Abstract: The present invention relates to tetracaine based anesthetic formulations and methods of use thereof. The invention further relates to topical formulations of tetracaine and methods of topically anesthetizing body tissues. The present invention also relates to tetracaine based dental anesthetic formulations and methods for anesthetizing the maxillary dental arch using these formulations.

Abstract: This invention is in the field of controlled elution devices for therapeutic delivery. There exists a need for a stand-alone capable device for the localized and extended delivery of a therapeutic. This need is overcome by the present invention having an examplary embodiment comprised of a microfilm base (12), a reservoir of a therapeutic (14) disposed about the microfilm base (12) and a top layer (24) that is (i) a plurality of laminated layers (24) of para-xylyelne polymer and/or (ii) para-xylyelne polymer endowed with oxidatively functionalized para-xyele units. The thicknesses of the device is optimally in the range of about 10 to about 200 microns. The device is usable for the localized release of broad spectrum therapeutics for interventional and preventative medicine.

Abstract: A method of treatment of a wound, said method comprising the step of injecting an effective amount of an oxygen-containing fluid into said wound at a location below a surface of said wound, said step of injecting being carried out through a conduit having one or more outlets for said fluid, wherein substantially all of said outlets are positioned below the surface of the wound during said step of injecting. Injection of oxygen directly into the wound tissue below the wound surface provides enhanced wound healing.

Abstract: Disclosed is a bolus comprising: a bolus body comprising a matrix material and one or more biologically beneficial substances contained in and/or on the matrix; wherein the exterior surface of the bolus body is shaped so as to have a least one recessed portion; and at least part of the recessed portion of the bolus body is coated with a material which retards or inhibits release of the beneficial substance(s) from the matrix.

Abstract: A reservoir is incorporated in between a guide portion and an introducer tip of the introducer member. A spherical or similarly shaped plug is inserted into the guide portion. The plug is designed such that it forms a seal within the guide portion, preventing any fluid flow between the reservoir and an environment external to a distal end of the guide portion. This prevents a liquid or gel contained inside the reservoir from drying or leaking. The plug may further be held in place against a distal opening of the reservoir by positive pressure within the reservoir. The plug may further be held in place within the guide portion by a plurality of bumps or notches. When the catheter is advanced through the guide portion, the catheter tip pushes the plug into the reservoir, thereby breaking the seal and lubricating the catheter.

Abstract: Methods and devices are adapted for implanting into the eye. An incision is formed in the cornea of the eye and a shunt is inserted through the incision into the anterior chamber of the eye. The shunt includes a fluid passageway. The shunt is passed along a pathway from the anterior chamber through the scleral spur of the eye into the suprachoroidal space and positioned in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber.

Abstract: A device for inserting a cannula into tissue, including a cannula, a protective element which can accommodate said cannula, an operating element for moving the cannula out of the protective element, and a holder fixedly connected to the cannula. The invention encompasses a system for connecting a liquid supply to the cannula.

Abstract: A novel process for bacterial production of nanocellulose hydrogel pouches for applications for cell therapy, cell encapsulation, cell delivery, cell proliferation and cell differentiation has been invented. The process is based on fermentation of bacteria producing nanocellulose in oxygen permeable mold interconnected with tubing with diameter less than 5 mm. The resulting Bacterial Nanocellulose (BNC) hydrogel pouch is biocompatible and non-degradable in the human body. The inner wall of the pouch is highly porous and supports cell migration, cell proliferation and cell differentiation. The wall of the pouch allows controlled diffusion of extracellular components. The BNC pouch with injected cells can be implanted and used for treatment of diseases such as diabetes by local delivery of insulin. There are numerous applications of BNC pouches with injected cells in tissue engineering, regenerative medicine and cancer treatment.

Abstract: A medical implant according to the present invention includes a substrate having a first plurality of openings and a second plurality of openings formed therein. An outer covering substantially encompasses the substrate. The outer covering has an absence of sharp edges and extends into the first plurality of openings and around the second plurality of openings. A kit including the implant and at least one fastener is also disclosed.

Abstract: A nano-carrier comprising an antiproliferative drug encapsulated by a lipophilic enhancement agent.

Abstract: A device for inserting a needle used to introduce a cannula can include a housing including a closed end, an open end, and an arm including a tab extending from the open end, and a sleeve configured to be placed against the patient's skin, the sleeve defining a slot extending along a length of the sleeve, and a barb positioned adjacent to an end of the slot. The slot is sized to receive at least a portion of the arm and the tab of the housing so that the arm and the tab of the housing slides within the slot as the housing is moved relative to the sleeve, and the barb is positioned to engage the tab of the housing to limit movement of the housing relative to the sleeve. The device can also include a threaded portion of the housing extending towards the closed end of the housing.

Abstract: A medical device includes an elongated body including an outer surface having a plurality of barbs extending therefrom and an inner surface defining a lumen therethrough. The elongated body includes at least one channel extending through the inner surface and the outer surface, the channel defined between an inner surface of one of the plurality of barbs and a cut outer surface of the elongated body. A wound treatment material is disposed within the lumen of the elongated body. The barb is configured to move between a first position to close the channel and retain the wound treatment material within the lumen and a second position to open the channel and permit the release of the wound treatment material therethrough.

Abstract: A gastric restrictor assembly is provided. The assembly includes a housing defining a throughbore and having a base portion, a waist portion and head portion. The assembly also includes a pin holder including a plurality of pins extending therefrom. The pin holder is configured for being lockingly received within the housing. The plurality of pins extends across the waist portion when the pin holder is received within the housing.

Abstract: The present application relates to a molecular exchange device (1) for use with an analysis and control apparatus and a method of manufacturing a molecular exchange device.

Abstract: A biocompatible material may be configured into any number of implantable medical devices including a vascular closure device. The vascular closure device includes a fibrous structure formed from at least one randomly oriented fiber, the randomly oriented fiber comprising at least one polymer, and at least one agent, in therapeutic dosage, incorporated into at least one of the fibrous structure and the at least one randomly oriented fiber.

Abstract: The present invention relates to mechanically elongated neurons and provides useful compositions, devices and methods for treating a nerve lesion using such mechanically elongated neurons.

Abstract: Several different smart stent structures are described for placement in vessel of a mammal. The stents can be advantageously used to perform measurements of the conditions in the vessel and transmit the measurements wireless out from the patient. In some embodiments, the stent performs therapy within the vessel and may be controlled with a microprocessor, which may or may not communicate wirelessly. Some implantable devices comprise a drug delivery system based, for example, on either a microelectromechanical structure or a cover that opens upon application of an electrical current. Smart devices can be used, for example, the detect deposits in a vessel, aneurysms in the vessel or other modifications of flow in the vessel.

Abstract: The steerable catheter comprises a flexible tube, inside of which different conducts are arranged: one or more conducts for drug administration, vacuum conducts associated with different radiofrequency electrodes, conducts for the conductive wires that conducts the radiofrequency energy to the distal end of the catheter, conducts for the fiber optic cable/s that conducts the laser energy to the distal end of the catheter, a guiding wire for the catherization, and another components; the steerable catheter being connected from the proximal end to a energy unit and other pressure and/or dosing devices; and the steerable catheter optionally including an inflatable balloon to help occluding the vessel; and it also incorporates one or two electrode/s or conductive layer/s in the distal end of the catheter; the objective of the steerable catheter being the obtaining of better results in the embolization and/or chemoembolization treatments.

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

Abstract: Sterile micron-sized gold particles contained in capped vials, a kit of part including the vial and a liquid capable of suspending the particles, as well as their preparation, medical devices or medicaments prepared by their preparation as well as uses thereof in treating inflammation. Also, gold coated implants preferably for use in combination with the medical devices.

Abstract: Cannula anchor assemblies are disclosed which consist of a threaded cannula and a cannula anchor. The cannula anchor system allows for secure anchoring into the body wall, and proper cannula height adjustment prior to and during surgery. Sutures through the body wall may be secured to the cannula anchor either directly through the cannula anchor, or around suture posts attached therein. The cannula anchor also prevents excessive plunge of a trocar into the patient. The cannula anchor is generally configured with internal threads that mate with a threaded cannula.

Abstract: A reduced pressure delivery system for applying a reduced pressure to a tissue site includes a manifold delivery tube having a passageway and a distal end, the distal end configured to be percutaneously inserted and placed adjacent the tissue site. A flowable material is provided and is percutaneously deliverable through the manifold delivery tube to the tissue site. The flowable material is capable of filling a void adjacent the tissue site to create a manifold having a plurality of flow channels in fluid communication with the tissue site. A reduced pressure delivery tube is provided that is capable of fluid communication with the flow channels of the manifold.

Abstract: A guide block for an MRI device has a block body with a proximal face, a distal face, and a plurality of passageways extending between the two faces. A first guide passageway within the guide block is open along the body length, extends between the proximal face and the distal face, and is configured to receive a tissue-removing device. A second guide passageway within the guide block is open along the body length, extends between the proximal face and the distal face, and is configured to receive the tissue-removing device. A longitudinal opening extends between the first guide passageway and the second guide passageway, and is coextensive with the first guide passageway and the second guide passageway between the proximal face and the distal face.

Abstract: An improved propellant pillow and method for filling a propellant chamber of an implantable pump with propellant through the use of such an improved propellant pillow are disclosed. The propellant pillow includes an improved design that prevents the damage of such during evacuating and filling procedures.

Abstract: Described are coordinated apparatus and methods for drug targeting, clearing the lumen, placing implants within the wall of, and stenting, as necessary, any tubular anatomical structure with single luminal entry. Miniature balls, or miniballs, are introduced into the wall aeroballistically from within the lumen, or small arcuate bands called stays inserted through the outer tunic by means of a hand tool. When miniballs must be placed too closely together to be controlled by hand, a positional control system assists in discharge. Implantation within or proximal to diseased tissue targeting, and thus concentrating the medication in that tissue, miniballs and stays can be used to deliver and controllably release multiple drugs, a radionuclide, or an open or closed loop smart-pill, for example. A glossary of terms follows the specification. Balance of abstract appended to paragraph [0004].

Abstract: A medical device can be used to drain fluids from the body during a medical procedure that requires the insertion of a medical instrument into an anatomical lumen or cavity. The device generally allows the simultaneous introduction of the medical instrument into the body and drainage of fluid out of the body during a medical procedure.

Abstract: Described here are devices and methods for treating one or more conditions or symptoms associated with a tonsil procedure. In some variations, a drug-releasing device may be at least partially delivered to one or more tonsillar tissues before, during, or after a tonsil procedure. In some variations, the drug-releasing device may be configured to be biodegradable. In other variations, the drug-releasing device may comprise one or more hemostatic materials or one or more adhesives. The drug-releasing device may be configured to release one or more drugs or agents, such as, for example, one or more analgesics, local anesthetics, vasoconstrictors, antibiotics, combinations thereof and the like.

Abstract: Various exemplary embodiments relate to a method of using an emergency medicament device. The method includes reading an ID tag from the medicament device using a mobile device; automatically requesting instructions for using the medicament device based on the ID tag; and displaying a video to a user of the mobile device, the video providing instructions for using the medicament device in accordance with approved labeling of the medicament device. Various exemplary embodiments relate to an electronic medicament device including: a reservoir configured to store an amount of medication for treating anaphylaxis; an administration component for administering the medication to a patient; a processor communicatively connected to a memory storing medicament device information; and an identification tag configured to be read by another device, the identification tag providing the medicament device information including identification of instructions for using the medicament device.

Abstract: Devices and methods are provided for selectively delivering a drug by laser activation. The device includes structural elements forming a hermetic, enclosed reservoir, and at least one drug unit contained in the enclosed reservoir. The at least one drug unit includes a drug. The device is able to absorb laser irradiation effective to open the enclosed reservoir to permit release of the drug. The method includes implanting a drug delivery device into a tissue site of a patient, and irradiating at least a portion of the drug delivery device to breach the enclosed reservoir to permit the drug to be released in tissues at the tissue site.

Abstract: Methods and devices are adapted for implanting into the eye. An incision is formed in the cornea of the eye and a shunt is inserted through the incision into the anterior chamber of the eye. The shunt includes a fluid passageway. The shunt is passed along a pathway from the anterior chamber through the scleral spur of the eye into the suprachoroidal space and positioned in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber.

Abstract: Methods and systems for determining the concentration of one or more analytes from a sample such as blood or plasma are described. The systems described herein can be configured to withdraw a sample from a source of fluid, direct a first portion of the withdrawn sample to an analyte monitoring system and return a second portion of the sample. The analyte monitoring system can be connected to the fluid source via a connector that is configured to improve fluid flow and reduce blood clotting risk. These goals can be accomplished, for example, by employing coatings in or on a connector, positioning a resilient substance at or near the junction, by reducing dead space volume, by using resiliency to improve fit, by extending a portion of one connector to better mate with a portion of another connector, etc.

Abstract: Apparatus, systems and methods related to monitoring intravenous fluids during administration to a subject are disclosed. These apparatus, systems and methods provide near real-time monitoring of the identity of one or more components of an intravenous fluid.

Abstract: Embodiments of the present disclosure are directed to delivery devices, methods, and systems for delivering an implant to a target site. In one embodiment, a delivery device includes a core member defining a proximal end and a distal end and an outer winding defining a proximal end and a distal end, wherein the outer winding surrounds and is coupled to the core member. The outer winding extends at least partially between the proximal end of the core member and the distal end of the core member, and the outer winding is configured for displacement within a delivery catheter. The delivery device further includes a coupling member at the distal end of the core member configured to releasably attach to an implant.

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: Methods and devices are adapted for implanting into the eye. An incision is formed in the cornea of the eye and a shunt is inserted through the incision into the anterior chamber of the eye. The shunt includes a fluid passageway. The shunt is passed along a pathway from the anterior chamber through the scleral spur of the eye into the suprachoroidal space and positioned in a first position such that a first portion of the fluid passageway communicates with the anterior chamber and a second portion of the fluid passageway communicates with the suprachoroidal space to provide a fluid passageway between the suprachoroidal space and the anterior chamber.

Abstract: A percutaneous gastrostomy introduction system may include may include an elongate tube assembly including one or both of a dilator portion and a gastrostomy tube portion, which may be continuously formed or joined by one or more connection joints that may—in certain embodiments—provide for rotation about a common longitudinal axis. The dilator portion includes a helical surface for advancing contact with body tissue and may be disposed near (including up to and defining) a first end of the elongate tube assembly. An engagement structure, including—for example—one or more of a wire loop, a user-graspable handle, or another graspable structure may be included at the first end of the device. Device embodiments may be effective to lessen or prevent tenting of patient tissue during introduction.

Abstract: Needle assemblies are disclosed. In some embodiments, the needle assembly includes a main housing including an obturator insertion opening and an opposite needle connection opening, a connector housing configured to engage the main housing, the connector housing including obturator, tubing, and plug openings, a self-sealing plug including a channel, the plug positioned within the connector housing so the channel is aligned with the tubing opening, a needle holder base, and a needle. The connector housing is configured to engage the main housing in first and second positions. The obturator opening is axially aligned with the obturator insertion opening and axially aligned with the needle in the first position. The tubing opening is axially aligned with the obturator insertion opening and in fluid connection with the needle in the second position.

Abstract: Embodiments of the invention disclose a system for controlled oral drug delivery. The system comprising a removable device comprising a drug to be delivered, wherein the drug is delivered based on osmotic pressure generated in the removable device. Further, the system comprises a receptacle to hold the removable device in an oral cavity, and a base station configured to dock the removable device for determining information about one or more characteristics of the removable device.

Abstract: A medical device system comprises a reservoir configured to store a therapeutic fluid and a medical pump configured to deliver the therapeutic fluid from the reservoir to a patient. The system also comprises a reservoir fill level detector configured to detect a fill status of the reservoir, the reservoir fill level detector including a contact pad operably attached to the reservoir whereby the contact pad moves in a predetermined path during the emptying and filling of the reservoir. A resistor strip mounted on the inside of the chamber is in continual contact with the contact pad and the resistance of an electric current passed through the resistor strip is monitored by a processor to determine the position of a selected portion of the reservoir. The position of the reservoir is directly related to the fill status.

Abstract: A method for directly delivering whereby a substance is introduced into an intradermal space within mammalian skin which involves administering the substance through at least one small gauge hollow needle having an outlet with an exposed height between 0 and 1 mm. The outlet is inserted into the skin to a depth of between 0.3 mm and 2 mm such that the delivery of the substance occurs at a depth between 0.3 mm and 2 mm.

Abstract: A catheter for collecting fluid such as blood from a vessel such as a coronary sinus of a patient has an elongated, flexible tubular portion and an annular sealing member spaced from a distal end of the tubular member. A proximal end of the tubular member is adapted to be connected to a source of suction for applying suction to a collection lumen of the tubular member. The distal end is placed in a blood vessel with the sealing member spaced from opposing surface of the vessel in an absence of a suction applied to the collection lumen. Suction is applied to the collection lumen in an amount sufficient to draw blood from the vessel through the fluid inlet and into the collection lumen and further sufficient to urge the opposing surface of the vessel to migrate into sealing engagement with the sealing member.

Abstract: A scalable parallel injector array has a support structure for holding injector tubes in a spatial pattern in order to enable delivery of fluidic materials simultaneously to a group of specific target areas in the brain or a body part. Each injector is individually connectible at one end to a displacement-controlled pump and is designed at the other end to be inserted into the brain or body part. The injector tubes are connected to the pump by fluid-filled tubing. The spatial pattern is patient- and/or application-customizable, and the length of the injector tubes is customizable in order to more precisely reach individual target areas. A clamping device may be used to attach the injector array to a stereotaxic arm or other support structure. The action of the pump permits controlled simultaneous delivery of the fluidic materials to the target areas.

Abstract: The present invention relates to a method for coating a surface of a substrate with a drug for sustained release: (i) providing a substrate with a surface to be coated, (ii) depositing at least one bilayer on at least a portion of said surface, wherein one layer of the bilayer comprises a polyelectrolyte and the other layer comprises a pharmaceutically active ingredient, and wherein the two layers of the bilayer are oppositely charged under conditions of the deposition and one layer of the bilayer has a substantially different net charge under physiological conditions. The invention also pertains to substrates with microscopic or macroscopic surfaces coated with the method according to the invention.

Abstract: In one aspect, the present invention provides therapeutic-agent-releasing medical devices which comprise at least one region of piezoelectric material. Therapeutic agent release is initiated or increased when the piezoelectric material is subjected to mechanical stress, which leads to the development of a voltage across the piezoelectric material. This voltage is used to initiate or increase therapeutic agent release.

Abstract: An insertion device for a fluid delivery device for delivering a therapeutic fluid to a body of a patient and/or for sensing of a bodily analyte is disclosed. The insertion device includes a housing and accommodated therein at least one penetrating cartridge provided with a penetrating member and with a subcutaneously insertable element; The insertion device is provided with a displacement mechanism which upon actuation is capable of protracting the penetrating cartridge towards the said device for delivery and/or sensing, wherein said protracting results in inserting of the penetrating cartridge into subcutaneous compartment of the body via an opening provided at the said device for delivery and/or sensing and said insertion device allows evacuation of the penetrating member from the subcutaneous compartment via the said opening.

Abstract: An infusion set includes a base with a rigid piercing cannula or a soft catheter and rigid introducer needle. The infusion set also includes a line set with a fluid connector. The base and line set are configured such that the fluid connector can be used as a protector for the piercing cannula or the soft catheter, either before the device is attached to a user, or after the device is detached from the user, or both.

Abstract: In various embodiments, a device for delivering pressurized irrigation may include a squeeze plate and a pressure sensor module. The squeeze plate may move relative to the pressure sensor module to apply pressure to a flexible container (e.g., a bag of irrigation fluid) between the squeeze plate and the pressure sensor module. The pressure sensor module may include a pressure sensor to measure a force exerted on the pressure sensor module by the flexible container as pressure is applied to the flexible container from the squeeze plate. In some embodiments, the pressure sensor module may include a bag contact plate and the pressure sensor may measure a force exerted on the bag contact plate by the flexible container located between the bag contact plate and the squeeze plate. In some embodiments, the pressure sensor may sense a pressure associated with the flexible container without an intervening bag contact plate.

Abstract: A syringe system and components thereof are disclosed. The system may include a syringe body having a hollow lumen, a proximal open end, and a distal end. The syringe body may be configured to house a fluid therein. The syringe system may further include a plunger positioned in the hollow lumen of the syringe body, forming a seal with an inner wall of the syringe body. The plunger may include a removable piston having a shaft extending from the distal end towards the proximal open end, a stopper removably connected to a distal portion of the shaft, and at least one coupler attached to the distal portion of the shaft. The stopper may be configured to slidably move within the hollow lumen to facilitate movement of the fluid within the syringe body. The coupler may be configured to facilitate removal and attachment of the stopper from the piston.

Abstract: A medical implant system is described for inhibiting infection associated with a joint prosthesis implant. An inventive system includes an implant body made of a biocompatible material which has a metal component disposed on an external surface of the implant body. A current is allowed to flow to the metal component, stimulating release of metal ions toxic to microbes, such as bacteria, protozoa, fungi, and viruses. One detailed system is completely surgically implantable in the patient such that no part of the system is external to the patient while the system is in use. In addition, externally controlled devices are provided which allow for modulation of implanted components.

Abstract: Devices and methods are provided for drug delivery. The device may include a housing configured for intralumenal deployment into a human or animal subject and a reservoir contained within the housing and having an actuation end and a release end. The release end may include at least one outlet. A first drug formulation and a second drug formulation may be disposed within the reservoir and adjacent to each other and immiscible, or separated from each other by a first barrier. The device may also include a plug within the reservoir at the actuation end, the plug being movable toward the release end to drive the first and second drug formulations out of the reservoir. The device may also include an actuation system operably connected to the actuation end of the reservoir and configured to drive the plug toward the release end and release the drug formulations from the reservoir.