Prosthesis seals and methods for sealing an expandable prosthesis
View Patent ↗Embodiments of the present disclosure are related to devices and techniques for para-valve sealing of an expandable stent-valve implanted using a catheter. In some embodiments, a stent-valve is provided which comprises a seal sleeve/cuff containing material that swells when contacted by blood. A piercing tool may be included and used to permit a user to puncture the sleeve/cuff prior to introduction into a patient's body. In some embodiments, the sleeve/cuff has an integral tubular structure configured to withstand balloon expansion of the stent-valve during or after implantation. In some embodiments, the seal is provided as a separate component from the stent-valve.
1. An apparatus configured for delivery from a delivery catheter, comprising:
a stent-valve disposable, in a compressed configuration, within the delivery catheter, the stent-valve comprising an accommodation region for accommodating a seal component to form a seal around the exterior of the stent-valve, and the stent-valve being expandable from the compressed configuration to an operative configuration after delivery from the delivery catheter;
the seal component comprising swellable material that swells in response to contact with blood or a blood component, the seal component being mountable and/or introducible to the accommodation region to form a combined assembly with the stent-valve, in the compressed configuration, prior to delivery of the stent-valve from the delivery catheter;
wherein the accommodation region comprises an accommodation channel configured to receive the seal component therein, the accommodation channel being attached to the exterior of the stent-valve; and
a loading filament slidably disposed within the accommodation channel along a predefined path extending circumferentially around the stent-valve, the loading filament being configured to circumferentially pull the seal component into the accommodation channel along the predefined path thereby forming the combined assembly;
wherein the combined assembly is disposed within the delivery catheter prior to delivery.
2. The apparatus of claim 1 , wherein the accommodation channel is a continuous accommodation channel.
3. The apparatus of claim 1 , wherein the seal component comprises a tube surrounding the swellable material.
4. The apparatus of claim 1 , wherein the seal component comprises exposed swellable material.
5. The apparatus of claim 1 , wherein the accommodation channel defines a cuff for confining the swellable material in use.
6. The apparatus of claim 1 , further comprising an introducer tube for facilitating mounting or introduction of the seal component to the stent-valve.
7. The apparatus of claim 1 , wherein the accommodation channel is a discontinuous accommodation channel.
8. The apparatus of claim 7 , wherein the accommodation channel is formed by a series of spaced-apart loops disposed circumferentially about the stent-valve.
9. The apparatus of claim 1 , wherein the stent-valve includes a stent having an inflow portion and an outflow portion each formed by a lattice structure of the stent, and a plurality of stabilization arches extending downstream from the outflow portion.
10. The apparatus of claim 9 , wherein the inflow portion includes an extremity formed with a zig-zag shape comprising upstream apexes and downstream apexes;
wherein the accommodation region is disposed between the downstream apexes and the outflow portion.