The ULiSSES™ Device for Organ and Limb Preservation

Leonid Bunegin, Chief Scientific Officer;
Rafael J Veraza, MPH, PhD, Senior Scientist;
Tom DeBrooke, MA, MBA,Chief Executive Officer,
Vascular Perfusion Solutions, San Antonio, TX

One of the main reasons for the present shortage of organs is due to organ preservation constraints; for example, current technology cannot preserve hearts for more than 4 to 6 hours, and the distance between donor and recipient becomes a significant problem. Currently, the most commonly used and accepted method for organ transport and preservation is an ice chest, which offers no oxygenation – only insulation. Ice — dry, frozen, or Blu — is used in the cooler to slow down the deterioration process.

The Universal Limb/Organ Stasis System for Extended Storage (ULiSSES™) is a unique medical device that extends organ and limb viability. ULiSSES will provide organ and limb resuscitation, preservation, and transport capabilities in both civilian and military environments. It uses only a small oxygen cylinder for power and active perfusion to allow transport of organs or limbs anywhere in the world.

ULiSSES is highly portable, single-use, simple to operate, lightweight, and inexpensive. It can easily be transported in a commercial airliner where it can be stored in an overhead compartment or under the seat. On the battlefield, the ULiSSES device offers a flexible casing option using the same fluid carried by medics in common IV bags to preserve an avulsed hand, arm, or leg until a warfighter can have it reattached at a hospital.

VPS has licensed its core technology from the Office of Technology Commercialization at the University of Texas Health San Antonio to preserve and transport limbs and vascularized tissue for both replantation and transplantation.

Every 30 seconds a patient dies from diseases that could be treated with vascularized tissue replacement. With its ability to preserve and resuscitate organs and limbs for more than 24-hours, ULISSES removes the geographic limitations associated with transportation. With more organs available, surgeons are able to select a better match, rather than settling for a possible match.

The ULiSSES device operates using a combination of fluidics and mechano-elastic principles for the hypothermic, oxygenated, perfusion preservation of limbs and vascularized tissue. The device does not rely on electrical power to operate but instead, it harvests energy from expanding compressed oxygen to simultaneously drive pulsatile perfusion of vascularized tissue and oxygenation of the preservation medium. Oxygen, fluid, and fluidics logic combine to perfuse, preserve, and resuscitate tissue at a rate that mimics a natural heartbeat. Capillary fibers with a large surface area and permeable to O2/CO2 provide gas exchange and efficient oxygenation of the perfusate. These innovations result in a dramatic reduction in size, weight, and cost, leading to a portable, single-use device that is expected to provide long-term limb and vascularized tissue preservation.

A commercial prototype was translated from a 3D-printed lab prototype. VPS plans to collect additional test data and anticipates submitting for FDA clearance this year using the current commercial ULiSSES prototype in collaboration with the Department of Defense.

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