Healthy Adult Volunteer Study of Intraosseous Infusion Using the Sternum

A Follow-Up Volunteer Study Evaluating Intraosseous Vascular Access Infusion in the Sternum Using the EZ-IO T.A.L.O.N.Intraosseous System.

This study is being done to evaluate intraosseous vascular access through the sternum.

The purpose of this study is to evaluate the presence or absence of extravasation when using the T.A.L.O.N. Intraosseous System to establish sternal intraosseous infusion. This study will also evaluate the user preference feedback received from the device operators about the ease of use and level of satisfaction with the device. Lastly, this study will evaluate the infusion flow rates obtained when using intraosseous infusion in the sternum.

Inclusion Criteria:

• 21 years of age or older;
• healthy adult subjects

Exclusion Criteria:

• Weight < 45kg;
• BMI greater or equal to 30 with absence of adequate landmarks or too much overlaying tissue, as determined by the PI;
• Imprisoned subjects;
• pregnant subjects;
• prior sternotomy;
• cognitively impaired subjects;
• fracture in target bone, or significant trauma to the site;
• excessive tissue and/or absence of adequate anatomical landmarks in target bone;
• infection in target area;
• IO insertion in past 48 hours or other significant orthopedic procedure in target bone;
• current use of anti-coagulants;
• previous adverse reaction to Lidocaine;
• current cardiac condition requiring pacemaker or anti-arrhythmic drugs
• previous adverse reaction to contrast dye
• Allergy to any food and drug
• History of impaired renal function
• History of impaired hepatic function
• History of cardiac disease
• History of pheochromocytoma