Abstract: A hypodermic interface assembly is disclosed. The hypodermic interface assembly includes a hub, a cannula, and a cannula carrier. The cannula carrier is non-removably-connected to the cannula. The cannula carrier is controllably separable from the hub.

Abstract: A tissue guard includes an elongated body having a proximal end and a distal end and defining a lumen therethrough. A plurality of torsion springs is included, each torsion spring having a first leg and a second leg and a spring defined therebetween. The first leg of each torsion spring is operably engaged to the distal end of the elongated body. Two or more petals extend from the distal end of the elongated body, each petal is operably engaged to the second leg of one of the torsion springs. The petals are movable between a first, compressed configuration wherein the petals are compressed relative to one another against the bias of the plurality of torsion springs to facilitate insertion of the tissue guard within an access device or natural orifice and a second, expanded configuration to facilitate engagement of the petals beneath the access device or within the natural orifical to secure the tissue guard therein.

Abstract: A dilator that includes a shaft and a spirally-arranged protruding portion. The shaft includes a tapered section, a distal end section, and a body section. The spirally-arranged protruding portion includes spirally-arranged protruding sections provided on outer peripheral surfaces of each of the tapered section, the distal end section, and the body section, and gaps between adjacent spirally-arranged protruding sections along an axial direction of the shaft. At least one of a height t of the spirally-arranged protruding portion at a first location gradually decreases toward a distal end side and a height of the spirally-arranged protruding portion at a second location gradually decreases toward a proximal end side.

Abstract: A dilator that includes a hollow shaft including a tapered section having a diameter increasing from a distal end toward a proximal end, and a spirally-arranged protruding portion provided on an outer peripheral surface of the hollow shaft and including spirally-arranged protruding sections and gaps between adjacent spirally-arranged protruding sections along an axial direction of the hollow shaft. The spirally-arranged protruding portion includes an apex section having the greatest height from the outer peripheral surface in a transverse cross-section thereof, and a side surface section facing outward and extending from the apex section toward the outer peripheral surface. The side surface section includes an inclined surface inclined substantially linearly toward at least one of the distal and proximal end direction between the outer peripheral surface and the apex section in the transverse cross-section of the spirally-arranged protruding portion.

Abstract: Apparatuses, systems, and methods are provided for securing an intra-osseous device within a safety device to prevent stick injuries and to guide the removal of the intra-osseous device from the bone of a patient. A body of the safety device has a cavity that receives the intra-osseous device, and the cavity guides the removal of the intra-osseous device along a straight line to prevent injury during removal. The intra-osseous device is drawn past a lock feature that secures the intra-osseous device within the body such that a needle of the intra-osseous device is contained within a cavity of the body and cannot injure the patient, staff members, etc.

Abstract: The present disclosure pertains to devices and methods for diagnosis and treatment of biological tissue in which the tissue is accessed by a catheter through a working channel of an endoscope and in which the degree of extension of a distal tip of the catheter beyond a distal tip of the endoscope is controlled.

Abstract: Assemblies for and methods of intraocular injection. An injector assembly includes a housing defining an internal chamber and having a slot on an external surface thereof; a cannula needle having a lumen and a cutout on an outer surface; a flexible arm having a proximal end affixed to the outer surface of the cannula needle and a distal end having a hook such that the hook is disposed within the cutout; a pushrod slidably disposed within the lumen; and a latch slidably disposed in the slot of the housing, the latch coupled to the pushrod such that translation of the latch causes translation of the pushrod to thereby eject an implant disposed within the lumen between the hook and pushrod.

Abstract: Benign prosthetic hyperplasia (BPH) is a non-cancerous enlargement of the prostate gland. Treatment options for BPH include medication, surgery (e.g., removal of enlarged prostate tissue), and minimally invasive procedures (e.g., needle ablation, electrovaporization, thermotherapy, and stent insertion). Minimally invasive procedure is typically the preferred choice if medication is ineffective. Accordingly, disclosed herein are system and method for treating BPH using improved implant and delivery device. Certain embodiments of the delivery device can include: a camming barrel having a first groove at the distal end of the camming barrel; a sheath, located within a lumen of the camming barrel, for storing the implantable device; and a first cam follower coupled to the sheath.

Abstract: Devices and methods for performing a skin biopsy are discussed herein. The skin biopsy device provides for consistent depth and shape, such as by reducing or eliminating operator error or inter-operator variability by generating the same forces across multiple uses. The skin biopsy device can also eliminate puckering of wound closures by incorporating a fusiform blade (e.g., elliptical blade or a diamond-shaped blade). The skin biopsy device includes a casing, a firing pin, a retaining rod, and a blade. The retaining rod holds the blade or can attach to a punch biopsy. The firing pin generates and impacts the retaining rod with a force necessary to drive the blade a given depth into a target tissue to obtain a biological sample.

Abstract: There is described a pressure guidewire. It comprises a sensor housing and a sensor assembly embedded in the sensor housing and comprising a pressure sensor. There is a band to support the pressure sensor assembly, the band being embedded inside the sensor housing and fixed to the pressure sensor assembly for holding the pressure sensor inside the sensor housing.

Abstract: Methods and apparatus provide a therapeutic fluid to devices implanted in the body, for example to containers of devices implanted in the eye of a patient. The methods and apparatus may comprise an injector to increase an amount of therapeutic agent injected into the device implanted in the eye, or a structure to receive the therapeutic fluid within the device implanted in the eye, or combinations thereof. The device implanted in the eye may comprise a reservoir chamber having a fluid with a density different than the therapeutic fluid, and the apparatus can be adapted to at least partially separate the implanted device fluid from therapeutic fluid within the reservoir chamber to increase and amount of therapeutic fluid placed in the reservoir chamber.

Abstract: An integrated catheter placement system for placing a catheter in a vasculature of a patient. The system includes a system console with a tip location mode and an ultrasound mode viewable on a display, a magnetic assembly emanating a magnetic field, a tip location sensor designed to sense the magnetic field, and an ultrasound probe for ultrasonically imaging an internal portion of the patient. The magnetic field may provide magnetic field information for locating the magnetic assembly relative to the tip location sensor. The tip location sensor is designed to communicate the magnetic field information to the system console. The system console is designed to display an icon representative of a location of the magnetic assembly relative to the tip location sensor in the tip location mode.

Abstract: A protective assembly includes a body for receiving the syringe; and a coupling device inside the body, rigidly connected to the barrel as regards to axial movement relative to the body. The coupling device includes an attaching element which can be either in an engaged state to axially fix the coupling device and the plunger rod, or in a release state in which the coupling device and the plunger rod are axially free relative to one another. The coupling device is axially movable in the body from a storage position to an injection position in which the needle extends beyond the body, and in which the attaching element can move towards the release state. The coupling device is axially movable in the body from the injection position towards a safety position, in which the needle is covered by the body.

Abstract: An insertion mechanism for a drug pump includes an insertion mechanism housing; a sleeve; a rotational biasing member initially held in an energized state; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the sleeve. The needle is inserted into a target tissue by the rotational biasing member and interaction between the hub and housing. Retraction of the needle is caused by decompressing or de-energizing of the retraction biasing member. A drug delivery pump includes an activation mechanism, a drive mechanism, a sterile access connection, and the insertion mechanism. Assembly and operation methods are provided.

Abstract: Disclosed herein are intraosseous access devices having various operating mechanisms, as well as methods of the intraosseous access devices. For example, an intraosseous access device includes, in some embodiments, a constant-torque spring assembly, a drive shaft, an intraosseous needle, and an interlock mechanism. The constant-torque spring assembly is disposed in a housing, and the drive shaft extends from the housing. The drive shaft is coupled to the constant-torque spring assembly. The intraosseous needle is coupled to the drive shaft. The intraosseous needle is configured for drilling through bone and providing intraosseous access to a medullary cavity of a patient. The interlock mechanism is configured to prevent rotation of the intraosseous needle and the drilling therewith until the interlock mechanism is disengaged.

Abstract: A bone marrow aspiration device and related method includes an introducer assembly and an aspiration assembly to couple to the introducer assembly. The introducer assembly includes an introducer cannula having a proximal end and a distal end. The introducer cannula defines a lumen between the distal and proximal ends, the distal end being configured to penetrate bone of a patient. The aspiration assembly includes an aspiration cannula that is receivable in the lumen of the introducer cannula and that extends beyond the distal end of the introducer cannula. The aspiration cannula includes a port to aspirate bone marrow, the port being distal to the distal end of the introducer cannula. The aspiration device further includes a mechanism at the introducer assembly to move the introducer cannula and the aspiration cannula in tandem relative to a distal end of the mechanism when the aspiration cannula is positioned within bone.

Abstract: A syringe and needle hub for a syringe has distal patient-facing side having a surface for contact with the subject's skin during injection. The contact surface is formed by a distal face of a post supporting a cannula and an outer collar surrounding the post. The axial distance between the distal face of the post and the distal face of the collar provided a contact surface with a radius of curvature to control the desired injection. The syringe barrel can have finger flanges extending outwardly where the flanges have a tactile member such as a dimple projecting from a proximal face of the flange and recess in a distal face of the flange.

Abstract: A venous access port assembly having a housing base with a discharge stem, a cap, and an interior reservoir. The port assembly is provided with X-ray discernable indicia to identify an attribute of the assembly after its implantation and clearly appear on an X-ray of the patient in a manner informing the radiologist or technologist and the medical practitioner of that particular attribute. The indicia are cuts in a reservoir lining of radiopaque material such as metal where the cuts having narrow slot width are in the form of one or more sets of alphabetical letters such as “CT” in the lining's side wall or bottom wall.

Abstract: A device configured to administer a medication can comprise a lower housing that includes a housing latch. The device can further comprise a needle guard that is movable relative to the lower housing along a first direction from a first position to a second position so as to expose a needle, and an upper housing supported relative to the lower housing. The upper housing can be configured to move with respect to the lower housing along a second direction from a pre-use position to a dispensed position. The housing latch can releasably interfere with the upper housing when the upper housing is in the pre-use position so as to prevent the upper housing from moving toward the dispensed position, and the movement of the needle guard toward the second position, causes the interference to be removed, thereby allowing the upper housing to move toward the second position.

Abstract: According to the invention a safety device for a pre-filled syringe comprises a substantially cylindrical and hollow support body and a hollow needle shield slideably arranged relative to the support body. The support body comprises at least one resilient arm and the hollow needle shield or a needle shield assembly comprises at least one curved actuation ramp. The curved actuation ramp protrudes in a lateral direction (L) perpendicular to a central axis (A) of the safety device. The curved actuation ramp comprises a first lateral dimension (L1) at a proximal end of the needle shield and a second lateral dimension (L2) exceeding the first lateral dimension (L1) at a distal end of the needle shield. The resilient arm engages the curved actuation ramp when the needle shield is slid relative to the support body.

Abstract: Systems and methods are provided for measuring depth, position, and/or angle of a cannula in a medical drug delivery device. In particular, a drug delivery device having a cannula is positioned adjacent to tissue, a voltage pulse is provided to the cannula, a charge is measured at an electrode in the drug delivery device, and the depth of penetration of the cannula is determined based in part on the charge at the first electrode. Systems and methods described herein can be used to determine subcutaneous insertion depth in a wearable bolus injector. In some implementations, insertion depth determination is achieved through capacitive sensors which measure needle depth in a drug delivery device.

Abstract: A precision steerable and angled medication delivery system is disclosed. The system may direct a delivery mechanism in connection with a control syringe to delivery sites within a patient's body. In this manner, therapeutic injections may be performed at precise locations as desired. The precision steerable and angled medication delivery system may have a structure configured to orient at least a portion of an elongate penetrative feature such as needle to be at least partially non-parallel to a longitudinal axis, further facilitating performance of therapeutic injections at precise locations.

Abstract: A force actuated injection device including a body adapted to contain medication, a grip slidably disposed over the body, a lock disposed between the body and the grip, the lock when locked preventing movement of the grip relative to the body and when unlocked permitting movement of the grip relative to the body, a needle guard retractable relative to the body, a biasing member biasing the needle guard away from the body, and a resistance band disposed between the body and the needle guard adapted to resist initial needle guard retraction relative to the body, wherein force on the needle guard exceeding a predetermined amount overcomes a frictional force of the resistance band allowing the needle guard to retract relative to the body to unlock the grip relative to the body such that movement of the grip relative to the body causes medication to be delivered from the body.

Abstract: A needle or stylet has a tip contour with a reverse back bevel curved toward the longitudinal axis of the needle or stylet. The needle has a flexible intermediate portion and/or a two-part construction in which a distal portion of the needle to crimped onto a proximal portion of the needle. The needle or a stylet is combined with a spring mechanism in the hub of the needle or stylet assembly. The spring mechanism positions the tip of the needle or stylet in a middle position extending from the distal end of the assembly, allows the needle or stylet to be moved into a spring loaded fully retracted configuration within the assembly as the septal wall is tented, and then releasing the spring loaded needle or stylet as the needle or stylet penetrates the septal wall. A method of using a needle or stylet with a spring mechanism is included.

Abstract: An insert according to the invention includes a needle tube that has an inclined surface having a leading end opening, a needle base that has a chamber communicating with an inside of the needle tube and holds the needle tube, and a light introduction portion that communicates with the chamber and has an insertion path into which a light guide member is inserted.

Abstract: Embodiments of the invention provide apparatus, systems and method for introducing fluids into a body cavity for treatment. One embodiment provides an apparatus for treating a patient including an access device for insertion into the peritoneal cavity of the patient including an infusion member in a lumen of the access device. An oxygenated solution may be infused and removed into and out of the cavity via the infusion member.

Abstract: The present disclosure provides methods, uses and compositions and kits for use in inducing an antibody immune response in a human subject. The methods and uses involve administering parenterally a low dose volume of a composition comprising an antigen comprising a B-cell epitope, an amphipathic compound, and a hydrophobic carrier, wherein the low dose volume of the composition is less than 100 ?l and induces an antibody immune response to the B-cell epitope in the human subject.

Abstract: A needle-bearing hub for a pen needle is provided with a distal patient-facing side having an enlarged surface for contact with the subject's skin. The enlarged surface is provided with a radius of curvature that increases the likelihood that the needle reaches full injection depth when an injection is performed at an inclined angle with respect to the surface of the skin and with to the desired depth less discomfort to the patient.

Abstract: A delivery adapter which may be used as an interface between a syringe and a catheter hub is described.

Abstract: An inserter for a medical device, where the inserter includes a housing having a first end with an opening therein, an actuator connected to a first gear, an actuator biasing element, a cam gear assembly including a cam member and a second gear, a cam bridge follower in contact with the cam member, and a first plunger assembly having a first plunger and a first biasing element.

Abstract: The present invention relates to a handheld mechanical injection device by which set doses of a liquid medicament can be injected from a medical reservoir. The medicament is expelled through an injection needle by release of a power reservoir in the device, the power reservoir being fully or partially released by actuation of a user operable release member being positioned at or near an upper end of the injection device, the upper end being that end of the injection device which is opposite the injection needle.

Abstract: A penetrator assembly for penetrating a bone and associated bone marrow is provided. The penetrator assembly may include a first connector having a first end and a second end; an outer penetrator extending from the second end of the first connector; the outer penetrator comprising a longitudinal passageway and a first tip; a second connector having a first end and a second end; and an inner penetrator extending from the second end of the second connector, the inner penetrator comprising a second tip. The first connector may be configured to engage the second connector, and the inner penetrator may be disposed in the longitudinal passageway of the outer penetrator when the first connector is engaged with the second connector.

Abstract: Provided is an apparatus for injecting a lipolysis composition, the apparatus including a lipolysis composition storage, a pump, and at least one nozzle-type needle.

Abstract: The present invention teaches apparatuses, systems and methods for performing a variety of medical procedures, including those involving introducing one or more substances into a subject's body. In some embodiments, the invention teaches automatically performing guided injections into a tissue site (e.g. spinal cord) of a subject by using one or more electronically operated components including a cannula, a syringe pump, and a stereotactic device.

Abstract: According to the invention, a safety device for a pre-filled syringe with an injection needle comprises of a support body adapted to mount the pre-filled syringe, a needle shield slidably arranged with respect to the support body, a retention and locking means (M) for retaining and locking the needle shield with respect to the support body in a first and a second advanced position (PA1, PA2) and in a retracted position (PR). The needle shield comprises an annular flange adapted to rest on the skin of the patient receiving an injection. The retention and locking means (M) are arranged at a distal end of the safety device.

Abstract: A transdermal drug delivery apparatus includes a receptacle having a housing and a microneedle assembly mounted to the housing. The apparatus includes a reservoir for being mounted to the receptacle. The reservoir has an interior for containing fluid for being supplied to the microneedle assembly. The apparatus is adapted so that, when the apparatus is assembled, the reservoir is configured to move relative to the microneedle assembly along a path from an outer position to an inner position. The reservoir is closer to the microneedle assembly in the inner position than in the outer position. In the outer position, the reservoir is out of fluid communication with the microneedle assembly, and in the inner position, the reservoir is in fluid communication with the microneedle assembly. The apparatus also includes a plurality of connector parts spaced apart from one another along the path.

Abstract: A cannula for use in a terminable intraosseous device comprises a cannula body, and a penetrator-independent proximal bone penetration indicator (PBPI) associated with the body for positively indicating initial penetration into the proximal bone. In various embodiments, the PBPI comprises a roughened surface provided at a distal end of the cannula body to assist in increasing an amplitude of vibrations that are generated immediately upon contact with a proximal bone cortex during performance of an intraosseous injection, a resilient element fixed at one end which becomes plastically deformed, a visually indicative element which is exposed when the distance between the cannula body and penetrator is changed, or a frictionally engageable element. In some embodiments, a stopper prevents additional penetration into the proximal bone, and a reinforcing member inserted within a cannula body lumen reinforces a thin-walled portion of the cannula body.

Abstract: Embodiments are disclosed of a method of controlling timing and/or dosage of a transdermal drug patch. For example, a control device operative to move the patch to one or more of a plurality of operational relationships with a skin of a patient, including being fully engaged with the skin, partially engaged with the skin, and disengaged with the skin. The device may include a roller that peels a patch on and off the skin. Optionally a convention patch is used. In some embodiments a patch and/or an adaptor has a mobile zone and an immobile zone. In some embodiments, an active surface of the patch fully contacts the skin in an engaged state. For example the patch may be attached to the device on a passive portion thereof.

Abstract: Methods and apparatus for the reproducible, consistent and efficacious delivery of a therapeutic agent to a subject. The present disclosure comprises apparatus for the controlled administration of the therapeutic agent through an orifice to the subject, a plurality of penetrating electrodes arranged with a predetermined spatial relationship relative to the orifice, and an electrical signal generator operatively connected to the electrodes.

Abstract: Skin can be treated by piercing skin with a plurality of needles of an injection device and ejecting a dose of fluid therethrough. The device can include a housing, a plunger disposed in the housing, a cartridge disposed in the housing, and one or more dosing chambers. The plurality of needles can be coupled to the housing and be in fluid communication with the cartridge. Advancement of the plunger can cause a dose of fluid to be ejected from the plurality of needles.

Abstract: The present invention relates to applicators for administering microprojection arrays to skin and methods of administering microprojection arrays.

Abstract: An apparatus for use with a syringe to provide a safety syringe, the apparatus including: a sheath deployable for at least partially covering a needle of the syringe; a sheath actuator for deploying the sheath; and a ratioed mechanism linking the sheath and the sheath actuator and configured such that a magnitude of movement of the sheath is greater than a magnitude of movement of the sheath actuator during deployment of the sheath.

Abstract: A system and method for a modular external interface for a skin penetrating appliance is provided. The modular device prevents internalization of bacteria, other infectious agents, or other unwanted materials from entering the access point for a catheter, Steinman pin, Kirschner wires, or other percutaneous instruments. The modular external interface provides for the hermaticity in the vicinity of the skin-appliance interface with fluid exudate or transudate egressing from the vicinity of the skin-appliance interface. The modular external interface forms a hermetic seal with the external neck of an implanted appliance with a locking feature that joins the main body of the modular external interface together around the neck of the appliance. The modular external interface provides mechanical stability to an implanted appliance so as to speed healing around a semi-permanent implanted appliance, as well as connection points for vacuum lines and drive lines for the insertion of medical devices.

Abstract: Needle assemblies are disclosed having a multi-purpose protective cap. The needle assemblies can embody a catheter assembly having a catheter hub and a catheter tube or a hypodermic needle mounted on a needle hub. The multi-purpose cap includes a first section covering the needle and a second section having a base portion for covering a hub, such as a needle hub or a catheter hub. The first section and the second section are separable from one another along a detachment line and the second section is re-useable as a securement device.

Abstract: An image guided autonomous needle insertion device including a delivery system, a path planner, an image processor, and a human machine interface. The system also includes an ultrasound probe in communication with a frame grabber, a percutaneous insertion device, and at least a first actuator for moving the percutaneous insertion device within a first degree of freedom and a second actuator for moving the percutaneous insertion device within a second degree of freedom. Each actuator has a corresponding position sensor for detecting its location with respect to a target. The system can further comprise an image processor for removing noise and segmenting the ultrasound images to highlight potential targets.

Abstract: An injection pen comprises a starting mechanism (1) and a driving mechanism (2). A needle pin (40) of the starting mechanism (1) fitted to a connecting rod (30) and a front spring (60) is disposed in a front housing (10) and an inner casing (20) therein. A front cover (50) is disposed at the front end of the front housing (10) and covers the needle pin (40). A rear housing (70) of the driving mechanism (2) and a driving casing (80) therein are connected to the front housing (10). A trigger tube (90) and a key panel (A0) are mounted in the driving casing (80). A push rod (A1) fitted to a rear spring (A2) is mounted in the trigger tube (90). An elastic baffle (83) of the driving casing (80) fastens the driving casing (80) and the push Rod (A1) and locks the rear spring (A2). An injection needle group (3) can be mounted between the starting mechanism (1) and the driving mechanism (2).

Abstract: A detection device for recognizing the epidural space is provided. The detection device includes an upper case having a predetermined shape and a lower case coupled to the upper case to form a predetermined space part. A connection tube is provided at a predetermined position of the space part, one end of the connection tube communicates with a paracentesis needle part and the connection tube communicates with a pressure sensor for measuring pressure at a predetermined position of an outer peripheral part thereof. When the paracentesis needle part reaches the epidural space, the device allows a medicine injection catheter to be inserted into the connection tube thereby reaching the epidural space, with the connection tube and the paracentesis needle part connected to each other.

Abstract: The present disclosure is generally directed to a resettable drug delivery device for selecting and dispensing a number of user variable doses of a medicament. The drug delivery device comprises a housing, a cartridge holder, releasably attached to the distal end of the housing, a piston rod, engaging a housing insert and a drive member, a dose setting member, guided within the housing to allow rotation of the dose setting member during dose setting and dose dispensing, and a clutch for rotationally coupling the drive member and the dose setting member. The housing insert is rotationally constrained to the housing and is axially movable together with the drive member relative to the housing between a dose setting and dispensing position, and a resetting position. In the dose resetting position, the drive member is rotationally de-coupled from the housing.

Abstract: A punching device for punching a lumen and implanting an implant device includes at least the implant device for punching the lumen and for implantation into the lumen. In addition, the punching device includes an implantation device, a closure device, and an actuation device.

Abstract: The invention relates to a cannulation device (1) for providing an access to a patient through a skin of the patient, comprising a puncture needle (11) with a needle tip (113) for puncturing the skin of the patient and a cannula (12). The cannulation device (1) is characterized in that the puncture needle (11) is movably connected to the cannula (12).