Patent Description:
Prosthetic heart valves can replace defective human valves in patients. Prosthetic heart valves come in two varieties: bioprosthetic (e.g., tissue) heart valves and mechanical heart valves. During a valve replacement procedure, valve prostheses are typically sutured to peripheral tissue of a natural heart valve orifice (the "annulus") after surgical removal of damaged or diseased natural valve structure. For example, the sewing ring of the prosthetic valve may be secured to the annulus via sutures. This procedure can be very complicated, as surgeons are manipulating multiple sutures and small components while working in tight spaces with limited visibility. The difficulties can be even greater with the implementation of tissue valves, given their shape and construction.

When placing a bioprosthetic heart valve in a mitral position, for example, the commissure posts are the first portion of the valve entering inside the patient's annulus during valve delivery. Given the close proximity of the multiple pre-installed sutures and the commissure posts, it is not uncommon for one or more of the commissure posts to become entangled with one or more of the pre-installed sutures (commonly referred to as "suture looping"). Moreover, as the commissure posts are not visible at this point during the procedure, the surgeon cannot visually detect whether any such entanglement has occurred. This problem is even more pronounced during a minimally-invasive access approach, a technique that is quickly becoming more common in the industry, which provides even more limited visibility of the surgical field during valve delivery.

Prosthetic heart valves are often implanted using minimally invasive cardiothoracic surgery (MICS) tools and techniques. MICS techniques involve performing a procedure or implanting a device through a small incision (e.g., often through the ribs), so require tools allowing access to the cardiothoracic region through this smaller incision. There is a need for implantation accessories, systems and methods to efficiently size and align the valve for ease of implantation.

While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

The present device and method can be utilized to improve implantation procedures and performance of heart valve prostheses in a wide variety of applications where the heart valve prosthesis is surgically attached to a prepared valvular rim (or annulus). The embodiments disclosed herein are directed to improved removable bioprosthetic heart valves for implantation into an implantable abutment ring, the removable bioprosthetic heart valve comprising a valve frame having tissue leaflets attached thereto (or alternatively, a mechanical pivotal disk or mechanical leaflets or equivalents thereof). The various aspects of the present invention may be utilized in mitral valve (or other heart valve-aortic, etc.) replacement wherein a prosthetic heart valve frame operates in accordance with a suture ring.

<FIG> a schematic view illustrating a removable bioprosthetic heart valve assembly <NUM> and implantation into a patient, according to some embodiments described in the disclosure. In various embodiments, the removable prosthetic heart valve assembly <NUM> is a bioprosthetic (i.e., tissue) heart valve assembly. As discussed above, tissue valves generally include a plurality of tissue cusps or leaflets, e.g., made from bovine pericardium or harvested porcine heart valve tissue, mounted onto a stationary metal or plastic frame structure. This frame structure operates to maintain the various cusps or leaflets in a desired orientation and shape that promotes sufficient valve opening and closing characteristics and proper blood flow.

In various other embodiments, the prosthetic heart valve assembly <NUM> is a mechanical heart valve assembly. As mentioned above, a modern mechanical heart valve prosthesis is typically formed of an annular valve seat in a relatively rigid valve body and includes an occluding disk or pair of leaflets that moves between a closed, seated position and an open position in a prescribed range of motion.

While the embodiments discussed herein can operate to employ either bioprosthetic or mechanical heart valves, the discussion below is provided with reference to bioprosthetic heart valves as shown in <FIG>. It should be appreciated, however, that mechanical heart valves (as shown in <FIG> and <FIG>) may also be employed with the embodiments discussed herein, and that reference to bioprosthetic heart valves should not serve to limit the teaching of this disclosure.

In one embodiment, removable bioprosthetic heart valve assembly <NUM> for implantation into an implantable abutment ring <NUM> includes valve frame <NUM> having tissue leaflets therein and holder <NUM>. As discussed in greater detail below, abutment ring <NUM> is configured to receive valve frame <NUM>, and valve frame <NUM> is configured to be received by abutment ring <NUM>. Together, holder <NUM>, valve frame <NUM>, and a plurality of tissue leaflets (not shown) located within the valve frame <NUM> generally make up the structure of the removable bioprosthetic heart valve assembly <NUM>. Together, removable bioprosthetic heart valve assembly <NUM> and abutment ring <NUM> generally make a multiple component heart valve prosthesis <NUM> for implantation at a heart valve annulus location of a patient's heart, in its assembled configuration. As mentioned, removable bioprosthetic heart valve assembly <NUM> includes holder <NUM> for maneuvering and implanting valve frame <NUM> into abutment ring <NUM>. Advantageously, holder <NUM> is detachable and removable after successful implantation of valve frame <NUM> into abutment ring <NUM>. Valve frame <NUM> is interchangeably referred to herein as valve <NUM>, and it is understood that valve or valve frame <NUM> further includes a plurality of tissue leaflets located within the valve frame <NUM>.

As shown in <FIG>, removable bioprosthetic heart valve assembly <NUM> for implantation into abutment ring <NUM>, having axis A1, is attached at heart valve annulus location <NUM> of a patient's heart. Patient <NUM>, in a minimally-invasive access approach, for example, is entered through patient chest opening <NUM> to access ventricle <NUM>. Abutment ring <NUM> is secured to patient annulus <NUM>. Abutment ring <NUM> includes axis A1 passing through its center. Axis A1 is generally perpendicular to the annulus. Once secured to annulus <NUM>, there is limited access to abutment ring <NUM> due to physical constraints within patient <NUM>, thus making implantation of valve <NUM> challenging.

Removable bioprosthetic heart valve assembly <NUM> comprises bioprosthetic valve <NUM> for coupling to abutment ring <NUM>, and holder <NUM> detachably coupled to valve <NUM>. To facilitate implanting valve <NUM>, holder <NUM> is coupled also to handle <NUM> via fit joint (<NUM>, shown in <FIG>). Holder <NUM>, coupled to valve <NUM>, includes surface <NUM> and axis A2. Axis A2 is perpendicular to surface <NUM>. Surface <NUM> is planar and disc shaped to couple with valve <NUM>. Upon inserting holder <NUM> via handle <NUM> through opening <NUM>, axis A2 is offset to axis A1 by angle <NUM>. Angle <NUM> is an acute angle, ranging in measurement from less than <NUM> degrees but more than zero degrees. Holder <NUM> further includes maneuvering system <NUM> (<FIG>) for aligning axis A2 with axis A1. Alignment of axes A1 and A2 prior to seating of valve <NUM> into abutment ring <NUM> ensures proper implantation of valve <NUM> into abutment ring <NUM>. Holder <NUM>, having maneuvering system <NUM>, is interchangeably referred to herein as tiltable holder <NUM>. In some embodiments, abutment ring <NUM> is attachable to a patient's mitral valve rim.

<FIG> is a perspective view illustrating holder <NUM> and fit joint <NUM> for removable bioprosthetic heart valve assembly <NUM> as shown in <FIG>. Holder <NUM> is coupled to fit joint <NUM>. <FIG> is a perspective view illustrating fit joint <NUM> as in <FIG>. Fit joint <NUM> includes proximal end <NUM> and distal end <NUM>, proximal end <NUM> is configured for coupling to holder <NUM> and distal end <NUM> is configured for coupling to elongated handle <NUM> (as shown in <FIG>). Fit joint <NUM> is detachable as needed. Advantageously, fit joint <NUM> detaches from holder <NUM> to allow access to maneuvering system <NUM> by the physician using, for example, MICS forceps. <FIG> is a perspective view illustrating holder <NUM> for detachable coupling to fit joint <NUM> as in <FIG>. Holder <NUM> is interchangeably referred to herein as holder template.

<FIG> is a perspective view illustrating holder <NUM> of removable bioprosthetic heart valve assembly <NUM>. Holder <NUM>, having axis A2, includes surface <NUM> and maneuvering system <NUM>. Maneuvering system <NUM> includes central pin <NUM> pivotable relative to holder <NUM>, pivoting as indicated by direction <NUM>. Axis A2 passes through central pin <NUM>. Central pin <NUM> is further rotatable with the holder in a first clockwise direction D1 and in a second counter-clockwise direction D2. In some embodiments, central pin <NUM> is attachable to a minimally invasive cardiothorasic surgery (MICS) forceps for ease in maneuverability. Maneuvering system <NUM> further includes threadable arcuate bores <NUM> and <NUM>. Each threadable arcuate bore, bores <NUM> and <NUM>, include first and second openings disposed at surface <NUM>. Bore <NUM> includes openings <NUM> and <NUM>. Bore <NUM> includes openings <NUM> and <NUM>.

<FIG> is a perspective view illustrating holder <NUM> of removable bioprosthetic heart valve assembly <NUM>. Threadable arcuate bore <NUM> and threadable arcuate bore <NUM> include threads <NUM> and <NUM> therethrough, respectively. Manipulation or pulling on threads <NUM> and <NUM>, while grasping the central pin <NUM> (e.g., with a MICS forceps), operate to tilt surface <NUM> and aligning axis A1 and axis A2. Surface <NUM> is tiltable about axis z (see coordinates <NUM>), which extends parallel to the central pin <NUM>. Advantageously, surface <NUM> is maneuverable to align axes A1 and A2 when holder <NUM> and valve <NUM>, as coupled, are proximate abutment ring <NUM>. In some embodiments, a retaining surgical suture may be attached to at least one of the bores <NUM>, <NUM>. This retaining suture may extend to outside the patient (e.g., to the surgeon) and may be used to ensure the device does not get lost inside the patient.

<FIG> also illustrates holes <NUM> through the thickness of holder <NUM>, the holes extending from surface <NUM> to surface <NUM> opposite thereof. These holes enable coupling of holder <NUM> to valve <NUM> and include sutures <NUM>, <NUM>, and <NUM> for attachment as shown in <FIG>. Advantageously, sutures <NUM>, <NUM>, and <NUM> can be cut after successful seating and securing of valve <NUM> into abutment ring <NUM>. Thusly, holder <NUM> is detachable and able to be removed from the patient. Holders <NUM> are sized according to patient valve requirements and are generally formed of a biocompatible metal (e.g., titanium, stainless steel, or other suitable metal alloy), a plastic material (e.g., acetal homopolymer plastic) or of any other suitable biocompatible material. Holder <NUM> is detachable and disposable, suitable for single-use.

<FIG> are top-views of removable bioprosthetic heart valve assembly <NUM> according to some embodiments. In some embodiments, heart valve assembly <NUM> includes a two-piece mechanical heart valve. <FIG> illustrates abutment ring <NUM> and valve frame <NUM> in a disengaged configuration <NUM>. Abutment ring <NUM> includes locking system <NUM>. In some embodiments, locking system <NUM> includes one or more notches capable of accepting locking features on valve frame <NUM>, along with a channel extending between the notches to allow rotation of the locking features through the channel to a position not aligned with the notches in the locking system to an engaged position (also referred to herein as a "locked" position). Valve frame <NUM> includes at least one locking feature <NUM>. As shown in <FIG>, the valve frame <NUM> includes three locking features, which protrude radially outward to mate with the valve system <NUM>.

<FIG> illustrates abutment ring <NUM> and valve frame <NUM> in an engaged configuration <NUM>. The at least one locking feature <NUM> is configured to be received by the locking system, for example by channel <NUM> of abutment ring <NUM> extending between the notches. International Application No. PCT/IB2016/<NUM>, describes locking systems suitable in removable bioprosthetic valve assemblies according to at least some embodiments of the present disclosure. When the locking features of the valve frame <NUM> are mated with the notches of the locking system <NUM>, the maneuvering system having central pin (<NUM> as shown in <FIG>) may be used to rotate the valve frame <NUM> relative to the abutment ring <NUM> in a first (e.g., clockwise) direction into the locked position. Likewise, the maneuvering system may be used to rotate the valve from <NUM> relative to the abutment ring <NUM> in a second (e.g., counter-clockwise) direction to a disengaged position. This enables the valve to be seated and secured to the abutment ring after alignment of axes A1 and A2. Likewise, it conversely allows the valve to be disengaged and removed from the abutment ring.

Generally in some embodiments of the present disclosure, and in advance of inserting a holder/valve assembly, an implantation accessory such as a sizer is introduced into the native valve annulus in order to evaluate the size of the annulus. In some embodiments, multiple sizers having different dimensions are introduced independently for annulus size determination. For example, the medical team may have three or four sizers of varying dimensions available to perform the sizing procedure with sizer <NUM>. That way, an appropriate sized corresponding holder/valve assembly can be selected by the medical team that best fits the native valve annulus, thus ensuring a successful procedure, which include (among others) implantation of a bioprosthetic heart valve, a mechanical heart valve and an annuloplasty ring.

<FIG> is a perspective view illustrating a sizer <NUM> for determining annulus size. Sizer <NUM>, which may also be referred to interchangeably herein as D-shaped sizer <NUM>, is designed to complement a D-shaped mitral annulus, for example. D-shaped refers to an approximate shape including a long side <NUM> and a curved profile side <NUM>. Side <NUM> is generally placed anteriorly in the patient, while side <NUM> is generally placed posteriorly. Sizer <NUM> includes a long axis A3 and a short axis A4 as shown on <FIG>. According to various embodiments, long axis A3 of sizer <NUM> ranges from <NUM> to <NUM>. According to some embodiments, the long axis A3 is <NUM>, or <NUM>, or <NUM>, or <NUM>, or <NUM>, or <NUM>, or <NUM>, or <NUM>, or <NUM>, or <NUM>. According to exemplary embodiments, the ratio of the long axis to the short axis A3/A4 ranges from <NUM> to <NUM>. Advantageously, sizer <NUM> for use with mitral valve prosthesis and annuloplasty rings provides for minimally invasive procedures with a reduced height for insertion through a small wound, as for example in a MICS procedure. In other words, sizer <NUM> is shaped such that it corresponds to the shape of the native valve annulus, while also having a thickness capable of insertion through a space between the ribs of the patient during the procedure.

As shown in <FIG>, sizer <NUM> includes central pin <NUM> for grasping and maneuvering with a MICS forceps. <FIG> also illustrates holes <NUM> and <NUM> through the thickness of sizer <NUM>, the holes extending from surface <NUM> to surface <NUM> opposite thereof. Threadable holes <NUM> and <NUM> are for inserting threads therethrough (i.e. one thread through holes <NUM> and a second thread through holes <NUM>). Threads passing through holes or openings <NUM> and <NUM> can also be used for maneuvering the sizer, i.e. tipping or angling surface <NUM>, by pulling or maneuvering the threads in similar manner as for threadable arcuate bores <NUM> and <NUM> for holder <NUM> of <FIG>. As noted above, in various embodiments, the threads are also used to help ensure the sizer <NUM> is not left behind in the patient. In some embodiments, holes <NUM> is referred to interchangeably herein as a first threadable bore formed by the pair of holes <NUM>; and holes <NUM> is referred to interchangeably herein as a second threadable bore formed by the pair of holes <NUM>. Maneuvering system <NUM>, including central pin <NUM> and threadable holes <NUM> and <NUM>, operates similarly as described for system <NUM> for holder <NUM>. Sizer <NUM> further includes bores or slots <NUM> and <NUM>, slots <NUM> and <NUM> configured to allow coupling of the central fit joint to the sizes <NUM>, in a manner as described similarly as shown for fit joint <NUM> of <FIG>. This allows the connection of a handle to parachute the sizers to the annulus. Such parachuting may also be accomplished using a MICS forceps to engage the central pin <NUM>. Surface <NUM> of sizer <NUM> is placed adjacent to and/or in contact with the patient's annulus during sizing, while surface <NUM> faces the direction of the physician performing the sizing. For a MICS procedure, the fit joint may be removed to allow the sizer to be tilted for insertion through a small incision.

Generally in some embodiments of the present disclosure, an implantation accessory for placement at a patient's heart valve annulus location is provided. In some embodiments, the accessory includes a mechanical heart valve for placement at a patient's native valve annulus. The native valve annulus can be at an aortic valve or at a mitral valve location. In some embodiments, the implantation accessory includes a rotator to rotate the already implanted valve in order to orient or reposition the leaflet(s) of the mechanical heart valve. In <FIG>, implantation accessory <NUM> is shown for implantation into mechanical heart valve <NUM>, which includes valve housing attached at heart valve annulus location <NUM> of a patient's heart. Valve <NUM> is also referred to as valve housing <NUM> interchangeably herein. Implantation accessory <NUM> is also referred to interchangeably herein as rotator <NUM> or as holder <NUM>. Using rotator <NUM>, the valve <NUM> rotates within its housing for fine tuning and leaflet orientation after valve implantation. Implantation assembly <NUM> includes mechanical heart valve <NUM> (see <FIG> and <FIG>) and rotator <NUM>. Valve <NUM> further includes leaflets <NUM>. Multiple component heart valve accessory <NUM> includes rotator <NUM> and fit joint <NUM>, which may be similar to the above-described fit joint <NUM>. Fit joint <NUM> is attachable to handle <NUM>. Patient <NUM>, in a minimally-invasive access approach, for example, is entered through patient chest opening <NUM> to access ventricle <NUM>. Mechanical heart valve <NUM> is secured to patient annulus <NUM> and includes axis A1 passing through its center as shown in <FIG>. Axis A1 is generally perpendicular to the annulus. Once secured to annulus <NUM>, there is limited access to valve <NUM> due to physical constraints within patient <NUM>, thus making positioning of mechanical heart valve <NUM> and orientation of leaflets <NUM> challenging.

As shown in <FIG>, implantation assembly <NUM> comprises mechanical valve <NUM> (coupled with valve housing <NUM>) and rotator <NUM> detachably coupled to valve <NUM>. To facilitate implanting valve <NUM>, rotator <NUM> is coupled also to handle <NUM> via fit joint <NUM> as shown in <FIG>. Fit joint <NUM> and rotator <NUM> are two separate components shown coupled together in <FIG>. Rotator <NUM> is further useful in rotating or aligning leaflets <NUM> within valve housing <NUM> by using maneuvering system <NUM>. Implantation accessory <NUM>, as shown in the exploded view of <FIG>, includes rotator <NUM> having central pin <NUM>, the rotator <NUM> attachable to fit joint <NUM>. Component <NUM>, which is a rotator or holder, includes central pin <NUM>. Fit joint <NUM> is useful for valve placement by a physician when an open chest is accessible wherein holder <NUM> is used assembled. In a minimally invasive procedure, the fit joint <NUM> is removed outside of the patient before insertion of the assembly so that only the rotator <NUM> remains on the valve, thereby reducing the height of the implantation accessory and allowing insertion through a small wound. In the embodiments disclosed herein, fit joint <NUM> is removed prior to implantation and, therefore, the maneuvering system <NUM> is fully exposed and accessible to be used by the physician in a similar manner as for maneuvering system <NUM> as detailed above. Central pin <NUM> operates similarly as described for central pin <NUM> for holder <NUM> and is graspable by forceps. Rotator <NUM> includes holes <NUM> and <NUM>. Holes <NUM> and <NUM> allow fixing the valve <NUM> to holder <NUM> by threading threads therethrough and is also referred to as a retaining system to affix to a valve. Teeth <NUM> of fit joint <NUM> facilitate coupling to rotator <NUM> via a snap fit connection wherein teeth <NUM> mate with holes <NUM> of holder <NUM>. After the valve <NUM> has been detached from rotator <NUM>, both holes <NUM> are used to insert the surgical thread by the physician to tilt the holder as part of maneuvering system <NUM> working in conjunction with forceps grasping the rotatable central pin <NUM>.

As shown in <FIG>, rotator <NUM> includes surface <NUM> and axis A2. Axis A2 is perpendicular to surface <NUM>. Surface <NUM> is planar and disk shaped to couple with valve <NUM>. Upon inserting rotator <NUM> via handle <NUM> through opening <NUM> as shown in <FIG>, axis A2 is offset to axis A1 by at an acute angle, angle <NUM>, ranging in measurement from less than <NUM> degrees but more than zero degrees.

An alternate embodiment of an implantation accessory or rotator is shown as in <FIG>. Rotator <NUM> is similar to rotator <NUM> of <FIG> except that rotator <NUM> having maneuvering system <NUM> includes threadable arcuate bores <NUM> and <NUM>, the bores being threadable for tilting the rotator similarly as for arcuate bores <NUM> and <NUM> for holder <NUM> as detailed above and as shown in <FIG>. Rotator <NUM> includes maneuvering system <NUM> for aligning axis A2 with axis A1, maneuvering system <NUM> including central pin <NUM>. Alignment of axes A1 and A2 prior to seating of valve <NUM> ensures proper implantation of valve <NUM> and orientation of valve leaflets <NUM>, which may be metallic, into valve housing <NUM>. Implantation accessory <NUM> is configured to position a plurality of leaflets <NUM> of the removable mechanical heart valve assembly <NUM>. Positioning leaflets includes at least one of pivoting and tilting. Rotator <NUM> is interchangeably referred to herein as tiltable rotator <NUM>. In some embodiments, valve housing <NUM> is attachable to a patient's mitral valve rim via a sewing cuff. In other embodiments, valve housing <NUM> is attachable to a patient's aortic valve rim.

In some embodiments, central pin <NUM> is attachable to a minimally invasive cardiothorasic surgery (MICS) forceps. As shown in <FIG>, rotator <NUM> includes central pin <NUM> for grasping and maneuvering with a MICS forceps. While grasping central pin <NUM> with minimally invasive cardiothoracic surgery (MICS) forceps is not shown in <FIG>, central pin <NUM> is graspable by MICS forceps similarly as shown for the embodiment having central pin <NUM> as in <FIG> or as in the embodiment having central pin <NUM> as in <FIG> and <FIG>. Maneuvering system <NUM>, including central pin <NUM> and threadable bores <NUM> and <NUM>, operates similarly as described for system <NUM> for holder <NUM>. Central pin <NUM> is pivotable relative to surface <NUM>, and the second axis A2 passes through and is orthogonal to the central pin <NUM>. Threadable bore <NUM> includes openings <NUM> and <NUM>, and threadable bore <NUM> includes openings <NUM> and <NUM>, the bores and openings for receiving first and second threads <NUM> and <NUM> therethrough, respectively, for tilting the surface <NUM> and aligning the first axis A1 and the second axis A2. As shown in <FIG>, fit joint <NUM> includes snap fit prongs or teeth <NUM> for attachment to rotator <NUM>. <FIG> illustrates schematically the multiple component heart valve prosthesis <NUM> positioned into valve housing <NUM>.

More generally in some embodiments of the present disclosure, an implantation accessory for placement at a heart valve annulus location of a patient's heart is provided. The annulus has a first axis (refer to A1 of <FIG>). The implantation accessory (<NUM>, <NUM>, <NUM>, <NUM>) comprises a first surface (i.e. <NUM> of <FIG> and <FIG>, or <NUM> of <FIG>, or <NUM> of <FIG>) having a second axis perpendicular to the first surface. The implantation accessory (<NUM>, <NUM>, <NUM>, <NUM>) includes a maneuvering system (<NUM>, <NUM>, <NUM>, <NUM>) for aligning the first axis and the second axis. The maneuvering system (<NUM>, <NUM>, <NUM>, <NUM>) includes a central pin (<NUM>, <NUM>, <NUM>) pivotable relative to the surface (<NUM>, <NUM>, <NUM>). The second axis passes through the central pin. The maneuvering system (<NUM>, <NUM>, <NUM>, <NUM>) includes a first threadable bore (<NUM>, <NUM>, <NUM>) and a second threadable bore (<NUM>, <NUM>, <NUM>), each bore having first and second openings disposed at the first surface. The first threadable bore and the second threadable bore include a first thread and a second thread therethrough, respectively, for tilting the first surface and aligning the first axis and the second axis. The central pin (<NUM>, <NUM>, <NUM>) is attachable to a minimally invasive cardiothorasic surgery (MICS) forceps (<NUM> of <FIG> and <FIG>). In some embodiments, the implantation accessory is configured to size the annulus and the implantation accessory is referred to as a sizer. In other embodiments, the implantation accessory is configured to implant a removable bioprosthetic heart valve assembly and the implantation accessory is referred to as a holder or template. In yet other embodiments, the implantation accessory is configured to implant a removable mechanical heart valve assembly and the implantation accessory is referred to as a rotator.

<FIG> illustrate a method for implanting a multiple component heart valve prosthesis <NUM>, according to some embodiments described in the disclosure. The method optionally includes sizing the native annulus as shown in <FIG>. Sizer <NUM> is advanced near annulus <NUM> of a patient. Sizer <NUM> is attachable or graspable to MICS forceps <NUM> to facilitate advancement and placement of sizer <NUM> close to annulus. Sizer <NUM> is maneuverable by grasping central pin <NUM> and/or adjusting thread <NUM> or <NUM> to angle surface <NUM> as needed to position sizer <NUM> into annulus <NUM>. Sizer <NUM>, including axis A2 perpendicular to surface <NUM>, is maneuverable to align axis A1 corresponding to the central axis of the annulus with axis A2. Sizing is repeated as needed with different dimension sizers <NUM> until an appropriate fit of the sizer to the annulus is achieved by the user. Thereby, the appropriate sized removable bioprosthetic heart valve assembly <NUM> is selected. While the sizer <NUM> in <FIG> is shown having an approximate D-shape cross-section, in other embodiments, the sizer <NUM> is substantially circular in cross-section, similar to the cross sectional shape of the typical prosthetic valve.

The method includes, as shown in <FIG>, inserting and securing abutment ring <NUM> to heart valve annulus <NUM> of a patient's heart via sutures <NUM>. Abutment ring <NUM> has a first axis A1. The method further includes, as shown in <FIG>, advancing removable bioprosthetic heart valve assembly <NUM> to abutment ring <NUM>. As assembly <NUM> is advanced, axes A1 and A2 are not aligned (see <FIG>) due to physical constraints upon entering the patient. Removable bioprosthetic heart valve assembly <NUM> comprises bioprosthetic valve <NUM> for coupling to abutment ring <NUM> and holder <NUM> detachably coupled to bioprosthetic valve <NUM>. In some embodiments, the method includes wherein the removable bioprosthetic heart valve assembly further comprises a detachable fit joint having a proximal end and a distal end, the proximal end coupled to the holder and the distal end coupled to an elongated handle, and wherein the step of advancing further includes inserting the removable bioprosthetic heart valve assembly via the handle (not shown). Referring also to <FIG> and <FIG>, the advancement includes advancing holder <NUM> attached to fit joint <NUM> and handle <NUM>; the holder includes a first surface, second axis A2 perpendicular to the first surface, and a maneuvering system for aligning axes A1 and A2 (accessible upon removal of the fit joint <NUM>). In some embodiments, detaching the fit joint coupled to the elongated handle from the valve assembly before advancing the valve into the patient. Maneuvering by pivoting the central pin using an attachable minimally invasive cardiothorasic surgery (MICS) forceps <NUM> is shown as in <FIG>.

As shown in <FIG>, the method further includes maneuvering the maneuvering system to align axes A1 and A2. Referring also to <FIG>, maneuvering includes pivoting the central pin <NUM>, using for example MICS forceps <NUM>, and/or by tilting the first surface by manipulating or pulling on threads <NUM> and <NUM> as shown in <FIG>. In some embodiments, the method includes wherein the maneuvering system comprises a central pin pivotable relative to the holder, axis A2 passing through the central pin <NUM>, and wherein the step of maneuvering includes pivoting the central pin using an attachable minimally invasive cardiothorasic surgery (MICS) forceps <NUM>. In some embodiments, the method includes wherein the central pin is rotatable with the holder, and wherein the step of maneuvering includes rotating the holder in a clockwise direction D1 to engage or lock the valve assembly <NUM> with the abutment ring <NUM> and in a counter-clockwise direction D2 to disengage the valve assembly from the abutment ring. In some embodiments, the method includes wherein the maneuvering system comprises a first threadable arcuate bore and a second threadable arcuate bore, each bore having first and second openings disposed at the first surface and first and second threads disposed therethrough, and wherein the step of maneuvering includes pulling on the first and second threads (<NUM>, <NUM>) to tilt the first surface and to align the first axis and the second axis.

Once axes A1 and A2 are aligned, the method further includes seating the bioprosthetic valve by further advancing the removable bioprosthetic heart valve assembly into the abutment ring and coupling the bioprosthetic valve to the abutment ring. In some embodiments, the method includes wherein the abutment ring includes a locking system and the bioprosthetic valve includes at least one locking feature, the at least one locking feature configured to be received by the locking system, and wherein the step of seating the bioprosthetic valve to the abutment ring includes rotating the holder in the clockwise direction to an engaged position and in a counter-clockwise direction to a disengage position.

After seating of the valve, the holder is removed. Sutures (refer to sutures <NUM>, <NUM>, and <NUM> of <FIG>) may then be cut to detach and remove holder <NUM>. The MICS forceps, which remains coupled to the central pin <NUM>, may then be used to remove holder <NUM> as shown in <FIG>. While holder <NUM> is removed from the patient upon completion of the valve implantation, abutment ring <NUM> and valve <NUM> remain in the patient.

<FIG> is a flow chart illustrating method <NUM> according to some embodiments. Step <NUM> includes securing an abutment ring having a first axis to a patient's annulus. Step <NUM> includes advancing a removable bioprosthetic heart valve assembly adjacent to the abutment ring, the removable bioprosthetic heart valve assembly comprising a bioprosthetic valve for coupling to the abutment ring and a holder detachably coupled to the bioprosthetic valve. The holder having a first surface, a second axis perpendicular to the first surface, and a maneuvering system for aligning the first axis and the second axis. Step <NUM> includes maneuvering the maneuvering system to align the first axis and the second axis. Step <NUM> includes seating the bioprosthetic valve by further advancing the removable bioprosthetic heart valve assembly into the abutment ring and coupling the bioprosthetic valve to the abutment ring. Step <NUM> includes removing the holder.

Claim 1:
An implantation accessory (<NUM>, <NUM>, <NUM>, <NUM>) for placement at a heart valve annulus location of a patient's heart, the annulus having a first axis (A1), the implantation accessory (<NUM>, <NUM>, <NUM>, <NUM>) comprising:
a first surface (<NUM>, <NUM>, <NUM>);
a second axis (A2) perpendicular to the first surface (<NUM>, <NUM>, <NUM>); and,
a maneuvering system (<NUM>, <NUM>, <NUM>, <NUM>) for aligning the first axis (A1) and the second axis (A2),
wherein the maneuvering system (<NUM>, <NUM>, <NUM>, <NUM>) includes a first threadable bore (<NUM>, <NUM>, <NUM>, <NUM>) and a second threadable bore (<NUM>, <NUM>, <NUM>, <NUM>), each bore having first and second openings (<NUM>, <NUM>, <NUM>, <NUM>; <NUM>, <NUM>, <NUM>, <NUM>) disposed at the first surface (<NUM>, <NUM>, <NUM>),
wherein the first threadable bore (<NUM>, <NUM>, <NUM>, <NUM>) and the second threadable bore (<NUM>, <NUM>, <NUM>, <NUM>) include a first thread (<NUM>, <NUM>, <NUM>) and a second thread (<NUM>, <NUM>, <NUM>) therethrough, respectively, for tilting the first surface (<NUM>, <NUM>, <NUM>) and aligning the first axis (A1) and the second axis (A2),
wherein the maneuvering system (<NUM>, <NUM>, <NUM>, <NUM>) includes a graspable central pin (<NUM>, <NUM>, <NUM>) pivotable relative to the implantation accessory (<NUM>, <NUM>, <NUM>, <NUM>),
wherein the second axis (A2) passes through central pin (<NUM>, <NUM>, <NUM>), wherein the central pin (<NUM>, <NUM>, <NUM>) is further rotatable with the implantation accessory (<NUM>, <NUM>, <NUM>, <NUM>) in a first clockwise direction (D1) and in a second counter-clockwise direction (D2), and wherein manipulation or pulling on first (<NUM>, <NUM>, <NUM>) and second (<NUM>, <NUM>, <NUM>) threads, while grasping the central pin (<NUM>, <NUM>, <NUM>), operate to tilt the first surface (<NUM>, <NUM>, <NUM>) and aligning the first axis (A1) and the second axis (A2).