VALVED CONDUIT IN A CONDUIT PROSTHESES
Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a valved conduit prosthesis including a valved conduit subassembly within a secondary conduit. The valved conduit subassembly include at least one leaflet that is coupled to an exterior surface of a primary conduit.
1 . A valved conduit prosthesis comprising:
a secondary conduit having a secondary conduit inner surface defining a secondary conduit lumen therethrough; and
a valved conduit subassembly including:
a primary conduit having a primary conduit exterior surface and a primary conduit interior surface defining a primary conduit lumen and a slot therethrough; and
at least one leaflet having an external portion coupled to the primary conduit exterior surface and an internal portion arranged within the primary conduit lumen so as to be operable as a one-way valve, the leaflet defining a valve structure,
wherein the valved conduit subassembly is located within the secondary conduit lumen and coupled to the secondary conduit inner surface.
2 . The valved conduit prosthesis of claim 1 , wherein the external portion of the at least one leaflet is adhered to the primary conduit exterior surface by adhesive, thermal bonding, or chemical bonding.
3 . The valved conduit prosthesis of claim 1 , wherein the external portion of the at least one leaflet is coupled to the primary conduit exterior surface by a layer of adhesive film.
4 . The valved conduit prosthesis of claim 1 , wherein the valved conduit subassembly defines at least one step with the secondary conduit inner surface.
5 . The valved conduit prosthesis of claim 4 , wherein the at least one step is defined by the secondary conduit having a larger inner diameter compared with the inner diameter of the valved conduit subassembly.
6 . The valved conduit prosthesis of claim 4 , wherein the step may have a step height defined by the primary conduit inner surface and the secondary conduit inner surface at the step, wherein the step height is operable as a barrier to prevent pannus or other biological material from advancing into an upstream or downstream portion of the valved conduit subassembly.
7 . The valved conduit prosthesis of claim 4 , wherein the valved conduit subassembly defines an upstream length between the leaflet and the step, wherein the upstream length has a dimension of 0.1 mm to 3 mm, and a step height has a dimension of 0 mm to 3 mm.
8 . The valved conduit prosthesis of claim 1 , wherein the valved conduit has an inflow portion defining an inflow end and an outflow portion defining an outflow end, wherein the at least one leaflet is coupled to the primary conduit is operable to open to allow flow from the inflow end to pass through the outflow end in antegrade flow conditions, and are operable to close to restrict flow from flowing from the outflow end through the inflow end in retrograde flow conditions.
9 . The valved conduit prosthesis of claim 1 , wherein the at least one leaflet comprises a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores, and optionally TFE-PMVE copolymer comprising from 27 to 32 weight percent perfluoromethyl vinyl ether and respectively from 73 to 68 weight percent tetrafluoroethylene on at least a portion of the composite material, and optionally, the elastomer or elastomeric material comprises a TFE-PMVE copolymer, and optionally, the porous synthetic fluoropolymer membrane is ePTFE.
10 . The valved conduit prosthesis of claim 1 , wherein the at least one leaflet includes more than one leaflets, and the more than one leaflets are separated from one another within the primary conduit inner surface of the primary conduit by commissure gaps.
11 . The valved conduit prosthesis of claim 10 , wherein the at least one leaflet is more than one leaflet and the primary conduit includes lands separating each leaflet at a conduit attachment section of each of the leaflets to form the commissure gaps between the leaflets within the primary conduit inner surface of the primary conduit.
12 . The valved conduit prosthesis of claim 1 , wherein the valved conduit subassembly is attached to the secondary conduit inner surface by an adhesive, thermal bonding, or chemical bonding.
13 . A method of treating aortic valve disease by replacing an aortic root, comprising the steps of:
providing a valved conduit prosthesis of claim 1 ; and
surgically implanting the valved conduit prosthesis.