Coherent single-layer high-strength synthetic polymer composites for artificial valves
An artificial valve and polymer technology, applied in the field of medical implant materials, can solve problems such as valve failure, affecting valve function, and calcified valves
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Embodiment 1
[0160] According to one embodiment, the heart valve leaflets are formed from a composite material comprising an expandable fluoropolymer membrane and an elastomeric material and attached to a metallic balloon-expandable stent as described in the embodiments below.
[0161] A thick sacrificial tool cushion or cushion is formed by repeatedly folding one layer of ePTFE to form a total of four layers. The ePTFE layer is approximately 5 cm (2") wide, approximately 0.5 mm (0.02") thick and highly compressible, forming a cushion. Referring to FIGS. 1 and 2 , the aforementioned cushion 200 is then stretched over a leaflet tool, generally designated 100 , ( FIG. 2 ). The leaflet tool 100 described above has a leaflet portion 102 , a body portion 104 and a bottom end 106 . The leaflet portion 102 of the leaflet tool 100 described above generally has a curved, convexly shaped end surface 103 . The cushion 200 described above is stretched and smoothed over the end surface 103 of the lea...
Embodiment 2
[0208] An embodiment of a heart valve comprising polymer leaflets bonded to a rigid metal frame is constructed according to one embodiment of the following method:
[0209] Mandrel 900 is made of PTFE, and above-mentioned mandrel 900 has such as Figure 14 the shape shown. The mandrel 900 has a first end 902 and a second end 904 opposite the first end 902 and extends longitudinally therebetween. The outer surface 910 of the mandrel 900 has three (two shown) substantially arcuate convex lobes 912, each for forming a leaflet (not shown) of a finished valve assembly (not shown). The outer surface 910 also includes a frame seating area 920 for holding the valve frame ( Figure 15 930 in ) is placed relative to the convex lobe 912.
[0210] Such as Figure 15 As shown, a certain length of 316 stainless steel tube is laser cut to form a valve frame 930, which is shaped as Figure 15 As shown, the above stainless steel tube has an outer diameter of about 25.4 mm and a wall thick...
Embodiment 3
[0223] An embodiment of a heart valve comprising polymer leaflets bonded to a rigid metal frame is constructed according to one embodiment of the following method:
[0224] A length of 316 stainless steel tubing is laser cut to form a valve support structure or frame 960 shaped like Figure 19 As shown, the above stainless steel tube has an outer diameter of about 25.4 mm and a wall thickness of about 0.5 mm. In the illustrated embodiment, the frame 960 extends axially between a bottom end 962 and an opposite top end generally defined by a plurality of axially extending, generally helical rods 964. , and the number thereof corresponds to the number of leaflets in the target finished valve assembly (not shown). A parabolic top edge 968 extends between adjacent rods 964 . In one embodiment, three rods 964 and three top edges 968 form the top end of frame 960 . The corners of the frame that will be in contact with leaflet material are rounded with a grinder and polished by han...
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Abstract
Description
Claims
Application Information
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