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: A device for delivering a substance into the skin of a patient includes a body and a skin penetrating device having at least one skin penetrating member, such as a microneedle. The body includes an internal cavity and a device for indicating the delivery of a sufficient amount of the substance to the patient and for producing a dispensing pressure to dispense and deliver the substance from the cavity. The indicating device is visible from the exterior of the delivery device. In some embodiments, the indicating device is an elastic expandable diaphragm which, when the cavity is filled with a substance, creates the dispensing pressure.

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 medicament respiratory delivery device including a housing formed of opposed thermoformed polymeric sheets bonded together having formed therebetween a chamber having a medicament cartridge encapsulated between the sheets, an inlet aligned with a passage through the cartridge having a pierceable closure and an outlet aligned with the passage outlet having a burstable membrane. The device includes a pressure actuator formed as a blister between the sheets and a piercing element having a bow-shaped actuator portion and a shaft which pierces the pierceable closure upon actuation of the pressure actuator, delivering fluid under pressure to the cartridge passage, rupturing the membrane and expressing the medicament.

Abstract: A method for using a needle assembly for an intradermal injection, and a drug delivery device is provided, which includes a needle cannula and a limiter surrounding the needle cannula and includes a skin engaging surface on the limiter. The limiter is moveable from a first position in which an elongate portion of the needle cannula is exposed for access to a medication vial, to a locked second position in which the limiter is not movable from the second position to the first position. In the second position, the needle tip extends beyond the skin engaging surface a distance of about 3 mm or less.

Abstract: A system and method for a patch-like, self-contained substance infusion device which provides one or more substantially hidden patient needles which can be placed in fluid communication with a fluid reservoir subassembly that includes a rigid bladder portion used in conjunction with a non-distensible bladder film, such as a metallized film. Simple removal of an interlock allows a disk, or Belleville spring assembly to apply an essentially even and constant pressure to the contents of the fluid reservoir assembly, and allows the device to then be attached to a skin surface via an adhesive contact surface. A push button activation assembly is provided which can then be used to release and seat one or more spring-loaded patient needles into the skin surface, and establish a fluid communication path between the patient needles and the pressurized fluid reservoir contents thereby delivering an infusion into the skin.

Abstract: An intradermal needle comprising a needle cannula assembly having a limiter portion, a hub portion and a needle cannula, a protective cap having a forward and rearward cap to protect and shield a needle cannula prior to and after use, and means for engaging the needle cannula assembly and the rearward cap after use. The mated forward and rearward cap provide a sterile enclosure for the needle cannula assembly prior to use. Removing the rearward cap permits the needle cannula assembly to be coupled to a drug delivery device, while the forward cap removably shields the needle cannula. Removing the forward cap then exposes the needle cannula for use. After use, the distal end of the needle cannula assembly is placed into the rearward cap and lockingly engaged therewith.

Abstract: A fluid delivery device for delivering a substance to a patient by way of infusion delivers the preparation at a rate of flow which varies in steps from a substantially constant higher rate, to a stepped-down substantially constant lower rate or rates. The delivery device includes one or more reservoirs, and one or more Belleville springs for applying generally constant pressures to the substance contained in the reservoirs. Each reservoir will have a different constant pressure applied in a mid-range of operation. The reservoirs can be interconnected to each other and to an infusion device in a number of arrangements, including various manifolds and flow restrictors, such that the rate of flow is controlled in steps in accordance with the pressures applied by the springs of the plurality of reservoirs.

Abstract: The present invention relates to an apparatus and method for intradermally administering a pharmaceutical composition or other substance into and through the skin of a mammalian body in a manner that avoids or eliminates excess pain and discomfort normally caused as a result of the microabraders or microneedles entering the epithelial layers beneath the stratum corneum. In a preferred embodiment, the apparatus is a microdevice with an array of microabraders or microneedles with a manipulating member.

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 delivery device for delivering a substance intradermally into the skin of a patient including a housing for contacting the surface of the skin and a disposable cartridge to be received in the housing. The cartridge includes an internal reservoir containing a substance to be delivered to the patient, a plurality of micro skin penetrating members and a fluid channel extending between the micro skin penetrating members and the reservoir. The housing includes a bottom wall with a central opening and a cover member. The cartridge is positioned in the housing with the micro skin penetrating members extending through the central opening of the bottom wall and positioned on the surface of the skin of a patient. The cover is closed onto the cartridge to dispense the substance from the cartridge through the micro skin penetrating members and into or through the skin of the patient.

Abstract: Methods for filling and sealing containers having one or more flexible sides. Non-standard containers for holding fluid are releasably supported during the filling and sealing process. Both the interior and exterior of the filled container are subjected to an environment of reduced pressure to minimize the headspace and sealed.

Abstract: A device for delivering a substance into the skin of a patient includes a body and a skin penetrating device having at least one skin penetrating member, such as a microneedle. The body includes an internal cavity and a device for indicating the delivery of a sufficient amount of the substance to the patient and for producing a dispensing pressure to dispense and deliver the substance from the cavity. The indicating device is visible from the exterior of the delivery device. In some embodiments, the indicating device is an elastic expandable diaphragm which, when the cavity is filled with a substance, creates the dispensing pressure.

Abstract: A needle assembly for an intradermal injection device, and a drug delivery device, which includes a needle cannula and a limiter surrounding the needle cannula and includes a skin engaging surface on the limiter. The limiter is moveable from a first position in which an elongate portion of the needle cannula is exposed for access to a medication vial, to a locked second position in which the limiter is not movable from the second position to the first position. In the second position, the needle tip extends beyond the skin engaging surface a distance of about 3 mm or less.

Abstract: A method of producing a tubular device is provided. The method comprises providing a tubular stock having an axial passage, heating the tubular stock at a first heating location to form a softened section, the softened section separating a workpiece portion of the tubular stock from a remaining portion of the tubular stock, and drawing the workpiece portion away from the remaining portion to elongate the softened section and separate the workpiece portion from the remaining portion to form the tubular device. The drawing is performed at a rate such that the tubular device has an axial passage having a substantially uniform inside diameter, and an end of the tubular device formed from the elongated softened section is tapered.

Abstract: An intradermal delivery device for use in intradermally injecting substances into the skin of an animal includes a needle cannula supported by a hub portion that is attachable to a prefillable container. A limiter portion surrounds the needle cannula and extends away from the hub portion toward a forward tip of the needle cannula. The limiter portion includes a skin engaging surface extending in a plane generally perpendicular to an axis of the needle cannula. The skin engaging surface is received against skin of an animal to administer an intradermal injection. The forward tip extends beyond the skin engaging surface a distance that enables penetration of the needle cannula into the dermis layer of the skin of the animal enabling injection of the substance into the dermis layer of the animal. The device includes enclosure means that is moveable for concealing the needle cannula after the injection has been administered.

Abstract: An apparatus for delivering or withdrawing a fluid through at least one layer of the skin is provided. A device includes a body having a top face, a bottom face, a side edge and at least one channel. The bottom face includes a first surface area and a second surface area adjacent to and recessed at a first distance from the first surface area. The bottom face further includes at least one raised protrusion disposed on the second surface area. The protrusion has a height from the first surface greater than the first distance. At least one dermal-access member is provided in the protrusion and is in fluid communication with the channel to deliver or withdraw the fluid. The dermal-access member extends at least 1 mm from the protrusion. A mechanism drives the device against the skin at a calculated speed of about 6 m/s to about 18 m/s.

Abstract: A device, preferably a micro-device, is molded from a plastic material by injection molding, compression molding or embossing. A microabrader can be molded having microneedles for abrading the stratum corneum of the skin to form an abraded site in the tissue for enhancing drug delivery. The micro-device is molded using a mold assembly having a silicon molding surface. The silicon molding surface can include a recess corresponding to the desired shape and length of the microneedles. The silicon molding surface enables micron and submicron size features to be molded from polymeric materials without the polymeric material adhering to the mold surface. Micro-devices having molded features having micron and submicron dimensions can be rapidly produced without the use of a release agent.

Abstract: A medicament respiratory delivery device including a housing having a chamber including coaxially aligned inlet and outlet, a medicament cartridge located within the chamber having a passage therethrough and membranes sealing the passage having a burst pressure of less than 10 atmospheres, a manually actuatable fluid delivery device having an outlet in fluid communication with the chamber and a manually actuated valve located between the outlet of the fluid delivery device and the chamber inlet for delivery of fluid under pressure to the valve. The medicament respiratory delivery device of this invention may be utilized to deliver a controlled unit dose of an aerosolizable medicament on demand by first pressurizing a pressure chamber in the pressure delivery device upstream of the valve, then opening the valve to open the membranes and express the medicament through the chamber outlet.