Abstract: A valve for use in a shunt system to drain fluid from one part of a patient's body to another is provided. In an exemplary embodiment, the valve is operable at a threshold pressure that is selectively adjustable up to at least about 400 mm H2O at increments in the range of about 10 mm H2O to 40 mm H2O. The ability of the valve to operate at a high threshold pressure and to be adjusted at relatively small increments renders the valve particularly advantageous for use in younger hydrocephalus patients. In particular, the operating pressure of the valve can be gradually limited in small increments over a period of time to slowly force the patient's own resorption system to circulate cerebrospinal fluid. At high operating pressures of at least about 400 mm H2O shunt independence can be achieved thereby allowing the shunt to be successfully removed.

Abstract: A pressure sensing apparatus has a pressure sensor component that includes a pressure sensing port, a pressure sensor for sensing a pressure of a fluid in the pressure sensing port, and a digital processor communicating with the pressure sensor for performing calculations involving fluid pressures sensed. The pressure sensing apparatus further includes a first chamber in fluid contact with the pressure sensing port, a second chamber fluidically connectable with a patient's cerebrospinal fluid system, and a membrane located between the first and second chambers so as to transmit fluid pressure from the second chamber to the first chamber.

Abstract: A pressure sensing apparatus has a pressure sensor component that includes a pressure sensing port, a pressure sensor for sensing a pressure of a fluid in the pressure sensing port, and a digital processor communicating with the pressure sensor for performing calculations involving fluid pressures sensed. The pressure sensing apparatus further includes a first chamber in fluid contact with the pressure sensing port, a second chamber fluidically connectable with a patient's cerebrospinal fluid system, and a membrane located between the first and second chambers so as to transmit fluid pressure from the second chamber to the first chamber.

Abstract: A valve for use in a shunt system to drain fluid from one part of a patient's body to another is provided. In an exemplary embodiment, the valve is operable at a threshold pressure that is selectively adjustable up to at least about 400 mm H2O at increments in the range of about 10 mm H2O to 40 mm H2O. The ability of the valve to operate at a high threshold pressure and to be adjusted at relatively small increments renders the valve particularly advantageous for use in younger hydrocephalus patients. In particular, the operating pressure of the valve can be gradually limited in small increments over a period of time to slowly force the patient's own resorption system to circulate cerebrospinal fluid. At high operating pressures of at least about 400 mm H2O shunt independence can be achieved thereby allowing the shunt to be successfully removed.

Abstract: A pressure sensing catheter having a pressure sensor and an antenna that is coupled to the pressure sensor, e.g., by a connector, are provided. The pressure sensor can be adapted to measure a pressure surrounding the catheter, and the antenna can be adapted to telemetrically communicate the measured pressure to an external device. In an exemplary embodiment, the antenna, pressure sensor, and/or connector are hermetically sealed, e.g., by the catheter and/or a coating, to prevent the antenna, pressure sensor, and connector from coming into contact with fluid, thereby allowing the catheter to be permanently implanted or otherwise used for long term use. Exemplary methods for manufacturing and using pressure sensing catheters are also provided.

Abstract: A pressure sensing catheter having a pressure sensor and an antenna that is coupled to the pressure sensor, e.g., by a connector, are provided. The pressure sensor can be adapted to measure a pressure surrounding the catheter, and the antenna can be adapted to telemetrically communicate the measured pressure to an external device. In an exemplary embodiment, the antenna, pressure sensor, and/or connector are hermetically sealed, e.g., by the catheter and/or a coating, to prevent the antenna, pressure sensor, and connector from coming into contact with fluid, thereby allowing the catheter to be permanently implanted or otherwise used for long term use. Exemplary methods for manufacturing and using pressure sensing catheters are also provided.

Abstract: A pressure sensing catheter having a pressure sensor and an antenna that is coupled to the pressure sensor, e.g., by a connector, are provided. The pressure sensor can be adapted to measure a pressure surrounding the catheter, and the antenna can be adapted to telemetrically communicate the measured pressure to an external device. In an exemplary embodiment, the antenna, pressure sensor, and/or connector are hermetically sealed, e.g., by the catheter and/or a coating, to prevent the antenna, pressure sensor, and connector from coming into contact with fluid, thereby allowing the catheter to be permanently implanted or otherwise used for long term use. Exemplary methods for manufacturing and using pressure sensing catheters are also provided.

Abstract: A locking assembly is provided to simply and effectively prevent any unintentional adjustment of the adjustable valve mechanism in a fluid flow control device, without compromising the function of the device. The locking assembly generally includes at least one gripping arm for frictionally engaging at least a portion of the adjustable valve mechanism, and an actuating mechanism for controlling the deployment and release of the gripping arm. The locking assembly prevents unintentional adjustments that can adversely affect the pressure settings of the fluid flow control device. In particular, the locking assembly prevents unintentional adjustment, such as may be caused by the presence of a strong external magnetic field. The locking assembly can be easily disengaged, such as through the application or removal of an external mechanical force, to allow a clinician to adjust the pressure settings of the fluid flow control device as necessary.

Abstract: A locking assembly is provided to simply and effectively prevent any unintentional adjustment of the adjustable valve mechanism in a fluid flow control device, without compromising the function of the device. The locking assembly generally includes at least one gripping arm for frictionally engaging at least a portion of the adjustable valve mechanism, and an actuating mechanism for controlling the deployment and release of the gripping arm. The locking assembly prevents unintentional adjustments that can adversely affect the pressure settings of the fluid flow control device. In particular, the locking assembly prevents unintentional adjustment, such as may be caused by the presence of a strong external magnetic field. The locking assembly can be easily disengaged, such as through the application or removal of an external mechanical force, to allow a clinician to adjust the pressure settings of the fluid flow control device as necessary.

Abstract: An implantable drug delivery system includes an infusion pump assembly with a fluid outlet, a fluid delivery pathway extending from the pump outlet to a target tissue site; and a controlled release material unit positioned in the fluid delivery pathway to release a drug or bioactive material into the delivery pathway. The pump assembly delivers fluid as a high flow infusion flow in said pathway, entraining drug material released by the release unit and establishing a pressure gradient at the distal end of the pathway that results in convection-enhanced transport such that the released drug(s) or treatment material enter the target tissue site with enhanced penetration depth and/or concentration. The pump delivers a carrier fluid that may reside in an external or in an implanted reservoir, or that may be an endogenous fluid, such as plasma or CSF.

Abstract: A needle or puncture guard that has inherent probe directing features for use in an in-line configured shunt valve is provided. The guard comprises a base member configured for mounting within the domed reservoir of the shunt valve, and a guide wall seated on the base member. The guide wall is defined by a top wall, an inner side wall, and an opposed outer side wall. The inner side wall has an indented section with an aperture extending through the indented section. The inner side wall can be concavely curved, while the indented section has a curvature that directs instruments that are pressed against the guide wall towards the aperture. A method for performing catheter revisions on a shunt system having a guard within the shunt valve is provided as well. Also provided is a method for placement of an intracranial pressure sensor percutaneously into a ventricular catheter for determining intracranial pressure.

Abstract: A delivery system for a drug or bioactive agent includes an implantable pump and a delivery conduit that may be implanted in an organ or other tissue (e.g., the central or the peripheral nervous system) of a subject. A sensor is also implanted, and a controller unit receives the sensor output and directs drug delivery from within the patient pump accordingly. The sensor directly measures a primary biochemical material or state in the tissue or organ system, and the monitoring unit effects closed loop feedback control of the pump to achieve a desired end. The end may be the regulation of metabolism or maintenance of a stable metabolic or other state, or may be treatment regimen, e.g., by delivery of a dosage level or distribution of a drug in specific brain or nervous an system tissue. The sensed material may be the agent itself, a metabolite, or a related native material, tissue state or condition.

Abstract: A shunt has a housing and a base. The base has a first set of electrodes extending across the base. A catheter is connected to the housing. The catheter has a longitudinal length, a proximal end, and a distal end. The catheter has a second set of electrodes extending along the longitudinal length of the catheter. At least two of the electrodes of said first set are electrically connected to two of the electrodes of the second set. The housing including a self sealing, needle penetrable outer housing wall. The system includes a probe assembly that is selectively penetratable through an outer housing wall.

Abstract: A package for a drug-device combination product includes an outer package including a first gas impermeable sheet and a second gas impermeable sheet hermetically sealed there to on three sides. A gas permeable header is attached to an unsealed side of the first sheet and sealed to the second sheet on two sides. The first and second gas impermeable sheets and the header form an interior and an opening communicating with the interior. A gas permeable inner package is disposed within the outer package. A product is sealed within the inner package. The inner package is placed within the outer package and a top end of the header is sealed to the second sheet. The outer package is then sealed by sealing the first gas impermeable sheet to the second gas impermeable sheet at a seal point below the point where the header attaches to the first sheet.

Abstract: A detection device, for detecting a strength of a magnetic field of an object, includes a housing having a center, a first end and a detection end. A permanent magnetic element is suspended above the center of the housing having a first magnetic field strength and an indicator. A biasing permanent magnetic element is disposed at the first end of the housing and has a second magnetic field strength for biasing the indicator toward the first end. A first distance is between the permanent magnetic element and the biasing permanent magnetic element so that a threshold magnetic field strength can be determined from the first magnetic field strength, the second magnetic field strength and the first distance. Thus, when the object is placed approximate to the detection end and the object magnetic field strength is greater than the threshold magnetic field strength, the indicator rotates toward the detection end.

Abstract: A package for a drug-device combination product includes an outer package including a first gas impermeable sheet and a second gas impermeable sheet hermetically sealed there to on three sides. A gas permeable header is attached to an unsealed side of the first sheet and sealed to the second sheet on two sides. The first and second gas impermeable sheets and the header form an interior and an opening communicating with the interior. A gas permeable inner package is disposed within the outer package. A product is sealed within the inner package. The inner package is placed within the outer package and a top end of the header is sealed to the second sheet. The outer package is then sealed by sealing the first gas impermeable sheet to the second gas impermeable sheet at a seal point below the point where the header attaches to the first sheet.

Abstract: An implantable shunt device having a primary catheter and at least two secondary catheters extending from the primary catheter is provided. The primary catheter includes a connecting end, an open end, and an inner lumen extending therebetween. Each of the secondary catheters extend from the connecting end of the primary catheter and include a fluid passageway formed therein in fluid communication with the inner lumen of the primary catheter. Each secondary catheter also includes at least one fluid entry port in fluid communication with the fluid passageway. In an exemplary embodiment, the fluid entry ports are disposed on an inwardly facing portion of each of the secondary catheters. The shunt device can be used for a variety of diagnostic and therapeutic procedures, including for the removal or introduction of fluid to a treatment site.

Abstract: A shunt has a housing and a base. The base has a first set of electrodes extending across the base. A catheter is connected to the housing. The catheter has a longitudinal length, a proximal end, and a distal end. The catheter has a second set of electrodes extending along the longitudinal length of the catheter. At least two of the electrodes of said first set are electrically connected to two of the electrodes of the second set. The housing including a self sealing, needle penetrable outer housing wall. The system includes a probe assembly that is selectively penetratable through an outer housing wall.

Abstract: A needle or puncture guard that has inherent probe directing features for use in an in-line configured shunt valve is provided. The guard comprises a base member configured for mounting within the domed reservoir of the shunt valve, and a guide wall seated on the base member. The guide wall is defined by a top wall, an inner side wall, and an opposed outer side wall. The inner side wall has an indented section with an aperture extending through the indented section. The inner side wall can be concavely curved, while the indented section has a curvature that directs instruments that are pressed against the guide wall towards the aperture. A method for performing catheter revisions on a shunt system having a guard within the shunt valve is provided as well. Also provided is a method for placement of an intracranial pressure sensor percutaneously into a ventricular catheter for determining intracranial pressure.

Abstract: An implantable infusion pump for infusing medicine into a patient has a reservoir for holding the medicine, an injection port for injecting medicine into the reservoir and a controllable shield for selectively blocking access to the injection port.

Abstract: A hollow fiber with a plurality of members projecting from its outer surface in an arc turned back on itself is formed from a spinneret having a segmented orifice wherein each segment comprises a first portion in the form of an arc curved about the center of the orifice, a second portion extending from the first and connected to a third portion which is in the form of a reverse curve with respect to the first.