Abstract: A method of coating a microneedle array by applying a coating fluid using a flexible film in a brush-like manner. A method of coating a microneedle array comprising: providing a microneedle array having a substrate and a plurality of microneedles; providing a flexible film; providing a coating solution comprising a carrier fluid and a coating material; applying the coating solution onto a first major surface of the flexible film; performing a transfer step of bringing the first major surface of the flexible film into contact with the microneedles and removing the flexible film from contact with the microneedles; and allowing the carrier fluid to evaporate.

Abstract: A method of reducing infections associated with vascular access procedures. A powder containment device (PCD) is preferably adhesively attached to a skin area, the PCD having a hole formed centrally therethrough adapted to completely surround the catheter wound site. The open cavity formed by the PCD being attached to the skin is filled with a hemostatic agent of a salt ferrate and an insoluble cation exchange material. The salt ferrate combines with blood to form a trivalent Fe+++ ion promoting blood clotting and producing oxygen at the wound site for bacteria reduction. The cation exchange material also forms a protective cover over the wound site as the trivalent Fe+++ ion is formed. Semi-occlusive pressure is applied against the hemostatic agent for a time sufficient to arrest blood flow from the wound site right after inserting or removing the catheter. The PCD and hemostatic agent are then covered with an adhesive dressing.

Abstract: A method of extravasated drug delivery is disclosed, including inserting a catheter with a first balloon, a second balloon, and a third balloon positioned between the first and second balloons and having a wall with an abrasive outer surface, into a bodily cavity, inflating the first and second balloons to create a chamber therebetween, stimulating a flow of blood cells by inflating the third balloon until the abrasive outer surface abrades tissue, and delivering the agent to the chamber. A balloon catheter system is also provided including a balloon having a wall with an abrasive outer surface for abrading tissue, a catheter having a first lumen for supplying fluid to the balloon to inflate the balloon such that the abrasive surface stimulates a flow of blood cells, and a second lumen for supplying an agent to tissue.

Abstract: The device including a plurality of stratum corneum-piercing microprojections, and a solid coating disposed upon the microprojections, wherein the solid coating includes at least one beneficial agent and a biocompatible carrier is provided. The device is applied to the skin of a living animal (e.g., a human), causing the microprojections to pierce the stratum corneum and deliver an effective dose of the agent to the animal.

Abstract: A dermal, transdermal, mucosal or transmucosal delivery device includes a backing layer overlying an ingredient containing reservoir, and having a microprotrusion array attached thereto, a cover for the reservoir having at least one opening therethrough, an adhesive layer and a liner layer. Upon removal of the liner layer, the device may be placed over the desired area of the skin or mucosa and adhesively applied thereto allowing the ingredients to flow from the reservoir through the at least one opening to the skin or mucosa.

Abstract: Compositions that include microthreads are provided. The compositions can be fully or partially encased in a sleeve along at least a portion of their length and can include biological cells and, optionally, therapeutic agents. Also provided are methods for using the compositions to repair or ameliorate damaged or defective tissue, including cardiovascular tissue (e.g., the myocardium).

Abstract: The invention features methods, kits, and compositions for administering pharmaceutical compounds using microdermabrasion particles.

Abstract: A method and device for the diagnosis of gastrointestinal allergy. The method and the device expose a surface to at least one antigen at a fixed depth. The device includes an application point each having an antigen allowing for the application of the antigen to the surface at a fixed depth. The device may include multiple applications points each with an antigen for simultaneously applying the antigens to the surface.

Abstract: A method and device are described for applying a microprotrusion member (44) including a plurality of microprotrusions (90) to the stratum corneum with impact. The method and device are used to improve transport of an agent across the skin for agent delivery or sampling. The applicator (10, 60, 80) causes the microprotrusion member (44) to impact the stratum corneum with a certain amount of impact determined to effectively pierce the skin with the microprotrusions (90). The preferred applicator (10, 60, 80) impacts the stratum corneum with the microprotrusion member (44) with an impact of at least 0.05 joules per cm2 of the microprotrusion member (44) in 10 msec or less.

Abstract: An epicutaneous test plaster, which is intended for removable adhesion to a skin portion of a person subjected to testing, has a flexible carrier (10) with a medical adhesive layer (12) and a number of test chambers (31). The test chambers contain a filter element (17) for absorption of allergen and are oriented with their opening directed away from the flexible carrier (10). A removable cover layer (27, 32) extends over all the test chambers and the carrier (10) and is removably secured to them by means of the adhesive layer (12) of the carrier. According to the invention, the test chambers (31) are formed as separate chambers, which are each separately fixed to the carrier and which are made up of a number of different sub-layers (13, 17, 19, 20, 24, 26).

Abstract: Microneedle arrays are provided for use on a contoured or flexible tissue surface. In one embodiment, the microneedle array includes a plurality of microneedles, each having a base portion, a tip end portion distal to the base portion, and body portion therebetween; and a flexible substrate which comprises a plurality of apertures, each of which are defined by (i) a plurality of substrate elements which are integral with the base portions of the microneedles, and (ii) at least one spring element connecting at least two of the substrate elements. The spring element may include a curved element, such as a C-shaped, U-shaped, or S-shaped element. Apertures may be defined, for example, by two substrate elements, which connected to three or four spring elements. A skin patch is provided for therapeutic or diagnostic applications, which includes the microneedle array and an adhesive material.

Abstract: An infusion sleeve of an ultrasonic vibrating needle. The sleeve is collapsible and serrated or scalloped at a distal end. Fluid flows through a passage between the needle and the infusion sleeve in a direction from the proximal end of the sleeve to a distal end of the sleeve. Upon reaching the distal end, the fluid emerges by flowing across valley formations that are between peak formations of the distal end of the infusion sleeve. The peak formations abut the exterior of the incision so that the fluid flow cools tissue at the incision and the needle.

Abstract: An apparatus and method for transdermally delivering a biologically active agent comprising a delivery system having a microprojection member (or system) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers. In one embodiment, the PTH-based agent is contained in a biocompatible coating that is applied to the microprojection member.

Abstract: The present invention relates to use of convertase inhibitors for the reduction of scarring during the healing of wounds and also for reducing fibrosis in the treatment of fibrotic conditions.

Abstract: An apparatus for the injection of therapeutic and other agents at a target site within a patient's body. A catheter including a first elongated shaft having a distal end and a proximal end and a lumen extending therebetween. The catheter also including a second elongated shaft slidingly disposed in the first elongated shaft, the second elongated shaft having a distal end and a proximal and a lumen extending therebetween. The catheter further including a third elongated shaft disposed in and attached to the second elongate shaft, the third elongated shaft to move in a one-to-one relationship with the first elongated shaft and the second elongated shaft to maintain a predetermined needle deployment length as each are subjected to various bend configurations.

Abstract: Microneedle arrays and drug delivery devices are provided for transdermally delivering a drug formulation to a patient. The microneedle array device includes a substantially planar substrate having an array of apertures; and a plurality of microneedles projecting at angle from the planar substrate, the microneedles having a base portion integrally connected to the substrate, a tip end portion distal to the base portion, and body portion therebetween, wherein each microneedle has at least one channel extending substantially from the base portion through at least a part of the body portion, the channel being open along at least part of the body portion and in fluid communication with at least one of the apertures in the substrate. In a preferred embodiment, each microneedle has a substantially rectangular cross-sectional shape and the channel is open to two opposing surfaces of the microneedle.

Abstract: Disclosed is an apparatus for the treatment of a wound on a patient. The apparatus is capable of administering localized negative pressure therapy to the wound using a negative pressure source and a drain line for removing exudate from the wound. The apparatus is also capable of administering localized hyperbaric fluid therapy to the wound using a fluid source and a supply line for supplying fluid to the wound.

Abstract: A shieldable unit dose needle assembly including a needle holding member, a unit dose needle, a shield in pivotal engagement with respect to the needle, and a collar providing pivotal engagement between the needle and the shield. The shield is pivotally movable between a retracted position and a shielded position in which a portion of the shield encompasses the unit dose needle for safety purposes. The needle holding member includes a distal end having a male tapering surface. The collar further includes a proximal end having a female tapering surface in engagement with the male tapering surface of the needle holding member.

Abstract: A dermal, transdermal, mucosal or transmucosal delivery device includes a backing layer overlying an ingredient containing reservoir, and having a microprotrusion array attached thereto, a cover for the reservoir having at least one opening therethrough, an adhesive layer and a liner layer. Upon removal of the liner layer, the device may be placed over the desired area of the skin or mucosa and adhesively applied thereto allowing the ingredients to flow from the reservoir through the at least one opening to the skin or mucosa.

Abstract: A method for manufacturing microabraders by machining a surface of a workpiece, each of the microabraders having a plurality of sides; for each of the microabraders the method comprising: (a) making a plurality of cuts into the surface, the plurality of cuts being in a required sequence around the plurality of sides to form a microabrader of a required shape; (b) the plurality of cuts being of progressively reducing depth such that a final cut is of a smallest depth of all the cuts; (c) the plurality of cuts, the required sequence and the progressively reducing depth being selected to provide material of the workpiece to support the microabrader until machining is completed.

Abstract: A device (10) and method for transporting fluids across biological barriers enhances penetration of a biological barrier by the use of directional insertion, preferably with asymmetric microneedles (18) and/or microneedles (18) with sharp edges. Additionally, or alternatively, adhesion followed by alteration of contact geometry is employed to stretch the biological barrier across the microneedles (18), thereby also enhancing penetration. Also disclosed is a device (10) and method which combine shallow penetration by hollow microneedles (18) with jet injection via the microneedles (18) to achieve a total liquid penetration depth greater than the mechanical penetration depth of the microneedles (18).

Abstract: The invention relates to a method of fabricating a microneedle array in a substrate, a drug delivery device comprising one or more microneedles extending upwards from the front surface of the substrate, the microneedles having a generally conical-shaped body defined by a plurality of surfaces sloping upwards from a relatively broad base to a tip, and one or more substances coating the microneedles, the one or more substances being operable to be administered to a patient, wherein the tips of the one or more microneedles are sufficiently sharp to penetrate an outer layer of the skin of the patient, and a method of administering one or more substances to a patient using the device.

Abstract: A device (100, 200) for superficial abrasive treatment of the skin includes a skin interface element (102, 202) with a number of protrusions (106, 206) projecting to a height above a substrate (104, 204) of no greater than 200 microns. A vibration generating mechanism (108, 208) is mechanically linked to the skin interface element (102, 202) so as to generate vibratory motion of the skin interface element (102, 202).

Abstract: A device for creating a plurality of small wounds in a patient's skin and introducing topically-applied substances therein is disclosed. The device comprises a rigid plate that has a top side, a bottom side, and at least one peripheral edge that connects the top and bottom sides. The device further includes a tool attachment means fixed with the top side of the plate and adapted to fix the device to a motorized tool that oscillates reciprocally back and forth along the longitudinal axis of the plate. A plurality of needles project generally orthogonally away from the bottom side of the plate. In use, the plate is fixed with the tool and the tool activated. The bottom side of the plate is then applied to the skin of the patient such that each needle repeatedly pierces same to create the plurality of small wounds therein. When the substance is applied to the skin first, each needle draws a portion of the substance into the skin with each oscillation of the tool.

Abstract: Methods and devices for augmenting bone, such as in performing vertebroplasty are disclosed. A bone cement injection needle is provided, having a laterally deflectable distal end. Systems are also disclosed, including the steerable injection needle, introducer and stylet. The system may additionally include a cement delivery gun, one-time use disposable cement cartridges and a cement mixing chamber. Methods are also disclosed.

Abstract: A vaccine delivered by transcutaneous immunization provides an effective treatment against infections by pathogens such as, for example, enterotoxigenic Escherichia coli (ETEC) and/or for symptoms of diarrheal disease caused thereby. For example, one, two, three, four, five or more antigens derived from ETEC and capable of inducing an antigen-specific immune response (e.g., toxins, colonization or virulence factors) and one or more optional adjuvant (e.g., whole bacterial ADP-ribosylating exotoxins, B subunits or toxoids thereof, detoxified mutants and derivatives thereof) are used to manufacture vaccines or to induce systemic and/or mucosal immunity.

Abstract: To treat body surfaces, such as the sinuses, which are coated with biofilms, the surface is irrigated and suctioned with a fluid which may contain a biocide or other chemical agent for disrupting the biofilm while ultrasonic energy is applied to either the fluid barrier formed over the biofilm or a body surface proximal to the biofilm. Action of the fluid enhanced by the ultrasonic energy tends to remove sections of biofilm which are suctioned out of the site. An electrical field may also be applied to the biofilm to enhance the disruptive action. Apparatus for practicing this method to treat chronic rhinosinusitis comprises an elongated tube adapted to be inserted into sinus cavities through the nose or mouth. The tube includes a first lumen which feeds an irrigating fluid containing biocides and/or biofilm-disruptive chemicals to the treatment site and a second lumen which suctions fluid from the site.

Abstract: The intervertebral disc is avascular. With aging, calcified layers occlude the cartilaginous endplates, blocking the diffusion of nutrients and oxygen into the avascular disc. Under anaerobic condition, excessive production of lactic acid irritates nerves and further hinders transport of sodium sulfate essential for biosynthesis of the water retaining and load sustaining sulfated glycosaminoglycans. As the result of acid irritation and load shifting to facet joints, pain ensues. Through the pedicle, calcified endplate is punctured by a well-supported and elastically curved needle, injecting antacid to neutralize the lactic acid and enhance transport of sodium sulfate into the shielded discs between ilia. Disc filler or nutrients can also be injected through the curved needle into the degenerated disc.

Abstract: A wound dressing or bandage that provides a galvanic current for extended periods of time before having to change the dressing or bandage is addressed in the present invention. The present invention is directed to a galvanic current wound dressing having antimicrobial properties and to a method for treating a patient with the wound dressing.

Abstract: A device includes a plurality of microneedles for abrading the stratum corneum of the skin to form a plurality of grooves in the tissue having a controlled depth and width. The microneedles have a length of about 5-250 microns and generally about 5-200 microns. The device is rubbed over the skin to prepare an abraded site after which a transdermal delivery or sampling device is applied to the abraded delivery site. The abrasion increases the permeability of the skin and the rate of delivery and extraction of a substance without pain or irritation to the patient.

Abstract: A tissue cutting device is disclosed, which is structured and arranged to be inserted through the vascular system into a body vessel adjacent to the heart and/or into the heart, and to be subsequently subjected to a change of shape in order to penetrate into the heart tissue. The tissue cutting device may thus be used for treating disorders to the heart rhythm regulation system. A kit of devices provides a plurality of devices for creating a lesion pattern for treating such disorders.

Abstract: Topical compositions having as the active ingredient a lipid, fatty acid ester, natural wax, sterol, or combinations thereof referred to herein as “lipophilic vehicle” or “LV” and methods of use, have been developed for the amelioration or prevention of pain or the sequelae of pain. The composition may be in the form of an ointment, cream, gel, lotion, spray, foam, paste, patch, suspension or dispersion. In the preferred embodiment, the formulation is a gel. The LV may contain a penetration enhancer, most preferably one with membrane disruptive properties. The formulation may be applied to or impregnated into a gauze, wrap, bandage, cotton-tipped stick, adhesive bandage strip, or other support wrap or medical bandage or wound cover. For example, the compositions may be are incorporated onto or into disposables such as hemorrhoid wipes, sponge, mouth guards, dental trays; needles or catheters; adult diapers; gloves, socks or wrist bands, for ease of application.

Abstract: An apparatus for transdermally delivering a nicotine-based agent to a tobacco or nicotine user comprising a microprojection member having a plurality of microprojections that are adapted to pierce the stratum corneum of the tobacco user, the microprojection member having a biocompatible coating disposed thereon that includes a nicotine-based agent.

Abstract: A skin attachment member having first and second surface with a plurality of skin penetrating elements extending integrally from the first surface of the backing to a distal tip. The skin penetrating elements are sized to avoid contact with nerves below the epidermal skin layer and have a foam disposed between at least some of the skin penetrating elements. A method of using the skin attachment member to deliver a pharmaceutical composition through the skin.

Abstract: A microneedle array having a substrate and a plurality of microneedles extending out from the substrate with a multi-phase matrix coating on at least a portion of the microneedle surface of the microneedle array. The multi-phase matrix coating comprises an active substance and has a first solid phase and a liquid phase. The first solid phase comprises a water-soluble polymer. Also, a method of providing an active substance- containing matrix coating on a microneedle array in which a water-soluble polymer is applied to the microneedle surface of the array to form a dried coating of water-soluble polymer. A coating solution comprising an active substance, a liquid capable of phase separating from the water-soluble polymer, and a carrier fluid is prepared and applied to the dried coating of water-soluble polymer. At least a portion of the carrier fluid is removed from the array.

Abstract: An abrader device for delivering a substance into skin via an abrasion process includes a housing adapted to be pressed against the skin at a desired delivery site, an applicator head disposed in an upper opening of the housing and movable across a lower opening of the housing to abrade the delivery site in at least one furrow, and an abrader surface attached to the applicator head whereby the housing remains firm and stationary at the delivery site and structure of the housing and the applicator head controls parameters of the abrasion process. In particular, the amount of force or pressure applied to the abrader surface, the speed at which the abrader surface moves across the skin and the number of lateral passes of the abrader surface across the skin are controlled so that the abrader device provides a furrow with a length of substantially the same depth thereby providing reproducible results, even though different technicians are applying the abrader device against a patient's skin.

Abstract: Coated microneedle devices and methods of making such devices are provided. In one aspect, a method for coating includes providing a microstructure having at least one surface in need of coating; and applying a coating liquid, which comprises at least one drug, to the at least one surface of the microstructure, wherein the surface energy of the coating liquid is less than the surface energy of the surface of the microstructure. The coating liquid may include a viscosity enhancer and surfactant. Microneedles having heterogeneous coatings, pockets, or both are also provided.

Abstract: A method and device are described for applying a microprotrusion member (44) including a plurality of microprotrusions (90) to the stratum corneum with impact. The method and device are used to improve transport of an agent across the skin for agent delivery or sampling. The applicator (10, 60, 80) causes the microprotrusion member (44) to impact the stratum corneum with a certain amount of impact determined to effectively pierce the skin with the microprotrusions (90). The preferred applicator (10, 60, 80) impacts the stratum corneum with the microprotrusion member (44) with an impact of at least 0.05 joules per cm2 of the microprotrusion member (44) in 10 msec or less.

Abstract: A phacoemulsification needle 10 includes an elongated lumen 12, a hub 14, and a rigid sleeve 16 concentrically formed around at least a majority of the lumen 12. The sleeve 16 is attached to the hub 14. An irrigation fluid path 24 is formed between the sleeve 16 and lumen 12 and a portion of the path 24 is also formed in the hub 14 for carrying irrigation fluid from a source through the path 24 to a patient's eye during surgery.

Abstract: An infusion sleeve of an ultrasonic vibrating needle. The sleeve is collapsible and serrated or scalloped at a distal end. Fluid flows through a passage between the needle and the infusion sleeve in a direction from the proximal end of the sleeve to a distal end of the sleeve. Upon reaching the distal end, the fluid emerges by flowing across valley formations that are between peak formations of the distal end of the infusion sleeve. The peak formations abut the exterior of the incision so that the fluid flow cools tissue at the incision and the needle.

Abstract: The present invention provides a production process for obtaining a pad base for endermism capable of administering a drug in the skin without vibration. One side end of a thin metal wire is immersed in a solution containing a synthetic resin raw material in a lengthwise direction, the synthetic resin raw material solution adheres to a periphery of the thin metal wire, the synthetic resin raw material solution is hardened and then the thin metal wire is pulled out. The resulting minute needle is a hollow tubular body and the outer wall thereof is thickened toward the bottom. The minute needle is installed upright on the skin side of a patch base, and a drug in the hollow portion of the minute needle is injected in the skin and can be provided for endermism.

Abstract: An infusion medium delivery system, device and method for delivering an infusion medium to a patient-user, includes a needle inserter device and method for inserting a needle and/or cannula into a patient-user to convey the infusion medium to the patient-user. The needle inserter device and method operate to insert a needle and cannula into a patient-user's skin and automatically withdraw the needle from the patient-user, leaving the cannula in place and in fluid flow communication with a reservoir. The delivery device may include a base portion and a durable portion connectable to the base portion, and wherein the base portion can be separated from the durable portion and disposed of after one or more specified number of uses. The base portion supports the reservoir and the needle inserter device, while the durable portion supports a drive device for selectively driving the infusion medium out of the reservoir and into the needle and/or cannula.

Abstract: An abrasion device and method for delivery of substances into the skin using a microabrader for delivering a substance into the skin are disclosed. An abrasion device with a cover is also disclosed. Such devices and methods can be effectively used to deliver bioactive substances into skin.

Abstract: Improved microprotrusion abrasion devices having fluid retaining or directing patterns, and specific design parameters and method for delivery of substances into the skin. Various configurations of such devices are disclosed, including domed, channeled, patterned and stepped.

Abstract: A dressing having a flexible sleeve shaped to accommodate a substantially cylindrical body or plant portion, the sleeve having a lining which is substantially non-adherent to the body or plant part being bandaged and having a peripheral securement means which attaches two peripheral portions to each other without those portions being circumferentially adhered to the sleeve portion.

Abstract: A solid drug perforator (SSP) system and an associated drug reservoir are provided for delivering theraputic, prophylactic and/or cosmetic compounds, for nutrient delivery and for drug targeting. For drug delivery, the SSP system includes an active drug ingredient and a matrix of perforator material that biodegrades or dissolves quickly upon contact with a patient's body. The SSP system provides a skin barrier perforator and a controller for prompt initiation and cut-off of drug delivery. In a preferred method of transdermal drug delivery, an SSP system containing a selected drug penetrates into an epidermis or dermis, and the drug is promptly released from the (dissolving) SSP system perforator. An additional drug is optionally delivered from a patch reservoir through skin pores created by insertion of the perforator. Formulation and fabrication procedures for the SSP and associated reservoir are also provided. An SSP system can be fabricated with variety of shapes and dimensions.

Abstract: A solid drug solution perforator (SSP) system and an associated drug reservoir are provided for delivering therapeutic, prophylactic and/or cosmetic compounds, for nutrient delivery and for drug targeting. For drug delivery, the SSP system includes an active drug ingredient and a matrix of perforator material that biodegrades or dissolves quickly upon contact with a patient's body. The SSP system provides a skin barrier perforator and a controller for prompt initiation and cut-off of drug delivery. In a preferred method of transdermal drug delivery, an SSP system containing a selected drug penetrates into an epidermis or dermis, and the drug is promptly released from the (dissolving) SSP system perforator. An additional drug is optionally delivered from a patch reservoir through skin pores created by insertion of the perforator. Formulation and fabrication procedures for the SSP and associated reservoir are also provided. An SSP system can be fabricated with variety of shapes and dimensions.

Abstract: A method and device for the delivery of a substance into skin via the rotational movement of a microabrader device reduces the effects of operator variability. The method includes applying a substance to an area of a patient's skin through the rotational movement of microprotrusions which may be imparted by a spring device present in the microabrader device or the motion of the operator through the handle of the microabrader device. The device may further include system and methods for monitoring pressure of the device against the skin and thereby promote consistency between applications and control of penetration depth. The delivered substance may be placed on the microprotrusions and a reconstituting liquid included in the microabrader device.

Abstract: A transdermal drug delivery device for forming a micropore in a tissue membrane of an animal comprising a substrate and a porator that is located on or within the substrate. The porator is constructed of a material that is destroyed upon forming the micropore. The transdermal drug delivery device also comprises at least one reservoir and a controller for controlling the formation of said micropore by the porator and destroying the porator after the formation of the micropore.

Abstract: A method and device are described for applying a microprotrusion member (44) including a plurality of microprotrusions (90) to the stratum corneum with impact. The method and device are used to improve transport of an agent across the skin for agent delivery or sampling. The applicator (10, 60, 80) causes the microprotrusion member (44) to impact the stratum corneum with a certain amount of impact determined to effectively pierce the skin with the microprotrusions (90). The preferred applicator (10, 60, 80) impacts the stratum corneum with the microprotrusion member (44) with an impact of at least 0.05 joules per cm2 of the microprotrusion member (44) in 10 msec or less.