Abstract: Methods and devices are provided for shunting fluid to treat hydrocephalous, and in particular for treating normal pressure hydrocephalous, or Alzheimer's, Idiopathic Intracranial Hypertension (IIH), or any other condition in which it is necessary to drain and/or cleanse CSF. The methods and devices utilize a shunt having an inlet port, and outlet port, and a flow control component for controlling fluid flow from the inlet port to the outlet port. The shunt can be implanted at a location along or within a patient's spinal column. In one exemplary embodiment, an inlet port of a shunt can be implanted within the subarachnoid space, and an outlet port of a shunt can be implanted at a drainage site. In certain exemplary embodiments, the cerebrospinal fluid is drained into the epidural space.

Abstract: A device and method for monitoring a patient having a sensing device taking sensor data continuously and a transmitter located on the patient and internally powered. The transmitter is normally in a power-down state and powered-up for transmitting the sensor data. A receiver is located remote from the patient and receives the sensor data transmitted wirelessly from the transmitter. The transmission is typically a burst and can also be initiated on a command. For the burst, the sensor data is accumulated over a first period. The transmitter can transmit the sensor data over a second period of time. The second period of time is shorter than the first period of time. Once the transmission is complete, transmitter can be powered down. A further step displays the sensor data at the receiver in pseudo real-time. The display is shifted by a sum of the first and the second period of time.

Abstract: Methods and devices are provided for shunting fluid to treat hydrocephalous, and in particular for treating normal pressure hydrocephalous, or Alzheimer's, Idiopathic Intracranial Hypertension (IIH), or any other condition in which it is necessary to drain and/or cleanse CSF. The methods and devices utilize a shunt having an inlet port, and outlet port, and a flow control component for controlling fluid flow from the inlet port to the outlet port. The shunt can be implanted at a location along or within a patient's spinal column. In one exemplary embodiment, an inlet port of a shunt can be implanted within the subarachnoid space, and an outlet port of a shunt can be implanted at a drainage site. In certain exemplary embodiments, the cerebrospinal fluid is drained into the epidural space.

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 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: An implantable pump and methods for detecting leaks in an implantable pump are provided. In one embodiment, the implantable drug pump includes a housing having at least one inlet port and an outlet port formed therein. The outlet port is adapted to communicate with a catheter for delivering fluid to a patient's body, and the inlet port(s) are effective to deliver fluid into the housing. The housing further includes at least one reservoir disposed therein and effective to contain a fluid. In use, the pump preferably includes a fluid having one or more drugs disposed in at least one of the reservoirs, and a radiolucent fluid disposed in one of the reservoirs. A user programmable control mechanism is coupled to the drug pump and is effective to selectively control movement of the valves between the open and closed positions.

Abstract: A thermal flow sensor has a first substrate, second substrate and a third substrate, each of which has a first side and a second opposite side. The first substrate is connected to the second substrate such that the second side of the first substrate abuts the first side of the second substrate. The third substrate is connected to the second substrate such that the second side of the second substrate abuts the first side of the third substrate. The second substrate has a groove formed therein so as to form a conduit bounded by the second substrate and the second side of the first substrate and the first side of the third substrate. A heater is disposed on the first side of the first substrate opposed to the conduit. A first temperature sensor is disposed on the first side of the first substrate opposed to the conduit.

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 thermal flow sensor has a first, second and third substrate, each having a first side and a second opposite side. The first substrate is connected to the second substrate such that the second side of the first substrate abuts the first side of the second substrate. The third substrate is connected to the second substrate such that the second side of the second substrate abuts the first side of the third substrate. The second substrate has a groove formed therein so as to form a conduit bounded by the second substrate and the second side of the first substrate and the first side of the third substrate. A heater is disposed on the first side of the first substrate opposed to the conduit. A first temperature sensor is disposed on the first side of the first substrate opposed to the conduit. A second temperature sensor is disposed on the first side of the first substrate opposed to the conduit.

Abstract: An implantable fluid management device includes a catheter with an elongate proximal portion, a flexible distal portion, and a fluid passageway flowing therethrough. The distal portion includes a coil-shaped portion that defines a spiral having at least one turn. The distal portion of the catheter includes at least one pore in fluid communication with the fluid passageway of the catheter, which is located on an internal portion of the spiral. The positioning of the pore(s) on the internal portion of the spiral protects the pore(s) from obstruction or occlusion caused by tissue growing into or around the catheter.

Abstract: A disposable cover for a retractor of a self-retaining retractor system has an elastic sheath that can be easily placed and removed by elastically engaging the blade and a disposable pad attached on the elastic sheath. The elastic sheath can be an open cylinder (band shaped) or closed at one end (sock shaped) and is sized to cover a majority of the different size and shaped retractor blades. The elastic sheath retains the disposable pad on the blade by elastic compressive force. A single elastic sheath must be elastic enough to accommodate multiple sized blades and retain them in a fixed position while the blade is approximately vertically disposed within patient. The elastic sheath can be made from latex, nylon or any other surgical grade elastic or elastic type product.

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 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 rongeur has a detachable crossbar to enhance cleaning and sterilization. A pin in a slot on one of the rongeur's handles is moveable out of the slot to permit extended retraction of the crossbar to a position in which it may disengage from the shank of the rongeur.

Abstract: A laminated, bioimplantable dural graft product is configured for use as both an onlay graft and a suturable graft. The dural graft product is sufficiently pliable so as to sufficiently conform to a curvature of a tissue surface to which it is applied, such as the curved surface of a meningeal membrane. The use of the graft product can have improved properties, including suture retention strength and fluid impermeability. To use the dural graft product as an implant to replace, reinforce or strengthen bodily tissue, or to act as an adhesion barrier, the dural graft is placed in contact with bodily tissue and conforms to the curvature of the bodily tissue. Sutures can be used to maintain the contact between the dural graft and the bodily tissue.

Abstract: A cranial bolt secured to a skull of a patient includes a threaded portion and a lumen portion. Threaded portion has an inner surface forming a central passageway which extends throughout the threaded portion. The inner surface includes a connector mating with the lumen portion. The threaded portion has an outer surface having a plurality of threads for engaging a hole formed in the patient's skull. The lumen portion includes a stem portion that enters the central passageway and engages the mating connector. A fluid tight seal is formed between the inner surface of the threaded portion and the stem portion. At least two lumens are disposed through the stem portion and the base portion. The lumens have a proximal end opening outside the skull and a distal end opening inside the skull. One embodiment includes sensor lumens diverging from the centerline and another allows lumen portion to rotate independent of threaded portion.