Abstract: The invention provides a drainage system that includes a ventricular catheter, a drainage catheter, and a positive displacement pump that can function to actively drain CSF from the ventricles of the brain of a patient. Methods of using a drainage system in accordance with the invention are also provided, as well as kits.

Abstract: A luer connector is described that is angled away from the patient's scalp in the direction of the drip assembly line. In the preferred embodiment, the luer connector has a female luer connector that mates with a male luer connector on the drip assembly line. The luer connector also has a hollow protrusion that extends into a catheter thereby allowing the luer connector to be fluidly connected to the catheter. A fluid passage is formed through the angled luer connector from the female luer connector, through the body of the angled luer connector and through the hollow protrusion. The luer connector has a pair of “wings” that extend outwardly from the luer connector and allow the luer connector to be sutured to the patient's scalp.

Abstract: A pump, includes a pump engine; a compartment adapted to store a fluid, the compartment being disposed at least partially around the pump engine, and a piston disposed within the compartment, the compartment and the engine being configured to cause the piston to travel within the compartment along an arcuate path and to force a volume of the fluid out of the pump.

Abstract: Implantable devices and osmotic pump and catheter systems for delivering a pharmaceutical agent to a patient at selectable rates include an impermeable pump housing and a moveable partition disposed within the housing, the partition dividing the housing into an osmotic driving compartment having an open end and a pharmaceutical agent compartment having a delivery orifice. A plurality of semi permeable membranes may be disposed in the open end of the osmotic driving compartment and a number of impermeable barriers may seal selected ones of the plurality of semi permeable membranes from the patient until breached. Breaching one or more of the impermeable barriers increases the surface area of semi permeable membrane exposed to the patient and controllably increases the delivery rate of the pharmaceutical agent through the delivery orifice and catheter.

Abstract: An implantable pump for delivering a pharmaceutical agent includes a pump engine, a piston, a pharmaceutical agent compartment and a rate adjustment assembly. The pharmaceutical agent compartment is configured to enclose a volume of pharmaceutical agent and the piston. When the piston is acted upon by the pump engine, the piston moves within the pharmaceutical agent compartment along a substantially circular path and delivers the pharmaceutical agent. The rate adjustment assembly is configured to enable a selective and reversible increase or decrease of the delivery rate of the pharmaceutical agent.

Abstract: An implantable osmotic pump for delivering a pharmaceutical agent to a patient includes an osmotic engine, a substantially toroidal compartment disposed at least partially around the osmotic engine and a piston disposed within the compartment. The osmotic engine is configured to cause the piston to travel within the compartment and deliver a dose pharmaceutical agent contained within the compartment when the pump is implanted in an aqueous environment. A dose escalation assembly may be fitted to the pump, the dose escalation assembly being adapted to selectively increase the rate at which the pharmaceutical agent is delivered from the pump.

Abstract: An implantable osmotic pump system includes a pre-hydrated semipermeable membrane to reduce the time interval between implantation of the system into the patient and full operation of the pump system. The semipermeable membrane is maintained in a hydrated state prior to implantation by fluid contact with a saline solution maintained in a saturated state by a salt tablet. As the differential osmotic pressure across the hydrated semipermeable membrane is negligible as the saline concentration on both sides of the membrane is the same, the pump system does not operate and does not infuse the pharmaceutical agent as long as this osmotic equipotential state is maintained. When the saturated saline solution is removed from fluid contact with the semipermeable membrane and the system is implanted in a patient, the osmotic pressure differential across the semipermeable membrane increases, thereby causing the pump to immediately begin operation at or near its intended and designed steady state infusion rate.

Abstract: An implantable osmotic pump for delivering a pharmaceutical agent to a patient includes an osmotic engine, a substantially toroidal compartment disposed at least partially around the osmotic engine and a piston disposed within the compartment. The osmotic engine is configured to cause the piston to travel within the compartment and deliver a dose pharmaceutical agent contained within the compartment when the pump is implanted in an aqueous environment. A dose escalation assembly may be fitted to the pump, the dose escalation assembly being adapted to selectively increase the rate at which the pharmaceutical agent is delivered from the pump.

Abstract: A process for treating a patient with hydrocephalus is disclosed which utilizes an external medical drainage system having a slide interface between a mounting assembly and a disposable drip assembly. The mounting assembly is generally reusable and the drip assembly disposable. The mounting assembly includes a clamp which is fastenable to the pole, and a support rail affixed to the clamp and which has a longitudinal slot that defines an open-face elongated channel. The drip assembly includes a key adjustably positionable within the channel, a graduated cylinder supported by the key, a drainage bag fluidly connected to the graduated cylinder, and tubing extending from the graduated cylinder opposite the drainage bag. A portion of the key disposed within the channel has a cross-sectioned configuration substantially matching the cross section of the channel.

Abstract: An external medical drainage system is provided which has a slide interface between a mounting assembly to a pole, and a disposable drip assembly and a stopcock which snap-fits to the mounting assembly. The mounting assembly includes a clamp which is fastenable to the pole, and a support rail affixed to the clamp and which has a longitudinal slot that defines an open-face elongated channel. The drip assembly includes a key adjustably positionable within the channel, a graduated cylinder supported by the key, a drainage bag fluidly connected to the graduated cylinder, tubing extending from the graduated cylinder opposite the drainage bag, and a stopcock associated with the tubing and fixed to a clip. The stopcock clip snap-fits into clip-accepting notches of the clamp. A portion of the key disposed within the channel has a cross-sectioned configuration substantially matching the cross section of the channel.

Abstract: Implantable osmotic pump devices and systems include multiple osmotic pumps and/or semipermeable membranes to extend the useful life cycle and functionality of the drug delivery system. Use of an implantable system including multiple implantable osmotic pumps allows different drugs to be administered from the same implanted system. One or more of the semipermeable membranes of the system may be initially sealed by an overlying impermeable membrane upon implantation of the system into the patient. When the patient develops a tolerance to a first drug or to a first dose of the first drug, the impermeable membrane may be breached, to expose the underlying semipermeable membrane to the osmotic pressure of the patient at the implant site. This causes the infusion rate to increase, thereby providing the patient with the needed relief and/or other desired therapeutic effect. In the case of a multiple pump system, breaching an impermeable membrane may cause the infusion of a second drug.

Abstract: An implantable osmotic pump for delivering a pharmaceutical agent to a patient includes an osmotic engine, a substantially toroidal compartment disposed at least partially around the osmotic engine and a piston disposed within the compartment. The osmotic engine is configured to cause the piston to travel within the compartment and deliver a dose pharmaceutical agent contained within the compartment when the pump is implanted in an aqueous environment. A dose escalation assembly may be fitted to the pump, the dose escalation assembly being adapted to selectively increase the rate at which the pharmaceutical agent is delivered from the pump.

Abstract: Implantable osmotic pump devices and systems include multiple osmotic pumps and/or semipermeable membranes to extend the useful life cycle and functionality of the drug delivery system. Use of an implantable system including multiple implantable osmotic pumps allows different drugs to be administered from the same implanted system. One or more of the semipermeable membranes of the system may be initially sealed by an overlying impermeable membrane upon implantation of the system into the patient. When the patient develops a tolerance to a first drug or to a first dose of the first drug, the impermeable membrane may be breached, to expose the underlying semipermeable membrane to the osmotic pressure of the patient at the implant site. This causes the infusion rate to increase, thereby providing the patient with the needed relief and/or other desired therapeutic effect. In the case of a multiple pump system, breaching an impermeable membrane may cause the infusion of a second drug.

Abstract: An implantable osmotic pump system includes a rigid pump housing defining an opening adapted to receive a catheter; one or more membrane assemblies fitted to the pump housing; an osmotic engine within the rigid pump housing and a flexible pharmaceutical agent compartment disposed within the pump housing. The flexible pharmaceutical agent compartment is adapted to enclose a volume of a pharmaceutical agent and to cause the pharmaceutical agent to be infused through the opening as water crosses the membrane assembly or assemblies and increases the volume of the osmotic engine. The flexible pharmaceutical agent compartment may include polyethylene teraphthalate (PET), for example, and/or may include a metallic layer such as gold, silver, platinum and/or aluminum, for example, to inhibit the transfer of gas or liquid across the compartment. A catheter may be bonded to the opening of the pump housing and to a corresponding opening in the flexible pharmaceutical agent compartment.

Abstract: Implantable devices and osmotic pump and catheter systems for delivering a pharmaceutical agent to a patient at selectable rates include an impermeable pump housing and a moveable partition disposed within the housing, the partition dividing the housing into an osmotic driving compartment having an open end and a pharmaceutical agent compartment having a delivery orifice. A plurality of semi permeable membranes may be disposed in the open end of the osmotic driving compartment and a number of impermeable barriers may seal selected ones of the plurality of semi permeable membranes from the patient until breached. Breaching one or more of the impermeable barriers increases the surface area of semi permeable membrane exposed to the patient and controllably increases the delivery rate of the pharmaceutical agent through the delivery orifice and catheter.

Abstract: A process for treating a patient with hydrocephalus is disclosed which utilizes an external medical drainage system having a slide interface between a mounting assembly and a disposable drip assembly. The mounting assembly is generally reusable and the drip assembly disposable. The mounting assembly includes a clamp which is fastenable to the pole, and a support rail affixed to the clamp and which has a longitudinal slot that defines an open-face elongated channel. The drip assembly includes a key adjustably positionable within the channel, a graduated cylinder supported by the key, a drainage bag fluidly connected to the graduated cylinder, and tubing extending from the graduated cylinder opposite the drainage bag. A portion of the key disposed within the channel has a cross-sectioned configuration substantially matching the cross section of the channel.

Abstract: An external medical drainage system is provided which has a slide interface between a mounting assembly to a pole, and a disposable drip assembly and a stopcock which snap-fits to the mounting assembly. The mounting assembly includes a clamp which is fastenable to the pole, and a support rail affixed to the clamp and which has a longitudinal slot that defines an open-face elongated channel. The drip assembly includes a key adjustably positionable within the channel, a graduated cylinder supported by the key, a drainage bag fluidly connected to the graduated cylinder, tubing extending from the graduated cylinder opposite the drainage bag, and a stopcock associated with the tubing and fixed to a clip. The stopcock clip snap-fits into clip-accepting notches of the clamp. A portion of the key disposed within the channel has a cross-sectioned configuration substantially matching the cross section of the channel.

Abstract: An external medical drainage system is provided which has a slide interface between a mounting assembly and a disposable drip assembly. The mounting assembly is generally reusable and the drip assembly disposable. The mounting assembly includes a clamp which is fastenable to the pole, and a support rail affixed to the clamp and which has a longitudinal slot that defines an open-face elongated channel. The drip assembly includes a key adjustably positionable within the channel, a graduated cylinder supported by the key, a drainage bag fluidly connected to the graduated cylinder, and tubing extending from the graduated cylinder opposite the drainage bag. A portion of the key disposed within the channel has a cross-sectioned configuration substantially matching the cross section of the channel. The key extends through the slot, but the channel is configured such that the support rail provides means for restricting the key to longitudinal movement within the channel.

Abstract: An external medical drainage system is provided which has a slide interface between a mounting assembly to a pole, and a disposable drip assembly and a stopcock which snap-fits to the mounting assembly. The mounting assembly includes a clamp which is fastenable to the pole, and a support rail affixed to the clamp and which has a longitudinal slot that defines an open-face elongated channel. The drip assembly includes a key adjustably positionable within the channel, a graduated cylinder supported by the key, a drainage bag fluidly connected to the graduated cylinder, tubing extending from the graduated cylinder opposite the drainage bag, and a stopcock associated with the tubing and fixed to a clip. The stopcock clip snap-fits into clip-accepting notches of the clamp. A portion of the key disposed within the channel has a cross-sectioned configuration substantially matching the cross section of the channel.