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The Alpha Infusion Pump is intended for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. Medication is intended to be delivered through a catheter containing a flow restriction element. The Alpha Infusion Pump is intended for use in the hospital or by an ambulatory patient.

The Alpha Infusion Pump consists of two elastomeric chambers, which pressurize the medication. These chambers are protected in a plastic housing. A one-way check valve is provided to fill these chambers. Medication delivered from the elastomeric chambers is filtered through a 5-micron filter and held in an outflow chamber. An internal pressure regulator maintains the pressure of the medication in the outflow chamber at 6 psi in order to provide a constant flow rate through each infusion catheter inserted through the septum into the outflow chamber of the pump.

The STA Cath® Attachable Infusion Catheter is intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. The STA Cath Attachable Infusion Catheter is intended for use in the hospital or by an ambulatory patient.

The STA Cath® Attachable Infusion Catheter is an open end style catheter similar to the Alpha Cath™ Infusion Catheter. This catheter consists of a length of PVC tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion into the Alpha Infusion Pump. The distal end of the tubing contains axial slit ports near the distal tip which are designed to infuse medication in case the end of the catheter becomes blocked. The distal end of the catheter has a short length of tubing attached to it. A loop of monofilament extends beyond both ends of this attached tube, and is used by the physician to draw a 4-0 suture, placed at an attachment site in the patient, through the attached tube in order to temporarily hold the catheter in place.

The Polyurethane Infusion Catheters are intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, postoperatively, for the relief of pain. The Polyurethane Infusion Catheters are intended for use in the hospital or by an ambulatory patient.

The Polyurethane Infusion Catheter consists of two design options: Alpha Cath™ open end style catheter: this style catheter consists of a length of tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion into the Alpha Infusion Pump. The distal end of the tubing contains axial slit ports near the distal tip which are designed to infuse medication in case the end of the catheter becomes blocked. Multi Drip® closed end style catheter: this style catheter consists of a length of tubing which functions as a flow restrictor. The proximal end of the tubing has a stainless needle for insertion into the Alpha Infusion Pump. The distal end of the tubing has a series of tiny ports along the distal portion of the catheter which are designed to spread medication along an infusion zone.

The Multi Drip™ Infusion Catheter is a single-use, short duration catheter intended for use with the Alpha Infusion Pump for the continuous infusion of medication directly into an intraoperative site for postoperative pain management. Infusions may also be administered percutaneously.

The Multi Drip™ Infusion Catheter is designed to be used with the Alpha Infusion Pump (K021964) to deliver a continuous infusion of medication to a patient at a predetermined flow rate. It is a sterile, non-pyrogenic, single use device for use in the hospital or by an ambulatory patient. Except for the size of the exit ports and the closed distal end of the catheter, the Multi Drip Infusion Catheter is identical in construction and operation to the previously cleared Alpha Cath Infusion Catheter series (K021964). Like the Alpha Cath Infusion Catheter, the proximal end of the Multi Drip™ Infusion Catheter has a stainless steel needle attached to it for insertion of the catheter into the outflow septum of the Alpha Infusion Pump. The flow rate of the fluid delivered from the Alpha Infusion Pump through the catheter is determined by the preset delivery pressure of the pump and the internal diameter and length of the micro-bore PVC tubing forming the catheter. The Multi Drip™ Infusion Catheters are available in a range of lengths and flow rates identical to the Alpha Cath Infusion Catheters. Both catheter series are packaged in individual Tyvek pouches and sterilized by gamma irradiation.

The Alpha Infusion Pump and associated Catheters are intended for intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered through a catheter containing a flow restriction element. The Alpha Infusion Pump and associated Catheters are suitable for use as an ambulatory device and are intended for use in the home environment but not limited to use in the home environment.

The Alpha Infusion Pump is comprised of dual elastomeric chambers which hold the fluid to be infused under pressure. These chambers are contained within a hard shell case. The infusion pump also contains a luer lock checkvalve used to fill the chambers, a 5-micron fluid filter, a hydrophobic air vent filter, a pressure regulator, and an elastomeric septum for attaching infusion catheter(s) to the pump. The infusion pump is packaged as a kit in a tray containing an insertion needle used for placement of the catheter into the patient, a 60cc syringe used to fill the pump, a fabric belt used for holding the pump onto the patient, patient labels, and an Instructions For Use. The Alpha Cath Infusion Catheters are micro-bore tubing catheters with a needle attached to one end for insertion of the catheter into the infusion pump septum. The internal diameter and length of the catheter tubing acts as the flow restrictor and determines the flow rate of the fluid through the catheter. The infusion catheters are packaged separately in Tyvek pouches and are contained in cartons along with Tegaderm adhesive dressings and an Instruction For Use.

The Alpha Infusion Pump is intended for intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered percutaneously through a catheter. The Alpha Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.

The proposed device, the Alpha Infusion Pump, is an elastomeric chamber infusion pump intended to deliver medications or fluids to a patient by an intravenous, intra-arterial, subcutaneous, or epidural route. These pumps are ambulatory, external, disposable infusion pumps which deliver medication or fluids percutaneously to the patient via a catheter. They control flow rate using a flow restrictor.