Abstract: An infusion pump system is described that increases patient comfort and convenience. The infusion pump system includes an infusion site interface that is releasably connected to an infusion pump body, and has no tubing associated between the infusion site interface and the pump body. The infusion pump body may include a carrier frame that may be adhered to the skin of a user.

Abstract: Stabilizing an object in the body of a patient involves the injection of a lower critical solution temperature (LCST) material or other flowable material into the body of the patient so that the material contacts the object. The LCST material or other flowable material then forms a gel in the body such that the object is contained at least partially within the gel and thereby stabilized by the gel such that the object can then be easily fragmented within the body and/or retrieved from the body.

Abstract: Devices and methods for delivering a therapeutic agent produced via a genetically-altered chondrocyte are provided. More specifically, the device includes a housing which defines a cell chamber configured to retain a large volume of chondrocytes while selectively releasing therapeutic agents produced via these entrapped cells. In an exemplary embodiment, the cell chamber can be configured such that a portion of cells can be positioned at least about 1.5 mm from an external wall of the device (i.e., about 1.5 mm away from an external nutrient supply). For example, the cell chamber can have a tubular configuration having a length and a diameter wherein each of these dimensions is at least about 3 mm (thereby the central core to the chamber is at least about 1.5 mm from the outer wall of the device).

Abstract: The present disclosure provides various systems and methods for focusing electromagnetic radiation (EMR) within a diffusion medium, such as a turbid medium. A diffusion medium is irradiated with EMR. The EMR may be modulated by an acoustical wave focused on a focus volume within the diffusion medium. The EMR may be modulated by a beat frequency or other function of multiple focused acoustical waves. The EMR may be modulated at a harmonic of a fundamental frequency of one or more acoustical waves. A filter may filter the emerging EMR to remove all but specifically modulated EMR scattered from the focus volume. The modulated EMR may be focused and/or used for various purposes, including imaging. In some embodiments, the modulated EMR may be reflected and/or amplified by a phase conjugating mirror. Furthermore, in some embodiments, acoustical phase conjugation may be used to focus an acoustical wave on a focus volume.

Abstract: Provided are methods of delivering at least one pharmaceutical agent to the central nervous system (CNS) of a subject, methods of treating a neurological disorder or pain in a subject that include administering at least one pharmaceutical agent onto a SEM graft in the skull base of the subject. Also provided are methods of treating a neurological disorder or pain in a subject that include forming a SEM graft in the skull base of the subject and administering at least one pharmaceutical agent onto the SEM graft in the skull base of the subject. Also provided are methods of forming a SEM graft in the skull base of a subject, compositions for administration onto a SEM graft in the skull base or into an endonasal reservoir or endonasal reservoir device in a subject, and devices for administering such compositions onto a SEM graft in the skull base of a subject.

Abstract: Medicament devices include a sealed medicament dose container comprising a cell based medicament that is stored at a temperature less than about ?40 degrees Celsius, then thawed into a liquid prior to administration and a medicament dose cartridge configured and sized to snugly hold the dose container therein during extraction of the liquid medicament. Related dose containers, retainers and extraction/dispensing systems are also described.

Abstract: A spacer for delivery into the natural or man-made openings to the frontal, maxillary, sphenoid, anterior or posterior ethmoid sinuses, or other cells or cavities, anatomical regions such as nostrils, nasal cavities, nasal meatus, and other passageways such as the Eustachian tubes, naso-lachrymal ducts or airway is described. The bioabsorbable polymeric spacers maintain the opening and/or are useful for delivering drugs or other substances to the natural or man-made openings.

Abstract: A silk mesh used for treating plantar fasciitis and a method of treating plantar fasciitis. The silk mesh optionally comprises a low dose corticosteroid. The method of treating plantar fasciitis comprises inserting a silk, biocompatible surgical mesh over the plantar aspect of the foot to treat plantar fasciitis.

Abstract: Apparatus are provided for infusion devices and related control systems and methods. In one embodiment, an infusion device includes a voided portion adapted to receive a shaft portion that includes a shaft coupled to a plunger of a reservoir. The shaft portion includes a detectable feature, and the infusion device includes a sensing arrangement proximate the voided portion to sense the detectable feature. In some embodiments, a control module is coupled to the sensing arrangement to determine a remaining amount of fluid in the reservoir based at least in part on the sensed position of the detectable feature. In other embodiments, the control module identifies an anomalous condition based at least in part on the sensed position of the detectable feature.

Abstract: The present invention creates a biologically protected or enhanced space in vivo in a mammal to allow the mammal's immune system and/or other biological processes to function properly in order to treat autoimmune diseases. In particular, the biologically protected/enhanced space allows biological processes to occur that can therapeutically treat Type I diabetes. The biologically enhanced/protected space can also be used to promote growth of specific cells such as insulin producing islet cells of the pancreas. Microfluidic devices can also be used to remove soluble TNF receptors and autoreactive T Cells in treating autoimmune diseases. Additionally, microfluidic devices can be used to remove blood glucose, soluble insulin receptors and insulin-like growth factor (IGF) from blood in the treatment of adult onset (Type II) diabetes.

Abstract: An interventional catheter assembly comprising a catheter for insertion and guidance to a target site in a body lumen or a cavity and an operating head mounted in proximity to a distal end of the catheter and comprising a system for removing obstructive material from the target site is provided. In certain embodiments, the catheter assembly includes at least one aspiration port located proximal to the operating head that communicates with a first sealed lumen for withdrawing fluids and obstructive material from the target site, together with at least one liquid infusion port penetrating the catheter and located proximal to the at least one aspiration port that communicates with a second sealed lumen for supplying fluid to a location in proximity to the target site.

Abstract: The present invention provides a drug eluting surgical screw and a method for manufacturing a drug eluting surgical screw. The drug eluting surgical screw may include a shaft having a threaded portion, a head having a drive recess disposed at a proximal end of the shaft, the drive recess having a reservoir region and a driver engagement region, and at least one or more drug eluting components disposed within the reservoir region of the drive recess in a manner that does not substantially impair a connection between a driver and the surgical screw when the driver is operably disposed within the driver engagement region, each of the at least one or more drug eluting components including a carrier matrix and a therapeutic agent, the therapeutic agent being at least 20 wt % of the drug eluting component prior to any implantation of the drug eluting surgical screw.

Abstract: The present invention provides implantable systems that communicate wirelessly with each other using a unique format that enables devices configurations and applications heretofore not possible. Embodiments of the present invention provide communication apparatuses and methods for exchanging information with implantable medical devices. In some embodiments, two implantable devices communicate with each other using quasi-electrostatic signal transmission in a long wavelength/low frequency electromagnetic band, with the patient's body acting as a conductive medium.

Abstract: A balloon catheter is used in a closed-loop heat exchange system for manipulating the temperature of a patient. The balloon catheter is positioned in the stomach of the patient, and then expanded with a heat exchange fluid delivered through a lumen formed in the shaft of the catheter. The balloon catheter comes into contact with the wall of the stomach, and the stomach substantially conforms around the expanded balloon catheter. The heat exchange fluid is allowed to flow continuously into and out of the balloon catheter. Heat is exchanged between the balloon catheter and the stomach so as to controllably alter the temperature of at least a portion of the patient. Anti-shivering mechanisms and automatic control based on temperature feedback from the patient may be used in connection with the heat exchange system.

Abstract: Pharmaceutical delivery systems for delivering dosages according to the present invention include a carrier component and a cap configured to seal an internal volume of the carrier component, wherein the cap includes a device that produces a unique current signature. Dosages prepared to be delivered according to embodiments of the invention find use in a variety of different applications, including clinical trials.

Abstract: A drug delivery device that includes a capsule for implantation into the body; the capsule further includes a reservoir for containing a substance such as a therapeutic agent, at least one port for allowing the substance to diffuse from or otherwise exit the reservoir, and a nanopore membrane in communication with the capsule at or near the exit port for controlling the rate of diffusion of the substance from the exit port. The device also includes an optional screen for providing structural stability to the nanopore membrane and for keeping the pores of the nanopore membrane clear. One embodiment of the drug delivery device includes an osmotic engine internal to the device for creating fluid flow through the device.

Abstract: A direct stream hydrodynamic catheter system is provided for the removal of thrombus, lesions and the like including provisions for the infusion of drugs, lysing fluids and the like into a blood vessel. Physician controlled high powered direct fluid jet streams emanate from a fluid jet emanator in the form of robust radially directed fluid jet streams to impinge upon and ablate difficult and strong thrombus or lesions within a blood vessel. Effluent aspiration is controlled by an exhaust regulator in the form of a roller pump, but effluent removal can be assistingly influenced by the fluid pressure associated with the radially directed fluid jet streams.

Abstract: Anti-cancer coating compositions comprising 3-hydroxymethyl-5-aziridinyl-1-1-methyl-2-[1H-indole-4,7-dione]propenol (E09) are disclosed. More specifically, the coating compositions comprise EO9 and a formulation vehicle. The formulation vehicle improves the solubility and stability of EO9. Additionally, the coating compositions can include coating agents that provide better adhesion of the coating composition to the bladder wall during intravesical delivery of the coating composition.

Abstract: The current invention concerns systems, devices and methods for the ablation of a vessel's wall from the inside, more specifically to implant devices and to the ablation of the wall of one or more pulmonary veins (PV) from the inside, preferably transmural ablation and preferably at the level of the antrum. Hereby, one or more implant devices can be implanted in the vessels and can subsequently be heated by external energy-providing means.

Abstract: The present invention includes a microneedle assembly having a support that includes a first surface and a second surface, the second surface further including a slanted surface. A plurality of microneedles are provided which project outwardly from the second surface of the support. A pathway through the microneedle assembly is formed and includes an aperture extending between the first surface of the support and the second surface of the support, a channel disposed on the exterior surface of at least one microneedle, the channel having a surface, the channel being in alignment with at least a portion of the aperture to form a junction through which fluids may pass.

Abstract: An injector device for the percutaneous injection of fluids, such as medications, is disclosed. The device can have a mobile phone case. The mobile phone case can hold an auto-injector cartridge having a trigger, spring-loaded needle and reservoir holding a medication such as epinephrine or insulin. The device mobile phone case can communicate injection data to the phone. The phone can communicate the injection data to an emergency service provider.

Abstract: A catheter includes an elongated tubular body including a first wall and second wall defining first and second lumens, respectively. Each wall extends to a distal end and defines a distal opening. The first and second walls may each include one or more side openings disposed proximal of the distal end. The first and second lumens are separated by a septum. The septum includes a septum extension extending distally from the septum. The septum extension is adapted to articulate relative to the septum in response to fluid flow into and out of the distal openings of the first and second lumens. The septum extension is dimensioned to partially obstruct fluid flow into the catheter through one of the distal openings upon the articulation of the septum extension.

Abstract: A pen needle assembly includes a cap for covering the non-injection end of a needle of a pen needle. The needle is received by a hub, which is disposed in an outer cover. The cap is adapted to be connected to the outer cover in a first or second position. The cap is removable in the first position and the cap is locked to the outer cover in the second position.

Abstract: A dilation device (206) for an intra-body lumen, for example, a urethra partially occluded by an enlarged prostate in the form of a resilient curved body configured to be implanted in a cut around the lumen, and a method for dilating such a lumen by implanting a dilation device in a cut around the outside of the lumen. Also, a deployment system (300) including a delivery device for the implant, and a device for dilating the lumen before and while the cut is being made, and a method of using the implant and the deployment system. The implant may be formed of a strip or a coiled wire. The cut may be performed in part by the implant. The cut may be performed by a sharp edge, and/or by application of electrical current to the area being cut, or by a piezoelectric transducer.

Abstract: A device and method for using the device is used for clotting volumes created postoperatively. The device is inserted into a cavity formed by removal of tissue or organ within a patient. The device may have a flexible tubing having a surface material; a blood clotting material enclosed within the surface material of the tubing; a guidewire associated with the device that when placed under tension, stabilizes the tubing radially or longitudinally; and the surface material of the tubing being removable from the enclosed blood clotting material while the guidewire is under tension.

Abstract: Methods, system and devices for monitoring a closed loop control operation including signal levels received from an analyte sensor at a predetermined frequency, determining a variation in the monitored analyte level, determining a medication delivery rate adjustment frequency to deliver a medication based on the determined variation in the monitored analyte level, and adjusting the closed loop control operation to modify the medication delivery rate frequency are provided.

Abstract: A method for delivering a fluid to an animal with a drug delivery device without causing contamination to the drug delivery device. The drug delivery device used by the method may comprise a fluid subsystem with a switching device, disposable syringes, fluid reservoirs, disposable tubing, and a catheter. In one embodiment, the method allows a user to deliver multiple drugs to an animal without contaminating the valves that control the flow of fluid.

Abstract: One aspect of the present invention relates to a drug delivery system comprising a layered structure where a drug layer and a biodegradable polymer layer for controlling the release of drugs are alternately laminated. The drug delivery system can easily control an in-vivo drug release rate and a release amount.

Abstract: An implantable biomedical conductor assembly is configured for at least partial insertion in a living body. The implantable conductor assembly includes an inner tubular structure and an outer tubular structure generally surrounding the inner tubular structures such that a gap of less than about 0.030 inches exists there between. A dynamic coil is located in the gap. The dynamic coil includes a plurality of insulated conductors that are coiled generally at or below a yield point. The insulated conductors are permitted to expand within the gap to engage an inner surface of the outer tubular structure in an expanded coiled configuration. At least one mechanical restraint at each of a distal end and a proximal end retains the dynamic coil in the tubular structures. Free ends of the insulated conductors extend beyond the proximal and distal ends to facilitate attachment to electrodes and connectors.

Abstract: An earplug insertion device can include a housing that is configured to hold a first earplug and a second earplug. The device can also include an ejection mechanism that can be configured to respond to a first user force by ejecting the first earplug from the device in a first ejection motion. The ejection mechanism can also being configured to respond to a second user force by ejecting the second earplug from the device in a second ejection motion.

Abstract: A reduced pressure delivery system for applying reduced pressure tissue treatment to a tissue site is provided. The system includes a manifold delivery tube and a balloon having an inner space. The balloon is capable of assuming collapsed and expanded positions. The system further includes a manifold having a plurality of flow channels. The manifold is disposed within the inner space of the balloon. A sharp tip is configured to be delivered within the manifold delivery tube to puncture the balloon.

Abstract: Disclosed are devices, methods and systems for treatment of eye disease such as glaucoma. Implants are described herein that enhance aqueous flow through the normal outflow system of the eye with minimal to no complications. The implant can be reversibly deformed to a first shape, such as a generally linear shape conducive to insertion. Upon insertion, the implant can deform to a second shape, such as a generally non-linear shape conducive to retention within the eye. The shape also improves fluid flow from the anterior chamber and prevents or reduces clogging.

Abstract: A combined multi-lumen central access catheter and an embolic filter including ports proximal and distal the filter for fluid infusion and/or pressure sensing and infusion ports in the catheter to permit infusion of bioactive agents, flushing agents and/or contrast agents and managing the capture of the clot thereafter.

Abstract: The subject invention pertains to medical apparatuses and methods for reducing or preventing leakage of injected therapeutic agents (including liquid-containing substances, cells) into a solid or hollow tissue/organ after puncturing.

Abstract: An introducer for providing intravascular access to a patient is disclosed, and includes a dilator and sheath that are configured to prevent peelback, or “fishmouthing,” of the sheath during introducer advancement. In one embodiment, the introducer comprises a dilator including a distal tapered region, and a sheath including an inner bore that receives the dilator such that a portion of the tapered region of the dilator extends from the sheath distal end. A distal outer surface of the sheath includes a first curved portion defined by a first radius and extending proximally from the distal end of the sheath to a first end point, and a second curved portion defined by a second radius and extending proximally from the first end point to a second end point. Additionally, an interference fit is established between the dilator tapered region and the sheath distal end to further prevent sheath end deformation.

Abstract: A method of washing blood mixed with undesirable elements not normally found in healthy whole blood to remove the undesirable elements, the method comprising: separating the blood into components according to relative densities of the components with a rotating centrifuge bowl; providing a port through which fluid exits the bowl, the exiting fluid having a concentration of undesirable elements; flowing washing solution into the centrifuge bowl at an initial flow rate; monitoring the fluid exiting the bowl with an optical sensor having an output signal indicative of the composition of the exiting fluid; and increasing and decreasing the flow rate of the wash solution as a function of the output signal.

Abstract: A cochlear implant electrode includes an electrode carrier having an electrode array with a groove disposed in a longitudinal direction along the electrode carrier, and a stopper positioned around the electrode carrier. The stopper has a protrusion on its inner surface that is configured to be positioned within the groove such that the stopper is movable with respect to the electrode carrier.

Abstract: An enhanced cross stream mechanical thrombectomy catheter having a distal end with outflow and inflow orifices at one side for producing concentrated cross stream jet flow for selective and concentrated thrombus ablation during thrombectomy procedures. A multidirectional fluid jet emanator positioned within the distal catheter lumen comprises high velocity fluid jets which produce jet flow that is directed toward distal and proximal ends of the catheter. Jet flow directed toward the proximal end provides a region of low pressure near an inflow orifice which acts to pull thrombotic particulate from the vasculature. The invention provides for suitable distancing of high powered ablation or suction forces from the near walls of the vasculature. Cross stream flow emanating from one side of the catheter distal end urges the opposing non-orificed side of the catheter distal end toward and against the vascular wall to inhibit contact of the inflow orifice with the vascular wall.

Abstract: A therapeutic implantable device comprises a biodegradable outer shell, a plurality of spaced biodegradable layers within the outer shell, a first therapeutic mass between the plurality of spaced biodegradable layers and a second therapeutic mass between the plurality of spaced biodegradable layers. The plurality of spaced biodegradable layers are arranged such that the first therapeutic mass is exposed external to the implantable device before exposure of the second therapeutic mass external to the implantable device.

Abstract: The present invention relates to a structure having a nanoantenna, a method for manufacturing same, a drug delivery body having the same, a thermotherapy complex, a drug therapy device, and a thermotherapy device. The structure of the present invention has a nanoantenna pattern formed on the outer surface of a porous micro-container, thereby enabling wireless control from the outside, and when the structure is used as a drug delivery system and a thermotherapy complex, drug therapy and thermotherapy can be carried out at a desired application region inside a living body at a desired time. Also, the structure of the present invention enables transmission and reception of a wireless signal with an external controller through the nanoantenna, thereby enabling the detection of a signal inside the living body and the transmission of the signal to the external controller, and the discharge of a drug or nanowires according to a response signal transmitted from the external controller.

Abstract: A combined multi-lumen central access catheter and an embolic filter including ports proximal and distal the filter for fluid infusion and/or pressure sensing and infusion ports in the catheter to permit infusion of bioactive agents, flushing agents and/or contrast agents and managing the capture of the clot thereafter.

Abstract: Biomarkers are collected and used to determine biological propensities of a patient, to determine the efficacy of medical devices, to select and administer therapeutic agents, to select medical devices, to make adjustments to medical devices, and/or to adjust surgical techniques. An apparatus includes a port to draw a biological fluid (e.g., a mist) from a surgical site. The apparatus includes a sensor having a cantilevered beam. The beam includes substances selected to attract certain biomarkers as the fluid is communicated across the beam. The same apparatus or another apparatus is used to administer a therapeutic agent based at least in part on collected biomarker data. The therapeutic agent delivery apparatus may include a device that is also used to create a wound at a surgical site. For instance, a harmonic surgical instrument may be used to both collect biomarkers and administer a therapeutic agent (e.g., gene therapy using sonoporation).

Abstract: This invention is related to the use of polyurethane based polymer as a drug delivery device to deliver biologically active compounds at a constant rate for an extended period of time and methods of manufactures thereof. The device is very biocompatible and biostable, and is useful as an implant in patients (humans and animals) for the delivery of appropriate bioactive substances to tissues or organs. The drug delivery device for releasing one or more drugs at controlled rates for an extended period of time to produce local or systemic pharmacological effects comprises: 1. a reservoir, said reservoir comprising; 2. at least one active ingredient; and, optionally, 3. at least one pharmaceutically acceptable carrier; a polyurethane based polymer completely surrounding the reservoir.

Abstract: Devices and methods for determining fallopian tube occlusion. The methods may include determining fallopian tube occlusions through a pressurization or volumetric determination.

Abstract: A laparoscopic port device includes a compliant port body having a distal and proximal end having a lumen extending therethrough. The lumen has a filtering agent configured to retain or treat particulate contaminates present in insufflation gases. The laparoscopic port device further includes a valve operatively connected with the lumen to selectively regulate flow of the insufflation gases therethrough.

Abstract: The present invention generally relates to systems for deploying intraocular shunts without the use of an optical apparatus that contacts an eye, such as a goniolens. In certain embodiments, systems of the invention include a locking mechanism, and a device configured to hold and deploy an intraocular shunt, in which a distal portion of the device is movable within a proximal portion of the device and the distal portion of the device is configured to mate with the locking mechanism to prevent movement of the distal portion when the locking mechanism is engaged.

Abstract: Various embodiments of drug delivery devices and methods of assembling such devices are provided. In one embodiment, a drug delivery device for dispensing medicament comprises a medicament cartridge, wherein the cartridge comprises (i) a distal end, (ii) a proximal end that is opposite the distal end along a body axis of the cartridge, and (iii) a movable piston arranged substantially at the proximate end of the cartridge. The drug delivery device further comprises a piston rod having a distal end for axially moving the piston in the distal direction during dispensing of a set dose of medicament, wherein a relative axial distance between the distal end of the piston rod and a proximal face of the piston is set during assembly of the drug delivery system. The relative axial position between may be set such that the piston rod and the proximal face of the piston abut each other.

Abstract: A bone fastener or an orthopedic implant that resides within the bone after orthopedic surgery has a threaded and/or unthreaded shaft, said shaft has a hollow portion and a solid portion. The hollow portion may have a structure that enhances tissue growth and may also hold materials that enhance tissue growth. The hollow portion may also hold materials to treat diseases and/or promote bone fracture healing.

Abstract: The present disclosure relates to implantable medical devices which include at least one mesh and at least one film pivotably attached to the mesh.

Abstract: This disclosure generally relates to dialysis systems and related methods. In one aspect of the invention, a dialysis system includes a device configured so that a medical fluid can pass therethrough, and the device is adapted to remove one or more substances from the medical fluid as the medical fluid passes through the device. The dialysis system can also include a sodium control system adapted to alter a sodium concentration of the medical fluid.