Abstract: A system for the administration of a bisphosphonate to a subject comprises a bisphosphonate formulation and a microinjection device. In an embodiment, the bisphosphonate formulation includes ibandronate sodium. In some cases, the bisphosphonate formulation includes an excipient. The bisphosphonate formulation may be delivered to the subject subcutaneously, transdermally or intradermally.

Abstract: An apparatus that includes a nano-projection array and an application unit configured to displace the nano-projection array to thereby deliver a composition (e.g., vaccine) to a controlled depth within the skin. The nano-projection array includes nano-projections carried by a carrier substrate. The application unit includes a peripheral structure and a displaceable carrier. The nano-projection array can be disposed within the peripheral structure. Displacement of the displaceable carrier causes a corresponding displacement to the nano-projection array. The displacement of the displaceable carrier can be controlled. For instance the distance of displacement of the displaceable carrier can be controlled. A method or process for manufacturing the apparatus is also provided.

Abstract: A device for delivery of material or stimulus to targets within a body to produce a desired response, the targets being at least one of cells of interest, cell organelles of interest and cell nuclei of interest. The device includes a number of projections for penetrating a body surface, with the number of projections being selected to produce a desired response, and the number being at least 500. A spacing between projections is also at least partially determined based on an arrangement of the targets within the body.

Abstract: A needle array transdermal absorption sheet to be attached onto a skin for supplying a drug into the skin, includes: a plurality of needle portions each having a tapered shape, each of the needle portions including a needle having a conical or pyramidal shape and a body part which has a columnar shape and whose end surface is connected to a base of the needle; a sheet portion having a flat-plate shape; and a plurality of frustum portions each having a frustum shape, the frustum portions which are arranged on a surface of the sheet portion in a manner that perimeters of larger bases of adjacent frustum portions are in contact with each other on the surface of the sheet portion, and smaller bases of which are respectively connected to the body parts of the needle portions.

Abstract: A neural drug delivery system with fluidic threads implantable into tissue, including: a plurality of fluid delivery conduits configured to transport fluid and having an array of fluid delivery ports through which the fluid is selectively released; a plurality of port gates each including a mesh structure coupled to a corresponding fluid delivery port and coated with an electroactive polymer; a voltage source providing a conductive signal; and an interconnect network that carries the conductive signal to the port gates. In response of the electroactive polymer to the conductive signal, each port gate is selectively operable between a closed mode that prevents transfer of fluid through its corresponding fluid delivery port to the tissue, and an open mode that allows transfer of the fluid through its corresponding fluid delivery port to the tissue.

Abstract: Medical device (10) for delivering therapeutic material to a patient. The device comprises an access sheath (12) having a proximal section (18) extending to a distal section (20). A working lumen (22) is formed in the proximal and distal sections. The distal section has a plurality of side ports (48) formed therethrough in fluid communication with the working lumen. The distal section has a deflection section (42) actuatable to bend at an angle for positioning the side ports in the patient. A needle assembly (14) is configured to move within the working lumen between a retracted position and an extended position. In fluid communication with a central lumen is a plurality of needles (80). The needles are disposed within the access sheath in the retracted position and the needles extend through the side ports outwardly from the access sheath in the extended position.

Abstract: Provided is a drug delivery composition comprising at least one polymer and at least one active agent; wherein the active agent is present in crystalline form on at least one region of an outer surface of the composition and wherein active agent surface content is adjusted to provide a selected active agent release profile.

Abstract: Provided is a microneedle unit comprising a case having a space accommodating a fluid and a fluid channel through which the fluid is discharged, a microneedle coupled to a lower portion of the case, a base cover disposed at the lower portion of the case, having a hole through which the microneedle passes, and being vertically movable, a guide pin coupled to the base cover and configured to open and close the fluid channel, and an elastic member configured to impart a restoring force such that the base cover is moved upward by an external pressure and then returns downward again. Therefore, the microneedle unit, which is provided to deliver a fluid into the skin with no pain and no scar, can control injection of the fluid using the guide pin, and repeatedly and conveniently control injection of the fluid using the elastic member.

Abstract: The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood, from subjects, e.g., from the skin and/or from other tissues of the body. In some cases, the device may contain a substance transfer component such as needles or microneedles, which can be inserted into the skin or another organ to deliver and/or receiving fluid or other substances from the subject. In some embodiments, the device may include an activator constructed and arranged to insert one or more substance transfer components into the skin or other organ. In certain cases, the device may also include a storage chamber for receiving a fluid received from the subject.

Abstract: An apparatus is disclosed for storing and changing needles for connection with a medicament delivery device, comprising an inner housing, a reservoir disposed within the inner housing, and a needle holder disposed within the inner housing, for fluidly connecting a medicament container of the medicament delivery device with the reservoir. The apparatus also includes a plurality of patient needles displaceably disposed on the needle holder, and an outer housing displaceably disposed about the inner housing and providing a user interface to individually select one of the plurality of patient needles, connect the selected needle with the reservoir, expose the selected needle outside of the apparatus for injection, and store the selected needle.

Abstract: The present invention relates to a needle unit for injecting liquids such as medicine or tattooing pigment spread to a skin, into the skin, and a dermatological liquid injection apparatus using the same. The present invention includes a body unit including a driving device, a cam member rotated by the driving device, and a connecting member reciprocally driven by the cam member; a needle unit detachably mounted to a front end of the body unit; and a rubber member installed to the needle unit, for blocking blood and liquid mixture which are discharged from a skin of a patient and flow into the needle unit, from flowing to the body unit during a medical procedure.

Abstract: Provided is a microneedle device which protects microneedle, has an easily portable shape, is free from such problems as breakage of small needles in the step of puncturing the skin with the microneedle, and ensures appropriate skin puncture for administering a drug. By studying the relationship between a device to be pressed to the skin and the height of an elevation on the skin surface under the pressing and thus producing a device equipped with microneedle that are embedded in a concave part having a definite depth, the microneedle can be surely and easily inserted and punctured into the skin while avoiding such problems as breakage of the small needles of the microneedle. Thus, a microneedle patch formulation, which is easily portable and ensures convenient drug administration to the skin, can be produced.

Abstract: An applicator for treating skin, includes a housing, in which a device for perforating an area of skin is arranged, wherein the device for perforating the skin can be brought into contact with the area of skin through an opening in the housing. At least one device for disinfecting is additionally arranged in the housing, and the device for disinfecting acts upon the area of skin through the same opening. With the applicator, a particularly secure and simple handling can be achieved.

Abstract: A device is provided which is suitable for delivering at least one nanoparticle(s) to a subject. The device can be used to deliver a variety of nanoparticles, for example, therapeutic agents, directly through the outer layers of the skin without passing completely through the epidermis of the subject. Thus the device can be used to deliver therapeutic agents to a predetermined depth and avoid disturbing the pain receptors in the skin. Thus the device can be used to deliver agents, including therapeutic agents, in a non-invasive manner. A method of fabricating devices with associated nanoparticles is also provided.

Abstract: The present invention generally relates to systems and methods for delivering and/or withdrawing fluid from subjects, e.g., through the skin, including packaging associated with such systems. Certain aspects of the invention are generally directed to devices for withdrawing a substance from the skin and/or from beneath the skin of a subject, and/or for delivering a substance to the skin and/or to a location beneath the skin of a subject. In some embodiments, the devices may comprise one or more skin insertion objects, such as needles or microneedles. In some cases, the device also may comprise one or more vacuum chambers, e.g., having an internal pressure less than atmospheric pressure. In some aspects, the device may be contained within an environment able to assist with maintenance of such pressures.

Abstract: The present invention generally relates to systems and methods for delivering and/or receiving a substance or substances such as blood, from subjects, e.g., to the skin and/or from the skin. In one aspect, the present invention is generally directed to devices and methods for receiving blood from a subject, e.g., from the skin, using devices including a substance transfer component (which may contain, for example, one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In certain embodiments, substances may be received from and/or delivered to the subject with relatively little pain. The pain may be assessed, to for example, using pain scales such as the Wong-Baker FACES Pain Scale. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to receive blood from the subject.

Abstract: A production process for a microneedle arrangement and a corresponding microneedle arrangement as well as a use for it is disclosed. The process has the following steps: forming an etching mask in grid form, with grid bars with corresponding grid crossing regions and grid openings in between on a substrate; carrying out an etching process to form the microneedle arrangement on the substrate using the etching mask and removing the etching mask. The etching mask in grid form has at least some of the grid crossing regions flat reinforcing regions, which extend beyond the grid bars.

Abstract: A delivery device including a roller rotatably mounted on an axle, a reservoir, and at least one hollow needle positioned in the roller are in fluid communication with the reservoir, wherein as the roller rotates about the axle, contents of the reservoir pass through the at least one hollow needle.

Abstract: This is a Local Anesthesia Injection Cone. It is made of a very simple cone shaped piece of clear plastic with a flange on the tip of the cone where a Luer lock syringe can attach. There are a multiple tiny hypodermic needles protruding from the base of the cone. The number of needles would be directly proportional to the diameter of the device. It would be available in many sizes identified by the diameter of the base of the cone.

Abstract: A micro-needle roller (MNR) infusion system for transdermal delivery of active agents, skin-care products, and other topical formulations is described herein. The infusion system of the instant invention comprises a needle roller assembly with 0.25 mm needles enclosed in a housing with a vacuum line and a disposable cartridge having the active agent, the skin-care product or the topical formulation. The vacuum delivers the fluid and ensures that the skin is being pulled against the needle wheel surface to ensure that penetration of the needles is complete into the skin, simultaneously the fluid is flowing to the wheel and to skin as it rolls along with the outer housing of the tip cap assembly being occluded to the skin surface.

Abstract: Described are novel medical delivery devices that can be used to effectively distribute a medical agent to multiple sites within a tissue volume without requiring the device to be repositioned, including for example to distribute the medical agent within the nucleus pulposus tissue of a spinal disc. Also described are medical delivery devices configured to simultaneously remove fluid from the tissue volume into which a medical agent is being delivered, thus avoiding or otherwise decreasing any pressure build-up and facilitating an effective, uniform delivery of the therapeutic agent.

Abstract: A hypodermic needle, particularly for injecting a pharmaceutical substance into a human or animal body is disclosed. The needle provides a simple way of improving long-term use in a human or animal body. The hypodermic needle includes a tubular hollow body having a needle tip for introducing the hypodermic needle into the human or animal body, wherein the hollow body has a rigidity which is reducible by the influence of heat and/or moisture.

Abstract: A body fluid sampling or fluid delivery system includes a polymeric support and an array of polymeric microneedles coupled to the support, each of a microneedle having a height of 500 to 2000 ?m and a tapering angle of 60 to 90°. A plurality of polymeric microchannels are provided with being associated with a microneedle. The plurality of polymeric microchannels are integrally formed with the array of polymeric microneedles without bonding. At least one polymeric reservoir is coupled to the plurality of microchannels.

Abstract: The present invention is a Miniature Vein Enhancer that includes a Miniature Projection Head. The Miniature Projection Head may be operated in one of three modes, AFM, DBM, and RTM. The Miniature Projection Head of the present invention projects an image of the veins of a patient, which aids the practitioner in pinpointing a vein for an intravenous drip, blood test, and the like. The Miniature projection head may have a cavity for a power source or it may have a power source located in a body portion of the Miniature Vein Enhancer. The Miniature Vein Enhancer may be attached to one of several improved needle protectors, or the Miniature Vein Enhancer may be attached to a body similar to a flashlight for hand held use. The Miniature Vein Enhancer of the present invention may also be attached to a magnifying glass, a flat panel display, and the like.

Abstract: Provided is a microneedle device having a microneedle base and microneedles capable of piercing the skin and being from 300 ?m to 500 ?m in height disposed on the base, where at least a part of the surface of the microneedles and/or the microneedle base is coated with a coating agent containing an active ingredient and a coating carrier, and a blending ratio of the active ingredient and the coating carrier is 10:0.1 to 1:10. Also provided are methods for administering active ingredients efficiently and simply through the skin using the microneedle device.

Abstract: A method of coating projections on a patch, the method including, selecting a coating solution viscosity, the viscosity being selected to reduce the degree of capillary action between the patch and the coating solution and immersing at least part of tips of projections in a coating solution having the selected coating solution viscosity such that substantially only tips of the projections are coated.

Abstract: An applicator for a microprojection array is described. In one embodiment, the applicator comprises an energy-storing element. Application of force causes the compressed energy-storing element to extend or transition from first and second configurations, releasing stored energy to deploy a holding member in the application which is configured to hold an array of microprojections. In another embodiment, the applicator comprises an energy storing element with two stable configurations, a first stable configuration and second stable configuration. Application of force causes the energy-storing element to transition from the higher energy first stable configuration to the lower energy second stable configuration, releasing the difference in energies of the two states to deploy a holding member in the application which is configured to hold an array of microprojections.

Abstract: The present invention relates to a microneedle cap system to be mounted to a container containing an active substance. The system comprises a container cap unit and a microneedle unit, which, among others, allows the active substance to be delivered in a desired amount.

Abstract: A method and a drug delivery system for transdermally administering parathyroid hormone (PTH) in a pulsatile fashion are provided, where the drug delivery system comprises an array of microprojections each comprising PTH.

Abstract: The invention relates to a method of manufacturing of a microneedle array comprising the steps of selecting a soft production mold comprising a set of microscopic incisions defining geometry of the microneedles, said soft production mold being capable of providing the microneedle array integrated into a base plate; using a filler material for abundantly filling the microscopic incisions of the soft production mold thereby producing the microneedle array with pre-defined geometry integrated into the base plate; wherein for the filler material a water or alcohol based ceramic or polymer-ceramic slurry is selected. The invention further relates to a microneedle array, a composition comprising a microneedle array, a system for enabling transport of a substance through a barrier and a system for measuring an electric signal using an electrode.

Abstract: Disclosed are nanotopography-based methods and devices for interacting with a component of the dermal connective tissue. Devices include structures fabricated on a surface to form a nanotopography. A random or non-random pattern of structures may be fabricated such as a complex pattern including structures of differing sizes and/or shapes. Microneedles may be beneficially utilized for delivery of an agent to a cell or tissue. Devices may be utilized to directly or indirectly alter cell behavior through the interaction of a fabricated nanotopography with the plasma membrane of a cell and/or with an extracellular matrix component.

Abstract: A device for delivery of biologic materials, comprising: a cartridge having at least two cylinder bores for fluids to be delivered, wherein each cylinder includes an exit port for a fluid, a plunger within each cylinder for pushing the fluids out of the cylinder, a housing adapted to receive the cartridge, wherein the housing or cartridge includes an adaptor to receive and lock a manifold that operably connects to the exit ports of the cartridge, at least two toothed rams, wherein each toothed ram is at least partially within a cylinder bore, a trigger connected to the housing, wherein the trigger includes a toothed drive rack, a toothed wheel assembly that cooperates with the toothed drive rack and with the toothed rams, as well as methods of making the device, methods of using the device to treat discs, kits including the device.

Abstract: The present invention relates to an active transdermal drug delivery system performing transdermal drug delivery comprising of a patch capable of being attachable to the skin of the subject; at least one electrical energy power input; a plurality of converters/energy transducers configured for converting the electrical energy to different forms of energy; and a controller including a programmable microprocessor configured for providing the intensity, sequence, nature, and timing information for the different energies supplied and thereby providing activating signals to the said converters for the transdermal drug delivery by the said patch, and a method for performing transdermal drug delivery using said electronic patch.

Abstract: A micro-needle delivery device (1) comprises an active substance accommodating layer (17) having active substance accommodating chambers (20) therein, a drive substance accommodating layer (32) having drive substance accommodating chambers (35) therein aligned with the active substance accommodating chambers (20), an activating layer (45) having heating elements (48) aligned with the drive substance accommodating chambers (35) for heating a drive substance therein, and a micro-needle element (8) having a needle support layer (9) and a plurality of micro-needles (12) extending therefrom. A burstable first membrane (22) is located between and sealably secured to the micro-needle element (8) and to the active substance accommodating layer (17) for sealably closing the active substance accommodating chambers (20) at one end.

Abstract: The present invention generally relates to systems and methods for delivering and/or withdrawing a substance or substances such as blood or interstitial fluid, from subjects, e.g., from the skin and/or from beneath the skin. In one aspect, the present invention is generally directed to devices and methods for withdrawing or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a fluid transporter (for example, one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to withdraw blood from the subject. The device, or a portion thereof, may then be processed to determine the blood and/or an analyte within the blood, alone or with an external apparatus.

Abstract: The transdermal administration device of the present invention includes: a device body including a needle form body, which includes a plurality of microneedles formed on a surface thereof and is provided with a fluid passage hole through the front surface to a back surface thereof, and a medical fluid filling section for providing a medical fluid to the back surface of the needle form body; a stratum corneum peeling system; and a connection section for connecting the device body and the stratum corneum peeling system, where the stratum corneum peeling system is connected to the device body by the connection section such that the microneedles of the needle form body of the device body are positioned in an area of a skin surface in which a stratum corneum is peeled by the stratum corneum peeling system.

Abstract: A device for delivery of material or stimulus to targets within a body to produce a desired response, the targets being at least one of cells of interest, cell organelles of interest and cell nuclei of interest. The device includes a number of projections for penetrating a body surface, with the number of projections being selected to produce a desired response, and the number being at least 500. A spacing between projections is also at least partially determined based on an arrangement of the targets within the body.

Abstract: Transcutaneous immunization can deliver antigen to the immune system through the stratum corneum without physical or chemical penetration to the dermis layer of the skin. This delivery system induces an antigen-specific immune response. Use of skin-active adjuvants is preferred. Although perforation of intact skin is not required, superficial penetration or micropenetration of the skin can act as an enhancer; similarly, hydration may enhance the immune response. This system can induce antigen-specific immune effectors after epicutaneous application of a formulation containing one or more antigen and adjuvant. The formulation may initiate processes such as antigen uptake, processing, and presentation; Langerhans cell activation, migration from the skin to other immune organs, and differentiation to mature dendritic cells; contacting antigen with lymphocytes bearing cognate antigen receptors on the cell surface and their stimulation; and combinations thereof.

Abstract: The invention discloses a microneedle array chip comprising metal microneedles and a substrate, wherein the microneedle consists of a needle head with a tip at its top, a needle bar and a needle seat, and is fixed onto the substrate via the needle seat; and the needle bar of the metal microneedle, having a cylindrical or conical shape, is inclined toward the substrate at a preset angle, and the needle head has a conical shape, or the upper surface of the tip is an oval plane or oval ring plane parallel to the substrate or inclined toward it at a preset acute angle. The metal microneedles in the microneedle array chip of the invention have firm structures to avoid fracture, and have sharp tips to facilitate puncturing. The maximal puncturing depth of the microneedles is easy to adjust and control. The microneedles in the array have good uniformity, and are safe and reliable to use.

Abstract: A fluid delivery device includes an array of needles, each in fluid communication with a respective reservoir. Respective actuators are coupled so as to be operable to drive fluid from the reservoirs via needle ports. Each needle can have a plurality of ports, and the ports can be arranged to deliver a substantially equal amount of fluid at any given location along its length. A driver is coupled to the actuators to selectively control the rate, volume, and direction of flow of fluid through the needles. The device can simultaneously deliver a plurality of fluid agents along respective axes in solid tissue in vivo. If thereafter resected, the tissue can be sectioned for evaluation of an effect of each agent on the tissue, and based on the evaluation, candidate agents selected or deselected for clinical trials or therapy, and subjects selected or deselected for clinical trials or therapeutic treatment.

Abstract: Described here are devices, systems, and kits for delivering substances to tissues. The devices generally include one or more chambers (102) and a reservoir (108) within each chamber. The reservoir may locally deliver a microdose amount of a substance to a target tissue. In some variations, a microdose amount is used in early human studies, e.g., before a phase I clinical trial, to evaluate the effect of the substance on a target tissue, or to obtain pharmacokinetic or metabolic data. In other variations, a microdose amount is used to locally treat a medical condition. In yet other variations, a microdose amount is used to locally deliver a contrast agent for a structural or functional imaging procedure. Methods for delivering and retrieving the devices from the target tissue are also described.

Abstract: A multiple-injection medical apparatus for injection of a medical fluid is described. The multiple-injection medical apparatus comprises a disk-like support member, a plurality of substantially radial needles housed in the disk-like support member, a chamber connected to one or more of the needles and suitable for containing the medical fluid to be injected, and a means for continuously refilling the chamber with the medical fluid after each injection.

Abstract: Described are novel methods for delivering a medical agent to a plurality of locations within a patient tissue volume such as the interior space of a spinal disc, and also for removing material therefrom during medical agent delivery to enhance the delivery. Also described are medical delivery devices such as needle assemblies configured to facilitate the regional delivery of medical agents to patient tissue.

Abstract: A system and method for delivering fluid into a flexible biological barrier employs a microneedle structure wherein a final position of microneedles inserted into the biological barrier is generally sideways projecting from the delivery configuration instead of the conventional downwards projecting arrangement. The microneedles project from a relief surface which is distinct from a primary biological-barrier contact region of the delivery configuration, and is typically angled upwards away from the biological barrier. During insertion, the contact region is brought into contact with the biological barrier and moved parallel to the surface of the flexible biological barrier so as to generate a boundary between a stretched portion and a non-stretched portion of the barrier.

Abstract: The present application provides a device and a system for the delivery of biological material across the biological tissue. The device may be for the programmed delivery of biological material through a needle or a micro-needle or micro-needles or biodegradable microneedles.

Abstract: A multifunctional device featuring a cartridge having first and second ports; first and second chambers which have outlets disposed at proximal ends connected to tubes that bifurcate to form intake lines and deposit lines, wherein one-way valves are disposed in the intake and deposit lines, wherein pistons are disposed in the chambers which oscillate between moving toward the proximal or distal end, when the piston moves toward the distal end a material can be drawn into the chamber and when the piston moves toward the proximal end the material can be pumped out of the chamber; and wherein the intake lines are formed from bifurcation of a main intake fine fluidly connected to the first port; wherein the deposit lines feed into a main deposit line fluidly connected to the second port; wherein the device can pump material from the first port to the second port.

Abstract: A connector is described that comprises a male connector portion that is releasably connectable to a complimentary female connector portion. The male fluid connector portion comprises a plurality of hollow needles that are each in fluid communication with a lumen of the associated tubing. The female connector portion comprises plurality of chambers or apertures that comprise a septum seal through which a hollow needle can be passed. Tubing having a plurality of lumens is coupled to the female connector portion and each lumen is in fluid communication with one of said chambers. The male and/or female connector portions also include an alignment guide that allows the hollow needles of the male part to be uniquely aligned with the corresponding septum seals of the female part. The use of the connector for medical purposes is described.

Abstract: A method for placing a device into a target vasculature. The method comprises accessing the target vasculature with an access guide catheter to sub-select a proximal portion of the target vasculature. A rail catheter is tracked into the access guide catheter to place the rail catheter more distally and into a distal portion of the target vasculature. The access guide catheter is removed. A delivery catheter is tracked over the rail catheter. The rail catheter is then removed. A device catheter having the device is placed into the delivery catheter and positioned at a desired location within the distal portion of the target vasculature.

Abstract: The present invention generally relates to systems and methods for delivering and/or withdrawing a substance or substances such as blood or interstitial fluid, from subjects, e.g., from the skin and/or from beneath the skin. In one aspect, the present invention is generally directed to devices and methods for withdrawing or extracting blood from a subject, e.g., from the skin and/or from beneath the skin, using devices containing a fluid transporter (for example, one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In some cases, the device may be self-contained, and in certain instances, the device can be applied to the skin, and activated to withdraw blood from the subject. The device, or a portion thereof, may then be processed to determine the blood and/or an analyte within the blood, alone or with an external apparatus.

Abstract: A drug delivery device for delivering a drug to a subject includes a microneedle configured to facilitate delivery of the drug to the subject. The microneedle includes a tip portion and is moveable from an inactive position to an activated position. When the microneedle is moved to the activated position, the tip portion of the microneedle is configured to penetrate the skin of the subject. The drug delivery device includes a tissue support structure that includes a channel and an engagement element. The channel has a first end and a second end and is in axial alignment with the microneedle. At least the tip portion of the microneedle extends past the second end of the channel in the activated position.