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The BridgePoint Medical System (consisting of the CrossBoss™ Catheter, Stingray™ Orienting Balloon Catheter, and Stingray™ Guidewire) is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention.

The CrossBoss Catheter is a single use over the wire disposable percutaneous catheter consisting of a full length coiled stainless steel shaft with polyester and polyurethane exterior. The coiled shaft provides torque and makes it possible to push the device, and also provides a guidewire lumen. The distal shaft transitions to an enlarged (1mm diameter) rounded distal tip. This stainless steel tip provides an atraumatic element that is intended to enhance the catheter's ability to move within the vasculature with reduced risk of arterial tissue engagement while providing radiopaque visibility. The distal portion of the CrossBoss Catheter is hydrophilic coated to enhance lubricity. The proximal portion includes an internal stainless steel hypotube stiffener that provides additional push. A torque device, coaxially positioned over the proximal portion of the CrossBoss Catheter, provides a comfortable user interface for device manipulation. The torque device (similar to a guidewire torque device) is positionable along the proximal portion of the catheter and includes a torsion release safety mechanism. This safety mechanism insures the torque input generated by the user remains within the torsional operating strength of the catheter shaft. The Stingray Orienting Balloon Catheter is a single use, over-the-wire, disposable, dual lumen percutaneous catheter that facilitates the placement, support and steering of a guidewire into discrete regions of the coronary and peripheral vasculature through the central guidewire lumen or through one of two side-ports (identified by radiopaque markers). The side-ports connect with the central guidewire lumen and facilitate guidewire steering (at an angle to the central lumen) by allowing the guidewire to exit the catheter. The catheter contains a small non-compliant balloon segment used for fluoroscopic orientation on the distal tip of the flexible shaft. The Stingray Guidewire is a conventionally constructed 0.014" diameter, single use, disposable guidewire that consists of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the shaft is taper ground to provide distal flexibility. The distal portion also includes a coaxially positioned coil constructed of platinum/tungsten material for visibility under fluoroscopy. The coil is fixed to the stainless steel core wire via silver alloy solder and is coated with hydrophilic coating. The distal tip of the guidewire is supplied with an angled geometry which transitions to a conventional rounded tip. The core wire (~0.0035" diameter) extends approximately 0.007" distal of the rounded tip.

The Bridge Sentry™ System is intended for the infusion (or administration) of fluids of medications. It is also intended for the preparation (reconstitution, as required, and mixing) of single dose, intermittent, anti-infective and gastrointestinal medications. It is not intended for use with blood, blood products or lipids.

The Bridge Sentry™ Bedside Unit. The Bridge Sentry Pharmacy Utility and the Bridge Sentry™ Administration Sets are collectively referred to as the Sentry System. The Sentry System includes an electrical, external, volumetric drug compounder and infusion pump. The administration sets contain a dedicated cassette that is compatible with the Bridge Seotry Bedside Unit. The Sentry is an electro-mechanical device incorporating a sterile disposable cassette with ancillary fluid delivery tubing and components. The Sentov stores drug delivery preset information for reconstitution, dilution and delivery. These presets are based on industry standards derived from drug labeling. The preset information is downloaded into each Sentry device. The Sentry requires identification of the patient, the user, the drug, and the dillo oching part of the setup operation. The identification may be accomplished via bar code scan or menu selection. The Sentry uses the identification information in conjunction with the pharmacy presets to minimize emars and capture drig event information. The Sentry System provides accurate and continuous flow of fluids to the patient. The device operates using a proprietary Acoustic Volume Sensor, a form of actuation pressure and a precision fluid impedance in the set to for a closed loop flow control system. The system detect occlusions in the patient line downstream and determines if sufficient fluid can be drawn from an upstream source to continue patient delivery. The system also detects air in line and when possible eliminates the air. The administration sets are sterile, and for single patient use. The Administration Sets are composed of a unique cassette and various combinations of other standard administration set components including tubing, filters, spikes, drip chambers, injection sites, clamps, caps or protectors, and luer connectors. The Sentry Cassette contains 10 valves to control fluid flow, a precision control orifice for flow control, a front cover, rear cover, mid-body, an inlet port, outlet port, a luer connection, and three drug vial spikes. The Sentry device contains a System Management Module, a Fluid Delivery Module, bar code scanner, infusion stand base and pole(s), vial attachment mechanism, battery, pharmacy utility, air in line sensor, and a data acquisition computer.