Prosthetic heart valve with retention elements

Abstract

Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame and a leaflet construct. The leaflet construct is at least partially coupled to a leaflet frame outer side of the leaflet frame and being coupled thereto by a retention element.

What is claimed: 
     
         1 . A method of making a prosthetic valve, the method comprising:
 cutting a leaflet construct from a tube of material such that the leaflet construct includes a plurality of leaflets each separated by a bridge region and having fold-over apertures in fold-over portions of each leaflet and bridge apertures in the bridge region;   folding each of the bridge regions into a bridge loop, each bridge loop of the plurality of leaflets defining coaptation necks between the bridge loop and two adjacent leaflets of the plurality of leaflets;   locating a retention element in each of the bridge loops;   suturing each retention element to the respective bridge loop by passing suture through the bridge apertures and respective retention element apertures that are aligned therewith;   disposing each coaptation neck in a respective post slot of a leaflet frame that is a tube defining leaflet frame windows and a plurality of commissure posts therebetween, where each of the plurality of commissure posts defines a post slot dimensioned to receive a double thickness of the tube at the bridge region and the leaflet frame has leaflet window frame apertures in the leaflet window frame and post apertures in the commissure posts;   positioning the retention elements adjacent an outer side of a respective one of the commissure posts and disposing the leaflets in the leaflet frame;   aligning the retention element apertures with the post apertures;   suturing each retention element to the respective commissure post passing suture through the retention element apertures and the post apertures that are aligned therewith;   folding the fold-over portions of each leaflet along a leaflet frame inflow edge and against a leaflet frame outer side aligning the fold-over apertures with the leaflet window frame apertures; and   suturing each fold-over portion to the respective leaflet window frame passing suture through the fold-over apertures and the leaflet window frame apertures that are aligned therewith.   
     
     
         2 . The method of  claim 1 , wherein the tube of material comprises one or more layers of expanded PTFE composite. 
     
     
         3 . The method of  claim 1 , further comprising:
 providing strips of fabric;   wrapping and sewing the strips of fabric on the leaflet frame to provide a cushion between the leaflet frame and the leaflet construct; and   trimming the strips of fabric to adjacent a leaflet frame outflow edge of the leaflet frame.   
     
     
         4 . The method of  claim 3 , further comprising:
 providing a base frame that is a tube defining base frame apertures, the base frame defining a base frame central axis;   placing the leaflet frame and base frame in coaxial alignment; and   coupling the base frame to the leaflet frame inflow edge of the leaflet frame.   
     
     
         5 . The method of  claim 4 , further comprising:
 providing a fabric tube;   inserting the fabric tube through the base frame along the base frame central axis;   folding a fabric outflow edge of the fabric tube over a base frame outflow edge of the base frame;   coupling the fabric outflow edge to the base frame by sewing the fabric outflow edge using suture through the base frame apertures in the base frame;   inverting a fabric inflow edge of the fabric tube over the base frame;   coupling the fabric inflow edge to an inflow edge of the base frame by sewing the fabric inflow edge using suture through the base frame apertures that are adjacent the inflow edge of the base frame;   disposing a sewing cuff insert inside a pocket defined by the fabric tube that has been inverted;   tucking the fabric tube in between the base frame and the sewing cuff insert such that all slack of the fabric tube is removed around the sewing cuff insert;   placing the leaflet frame coaxially with and adjacent to the base frame and inside the fabric tube;   trimming the fabric tube to adjacent a leaflet frame outflow edge;   suturing the leaflet frame to the base frame at a leaflet window base using suture passing through the respective leaflet window frame apertures and the base frame apertures;   folding a trimmed edge of the fabric tube over the leaflet frame outflow edge;   tucking the trimmed edge underneath itself to conceal any frayed edges; and   sewing the fabric tube to the strips of fabric on the leaflet frame.   
     
     
         6 . A method of making a prosthetic valve, the method comprising:
 forming a leaflet construct including a plurality of leaflets that are contiguous with one another and are interconnected by a plurality of bridge regions;   folding each of the plurality of bridge regions into a plurality of bridge loops;   passing each of the plurality of bridge loops through a plurality of post slots in a plurality of commissure posts of a leaflet frame;   receiving a plurality of retention elements in the plurality of bridge loops such that each of the plurality of retention elements is abutted against an outer side of the plurality of commissure posts of the leaflet frame;   securing the plurality of bridge loops to the plurality of retention elements, the plurality of retention elements to the plurality of commissure posts, and the plurality of bridge loops to the plurality of commissure posts; and   folding portions of each of the plurality of leaflets over the leaflet frame to define a plurality of fold-over portions and securing the fold-over portions in a folded configuration to couple the fold-over portions to the leaflet frame.   
     
     
         7 . The method of  claim 6 , further comprising using a plurality of sutures to secure the plurality of bridge loops to the plurality of retention elements, the plurality of retention elements to the plurality of commissure posts, and the plurality of bridge loops to the plurality of commissure posts. 
     
     
         8 . The method of  claim 6 , further comprising using a plurality of sutures to secure the fold-over portions in the folded configuration to couple the fold-over portions to the leaflet frame. 
     
     
         9 . The method of  claim 6 , further comprising forming the leaflet construct including the plurality of leaflets that are contiguous with one another and are interconnected by the plurality of bridge regions by cutting a tube of material into the leaflet construct. 
     
     
         10 . The method of  claim 6 , further comprising forming a plurality of apertures through each of the plurality of bridge regions, each of the plurality of commissure posts, and each of the plurality of retention elements locating a plurality of securement structures in the plurality of apertures through each of the plurality of bridge regions, each of the plurality of commissure posts, and each of the plurality of retention elements to secure the plurality of bridge regions, the plurality of commissure posts, and the plurality of retention elements together. 
     
     
         11 . The method of  claim 6 , wherein the leaflet construct is formed of one or more layers of expanded PTFE composite. 
     
     
         12 . A method of implanting a prosthetic valve, the method comprising:
 positioning a prosthetic valve at an implant site in a body of a patient, the prosthetic valve including a leaflet frame, a leaflet construct, and a retention element, the leaflet construct defining a cylinder having a leaflet frame inner side and a leaflet frame outer side, the leaflet frame having a leaflet frame central axis and a plurality of commissure posts extending parallel to the leaflet frame central axis that are spaced from one another, each commissure post defining a post slot therethrough that is aligned parallel to the leaflet frame central axis, between the commissure posts and contiguous therewith is a leaflet window, the leaflet construct defining a continuous, uninterrupted cylinder comprising a plurality of leaflets and a bridge region seamlessly interconnecting each of the leaflets, the leaflets extending inward from the leaflet frame, each of the leaflets defining a fold-over portion that is folded over and lies against the leaflet frame outer side of the leaflet frame and coupled thereto, each of the bridge regions extending through one of the post slots and defining a bridge loop that is adjacent to the leaflet frame outer side, and the retention element having a width that is larger than a width of the post slot, the retention element being disposed in the bridge loop and operable to prevent the bridge loop from passing through the post slot; and   securing the prosthetic valve at the implant site in the body of the patient.   
     
     
         13 . The method of  claim 12 , further comprising securing the prosthetic valve at the implant site in the body of the patient by sewing a sewing cuff of the prosthetic valve to tissue at the treatment site. 
     
     
         14 . The method of  claim 12 , wherein following implantation of the prosthetic valve at the implant site, blood flows into the valve past an inflow edge of the leaflet frame over which the fold-over portion of each of the leaflets is folded around. 
     
     
         15 . A method of implanting a prosthetic valve, the method comprising:
 positioning a prosthetic valve at an implant site in a body of a patient, the prosthetic valve including a leaflet frame, a leaflet construct, and a plurality of retention elements, the leaflet frame defining a plurality of commissure posts each defined by a first post leg and a second post leg separated by a post slot, the leaflet construct defining a continuous, uninterrupted cylinder including a plurality of leaflets and a plurality of bridge regions seamlessly interconnecting each of the plurality of leaflets,
 where each of the plurality of bridge region is folded into a loop, is received through one of the post slots of the plurality of commissure posts, and is wrapped around one of the plurality of retention elements; and 
   securing the prosthetic valve at the implant site in the body of the patient.   
     
     
         16 . The method of  claim 15 , further comprising securing the prosthetic valve at the implant site in the body of the patient by sewing a sewing cuff of the prosthetic valve to tissue at the treatment site. 
     
     
         17 . The method of  claim 15 , wherein portions of each of the plurality of leaflets are folded over an inflow edge of the leaflet frame to define a plurality of fold-over portions and following implantation of the prosthetic valve at the implant site, blood flows into the valve past the inflow edge of the leaflet frame.