Holder for heart valve prostheses, corresponding storage arrangement, delivery instrument and kit

A kit for delivering expandable heart valve prostheses, the kit comprising:

• a delivery instrument for expandable heart valve prostheses, the delivery instrument comprising:
• a handle;
• a shaft;
• and
• a delivery sheath displaceable along a longitudinal axis of the delivery instrument;
• wherein the shaft includes a connector member and a funnel shaped member coupled to the delivery sheath, the connector member coupleable to a holder comprising:
• a hub portion having a longitudinal axis;
• and
• an engagement portion coupled to the hub portion and including a plurality of finger members variably positionable relative to the hub portion between a collapsed condition, wherein the finger members are closed onto the hub portion, and an expanded condition, wherein the finger members radially protrude with respect to the hub portion for engaging a heart valve prosthesis, wherein the finger members are L-shaped;
• wherein a heart valve prosthesis is coupled to the holder, with the delivery sheath in a fully retracted position, and the delivery sheath is displaceable axially towards a fully advanced position, whereby the relative movement between the funnel shaped member and the heart valve prosthesis coupled to the holder results in a radial contraction of the heart valve prosthesis and loading of the heart valve prosthesis into the delivery sheath;
• and
• a heart valve prosthesis storage system comprising a container with a filling of a storage solution, the heart valve prosthesis being held within the container with the filling of the storage solution by the holder.

A kit for crimping, loading and delivering expandable heart valve prostheses, the kit comprising:

• a storage system comprising:
• a container with a filling of a storage solution for heart valve prostheses;
• an expandable heart valve prosthesis having an armature, the expandable heart valve prosthesis being held within the container with the filling of the storage solution by means of a holder comprising:
• a hub portion having a longitudinal axis;
• and
• an engagement portion coupled to the hub portion and including a plurality of finger members variably positionable relative to the hub portion between a collapsed condition, wherein the finger members are closed onto the hub portion, and an expanded condition, wherein the finger members radially protrude with respect to the hub portion for engaging a heart valve prosthesis, wherein the finger members are L-shaped and include proximal ends coupled to the hub portion and distal ends opposite the proximal ends;
• wherein the holder is in the expanded condition and the heart valve prosthesis is supported within the container by the armature of the heart valve prosthesis resting on the distal ends of the finger members of the holder;
• a loading fixture configured to mate with the holder with the heart valve prosthesis coupled thereto;
• and
• a delivery instrument;
• wherein the delivery instrument includes a handle, a shaft, and a delivery sheath displaceable along a longitudinal axis of the delivery instrument;
• wherein the shaft includes a connector member configured for mating with the holder and a funnel shaped member coupled to the delivery sheath;
• and
• further wherein the delivery instrument is configured to mate with the holder, already mating with the loading fixture, with the delivery sheath in a fully retracted position, when the delivery sheath is displaced axially towards a fully advanced position, the relative movement between the funnel shaped member and the heart valve prosthesis coupled to the holder results in a radial contraction of the heart valve prosthesis and loading of the heart valve prosthesis into the delivery sheath.

A method of crimping a heart valve prosthesis, the method comprising the steps of:

• providing a kit comprising:
• a storage system comprising:
• a container with a filling of a storage solution for heart valve prostheses;
• an expandable heart valve prosthesis having an armature, the expandable heart valve prosthesis being held within the container with the filling of the storage solution by means of a holder comprising:
• a hub portion having a longitudinal axis;
• and
• an engagement portion coupled to the hub portion and including a plurality of finger members variably positionable relative to the hub portion between a collapsed condition, wherein the finger members are closed onto the hub portion, and an expanded condition, wherein the finger members radially protrude with respect to the hub portion for engaging a heart valve prosthesis, wherein the finger members are L-shaped and include proximal ends coupled to the hub portion and distal ends opposite the proximal ends;
• wherein the holder is in the expanded condition and the heart valve prosthesis is supported within the container by the armature of the heart valve prosthesis resting on the distal ends of the finger members of the holder;
• a loading fixture configured to mate with the holder with the heart valve prosthesis coupled thereto;
• and
• a delivery instrument;
• wherein the delivery instrument includes a handle, a shaft, and a delivery sheath displaceable along a longitudinal axis of the delivery instrument;
• wherein the shaft includes a connector member configured for mating with the holder and a funnel shaped member coupled to the delivery sheath;
• and
• further wherein the delivery instrument is configured to mate with the holder, already mating with the loading fixture, with the delivery sheath in a fully retracted position, when the delivery sheath is displaced axially towards a fully advanced position, the relative movement between the funnel shaped member and the heart valve prosthesis coupled to the holder results in a radial contraction of the heart valve prosthesis and loading of the heart valve prosthesis into the delivery sheath;
• extracting the holder having the heart valve prosthesis coupled thereto from the container of the storage system;
• mating the holder having the heart valve prosthesis coupled thereto with the loading fixture;
• mating the connector member of the shaft of the delivery instrument with the holder, wherein the delivery sheath is in a fully retracted position;
• and
• displacing the delivery sheath axially towards a fully advanced position so that the relative movement between the funnel shaped member and the heart valve prosthesis coupled to the holder results in a radial contraction of the heart valve prosthesis and loading of the heart valve prosthesis into the delivery sheath.