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: The present invention features a composite catheter comprising an elongate outer member and an elongate inner member positioned within the outer member so that the inner and outer members define an interstitial space. The outer member has a size and other characteristics that facilitate handling and implantation of the composite catheter, while the inner diameter of the inner member has the size and other characteristics suitable for delivery of a drug through a lumen of the inner member. The interstitial space imparts flexibility to the composite catheter by, for example, removing material from the cross-sectional area that would otherwise provide additional stiffness to the catheter, and/or by accommodating movement of the outer member relative to the inner member.

Abstract: The present invention is a trocar/cannula assembly that is capable of delivering large-diameter objects/fluids into a body cavity interior, while minimizing the puncture footprint left after insertion. Generally, the invention could be a composite needle having a composite wall forming a trocar shaft with at least two rigid elements, and flexible material therebetween, which together at least partially define a trocar bore having a diameter, and a puncture tip. Together these elements enable the composite wall to flex outward so as to increase the diameter of the trocar bore. Additionally, the present invention could also be described as an expandable bore trocar/cannula that is made up of an expandable cannula body having an interior channel that is capable of flexing radially outward, and a trocar tip associated with the cannula body to facilitate the insertion of the trocar/cannula into a patient.

Abstract: The present invention features devices and methods for delivery of drug to an internal organ surface by delivery of drug directly to the surface of the organ such that the drug traverses the organ surface and enters the organ tissue. The device is in the form of an implantable drug delivery patch comprising a first layer, which is generally substantially drug-impermeable. When the first layer is placed on an outer surface of an organ, a drug reservoir is defined by the first layer and the organ surface.

Abstract: The present invention provides a catheter for use in delivering formulation that allows modification of the formulation prior to or concomitant with its transport or at a delivery site. The catheter comprises an elongate body, which defines an inner lumen extending between the proximal and distal ends, and a modifying element, which provides for modification of one or more components of a formulation prior to or concomitant with release at the delivery site.

Abstract: The invention features devices and methods for the systemic delivery of fentanyl or a fentanyl congener (e.g., sufentanil) to treat pain. In the present invention, a drug formulation comprising fentanyl or a fentanyl congener is stored within a drug delivery device (e.g., contained in a reservoir or impregnated within a matrix within the controlled drug delivery device). The drug formulation comprises an amount of drug sufficient for treatment and is stable at body temperatures (i.e., no unacceptable degradation) for the entire pre-selected treatment period. The drug delivery devices store the drug formulation safely (e.g., without dose dumping), provide sufficient protection from bodily processes to prevent unacceptable degradation of the formulation, and release the drug formulation in a controlled fashion at a therapeutically effective rate to treat pain.

Abstract: The present invention provides methods and devices for controlled delivery of a therapeutic agent to an internal cavity of the ear, particularly to the inner ear. In general, the invention uses a drug delivery unit for inner ear treatment which employs a portion of carrier media material containing one or more therapeutic agents therein. The carrier media material is designed to release the therapeutic agents in a controlled manner over time. The drug delivery unit is shaped and sized for placement of at least a portion thereof in the round window niche of a patient. The released therapeutic agents come in contact with the round window membrane and pass therethrough into the inner ear for treatment purposes. This system provides many benefits ranging from the ability to deliver drugs in a site specific, highly controlled manner to the transfer of such materials with minimal patient discomfort and monitoring requirements.

Abstract: The present invention features methods and devices for modulating the rate of delivery of a drug formulation from a drug delivery device by diverting drug away from a drug delivery pathway. In one embodiment, a flow regulator is positioned relative to a drug delivery pathway of a drug delivery system so that adjustment of the flow regulator can provide for diversion of drug away from the drug delivery pathway. Diverted drug can be either delivered into the systemic circulation of the subject, or can be captured in a waste reservoir.

Abstract: The present invention provides a catheter for use in delivering formulation that allows modification of the formulation prior to or concomitant with its transport or at a delivery site. The catheter comprises an elongate body, which defines an inner lumen extending between the proximal and distal ends, and a modifying element, which provides for modification of one or more components of a formulation prior to or concomitant with release at the delivery site.

Abstract: The present invention provides an implantable guide for access to a treatment site. The implantable guide comprises a proximal end, a distal end, and a guide body defining a lumen, and can optionally comprise a stable positioning element for stably positioning a drug delivery device within the guide. The guide can be provided in connection with a drug delivery device. In use, the guide is implanted within a subject so as to provide a conduit through which a drug delivery device can be retrievably introduced to facilitate delivery of drug to a treatment site within a subject at a site distal to an accessible implantation site. The drug delivery device is then positioned within the guide lumen to provide for delivery of drug from the drug delivery to the desired treatment site.

Abstract: The invention features devices and methods for the systemic delivery of fentanyl or a fentanyl congener (e.g., sufentanil) to treat pain. In the present invention, a drug formulation comprising fentanyl or a fentanyl congener is stored within a drug delivery device (e.g., contained in a reservoir or impregnated within a matrix within the controlled drug delivery device). The drug formulation comprises an amount of drug sufficient for treatment and is stable at body temperatures (i.e., no unacceptable degradation) for the entire pre-selected treatment period. The drug delivery devices store the drug formulation safely (e.g., without dose dumping), provide sufficient protection from bodily processes to prevent unacceptable degradation of the formulation, and release the drug formulation in a controlled fashion at a therapeutically effective rate to treat pain.

Abstract: A fluid delivery device generally including: an electrochemical pump, wherein the electrochemical pump is capable of generating water; an electrochemical pump product chamber, wherein the electrochemical pump product chamber is capable of retaining water generated from the electrochemical pump; a displaceable member positioned between the electrochemical pump product chamber and a reservoir, wherein the displaceable member is controllably displaced upon generation of water from the electrical pump; a reservoir, wherein the reservoir is capable of containing a fluid which is delivered upon displacement of the displaceable member; and a housing for containing the electrochemical pump, the electrochemical pump product chamber, the displaceable member, and the reservoir.

Abstract: The invention provides a means of closed exchange of implanted medical device components. An exchanger is brought into contact with the implanted medical device in situ. The component is withdrawn from the implanted device and brought into a closed chamber of the exchanger. Without breaking the contact between implanted device and exchanger, the replacement component is then moved from its position in the exchanger, and inserted into the correct position in the implanted device. The surfaces of the implanted device are not brought into contact with the outside environment, thereby minimizing the possibility of introducing contaminants into the body during the exchange process. The invention is particularly useful for devices that are difficult to position and re-position, thus making it advantageous to exchange only an expended component, rather than the entire device.

Abstract: An apparatus for delivering fluid materials into and out of the inner ear via the round window membrane. A fluid transfer conduit is provided which includes one or more passageways therethrough which may have a semipermeable membrane associated therewith to control fluid flow. Attached to the conduit is an inflatable bladder sized for insertion within the round window niche. When inflated, the bladder engages the internal side wall of the niche, thereby securing the bladder and part of the conduit within the niche. The conduit can then transfer fluids to and from the niche and the fluid-permeable round window membrane therein. Bladder inflation may be achieved through one of the passageways within the conduit which can deliver an inflation fluid into the bladder. Also, the conduit may include an elongate conductive diagnostic member for transferring electrical potentials to and from the inner ear.

Abstract: The present invention features a composite catheter comprising an elongate outer member and an elongate inner member positioned within the outer member so that the inner and outer members define an interstitial space. The outer member has a size and other characteristics that facilitate handling and implantation of the composite catheter, while the inner diameter of the inner member has the size and other characteristics suitable for delivery of a drug through a lumen of the inner member. The interstitial space imparts flexibility to the composite catheter by, for example, removing material from the cross-sectional area that would otherwise provide additional stiffness to the catheter, and/or by accommodating movement of the outer member relative to the inner member.