Ambulatory cryocooling therapy device

NIH RePORTER · NIH · R44 · $258,500 · view on reporter.nih.gov ↗

Abstract

PI: Savoy Project Summary Tissue protection following injury begins with shutting down vasodilation and limiting subsequent swelling through the application of cold. In many cases, the cold comes in the form of bags of ice or frozen cold packs, or commercial cooling products such ice packs or ice pack holding limb wraps. In others it may be via a chilled water circulator device, for example the Polar Care Kodiak Cold Therapy where ice water is sent from the “holding box” through ¾” tubing into a cooling pad applied to the skin. The drawback with ice and frozen packs is the risk of skin burn and soft tissue damage stemming from skin contact with such a low temperature. With as little as 20-30 minutes of an icepack lying against the skin, damage may occur. However, studies have shown that 20 minutes of cooling one time is not enough to change the course of treatment and decrease the swelling. Longer term cooling is needed to make a difference. However, the patient’s functional mobility and compliance is limited due the bulk of the apparatus, and this discourages longer term use and increases risks associated with deep vein thrombosis which combine decrease patient outcome. Ideally, the device could be worn “hands-free” for extended periods providing a long-term (full day) programmable therapeutic regimen which includes periods of anti-inflammation (T ~ 10 °C) followed by brief periods of elevated temperature (T ~ 20 °C) to prevent skin damage. An alternative electrical-to-thermal cooling device that could be applied directly to the injury site would increase patient adoption and improve patient therapy benefit. Nanohmics’ direct electric-to-thermal approach to address this shortcoming will provide programmable temperature control over the entire contact region in a low-profile, low-power consumption device that will enable the patient full ambulatory freedom during the therapeutic regimen after injury (e.g. ankle/wrist sprain) or surgery (e.g. knee arthroscopy). No ice means there are no issues with melting and replacement, and the temperature can be programmed for cold (anti- inflammatory) and heat (cellular debris clearing, thrombosis) which may lead to benefits in decreased pain medicine consumption, post-injury range of motion, and decreased pain score and risks associated with deep vein thrombosis.

Key facts

NIH application ID
10603705
Project number
1R44AR081321-01A1
Recipient
NANOHMICS, INC.
Principal Investigator
Steve Michael Savoy
Activity code
R44
Funding institute
NIH
Fiscal year
2022
Award amount
$258,500
Award type
1
Project period
2022-09-23 → 2023-07-31