Abstract: Apparatus located in an implantable medication infusion pump for quickly and easily detecting a condition adversely affecting medication delivery in the implantable medication infusion pump is disclosed which can reliably detect occurrences including an occluded catheter, the presence of air in the pumping mechanism, and the failure of the pumping mechanism. The system uses the amplitude of an acoustic signal generated by operation of the pumping mechanism as compared with a baseline signal to detect an encapsulated or occluded catheter or air in the fluid line. In addition, the system can detect a partially encapsulated or occluded catheter by detecting repeated downward slope patterns during repetitive, closely spaced pumping cycles.

Abstract: An adapter plug clip is provided for convenient and secure temporary support of an electrical plug associated with an electronic instrument, particularly wherein the plug is formed as part of a relatively heavy AC/DC plug-in power supply adapter. The adapter plug clip is designed for clip-on mounting to a support structure, such as a bracket arm of a clamp fixture having an electronic instrument such as a medical fluid infusion pump mounted thereon. The adaptor plug clip includes a face plate having a visually identifiable pattern of holes formed therein for seated reception of the conductive prongs of the electrical plug, thereby providing a stable temporary plug mounting site.

Abstract: An ultrasonic air-in-line detection system for use in detecting entrained air bubbles in the fluid line of a disposable cassette mounted on a main pump unit is disclosed which can accurately detect entrained air bubbles in any type of fluid, whether clear or opaque. The system uses multiple windowing and air volume number weighting to determine when a threshold count of entrained air in a predetermined number of windows of material pumped occurs, with the alarm being sounded only when this threshold count of air bubbles is present in the multiple window volume. The system of the present invention thus will detect entrained air while avoiding so-called nuisance alarms.

Abstract: An improved and simplified pressure reservoir is provided for use with an implantable medication infusion pump to maintain a selected medication in liquid form with a pump housing under a substantially constant pressure. The pressure reservoir comprises a hollow structural enclousre having at least one flexible resilient wall and is adapted to be filled with a selected quantity of a pressure fluid, such as a selected fluorocarbon in a liquid-vapor state, prior to mounting of the reservoir as a structural unit into the infusion pump housing. Within the pump housing, the flexible reservoir wall defines one side of a medication chamber, with the pressure fluid undergoing appropriate change of state to expand or contact the reservoir in a manner maintaining the medication under a substantially constant pressure.

Abstract: An ultrasonic air-in-line detection system for use in detecting air bubbles in the fluid line of a disposable cassette mounted on a main pump unit is disclosed which utilizes an innovative construction used to attach electrical connectors to the ultrasonic transducers. Rather than wires, a thin flex circuit having a plurality of arms is used, with the flex circuit having a circular conductive pad located at the end of each arm. A circular segment of conductive transfer tape is used to attach each of the conductive pads to the thin layer of conductive metal located on each side of the ultrasonic transducer.

Abstract: An optical motion sensor is provided for monitoring movement of a mechanical device, particularly such as an infusion pump of the type used for controlled delivery of medication to a patient. The motion sensor includes a disk member mounted upon a selected mechanical output component driven by the infusion pump, such that the disk member undergoes displacement during normal pump operation. The disk member defines a pattern of reflective and substantially nonreflective surface zones which are alternately illuminated by a light source during normal pump operation. A light detector responds to the level of reflection from the disk member to provide an output signal which varies according to disk member displacement. This output signal is connected to a controller for comparison with drive signals supplied to the infusion pump, to verify proper mechanical output operation of the pump.

Abstract: An improved infusion pump is provided for controlled delivery of medication from a syringe to a patient, wherein a pump housing includes a syringe chamber and associated lock members for receiving and supporting the syringe in one of two different positions. The syringe includes a medication-containing barrel connected to a luer fitting at a nose end thereof by a luer neck of reduced cross sectional size. In one position, the syringe seats into the chamber with the luer neck protruding through an outlet port of mating size and with the luer fitting disposed outside the housing, such that the housing defines a lock member engaged axially between the syringe barrel and luer fitting to secure the barrel against axial displacement. In another position, a retainer key is adapted for installation into the syringe chamber at a position spaced inboard from the outlet port and defines an alternative lock member for axially securing the syringe with the luer fitting disposed inside the housing.

Abstract: An ultrasonic air-in-line detection system for use in detecting air bubbles in the fluid line of a disposable cassette mounted on a main pump unit is disclosed which can accurately detect air bubbles in any type of fluid, whether clear or opaque. The system uses a windowing technique to determine when a threshold amount of air bubbles in a predetermined volume of material pumped occurs, with the alarm being sounded only when this threshold amount of air bubbles is present in the window volume. The system of the present invention thus avoids so-called nuisance alarms due to the presence of small isolated air bubbles in the fluid due to the fluid pumped not having been degassed.

Abstract: A system for sealing a case with a lid and method of forming a seal generally comprises a raised edge on the case, a shaped channel in the lid and a cross-sectionally shaped gasket that is laterally compressed by the side walls of the channel and seals the lid and case between the side walls of the channel and the case raised edge.

Abstract: A medication infusion system may be selectively configured to perform an emulation of any one of a plurality of Device Types corresponding to the environment of use. The particular parameters which relate to a given Device Type are set into the system either at the factory or by biomedical engineers at the hospital or other medical institution by resort to an intercoupled computer driven by appropriate software. With the system set up in this fashion, a clinical user can select a given Device Type and can view but cannot change the critical operating parameters thereof. Substantial economies and improvement of device operation are realized by the provision of one switchable system in place of the plurality of different types of devices now required in a given institution.

Abstract: A device for use as an attachment for use with a main pump unit containing a prime mover and a control system for controlling the operation of a disposable cassette containing a fluid pump which is mounted on the main pump unit is disclosed which includes both a compartment for securely storing the medication supply and means for preventing either the cassette or the fluid line between the storage compartment and the cassette from being removed or tampered with. The device is locked onto the main pump unit with a single key operated lock which also locks the cassette in position on the main pump unit, the compartment for storing the medication supply, and a cover sealing the fluid line. The system is compact, and is capable of being used with a variety of fluid sources including both syringes and bags.

Abstract: An air-in-line detection system for use in detecting air bubbles in the fluid line of a disposable cassette mounted on a main pump unit is disclosed which can accurately detect air bubbles in any type of fluid, whether clear or opaque. The system uses an optical module mounted on the main pump unit to supply light and to detect light returned from the cassette, and an optical viewing area in the fluid flow path near the outlet end of the cassette. An inverted prism in the optical viewing path reflects light back to the optical module when air is contained in the fluid flow path adjacent the optical viewing area, with the light not being returned if there are no air bubbles contained in the fluid flow path.

Abstract: An ultrasonic air-in-line detection system for use in detecting air bubbles in the fluid line of a disposable cassette mounted on a main pump unit is disclosed which automatically loads the outlet tubing at the bottom of the cassette into a slot in an ultrasonic sensor housing when the cassette is installed on the main pump unit. The system uses a tubing adapter mounted on the outlet tube below the cassette, with the tubing adapter having a tapered top end. The tubing adapter interacts with a pair of ramps located on the bottom and front of the ultrasonic sensor housing around the slot to draw the tubing adapter into a recess located on the bottom of the ultrasonic sensor housing, thereby drawing the outlet tubing fully into the slot between an ultrasonic transmitter and an ultrasonic receiver in the ultrasonic sensor housing when the cassette is installed.

Abstract: A system for detecting an occlusion in a fluid line is disclosed which can detect occlusions in the upstream or container side of a disposable cassette containing a fluid pump therein. The cassette includes a piston-type pump with inlet and outlet valves, and is for installation onto and use with a main pump unit including motors for driving the pump and valves contained in each cassette. The system utilizes control circuitry to monitor the intake stroke of the pump in the cassette, to detect an upstream occlusion in the fluid line leading to the pump, and to provide an alarm in the event of a container-side occlusion.

Abstract: A method of significantly enhancing the period of time that an implanted intraperitoneal catheter used for the delivery of therapeutic medication will operate without encountering significant blockage by fibrotic tissue is disclosed. By monitoring and maintaining certain physical parameters in patients having an implantable catheter below desirable levels for the parameters, catheter survival in the patients is maximized. The four parameters used are blood triglyceride level, blood cholesterol level, the level of insulin dosage per day, and mean blood glucose (MBG) level, with the first two being the more accurate parameters.

Abstract: A unitary piston cap and boot seal for use in a medication infustion system is disclosed which is mounted on a rigid piston contained in a cylinder disposed in a cassette. The piston cap and boot seal, which are made of a flexible, elastomeric material, effectively both form the pumping element disposed in the cylinder, and prevent contamination of the pump through use of a rolling seal. The device may be sterilized by gas, since a tortuous path affording passage to gas is included in the retaining skirt mounted around the outer diameter of the pump cylinder.

Abstract: A fluid delivery monitoring and control apparatus for use in a medication infusion system is designed for use with a disposable fluid pathway that incorporates a sterile cassette containing pumping elements and sensor interfaces. The apparatus comprises a multi-segment drive mechanism, controller, and monitoring system. Fluid pumping is accomplished by controlling DC motors in the drive mechanism, each of which is coupled to two valves and a reciprocating piston for an individual pumping channel in the cassette. The motor is geared down to provide an appropriate maximum speed and torque. A cam sequentially actuates an inlet valve, piston, and an outlet valve in the cassette. A range of fluid delivery rates is achieved by periodically sending pulses to the motor. The output flow rate of the pump is maintained by a digital feedback controller which uses closed-loop feedback control to provide accurate regulation.

Abstract: A method of screening potential recipients of an implantable medication infusion system including an implanted intraperitoneal catheter is disclosed which seeks to select only those candidates who will have a high degree of resistance to catheter blockage due to fibrotic tissue growth. By checking certain physical parameters in candidates for an implantable catheter, and by declining to implant in those candidates who have higher than desirable levels of the parameters, catheter survival in those patients chosen for implant is maximized. The four parameters used are blood triglyceride level, blood cholesterol level, the level of insulin dosage per day, and mean blood glucose (MBG) level, with the first two being the more accurate parameters.

Abstract: A device for use to detect air in a fluid line between a medication infusion reservoir such as an IV bottle or bag and an IV injection set or a medication infusion pump is disclosed which utilizes a detector apparatus which clamps onto a segment of tubing. The detector uses a light source to generate light which is directed into the tubing, and two light detecting devices, one of which is used to determine whether or not the tubing is properly installed in the detector, and the other of which is used to detect the presence of air in the segment of tubing. The detector works equally well with transparent, translucent, or opaque fluids and includes means for ensuring that the detection system is functioning normally.