Devices Designed to Save Lives

In April 2013, ZOLL Medical entered into an agreement with Reflectance Medical Inc. (RMI) to develop and market a ruggedized version of the Mobile CareGuide 3100, a sensor enabling medical personnel to obtain tissue measurements of oxygen and pH without a blood sample so that patients that are about to go into shock can be identified.

Since 2009, the RMI team has been working to develop the next generation military sensor. The original CareGuide 1100 received FDA clearance in July 2012 with the second-generation CareGuide 2100 following with clearance in December 2012. The latest Mobile CareGuide 3100 received FDA clearance July 2013.

“The FDA clearance of the Mobile CareGuide 3100 with non-invasive pH measurement is a major milestone for the company,’ said Babs Soller, CEO at RMI. “For the first time, we can provide continuous, non-invasive, real-time assessment of the patient’s acid-base status. The U.S Army Medical Research and Materiel Command (USAMRMC) and the Combat Casualty Care (CCCRP) Research Program funded the development of CareGuides 1100, 2100, and 3100.

The company is currently working on Mobile CareGuide 4100 which will be a modified Mobile CareGuide 3100 being developed to integrate with ZOLL’s monitor and defibrillator technologies. The new CareGuide will have more ruggedized packaging for the optical sensor and attach to the patient. Additional software modifications will make it quicker and easier to get measurements started on injured patients.

“This effort is being funded by ZOLL, but the researchers are incorporating the needs of the military into our specifications through on-going discussions with USAMRMC and the CCCRP” added Soller. “Long term, we plan to work with commercial partners to make Mobile CareGuide technology the standard of care for continuous assessment of trauma patient metabolic status both inside and outside of the hospital.”

Another device XSTAT being developed by USAMRMC and CCCRP is addressing hemorrhaging. One of the most challenging forms of hemorrhaging has been at the junction of the legs or arms with the torso and where there is hemorrhaging from deep wounds. This situation makes it impossible to apply a tourniquet or apply manual compression externally.

The XSTAT device to control hemorrhaging looks like a large plastic syringe filled with many small pellet-shaped sponges that enlarge to fill up a wound area quickly to prevent blood loss. The technology looks promising enough that the Army has chosen to fund it through to the completion of the project.