Abstract: An implantable drug delivery device that uses multiple reservoir elements to contain and release doses of active pharmaceutical ingredients. The device includes a first shell element, which has a first enclosed cavity volume and forms a low-permeability barrier. The first shell element is configured to absorb light irradiation from a laser source, the laser irradiation causing a breach in the first shell element. A first active pharmaceutical ingredient is contained in the first enclosed cavity volume and is released when the first shell element is breached. The device also includes a second shell element, which has a second enclosed cavity volume and also forms a low-permeability barrier. A second active pharmaceutical ingredient is contained in the second enclosed cavity volume. The device also includes an envelope element containing the first and second shell elements.

Abstract: Compositions, systems and methods for administration of small volume sufentanil drug dosage forms via the oral transmucosal route of a subject for treatment of pain.

Abstract: A method of treating an airway disorder includes placing an implant in a patient's tongue, wherein the implant has first and second end portions that attach to tissue, and a tensioned medial portion between the first and second ends. The medial portion is configured to apply a pressure of less than a predetermined amount. Device systems associated with such methods are also provided.

Abstract: A system for treating an airway disorder is provided with an implant body configured to conform to an airway-interface tissue site in a manner compatible with normal physiological function of the site. In some embodiments, the implant body has a V-shape with first and second elongated legs configured for implantation in airway-interface tissue. The first and second elongated legs are configured to apply tensile forces to the tissue. Methods of using such systems are also provided.

Abstract: A system for treating an airway disorder is provided with an implant body configured to conform to an airway-interface tissue site in a manner compatible with normal physiological function of the site. In some embodiments, the implant body has first and second end portions and a medial portion. The implant body also includes a coupler configured to couple the end portions to one another such that the medial portion encircles targeted tissue. Methods of using such systems are also provided.

Abstract: A system for treating an airway disorder is provided with an implant body configured to conform to an airway-interface tissue site in a manner compatible with normal physiological function of the site. In some embodiments, the implant body includes an adjustment element configured to allow in-situ adjustment of the implant body between first and second tensioning forces applied to the site. Methods of using such systems are also provided.

Abstract: Dispensing devices and systems for oral transmucosal administration of small volume drug dosage forms to the oral mucosa are provided. The dispensing device may be a single dose applicator (SDA), or an electromechanical device comprising a means for patient identification such as a wrist worn RFID tag and annular bidirectional antenna together with a lock-out feature.

Abstract: A system is provided for delivery and monitoring the administration of controlled substances which includes one or more databases including a national database of controlled substance users, a database including physician/pharmacy information, a controlled substance delivery device and a docking station for use together with a network and software for communication between the various components of the system.

Abstract: Formulations for controlled delivery of oral transmucosal medications are provided. The formulations are characterized as hydrogel-forming or eroding-types which are bioadhesive and provide for controlled and sustained release of the medication such that enhanced bioavailability and efficacy is provided.

Abstract: Drug storage and dispensing devices for dispensing a drug dosage form to a patient are disclosed. The dispensing device has a programmable lock-out feature for locking the dispensing device and is capable of detecting the identity of a user. The invention further provides a method for the treatment of subject, by administering to the subject a drug dosage form using a dispensing device of the invention.

Abstract: An implantable flow regulator (22) for regulating flow of a drug along a drug delivery pathway (14) from a drug source to a treatment site within a subject includes a movable diversion member (24) and an actuator. The movable diversion member (24) is operably coupled to a delivery pathway (14). The actuator is actuatable to move the diversion member (24) between at least a first mode position where the diversion member (24) restricts flow through the delivery pathway (14) (i.e., delivery pathway is “closed”), and a second mode position where the diversion member (24) is position to allow flow through the delivery pathway (14) (i.e., delivery pathway is “open”). Supplying power to actuate the actuator moves the diversion member (24) from its normally biased first mode or “closed” position, which is also a failsafe position, toward its second mode or “open” position. In the “open” position, drug is supplied to target sites, typically from a drug supply reserve within the regulator.

Abstract: Implantable delivery devices (1) for accurately controlling release of an agent therefrom and for preventing release of the agent during storage, prior to use. The devices include a reservoir (3) for storing the agent, a driving means for driving the agent from the reservoir (3) and a valving and control mechanism (10) which is positively actuatable between a closed configuration and an open configuration.

Abstract: A catheter feed through guide apparatus and method which facilitates the feeding of a catheter through a tunneler during implant procedures and avoids damage to the catheter and catheter tip during the catheter feed through procedure. The apparatus comprises a guide element configured to fit through a tunneler and to releasibly engage a catheter or catheter end.

Abstract: A catheter loop manager apparatus which controls the slack portion of a catheter located adjacent to an implanted pump and prevents fibrotic encapsulation of the slack catheter portion. The catheter loop manager comprises a retainer element configured to associate with an implantable pump and to releasibly hold or retain a loop or section of catheter adjacent to the pump. A pull tool is used to releasibly engage a catheter section and pull the catheter section into a loop within a retention channel in retainer element.

Abstract: An implantable flow regulator (22) for regulating flow of a drug along drug delivery pathway (14) form a drug source to a treatment site within a subject includes a movable diversion member (24) and an actuator. The movable diversion member (24) is operably coupled to a delivery pathway (14). The actuator is actuatable to move the diversion member (24) between at least a first mode position where the diversion member (24) restricts flow through the delivery pathway (14) (i.e., delivery pathway is “closed”), and a second mode position where the diversion member (24) is positioned to allow flow through the delivery pathway (14) (i.e., delivery pathway is “open”). Supplying power to actuate the actuator moves the diversion member (24) from its normally biased first mode or “closed” position, which is also a failsafe position, toward its second mode or “open” position. In the “open” position, drug is supplied to target sites, typically from a drug supply reserve within the regulator.

Abstract: The invention features devices and methods for treatment of pain. The drug delivery device is a drug delivery system adapted for whole implantation in a subject and to provide pain relief by delivery of fentanyl or a fentanyl congener (e.g., sufentanil) over a protracted period of time (e.g., at least 3 days or more than 3 days). The device comprises a housing defining a reservoir that contains a drug formulation, a pump operatively connected to the housing so as to facilitate movement of drug out of the reservoir and out of the device, and a thermal expansion element which defines a flow pathway comprising a thermal expansion channel to accommodate thermal expansion of formulation in the reservoir. The device can further comprise a valve positioned within the flow pathway so as to prevent movement of drug out of the reservoir prior to use.

Abstract: Implantable delivery devices (1) for accurately controlling release of an agent therefrom and for preventing release of the agent during storage, prior to use. The devices include a reservoir (3) for storing the agent, a driving means for driving the agent from the reservoir (3) and a valving and control mechanism (10) which is positively actuatable between a closed configuration and an open configuration.

Abstract: A device and method for enhancing skin piercing by microprotrusions involves pre-stretching the skin to enhance pathway formation when the microprotrusions are pressed into the skin. An expandable device includes skin engaging opposite ends that contact the skin surface so that when the device is expanded the skin is stretched. The skin is placed under a tension of about 0.01 to about 10 megapascals, preferably about 0.05 to 2 megapascals. The device has a plurality of microprotrusions which penetrate the skin while the skin is being stretched by the expanded device. Another stretching device employs suction for skin stretching.

Abstract: The invention features devices and methods for treatment of pain. The drug delivery device is a drug delivery system adapted for whole implantation in a subject and to provide pain relief by delivery of fentanyl or a fentanyl congener (e.g., sufentanil) over a protracted period of time (e.g., at least 3 days or more than 3 days). The device comprises a housing defining a reservoir that contains a drug formulation, a pump operatively connected to the housing so as to facilitate movement of drug out of the reservoir and out of the device, and a thermal expansion element which defines a flow pathway comprising a thermal expansion channel to accommodate thermal expansion of formulation in the reservoir. The device can further comprise a valve positioned within the flow pathway so as to prevent movement of drug out of the reservoir prior to use.

Abstract: The invention features devices and methods for treatment of pain. The drug delivery device is a drug delivery system adapted for whole implantation in a subject and to provide pain relief by delivery of fentanyl or a fentanyl congener (e.g., sufentanil) over a protracted period of time (e.g., at least 3 days or more than 3 days). The device comprises a housing defining a reservoir that contains a drug formulation, a pump operatively connected to the housing so as to facilitate movement of drug out of the reservoir and out of the device, and a thermal expansion element which defines a flow pathway comprising a thermal expansion channel to accommodate thermal expansion of formulation in the reservoir. The device can further comprise a valve positioned within the flow pathway so as to prevent movement of drug out of the reservoir prior to use.