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 device for withdrawing or delivering a substance through the skin of a patient includes a body and a skin penetrating device having a plurality of skin penetrating members, such microneedles. The body includes a bottom surface having a first inner surface area supporting the skin penetrating members and a second outer surface having an adhesive for attaching the device to the skin. In one embodiment, the firs inner surface is spaced outwardly from the second outer surface when the device is attached to the skin. The inner surface can have a textured visually wettable surface, such as an etched surface, to provide a visual indication of leakage from the interface between the skin penetrating members and the skin.

Abstract: A device for delivering a substance into the skin of a patient includes a housing and a plurality of microneedles for penetrating the skin. The housing includes a bottom wall with a plurality of apertures for supplying the substance to the microneedles. The housing also includes a flexible top cover member enclosing a bladder containing the substance to be delivered. The bottom wall of the housing has at least one cannula facing the bladder. Pressing on the top cover member causes the cannula to puncture the bladder and deliver the substance to the microneedles for delivery to the patient. In one embodiment, the cannula is surrounded by a flexible member to prevent piercing of the bladder until sufficient pressure is applied to the cover member to depress the flexible member.

Abstract: A transdermal delivery device includes a plurality of microneedles for injecting a substance such as a pharmaceutical agent into or below the stratum corneum of the skin. The device has housing formed from a top and bottom wall to define a chamber for containing a pharmaceutical agent. An inlet port is provided in the top wall of the housing for supplying the pharmaceutical agent to the chamber and directing the agent to the microneedles. The housing can have a Luer lock type fitting for coupling with a syringe having a Luer lock collar to inject the pharmaceutical agent into the housing. The housing can be divided into a plurality of chambers by an internal wall for supplying different agents simultaneously or sequentially to a patient. The microneedles have a length of about 5-250 microns and generally about 50-100 microns.

Abstract: A device includes a plurality of skin penetrating devices for delivering or withdrawing a substance through the skin of a patient. The device has a support formed with a top and bottom end and a plurality of channels extending axially through the support. A plurality of the skin penetrating members is positioned in the channels with a tip extending from the bottom end of the support. A coupling member is attached to the support for coupling with a fluid supply and directing the fluid to the skin penetrating members. The skin penetrating members have a length of about 100 microns to about 2000 microns and are about 30 to 50 gauge.

Abstract: A method for delivering a substance to the epidermal tissue of skin. The method involves simultaneously disrupting only the stratum corneum of the skin and delivering the substance to the epidermal tissue of the skin.

Abstract: A device for monitoring, sampling or delivering a substance though the skin of a patient includes a support and a microdevice having at least one skin penetrating member. The support has a substantially flat bottom surface with the skin penetrating member extending beyond the bottom surface. An outlet port extends through the support to the bottom surface at a location between the skin penetrating member and the outer edge of the support for drawing a vacuum to enhance penetration of the skin. The device is produced by positioning the microdevice in a recess formed in the support and applying a bonding agent to wick into a gap formed between the microdevice and the wall of the recess.

Abstract: A catheter and introducer needle assembly with needle shield is provided wherein the needle includes an enlarged diameter portion and a distally facing shoulder. The needle shield includes a means for engaging the distally facing shoulder to prevent unwanted distal movement of the needle once the needle has been withdrawn into the needle shield. The needle shield also includes a small diameter opening adjacent to its proximal portion to limit proximal movement of the needle out of the needle shield.

Abstract: The applicator for an anti-microbial prep solution of this invention includes a generally hollow handle having a closed proximal end and an open distal end, a foam pad attached to the hollow handle over the open distal end, and a slit formed in the foam pad that acts as a flow control valve.

Abstract: A self-contained electrolocation apparatus of the present invention includes an electrically conducting needle cannula having a proximal end, a distal end and a hollow bore therethrough. The invention further includes a non-conductive tube having a proximal end and a distal end, the tube being mounted over the needle cannula so that the distal end of the non-conductive tube is proximal to the distal end of the needle cannula. The non-conductive tube has a conductive layer thereon, whereby the needle cannula and the conductive layer respectively define first and second conductors coaxially spaced from one another by the non-conductive tube. There is a grip fixedly attached to the needle cannula for manipulating the apparatus. The grip has an electrical stimulus generator circuit within it that is electrically connected to the first conductor and the second conductor.

Abstract: A foam dispensing apparatus of the present invention includes a reservoir containing a foamable liquid, with a closed headspace above a surface of the liquid. The apparatus also includes a source of a gas disposed to impose a gas pressure higher than ambient atmospheric pressure into the closed headspace. There is a mixing chamber having an inside diameter, an inlet and an outlet open to the ambient atmosphere with a flow restricter having a plurality of openings therein in gaseous communication with the closed headspace. The foam dispensing apparatus also includes a hydrophobic filter.

Abstract: A protected peelable introducer for insertion into an anatomical passageway such as a vein or artery. The introducer comprises a needle assembly having a U-wing member and a stylet in fluid communication with the U-wing member that defines a sharpened distal tip. Additionally, the introducer includes a protective sheath cooperatively engaged to the U-wing member of the needle assembly. The sheath is movable relative to the U-wing member from a non-operative position whereat the distal tip is exposed to an operative position whereat the distal tip is covered by the sheath. Furthermore, the sheath is separable into two halves such that when the needle assembly is divided into two halves, the sheath covers the sharpened distal tips of the separated stylet. Therefore, upon separation of the needle assembly, the sheath protects health care workers from inadvertent needle sticks caused by the sharpened distal tip of the stylet.

Abstract: An epidural needle is provided with a curved distal end to facilitate placement of a catheter into the epidural space of a spine. The distal end is further characterized by a primary bevel aligned to the longitudinal axis of the epidural needle at an angle of approximately 10°. A secondary bevel also is provided at the extreme distal end of the needle. The secondary bevel is aligned to the longitudinal axis of the needle at an angle of between 60°-80°. The curve, the primary bevel and the secondary bevel all are symmetrical about common plane passing through the longitudinal axis of the needle. The secondary bevel aligned at an angle of 60°-80° to the longitudinal axis provides a sufficiently sharp point to penetrate easily into the epidural space, but provides sufficient blunting to avoid inadvertent damage to the dura matter.

Abstract: A catheter introducer is disclosed having a splittable introducer and an introducer needle. The splittable introducer includes a pair of wings and a tray with an open top extending from the proximal end of the introducer cannula between the wings to lead the distal end of a long, thin and flexible medical device into the open proximal end of the splittable introducer cannula.

Abstract: A needleless injection site comprising a housing defining proximal and distal ends and including a reseal member disposed therein. The reseal member has an elastically openable and closable aperture formed therein, and normally resides within the housing in a closed position wherein the aperture is in a closed configuration. The reseal member is deformable such that the application of distally directed pressure thereto will cause the reseal member to distally advance within the housing to an open position wherein the aperture assumes an open configuration. The removal of the distally directed pressure from the reseal member will cause it to resiliently return to the closed position wherein the aperture assumes the closed configuration.

Abstract: A needle retraction mechanism includes a hollow handle defining a cavity, a needle hub assembly movably disposed in the handle, a biasing mechanism to move the needle hub assembly from an extended position to a retracted position and a latch to hold needle hub assembly in the extended position against the bias of the biasing mechanism. The needle hub assembly includes a flexible stopper at its proximal end that creates an air tight seal with the inner wall of the handle. This allows a vacuum to be created between the proximal end of the handle and the flexible stopper when the needle hub is moved from the retracted position to the extended position. The configuration of the flexible stopper allows it to change the amount of frictional force created between the inner wall of the handle and the flexible stopper when the device is at different elevations.

Abstract: The present invention is directed to a vascular access device for introducing a catheter in a blood vessel using a guide advancing mechanism. The device generally comprises a housing, an introducer needle, a catheter, a guide wire and an actuating means. The introducer needle of the vascular access device is used to penetrate the blood vessel. The actuating means is then initiated and the guide wire is steadily propelled into the blood vessel. Once the guide wire is in place, the catheter, which is concentrically placed over the introducer needle and guide wire, is uncoupled from the vascular access device and guided into the blood vessel by the guide wire.