Stent fabrication via tubular casting processes

• US 9,908,143 B2
• Filed: 05/21/2012
• Issued: 03/06/2018
• Est. Priority Date: 06/20/2008
• Status: Active Grant

• Current Assignee: Razmodics, LLC
• Original Assignee: Amaranth Medical Pte.
• Inventors: Ramzipoor, Kamal, Chia, Alfred N. K., Wang, Liwei, Lee, Chang Y.
• Primary Examiner(s): Schall, Matthew
• Application Number:
  US13/476,858
• Publication Number:
  US 20120232644A1
• Time in Patent Office: 2,115 Days
• Field of Search: 623 115
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: B05D 1/18 performed by dipping

Abstract

Tubular casting processes, such as dip-coating, may be used to form substrates from polymeric solutions which may be used to fabricate implantable devices such as stents. The polymeric substrates may have multiple layers which retain the inherent properties of their starting materials and which are sufficiently ductile to prevent brittle fracture. Parameters such as the number of times the mandrel is immersed, the duration of time of each immersion within the solution, as well as the delay time between each immersion or the drying or curing time between dips and withdrawal rates of the mandrel from the solution may each be controlled to result in the desired mechanical characteristics. Additional post-processing may also be utilized to further increase strength of the substrate or to alter its shape.

Claims

1. A method of forming a polymeric stent, comprising:

repeatedly immersing a mandrel in a solution comprising a bioabsorbable polymer and a solvent,

wherein the bioabsorbable polymer is a polylactide having a weight average molecular weight at or greater than about 9.80×

10⁵ g/mol,

wherein a polymeric substrate is formed on the mandrel from repeatedly immersing the mandrel in the solution,

wherein the polymeric substrate is a tubular member formed as multiple dip-coated layers of the polymeric solution on the mandrel;

drying and heating the polymeric substrate in order to remove residual amounts of the solvent from the multiple dip-coated layers of the polymeric solution; and

forming the polymeric stent by further processing the tubular member, wherein the polymeric stent comprises at least one dip-coated layer of the polylactide having a thickness and wherein a degree of crystallinity of the at least one dip-coated layer is between about 20% and 40%.

2. The method of claim 1 further comprising:

reducing a first diameter of the polymeric stent to a second diameter which is less than the first diameter.

3. The method of claim 2 further comprising expanding the polymeric stent with an inflation balloon from the second diameter to a third diameter.

4. The method of claim 3 further comprising removing the inflation balloon from the polymeric stent.

5. The method of claim 2 further comprising allowing the polymeric stent to self-expand from the second diameter.

6. The method of claim 1, wherein the polylactide is poly-L-lactide (PLLA).

7. The method of claim 1, wherein drying and heating the polymeric substrate is done at a temperature at or above a glass transition temperature of the bioabsorbable polymer.

8. The method of claim 1, wherein the degree of crystallinity of the at least one dip-coated layer is between about 20.90% and 38.40%.

9. The method of claim 1, wherein the degree of crystallinity of the at least one dip-coated layer is between about 20.90% and 46.20%.