Method and system for packaging and preparing a prosthetic heart valve and associated delivery system

Abstract

A valve cover apparatus for use in a medical assembly including a prosthetic valve and a valve delivery apparatus. The valve cover apparatus includes a housing, a chamber disposed within the housing for receiving a prosthetic heart valve in an at least partially expanded state, a tapered surface defining a portion of the chamber, and a lock ring that is axially movable over at least a portion of the housing between a locked position and an unlocked position. The tapered surface is enables loading and/or guiding of the prosthetic heart valve from the chamber of the valve cover apparatus into a delivery sheath of the valve delivery apparatus and transition the prosthetic heart valve to a radially compressed state. The lock ring restricts movement of the valve cover relative to the delivery sheath when in the locked position, and enables movement of the valve cover when in the unlocked position.

1 . A medical assembly comprising:
 a valve delivery apparatus configured for implanting a prosthetic heart valve in a heart, the delivery apparatus comprising:
 a flexible shaft; and 
 a delivery sheath coupled a distal end portion of the flexible shaft, the delivery sheath configured to receive the prosthetic heart valve and house the prosthetic heart valve in a radially compressed state, wherein, in the radially compressed state, the prosthetic heart valve has a first diameter; and 
   a valve cover apparatus configured to be coupled with the delivery sheath prior to use of the delivery apparatus for implanting of the prosthetic heart valve, the valve cover apparatus comprising:
 a housing; 
 a chamber disposed within the housing, the chamber configured to receive the prosthetic heart valve in an at least partially radially expanded state, wherein, in the at least partially radially expanded state, the prosthetic heart valve has a second diameter that is greater than the first diameter; 
 a tapered surface defining at least a portion of the chamber, the tapered surface progressively narrowed in a direction toward a proximal end of the valve cover apparatus; and 
 a lock ring that is axially movable over at least a portion of the housing between a locked position and an unlocked position, wherein, in the locked position, the lock ring is configured to restrict movement of the valve cover apparatus relative to the delivery sheath, and wherein, in the unlocked position, the valve cover apparatus is movable relative to the delivery sheath. 
   
     
     
         2 . The medical assembly of  claim 1 , wherein the tapered surface is configured to guide the prosthetic heart valve from the chamber of the valve cover apparatus into the delivery sheath, resulting in the prosthetic heart valve transitioning from the at least partially radially expanded state to the radially compressed state. 
     
     
         3 . The medical assembly of  claim 1 , wherein the lock ring and the housing comprise a locking mechanism configured to retain the lock ring in the locked position via frictional engagement. 
     
     
         4 . The medical assembly of  claim 3 , wherein the locking mechanism comprises a pair of locking elements, and wherein the lock ring is rotatable relative to at least a portion of the housing to transition the pair of locking elements between an engaged position and a disengaged position. 
     
     
         5 . The medical assembly of  claim 4 , wherein the pair of locking elements comprises a protrusion and a slot configured to receive the protrusion. 
     
     
         6 . The medical assembly of  claim 1 , wherein the valve cover apparatus further comprises a distal element comprising a distal flared section, the distal element disposed at a distal end portion of the housing, the distal flared section comprising an open distal end having a greater diameter than a remainder of the valve cover apparatus, the open distal end configured to receive the prosthetic heart valve in a radially expanded state. 
     
     
         7 . The medical assembly of  claim 6 , wherein the distal element further comprises a proximal section, the distal flared portion tapered radially inward from the open distal end toward the proximal section, and wherein a proximal end portion of the proximal section is configured to be coupled to the distal end portion of the housing. 
     
     
         8 . The medical assembly of  claim 7 , wherein the distal flared section is configured to guide the prosthetic heart valve from the open distal end into the proximal, resulting in the prosthetic heart valve transitioning from the radially expanded state to a partially radially expanded state. 
     
     
         9 . The medical assembly of  claim 6 , wherein the delivery apparatus further comprises an inner shaft disposed in an inner lumen of the flexible shaft, the inner shaft configured to be coupled with the prosthetic heart valve and a nose cone, the nose cone distal relative to the prosthetic heart valve when coupled to the inner shaft, and wherein the distal element is configured to house the nose cone therein. 
     
     
         10 . The medical assembly of  claim 1 , wherein the delivery apparatus further comprises an inner shaft disposed in an inner lumen of the flexible shaft, the inner shaft configured to be coupled with the prosthetic heart valve and a nose cone, the nose cone distal relative to the prosthetic heart valve when coupled to the inner shaft, and wherein the valve cover apparatus is configured to stabilize a position of the nose cone relative to the prosthetic heart valve to restrict sliding of the nose cone and damage to leaflets of the prosthetic heart valve. 
     
     
         11 . A valve cover apparatus configured for use with a valve delivery apparatus and a prosthetic heart valve, the valve cover apparatus comprising:
 a housing configured to releasably couple to a distal portion of a the valve delivery apparatus, wherein the distal portion of the valve delivery apparatus comprises a delivery sheath coupled to a flexible shaft, the delivery sheath configured to house the prosthetic heart valve in a radially compressed state;   a chamber disposed within the housing, the chamber configured to receive the prosthetic heart valve;   a distal element disposed at a distal end portion of the housing and comprising a flared end section having an open distal end; and   a lock ring that is slidable over at least a portion of the housing and is configured to be slid between a locked position and an unlocked position, wherein, in the locked position, the locking mechanism is configured to exert an inward radial force on at least a portion of the housing to limit movement of the valve cover apparatus relative to the delivery sheath, and wherein, in the unlocked position, the valve cover apparatus is movable relative to the delivery sheath.   
     
     
         12 . The valve cover apparatus of  claim 11 , wherein the distal element further comprises a proximal section, the flared end section distal of the proximal section and tapered radially inward from the open distal end toward the proximal section, and wherein a proximal end portion of the proximal section is coupled to the distal end portion of the housing. 
     
     
         13 . The valve cover apparatus of  claim 12 , wherein the open distal end has a first diameter, the proximal section of the distal element has a second diameter, the first diameter greater than the second diameter. 
     
     
         14 . The cover apparatus of  claim 11 , further comprising a tapered surface defining at least a portion the chamber, the tapered surface progressively narrowed in a direction toward a proximal end of the valve cover apparatus. 
     
     
         15 . The cover apparatus of  claim 11 , further comprising a securing end coupler configured to provide a point of attachment for the valve cover apparatus to the distal portion of the valve delivery apparatus in each of the locked position and the unlocked position of the lock ring. 
     
     
         16 . A valve loading apparatus configured for use with a valve delivery apparatus and a prosthetic heart valve, the valve loading apparatus comprising:
 a housing configured to be releasably coupled to a distal portion of the valve delivery apparatus, wherein the distal portion of the valve delivery apparatus comprises a delivery sheath coupled to a flexible shaft, the delivery sheath configured to house the prosthetic heart valve in a radially compressed state, wherein, in the radially compressed state, the prosthetic heart valve has a first diameter;   a chamber disposed within the housing, the chamber configured to receive the prosthetic heart valve in an at least partially radially expanded state, wherein, in the at least partially radially expanded state, the prosthetic heart valve has a second diameter that is greater than the first diameter;   a tapered surface defining at least a portion of the chamber, the tapered surface progressively narrowed in a direction toward a proximal end of the valve cover, wherein the tapered surface is configured to guide loading of the prosthetic heart valve from the chamber into the delivery sheath and at least in part cause the prosthetic heart valve to be compressed from the at least partially radially expanded state to the radially compressed state; and   a locking mechanism configured to restrict movement of the valve loading apparatus relative to the delivery sheath.   
     
     
         17 . The valve loading apparatus of  claim 16 , wherein the locking mechanism comprises:
 a lock ring that is axially moveable over at least a portion of the housing; and   a pair of locking elements, wherein the lock ring is rotatable relative to at least a portion of the housing to transition the pair of locking elements between an engaged position and a disengaged position.   
     
     
         18 . The valve loading apparatus of  claim 17 , wherein, in the disengaged position, the lock ring is axially moveable over the portion of the housing; and
 wherein, in the engaged position, the lock ring is frictionally engaged with the housing and axial movement of the lock ring relative to the housing is impeded.   
     
     
         19 . The valve loading apparatus of  claim 16 , wherein the pair of locking elements comprises a protrusion and a slot configured to receive the protrusion. 
     
     
         20 . The valve loading apparatus of  claim 16 , wherein the locking mechanism further comprises an insertable locking element configured to engage with an opening in the housing to impede movement of the delivery sheath relative to the valve loading apparatus.