also includes a tether retention mechanism <NUM> coupled to a proximal end portion of the handle assembly <NUM>. The tether retention mechanism <NUM> can be configured the same as or similar to the retention mechanisms described herein and/or described in the `<NUM> application, and can be used to secure the tether to the recapture device <NUM>. The inner dilator <NUM> defines a lumen that can receive at least a portion of a prosthetic valve <NUM> and includes a distal tip configured to engage a prosthetic valve implanted within a heart as described in more detail below.

The handle assembly <NUM> includes a housing <NUM>, a proximal actuator knob <NUM> coupled to the housing <NUM> and operatively coupled to the sheath <NUM>, and a distal actuator knob <NUM> coupled to the housing <NUM> and operatively coupled to the dilator member <NUM>. A deployment travel window <NUM> is disposed on the housing <NUM> and can be used to view the progress of the removal or recapture of a prosthetic heart valve. The proximal actuator knob <NUM> (also referred to herein as "proximal actuator" or "first actuator") can be used to move the inner dilator <NUM> distally and proximally within the lumen of the outer dilator <NUM>. The distal actuator knob <NUM> (also referred to herein as "distal actuator" or "second actuator") can be used to actuate or move the outer sheath <NUM> distally and proximally.

As shown in <FIG> and <FIG>, to capture a prosthetic valve <NUM> that has been deployed within a heart, the tether coupled to the prosthetic valve <NUM> can be threaded or inserted through the lumen of the inner dilator <NUM> and the distal tip of the inner dilator <NUM> can engage a proximal portion of the valve <NUM> by actuating the proximal actuator <NUM> to move the inner dilator <NUM> distally into contact with the valve <NUM>. Thus, as the inner dilator <NUM> is moved distally, a portion of the valve <NUM> can be received and collapsed within the lumen of the inner dilator <NUM>, as shown in <FIG> and <FIG>. As shown in <FIG>, the inner dilator <NUM> can be actuated (e.g., turning or rotating the proximal actuator knob <NUM>) to move the inner dilator <NUM> proximally such that the distal tip of the dilator member <NUM> and a first portion of the valve <NUM> are pulled into the lumen of the outer dilator <NUM>. For example, with the portion of the valve <NUM> collapsed within the lumen of the inner dilator, the valve <NUM> will move distally with the inner dilator <NUM>. With the valve <NUM> captured as shown in <FIG>, the tether can be secured to the retention mechanism <NUM>, and the valve <NUM> can be moved/repositioned within the heart.

To fully remove/retrieve the valve <NUM>, the sheath <NUM> can be moved distally as shown in <FIG>, to further capture the valve <NUM> within the lumen of the sheath <NUM> until the valve <NUM> is fully captured within the lumen of the outer sheath <NUM>. For example, the distal actuator knob <NUM> can be actuated (e.g., rotated or turned) to move the outer sheath <NUM> distally relative to the inner dilator <NUM> and to the outer dilator <NUM>. The outer sheath <NUM> also moves relative to the handle assembly <NUM>. Thus, with the tether secured to the handle assembly <NUM> via the retention mechanism <NUM>, the outer sheath <NUM> moves distally relative to the valve <NUM> to capture the valve <NUM> within the lumen of the outer sheath <NUM>. With the valve <NUM> captured within the lumen of the sheath <NUM>, the valve <NUM> can be removed from the heart by removing the recapture device <NUM> from the heart and the patient's body.

The two-stage actuation of the recapture device <NUM> allows for a controlled capture of a prosthetic valve implanted within a heart to reposition and/or remove/retrieve the prosthetic valve. The proximal portion of the frame of the valve <NUM> can first be collapsed sufficiently for a portion of the frame to be disposed within the lumen of the outer dilator <NUM>, and then can transition into a more fully collapsed configuration as it is moved into the lumen of the outer sheath <NUM>. Further examples of a recapture device are described below with reference to <FIG>.

<FIG> illustrate a valve loading device <NUM> according to an embodiment. The valve loading device <NUM> can be used to load a prosthetic valve (not shown) into a valve holding tube <NUM> which can be similar to or the same as the valve holding tubes described herein (e.g., <NUM>, <NUM>). The valve loading device <NUM> can be used to compress the prosthetic valve to a desired size and shape prior to loading the valve into the valve holding tube. Another embodiment of a valve loading device is described in the '<NUM> application. The valve loading device <NUM> includes a handle assembly <NUM> and a funnel assembly <NUM> that includes a top cap assembly <NUM> and an outer funnel <NUM>. The top cap assembly <NUM> includes an inner funnel or centering cone <NUM>. As best shown in <FIG> and <FIG>, the handle assembly <NUM> includes a centering rod <NUM> operatively coupled to a centering rod locator <NUM>, a loading leadscrew <NUM> and a main loading knob or handle <NUM>. A tether piercing member <NUM> can be used to secure a tether extending from the prosthetic valve within the valve loading device <NUM>. The loading leadscrew <NUM> can be actuated to move the valve holding tube <NUM> and capture the prosthetic valve as described in more detail below.

The valve holding tube <NUM> can be removably coupled to the handle assembly <NUM> via a quick connect coupler <NUM> (a female connector in this embodiment) that can matingly couple to a quick connect coupler <NUM> (a male connector in this embodiment) on the loading leadscrew <NUM> of the handle assembly <NUM>. The valve holding tube <NUM> can also be coupled to the outer funnel <NUM> via a quick connect coupler <NUM> (a male connector in this embodiment) that can matingly couple to a quick connect coupler <NUM> (a female connector in this embodiment) on the outer funnel <NUM>. The quick connect couplers <NUM>, <NUM>, <NUM> and <NUM> can be, for example, bayonet connectors or ¼ turn connectors. The quick connect couplers can also include O-rings to maintain the position of the valve holding tube <NUM> to the handle assembly <NUM> and to the outer funnel <NUM>. The centering rod <NUM> can be used to center the prosthetic valve and hold the valve in position when the valve is loaded within the outer funnel <NUM>. A centering rod securement knob <NUM> secures the centering rod <NUM> in position. The centering rod securement knob <NUM> can be, for example, a thumb screw or set screw.

In some embodiments, prior to loading the prosthetic valve into the valve loading device <NUM>, the handle assembly <NUM> can be placed within a fixture such that the handle assembly <NUM> is positioned in a vertical orientation with the quick connect coupler <NUM> at the top. The valve holding tube <NUM> can be coupled to the handle assembly <NUM> as described above by coupling the quick connect coupler <NUM> of the valve holding tube <NUM> to the quick connect coupler <NUM> of the handle assembly <NUM>. The outer funnel <NUM> can be coupled to the valve holding tube <NUM> by coupling the quick connect coupler <NUM> of the outer funnel <NUM> to the quick connect coupler <NUM> of the valve holding tube <NUM>. Thus, the handle assembly <NUM>, valve holding tube <NUM> and outer funnel <NUM> will be coupled together in a vertical orientation within the fixture. The prosthetic heart valve can be placed within the interior region defined by the outer funnel <NUM> of the funnel assembly <NUM>. The tether of the valve is threaded through the outer funnel <NUM>, through the valve holding tube <NUM>, and through the centering rod <NUM> of the handle assembly <NUM>. The tether piercing member <NUM> can be turned to pierce the tether and secure the tether to the loading device <NUM>. In some embodiments, with an asymmetric prosthetic mitral valve, the valve is loaded into the loading device <NUM> so that the A2 section of the valve (see PCT application `<NUM>) is loaded upwards. This can ensure that the A2 segment of the valve is compressed in the same way it is delivered to the A2 region of the anterior native leaflet to reduce or prevent LVOT obstruction. The inner funnel or centering cone <NUM> can then be threadably attached to the outer funnel <NUM> with mating threaded portions <NUM> and <NUM>, respectively (see, e.g., <FIG>) and secured to the outer funnel <NUM> with a quick connector <NUM> (e.g., a thumb screw or set screw) that locks the inner funnel/centering cone <NUM> to the outer funnel <NUM> as shown, for example, in <FIG>.

A syringe can be coupled to a port <NUM> of the top cap assembly <NUM> to provide a saline flush to remove all trapped air bubbles within the loading device <NUM>. The valve can also be checked for air, shaken, tapped to remove trapped air, etc. while within the loading device <NUM>. If any bubbles are seen, they can be removed by flushing a saline through the loading device <NUM> (e.g., with a syringe coupled to the port <NUM>), especially out of any top pockets of the valve. In some cases, the process of loading the prosthetic valve into the valve loading device <NUM> can be performed with the valve and loading device <NUM> submerged in a saline / water bath with care being taken to remove all trapped air bubbles within the loading device <NUM>.

In an alternative procedure, the valve can be placed in the outer funnel <NUM> prior to the outer funnel being coupled to the valve holding tube <NUM>. The outer funnel <NUM> and centering cone <NUM> can be coupled together as described above, and the outer funnel <NUM> can be coupled to the valve holding tube <NUM> via the quick connect couplers <NUM> and <NUM>. In some cases, the valve holding tube <NUM> can be coupled to the handle assembly <NUM> via the quick connect couplers <NUM> and <NUM> prior to the funnel assembly <NUM> (outer funnel and top cap assembly <NUM>) being coupled to the valve holding tube <NUM>. In other cases, the valve holding tube <NUM> can be coupled to the handle assembly <NUM> prior to the funnel assembly <NUM> being coupled thereto.

With the funnel assembly <NUM> (with prosthetic valve loaded therein) coupled to the valve holding tube <NUM> and handle assembly <NUM>, the entire assembly can be removed from the fixture, flipped upside down, and placed back in the fixture in a vertical orientation, now with the distal end of the handle assembly <NUM> at the top and the funnel assembly <NUM> at the bottom. A saline flush can continue to be used (e.g., introduced through port <NUM>) during the procedure to move the valve from the funnel assembly <NUM> to the valve holding tube <NUM>. To move the prosthetic valve from the funnel assembly <NUM> (i.e., outer funnel <NUM> / centering cone <NUM>) into an interior region of the valve holding tube <NUM>, the main loading knob or handle <NUM> is actuated (e.g., rotated) which in turn moves the loading leadscrew <NUM> in the direction of arrow A relative to the handle <NUM>, as shown in <FIG>. As the loading leadscrew <NUM> is moved in the direction of arrow A, because the valve holding <NUM> is coupled to the loading leadscrew <NUM> via the quick connect couplers <NUM>, <NUM> and to the funnel assembly <NUM> via the quick connect couplers <NUM>, <NUM>, the valve holding tube <NUM> and the funnel assembly <NUM> also move with the loading leadscrew <NUM> in the direction of arrow A, as shown in <FIG> illustrates the valve holding tube <NUM> and funnel assembly <NUM> and loading leadscrew <NUM> prior to being moved proximally, and <FIG> illustrates the valve holding tube <NUM> and funnel assembly <NUM> and loading leadscrew <NUM> after being moved proximally in the direction of arrow A, relative to the handle assembly <NUM>.

The prosthetic valve (not shown) (disposed within the funnel assembly <NUM>) remains in a fixed position relative to the handle <NUM> due to the tether (attached to the valve) being secured to the handle assembly <NUM> (and handle <NUM>) via the tether piercing member <NUM>. Similarly, the centering rod <NUM> remains in a fixed position due to being held by the centering rod securement knob <NUM>, which remains fixed axially relative to the handle <NUM>. Thus, as the valve holding tube <NUM> and the funnel assembly <NUM> move in the direction of arrow A, the prosthetic valve (and centering rod <NUM>) do not move, and the funnel assembly <NUM> and the valve holding tube <NUM> move over the prosthetic valve until the prosthetic valve is captured within an interior region of the valve holding tube <NUM>. With the prosthetic valve within the valve holding tube <NUM>, the valve holding tube <NUM> can be disconnected from the outer funnel <NUM> and the handle assembly <NUM>. The valve holding tube <NUM> can then be coupled to a valve delivery device (e.g., <NUM>, <NUM>) as described herein to be delivered to a heart.

Although the above method of moving a prosthetic valve from being disposed within the funnel assembly <NUM> to being disposed within the valve holding tube <NUM> included moving the loading leadscrew <NUM> in the direction of arrow A to then move the funnel assembly <NUM> and valve holding tube <NUM> in the direction of arrow A, in an alternative method, the loading leadscrew <NUM> can be actuated to move in the opposite direction (i.e., in the direction of arrow B in <FIG>). In such a method, because the tether is coupled/secured to the tether retention mechanism <NUM>, and the retention mechanism is in a fixed relation to the actuator / handle <NUM>, if the actuator / handle <NUM> is moved in the direction of arrow B, the tether will be moved in the same direction along with the actuator / handle <NUM>. Thus, the tether (coupled to the valve) can pull the prosthetic valve out of the funnel assembly <NUM> and within the valve holding tube <NUM>.

<FIG> illustrates an alternative embodiment of a valve loading device <NUM>' which can include the same or similar features and can function the same as or similar to the valve loading device <NUM>. For example, the valve loading device <NUM>' includes a funnel assembly <NUM>' having an outer funnel <NUM>' and an inner funnel <NUM>, a valve holding tube <NUM>' and a handle assembly <NUM>' with a loading leadscrew <NUM>'. <FIG> illustrates the valve loading device after being actuated to move the valve holding tube <NUM>' and funnel assembly <NUM>' in the direction of arrow A. More details regarding the valve loading device <NUM>' are described in provisional application numbers <CIT> and <CIT>.

<FIG> is a flowchart illustrating a method of deploying a prosthetic mitral valve into a heart, according to an embodiment. At <NUM>, a prosthetic mitral valve is loaded into a valve loading device (e.g., <NUM>, <NUM>) and moved from a biased expanded configuration to a compressed configuration within the valve loading device. At <NUM>, the prosthetic mitral valve is transferred to a valve holding tube (e.g., <NUM>, <NUM>, <NUM>) while maintaining the compressed configuration. At <NUM>, the valve holding tube with the prosthetic mitral valve disposed therein in a compressed configuration is coupled to a distal end portion of a handle assembly of a valve delivery device (e.g., <NUM>, <NUM>). Prior to coupling the valve holding tube to the distal end of the handle assembly, a tether coupled to the prosthetic mitral valve can be threaded through a lumen of the handle assembly and through a lumen of a tether retention mechanism (e.g., <NUM>, <NUM>) of the handle assembly. At <NUM>, the valve holding tube can be coupled to a hub of a catheter assembly (e.g., <NUM>, <NUM>) of the valve delivery device. Thus, the proximal end of the valve holding tube is coupled to the handle assembly and the distal end of the valve holding tube is coupled to the catheter assembly. At <NUM>, the distal end of the catheter assembly is inserted into a heart and extended to the left atrium of the heart. For example, with the valve holding tube coupled to the catheter assembly and to the handle assembly, the distal end of the sheath of the catheter assembly can be inserted into the heart. At <NUM>, a proximal actuator knob is actuated such that the prosthetic mitral valve is moved distally out of the valve holding tube and into a distal end portion of the delivery sheath. At <NUM>, a distal actuator knob is actuated to move the delivery sheath proximally such that the prosthetic mitral valve is disposed outside a distal end of the delivery sheath and within the left atrium of the heart. The prosthetic mitral valve is moved to a biased expanded configuration within the heart when uncompressed within the holding tube and delivery sheath.

<FIG> is a schematic illustration of a kit according to an example. In some examples, a surgical kit <NUM> can include a delivery device <NUM> which can be, for example, a delivery device as described herein (e.g., delivery device <NUM>, <NUM>, <NUM>) and a valve loading device <NUM> (e.g., valve loading device <NUM>, <NUM>). A kit <NUM> can also optionally include a recapture device <NUM> (e.g., <NUM>, <NUM>, <NUM>, <NUM>, <NUM>). A kit <NUM> can optionally include one or more of a transcatheter prosthetic valve <NUM> (e.g., a prosthetic mitral valve) and/or an epicardial pad <NUM> to secure the transcatheter valve <NUM> in position within the heart and/or a dilator device <NUM> (e.g., dilator device <NUM>, <NUM>, <NUM>) as described herein and/or a guidewire (not shown in <FIG>). A kit <NUM> can also include a sterile package <NUM> in which the components of the kit can be sealed for transport.

<FIG> illustrate another example of a dilator device that can be used with a delivery device (not shown with respect to <FIG>), such as, for example, the delivery devices <NUM>, <NUM>, <NUM> described above. A dilator device <NUM> can be inserted through a port of a catheter assembly, such as the port <NUM> of catheter <NUM> or the port <NUM> of catheter assembly <NUM> described above. A hemostasis valve (not shown) can be coupled to the side port such that the dilator device <NUM> is passed through the hemostasis valve when inserted through the side port <NUM>, <NUM>.

As shown in the side view of <FIG>, the dilator device <NUM> includes an expandable dilator balloon member <NUM> (also referred to herein as "balloon member") that has a tapered distal end that can provide a lead-in for a delivery sheath (not shown) (such as the delivery sheath <NUM> described above), and used to help open or enlarge the entry opening at the epicardial surface of the heart and through the wall of the ventricle, e.g. at the apex. The balloon member <NUM> is shown in <FIG>, <FIG>, and <FIG> in a partially inflated or almost fully inflated configuration.

The balloon member <NUM> is coupled to a balloon manifold <NUM> via an elongate inflation tube <NUM>. The balloon manifold <NUM> can be the same as or similar to the balloon manifold <NUM> described above and includes an inflation port <NUM> and a guidewire port <NUM>. The inflation port <NUM> can be coupled to a source of an inflation medium used to inflate and deflate the balloon member <NUM>. The elongate inflation tube <NUM> (also referred to herein as "inflation tube") is coupled to the balloon manifold <NUM> and to the balloon member <NUM> as described in more detail below. The inflation tube <NUM> defines an inflation lumen in fluid communication with an interior region of the balloon member <NUM> such that the inflation medium can travel through the inflation port <NUM>, through the inflation lumen, and into the balloon member <NUM>. The dilator device <NUM> also includes an elongate guidewire tube <NUM> (also referred to herein as "guidewire tube") that is coupled to a distal neck portion <NUM> of the balloon member <NUM> (described in more detail below) and extends through the balloon member <NUM>, the inflation lumen of the inflation tube <NUM> and out a proximal end of the inflation tube <NUM>. The guidewire tube <NUM> defines a guidewire lumen through which a guidewire (not shown) can be inserted. The guidewire can be, for example, <NUM>,<NUM> (<NUM> inches) in diameter.

<FIG> is a cross-sectional view taken along line B-B in <FIG>. As shown in <FIG>, the balloon manifold <NUM> includes a manifold hub <NUM> and a tapered strain relief portion <NUM> that relieves bending strain of inflation tube <NUM> relative to relatively rigid manifold hub <NUM>. The manifold hub <NUM> and the strain relief portion <NUM> can be coupled together, for example, via adhesive, at, for example, locations <NUM>.

As shown in <FIG>, a shipping mandrel <NUM> can be inserted through the guidewire lumen of the guidewire tube <NUM> and includes an elongate member <NUM> coupled to a proximal knob <NUM>. The elongate member <NUM> can be inserted through the balloon manifold <NUM> and the elongate guidewire tube <NUM> until a distal end is disposed outside a distal end of the inflation tube <NUM> as shown in <FIG>. The shipping mandrel <NUM> can be used to maintain the alignment of the various components of the dilator device <NUM> and reduce or eliminate the possibility of the guidewire tube <NUM> collapsing prior to use of the dilator device <NUM>. In this embodiment, the proximal knob <NUM> of the shipping mandrel <NUM> can be coupled to the balloon manifold <NUM> with a quick connect coupler, such as, for example, a Luer lock coupling mechanism. For example, the proximal knob <NUM> can include a Luer lock feature <NUM> that can be matingly coupled to a Luer lock feature <NUM> of the guidewire port <NUM> of the balloon manifold <NUM>. Before use of the dilator device <NUM>, the shipping mandrel <NUM> can be removed from the dilator device <NUM> by releasing the Luer lock feature <NUM> from the Luer lock feature <NUM> of the guidewire port <NUM> and pulling the shipping mandrel <NUM> proximally such that the shipping mandrel <NUM> is removed from the elongate guidewire tube <NUM> and the balloon manifold <NUM>.

<FIG> is a side view of the balloon member <NUM> in the partially inflated/expanded configuration. The balloon member <NUM> includes a first body portion <NUM> and a second body portion <NUM> having a first outer diameter and a second outer diameter, respectively. The second outer diameter is larger than the first outer diameter. Distal end portion of the balloon member <NUM> includes a tapered concave distal portion <NUM> and a distal neck portion <NUM>. Proximal end portion of the balloon member <NUM> includes a cone-shaped portion <NUM> and a proximal neck portion <NUM>.

The balloon member <NUM>, and the individual portions of the balloon member <NUM>, can have any suitable length. For example, the concave distal portion <NUM>, the first body portion <NUM>, and the second body portion <NUM> can have a combined length L1. In some embodiments, the length L1 can be, for example, about <NUM>,<NUM> (<NUM> inches). The concave distal portion <NUM> can have a length L2, the first body portion <NUM> can have a length L3, and the second body portion <NUM> can have a length L4. In some embodiments, the length L2 can be, for example, about <NUM>,<NUM> (<NUM> inches), the length L3 can be, for example, about <NUM>,<NUM> (<NUM> inches), and the length L4 can be, for example, about <NUM>,<NUM> (<NUM> inches). Additionally, in some embodiments, the tapered concave distal portion <NUM> can include a hydrophilic coating.

In some examples, the distal neck portion <NUM> can have a length L5 that can be, for example, about <NUM>,<NUM> (<NUM> inches), and the proximal neck portion <NUM> can have a length L6 that can be, for example, about <NUM>,<NUM> (<NUM> inches). The cone-shaped portion <NUM> can taper from the second body portion <NUM> to the proximal neck portion <NUM> at any suitable angle. For example, the taper of the cone-shaped portion <NUM> relative to the proximal neck portion <NUM> can be an angle θ1. In some embodiments, the angle θ1 can be, for example, <NUM>°. When in an uninflated configuration, as shown in <FIG>, the balloon member <NUM> can be folded or collapsed to a smaller size for insertion into a delivery sheath.

In some situations, depending on the inflation pressure of the balloon member <NUM>, the concave distal portion <NUM> can expand to a non-concave shape when the balloon member <NUM> is expanded to an inflated configuration. In such a case, the distal portion <NUM> may be tapered, but not concave. In some embodiments, the balloon member <NUM> can be configured such that the target pressure in the balloon is <NUM>-<NUM> ATM in an inflated configuration for use. At <NUM>-<NUM> ATM, the concave distal portion <NUM> can be configured to maintain a concave shape or a slightly more straightened tapered shape.

<FIG> is an enlarged view of detail C in <FIG>. As shown in <FIG>, the balloon member <NUM> includes a first transition portion 831A and a second transition portion 833A between the first body portion <NUM> and the second body portion <NUM>. The first transition portion 831A and the second transition portion 833A provide a smooth and radiused transition between the first body portion <NUM> and the second body portion <NUM>.

<FIG> is a distal end view of the balloon member <NUM> shown in <FIG>. As shown in <FIG>, and described above, the outer diameter of the second body portion <NUM> is larger than the outer diameter of the first body portion <NUM>. For example, in some examples, the second body portion <NUM> can have an outer diameter of about <NUM>,<NUM> (<NUM> inches) and the first body portion <NUM> can have an outer diameter of about <NUM>,<NUM> (<NUM> inches). The first outer diameter can be selected such that, when the first body portion <NUM> is disposed within a sheath such as sheath <NUM> described above, there is a smooth transition between the concave distal portion <NUM> and the sheath <NUM>. Additionally, the first body portion <NUM> can include a hydrophilic coating. The second outer diameter (of the second body portion <NUM>) can be selected such that, in an expanded configuration, when disposed inside a delivery sheath (such as sheath <NUM> described above), the second body portion <NUM> can create a seal against the inner surface of the delivery sheath. Said another way, when unrestrained and in an expanded/inflated configuration, the second outer diameter of the second body portion <NUM> can be larger than the inner diameter of the sheath.

<FIG> is a cross-sectional view taken along the line D-D shown in <FIG>. As shown in <FIG>, the distal neck portion <NUM> has an outer diameter D1 and an inner diameter D2. In some embodiments, the outer diameter D1 can be, for example, about <NUM>,<NUM> (<NUM> inches) and the inner diameter D2 can be, for example, about <NUM>,<NUM> (<NUM> inches).

<FIG> is a cross-sectional view taken along the line E-E shown in <FIG>. As shown in <FIG>, the proximal neck portion <NUM> has an outer diameter D3 and an inner diameter D4. In some examples, the outer diameter D3 can be, for example, about <NUM>,<NUM> (<NUM> inches) and the inner diameter D4 can be, for example, about <NUM>,<NUM> (<NUM> inches).

<FIG> is a side view of the balloon member <NUM>, the elongate inflation tube <NUM>, and the elongate guidewire tube <NUM>. As described above, the elongate guidewire tube <NUM> is disposed through the balloon inflation tube <NUM>. A distal portion of the elongate guidewire tube <NUM> extends distally of the balloon member <NUM> and a proximal portion of the elongate guidewire tube <NUM> extends proximally of the proximal end of the elongate inflation tube <NUM> by a length L7. The length L7 can be any suitable length that can engage with the balloon inflation manifold <NUM> (shown in <FIG>) such that the guidewire lumen defined by the elongate guidewire tube <NUM> is accessible via the guidewire port <NUM>. For example, in some embodiments, the length L7 can be about <NUM>,<NUM> (<NUM> inches).

<FIG> is an enlarged view of detail F identified in <FIG>. As shown in <FIG>, the distal neck portion <NUM> of the balloon member <NUM> can be coupled to the elongate guidewire tube <NUM> via an adhesive <NUM>. The adhesive <NUM> can be applied such that it creates a smooth taper transition region between the outer surface of the elongate guidewire tube <NUM> and the outer surface of the distal neck portion <NUM>. The taper of the adhesive <NUM> can be over a length L8, which, in some embodiments can be, for example, about <NUM>,<NUM> (<NUM> inches).

<FIG> is a cross-sectional view of the enlarged detail of <FIG> taken along the line G-G in <FIG>. As shown in <FIG>, the adhesive <NUM> coupling the elongate inflation tube <NUM> to the distal neck portion <NUM> of the balloon member <NUM> can also be disposed over a length L9 between an inner surface of the distal neck portion <NUM> and the outer surface of the elongate guidewire tube <NUM>. In some embodiments, the length L9 can be, for example, between about <NUM>,<NUM> (<NUM> inches) and about <NUM>,<NUM> (<NUM> inches).

Additionally, as shown in <FIG>, the elongate guidewire tube <NUM> can include a first portion <NUM> at a distal end (also referred to as distal end portion <NUM>) that can be formed with a softer material than a remaining second portion <NUM> of the elongate guidewire tube <NUM> to provide an atraumatic distal end to reduce potential trauma to surrounding tissue when inserted into a patient's heart. For example, in some embodiments, the distal end portion <NUM> can be formed with a low durometer material, such as, Pebax®, cross-linked Pebax®, nylon, urethane, or the like. The elongate guidewire tube <NUM> can be disposed within the distal neck portion <NUM> such that the distal end portion <NUM> of the elongate guidewire tube <NUM> overlaps the distal neck portion <NUM> of the balloon member <NUM> by a length L10. In some embodiments, the length L10 can be, for example, about <NUM>,<NUM> (<NUM> inches). The remaining second portion <NUM> of the guidewire tube <NUM> can be formed with multiple layers to provide improved guidewire movement, kink resistance and bondability. For example, in some embodiments, the remaining second portion <NUM> of the guidewire tube <NUM> can be formed with a three layer construction including an inner layer of PTFE/PI composite material, a coil material formed with, for example, 304V Stainless steel, and an outer layer of material formed with Pebax® <NUM> SA01 for medical use. The first or distal end portion <NUM> of the guidewire tube <NUM> can have a larger inner diameter than an outer diameter of the second portion <NUM> of the guidewire tube <NUM> such that a distal end of the second portion <NUM> can be received within the lumen of the distal end portion <NUM>. The first or distal end portion <NUM> can also be coupled to the second portion of the guidewire tube <NUM> with an adhesive disposed between the outer surface of the remaining portion and the distal end portion <NUM>.

<FIG> is a side view of the balloon member <NUM> coupled to the elongate inflation tube <NUM>. As shown in <FIG>, the proximal neck portion <NUM> of the balloon member <NUM> can be coupled to the elongate inflation tube <NUM>. Also as shown, the elongate inflation tube <NUM> can have a length L11. In some examples, the length L11 can be, for example, about <NUM>,<NUM> (<NUM> inches). The elongate inflation tube <NUM> can be coupled to the balloon member <NUM> via an adhesive <NUM>.

<FIG> is an enlarged view of detail H in <FIG>. As shown in <FIG>, a distal end portion <NUM> of the elongate inflation tube <NUM> is disposed within the proximal neck portion <NUM> of the balloon member <NUM>. The proximal neck portion <NUM> can have a diameter D5, which in some examples can be, for example, about <NUM>,<NUM> (<NUM> inches) or less. The distal end portion <NUM> of the elongate inflation tube <NUM> can have a smaller outer diameter D6 than a diameter D7 of the remaining portion <NUM> of the inflation tube <NUM> such that it can be inserted into the proximal neck portion <NUM> of the balloon member <NUM> (as shown in <FIG>). For example, in some examples, the diameter D6 of the distal end portion <NUM> can be <NUM>,<NUM> (<NUM> inches), and the diameter D7 of the remaining portion <NUM> of the inflation tube <NUM> can be, for example, <NUM>,<NUM> (<NUM> inches). In some embodiments, an inner diameter of the distal end portion <NUM> can be the same as inner diameter of the remaining portion <NUM> of the inflation tube <NUM> as shown in <FIG>. In some embodiments, the distal end portion <NUM> and the remaining portion <NUM> of the inflation tube <NUM> can be formed as an integral or monolithically formed component. In some embodiments, the distal end portion <NUM> and the remaining portion <NUM> of the inflation tube <NUM> can be separate components that are coupled together.

As shown in <FIG>, in some examples, the distal end portion <NUM> of the inflation tube <NUM> can be disposed a length L13 into the proximal neck portion <NUM> of the balloon member <NUM>. In some examples, the length L13 can be, for example, at least about <NUM>,<NUM> (<NUM> inches). An adhesive <NUM> can be disposed between the proximal neck portion <NUM> of the balloon member <NUM> and the distal end portion <NUM> of the elongate inflation tube <NUM> to securely couple the proximal neck portion <NUM> to the elongate inflation tube <NUM>. In some embodiments, the distal end portion <NUM> is inserted into the proximal neck portion <NUM> such that there is a small gap between the proximal end of the neck portion <NUM> and the larger diameter portion <NUM> of the inflation tube <NUM> and the adhesive <NUM> can be disposed within this gap and smoothed along the outer surface of the two components. The adhesive <NUM> can provide a smooth, tapered transition between the outer surface of the proximal neck portion <NUM> and the outer surface of elongate inflation tube <NUM>. In some embodiments, the adhesive <NUM> can be disposed over a length L12, which can be, for example, about <NUM>,<NUM> (<NUM>. <NUM> inches).

In use, as described above, the dilator device <NUM> can be used in conjunction with a delivery device such as the delivery devices <NUM>, <NUM>, <NUM>, described above, to deliver and deploy a prosthetic mitral valve within a heart. When in an uninflated configuration (not shown), the dilator device <NUM> can be folded or collapsed and inserted through the hemostasis valve (not shown) coupled to a port of a hub of a catheter assembly (e.g., a port <NUM>, <NUM> of a hub <NUM>, <NUM> of a catheter assembly <NUM>, <NUM>). The dilator device <NUM> can be pushed or moved distally within the lumen of the delivery sheath <NUM>, <NUM> until the concave distal portion <NUM> of the balloon member <NUM> extends distally of the distal end of the delivery sheath <NUM>, <NUM> and the first body portion <NUM> and the second body portion <NUM> are disposed within the delivery sheath <NUM>, <NUM>. In some embodiments, the dilator device <NUM> can include a marker <NUM> (see <FIG>) on an exterior of the inflation tube <NUM> to assist in the positioning of the dilator device <NUM> within the delivery sheath <NUM>, <NUM>. For example, the marker <NUM> can be disposed on the inflation tube <NUM> at a location such that as the dilator device <NUM> is inserted into the delivery sheath, when the marker <NUM> reaches the hemostasis valve coupled to the side port of the delivery sheath, the balloon <NUM> will be positioned at the correct location within the delivery sheath.

With the dilator device <NUM> coupled to the catheter assembly (e.g., disposed within the delivery sheath <NUM>, <NUM> of the catheter assembly <NUM>, <NUM>), the catheter assembly can be coupled to or docked with the handle assembly of the delivery device (e.g., handle assembly <NUM>, <NUM> of delivery device <NUM>, <NUM>). The shipping mandrel <NUM> can be decoupled from the guidewire port <NUM> and removed from the elongate guidewire tube <NUM> before or after the catheter assembly (e.g., <NUM>, <NUM>) is docked/coupled to the handle assembly (e.g., <NUM>, <NUM>) of the delivery device (e.g., <NUM>, <NUM>). After coupling the catheter assembly (with the dilator device coupled thereto) to the handle assembly, the delivery sheath can be purged of air and the balloon member <NUM> can be expanded from the uninflated configuration (e.g., folded or collapsed) to an inflated configuration such that the second body portion <NUM> creates a seal against the inner surface of the delivery sheath <NUM>, <NUM>. The entire assembly can be loaded over a guidewire (not shown) via the distal end of the lumen of the elongate guidewire tube <NUM>. For example, a guidewire can be inserted into the patient's heart and extend outside the patient's body and a proximal end of the guidewire can be inserted into the distal end of the guidewire tube <NUM> and extended out the proximal end of the guidewire tube <NUM>. With the guidewire inserted therethrough, the distal end portion of the dilator device <NUM> and delivery sheath <NUM>, <NUM> can be inserted through the epicardial surface of the patient's heart (e.g. at the apex) and extended through the wall of the left ventricle and into the left atrium of the heart. The tapered distal end of the balloon member <NUM> helps to open or enlarge the entry opening at the epicardial surface. When the delivery sheath <NUM>, <NUM> is in a desired location, the balloon member <NUM> can be deflated and the dilator device <NUM> can be removed from the delivery device <NUM>, <NUM> via the port <NUM>, <NUM>. Then delivery device <NUM>, <NUM> can be actuated to deliver the prosthetic mitral valve as described above with reference to previous embodiments.

<FIG> is side view of a balloon member <NUM> engaged with a sheath <NUM> shown in cross-section. The balloon member <NUM> can be similar to the balloon member <NUM>. For example, the dilation device <NUM> includes a first body portion <NUM> and a second body portion <NUM> having a first outer diameter and a second outer diameter, respectively. The second outer diameter is larger than the first outer diameter. The balloon member <NUM> also includes a tapered concave distal portion <NUM> and a distal neck portion <NUM>. On the proximal side, the balloon member <NUM> includes a cone-shaped proximal portion <NUM> and a proximal neck portion <NUM>.

In this example, the balloon member <NUM> also includes an enlarged portion <NUM>. The enlarged portion <NUM> can be shaped as a ring and has an increased outer diameter relative to the first body portion <NUM> when inflated (as shown in <FIG>). The sheath <NUM> can be the same as or similar to the delivery sheaths <NUM> or <NUM> described above. As shown in <FIG>, the sheath <NUM> can abut the proximal side of the enlarged portion <NUM>. As a result of the abutment of the sheath <NUM> with the enlarged portion <NUM>, the transition between the balloon <NUM> and the sheath <NUM> is smooth. Said another way, as the balloon member <NUM> and sheath <NUM> are moved through the epicardial surface, tissue will not catch on the distal end of the sheath <NUM>. Additionally, the enlarged portion <NUM> can act as a limit or stop for the sheath <NUM> such that when the balloon member <NUM> is in the inflated configuration, the sheath <NUM> cannot translate distally beyond the enlarged portion <NUM>.

<FIG> illustrate another example of a recapture device that can be used to recapture a deployed/implanted prosthetic heart valve (e.g., prosthetic mitral valve) to reposition and/or retrieve/remove the prosthetic heart valve. A recapture device <NUM> includes an outer sheath <NUM> coupled to a handle assembly <NUM>, an outer dilator <NUM> operatively coupled to the handle assembly <NUM> and movably disposed within a lumen of the outer sheath <NUM>, and an inner dilator <NUM> movably disposed within a lumen of the outer dilator <NUM> and operatively coupled to the handle assembly <NUM>. In this example, the recapture device <NUM> includes a tether retention mechanism that is incorporated into the actuator assembly as described in more detail below. The inner dilator <NUM> defines a lumen that can receive a tether extending from a prosthetic valve (not shown) and can receive a portion of the prosthetic valve during a recapture procedure. The inner dilator <NUM> also includes a distal tip configured to engage the prosthetic valve implanted within a heart as described in more detail below.

As shown in <FIG>, the handle assembly <NUM> includes a housing <NUM>, an actuator knob <NUM> coupled to the housing <NUM> and operatively coupled to a drive shaft mechanism <NUM>. The drive shaft mechanism <NUM> is operatively coupled to the inner dilator <NUM> and includes a winding housing <NUM> that winds the tether (extending from the prosthetic valve) during the recapture procedure as described in more detail below. A first spring <NUM> is coupled to an elongate tube <NUM> and to the inner dilator <NUM>. The first spring <NUM> can be, for example a coil spring. The outer dilator <NUM> is coupled to an elongate rod <NUM> which is coupled to a pair of tape springs <NUM>, which can be, for example, constant force springs, or variable force springs.

To capture a prosthetic heart valve with the recapture device <NUM>, the tether extending from the prosthetic valve can be inserted through a distal end of the inner dilator <NUM>, extend through the lumen of the inner dilator <NUM>, through the elongate tube <NUM>, through the winding housing <NUM>, through a hypotube <NUM> and out a proximal end of the recapture device <NUM>. A Touhy valve <NUM> is coupled to the hypotube <NUM> and is configured to clamp the tether thereto and provide resistance as the tether is wound during a recapture procedure as described below. The valve <NUM> can also provide a seal to allow for a saline flush of the system.

With the tether threaded through the recapture device <NUM>, the distal tip of the inner dilator <NUM> can be moved distally along the tether to engage a proximal portion of the prosthetic valve. The actuator <NUM> can then be actuated (e.g., rotate or turn the knob) to move the inner dilator <NUM> proximally relative to the outer dilator <NUM>. As the inner dilator <NUM> is moved proximally, the tether is wound within the winding housing <NUM>, and the valve will in turn be pulled proximally. For example, the tether can be wound from both directions into the winding housing <NUM>. One direction coming from the tether extending into the hypotube <NUM> and the other direction being the tether entering the housing <NUM> from the elongate tube <NUM>. The inner dilator <NUM> can continue to be actuated to move proximally relative to the outer dilator <NUM> pulling the prosthetic valve partially within the lumen of the outer dilator <NUM> until the spring <NUM> collapses fully and bottoms out against the outer dilator <NUM> and the force on the spring <NUM> increases. At this point, the valve has been partially captured and can be repositioned within the heart if desired.

To fully capture and retrieve/remove the valve, the actuator <NUM> can continue to be actuated (e.g., rotated/turned), and due to the force of the spring <NUM> against the outer dilator <NUM>, the outer dilator <NUM> will begin to move proximally with the inner dilator <NUM> and the valve coupled thereto. In other words, the inner dilator <NUM> pulls the outer dilator <NUM> proximally relative to the outer sheath <NUM>. The outer sheath <NUM> remains fixed relative to the handle assembly <NUM>. As the outer dilator <NUM> is moved proximally, the elongate rod <NUM> engages with the tape springs <NUM> and slides within a slot <NUM>. The springs <NUM> coupled to the outer dilator <NUM> via the elongate rod <NUM> can control the force used to move the outer dilator <NUM> proximally. In some examples, the springs <NUM> can provide a constant force of, for example, <NUM>-<NUM> lbs. In some examples, the springs <NUM> can provide a variable force. For example, it may be desirable to provide a greater spring force at the start of the actuation of the outer dilator <NUM>. As the outer dilator <NUM> is moved proximally, the valve is pulled fully into the lumen of the outer sheath <NUM> and moved to a collapsed configuration. The valve can then be removed/retrieved from the heart by removing the recapture device <NUM> from the patient's body with the valve therein.

<FIG> illustrate another example of a recapture device that can be used to recapture a deployed/implanted prosthetic heart valve (e.g., prosthetic mitral valve) to reposition and/or retrieve/remove the prosthetic heart valve. A recapture device <NUM> includes an outer sheath <NUM> coupled to a handle assembly <NUM>, an outer dilator <NUM> operatively coupled to the handle assembly <NUM> and movably disposed within a lumen of the outer sheath <NUM>, and an inner dilator <NUM> movably disposed within a lumen of the outer dilator <NUM> and operatively coupled to the handle assembly <NUM>. As with the previous embodiment, the recapture device <NUM> includes a tether retention mechanism that is incorporated into the actuator assembly as described in more detail below. The inner dilator <NUM> defines a lumen that can receive a tether extending from a prosthetic valve (not shown) and can receive a portion of the prosthetic valve during a recapture procedure. The inner dilator <NUM> also includes a distal tip configured to engage the prosthetic valve implanted within a heart as described in more detail below.

As shown in <FIG>, the handle assembly <NUM> includes a housing <NUM>, an actuator knob <NUM> coupled to the housing <NUM> and operatively coupled to a drive shaft mechanism <NUM>. The drive shaft mechanism <NUM> is operatively coupled to the inner dilator <NUM> and includes a winding housing <NUM> that winds the tether (extending from the prosthetic valve) during the recapture procedure as described in more detail below. A first spring <NUM> is coupled to an elongate tube <NUM> and to the inner dilator <NUM>. The first spring <NUM> can be, for example a coil spring. In this embodiment, the outer dilator <NUM> is coupled to the elongate rod <NUM> which is also coupled to a second spring <NUM>, which can also be, for example, a coil spring. The spring <NUM> has a softer spring rate than the second spring <NUM>. A release lever <NUM> is couple to the drive shaft mechanism <NUM> and can prevent the drive mechanism <NUM> from moving backwards during a recapture procedure. If desired, however, the release lever <NUM> can be actuated to allow the drive mechanism to back up if needed.

To fully capture and retrieve/remove the valve, the actuator <NUM> can continue to be actuated (e.g., rotated/turned), which will cause the outer dilator <NUM> to begin to move proximally with the inner dilator <NUM> and the valve coupled thereto. In other words, the inner dilator <NUM> pulls the outer dilator <NUM> proximally relative to the outer sheath <NUM>. The outer sheath <NUM> remains fixed relative to the handle assembly <NUM>. As the outer dilator <NUM> is moved proximally, the outer dilator <NUM> applies a force against the second spring <NUM>. The second spring <NUM> can help control the force used to move the outer dilator <NUM> proximally. In some examples, the spring <NUM> can provide a constant force of, for example, <NUM>-<NUM> lbs. In some examples, the springs <NUM> and <NUM> can each provide a variable force. As the outer dilator <NUM> is moved proximally, the valve is pulled fully into the lumen of the outer sheath <NUM> and moved to a collapsed configuration. The valve can then be removed/retrieved from the heart by removing the recapture device <NUM> from the patient's body with the valve therein.

<FIG> illustrate another example of a recapture device that can be used to recapture a deployed/implanted prosthetic heart valve (e.g., prosthetic mitral valve) to reposition and/or retrieve/remove the prosthetic heart valve. A recapture device <NUM> includes an outer sheath <NUM> coupled to a handle assembly <NUM>, an outer dilator <NUM> operatively coupled to the handle assembly <NUM> and movably disposed within a lumen of the outer sheath <NUM>, and an inner dilator <NUM> movably disposed within a lumen of the outer dilator <NUM> and operatively coupled to the handle assembly <NUM>. The inner dilator <NUM> defines a lumen that can receive a tether (not shown) extending from a prosthetic valve (not shown) and can receive a portion of the prosthetic valve during a recapture procedure. The inner dilator <NUM> also includes a distal tip configured to engage the prosthetic valve implanted within a heart as described in more detail below. In this example, the recapture device <NUM> includes a tether retention mechanism <NUM> that includes a pinning member that can pierce the tether and secure the tether to the recapture device <NUM>.

As shown in <FIG>, the handle assembly <NUM> includes a housing <NUM>, a first actuator knob <NUM> operatively coupled to the inner dilator <NUM>, and a second actuator knob <NUM> operatively coupled to the outer dilator <NUM>. An elongate tube <NUM> is coupled to the inner dilator <NUM> and extends through the housing <NUM> and is coupled to the tether retention mechanism <NUM>.

To capture a prosthetic heart valve with the recapture device <NUM>, the tether extending from the prosthetic valve can be inserted through a distal end of the inner dilator <NUM>, extend through the lumen of the inner dilator <NUM>, through the elongate tube <NUM>, and is pinned by the retention mechanism <NUM> at a proximal end of the handle assembly <NUM>. With the tether threaded through the recapture device <NUM>, the distal tip of the inner dilator <NUM> can be moved distally along the tether to engage a proximal portion of the prosthetic valve. The first actuator <NUM> can then be actuated (e.g., rotate or turn the knob) to move the inner dilator <NUM> proximally relative to the outer dilator <NUM>. As the inner dilator <NUM> is moved proximally, the retention mechanism <NUM> and tether coupled thereto are pulled with the inner dilator <NUM>, and the valve will in turn be pulled proximally. As the valve is pulled proximally, a portion of the valve will be pulled into the lumen of the outer dilator <NUM> and moved to a collapsed configuration within the lumen. At this point, the valve has been partially captured and can be repositioned within the heart if desired.

To fully capture and retrieve/remove the valve, the second actuator knob <NUM> can be actuated (e.g., rotated/turned), which will cause the outer dilator <NUM> to begin to move proximally with the inner dilator <NUM> and the valve coupled thereto. The outer sheath <NUM> remains fixed relative to the handle assembly <NUM>. The outer dilator <NUM> can be moved proximally until the valve is fully disposed within the outer sheath <NUM> and moved to a collapsed configuration. The valve can then be removed/retrieved from the heart by removing the recapture device <NUM> from the patient's body with the valve disposed therein.

<FIG> illustrate another example of a recapture device that can be used to recapture a deployed/implanted prosthetic heart valve (e.g., prosthetic mitral valve) to reposition and/or retrieve/remove the prosthetic heart valve. A recapture device <NUM> includes an outer sheath <NUM> coupled to a handle assembly <NUM>, an outer dilator <NUM> operatively coupled to the handle assembly <NUM> and movably disposed within a lumen of the outer sheath <NUM>, and an inner dilator <NUM> movably disposed within a lumen of the outer dilator <NUM> and operatively coupled to the handle assembly <NUM>. The inner dilator <NUM> defines a lumen that can receive a tether (not shown) extending from a prosthetic valve (not shown) and can receive a portion of the prosthetic valve during a recapture procedure. The inner dilator <NUM> also includes a distal tip configured to engage the prosthetic valve implanted within a heart as described in more detail below. In this embodiment, the recapture device <NUM> includes a tether retention mechanism <NUM> that includes a pinning member that can pierce the tether and secure the tether to the recapture device <NUM>.

As shown in <FIG> and <FIG>, the handle assembly <NUM> includes a housing <NUM>, an elongate threaded member <NUM>, and an actuator knob <NUM>. The actuator knob <NUM> is operatively coupled to the inner dilator <NUM> and to the outer dilator <NUM>. An elongate tube <NUM> is coupled to the actuator knob <NUM> and also to the inner dilator <NUM> and to the outer dilator <NUM>, and extends through the housing <NUM>. The actuator knob <NUM> can be actuated by rotating the actuator knob <NUM>, which causes the actuator knob to travel along the threaded member <NUM>. The tether retention mechanism <NUM> is operatively coupled to the actuator knob <NUM> such that when the actuator knob is actuated (e.g., rotated/turned) the tether retention mechanism <NUM> moves with the actuator knob <NUM> relative to the threaded member <NUM>. As shown in <FIG>, the pinning member of the tether retention mechanism <NUM> extends out a slot of the elongate threaded member <NUM>, and the tether retention mechanism <NUM> can move along the slot <NUM> as the actuator knob <NUM> is actuated. In some embodiments, the actuator knob <NUM> and/or threaded member <NUM> includes a one-way mechanism that only allows the actuator knob <NUM> to travel along the threaded member <NUM> in one direction. This can prevent the actuator knob <NUM> from being inadvertently moved back distally during a recapture procedure. A release lever <NUM> is coupled to the outer dilator <NUM> and is configured to releasably secure the outer dilator <NUM> in a fixed position relative to the outer sheath <NUM> as described in more detail below.

To capture a prosthetic heart valve with the recapture device <NUM>, the tether extending from the prosthetic valve can be inserted through a distal end of the inner dilator <NUM>, extend through the lumen of the inner dilator <NUM>, through the elongate tube <NUM>, and is pinned by the retention mechanism <NUM>. With the tether threaded through the recapture device <NUM>, the distal tip of the inner dilator <NUM> can be moved distally along the tether to engage a proximal portion of the prosthetic valve. With the release lever <NUM> engaged (e.g., pushed in) such that the outer dilator <NUM> can't move relative to the outer sheath <NUM>, the actuator knob <NUM> can be actuated (e.g., rotate or turn the knob) to move the inner dilator <NUM> proximally relative to the outer dilator <NUM> and relative to the outer sheath <NUM>. As the inner dilator <NUM> is moved proximally, the retention mechanism <NUM> and tether coupled thereto move proximally with the inner dilator <NUM>, and the valve will in turn be moved proximally such that a portion of the valve will be pulled into the lumen of the outer dilator <NUM> and moved to a collapsed configuration within the lumen of the outer dilator <NUM>. At this point, the valve has been partially captured and can be repositioned within the heart if desired.

To fully capture and retrieve/remove the valve, the release lever <NUM> can be pulled or moved to release the outer dilator <NUM> from the outer sheath <NUM>. The actuator knob <NUM> can be actuated to travel further proximally along the elongate threaded member <NUM> which will cause the outer dilator <NUM> to move proximally with the inner dilator <NUM> and the valve coupled thereto. The outer sheath <NUM> remains fixed relative to the handle assembly <NUM>. The outer dilator <NUM> can be moved proximally until the valve is fully disposed within the lumen of the outer sheath <NUM> and moved to a collapsed configuration. The valve can then be removed/retrieved from the heart by removing the recapture device <NUM> from the patient's body with the valve disposed therein.

As described above for recapture device <NUM>, each of the recapture devices described herein (i.e., <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) include a two-stage actuation of the recapture device that allows for a controlled capture of a prosthetic valve implanted within a heart to reposition and/or remove/retrieve the prosthetic valve. The proximal portion of the frame of the valve can first be collapsed sufficiently for a portion of the frame to be disposed within the lumen of the outer dilator (e.g., <NUM>, <NUM>, <NUM>, <NUM>, <NUM>), and then can transition into a more fully collapsed configuration as it is moved into the lumen of the outer sheath (e.g., <NUM>, <NUM>, <NUM>, <NUM>, <NUM>).

While various examples <NUM>. have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.

Claim 1:
An apparatus (<NUM>, <NUM>, <NUM>'), comprising:
a loading funnel assembly (<NUM>, <NUM>, <NUM>') configured to receive therein a prosthetic heart valve (PMV) in a collapsed configuration;
a valve holding tube (<NUM>, <NUM>, <NUM>') defining an interior region configured to receive the prosthetic heart valve (PMV) in the collapsed configuration, the valve holding tube (<NUM>, <NUM>, <NUM>') having a first end portion configured to be releasably coupled to the loading funnel assembly (<NUM>, <NUM>, <NUM>') and a second end portion; and
a handle assembly (<NUM>, <NUM>) including a handle (<NUM>, <NUM>, <NUM>') and a loading leadscrew (<NUM>, <NUM>, <NUM>'), the loading leadscrew (<NUM>, <NUM>, <NUM>') configured to be releasably coupled to the second end portion of the valve holding tube (<NUM>, <NUM>, <NUM>'), the handle assembly (<NUM>, <NUM>) further including a tether retention mechanism (<NUM>, <NUM>, <NUM>') and an actuator knob, the tether retention mechanism (<NUM>, <NUM>, <NUM>') configured to secure a tether (T) extending from the prosthetic heart valve (PMV) disposed within the loading funnel assembly (<NUM>, <NUM>, <NUM>') in a fixed position relative to the handle assembly (<NUM>, <NUM>),
the actuator knob is operatively coupled to the loading leadscrew (<NUM>, <NUM>, <NUM>') and the handle (<NUM>, <NUM>, <NUM>') such that relative movement between the handle (<NUM>, <NUM>, <NUM>') and the loading leadscrew (<NUM>, <NUM>, <NUM>') causes the prosthetic heart valve (PMV) to be disposed within the valve holding tube (<NUM>, <NUM>, <NUM>').