Abstract: A medical device known as an implantable therapeutic substance delivery device is configured for implanting in humans to deliver a therapeutic substance such as pharmaceutical compositions, genetic materials, and biologics to treat a variety of medical conditions such as pain, spastisity, cancer, and many other conditions. The therapeutic substance delivery device has a permanent magnet solenoid pump that is energy efficient, accurate, small, compatible with therapeutic substances, and has many other improvements. The implantable therapeutic substance delivery device has a housing, a therapeutic substance reservoir, a power source, electronics, and a permanent magnet solenoid pump. The therapeutic substance reservoir is configured to contain a therapeutic substance and is coupled to the housing. The power source is carried in the housing to power the electronics and solenoid pump. The electronics are coupled to the solenoid pump and the solenoid pump is coupled to the therapeutic substance reservoir.

Abstract: An implantable medical catheter comprising at least one fluid passageway and a cured elastomer composition is disclosed. The cured elastomer composition is obtained by cross-linking an uncured blend composition that comprises an intimately admixed mixture that comprises the following components: (A) silica that had been silyliated by treatment and contains trialkylsilyl groups; (B) a polysiloxane copolymer; (C) a catalyst, and (D) an organohydrogen polysiloxane cross-linker, the catalyst and the cross-linker being present in the uncured blend composition in sufficient amount to cause the cross-linking reaction to occur.

Abstract: An implantable medical catheter comprising at least one fluid passageway and a cured elastomer composition is disclosed. The cured elastomer composition is obtained by cross-linking an uncured blend composition that comprises an intimately admixed mixture that comprises the following components: (A) silica that had been silyliated by treatment and contains trialkylsilyl groups; (B) a polysiloxane copolymer; (C) a catalyst, and (D) an organohydrogen polysiloxane cross-linker, the catalyst and the cross-linker being present in the uncured blend composition in sufficient amount to cause the cross-linking reaction to occur.

Abstract: A human body implantable drug delivery pump has a housing including at least a first shield and a second shield. The housing defines an interior within the shields. The pump further includes a fluid reservoir within the housing, a fluid conduit also within the housing from the reservoir, an outlet from the fluid conduit to the exterior of the housing, and a pump member in the housing adapted to move fluid through the fluid conduit to the outlet. The fluid in the reservoir and fluid conduit is isolated from the pump interior. The pump further has a desiccant in the pump interior, the desiccant absorbent of moisture in the pump interior, and preferably absorbent of substantially all the moisture in the pump interior. The desiccant also preferably has a moisture absorbent property dependent on temperature, being lessened at higher temperatures, the desiccant being pre-baked to improve its moisture absorbent property before being placed in the pump.

Abstract: An implantable medical catheter comprising at least one fluid passageway and a cured elastomer composition is disclosed. The cured elastomer composition is obtained by cross-linking an uncured blend composition that comprises an intimately admixed mixture that comprises the following components: (A) silica that had been silyliated by treatment and contains trialkylsilyl groups; (B) a polysiloxane copolymer; (C) a catalyst, and (D) an organohydrogen polysiloxane cross-linker, the catalyst and the cross-linker being present in the uncured blend composition in sufficient amount to cause the cross-linking reaction to occur.

Abstract: A connector and method of medical tubing is disclosed. The connector defines a fluid passageway, and the connector includes a first end, a first intermediate portion, a middle portion, a second intermediate portion, and a second end. The middle portion is located between the first intermediate portion and the second intermediate portion, and the first end is adapted to fit inside a proximal connector-receiving portion, and the second end is adapted to fit inside a distal connector-receiving portion. The connector includes at least a first protrusion and a second protrusion projecting from the connector, wherein a first protrusion is located between the first end and the first intermediate portion, and the second protrusion is located between the second intermediate portion and the second end.

Abstract: Low profile inlet valve embodiments for a piston pump therapeutic substance infusion device are disclosed that reduce dead volume, occupies little residential space, operates rapidly, and have many other improvements. The therapeutic substance infusion device has a housing, a therapeutic substance reservoir, a power source carried in the housing, electronics, a piston pump, and an inlet valve. The piston pump is configured for pumping therapeutic substance from the therapeutic substance reservoir through an infusion port at a programmed rate. The inlet valve is in fluid communication with a reservoir outlet to control the flow of therapeutic substance into the piston pump. The inlet valve has a substantially coplanar valve surface and valve spring. Many embodiments of the low profile inlet valve and its methods of operation are possible.

Abstract: A medical device known as an implantable therapeutic substance delivery device is configured for implanting in humans to deliver a therapeutic substance such as pharmaceutical compositions, genetic materials, and biologics to treat a variety of medical conditions such as pain, spastisity, cancer, and many other conditions. The therapeutic substance delivery device has a permanent magnet solenoid pump that is energy efficient, accurate, small, compatible with therapeutic substances, and has many other improvements. The implantable therapeutic substance delivery device has a housing, a therapeutic substance reservoir, a power source, electronics, and a permanent magnet solenoid pump. The therapeutic substance reservoir is configured to contain a therapeutic substance and is coupled to the housing. The power source is carried in the housing to power the electronics and solenoid pump. The electronics are coupled to the solenoid pump and the solenoid pump is coupled to the therapeutic substance reservoir.

Abstract: A human body implantable drug delivery pump comprises a housing including at least a first shield and a second shield. The housing defines an interior within the shields. The pump further includes a fluid reservoir within the housing, a fluid conduit also within the housing from the reservoir, an outlet from the fluid conduit to the exterior of the housing, and a pump member in the housing adapted to move fluid through the fluid conduit to the outlet. The fluid in the reservoir and fluid conduit is isolated from the pump interior. The pump further comprises a desiccant in the pump interior, the desiccant absorbent of moisture in the pump interior, and preferably absorbent of substantially all the moisture in the pump interior. The desiccant also preferably has a moisture absorbent property dependent on temperature, being lessened at higher temperatures, the desiccant being pre-baked to improve its moisture absorbent property before being placed in the pump.

Abstract: An implantable drug infusion pump for delivering drug therapy is made more reliable and its performance improved by monitoring drug pump temperature. Monitoring pump temperature can also provide for temperature-related drug therapy modification.

Abstract: An implantable drug infusion device includes a bulkhead having a chamber and a shield for the bulkhead. A transducer is secured to the shield. An electronic module is located in the bulkhead for controlling operation of a pump assembly. A biasing member is in electrical contact with the electronic module and the transducer such that current transmitted from the electronic module to the transducer through the biasing member actuates the transducer.

Abstract: The displacement of refill valves in an implantable drug delivery device is reduced to permit the housings of a drug delivery device to remain compact in size while permitting reservoirs of increased depth to be used. In a preferred embodiment, a collapsible link is provided as a telescoping member incorporating a coil spring. As the valve is pulled into contact with its seat, a detectable pressure increase is sensed in the refill device. In accordance with the invention, as the drug supply contained in the reservoir depletes, the reservoir surface moves towards a collapsed position, compressing the coil spring and eventually contacting the valve stem, thereby lifting the valve from its seat. By virtue of telescoping link, the valve stem length and therefore the valve travel may be reduced as compared to prior art devices, thus eliminating the need for increased housing depth when deeper reservoirs are used. The collapsible link may be comprised of a second spring combined with a telescoping link.

Abstract: A pressure-sensitive overfill protection system for a refillable drug delivery device includes a collapsible link which, in a preferred embodiment, comprises an aneroid having an internal volume of gas at a reference pressure. The collapsible link, in its expanded state, supports on inlet valve in an open position to permit the ingress of new drug fluid into a bellows reservoir. The external surface of the aneroid is exposed to the bellows pressure. When the bellows pressure exceeds the reference pressure, the aneroid collapses and permits the inlet valve to move to a closed position under a biasing force provided by a spring. Further flow of new drug fluid into the drug delivery device is thereby prevented. Moreover, the closure of the valve provides a large increase in pressure is experienced in the refill device and may therefore be sensed by a clinician. Because the overfill protection system is pressure sensitive, it may be used with different sized bellows without modification.

Abstract: The present invention concerns a pump provided with a control module and an attachable fluid reservoir cassette. The control module includes a pumping mechanism for pumping fluid from the fluid reservoir to the patient. The cassette is provided with appropriate indicia to identify differences between a plurality of cassettes. The control module further includes cassette indicia identification structure for identifying indicia on the cassette. One type of cassette identification system includes a projection extending from the cassette and structure associated with the control module which engages the projection. Another type of cassette identification system includes a light reflecting system which utilizes light from the control module and reflected off the cassette. Still other types of cassette identification systems utilize other non-contact switches or sensors to sense indicia on the cassette to identify the cassette from a plurality of cassettes.

Abstract: The invention relates to a method and system for monitoring pressure conditions in the fluid pressure upstream and downstream of an intravenous fluid administration system and to detect upstream and/or downstream occlusions. In addition, the invention incorporates a method for detecting pressure conditions at an upstream or downstream detector across the wall of the tubing to identify upstream or downstream occlusions, respectively. The present invention also relates to a process for determining the fluid pressure in a fluid tube across the tube wall where the normal tube force changes over time, and more particularly, using a normalization process to eliminate changes in the tubing resilience.

Abstract: The invention relates to a method and system for monitoring pressure conditions in the fluid pressure upstream and downstream of an intravenous fluid administration system and to detect upstream and/or downstream occlusions. In addition, the invention incorporates a method for detecting pressure conditions at an upstream or downstream detector across the wall of the tubing to identify upstream or downstream occlusions, respectively. The present invention also relates to a process for determining the fluid pressure in a fluid tube across the tube wall where the normal tube force changes over time, and more particularly, using a normalization process to eliminate changes in the tubing resilience.

Abstract: The present invention concerns a pump provided with a control module and an attachable fluid reservoir cassette. The control module includes a pumping mechanism for pumping fluid from the fluid reservoir to the patient. The cassette is provided with appropriate indicia to identify differences between a plurality of cassettes. The control module further includes cassette indicia identification structure for identifying indicia on the cassette. One type of cassette identification system includes a projection extending from the cassette and structure associated with the control module which engages the projection. Another type of cassette identification system includes a light reflecting system which utilizes light from the control module and reflected off the cassette. Still other types of cassette identification systems utilize other non-contact switches or sensors to sense indicia on the cassette to identify the cassette from a plurality of cassettes.

Abstract: The present invention concerns a pump provided with a control module and an attachable fluid reservoir cassette. The control module includes a pumping mechanism for pumping fluid from the fluid reservoir to the patient. The cassette is provided with appropriate indicia to identify differences between a plurality of cassettes. The control module further includes cassette indicia identification structure for identifying indicia on the cassette. One type of cassette identification system includes a projection extending from the cassette and structure associated with the control module which engages the projection. Another type of cassette identification system includes a light reflecting system which utilizes light from the control module and reflected off the cassette. Still other types of cassette identification systems utilize other non-contact switches or sensors to sense indicia on the cassette to identify the cassette from a plurality of cassettes.

Abstract: The present invention concerns a pump provided with a control module and an attachable fluid reservoir cassette. The control module includes a pumping mechanism for pumping fluid from the fluid reservoir to the patient. The cassette is provided with appropriate indicia to identify differences between a plurality of cassettes. The control module further includes cassette indicia identification structure for identifying indicia on the cassette. One type of cassette identification system includes a projection extending from the cassette and structure associated with the control module which engages the projection. Another type of cassette identification system includes a light reflecting system which utilizes light from the control module and reflected off the cassette. Still other types of cassette identification systems utilize other non-contact switches or sensors to sense indicia on the cassette to identify the cassette from a plurality of cassettes.

Abstract: A drug pump is disclosed having at least one rotatable cam and a reciprocally mounted follower engaged with the cam, and a tube which is compressed by the follower during rotation of the cam. The drug pump preferably has three followers, including an expulsor follower, an inlet valve follower, and an outlet valve follower. Three cams are provided to reciprocally move the followers, with one cam engaging each follower. The cams are interconnected by a cam shaft. The drug pump is ambulatory and provides two activations per revolution of the cams. The tube loading is nonlinear. Such nonlinear tube loading is taken into consideration to minimize energy consumption and to reduce peak torque loads. A design optimization and manufacturing system is provided to optimize energy consumption of the pump.