Method for making a laminar ventricular partitioning device

• US 9,332,992 B2
• Filed: 03/14/2013
• Issued: 05/10/2016
• Est. Priority Date: 08/05/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cardiokinetix Incorporated
• Inventors: Alexander, Miles D.
• Primary Examiner(s): Lee, Edmund
• Application Number:
  US13/827,927
• Publication Number:
  US 20130270735A1
• Time in Patent Office: 1,153 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: B29C 43/18 incorporating preformed parts or layers, e.g. compression moulding around inserts or for coating articles B29C43/206 takes precedence
• CPC Class Codes: B29C 65/12 and welding bar

Abstract

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.

Claims

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.