Prior studies have linked microbial contamination of intravenous (IV) ports and stopcocks with postoperative infections. Existing technologies to address contamination are not consistently utilized because of the time and effort they require. Herein, novel barrier devices were created that form a protective shell to passively prevent contact between injection sites and practitioner hands or environmental surfaces while still allowing rapid connection of a syringe for injection of medications via an opening in the shell. Prototypes were tested using a grossly contaminated environment and adenosine triphosphate (ATP)-bioluminescence assay. For eight pairs of unshielded versus shielded IV ports/stopcocks, average contamination was 4102 versus 35 RLU (p < 0.02), respectively, indicating that the devices could significantly reduce IV port/stopcock contamination.

The treatment of cerebral aneurysms is frequently accomplished via endovascular delivery of metal coils in order to occlude the aneurysm and prevent rupture. This procedure involves imprecise packing of large lengths of wire into the aneurysm and often results in high rates of aneurysm recanalization. Over time, this incomplete aneurysm occlusion can lead to aneurysm enlargement, which may have fatal consequences. This report describes the fabrication and preliminary testing of a novel aneurysm occlusion device composed of a single metal coil surrounded by a biocompatible polymer shell. These coil-in-shell devices were tested under flow conditions in synthetic in vitro models of saccular aneurysms and deployed in vivo in a short-term porcine aneurysm model to study occlusion efficacy. A single nickel titanium shape memory wire was used to deploy a biocompatible, elastic polymeric shell, leading to aneurysmal sac filling in both in vitro and in vivo aneurysm models. The deployment of this coil-in-shell device in synthetic aneurysm models in vitro resulted in varying degrees of aneurysm occlusion, with less than 2% of trials resulting in significant leakage of fluid into the aneurysm. Meanwhile, in vivo coil-in-shell device implantation in a porcine aneurysm model provided proof-of-concept for successful occlusion, as both aneurysms were completely occluded by the devices. Both in vitro and in vivo studies demonstrated that this coil-in-shell device may be attractive as an alternative to traditional coil embolization methods in some cases, allowing for a more precise and controlled aneurysm occlusion.

The primary function of the ventricular chambers of the heart is to provide the proper volume of blood to the entire body that fulfills its energy requirements under a wide variety of normal and pathologic settings. If the ventricles are unable to perform this task properly, and the functions of the body deteriorates despite optimal medical management, mechanical methods are utilized to either complement or replace the pumping function of the cardiac ventricles. This presentation will describe the evolution of a non-invasive method of assisting the circulation called “counterpulsation,” and the current state of the development of an “External Left Ventricular Assist Device” (XLVAV). In this method, in the first part of the cardiac cycle, when the heart is relaxed, cardiac diastole, the device exerts a positive pressure external to the lower extremities. This increases coronary artery blood flow and cardiac output. Then when the ventricle contracts, cardiac systole, the device exerts a negative pressure, thus drawing blood away from the heart into the lower extremities, resulting in a reduction of the work and energy requirement of the left ventricle. Experimental and clinical data will be presented that describe the following successive stages of development: 1. The initial experience of Osborn in 1962 using a pressure suit and air actuation was tested in a canine model and in normal volunteers, but was not successful since sufficient pressure was not exerted on the vascular bed of the lower extremities. 2. The initial experimental experience of Birtwell and Soroff in a canine model in 1962 using water as the actuating medium. 3. The construction of a device by Birtwell with cuff-type actuators around the legs, thighs and buttocks that were inflated with water. The cuffs had rigid shells to allow pressure to be exerted to the limbs. The device was successful in increasing diastolic pressure and coronary blood flow and was used successfully in a multicenter study as an initial treatment of patients with acute myocardial infarctions. However, since the device could only apply positive pressure, it could not be used to reduce systolic pressure. 4. The device was then modified to also apply negative pressure during cardiac systole, a major step forward, and tested in a multicenter study in patients with cardiogenic shock following myocardial infacrtions with an impressive increase in the survival rate from 15% to 45%. However, the device presented logistical and patient movement problems. 5. The next evolution in the device design was the use of air to inflate the actuator cuffs. This represented a significant breakthrough, and has been successfully used in the treatment of angina pectoris by increasing coronary blood flow and the promotion or creation of collateral circulation in the myocardium. The serious shortcoming of this device is that is cannot produce negative pressure during cardiac systole, i.e., the only means of assisting the left ventricle in patients with Congestive Heart Failure. 6. The device to be described can apply negative as well as positive pressure to the lower extremities using air as the actuating medium. The device is mobile and compact, and should be effective in the treatment of patients with Congestive Heart Failure both in the hospital setting and in the home, Acute Myocardial Infarction as well as Angina Pectoris.