Laminated prosthesis and method of manufacture
First Claim
1. A method of manufacturing a self-supporting, tissue expanding item constructed of multiple layers forming a molded flexible, expandable membrane surrounding and defining an interior lumen, said method comprising the steps of:
- (a) applying a fluid material comprised of a polymer to a mandrel, said fluid material having filaments of a stretchable material mixed therein;
(b) draining said fluid material off the mandrel in a first flow direction whereby said polymer and said filaments are generally oriented in said first flow direction;
(c) allowing said fluid material to harden to form a resilient, stretchable first layer on the mandrel;
(d) applying a second layer of the same said fluid and filament material onto said first layer;
(e) changing the orientation of the mandrel to allow the fluid material to drain off the mandrel in a second flow direction whereby said polymer and said filaments comprising said second layer are generally oriented in said second flow direction, the second flow direction being at a first angle with respect to said first flow direction;
(f) allowing the fluid material to harden to form a resilient, stretchable second layer on said first layer; and
(g) removing said molded multi-layered item from said mandrel whereby the cooperation of the different directional layers form a strengthened, self-supporting, multi-layered, molded item.
1 Assignment
0 Petitions
Accused Products
Abstract
A method of manufacturing a laminated item such as a prosthesis or tissue expander having a flexible, expandable membrane surrounding an interior lumen to enhance the strength and performance of the membrane comprises the steps of applying a first layer of a fluid, resilient, stretchable material to a mandrel; allowing the fluid material to drain off the mandrel in a first flow direction; allowing the fluid material to harden to form a resilient, stretchable first layer on the mandrel; applying a second layer of the fluid material on the first layer; changing the orientation of the mandrel to allow the fluid material to drain off the mandrel in a second flow direction, the second flow direction being at an angle to the first flow direction; and allowing the fluid material to harden to form a resilient, stretchable second layer on the first layer.
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Citations
30 Claims
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1. A method of manufacturing a self-supporting, tissue expanding item constructed of multiple layers forming a molded flexible, expandable membrane surrounding and defining an interior lumen, said method comprising the steps of:
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(a) applying a fluid material comprised of a polymer to a mandrel, said fluid material having filaments of a stretchable material mixed therein; (b) draining said fluid material off the mandrel in a first flow direction whereby said polymer and said filaments are generally oriented in said first flow direction; (c) allowing said fluid material to harden to form a resilient, stretchable first layer on the mandrel; (d) applying a second layer of the same said fluid and filament material onto said first layer; (e) changing the orientation of the mandrel to allow the fluid material to drain off the mandrel in a second flow direction whereby said polymer and said filaments comprising said second layer are generally oriented in said second flow direction, the second flow direction being at a first angle with respect to said first flow direction; (f) allowing the fluid material to harden to form a resilient, stretchable second layer on said first layer; and (g) removing said molded multi-layered item from said mandrel whereby the cooperation of the different directional layers form a strengthened, self-supporting, multi-layered, molded item. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method of manufacturing a self-supporting, tissue expanding item constructed of multiple layers forming a molded flexible, expandable membrane surrounding and defining an interior lumen, said method comprising the steps of:
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(a) applying a fluid material comprised of an orientable polymer to a mandrel; (b) draining said fluid material off the mandrel in a first flow direction; (c) allowing said fluid material to harden to form a resilient, stretchable first layer on the mandrel; (d) applying a second layer of the same said fluid material on said first layer; (e) changing the orientation of the mandrel to allow the fluid material to drain off the mandrel in a second flow direction, the second flow direction being at a first angle with respect to said first flow direction; (f) allowing the fluid material to harden to form a resilient, stretchable second layer on said first layer; (g) applying additional layers of fluid material to said second layer, changing the orientation of the mandrel to allow the fluid material to drain off the mandrel in additional flow directions, each flow direction being at a second angle with respect to the preceding flow direction, and allowing the fluid material to harden to form additional resilient, stretchable layers; and (h) removing said multi-layered item from said mandrel whereby the cooperation of the different directional layers forms a strengthened, multi-layered, molded item. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A method of manufacturing a self-supporting, tissue expanding item constructed of multiple, layers forming a flexible, expandable and self-supporting, molded membrane surrounding and defining an interior lumen, said method comprising the steps of:
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(a) applying a fluid material comprised of an orientable polymer to a mandrel, said fluid material further containing filaments of a stretchable material and being mixed in said fluid material; (b) draining said fluid material off the mandrel in a first flow direction whereby said polymer and said filaments are generally oriented in said first flow direction; (c) allowing the fluid material to harden to form a resilient, stretchable first layer on the mandrel; (d) applying a second layer of the same said fluid material on the first layer; (e) changing the orientation of the mandrel to allow the fluid material to drain off the mandrel in a second flow direction whereby said polymer and said filaments comprising said second layer are generally oriented in said second flow direction, the second flow direction being at a first angle with respect to said first flow direction; (f) allowing the fluid material to harden to form a resilient, stretchable second layer on the hardened first layer; (g) applying additional layers of said fluid material to the second hardened layer, changing the orientation of the mandrel to allow the fluid material to drain off the mandrel in additional flow directions, each flow direction being at an angle with respect to the preceding flow direction, and allowing the fluid material to harden to form additional resilient, stretchable layers; and (h) removing said multi-layered item from said mandrel whereby the cooperation of the different directional layers forms a strengthened, multi-layered, molded item. - View Dependent Claims (23)
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- 24. A multi-layered, self-supporting, molded item comprising a flexible, expandable membrane having a plurality of consecutive layers of flexible, stretchable material, each said layer of material further containing filaments embedded within said layer, each of said layers being oriented at a first angle with respect to the layer adjacent to it, said membrane surrounding and defining a lumen constructed and arranged to be filled with fluid or gel, whereby the cooperation of the different directional layers forms a molded, self-supporting, multi-layered item.
Specification