SEA-PAP High Oscillation Continuous Positive Airway Pressure Device

Target Users (Target Impact Group)

Distributors / Implementing Organizations

The NeoRest Team is in the process of finalizing the Sea-PAP device design, identifying manufacturers to produce the device and preparing to conduct clinical trials. It is not being distributed widely at this time.

Manufacturing/Building Method

The main Sea-PAP device body will be mass produced. The unit can be assembled on-site with a small tool kit of supplies including a continuous air supply, a breathing circuit tube, a tube for the nose and water.

Intellectural Property Type

Other

User Provision Model

Unknown

Distributions to Date Status

Prototype device which has not been distributed at scale.

Design Specifications

• The Sea-PAP is intended to provide continuous positive airway pressure (CPAP) to spontaneously breathing neonates and infants, up to weights of 10 kg, requiring respiratory support due to conditions associated with prematurity, such as Respiratory Distress Syndrome, or other conditions where CPAP is required and/or prescribed by a physician.Sea-PAP works similarly to conventional Bubble CPAP (bCPAP) devices in providing a continuous flow of air via tubes inserted in an infant's nostrils. The Sea-PAP is comprised of two key elements; a water container and a tube inserted into the water. The Water Reservoir contains the water and has a lid permanently attached to help prevent splashing and spillages. The lid has an integrated Water Level Adjustment Port, to allow a clinician to adjust the water level in the Reservoir, if necessary, without disconnecting the breathing circuit. The tube is comprised of a Funnel-Swivel that is permanently attached to Bubble Tube. The Funnel-Swivel helps prevent spillages when filling the Water Reservoir initially and can rotate to help reduce tension that may build up in the expiratory limb of the breathing circuit. The expiratory end of the patient's breathing circuit, distal to the patient, is inserted into the center of the Funnel-Swivel. A Bubble Tube Lock mechanism is used to ensure the depth of the tube in the water does not change unintentionally. The gas bubbling out of the end of the Tube creates air pressure oscillations in the breathing circuit. For the Sea-PAP device the breathing circuit tube is placed in water at a 135 degree slope, which creates fluctuations in the positive airway pressure and keep the lungs open, lessening the work required from respiratory muscles and making it easier for the infant to breathe.

Technical Support

N/A

Replacement Components

Unknown

Lifecycle

The breathing and nose tubes can be used multiple times if sterilized. Disposable units can be used, however require a robust consumables supply chain.

Manufacturer Specified Performance Parameters

Unknown

Vetted Performance Status

Unknown

Safety

Unknown

Complementary Technical Systems

The Hansen Ventilator - a separate respiratory device - can be used in conjunction to treat even more premature infants with respiratory distress.

Academic Research and References

Compliance with regulations

In October 2013, Sea-PAP received clearance from the Food and Drug Administration for use and distribution in the U.S.

Other Information

Unknown