Abstract: The invention provides an implantable apparatus which includes a power supply capable of converting non-electrical energy such as mechanical, chemical, thermal, or nuclear energy into electrical energy. The invention also provides a method of supplying energy to an electrical device within a mammalian body in which the mammal is implanted with an apparatus including a power supply capable of converting non-electrical energy into electrical energy, and non-electrical energy is transcutaneously applied to the apparatus.

Abstract: The invention provides an implantable apparatus which includes a power supply capable of converting non-electrical energy such as mechanical, chemical, thermal, or nuclear energy into electrical energy. The invention also provides a method of supplying energy to an electrical device within a mammalian body in which the mammal is implanted with an apparatus including a power supply capable of converting non-electrical energy into electrical energy, and non-electrical energy is transcutaneously applied to the apparatus.

Abstract: An implantable access device suitable for delivering a liquid medication to a site remote from the site of port implantation is disclosed, which contains a filter assembly for removing particulate material from fluid injected into the port. The filter assembly of the invention contains a first reservoir chamber having cutouts, recesses, and/or sharp corners in which particulate material may be trapped, and additionally having a first wall forming a filter barrier capable of 360.degree. of fluid flow therethrough. The implantable access device may also include an infusion pump apparatus coupled to the access device. A filter assembly for insertion into an implantable treatment material device is also described.

Abstract: An accumulator for an implantable infusion system employs a pair of separated diaphragms movable in unison by a transfer fluid disposed therebetween. A first chamber receives infusate in metered amounts and dispenses the contents as a function of toggled valve operation. During filling, the first diaphragm deflects upward and by pressure transfer causes a corresponding deflection in the second diaphragm. The second diaphragm is biased by springs, gas under pressure or the like. Hence, when the outlet valve opens, the pressure differential across the diaphragm causes downward deflection. No mechanical stops are needed in the infusate chamber for the first diaphragm since its movement is controlled by the pressure differential across the second diaphragm.

Abstract: A fluid metering device useful in implantable drug delivery systems is coupled between a pressurized fluid source and an outlet conduit to provide discrete flow pulses at a predetermined rate. The metering device consists of a first movable member constrained within a housing and a second movable member retained in a cavity by the first. Alternate positioning of the first member simultaneously fills and empties the cavity in which the second resides, discharging fluid through the conduit. The first movable member can be a planar slider, an axially translatable cylinder or a rotatable cylinder. The second movable member may be a flat shuttle, a sliding bar or a diaphragm.

Abstract: An implantable infusion reservoir having a resilient foam member in a rigid housing to urge fluid to an implantation site. The foam member compresses upon charging and then expands to maintain a predetermined pressure characteristic within the fluid. The foam replaces the previously used two-phase propellent and eliminates the need for a hermetic metal bellows. The foam may be either closed celled or open celled, with or without a barrier skin. The device can be conformal to any desired shape and employ various metering techniques to deliver accurate quantities of fluid.

Abstract: A flow regulator/restrictor placed in a fluid path to passively compensate for variations in fluid pressure by deflection or movement. In one embodiment a silicon micromachined housing has a damper beam cantilevered to the interior wall between inlet and outlet. Deflections of the beam vary the volume of the restrictive gap formed between the damper beam and the interanl wall of the housing adjacent the outlet. In another embodiment the damper element is a floating element in the housing and has conformal side walls with the interior of the housing. The restrictor elements may be stacked to provide a stepped pressure drop, restrictor system.

Abstract: A needle guard attachment for a syringe. The guard has a pair of concentric members one of which establishes fluid communication between the needle and the syringe body. The other member slides to cover the needle. Once in an extended position it locks into place to act as a sheath over the needle. The guard attaches to the needle and the syringe body by luers compatible to those already on the elements.

Abstract: A device that is implantable to provide access to multiple body sites for the administration or withdrawal of fluids. A hollow port has a self sealing septum on one end and an outlet at an opposite end. A catheter is connected to the outlet. The septum and outlet are positioned to be substantially in-line.

Abstract: An implantable pump system employing a flow regulator isolates the regulator sensing chamber from the path of drug flow. This is accomplished by establishing either an independent sensing chamber in the regulator or coupling it to the propellant chamber of the pump. Additionally, a downstream restrictor may be used to provide an additional pressure drop between the regulator and the outlet catheter.

Abstract: An implantable pump system employing a flow regulator isolates the regulator sensing chamber from the path of drug flow. This is accomplished by establishing either an independent sensing chamber in the regulator or coupling it to the propellant chamber of the pump. Additionally, a downstream restrictor may be used to provide an additional pressure drop between the regulator and the outlet catheter.

Abstract: A drug delivery system for implantation into a living body having a pressure actuated infusion pump and an adjustable flow regulator. The regulator comprises a body having a regulator cavity divided by a diaphragm into two chambers. One chamber serves as a pressure sensor and the other as a conduit through which fluid flows. The outlet from the conduit chamber can be sealed by diaphragm movement as a function of pressure increase or the flow restricted. The outlet itself is mounted on an adjustable fitting that is movable relative to the diaphragm. The distance between the outlet and the diaphragm may be set as a calibration of the regulator.

Abstract: An implantable valve accumulator pump for the delivery of medication is disclosed. The implantable pump comprises a drug reservoir maintained at constant pressure vapor. The medication metering assembly comprises a fixed volume accumulator positioned between a pair of valves. The valves alternately open and close to admit medication from the reservoir into the accumulator and to dispense a precise volume spike to an outlet catheter. In order to minimize dead volume and insure complete discharge, the accumulator employs a titanium diaphragm seated in one position by a recessed stop and in the discharge position by a spacer plate having a concentric groove pattern. The grooves are in fluid communication with the inlet and outlet. Also, a wide groove extending between inlet and outlet provides fluid communication between the grooves. The unit is externally programmed.

Abstract: An implantable device uses shape memory alloy (SMA) as the driver to compress a reservoir thereby providing a constant pressure source fluid delivery device. The SMA may form either the reservoir itself by appropriate shaped sheets or it may form bands around a flexible reservoir member. The reservoir may also be formed of rigid members pivoted or clamped using SMA actuators to bias the rigid members together.

Abstract: A method and apparatus to evaluate the performance of an implanted medication delivery device such as pumps and ports is described. In the case of a pump, the system measures ambient pressure and obtains two pressure measurements from the implanted device. One of these measurements is device reservoir pressure and the other is based on a disturbance pulse injected into the system at a point downstream of the reservoir. Based on those measurements and input calibration data, an expected flow rate is determined. The expected flow rate together with device refill data is in turn used to determine a normalized flow rate for the in-vivo device. Determinations are then made as to the performance of the reservoir, its pump and the condition of the outlet catheter without explant of the device. In the case of a port, the system measures the catheter resistance based on decay time of a disturbance pulse.

Abstract: A variable flow constant pressure implantable pump employs an in-line needle restrictor having a variable insertion distance in a capillary. The degree of insertion determines the effective restriction within the capillary. The restrictor may be repositioned following implantation to vary the drug delivery rate by changing the effective restriction in the capillary. Various couplings may be used such that an auxiliary or bolus port delivers infusate directly into the outlet catheter so that medication from the main chamber does not pass through the auxiliary chamber. A combination of double lumen catheters and T-connectors are employed to provide parallel infusion paths.

Abstract: An implantable infusion device having a nipple outlet over which a catheter is fitted. A locking sleeve slidably mounted on the catheter to expand over the nipple and engage the housing. The locking action provides a sensory indication by noise of tactile sensation that locking has been achieved. Both single and double lumen devices employ the locking sleeve.

Abstract: A device that is implantable to provide access to multiple body sites for the administration or withdrawal of fluids. A hollow port has a self sealing septum on one end and an outlet at an opposite end. A catheter is connected to the outlet. The septum and outlet are positioned to be substantially in-line.

Abstract: An implantable valve accumulator pump for the delivery of medication is disclosed. The implantable pump comprises a drug reservoir maintained a constant pressure vapor. The medication metering assembly comprises a fixed volume accumulator positioned between a pair of valves. The valves alternately open and close to admit medication from the reservoir into the accumulator and to dispense a precise volume spike to an outlet catheter. In order to minimize dead volume and insure complete discharge, the accumulator employs a titanium diaphragm seated in one position by a recessed stop and in the discharge position by a spacer plate having a groove pattern. The unit is externally programmed.

Abstract: A positive pressure positive displacement implantable infusion pump. A positive pressure fluid reservoir maintains infusate for delivery by a positive pressure displacement pump. Infusate is drawn by the pump into a drug pressurant chamber. A check valve prevents backflow into the reservoir. The check valve may independently establish a basal flow rate by not completely sealing in the forward flow direction. The pump pulses to expel and fill the chamber thereby establishing the flow rate, basal or bolus through a restrictor interposed between the chamber and the infusion site. The pump may run in open loop, pre-programmed or externally programmed modes of operation.