Abstract: An injector includes a support tube having one end surface to be brought into contact with skin, a movable tube advanceable in the support tube in the direction of the skin, an injection needle communicating with the movable tube, a plunger advanceable in the movable tube in the direction of the skin to introduce medicinal liquid filled in the movable tube to the injection needle, and a sealing material provided at the tip of the support tube and penetratable by the injection needle to penetrate the sealing material. In an initial state, the tip of the injection needle is sealed by the sealing material.

Abstract: A multi-needle assembly according to the present invention includes: a plurality of needles; a central hub for supporting the needles with the front part of the needles exposed and the rear part thereof fixedly surrounded; a suction cap with the front having needle penetration holes for receiving the needles, the suction cap surrounding the needles and in a sealed manner one side of the central hub; and an adjustment part rotatably connected to the rear end of the suction cap and screwed around one side of the central hub for moving the central hub forward or backward with regard to the suction cap by rotation so as to adjust the length of exposure of the needles, wherein the adjustment part has one side inscribed with continuous numbers or a scale around. Thus the exposed length of the needles may be easily adjusted and confirmed as being desired, so that easy treatment is possible without an additional means for confirming.

Abstract: A bone marrow aspiration apparatus comprising a hollow needle having a penetrating end and a distal end, a stylet having a penetrating end and a distal end, the stylet being removably positioned within said needle; a cylindrical threaded section; a depth gauge threadedly engagable with and movable longitudinally along the threaded section, the depth gauge having a proximal end and a distal annular end, the proximal end being spaced a variable first distance from the penetrating end of the hollow needle; a locking nut threadedly engagable with sand movable longitudinally along the threaded section; a cap connection section having a fluid fitting therein; a cap having an interior space, the cap being engagable with the cap connection and engaged with the stylet, the cap having a distal end closed by a distal endwall, an open proximal end, and a sidewall extending between the distal end and the proximal end; wherein the threaded section and the depth gauge define a stylet passage between the fluid fitting of the

Abstract: An apparatus provides feedback regarding the material in which tip of the apparatus is located as the tip is advanced into matter of varying resistances. The apparatus responds to a change in pressure, force, or other parameter such that when the tip reaches matter of a certain resistance, a change in the parameter is sensed. The apparatus provides a driving force to a penetrating medical device, such as a needle, when the apparatus tip encounters material of high resistance. When the apparatus tip encounters a low resistance material, no further driving force is applied to the apparatus. An inner core may be advanced into the low resistance material for deployment of a gas or a liquid as desired.

Abstract: The present invention provides improved methods for ID delivery of drugs and other substances to humans or animals. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to deliver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. The pharmacokinetics of hormone drugs delivered according to the methods of the invention have been found to be very similar to the pharmacokinetics of conventional SC delivery, indicating that ID administration according to the methods of the invention is likely to produce a similar clinical result (i.e., similar efficacy) with the advantage of reduction or elimination of pain for the patient.

Abstract: An intradermal injection device comprising a unitary body having an open distal end and a proximal end having a skin engaging surface defined thereon, a reservoir defined between the proximal and distal ends for accommodating a drug substance, and a channel defined at the proximal end of the unitary body and extending through, and distally from, the skin engaging surface to the reservoir. A needle cannula having a sharpened proximal end and a distal end may be provided in the channel. The needle cannula is secured in the channel with the distal end being in communication with the reservoir and the proximal end of the needle cannula extending from the skin engaging surface a distance in the range of about 0.5 mm to 3.0 mm such that the skin engaging surface limits penetration of the proximal end of the needle cannula to the dermis layer of the skin of a patient.

Abstract: The present invention provides improved methods for ID delivery of drugs and other substances to humans or animals. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to deliver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. The pharmacokinetics of hormone drugs delivered according to the methods of the invention have been found to be very similar to the pharmacokinetics of conventional SC delivery, indicating that ID administration according to the methods of the invention is likely to produce a similar clinical result (i.e., similar efficacy) with the advantage of reduction or elimination of pain for the patient.

Abstract: Apparatus and methods are provided to access bone marrow at various target areas. Such apparatus may include an intraosseous device operable to penetrate bone at a selected target area and a depth limiter operable to control depth of penetration of the intraosseous device into bone and associated bone marrow. A manual driver and a guide may be included to optimize optimum insertion of the intraosseous device at a selected insertion site on a sternum.

Abstract: A syringe is provided with an assembly received on the distal end for adjusting the penetration depth. In embodiments, the assembly includes a collar attached to the syringe hub which moves with respect to the needle between axial positions depending on the desired needle penetration depth. The adjustable penetration depth syringe is useful in the context of self-administered drugs such as insulin, where a longer length needle is needed to fill a syringe from a vial, but a shorter penetration depth is preferred for administering a subcutaneous injection.

Abstract: The present invention provides improved methods for ID delivery of drugs and other substances to humans or animals. The methods employ small gauge needles, especially microneedles, placed in the intradermal space to deliver the substance to the intradermal space as a bolus or by infusion. It has been discovered that the placement of the needle outlet within the skin and the exposed height of the needle outlet are critical for efficacious delivery of active substances via small gauge needles to prevent leakage of the substance out of the skin and to improve absorption within the intradermal space. The pharmacokinetics of hormone drugs delivered according to the methods of the invention have been found to be very similar to the pharmacokinetics of conventional SC delivery, indicating that ID administration according to the methods of the invention is likely to produce a similar clinical result (i.e., similar efficacy) with the advantage of reduction or elimination of pain for the patient.

Abstract: Embodiments of dermalogical cell treatment are described generally herein. Other embodiments may be described and claimed.

Abstract: A shielded pen needle assembly is provided in which the hub extends distally beyond an outer sleeve of the assembly.

Abstract: To prevent a coating agent applied to the surface of a needle tube from being infiltrated into the clearance between the needle tube and a needle hub, a device comprises a needle tube that has a needle tip capable of puncturing a living body and that is coated with a coating agent on the surface of a tip-end portion on the side of the needle tip; and a needle hub adapted to hold the needle tube in a state where the needle tip of the needle tube is protruded. The needle hub has a through-hole through which the needle tube is inserted, and a discharge hole extending from the through-hole to the outer surface of the needle hub and adapted to discharge the coating agent infiltrated into the through-hole.

Abstract: A system and method is provided for an injectable substance delivery pen comprising a microneedle hub assembly removably engaged with a pen device body which includes a cartridge, a plunger, and a drive mechanism. The hub assembly includes at least one microneedle for intradermal or shallow subcutaneous injection of the contents of the cartridge. The cartridge, plunger and drive mechanism components of the pen body are fabricated of non-compliant and non-compressible materials to allow effective communication of the cartridge contents via the microneedle patient interface.

Abstract: Provided herein is an injection device that can be used in minimally invasive procedures, such as laparoscopic surgeries, for direct administration of a fluid, such as a therapeutic, to a target tissue or organ.

Abstract: An apparatus for accessing the lumen of a vessel. The apparatus includes a main body and a disposable cartridge. The main body includes a imaging device attachment, wherein the imaging device attachment is utilized to secure an image capturing instrument to the main body; a cartridge carrier coupled to the imaging device attachment, wherein the cartridge carrier is adjustable to achieve a target insertion depth; and a first motor coupled to the cartridge carrier, wherein the first motor adjust the cartridge carrier to achieve the target insertion depth. The disposable cartridge is attached to the cartridge carrier and houses a sheath, needle, or guidewire to be inserted into the vessel to the target insertion depth.

Abstract: An apparatus includes a housing coupled to a medicament container, which is coupled to a needle. An injection assembly is disposed within the housing and includes an energy storage member and an actuation rod. A distal end portion of the actuation rod is disposed within the medicament container. The energy storage member can produce a force on a proximal end portion of the actuation rod sufficient to move the distal end portion of the actuation rod within the medicament container. This can convey at least a portion of a substance from the medicament container via the needle when a distal tip of the needle is disposed within a first region of a target location. The force is insufficient to move the distal end portion of the actuation rod within the medicament container when the distal tip of the needle is disposed within a second region of the target location.

Abstract: An apparatus for accessing the lumen of a vessel. The apparatus includes a reusable handheld device and a disposable cartridge. The reusable handheld device includes a imaging device attachment utilized to secure an image capturing instrument, an arm coupled to the imaging device attachment, and a depth scale coupled to the arm, wherein the depth scale provides a scale indicating an insertion depth. The disposable cartridge attaches to the reusable handheld device. The disposable cartridge includes a sheath, needle or guidewire coupled to the disposable cartridge. The sheath or needle extends to the insertion depth when fully advanced, thereby allowing the sheath, needle, or guidewire to access the lumen of a vessel.

Abstract: Many image guided needle procedures use ultrasound, computed tomography (CT) magnetic resonance imaging (MRI) or other imaging systems. In such procedures, there is currently a preference for long axis injections and related procedures where the long axis of the needle is parallel to the plane of the two dimensional images created by the imaging system. This is due to the fact that long axis imaging of a needle provides good visual indication of depth of penetration of the needle, whereas short axis imaging shows only a dot or small circle, which is the cross section of the needle and provides no depth of penetration information. Many procedures, however, benefit from, or require the use of, short axis imaging. The depth advancement marker needle of the present invention provides a feature along the shaft of the needle that provides a visual indicator of depth of penetration while performing short axis imaging.

Abstract: An endoluminal medical access device (1) is disclosed that is devised for endoluminal delivery to an extravascular target site (5) at a vasculature site of a human or animal body vasculature, such as the microvasculature.

Abstract: Methods and devices are disclosed herein that generally provide protection for devices (e.g., microcatheters) having small tips. Methods and devices are also disclosed herein that generally facilitate use of commercially-available stereotactic systems with devices (e.g., microcatheters) having small tips.

Abstract: A system and method is provided for an injectable substance delivery pen comprising a microneedle hub assembly removably engaged with a pen device body which includes a cartridge, a plunger, and a drive mechanism. The hub assembly includes at least one microneedle for intradermal or shallow subcutaneous injection of the contents of the cartridge. The cartridge, plunger and drive mechanism components of the pen body are fabricated of non-compliant and non-compressible materials to allow effective communication of the cartridge contents via the microneedle patient interface.

Abstract: A syringe (211) includes a syringe body (217) for receiving and administering a medicament. A needle (215) is received by the syringe body (217). A needle adjusting member (221) is movably disposed on the syringe body (217) between first and second positions. When the needle adjusting member (221) is in the first position, the needle (215) has a first length adapted to draw medicament into the syringe body (217). When the needle adjusting member (221) is in the second position, the needle (215) has a second length for injecting the medicament.

Abstract: A device to stimulate a scalp comprising an array of stimulating elements adapted to pierce the skin of the scalp no deeper than a thickness of a dermis, wherein the stimulating elements are arranged along a circumference of at least one wheel and the wheel is adapted to roll over the scalp.

Abstract: An intradermal injection adapter includes a body having a longitudinal axis and a central portion located distally relative to the body along the longitudinal axis. The central portion has a cannula channel therethrough extending generally parallel to the longitudinal axis. A cannula within the cannula channel has a sharpened tip for injection into a patient and a sharpened opposite proximal end for injection into a pen injector. A distal protrusion has a first skin contacting surface extending generally parallel to the longitudinal axis. The first skin contacting surface is spaced from the cannula such that a distal portion of the cannula extends generally parallel to the first skin contacting surface.

Abstract: An endoluminal medical access device (1) is disclosed that is devised for endoluminal delivery to an extravascular target site (5) at a vasculature site of a human or animal body vasculature, such as the microvasculature.

Abstract: A needle system for penetrating to or passing thought an object or an organ comprising a semiconductor die, one or more needles, wherein the needles slide over the plane of the die, one or more actuators that move the needles relative to the die plane, and one or more actuator drivers controlled by a controller wherein the controller instruct the needle to penetrate into or to pass through and/or retract from the object or organ. The needle system is used for drug delivery or blood extraction or blood analysis or glucose measurements or blood measurements or nerve system stimulus treatment or hair removal or skin lesions removal.

Abstract: An infusion set has a partially integrated ballistic inserter that can insert a needle at a controlled rate of speed to a depth to deliver content to the upper 3 mm of skin surface, and a skin-securing adhesive layer to secure the skin surface at the insertion site such that the inserter that can insert a needle with a reduced risk of tenting of the skin surface. A removable turnkey or pushable handle can be provided to release a driving spring of the ballistic inserter to insert a needle at a controlled rate of speed, of 3.3 ft/sec. (1.0 m/sec.) up to and including those greater than 10 ft/sec. (3.0 m/sec.), then release from the set for disposal. The infusion set can further include an extendable interface ring that retracts when the inserter is removed from the infusion set.

Abstract: In one aspect, a needle assembly is provided herein which includes a hub; a needle fixed to the hub, the needle having a proximal end and a distal end, the distal end formed for insertion into a patient; and, a body disposed on the hub so as to be moveable relative thereto, the body having a distal end with an aperture formed therein configured to permit passage therethrough of the needle. The body is releasably retainable in a first position on the hub where the distal end of the needle extends distally a first distance from the distal end of the body. Also, the body is retainable in a second position on the hub where the distal end of the needle extends distally a second distance from the distal end of the body, the second distance being less than the first distance. The hub is displaceable proximally relative to the body to urge the body from the first position to the second position.

Abstract: A transvascular system (10) for delivering a drug to a tissue region from a blood vessel, such as a coronary vein, includes a catheter (12) having a distal portion (26) with puncturing (14), orientation (16), drug delivery (62), and imaging elements (18). The puncturing element (14) is deployable for penetrating the vessel wall to access the tissue region. The orientation element (16), e.g. a “cage” including a plurality of struts (38) (40) and/or a radiopaque marker, has a predetermined relationship with the puncturing element (14), the imaging element (18) detecting the location of the orientation element (16) with respect to the tissue region to orient the puncturing element. The catheter (12) is percutaneously introducing into the vessel, the puncturing element (14) is oriented towards the tissue region, the puncturing element (14) is deployed to access the tissue region, and the drug is delivered to the tissue region.

Abstract: An injection delivery system for automatically injecting fluid into an injection site includes at least one support element and a carriage moveably mounted to the at least one support element so that the carriage can move linearly relative thereto. The carriage has a support structure for removably receiving and carrying a syringe assembly for movement with the carriage, and a carriage actuator is operable to cause such linear movement of the carriage. A plunger actuator is carried by the carriage so as to move with the carriage, and is adapted to be operably coupled to a syringe plunger for causing linear movement of the syringe plunger within a syringe barrel. The carriage actuator and plunger actuator include respective inputs for receiving movement instructions, and may be coupled to an electronic controller that provides such instructions.

Abstract: An injection device for injecting a material into tissue may include a sheath having a distal end. The injection device may also include an injector having an outlet tube. The outlet tube may be received in the sheath, and may include a distal portion with a penetrating tip for penetrating the tissue. The sheath and the outlet tube may be slidable relative to each other, to extend a length of the distal portion from the distal end. The injection device may also include an adjuster operatively coupled to at least one of the sheath and the outlet tube. The adjuster may be configured to control relative movement between the sheath and the outlet tube for selectively adjusting the extended length.

Abstract: Systems, methods, and devices for providing subcutaneous hydration are disclosed. A system for providing subcutaneous hydration may include an infusion bag including a hydration fluid, a tubing removably connected to the infusion bag, a squeezable bulb at least partially encompassing the tubing for at least one of flushing and priming the tubing, and a deployment device including an integrated needle which is operative provide subcutaneous hydration through the needle. A deployment device for subcutaneous hydration includes a base may include a needle aperture, a spring-loaded barrel attached the base and including a needle, and a firing mechanism within the barrel for deploying the needle from the barrel and further operative to project the needle through the aperture only when a tent of skin has been raised within the aperture for injection. A method for providing subcutaneous hydration may include steps necessary to operate the systems and devices for subcutaneous hydration.

Abstract: A needle assembly (10) includes a needle (14) attached to mounting structure (12), and is used to insert the needle into the body of a patient. A depth stop unit (50) of the needle assembly provides a stop surface (58) to limit the distance the needle can be inserted into the body. The depth stop unit may include a depth stop (52) that is adjustable to selectively change the depth to which the needle can be inserted. The entire depth stop unit can be removed from the needle assembly to permit the full length of the needle to penetrate into the body.

Abstract: An applicator for use in tissue repair is provided. The applicator includes a base configured to dispense a material and an applicator tip operably connected to the base. The applicator tip includes a body having a distal end configured to engage a tissue defect and a mold disposed about the body configured to engage tissue about the tissue defect. The mold is configured to be selectively positioned about the distal end of the body between at least a first position and a second position to deposit material to form at least a first layer and a second layer. Also provided are applicator tips, methods and kits for tissue repair.

Abstract: The present invention relates to an injection assistance device including a body with a needle, grasping arrangement and first elastic return arrangement to dampen limited movement of the grasping arrangement, in at least one of the two directions, respectively distal or proximal, during an injection phase, and to maintain the body in its insertion position and the needle at a constant insertion length during the injection step, when the user increases, respectively releases, a distal pressure on the grasping arrangement. The invention also relates to an injection set including an injection device and the assistance device.

Abstract: A syringe (211) includes a syringe body (217) for receiving and administering a medicament. A needle (215) is received by the syringe body (217). A needle adjusting member (221) is movably disposed on the syringe body (217) between first and second positions. When the needle adjusting member (221) is in the first position, the needle (215) has a first length adapted to draw medicament into the syringe body (217). When the needle adjusting member (221) is in the second position, the needle (215) has a second length for injecting the medicament.

Abstract: The invention relates to an apparatus for injection into an eye comprising of a means for displacing a conjunctival layer of the eye over an underlying scleral layer of the eye so as to form a fold in the conjunctival layer, and means for guiding a needle through the conjunctival layer once the fold has been formed.

Abstract: An injector for delivering an injectate into the myocardium of the heart may be implemented as a catheter or a handheld unit. The injector includes a body, a stabilizer secured to a distal end of the body, and a needle that may be controllably advanced from the distal end of the body. The stabilizer stabilizes the distal end of the body relative to the myocardium while the heart beats. An enlarged region disposed along the needle prevents the needle from being advanced into the myocardium beyond a desired penetration depth. To make an injection, the physician brings the distal end of the body in proximity to the myocardium, actuates the stabilizer to stabilize the distal end relative to the myocardium, and advances the needle into the myocardium. Advancement of the needle is impeded by the enlarged region, thereby placing the needle tip at the desired penetration depth for the injection.

Abstract: An endoscopic injection needle device includes a flexible elongate sheath attached to a handle. Disposed within the sheath is drive shaft having a lumen within and a needle at its distal end. The drive shaft is movable longitudinally within the sheath and is attached at its proximal end within the handle to an actuator. Advancing the actuator extends the needle from the distal end of the device. The actuator includes a locking mechanism that locks it in place with the handle when advanced a certain distance. The locking mechanism includes multiple locking positions wherein the exposed length of the needle corresponds to the distance advanced by the actuator at each locking position. Also included in the distal end of the sheath are a spring coil and a collar. The collar is positioned distal to the spring coil and includes a dome shaped distal end that extends beyond the distal end of the sheath. The drive shaft extends through the spring coil and, when retracted, the needle is housed within the collar.

Abstract: Disclosed are an ultrasound apparatus and a control method thereof, in which the thickness of subcutaneous tissue is measured using an ultrasound probe or vital data regarding a subject is acquired to select an appropriate injection needle and determine suitability of injection to a corresponding body region, which ensures safe and effective drug administration. In the ultrasound apparatus and the control method thereof, a map containing results of selection of an appropriate injection needle and determination of injection suitability is generated and provided to a patient, which ensures safe self-administration by the patient without a hospital visit. The ultrasound apparatus includes a data acquirer to acquire ultrasound data regarding a subject, a thickness calculator to calculate the thickness of subcutaneous tissue inside the subject based on the ultrasound data, and a needle selector to select a needle corresponding to the calculated thickness of subcutaneous tissue.

Abstract: An infusion set has a retraction dial that can be removably assembled with the infusion set and access a threaded needle hub contained therein such that the dial can be used to advance or retract a needle hub and an inserted needle to a more precisely controlled insertion depth to deliver insulin or other medicament intradermally (i.e. to the upper 3 mm of skin surface). Position of the inserted needle can be maintained by providing a separated and isolated needle hub, main base and main hub of the infusion set that can isolate the inserted needle from external forces such that the needle can be maintained at a depth to deliver content to the upper 3 mm of skin surface during normal use.

Abstract: A catheter set includes a catheter and a fixing device. The fixing device includes a tubular member which is formed in such a way as to increase or decrease in diameter under axial extension or compression. A first projection and a second projection are provided at both ends of the tubular member. A movable tubular body is disposed around the tubular member between the first projection and the second projection. A distal part is coupled to the tubular member by a support member. The distal part is disposed distally of the tubular member and is configured to at least contact a proximal portion of a tubular device for medical use through which the catheter runs.

Abstract: A body fluid sensing device with a body fluid capture structure and a body fluid measurement sensor positioned in the body fluid capture structure. A capacitance sensor is coupled to the body fluid measurement sensor. The capacitance sensor is used to assist in the positioning of a body part relative to the body fluid capture structure.

Abstract: In one aspect, a pen needle assembly is provided herein which includes a hub, and a needle fixed to the hub, the needle having proximal and distal ends with a lumen extending therebetween. The needle extends distally from the hub to define an exposed length between the distal end of the needle and the hub in the range of about 5.0 to 9.0 mm. The hub defines a post formed about the needle, the post having a distally-facing first skin engaging surface. The exposed length of the needle extends distally from the first skin engaging surface. The hub also defines a distally-facing second skin engaging surface which at least partially circumscribes the first skin engaging surface. The second skin engaging surface being located proximally of the first skin engaging surface. Advantageously, a pen needle assembly is provided having two skin engaging surfaces which provide stability in achieving subcutaneous injections.

Abstract: An applicator used to apply microneedle arrays to a mammal. In particular, an application device for applying a microneedle device to a skin surface comprising a flexible sheet having a raised central area attached to the microneedle device and a supporting member at or near the periphery of the flexible sheet, wherein the flexible sheet is configured such that it will undergo a stepwise motion in the direction orthogonal to the major plane of the sheet.

Abstract: A device (10) for at least partially inserting a needle (16) into the body of a patient is disclosed. The device (10) comprises a connector adapted for attachment to a needle (16), and a guard member (18) having a guide surface adapted to rest against a surface of the skin. The connector is adapted to set an attached needle (16) with a fixed position relative to the guard member (18), such that movement of the guide surface along the surface of the skin at least partially inserts the needle (16) into the body.

Abstract: An injection delivery system for automatically injecting fluid into an injection site includes at least one support element and a carriage moveably mounted to the at least one support element so that the carriage can move linearly relative thereto. The carriage has a support structure for removably receiving and carrying a syringe assembly for movement with the carriage, and a carriage actuator is operable to cause such linear movement of the carriage. A plunger actuator is carried by the carriage so as to move with the carriage, and is adapted to be operably coupled to a syringe plunger for causing linear movement of the syringe plunger within a syringe barrel. The carriage actuator and plunger actuator include respective inputs for receiving movement instructions, and may be coupled to an electronic controller that provides such instructions.

Abstract: An injection aid is a tool used by being attached to an injection device having an injection needle and a syringe, and includes an aid main body and a tapered guide. The aid main body includes; an engagement part to be engaged with the syringe; a hollow part through which the injection needle penetrates; and a needle-protruding surface from which a needle tip part of the injection needle protrudes and which is brought into contact with skin when sticking the injection needle into a living body. The tapered guide is arranged in the hollow part of the aid main body and includes an inner surface that becomes continuously reduced in diameter toward the needle-protruding surface.

Abstract: Systems, methods and devices are described herein for adjusting the insertion depth of a cannula associated with a portable therapeutic device within the body of a patient. The systems may include a mounting unit securable to the skin of the patient and having a mounting base and a well defining a passageway through the mounting base and a cannula unit including a cannula subcutaneously insertable through the well of the mounting unit. The well may have an adjustable height and/or adjustable anchoring mechanisms that allow for varying and customized insertion depths of the cannula within the body of the patient.