Prosthetic heart valve packaging and attachment assembly

A system for heart valve repair includes a packaging assembly for storing the replacement heart valve. The packaging assembly includes a valve support having a base for holding the replacement heart valve, a ring positioned within the valve support and configured to fit around a circumference of the replacement heart valve, and a retention mechanism. The retention mechanism includes a cap and plurality of sutures configured to be attached to the cap and to the replacement heart. The packaging assembly having a locked configuration in which the ring and the valve support are locked together and the sutures tension the replacement heart valve. The packaging assembly is designed to hold and transport a replacement heart valve and fits within a shipment jar.

BACKGROUND OF THE DISCLOSURE

A primary treatment for heart valve disease is valve replacement. One form of replacement device is a bio-prosthetic replacement valve. Following manufacture of the valve and prior to implantation, the replacement heart valve is packaged and transported to the site of use. Typically, replacement heart valves are packaged in liquid-filled jars. The replacement heart valve preferably is held stationary relative to the jar and submerged in the liquid to prevent or minimize damage to the replacement heart valve.

Prior to implantation, the replacement heart valve is removed from the jar and rinsed to remove the shipment fluid. The replacement heart valve is coupled to a delivery system for placement in the patient. However, rinsing and attaching the replacement heart valve to the delivery system are performed by a practitioner which requires skill and time and can lead to human error.

BRIEF SUMMARY OF THE DISCLOSURE

A first aspect of the disclosure includes a packaging assembly for packaging a replacement heart valve including a valve support having a base, a ring positioned within the valve support and configured to fit around a circumference of the replacement heart valve, and a retention mechanism including a pin extending through a lumen of the valve support and a plurality of sutures attached to the pin, the plurality of sutures are configured to be attached to the replacement heart valve.

In other embodiments, the packaging assembly may have an unlocked configuration, in which the ring and the valve support are detached, and a locked configuration, in which the ring and the valve support are locked together. In the locked configuration, the ring and the valve support may be rotationally and axially locked to one another. The packaging assembly may transition between the unlocked and locked configurations by rotation of at least one of the ring and the valve support relative to the other. In the locked configuration, the ring and the valve support may be locked together by a snap-fit connection. The retention mechanism may further include a cap attached to the pin for securing the plurality of sutures. The cap may include a plurality of openings, each opening is configured to receive at least one suture. An outer surface of the cap may be threaded for threaded engagement with a delivery system. The ring may include an annular body and at least one locking tab extending radially outward of the body. The valve support may include a ledge projecting radially inward from the base to define a groove for receiving a respective one of the at least one locking tab. The ring may include four locking tabs and the valve support includes four grooves for receiving the locking tabs. Each of the locking tabs may include an extension extending proximally from a proximal surface of the locking tab. A side surface of each extension may be configured to abut a side surface of the ledge to prevent over rotation of the ring. The pin may extend coaxial to a longitudinal axis of the replacement heart valve. The valve support may include a cannulated rod defining the lumen, the cannulated rod extending proximally from the base of the valve support. The valve support may include a plurality of ribs extending distally from the base.

Another aspect of the disclosure includes a system for heart valve repair including a replacement heart valve and a packaging assembly for storing the replacement heart valve. The packaging assembly includes a valve support having a base for holding the replacement heart valve, a ring positioned within the valve support and configured to fit around a circumference of the replacement heart valve, and a retention mechanism including a cap and plurality of sutures configured to be attached to the cap and to the replacement heart. The packaging assembly has a locked configuration in which the ring and the valve support are locked together and the sutures tension the replacement heart valve.

In other embodiments, the cap may include a threaded outer surface for threaded engagement with a delivery system. The replacement heart valve may have an hour glass shape defining a waist, and the ring may be configured to fit securely around the waist. The replacement heart valve may include a plurality of attachment members for receiving the sutures of the retention mechanism. The replacement heart valve may include an anchor assembly having an atrial anchor and a ventricular anchor, the atrial anchor including a plurality of attachment members in the form of pins for receiving the suture of the retention mechanism. The cap of the retention mechanism may include a plurality of openings for receiving the suture, such that the suture extends between a respective one of the plurality of openings of the cap and a respective one of the plurality of attachment members. The ring may include an annular body and at least one locking tab extending radially outward of the body. The valve support may include a ledge projecting radially inward from the base and defining a groove for receiving a respective one of the at least one locking tab. The ring may include four locking tabs and the valve support includes four grooves for receiving the locking tabs. Each of the locking tabs may include an extension extending proximally from a proximal surface of the locking tab. A side surface of each extension may be configured to abut a side surface of the ledge to prevent over rotation of the ring. The retention mechanism may further include a pin, a first end of the pin attached to the valve support and a second end of the pin attached to the cap. The valve support may include a cannulated rod defining a lumen for receiving the pin, the cannulated rod extending proximally from the base of the valve support. The valve support may include a plurality of ribs extending distally from the base.

Another aspect of the present disclosure includes a system for heart valve repair including a packaging assembly for storing a replacement heart valve and a shipment jar for receiving the packaging assembly. The packaging assembly includes a valve support having a base for holding the replacement heart valve, a ring positioned within the valve support and configured to fit around a circumference of the replacement heart valve, and a retention mechanism including a cap and plurality of sutures configured to be attached to the cap and to the replacement heart. The packaging assembly has a locked configuration in which the ring and the valve support are locked together and the sutures tension the replacement heart valve.

DETAILED DESCRIPTION

The packaging assemblies of the present disclosure hold a replacement heart valve securely in a shipment jar container and allow for pre-tensioning of the replacement valve such that the replacement valve is secured and tensioned in the packaging during shipment. The packaging assembly further allows rinsing and attachment to the delivery system to occur while the replacement heart valve is in a protected configuration securely within the packaging assembly.

The packaging assemblies of the present disclosure may be used with replacement heart valves, such as replacement heart valve100, which is an expandable prosthetic implant having an expanded configuration and a collapsed configuration. Replacement heart valve100may be a replacement mitral valve having a stent that includes an anchor assembly and a strut frame disposed within the anchor assembly. However, replacement heart valve100may be suitable for use in replacing other native heart valves, such as the tricuspid valve, aortic valve, or pulmonary valve, although it may be best suited for replacing the atrioventricular valves. Anchor assembly101includes an atrial anchor102, a ventricular anchor104and a central portion103positioned axially between the atrial and ventricular anchors. Atrial anchor102is configured to be positioned on an atrial side of a mitral valve annulus, and ventricular anchor104is configured to be positioned on a ventricular side of the mitral valve annulus. Anchor assembly101may have an hour glass shape in that each of the atrial anchor102and the ventricular anchor104flares radially outward of the central portion103, such that central portion103defines a waist between the atrial anchor102and the ventricular anchor104. Replacement heart valve100may also include a strut frame105positioned radially inward of anchor assembly101and formed of a plurality of connected struts. The radially inner surfaces of strut frame105define a perimeter of central opening106, which allows blood to flow through replacement heart valve100in the antegrade direction. Exemplary replacement heart valves are described in U.S. Pat. No. 10,470,881, filed on Feb. 28, 2018 and entitled Replacement Mitral Valves, the disclosure of which is hereby incorporated by reference herein in its entirety.

Replacement heart valve100includes one or more prosthetic leaflets (not shown). The leaflets may be secured to an interior of strut frame105and may be disposed at least partially in central opening106. The prosthetic leaflets are configured to coapt with each other in order to control blood flow therethrough, allowing blood to flow in a direction from the atrial anchor102toward the ventricular anchor104(the antegrade direction), but to substantially block from flowing in the opposite (retrograde) direction. The inner and/or outer surfaces of each of the anchor assembly101and the strut frame105may be partially or fully covered by cuffs or skirts, including those of fabric and/or tissue materials.

Replacement heart valve100includes a delivery device attachment mechanism. For example, at least one atrial tip114of atrial anchor102forms crest122having attachment members118, such as pins, to which suture loops can be secured, shown inFIGS.1A and1B. In the preferred embodiment, replacement heart valve100includes a plurality of attachment members118. These attachment members118can be straight hooks, curved hooks, pins, or other structures extending from a strut or member of the valve and to which a suture loop can be securely connected during shipment and subsequent delivery of the valve during surgery. Attachment members118are sized and shaped to allow release of the suture loops from the attachment member and thus the valve after deployment of the valve within the patient. Thus, in the illustrated embodiment ofFIG.1B, attachment member18is in the form of a pin provided at the apex of each crest122.

FIGS.2-4show packaging assembly130according to an aspect of the present disclosure in its assembled configuration with replacement heart valve100secured within the packaging assembly. In this regard, packaging assembly130is designed for use in conjunction with replacement heart valve100to form a system for heart valve repair. Packaging assembly130includes a ring140positioned at least partially within a valve support160, as shown inFIGS.2and3. Ring140and valve support160may each be formed via injection molding. Packaging assembly130further includes retention mechanism180for securely attaching and tensioning the replacement heart valve100so that the replacement heart valve is already prepared for attachment to the delivery system while in the packaging, allowing for more efficient implantation. Ring140has an inner diameter sized such that the ring fits snugly around central portion103of replacement heart valve100to prevent the replacement heart valve from shifting when positioned in a final configuration in the packaging assembly130. In some embodiments, the inner diameter of ring140is about equal to, or smaller than, the exterior diameter of the central portion103of replacement heart valve100while the replacement heart valve is in the expanded condition. Accordingly, ring140has a first, outer diameter that is smaller than a second, inner diameter of the valve support160to allow the ring to fit within the valve support160.

Ring140may attach to valve support160with an attachment mechanism that allows ring140to removably attach to valve support160such that ring140and valve support160can be moved from an unlocked configuration in which the two are detached and can rotate relative to one another to a locked configuration in which the ring140is rotationally and axially locked to the valve support160. Generally, valve support160forms the holding component of the packaging assembly130in which replacement heart valve100is securely positioned. Accordingly, valve support160defines a second, inner diameter that is greater than the first outer diameter of ring140so that the ring140can fit within the valve support160. Further, the height and outer diameter of valve support160are sized and configured to fit within a shipment jar, such as shipment jar120shown inFIG.12. With this sizing, valve support160does not interfere with the seal of the jar120. Additionally, the size and shape of valve support160allows for easy insertion and removal of the valve support from the jar120, such that sufficient clearance is provided to allow for insertion and removal of the valve support without damage to the valve support and/or replacement heart valve100, while also partially or fully limiting motion of the valve support160within the jar during transportation.

Ring140is described in further detail with reference toFIGS.5-7. Ring140includes body141having an annular shape and defining opening142therethrough. Ring140removably attaches to valve support160with an attachment mechanism. In the illustrated embodiment, the attachment mechanism is in the form of four spaced apart locking tabs144extending radially outward from body141and spaced around the circumference of the ring. As in the illustrated embodiment, locking tabs144may be evenly spaced apart around the circumference of the body141. Locking tabs144may be spaced about 90 degrees from adjacent locking tabs, as shown inFIG.6. In other examples, the locking tabs may be arranged at different intervals around body141relative to one another. InFIGS.5and6, ring140includes four locking tabs144, although in other examples there may be more or fewer the locking tabs.

As shown inFIG.7, each locking tab144includes a proximal surface146and opposing distal surface148. Proximal and distal surfaces146,148may be substantially planar. Locking tab144includes extension149that extends the furthest radially outward of the locking tab144. Extension149has a generally rectangular shape with the length extending in the proximal-distal direction. Although, in other examples the extensions may be trapezoidal, round, triangular and are not limited to the shape shown in the figures. Extension149may also include ridges153on an outer surface thereof. In the illustrated embodiment, ridges153extend in the proximal-distal direction and may facilitate a user in readily gripping the extensions149to manipulate (e.g. rotating) the ring140. It should be understood that additional or alternative texturizations may be provided to assist with manipulation and/or gripping of portions of ring140. A ramp155may be positioned between extension149and body141, and in the illustrated embodiment is connected to inner surface151of extension149and proximal surface146to provide structural support for extension149. Ramp155has a substantially triangular shape from the side view as shown inFIGS.5and7, which provides support to the extension149. Proximal surface146also includes a groove147for receiving a corresponding projection of the valve support to form a snap fit connection with the valve support.

Locking tabs144may allow ring140to be moved via rotation from an unlocked position to a locked position in which ring140is rotationally and axially locked with valve support160. Such connection is described in further detail below in connection with additional descriptions ofFIGS.2-4. Extensions149may provide a hard stop feature to prevent over-rotation of ring140within valve support160.

Valve support160is described in further detail with reference toFIGS.8-11. Valve support160has proximal end161and distal end162and includes base166near the proximal end. Base166includes outer rim168with four platforms169extending proximally from rim168and connected to the rim by a respective arm167, platforms which extend across rim168to form a “x’- or “cross”-shape such that outer rim168is radially outward of platforms169, as shown inFIGS.8and9. A proximal surface of base166may include ridges along the surface to provide rigidity to the base. Platforms169connect to each other at central portion175. The central portion175may be generally circular and may define a central opening172for receiving a pin182(shown inFIG.4) and/or a mandrel or other alignment tool therethrough. Each platform169may have a respective rib171extending proximally from a proximal surface of base166, and the ribs171may be positioned on respective platforms169between the outer diameter of the base and central portion175. Ribs171may provide locations for the user to grasp the valve support160to lift the valve support out of the jar, for example without sacrificing sterility of the replacement heart valve or contacting more sensitive components.

Base166includes a plurality of fins176extending distally from outer rim168which align with a respective one of the plurality of arms167. Each fin176includes lateral side walls which taper inward in the proximal-distal direction such that the fin has a generally trapezoidal shape. Fins176are designed to provide rigidity to valve support160and protect replacement heart valve100from the walls of the jar120during shipment. In this regard, the fins176may be any shape including round, rectangular, triangular, which would enable the fins to provide rigidity to the structure. In this embodiment, there are four fins176equally spaced around the circumference of outer rim168of valve support160with the fins176being spaced about 90 degrees apart from adjacent fins. Accordingly, the four arms167are also spaced apart from adjacent arms about 90 degrees. As shown inFIG.10, adjacent a side wall176aof each fin176is ledge173projecting radially inward of outer rim168to define a groove177between ledge173and outer rim168for receiving a portion of locking tab144. Further, ledge173includes projection179sized and shaped to engage groove146of locking tab144to form a snap fit connection. This connection rotationally and axially locks ring140to valve support160. Ledge173and groove177are best shown inFIGS.10and11. When locking tab144of ring140is positioned within the groove177of valve support160, extension149may abut a side surface of ledge173to prevent further rotation of ring140, as shown inFIG.3.

With reference toFIG.8, valve support160further includes cannulated rod178defining a central lumen (not shown) which aligns with central opening172of central portion175of base166, the lumen configured to receive pin182of retention mechanism180. When replacement heart valve100is packaged within packaging assembly130, cannulated rod178is positioned extending through central opening106of the replacement heart valve100, and also through an opening between the prosthetic leaflets disposed within support frame105. Rod178has an exterior surface that is advantageously smooth to prevent abrasion or damage to the replacement heart valve, including abrasion to the prosthetic leaflets.

Packaging assembly130further includes retention mechanism180, shown inFIGS.2-4. As shown inFIG.3, retention mechanism180of packaging assembly130includes pin182, cap186for attaching to the pin182and sutures190for attaching the retention mechanism to the replacement heart valve100. A first end of the sutures190is secured to cap186and a second end of each suture includes a loop to attach to attachment members118of the replacement heart valve100. Retention mechanism180allows for secure attachment of replacement heart valve100within packaging assembly130during shipment, removal from shipment jar120, and rinsing of the replacement heart valve.

As shown inFIG.4, cannulated pin182includes a distal portion183having a first diameter which transitions to a proximal portion184having a second diameter at step185, the second diameter being smaller than the first diameter. Proximal portion184is sized and configured to fit within an inner lumen (not shown) of cap186. Cap186can be attached to pin182via a cooperating threaded engagement between an external surface of proximal portion184and an inner surface of cap186(not shown) which defines the lumen.

Step185forms a shoulder to control the position of cap186on pin182. The outer surface of cap186is threaded for attaching the delivery system200to the retention mechanism180of packaging assembly130. Cap186includes a portion, either monolithic with the cap or attached thereto, that enables sutures190to be threaded therethrough. In the illustrated embodiment, cap186includes collar187having a plurality of openings (not shown) for receiving suture strands190such that a first end of the suture can be secured through the openings thereby securing the sutures to the cap. The cap and collar may be monolithic, e.g. constructed from a single piece, or they may be separate pieces mechanically joined together thereafter. A second end of the suture190is looped over a respective one of the plurality of attachment members118on a proximal end of replacement heart valve100which causes tension on suture strands190. In one example, there may be twelve suture strands190connected to pin182and attachment members118. In order to achieve tension on suture strands190, pin182is designed to have a height sufficient to create such tension when the suture strands are positioned through the retaining elements and the cap. Pin182can be positioned within rod178to the desired height based on the size of the replacement heart valve. In order to maintain pin182within the lumen of rod178, the pin182is structured to facilitate to an interference fit. In one example, the pin may be tapered such that the outer diameter of the pin is greater than the inner diameter of the rod178. This enables the pin182to be inserted to a specified depth and kept in place. Alternatively, the pin182could include threads for threaded engagement with the internally threaded rod, or the pin and/or lumen of the rod could be stepped and the engagement could be achieved through a friction fit of the stepped configuration. Crimp members192may be provided around at least a portion of each suture strand190to form the loop at the end of the suture. Crimp members192may help to prevent possible hooking onto other features of the valve holder assembly. In some cases, the crimps or coils on sutures405are secured in place by an adhesive, which can help maintain tension and avoid inadvertent separation of the sutures405. Although described herein as suture, the material can alternatively be wire or another flexible member capable of tensioning the replacement heart valve100.

To assemble packaging assembly130to its assembled configuration, shown inFIGS.2-4, in which ring140and valve support160are locked together and replacement heart valve100is positioned within and secured to ring140, ring140is positioned within valve support160and rotated in a first direction such that locking tabs144slide into the grooves defined by ledges173and mechanically lock to valve support160via the snap fit connection. Pin182is positioned within a proximal portion of cannulated rod178with proximal portion184of pin182extending beyond rod178. Body141of ring140is positioned so that it securely fits around the waist defined by central portion103of the hour-glass shaped anchor assembly101of replacement heart valve100(FIG.1). Replacement heart valve100is positioned with ventricular anchor104adjacent base166of valve support160. This allows for a circumferentially snug and secure fit prevents movement of the replacement heart valve100within the packaging assembly130. Pin182extends coaxial with a longitudinal axis of replacement heart valve100. Cap186is attached to pin182with suture strands190looped through the openings of cap186. For ease of assembly, suture strands190can be looped through the openings of cap186prior to attachment of the cap186with the valve support160and ring140structure. The loops of the suture strands190are attached to attachment members118of atrial anchor102of replacement heart valve100thereby tensioning suture strands190. The tension on suture strands190prevents inadvertent release of the suture loops on attachment members118and also constrains the valve fully in the axial direction. Further, the tension of suture strands190also holds cap186against the shoulder of pin182. Thus, the positioning of body141of ring140around the valve together with the tension of suture strands190provide for full axial and circumferential securement of replacement heart valve100.

The assembled configuration of packaging assembly130is in a final configuration for insertion into a shipment jar120, shown inFIG.12, which then is filled with shipment fluid. In this configuration, ventricular anchor104of replacement heart valve100faces toward the open end of jar120, and atrial anchor102of replacement heart valve100faces toward the bottom or closed end of jar120. During travel, replacement heart valve100is securely disposed within packaging assembly130such that it does not move around within shipment jar120and is prevented from hitting the walls of the jar. This, in turn, substantially reduces the risk of damage to the replacement heart valve during shipment.

For preparing replacement heart valve100for implantation within a patient, after shipment, packaging assembly130is lifted from the shipment jar120. The user holds onto at least one rib171and lifts the packaging assembly130from the shipment jar120, as shown inFIG.13. Packaging assembly130may then be placed into one or more bowls of rinsing materials, such as sterile saline. Preferably, packaging assembly130may be placed into three separate sterilizing bowls in successive steps. With the delivery system200assembled, packaging assembly130can be loaded onto delivery system200. A mandrel can be inserted through rod178and pin182to align retention mechanism180with the receiving component of the delivery system200when the replacement heart valve is being connected to the delivery system200to maintain the coaxial nature of the cap186and receiving portion205. Packaging assembly130is threadably attached to delivery system200by threading cap186of retention mechanism180onto receiving portion205of suture catheter210, as shown inFIGS.14and15. Exemplary methods of attaching the delivery system to the replacement heart valve are described in U.S. Patent Publication No. 2018/0092744 filed on Oct. 4, 2017 and entitled Systems and Methods for Delivering and Deploying an Artificial Heart Valve Within The Mitral Annulus,” the disclosure of which is hereby incorporated by reference herein.

As cap186is pulled into the delivery system200, the sutures190are also pulled within loading funnel215of delivery system200and replacement heart valve100moves into a partially collapsed configuration in which at least a portion of atrial anchor102is positioned within the loading funnel215. Packaging assembly130can be dissembled and removed. To do so, valve support160is rotated to overcome the snap fit and to release ring140from valve support160. Valve support160can be removed distally, e.g. in a direction away from the delivery system200. Upon further collapse of the ventricular anchor104of replacement heart valve100, a maximum diameter of the replacement heart valve100, including the ventricular anchor104, is less than the inner diameter of the ring. At that point, ring140can be pulled distally and away from the delivery system200to remove the ring component.

FIG.16shows packaging assembly330according to another aspect of the present disclosure. Packaging assembly330is substantially similar to packaging assembly130, such that only the differences will be discussed. In this aspect, ring340includes a plurality of locking tabs344for snap fit engagement with valve support360to prevent rotation and axial movement of the ring relative to the valve support. Locking tabs344project radially outward from body341of ring340and snaps into a groove (not shown) defined by two spaced apart ledges373such that there are two ledges373positioned between adjacent arms367. Further, in this embodiment, fins376are substantially rectangular in shape. Packaging assembly330functions in substantially the same manner as packaging assembly130, described above.

The packaging assemblies of the present disclosure are designed to securely hold a replacement heart valve within the packaging assembly during shipment in a shipment jar container and allow for pre-tensioning of the replacement valve such that the replacement valve is tensioned in the packaging. This allows the replacement heart valve to be rinsed and attached to the delivery device while in a protected configuration securely within the packaging assembly. The packaging assemblies further allow pre-tensioning of the replacement heart valve to the retention mechanism of the packaging assembly so that the assembly is tensioned when attached to the delivery device which enables a more efficient implantation preparation. Additionally, should the operator decide that a different catheter is needed, for example, if a different valve size is needed based on the anatomy of the patient, the devices described herein allow for quicker changeability amongst delivery devices.