High Performance Thermoplastic Elastomer Delivery Device Ensures Newborn Safety

When newborns need a bit of extra encouragement making their debut, obstetricians around the world rely on vacuum-assist delivery devices from CooperSurgical Inc., of Trumbull, Conn.

GLS TPE Used in Vacuum-assist Delivery Devices

The company’s self-contained Mystic® II vacuum delivery system, now in its third generation, has been made even better through the use of DYNALLOYä olefin block copolymer thermoplastic elastomers (OBC TPEs) from GLS, a PolyOne company and global leader in the manufacture of high-performance, custom-formulated TPEs. By replacing a competitor’s TPE with GLS DYNALLOY in a critical, overmolded part – which attaches the vacuum tube to the cap – CooperSurgical was able to achieve near-perfect performance consistency, higher pull force and improved flexibility for fast, accurate positioning of the device.

The Mystic II M-Style® System features a single-use device specifically designed for occiput posterior (OP) and other presentations requiring a higher pull force, features a malleable mushroom-shaped cup that is inserted vaginally and placed on the baby’s head. By applying gentle vacuum pressure, the obstetrician can maneuver the head during delivery, potentially avoiding the need for a Caesarian section.

“Safety is our number-one concern, and we are always looking for new technologies that can increase the reliability, ease of use and performance of our products to improve outcomes,” said Dr. Bob Auerbach, medical director for CooperSurgical and an associate clinical professor at Yale University School of Medicine. Now, thanks to GLS, we can offer the market an improved technology.”

CooperSurgical identified several key material properties required for the part: softness for patient comfort and protection; enhanced bonding to the low-density polyethylene (LDPE) vacuum tube for greater pull force; custom color; and the ability to be sterilized with ethylene oxide (EtO) gas. GLS recommended DYNALLOY OBC compounds, which are based on INFUSE™ OBC technology licensed from The Dow Chemical Company. GLS reformulated the DYNALLOY OBC TPE to provide the following benefits:

  • Exceptional chemical bonding to LDPE: CooperSurgical’s testing of the overmolded part indicated that the LDPE tube breaks before the TPE adhesion is compromised, which produces an overall increased maximum pull force.
  • DYNALLOY’s pull force is predictable, consistent and repeatable.
  • Shore A hardness of 46 for softness and flexibility.
  • Custom color-matching.
  • Sterilization with EtO.

In addition, GLS modified the rheology of the DYNALLOY material to achieve improved flow and minimize flashing of the part.

According to Joseph Kutka, technology launch manager, GLS, “This application is a great example of how GLS’ customization services can quickly create a tailored material to meet a complicated list of requirements. Our OBC-rich DYNALLOY TPE is helping CooperSurgical take their Mystic II device to the next generation of performance, comfort and dependability.”
 

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