Abstract: The present invention concerns an intravaginal delivery system, said system comprising at least one compartment comprising a core and a membrane encasing the core, wherein the core and the membrane essentially consist of a same or different polymer composition. Additionally the intravaginal delivery system comprises a coupling means to form a closed continuous delivery system. The present invention also concerns a method for manufacturing said intravaginal delivery system. The core and/or the membrane are preferably prepared by injection moulding or by extrusion.

Abstract: Devices and methods are provided for transmucosal drug delivery. The transmucosal drug delivery device may include a housing configured for intralumenal deployment, such as intravaginally, into a human or animal subject; a drug-dispensing portion which contains at least one drug, the drug-dispensing portion being configured to dispense the drug from the housing by positive displacement; and a permeability enhancer-dispensing portion configured to release or generate a permeability enhancing substance to disrupt at least one region of a mucosal barrier adjacent to the housing at a selected time while intralumenally deployed in the human or animal subject. The device may be operable to dispense the drug from the housing to a region of the mucosal barrier disrupted by the permeability enhancing substance.

Abstract: Devices and methods for transmucosal drug delivery are provided. A device includes a housing configured for intralumenal deployment into a human or animal subject; a drug-dispensing portion which contains at least one drug; and a plurality of microneedles extending, or being extendable from, the housing, the plurality of microneedles being configured to disrupt at least one region of a mucosal barrier adjacent the housing at a selected time after being intralumenally deployed in the human or animal subject. The device is operable to dispense the drug from the housing to a region of the mucosal barrier disrupted by the plurality of microneedles.

Abstract: A biomaterial mass is inserted through a punctum into a canaliculus in the lacrimal outflow system with a syringe. The mass has an outer cross section that is less than the inner cross section of the canaliculus. The mass absorbs liquid to swell to form a lacrimal filler or sealing mechanism. The lacrimal filler has an external cross section that conforms to the internal cross section of the canaliculus and a soft outer surface relative to the surrounding tissues to prevent erosion of the canaliculus lining. The lacrimal filler forms an occlusion that prevents the outflow of liquid through the lacrimal outflow system to retain tears within the eye to maintain eye lubrication and wetness. The mass and syringe are provided in kit with a rubber stopper and, optionally, a punctal dilator, an injecting catheter, and an enzyme for dissolving or degrading the lacrimal filler at a later time.

Abstract: This invention discloses methods and apparatus for providing pulsatile release of active agents via a punctal plug inserted into a punctum. A tube is provided which may be inserted into a cavity of a punctal plug. One or more pulsatile delivery units are arranged in a generally linear fashion within the tube. The pulsatile delivery units include a core comprising the active agent and an encapsulation layer around the core.

Abstract: A device that delivers one or more substances into a vaginal lumen according to one of a plurality of release patterns. The device comprises a supporting structure, substance dispensers, and/or coupling elements which are configured to release one or more substances, for example, drugs, in manner designed to optimize treatment of one or more medical conditions.

Abstract: An intrauterine system (1) for the retention of a biologically active compound within the uterus of a female mammal is formed by a frame (16) defining an interior space (20) for receipt of a deposit of the compound (22). The frame has an open structure (18) allowing access to a substantial part of an outer surface of the deposit and the deposit has a rate controlling structure that controls a rate of release of the compound within the Uterus. Retention elements (6) are provided on the frame for retaining the frame within the uterus.

Abstract: An insert (1) for treating human or animal body cavities, in particular ear cavities, comprises an operating element (2) which is located at one end of the insert intended to be introduced into the cavity and to come into contact with the internal walls of the latter, and is expandable from a radially compressed configuration, in which it may be introduced into the cavity without substantial interference with the internal walls, to a radially expanded configuration having a substantially larger cross-section relative to the compressed configuration, in which radially expanded configuration the operating element (2) is pressed against the internal walls of the cavity.

Abstract: A swallowable medical treatment device is configured to initially assume a contracted state having a volume of less than 4 cm3. The device includes a gastric anchor, which initially assumes a contracted size, and which is configured to, upon coming in contact with a liquid, expand sufficiently to prevent passage of the gastric anchor through a round opening having a diameter of between 1 cm and 3 cm. The device also includes a duodenal unit, which is configured to pass through the opening, and which is coupled to the gastric anchor such that the duodenal unit is held between 1 cm and 20 cm from the gastric anchor. Other embodiments are also described.

Abstract: A vaginal drug delivery system includes a device formed of porous material that holds a flowable therapeutic formulation. The device, preferably in a soft, prewetted state, is inserted into the vagina to reside typically at or near the cervix where it continuously releases the flowable therapeutic formulation through its outer surface which is in contact with the vaginal surfaces. In operation, the flowable therapeutic formulation migrates via capillary forces from a reservoir that is centrally located in the device and through a covering that envelopes the reservoir.

Abstract: Lacrimal implants for treating ocular diseases are disclosed. More particularly, lacrimal punctal plugs, methods of making such plugs, and methods of treating ocular diseases using such plugs are disclosed.

Abstract: Lacrimal implants and related methods providing secure, wedgable retention within a lacrimal punctum and associated canaliculus of an eye are disclosed. The lacrimal implants can comprise an implant body configured for at least partial insertion through the lacrimal punctum and into the canaliculus. The implant body can include first and second portions, and can extend from a proximal end of the first portion defining a longitudinal proximal axis to a distal end of the second portion defining a longitudinal distal axis. The implant body can be configured such that, when implanted using an integral dilator, an angled intersection exists between the proximal and distal axes. In this way, at least a portion of the implant body can be biased against at least a portion of the lacrimal canaliculus located at or more distal to a canalicular curvature, thereby retaining an implanted position of the lacrimal implant using anatomical structures.

Abstract: A device for application to a body cavity. The device is insertable into the cavity of a subject in need. The device includes a non-absorbable, flexible tube of an elongated shape, a removable core element situation within the tube, and a retention mechanism for maintaining the device within the cavity.

Abstract: The present disclosure relates to biodegradable intravaginal rings for the delivery of therapeutic or prophylactic agent, inter alia, antiviral agents. The present disclosure further relates to biodegradable polyurethanes which will allow therapeutic/prophylactic agents to be released in a controlled manner that will not degrade when in use, but will degrade upon disposal.

Abstract: A delivery tube assembly is provided, the delivery tube assembly including a delivery tube including a delivery tube attachment end, an open delivery tube second end opposite the delivery tube attachment end, an outer surface, and an inner surface defining a delivery tube cavity; and a dosage form including a therapeutic agent, wherein the dosage form is positioned within the delivery tube cavity. The assembly may also include an engagement mechanism positioned at the delivery tube attachment end. The assembly may also include a containment seal coupled to the delivery tube second end. The assembly may also include an inner containment seal positioned within the delivery tube cavity to seal the dosage form within the delivery tube cavity.

Abstract: The present invention relates to novel drug depot implant designs for optimal delivery of therapeutic agents to subjects. The invention provides a method for alleviating pain associated with neuromuscular or skeletal injury or inflammation by targeted delivery of one or more therapeutic agents to inhibit the inflammatory response which ultimately causes acute or chronic pain. Controlled and directed delivery can be provided by drug depot implants, comprising therapeutic agents, specifically designed to deliver the therapeutic agent to the desired location by facilitating their implantation, minimizing their migration from the desired tissue location, and without disrupting normal joint and soft tissue movement.

Abstract: A method and apparatus for an improved luer fitting connector, in one embodiment, has a luer fitting connector including a male or female luer fitting member and a locking member. The locking member may have at least one of a skeletal handle, a finlike handle, a cavity grip, and an undulating grip. The luer fitting connector also may include a male or female luer fitting member having a conical restraining surface and a locking member having a plateau shaped protrusion. A method of assembly of luer fitting connector members may include providing a male or female luer fitting member having a conical restraining surface and providing a locking member having a plateau shaped protrusion. The method also may include mounting the locking member upon the male or female luer fitting member from the rear.

Abstract: For applying medications in the form of active substances bound in a liquid or paste-like matrix in the ear canal, a means for absorbing and locally delivering a medication. The means includes a sack-like receptacle part in which a preferably textile tampon able to absorb the medication can be accommodated, and an elastic rubber retaining washer serving to fix the receptacle part in the outer ear. The receptacle part is firmly connected to a pulling device, such as a string, via the retaining washer. The retaining washer fixes the receptacle part in the outer ear canal and is thus supported on one side behind the anthelix and on the other side behind the tragus. In one embodiment, the retaining washer is made from a flat material stamped from foam rubber. The applicator can be sold with a charge of medication.

Abstract: A drug delivery device for the inner ear is described. A drug delivery member for the inner ear without any stimulation electrodes has an intra-cochlear portion that penetrates into the inner ear of the patient and contains a drug eluting polymer material having at least one therapeutic drug which is released over time in a therapeutically effective amount into fluid in the inner ear of the patient.

Abstract: There is provided a penetratable toothed fastener for clamping tissue during surgery. The toothed fastener includes first and second legs each having longitudinal rows of transverse teeth and a securing member configured to pass through the transverse teeth to hold first and second legs closed relative to each other and about tissue. A locking mechanism is provided to retain the securing member within the first and second legs of the toothed fastener. The toothed fastener additionally includes receptacles for the receipt of medicant materials and holes in the teeth to dispense the materials to clamped tissue.

Abstract: A stent comprises a flexible tube having a proximal end, a distal end, and a passageway extending from said proximal end toward said distal end. A first generally straight tube segment extends from the proximal end while a first generally curved segment extends from an end region of the first generally straight tube segment disposed away from the proximal end of the stent. A second generally straight tube segment extends from an end region of the first curved segment away from the first generally straight tube segment and is arranged at an acute angle relative to the first generally straight tube segment. A second generally curved tube segment extends from one end of the second generally straight tube segment and includes a channel on an exterior surface of the second generally curved tube segment.

Abstract: Lacrimal implants and related methods providing secure retention within the lacrimal punctum of an eye are described. The lacrimal implants can comprise a implant body configured for at least partial insertion through the lacrimal punctum and into a lacrimal canaliculus. The implant body can include a deformable retention structure that can be configured to substantially encapsulate an expandable retention element. In some examples, the expandable retention element can include a fluid absorbing material, which can be exposed to fluid such as via a fluid permeable retainer or a fluid permeable aperture. As the fluid absorbing material retains fluid (i.e., upon acceptance of fluid into the retention structure), its size increases and its shape can change to urge one or more portions of the retention structure outward, such as against a wall of the lacrimal canaliculus, thereby securely retaining the lacrimal implant within the punctum.

Abstract: Described here are delivery devices for delivering one or more implants to the body, and methods of using. The delivery devices may deliver implants to a variety of locations within the body, for a number of different uses. In some variations, the delivery devices have a cannula with one or more curved sections. In some variations, a pusher may be used to release one or more implants from the cannula. In some variations, one or more of the released implants may be a self-expanding device. Methods of delivering implants to one or more sinus cavities are also described here.

Abstract: A covering for delivering a substance or material to a surgical site is provided. The covering, with substance provided therein, may be referred to as a delivery system. Generally, the covering may be a single or multi-compartment structure capable of at least partially retaining a substance provided therein until the covering is placed at a surgical site. Upon placement, the covering may facilitate transfer of the substance or surrounding materials. For example, the substance may be released (actively or passively) to the surgical site. The covering may participate in, control, or otherwise adjust, the release of the substance.

Abstract: The aim of the invention is to provide an implant for releasing an active substance into a vessel through which a body medium flows. This aim is achieved by the inventive implant for releasing an active substance into a vessel through which a body medium flows. Said implant comprises a base that consists of a biodegradable material as the carrier of the active substance to be released. The body medium flows around said base on the inside and/or outside thereof.

Abstract: Systems and methods are described for implementing or deploying medical or veterinary utility modules comprising a first module operable in a digestive or respiratory tract to engage a second module, optionally by a magnetic field. Alternatively or additionally, systems may be operable to remain in situ and also operable to permit a therapeutic material dispensation. In some contexts, for example, systems or methods may dispense a therapeutic material via a subject's throat or elsewhere in the digestive or respiratory tract.

Abstract: A catheter assembly including a foldable internal bolster. According to one embodiment, the catheter assembly includes a catheter, a first flexible filament and a second flexible filament. The catheter includes a tubular body and a pair of flexible legs. The tubular body is a generally cylindrical member shaped to include a proximal end, a distal end, a longitudinal lumen, a pair of external notches, a first bore extending from the proximal end to one of the notches, and a second bore extending from the proximal end to the other of the notches. Each of the flexible legs has a fixed end and a free end, the fixed end being integrally formed on the distal end of the tubular body. One end of the first filament is fixed to one of the flexible legs, and the opposite end of the first filament is slidably inserted up through the first bore. One end of the second filament is fixed to the other of the flexible legs, and the opposite end of the second filament is slidably inserted up through the second bore.

Abstract: An ophthalmological device comprises an implant member carrying an antifibrotic agent that is released slowly over a prolonged period when inserted into a wound in an eye produced by surgery. The member is placed in the vicinity of a wound created during the surgery to inhibit inflammatory cell proliferation, thereby preventing the growth of fibrous tissue after the eye surgery.

Abstract: Featured are devices for delivering a treatment medium to an eye as well as methods related thereto. Such devices and methods allow a desired amount of the treatment medium to be delivered in a controllable manner over a predetermined time period. In particular embodiments, the delivery device is configured and arranged so the treatment medium is eluted from one portion of the delivery device and so that another portion thereof is removably secured within a natural opening or orifice in or proximal to the eye. In specific embodiments the another portion is configured and arranged so as to be removably secured within the natural opening comprising at least one punctum of an eye.

Abstract: Systems and methods are described for implementing or deploying medical or veterinary utility modules (a) operable for mooring at least partly within a digestive tract, (b) small enough to pass through the tract per vias naturales and including a wireless-control component, (c) having one or more attachment protrusions positionable adjacent to a mucous membrane, (d) configured to facilitate redundant modes of attachment, (e) facilitating a “primary” material supply deployable within a stomach for an extended and/or controllable period, (f) moored by one or more adaptable extender modules supported by a subject's head or neck, and/or (g) configured to facilitate supporting at least a sensor within a subject's body lumen for up to a day or more.

Abstract: A drug delivery system for an implantable medical device and methods for making and using the same. Embodiments include a housing of an implantable component of the medical device and one or more at least quasi-solid drug-delivery modules that retain an at least quasi-solid state if not a solid state. The drug-delivery modules and component housing are physically distinct, and as such, may be manufactured independently of each other. The independently-manufacturable drug delivery modules each carry a drug, while the component housing has an exterior surface with one or more recesses formed therein. Associated module(s) and recess(es) are correspondingly dimensioned so that each module may be securely retained within an associated recess via, for example, an interference fit such as by physical interlocking or by friction fit. When so retained in a housing recess, the drug-delivery module and surrounding exterior surface of the housing form a contiguous component surface.

Abstract: The invention is directed to marker delivery devices and methods of using such devices. The delivery devices embodying features of the invention include a delivery cannula with a discharge opening and a releasable plug disposed in the inner lumen of the delivery cannula so as to at least partially occlude the discharge opening. The releasable plug prevents ingress of tissue, body fluids and the like into the bore of the tube, and prevents the premature discharge of any markers proximal to the releasable plug from passing through the discharge opening before the distal end of the cannula is properly positioned at a desired location within a patient's body. The releasable plug preferably has an MRI detectable element. Preferably, at least one remotely detectable marker mass is provided in the inner lumen of the cannula proximal to the releasable plug.

Abstract: Treating of localized bacterial infection, comprising locally applying Taurolidine to the infection. A device for insertion into the body, the device comprising Taurolidine to render the device infection resistant. A medication for treating bacterial infections, comprising Taurolidine carried by one of: gels, liquid, thixotropic gels, colloidal mixtures, dispensal suspensions, injectable polymers, or a microparticle. A method for treating blood, comprising: removing blood from the body; treating the blood with Taurolidine; and returning the treated blood.

Abstract: Drug delivery devices, and methods of delivering pharmaceutically active agents to a target tissue within a body using such devices, are disclosed. One drug delivery device includes a body having an internal surface for disposing proximate a target tissue and a well having an opening to the internal surface. An inner core is disposed within the well. The inner core comprises a pharmaceutically active agent and a tunnel leading into the interior of the inner core.

Abstract: Intra-vaginal devices and methods are disclosed for a broad range of applications in the women's health field. The devices and methods provide for placement in the cervical region, and for transferring heat to a cervical region, a barrier contraception method, collection of menstrual fluid, and release of drugs and/or hormones intra-vaginally. The device also can address multiple women's health issues.

Abstract: A stent comprises a flexible tube having a proximal end, a distal end, and a passageway extending from said proximal end toward said distal end. A first generally straight tube segment extends from the proximal end while a first generally curved segment extends from an end region of the first generally straight tube segment disposed away from the proximal end of the stent. A second generally straight tube segment extends from an end region of the first curved segment away from the first generally straight tube segment and is arranged at an acute angle relative to the first generally straight tube segment. A second generally curved tube segment extends from one end of the second generally straight tube segment and includes a channel on an exterior surface of the second generally curved tube segment.

Abstract: A pharmaceutical delivery system that releases an active agent in a controlled manner for an extended period in the vaginal cavity to treat or cure ailments associated with the vaginal cavity or proximal areas. The delivery system includes an applicator which is composed of a high internal phase emulsion, allowing the delivery system to adhere to the mueosal surfaces of the body, primarily the lining of vaginal cavity. The delivery system can maintain the high internal phase emulsion at a temperature of 86° F. for at least one month, without decomposition or instability of the emulsion.

Abstract: A urethral suppository comprising a non-meltable base member sized to prevent insertion of the base member into the urethra, a non-meltable reinforcement projecting from the base member, and a meltable portion formed around a portion of the reinforcement. The meltable portion tapers along the reinforcement and is shaped for cooperating with the action of the periurethral musculature to retain the suppository within the urethra. A method of delivering one or more therapeutic agents to the female urinary tract, the method involving insertion of the urethral suppository into the urethra. A method for manufacturing a reinforced urethral suppository.

Abstract: A dispenser for delivering a suppository within a body cavity. The dispenser has two main components: a barrel and a plunger. The barrel includes a head, a foot, and a body having a length and extending between the head and the foot. The barrel further defines an axial passage disposed along substantially the entire length of the body beginning at the foot and ending proximate the head, and includes a side aperture providing external access through the body of the barrel to the axial passage at the head of the barrel. The plunger includes a nose, a tail, and a frame extending between the nose and the tail. The plunger is sized to travel within the axial passage of the barrel between a relaxed position and a compressed position, in which a suppository is ejected from the side aperture, upon actuation.

Abstract: An applicator for delivering pharmaceutical products or the like to a bodily cavity includes a barrel member having a distal end which is equipped with an opening. The applicator also includes a plurality of petals extending outwardly from the distal end in a generally axial direction. The petals cooperate with the opening so as to form a receptacle for releasably receiving a pharmaceutical product in the distal end of the barrel member. Each of the petals has a truncated flexible tip sized and shaped so as to engage a substantially central portion of the pharmaceutical product such that a large section of the pharmaceutical product extends outwardly beyond the petals so as to facilitate the release of the pharmaceutical product from the receptacle. The device also includes a plunger member for releasing the pharmaceutical product from the receptacle. In accordance with the present invention, the device can be packaged in a package together with the pharmaceutical product received in the receptacle.

Abstract: A ventilation tube has a tubular member with generally circular flanges at opposite ends. Each flange has a respective tab that is angled obliquely to the axis of the tubular member. The tabs are diametrically opposite, and angled in opposite senses. Each tab has straight non-cutting edges tangential to its associated flange, and an arcuate nose portion. Each flange (may be used either for grasping the ventilation tube, or for insertion into an incision in a tympanic membrane, thereby permitting the ventilation tube to be used reversibly.

Abstract: An apparatus for pumping fluid through tubing comprising a stop platen is disclosed. The stop platen is operatively arranged to depress a wall of the tubing along a section of a longitudinal axis of the tubing. The stop platen is narrower than the tubing along a transverse axis of the tubing. The invention further comprises a cabinet containing the stop platen, a door rotatably fixed to the cabinet, and locking means for preventing rotation of the door. The locking means are operatively arranged to be unlocked by a tubing occluder.

Abstract: The invention features a biologically pure culture of a newly identified single-celled organism Spiky Rotating Cells (SPR), methods to diagnose an SPR infection in a human patient, an instrument for collecting and detecting an SPR infection, and methods for treating an SPR infection.

Abstract: A tampon adapted to deliver a therapeutic agent includes a body having a proximal end and a distal end. The body includes an absorbency zone adjacent the distal end, wherein the absorbency zone includes absorbent material; an application zone adjacent the proximal end and spaced apart from the distal end; and a therapeutic agent positioned substantially within the application zone. A method produces a device for delivering a therapeutic agent. The method includes manufacturing a tampon having a body with a distal end, a proximal end, an absorbency zone adjacent the distal end, and an application zone adjacent the proximal end; and locating a therapeutic agent substantially within the application zone.

Abstract: A formulation effective in reducing the pH in a menstruating vagina or in a tampon inserted therein to below pH 5.5, comprising (a) 3-80% by weight of a solid organic acid polymer; (b) 92-15% by weight of a solid organic acid, and (c) 5-30% of a wetting agent. Also disclosed is a delivery system for releasing an active agent comprising: (a) a deposition comprising the active agent; and (b) a polymeric support on which the deposition is deposited. The delivery system is especially useful in a catamenial tampon for insertion in a human vagina which comprises (a) an inner core comprising an absorbent material; (b) an outer layer comprising a liquid permeable material; and (c) the delivery system.

Abstract: An absorbent personal care device, such as an interlabial pad, tampon, sanitary pad or liner, or incontinence product adapted to deliver a therapeutic agent to the vaginal epithelium for systemic and topical treatment, the tampon including absorbent material and a formulation including a therapeutic agent, wherein the therapeutic agent is a botanical. The botanical may be, but is not limited to, Agnus castus, aloe vera, comfrey, calendula, dong quai, black cohosh, chamomile, evening primrose, Hypericum perforatum, licorice root, black currant seed oil, St. John's wort, tea extracts, lemon balm, capsicum, rosemary, Areca catechu, mung bean, borage seed oil, witch hazel, fenugreek, lavender, soy, heath, cranberries, blueberries, azaleas, red onion skin, short red bell peppers, long red bell peppers, beet root extract, capsanthin, whortleberry, lingenberry, chokeberry, sweet rowan, rowanberry, seabuckhrouberry, crowberry, strawberries, or gooseberries.

Abstract: An absorbent device configured for partial disposition within the vestibule of a wearer, and adapted to deliver a therapeutic agent, the device including a fluid-absorbent body having an application region for projection within the vestibule; and a formulation including a therapeutic agent positioned substantially within the application region. Also, a method for producing an absorbent device configured for partial disposition within the vestibule of a wearer, and adapted to deliver a therapeutic agent, the method including manufacturing an absorbent device having a fluid-absorbent body having an application region for projection within the vestibule; and locating a formulation including the therapeutic agent substantially within the application region.

Abstract: The present invention relates to a diagnostic method used to indicate the migration of a medicament through the digestive apparatus and resorption during this migration, with the use of a negative MRI-contrast agent and a positive contract substance, introduced into gelatin capsules. The gelatin capsules are arranged as inner capsules in a common outer capsule, which is provided with barium sulphate in such an amount, relative to the specific gravity of the contents of the stomach, so that the capsule will be able to sink through the contents of the stomach and reach the small intestine without a substantial time-delay. The invention also relates to a diagnostic apparatus to carry out the diagnostic method.

Abstract: The control of fluid introduction into and out of body conduits such as vessels, is of great concern in medicine. As the development of more particular treatments to vessels and organs continues it is apparent that controlled introduction and removal of fluids is necessary. Fluid delivery and removal from such sites, usually referred to as irrigation and aspiration, using fluid exchange devices that control also need to be considerate of potential volume and/or pressure in the vessel or organ are described together with catheter and lumen configurations to achieve the fluid exchange. The devices include several electrically or mechanically controlled embodiments and produce both controlled and localized flow with defined volume exchange ratios for fluid management. The applications in medicine include diagnostic, therapeutic, imaging, and uses for the introduction or removal of concentrations of emboli within body cavities.

Abstract: An intra vaginal device which is of a variable geometry and which includes a silicone matrix impregnated with progesterone, the confirmation and content of the progesterone impregnated matrix being such as to optimize effectiveness with a lower initial loading of progesterone.