Method for making a laminar ventricular partitioning device
View Patent ↗Described herein are systems and methods for securing a polymeric sheet to rib components of a frame structure, wherein the rib components are jointed at a hub to form an expandable and collapsible implant. In general, the method may include the steps of decreasing a diameter of the frame structure; placing the frame structure into an assembly fixture, wherein the assembly fixture is configured to hold the frame structure in a loaded configuration with a decreased diameter; placing a polymeric sheet into the assembly fixture; and heating the assembly under pressure to fuse the sheet to the frame structure. In general, a fixture may include a first and second platen having a shaping portion and a rim portion positioned around the periphery of the platen, wherein the shaping portions are configured to hold the rib components of the frame structure in a loaded configuration with a decreased diameter.
1. A method of securing a polymeric sheet to rib components of a frame structure, wherein the rib components are jointed at a hub to form an expandable and collapsible implant, comprising:
disposing a tube comprising thermoplastic material over each of one or more rib components of the frame;
forming an assembly by applying the thermoplastic-encased rib adjacent to at least one polymeric sheet of material; and
heating the assembly to fuse the sheet to the thermoplastic material to form a fused sheet, the fusion occurring by the heating and reforming of the thermoplastic material to the sheet, the rib remaining within the reformed thermoplastic material, wherein the implant is adapted to span a left ventricle.
2. The method of claim 1 , further comprising the step of applying pressure to the assembly to form a fused sheet.
3. The method of claim 1 , wherein the disposing step further comprises forming a thermoplastic-material-encased rib.
4. The method of claim 1 , wherein the disposing step further comprises forming thermoplastic-material-encased ribs having proximal portions that are not encased in the thermoplastic material.
5. The method of claim 1 , wherein the disposing step further comprises forming thermoplastic-material-encased ribs having tissue-penetrating proximal ends that are not encased in the thermoplastic material.
6. The method of claim 1 , wherein the disposing step further comprises forming thermoplastic-material-encased ribs, wherein the thermoplastic material is disposed over a first portion of a first rib and a second portion of a second rib, wherein the first and second ribs are adjacent to one another and the first portion is at a different position along the length of the rib than the second portion.
7. The method of claim 1 , wherein the at least one polymeric sheet of material comprises ePTFE.
8. The method of claim 1 , wherein the fused sheet is a unilaminar sheet.