TABLE OF CONTENTS

Introduction

Device

Benefits of Pacing

Surgical Procedure

Demographics of Pacing

The Future

Links for More Information

The Group

BI108 Website

Brown University

Laproscopic Technology

Overview Current Study Criteria for Eligbility Procedure Benefits References

Introduction

Developed by Case Western Reserve University bio-medical engineers and physician researchers

The new laproscopic diaphragm pacing is a much less invasive, outpatient procedure. Instead of stimulating the phrenic nerve in the neck region, the electrodes are connected to the motor points of the diaphragm. This offers many benefits over the current phrenic nerve pacing, including lowered costs and decreased risks.


 Current Study


Criteria for Eligibility

  • Need to be above 18 years of age.
  • Need to have a high cervical spine injury resulting in tetraplegia.
  • Respiratory failure for the past six months that requires chronic mechanical ventilatory support.
  • Failure of vigorous attempts to wean from ventilatory support.
  • Normal bilateral phrenic nerve function is required.
  • No active cardiovascular disease, no active lung disease, no active brain disease, no significant scoliosis, no chest wall deformity, no obesity.


    •  Procedure

    1. Wires are threaded through four small incisions
    2. These wires connect 4 electrodes directly onto the diaphragm. The electrodes are not placed directly onto the phrenic nerve.
    3. 2 stainless steel intramuscular diaphragm electrodes are placed on each motor point of the diaphragm, using a specially designed delivery device that allows for the insertion of the electrodes in the same plane as the diaphragm. (The motor point is the place at which the phrenic nerve attaches to the diaphragm in order to cause movement.)
    4. A laparoscope and a previously designed mapping procedure is used to determine exactly where on the diaphragm these motor points are.
    5. The wires are brought out of the body and connected to an external battery/control that automatically sends mild currents to the electrodes inducing a natural breath. This battery is replaced every week.
  • Breathing is induced 12 times per minute. This is normal breathing rate.
  • This procedure is done on an outpatient basis.
  • Similarly to the current procedure, the patient's diaphragm requires conditioning.


    • Benefits of Laporoscopic Phrenic Nerve Pacing

  • Decreased cost ($10,000.00 vs $100,000.00)
  • Much less invasive procedure.
  • Decreased risk-Direct stimulation of the phrenic nerve may damage the nerve. Laporoscopic phrenic nerve pacing does not place the electrodes in direct contact with the phrenic nerve.
  • Less risk of infection because of smaller incisions.


    •  References
    http://www.clinicaltrials.gov/ct/gui/show/NCT00010374?order=3
    http://www.medtech1.com/new_tech/newtechnologyfeature.cfm/113/1
    http://mediswww.meds.cwru.edu/public_affairs/medlines/01may.pdf
    http://www.christopherreeve.org/ChristopherReeve/ChristopherReeveList.cfm?c=38