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Mitigation of SCS Lead Migration

SV

Sydney Vivian

Transcript

Prevention of Spinal Cord Stimulator (SCS) Lead Migration

Neeti Dave

Tim Silliman

Sydney Vivian

Sam Senneka

Background

  • Approximately 60,000 Americans have received an SCS implant in the last 15 years
  • around 15% experience lead migration

  • Patients experience loss of pain coverage when the leads migrate

  • No known solution

Project Introduction

Clinical Needs Statement

There is a need to reduce lead migration due to natural tissue migration and daily activities in SCS patients

Problem Statement

reducing lead migration will decrease the number of patients who

  • need lead relocation surgery
  • undergo device removal

What has been done, and how can we improve?

  • No existing, proven solutions
  • Emerging research solutions do exist

Design Criteria

Our Solution

Coiled wire connecting battery pack to leads, with bio-compatible adhesive applied to coil before implantation

Our Solution

Design Criteria

Design Criteria

Solution Specifics

Coiled wire extends at points of tension

Water soluble adhesive dissolves in two hours

Solution Specifics

Prototype

  • Coiled wire (larger scale)
  • solidified with PVA
  • recorded dissolution time in 0.9% saline solution

Prototype

Testing Results

Tensile Testing

  • Tensile testing run before and after solidifying coil
  • Wire became less rigid after PVA processing

Testing Results

PVA Mw and Dissolution Time

  • tested dissolution times of 3 Mw PVAs
  • 31000 Mw
  • 61000 Mw
  • 125000 Mw
  • 31000 Mw dissolution time is ideal
  • time is around 2 hours

Next Steps and Further Research

  • Cell viability testing using mouse osteoblasts
  • Ex-vivo testing using pig spine warmed to body temperature
  • FDA application (510k)
  • Device Trials within primates

Conclusion

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