Abstract: A neural injection system and related methods are herein disclosed. Various embodiments of a neural injection system of the present invention provide for at least one benefit of enhanced injection characteristics, increased operational efficiency, reduced cost per unit, reduced incidence of injury through intraneural/intravascular injection, reduced incidence of injury through pricking/piercing, and/or the like.

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: Catheters assemblies having structural configurations operable to reduce backflow along the catheter assembly track, and methods of making and using such catheter assemblies. Catheters assemblies in accordance with embodiments of the present invention find use in various applications including the treatment of acute and chronic medical conditions. An exemplary catheter assembly includes, in one illustrative embodiment, a flexible proximal catheter body portion, and a distal portion of a smaller diameter than the body portion. The distal portion includes a sealed distal tip or end and one or more side flow openings to permit flow of therapeutic substance from the catheter along an axis that is different than, e.g., skewed relative to, a longitudinal axis of the distal portion of the catheter assembly.

Abstract: A disposable remote-injection syringe for use under and an endoscope, comprises a syringe needle (2), an inner tube (3), an outer tube (4) and a casing (10), the syringe needle (2) being arranged on one end of the inner tube (3), the inner tube (3) being arranged in the outer tube (4), the outer tube (4) being connected with the casing (10).

Abstract: The invention generally relates to a continuous anesthesia nerve conduction apparatus and method thereof, and more particularly to a method and system for use in administering a continuous flow or intermittent bolus of anesthetic agent to facilitate a continuous or prolonged nerve block. In one embodiment, the apparatus includes a sheath having a proximal end, a distal end and at least one lumen extending from the proximal end to the distal end. The sheath also includes an embedded conductive element for transmitting an electrical signal from a proximal portion of the sheath to a distal portion of the sheath. A cannula is arranged in the at least one lumen of the sheath and has a distal end protruding from a distal portion of the sheath. The cannula is electrically coupled to at least a portion of the embedded conductive element and is configured to provide nerve stimulation.

Abstract: The invention generally relates to a continuous anesthesia nerve conduction apparatus and method thereof, and more particularly to a method and system for use in administering a continuous flow or intermittent bolus of anesthetic agent to facilitate a continuous or prolonged nerve block. In one embodiment, the apparatus includes a sheath having a proximal end, a distal end and at least one lumen extending from the proximal end to the distal end. The sheath also includes an embedded conductive element for transmitting an electrical signal from a proximal portion of the sheath to a distal portion of the sheath. A cannula is arranged in the at least one lumen of the sheath and has a distal end protruding from a distal portion of the sheath. The cannula is electrically coupled to at least a portion of the embedded conductive element and is configured to provide nerve stimulation.

Abstract: An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system may also include a means to limit and/or adjust the depth of penetration of the ablative fluid into and beyond the tissue of the vessel wall. The catheter may also include structures which provide radial and/or lateral support to the guide tubes so that the guide tubes expand uniformly and maintain their position against the interior surface of the vessel wall as the sharpened injection needles are advanced to penetrate into the vessel wall.

Abstract: A process for making a microneedle array master comprises: (a) providing a photoreactive composition, the photoreactive composition comprising: (1) at least one reactive species that is capable of undergoing an acid- or radical-initiated chemical reaction, and (2) at least one multiphoton photoinitiator system; and (b) imagewise exposing at least a portion of the composition to light sufficient to cause simultaneous absorption of at least two photons, thereby inducing at least one acid- or radical-initiated chemical reaction where the composition is exposed to the light, the imagewise exposing being carried out in a pattern that is effective to define at least the surface of a plurality of microneedles. The microneedles may be solid and the outer surface of the microneedles may be characterized by at least one concave area. The master may be used to fabricate a tool for replication.

Abstract: Described is a needle hub comprising a proximal end adapted to engage a medicament delivery device, a distal end having an opening, a shoulder disposed between the proximal end and the distal end, and a needle assembly engagement mechanism (F1) coupled to the shoulder and adapted to releasably engage a needle assembly. The needle assembly engagement mechanism (F1) includes two or more resilient arms adapted to releasably engage a retainer element on the needle assembly.

Abstract: Methods and kits for delivering pharmaceutical agents to the adventitia and other regions outside the external elastic lamina (EEL) surrounding a blood vessel utilize a catheter having a needle. The needle is positioned in up to 5 mm beyond the EEL and delivers an amount of pharmaceutical agent sufficient to circumferentially permeate around the blood vessel and, in many cases, extend longitudinally and radially along the blood vessel. Confirmation that a delivery aperture of the needle lies beyond the EEL may be required before delivering the pharmaceutical agent.

Abstract: A bone marrow harvesting device includes a flexible bone marrow harvesting needle that can bend during operation to prevent the needle tip from piercing the inner cortical wall of the target bone. The needle defines an aspiration channel that defines an intake end that is recessed to reduce the instances that the aspiration channel will be fouled by bone particles or other debris within the cancellous portion.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device comprises a capsule sized to be swallowed and pass through the intestinal tract. The capsule can include at least one guide tube, one or more tissue penetrating members positioned in the guide tube, a delivery member, an actuating mechanism and a release element. The release element degrades upon exposure to various conditions in the intestine so as to release and actuate the actuating mechanism. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: A penis erection stimulation system comprises a fully implantable drug delivery device for delivering a drug in relation to a penis to achieve erection of the penis. The drug delivery device may comprise a catheter adapted to be implanted in the corpora cavernosa of a penis or in close proximity thereto in order to deliver drugs through said catheter. Alternatively, one or more infusion needles may be disposed within and implanted along with one or more housings adjacent the patient's left and right corpora cavernosa. A reservoir and a pump may also be implanted inside the patient's body to supply the infusion needle with infusion liquid.

Abstract: Disclosed are biodegradable microspheres between 40 ?m and 200 ?m in diameter that are effectively retained in the anterior chamber of the eye without producing hyperemia. The microspheres generally contain a drug effective for the treatment of an ocular condition and include a biodegradable polymer matrix that can provide for the sustained (>7 day) release of the drug following administration to the anterior chamber of the eye. Methods for making and using the microspheres to treat an ocular condition are also disclosed.

Abstract: An injection needle 1 made of an alloy containing cobalt and molybdenum is manufactured as follows. First, lancet cut is carried out to a pipe-like metallic material composed of the alloy containing cobalt and molybdenum to form a blade tip 3 and a blade part 5. Then, a distal end part 1A including the blade tip 3 is mechanically polished, and thereafter, the distal end part 1A is immersed in an electrolytic solution and electrolytically polished. Thus, burrs at the blade tip 3 or the like generated during mechanical polishing are removed. Since the injection needle 1 is composed of the alloy containing cobalt and molybdenum, compared to a conventional injection needle made of stainless steel, an injection needle in which surface roughness of an inner peripheral surface of the injection needle is low and smooth can be provided.

Abstract: The present invention provides methods of delivering a composition comprising nanoparticles that comprise a macrolide and an albumin by directly injecting the nanoparticle composition into the blood vessel wall or the tissue surrounding the blood vessel wall. The methods can be used for inhibiting negative remodeling or vascular fibrosis in the blood vessel and are useful for treating various diseases.

Abstract: The present invention relates to plastic microneedle strips (10) that are used in transdermal drug delivery for increasing the drug delivery rate through the skin These microneedle strips (10) are mass produced singly or in a cluster (100) via precision injection moulding process, and may be assembled to form microneedle arrays subsequently. The individual microneedle strips can further broken into individual microneedles for other medical applications. The making of the mould (200) for precision injection moulding process is also provided.

Abstract: Embodiments of the invention provide multi-stage biodegradable drug delivery platforms and methods for the subcutaneous delivery of therapeutic agents (TA). Embodiments of the platform may be configured to subcutaneously deliver a first dose of a first TA which is absorbed into the body and/or blood stream (BBS) to produce a first therapeutic effect for a first selectable time period (STP), and subsequently after a second STP, deliver a second dose of a second TA which is absorbed into the BBS to produce a second therapeutic effect for a third STP. An embodiment of the platform may comprise a body having a tissue-penetrating end, a primary cavity having a first TA dose and a shell having a secondary cavity having a second TA dose. The first TA dose is released after the first STP and the second TA dose is released after the second STP by biodegradation of the shell.

Abstract: This invention provide novel compositions, methods and devices for sustained drug delivery. The microencapsulated sustained drug delivery compositions are deposited using oscillating needle apparatus oscillating at 10-12000 minutes per minutes. The injected compositions may undergo variety of physical chemical changes upon deposition. The physical and chemical changes enables improved drug encapsulation and sustained drug release. Also described are new methods to form polymer microparticles or polymer films/implants in situ inside the tissue. The invention also describes colored biodegradable microparticle based compositions wherein the compositions comprise drug encapsulated microparticles and coloring agent encapsulated microparticles mixed in any proportion. Medical applications of the compositions and methods described in this invention are also described.

Abstract: Medical guide devices, systems and methods are provided, comprising a base member and a rotatable medical guide component seated on the base member. The guide component defines a path extending through the guide component. The guide component includes a first radio-opaque marker located at a first end of the guide component corresponding with an entry point of the path and a second radio-opaque marker located at a second end of the guide component corresponding with an exit point of the path, and the second end is opposite the first end.

Abstract: An infusion set adapted to be secured to a skin surface includes a fixed base member and a movable slide member. The fixed base member is connectable to the skin surface. The movable slide member has a needle or cannula connected thereto and is movable relative to the fixed base member. The movable slide member is movable from a first position in which the needle or cannula is not exposed externally of the fixed base member to a second position in which the needle or cannula is exposed externally of the fixed base member. A hub is fixedly connected to the movable member and has a slot extending rearwardly in a lower surface from a first end thereof. The needle or cannula is received in the slot. The movable slide member is locked to the fixed base member in the second position.

Abstract: Methods and apparatus are provided for treating tissue with apparatus that includes an priming portion for initiating a healing response in the tissue to be treated, and which delivers a bioactive agent during or after preparing tissue adjacent the apparatus, as by generating or aiding a healing, regeneration or repair response in the tissue. The priming portion may comprise an abrasive surface, fluid ejection ports, and/or stimulation by electrical, thermal, or light energy.

Abstract: The present disclosure relates to devices for injecting material into a body. The devices include a housing having a deployment cannula extending therefrom. The device also includes a rotary drive member wherein rotational movement of the drive member relative to the housing results in linear movement of an elongated injection member within a lumen of and out of a distal end opening of the deployment cannula. The elongated injection member includes a proximal end portion that may have a Tuohy-Huber tip and/or varying radii therealong.

Abstract: A non-coring needle for use in accessing an implanted medical device is disclosed. The non-coring needle is configured so as to include a compact bevel face relative to standard non-coring needles. In one embodiment, the non-coring needle comprises a hollow cannula that defines a lumen and terminates at a sharpened distal tip. The cannula includes a proximal portion and a bent distal portion. The distal portion defines a bevel face extending proximally from the distal tip, and the bevel face includes the lumen distal opening. The bevel face defines an open angle of at least about one degree with respect to a longitudinal axis of the proximal portion of the cannula. The bevel face is also laterally offset from the proximal portion of the cannula by an offset distance of no more than about 0.010 inch. A portion of the bevel face is dulled to prevent access port septum coring.

Abstract: A method of forming a microneedle array can include forming a sheet of material having a plurality of layers and micromilling the sheet of material to form a microneedle array. At least one of the plurality of layers can include a bioactive component, and the microneedle array can include a base portion and plurality of microneedles extending from the base portion.

Abstract: A Veress needle assembly comprises an outer steel tube with a sharpened tip at the distal end surrounding an inner rod having a blunt distal end. The proximal end of the inner rod is spring biased towards a position in which its distal end extends beyond the distal end of the outer stainless steel tube so that while piercing the wall of a body cavity the inner rod is forced upwardly against the spring bias to allow the sharpened end of the outer tube to extend into a cutting position. An indicator light supported on the proximal end of the assembly is controlled by a switch which is in a first position when the outer tube is passing through the wall of the body cavity and a second position when the outer tube enters the body cavity behind the wall, allowing the rod to move beyond the distal end of the outer tube, thereby changing the illumination of the light source so that the operator is signaled that the Veress needle has passed into the body cavity.

Abstract: The invention relates to a device for guiding a medical needle, including said medical needle (1) and an insert (2) that is rotatably, translatably, and slidably arranged in the needle (1), wherein said device is characterized in that the insert (2) has, in the free state thereof, a curved distal portion (21), and in that the needle has at least two regions (11, 12), the mechanical behaviors of which are different, wherein the mechanical behaviors of each region (11, 12) and of the curved distal portion (21) of the insert are selected such that a movement of the insert (2) into the needle (1) causes a local deformation of the needle and/or of the insert. The invention also relates to a method for manufacturing said device.

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: A regular metallic, cylindrical tubular needle cannula (1) is subjected to a metal etching liquid (5) in the inside lumen (11) thereby increasing the inside diameter and enhancing the flow properties while maintaining the outside appearance. The inside diameter is only increased over a controlled length (14) of the full length of the needle cannula (10) leaving sufficient length and wall thickness to also taper the outside diameter if so wanted.

Abstract: Methods and devices for detecting positioning of a probe in a tissue of a patient. A method can include providing a detection device; advancing a device coupled probe through the tissue of the patient and toward the patient's spinal canal; detecting a change in pressure about the distal portion of the coupled probe during advancing, where the detected pressure change indicates probe positioning in the patient's spinal canal; outputting the detected pressure change or indication of probe positioning to a visual display.

Abstract: A delivery system for implanting a medical device into the body of a patient or subject and a method of use thereof. The delivery system includes a delivery catheter having a catheter lumen and an inner member extending therethrough. The inner member includes a distal tip portion, a proximal portion, and an intermediate portion, the intermediate portion being disposed adjacent to the distal end of the delivery catheter. A first sealing member, positioned near a distal end of the proximal portion, forms a fluid seal between the inner member and an inside surface of the delivery catheter. A second sealing member, positioned near a proximal end of the distal tip portion, forms a fluid seal between the inner member and an inside surface of the delivery catheter. The intermediate portion extends between the first seal and the second seal. In one embodiment, a medical device and a hydrating fluid are present in a device-containing region between the intermediate portion and the delivery catheter.

Abstract: A method for manufacturing a needle-equipped outer tube includes providing a needle; providing a joint member having a needle insertion hole into which the needle is insertable; providing an outer tube comprising a connection section at a first axial end portion of the outer tube; pressing the joint member, with the needle located in the needle insertion hole, toward the connection section, such that the joint member engages with the connection section of the outer tube; and thermally welding the needle and the joint member, as well as the joint member and the connection section, such that the needle is joined to the joint member, and the joint member is joined to the connection section of the outer tube.

Abstract: An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system may also include a means to limit and/or adjust the depth of penetration of the ablative fluid into and beyond the tissue of the vessel wall. The catheter may also include structures which provide radial and/or lateral support to the guide tubes so that the guide tubes expand uniformly and maintain their position against the interior surface of the vessel wall as the sharpened injection needles are advanced to penetrate into the vessel wall.

Abstract: Provided herewith is a needle for delivering dermal filler thread to a wrinkle in a patient. The needle can also be used to deliver the thread to a patient for the purposes of facial contouring. The needle comprises a coupler for attaching the thread to the needle and also a trocar to ease delivery through the skin.

Abstract: Implantable infusion devices configured to improve fill and evacuation procedures.

Abstract: A vascular access device for reproducible insertion of a cannula, comprising a carrier, a holder and a guide device, such that the guide device is designed as an inclined plane on one side and serves to support and guide a cannula, so that accurate guidance of the cannula is ensured, always in the same puncture angle and at the same depth of penetration in a puncture channel.

Abstract: This invention provides methods of preventing, reducing or inhibiting one or more symptoms of a tear film disorder by administration to a subject mesenchymal stem cells.

Abstract: A method of stress relieving drilled surgical needles is disclosed. At least the metal about a drilled bore hole is heat treated to relieve stress without annealing.

Abstract: An infection treatment system includes a first intramedullary rod for placement within an intramedullary canal and including a superior portion having a superior end, an inferior portion having an inferior end, and a shaft extending longitudinally between the superior and inferior portions. The shaft includes longitudinally extending channels. A second intramedullary rod for placement within an intramedullary canal includes a superior portion having a superior end, an inferior portion having an inferior end, and a shaft extending longitudinally between the superior and inferior portions. The shaft includes longitudinally extending channels. A coupler is operatively attached to the rods. The coupler has a superior face, an inferior face, an anterior face, a posterior face, a first lateral face and a second lateral face. At least one of the faces includes at least one opening in fluid communication with at least a portion of the channels of the first and second rods.

Abstract: The present invention is directed to methods and compositions for accomplishing systemic delivery of minimally-soluble bioactive agents such as, but not limited to, proteins of the TGF-? superfamily via a peripheral mode of administration. According to the invention, an exemplary bioactive agent is BMP-7. The invention further provides for minimally-invasive systemic treatment of skeletal disorders such as osteoporosis as well as minimally-invasive systemic treatment of injured or diseased non-mineralized tissues and organs such kidneys. Practice of the invention eliminates adverse side effects at the peripheral site of intravenous administration of the bioactive agent.

Abstract: An introducer, including a needle, a guide shaft, and a sheath, that can be used to place an access cannula into a blood vessel. In an embodiment, the guide shaft includes a Doppler flow sensor, allowing a user to easily identify a vein or artery beneath the skin. In another embodiment, the guide shaft also includes a pressure sensor.

Abstract: A system of catheter devices and methods for forming channels or passageways between a luminal anatomical structure (e.g., a blood vessel) and a target location (e.g., another blood vessel, an organ, a mass of tissue, etc.) for the purpose of rerouting blood flow or for delivering a substance or instrument, etc. to the target location.

Abstract: An endoscopic needle device comprises a handle and a catheter sheath connected to the handle, wherein the catheter sheath has at least one lumen, for example a needle lumen and a stabilization lumen, extending therethrough. A needle is selectively movable within the needle lumen between a needle retracted position and a needle extended position and a stabilization element is selectively movable within the stabilization lumen between a stabilizer retracted position and a stabilizer extended position. A linking mechanism may operatively connect the needle and the stabilization element so that when the needle is in the needle retracted position the stabilization element is in the stabilizer extended position and when the needle is in the needle extended position the stabilization element is in the stabilizer retracted position.

Abstract: Various embodiments may include methods of manufacture of a retrofitted neural injection system. Various embodiments may include acquiring an injection needle comprising a hollow cannula with an open distal end. Then, forming an at least one side port in the hollow cannula proximate to the distal end. Then, sealing the open distal end of the hollow cannula with a bio-compatible sealant so as to eliminate fluid communication between the inside and the outside of the hollow cannula via the distal end. In some embodiments, the bio-compatible sealant may be comprised of a thermosetting material. In some embodiments, the bio-compatible sealant may be comprised of a cured epoxy resin. In some embodiments, the bio-compatible sealant may be comprised of an aliphatic polymer. In some embodiments, the bio-compatible sealant may be comprised of an polyfluorocarbon.

Abstract: A fine metal structure having its surface furnished with microprojections of high strength, high precision and large aspect ratio; and a process for producing the fine metal structure free of defects. There is provided a fine metal structure having its surface furnished with microprojections, characterized in that the microprojections have a minimum thickness or minimum diameter ranging from 10 nanometers to 10 micrometers and that the ratio between minimum thickness or minimum diameter (D) of microprojections and height of microprojections (H), H/D, is greater than 1.

Abstract: A method of coating a microneedle array by applying a coating fluid using a flexible film in a brush-like manner. A method of coating a microneedle array comprising: providing a microneedle array having a substrate and a plurality of microneedles; providing a flexible film; providing a coating solution comprising a carrier fluid and a coating material; applying the coating solution onto a first major surface of the flexible film; performing a transfer step of bringing the first major surface of the flexible film into contact with the microneedles and removing the flexible film from contact with the microneedles; and allowing the carrier fluid to evaporate.

Abstract: An endoscopic instrument comprises a first flexible insertion member sized for insertion through a body lumen to a target site and a needle coupled to the insertion member for penetration of tissue, the needle including a plurality of flexibility enhancing grooves formed therein along at least a first portion of the length of the needle.

Abstract: Described is a needle assembly comprising a needle and a needle hub adapted to carry the needle. The needle hub includes a proximal portion adapted to engage a medicament delivery device having a first thread and a cover portion adapted to abut a distal surface of the delivery device. The proximal portion includes a second thread adapted to engage the first thread, and the second thread is offset from the cover portion by a first distance.

Abstract: The present disclosure relates to a catheter device comprising a catheter hub in which a valve member is disposed, a needle fixed in a needle hub, the needle extending through the valve member in the catheter hub in a ready position, and a tubular receptacle in which the needle hub is displaceably guided and biased by a spring in a proximal direction relative to the receptacle, wherein the needle hub is releasably held in the ready position in the receptacle against the force of the spring by frictional force between needle circumference and catheter or catheter hub, which frictional force is reduced on retraction of the needle through the catheter hub such that the force of the spring prevails.

Abstract: An optical spectroscopic injection needle assembly. According to one embodiment, the assembly may include an injection needle, a light source, a spectrometer, a computer and an indicator. The injection needle, in turn, may include a hollow outer needle, a hollow inner needle, a pair of optical fibers, an inner catheter, an outer catheter, an inner hub and an outer hub. The proximal end of the outer needle may be fixedly mounted within the distal end of the inner catheter. The distal end of the inner hub may be fixedly mounted on the proximal end of the inner catheter, the proximal end of the inner hub being suited for connection to a syringe. The inner needle, as well as the distal ends of the optical fibers, may be positioned within the outer needle and may be held in place by an optical bonding material. The proximal ends of the optical fibers may extend from a side arm of the inner hub, one fiber may be coupled to the light source, the other fiber may be coupled to the spectrometer.