Digitally Adjustable Phrenic Nerve (DAPhNe) Stimulator for Breathing Support

LU​NU 2017-153

INVENTORS
Matthew R Glucksberg*
Debra E Weese-Mayer*
Alexey Revinski
Kirby D Gong
Michelle Wang
Emma S Cripe
Anthony C Chin
 
SHORT DESCRIPTION
A wireless, adjustable, implantable device designed to stimulate the phrenic nerves for artificial breathing life-support.

BACKGROUND
Patients with respiratory insufficiency disorders but healthy lungs, including congenital central hypoventilation syndrome (CCHS), quadriplegia, and amyotrophic lateral sclerosis (ALS), may require continuous artificial ventilation for life-support, but options are limited. Existing treatment life-support options include mechanical ventilation via a semi-portable ventilator and phrenic nerve-diaphragm pacing via a handheld device. Currently available pacers (Mark IV and Spirit Transmitters, Avery Biomedical) require tethering of the patient to awkward external bilateral antennae and allow a maximum of two different programmable settings within a transmitter. There is a need for an updated and more efficient, customizable, and automated phrenic nerve-diaphragm pacer that provides life-support for infants, children, and adults while allowing them to safely participate in activities of daily living.

ABSTRACT
A team of Northwestern University and Ann & Robert H. Lurie Children’s Hospital researchers have developed a DAPhNe Stimulator.  The DAPhNe technology allows health care providers to utilize highly individualized, algorithm-incorporating, automated biofeedback to customize each child’s respiratory support based on their requirements, offering an alternative to mechanical ventilation. It includes an implantable digital nerve stimulator controlled externally using wireless technology. It eliminates the need to be tethered to a transmission system, allowing patients to be mobile while using it. Using this user-friendly system, patients can easily switch between multiple breathing modes set by their doctor or respiration may be automated via biofeedback to suit their individual needs for varied activities of daily living. DAPhNe efficiently stimulates both phrenic nerves, allowing it to be powered by a small portable and rechargeable lithium-iodide battery. Its technique of biphasic nerve stimulation, in comparison to monophasic, prevents long-term nerve damage from repeated stimulation over time. The need for new and improved treatment options for patients who require artificial ventilation as life-support is growing and the DAPhNe system offers multiple promising improvements over current ventilatory support systems.

APPLICATIONS

  • Ventilatory support for patients with diseases including CCHS, quadriplegia, ALS
  • Short-term ventilation management for battlefield/trauma and prematurity

ADVANTAGES

  • Significant progress towards totally implantable life-support technology
  • Wireless communication between controller and device, allowing patient to be untethered
  • Automated bio-feedback
  • Highly individualized algorithm to modify pacer settings
  • Multiple programmable breathing parameters and modes
  • Extended power efficiency
  • Biphasic nerve stimulation, reducing the potential for nerve damage from long-term stimulation

IP STATUS
A US Patent application is allowed and pending

 

Left, A device is implanted that stimulates the phrenic nerve and communicates wirelessly with an external controller. Right, table shows flexible adjustable settings of stimulation commands.

Patent Information: