Production of Stents

1
Production of Stents

• John Ritchie
• Production Group
• 24 April 2003

2
Outline

• Objective
• Stent Production Overview
• Typical Stent Production Process
• Laser Cutting
• Finishing
• Crimping
• Alternate Stent Production Methods
• Conclusions

3
Objective

• To gain insight into the production process for
  the metal stents which serve as the basic
  framework for drug eluting stents.

4
Stent Production Overview

• 460,000 Stent procedures performed in the United
  States in 2000.
• However, the Big 4 are highly secretive about
  their production methods.
• Many stents are produced by numerous smaller
  production facilities

Reference Stephan Bossards 5.22 Presentation
5
Typical Stent Production Process

• Laser cutting is a typically method for stent
  production
• Despite initial fabrication technique, most
  stents see a similar fabrication process

6
Laser Cutting

• Allows precise cutting of stent designs from
  tubular blank
• Computer Controlled mechanism allows for
  flexibility in stent designs

Reference Rofin-Baasel Inc.
7
Laser Cutter Design
8
Laser Cutter
9
Stent Finishing

• Precision laser cutting can leave unfinished
  edges on the stent.
• Stents are finished in various ways
• Laser Deburring/Chemical Finishing
• Electropolishing/Electroplating
• Finishing method is dictated by the desired
  surface of the stent Especially if further
  coating is added.

10
Coating

• Since the coating is critical to stent
  functionality, it drives many decisions about
  stent production.
• It will be the topic of other talks.
• Coating procedure is dictated by the material
  being coated. Options include spraying and
  dipping.

11
Crimping

• Stents are typically produced in their expanded
  form.
• Crimping collapses the stent onto its associated
  hardware.
• Crimping can be done by the manufacturer or prior
  to catheterization in the clinic.

Reference Machine Solutions, Inc.
12
Alternate Stent Production Methods

• Metal Injection Moulding
• Assembly from Wire

13
Conclusions

• Equipment is readily available to laser cut, and
  crimp metal stents. This equipment can be
  purchased or work can be outsourced.
• Plant development should focus on designing
  finishing and coating equipment which are
  tailored to our specific drug/coating choice.

14
Further Study

• Look into larger scale production equipment
• Develop economic aspects of analysis
• Refine process recommendation based on other
  production team recommendations

15
References

• U.S. Patents6,369,355 6,245,100
  6,428,5706,508,836 6,514,063
• Machine Solutions, Inc.
• www.machinesolutions.org
• Rofin-Baasel Inc
• www.ablasers.com
• Stephan Bossards 5.22 Presentation