Abstract: A prefilled syringe for injecting medicament into a patient includes a barrel constructed of a polymeric material, a cannula and a hub. The barrel has a diameter, a longitudinal axis, a proximal end and a distal end. The cannula has a proximal end and a tip opposite the proximal end. The proximal end of the cannula is fixed to the distal end of the barrel. The cannula is positioned generally coaxially with the longitudinal axis. The hub is integrally formed with the distal end. The hub includes a rib section and a cap. The rib section has a generally cruciform cross-section taken along a rib plane. The rib plane is generally perpendicular to the longitudinal axis. The cap has a generally U-shaped cross-section taken along a longitudinal plane. The longitudinal plane is generally parallel to the longitudinal axis.

Abstract: A combination of an irrigation sleeve 20 and a phacoemulsification needle 22. The irrigation sleeve 20 has a proximal end 32 and a distal end 30, the proximal end for attachment to a surgical handpiece. The phacoemulsification needle 22 has a proximal end 26, a distal end 24, and a lumen 38 spanning a length of the needle 22 from the proximal end 26 to the distal end 24. The needle proximal end 26 is for connection to the surgical handpiece, and the needle 22 has structure 44 proximate the needle distal end 24 for retaining the sleeve distal end 30 near the needle distal end 24.

Abstract: A method for directly delivering whereby a substance is introduced into an intradermal space within mammalian skin which involves administering the substance through at least one small gauge hollow needle having an outlet with an exposed height between 0 and 1 mm. The outlet is inserted into the skin to a depth of between 0.3 mm and 2 mm such that the delivery of the substance occurs at a depth between 0.3 mm and 2 mm.

Abstract: An embodiment of the claimed invention is a therapeutic delivery device having a plurality of fenestrations located around the circumference of its distal portion and an opening at the tip. The opening at the tip and the plurality of fenestrations reduce the injection resistance, making it easy to use, and ensure an even distribution of the injected material at the recipient location.

Abstract: A drug delivery device for delivering a drug to a preselected treatment site, includes a rupturable film capsule enclosing a quantity of the drug to be delivered; an array of micro-needles formed with passageways therethrough carried by the device; a covering layer overlying the capsule and forming a fluid-tight seal with the perimeter of the micro-needle array such that when the device is located with the micro-needles facing the treatment site, the application of pressure to the device causes the micro-needles to penetrate the treatment site and the capsule film to rupture to deliver the drug via the passageways to the treatment site; and an open mesh layer adjacent to the array of micro-needles effective, upon rupture of the capsule film, to uniformly distribute the drug to the micro-needles and also to reduce the possibility of clogging of the passageways.

Abstract: A transdermal patch that can easily deliver a controlled volume of a fluidic drug compound to skin is provided. More particularly, the patch contains a microneedle assembly that is configured to be placed in fluid communication with a drug delivery assembly. The microneedle assembly contains a support and a plurality of microneedles that extend outwardly from the support. The microneedles are formed with one or more channels of a certain dimension such that passive capillary flow drives a flow of the drug compound. The drug delivery assembly contains a reservoir for the drug compound that is in fluid communication with a rate control membrane that helps control a flow rate of the drug compound by modulating a pressure of the drug compound, downstream from the reservoir. A release member is also positioned adjacent to the microneedle and drug delivery assemblies. Prior to use, the release member acts as a barrier to the flow of the drug compound and thus inhibits premature leakage.

Abstract: An infusion set includes a base with a rigid piercing cannula or a soft catheter and rigid introducer needle. The infusion set also includes a line set with a fluid connector. The base and line set are configured such that the fluid connector can be used as a protector for the piercing cannula or the soft catheter, either before the device is attached to a user, or after the device is detached from the user, or both.

Abstract: A visually size-gauging hollow needle assembly having a needle, stylet, and hub. At least one of a needle sleeve, needle bedding, needle attachment compound, or external indicia is size-gauging, generally by color, to indicate different sized (gauging) needles. In some embodiments, a hub sidewall has at least one external surface with at least one humanly tactilely discernible surface feature indicating the rotational relationship between the hub and the needle. An operator pinching the hub between a thumb and forefinger thus immediately feels these surface features, which may reflect the position of a needle barrel. When the assembly is rotated between the thumb and forefinger, these orientation features rotate as well, and the difference in tactile sensation immediately alerts the operator to the position of the needle bevel.

Abstract: Therapeutics and methods of treatment to repair, preserve and grow cartilage are presented. In addition, systems and methods for delivering a therapeutic to a hard to reach anatomical area, such as, for example, the BCI, are presented. A cannulated delivery device provided with a cutting tip, cutting flutes and threads on its distal end is disclosed, as well as therapies for joint and cartilage repair, preservation and generation using it. Alternatively, for disc repair, a “PIARES” device for Percutaneous Intradiscal Annular Repair introduces therapeutics intradiscally. The device may have two-needles; a first cannula/needle with a finger grip, and a longer inner needle to penetrate through the outer needle into the disc, and introduce therapeutics via a syringe. When provided with a septum at the inner needle's proximal end, the PIARES device is a completely closed system; using it minimizes trauma.

Abstract: Biodegradable drug delivery systems, such as extruded implants, for the sustained delivery of a protein to an ocular region of the eye or intraarticular region in the body are described. The drug delivery systems may be used to treat a variety of ocular and medical conditions, including macular degeneration. Methods for using and making the drug delivery systems are also described. The drug delivery systems can be in the form of extruded filaments configured for placement in an ocular region such as the vitreous body or anterior chamber of the eye.

Abstract: A carrying case, which accommodates a pharmaceutical injection device for administering a pharmaceutical to a living body, comprises a case unit configured to accommodate the pharmaceutical injection device therein and a temperature regulation unit configured to regulate a temperature within the case unit. The temperature regulation unit includes: a cooling execution section configured to execute a cooling operation; a cooling fan configured to supply a cool air into the case unit; and a cooling control section configured to control the cooling execution section.

Abstract: A device and method for applying chemicals to internal tissue of living organisms, including the internal tissue of plants and animals, which organisms reside in mediums such as land, air or water. Piercing elements are engageable with a chemical reservoir in order to coat of the piercing elements with a chemical. Once coated, the piercing elements are used to pierce a living organism's tissue, such as plant tissue, to deliver the chemical.

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: A needle assembly 10 compromising an infusion needle 11 that includes a needle cannula 13 made of a superelastic material such as Nitinol. The needle cannula is cold-worked or heat annealed to produce a preformed bend 16 that can be straightened within passageway 21 of a coaxial outer cannula 12 for introduction into the body of a patient. Upon deployment from the outer cannula, the needle cannula substantially returns to the preformed configuration for the introduction or extraction of materials at areas lateral to the entry path of the needle assembly. The needle assembly can compromise a plurality of needle cannulae than can be variably arranged or configured for attaining a desired infusion pattern.

Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.

Abstract: The devices and methods shown provide for the minimization of extravasation during arthroscopic surgery. The anti-extravasation surgical portal plug allows a surgeon to drain excess fluids from the soft tissue surrounding the surgical field during arthroscopic surgical procedures.

Abstract: A guidance system for assisting with the insertion of a needle into a patient is disclosed. The guidance system utilizes ultrasound imaging or other suitable imaging technology. In one embodiment, the guidance system comprises an imaging device including a probe for producing an image of an internal body target, such as a vessel. One or more sensors are included with the probe. The sensors sense a detectable characteristic related to the needle, such as a magnetic field of a magnet included with the needle. The system includes a processor that uses data relating to the sensed characteristic to determine a 3-D position of the needle. The system includes a display for depicting the position of the needle. A needle assembly including a hub, cannula, and magnetic element is also disclosed, wherein a magnetic axis of the magnetic element is configured to be coaxially or otherwise aligned with the needle cannula.

Abstract: A needle assembly has a needle hub that has a body to which are formed two plates at opposite sides thereof in a parallel relationship. The plates have respective upper edges and lower edges that lie substantially along respective planes, so that the needle hub may be stably placed onto a surface by means of the respective edges. A partition is formed orthogonally proximate to the front ends of the parallel plates. The partition and the parallel plates together provide upper and lower three point stable supports for the needle hub. A notch at the partition provides a guided line of sight to the tip of the needle for the user. The connector at the proximal portion of the needle hub has a non-conventional configuration that allows it to mate only with a counterpart special connector of a fluid conveying device that has a complementary non-conventional configuration.

Abstract: An injection needle assembly includes a needle having a needle point to puncture skin, a needle hub including a first member which holds the needle, and a second member in which a discharge part of a syringe is to be fitted, and an elastic member disposed inside the second member to make liquid-tight close contact with the inner surface of the second member, with the elastic member having an insertion hole in which the needle tube is inserted.

Abstract: Arrangements and methods for delivering bioactive agents and/or cells into an extended volume of tissue are disclosed. In one embodiment, a cell-delivering needle arrangement has a tube positioned within a tube and fixedly attached to a wall thereof. In one exemplary method, a cell-delivering needle is advanced into tissue, a suspension of cells is passed through a first lumen and out of side ports, and a suspension of cells is passed through a second lumen and out of a distal opening. Other embodiments are disclosed.

Abstract: An apparatus and a method for use with a device for delivery of a therapeutic fluid into a body of a patient and/or for sensing of a bodily analyte are disclosed. The apparatus is adapted for accommodating at least one subcutaneously insertable element and at least one penetrating member for penetrating the skin of the patient. The apparatus includes a protective member having an elongate body from which the subcutaneously insertable element and the penetrating member can be protracted to penetrate the skin of the patient and into which the penetrating member can be retracted subsequent to the penetrating, thereby retaining the subcutaneously insertable element in the body of the patient.

Abstract: A one-piece connector for removing a housing and needle of a Huber needle assembly from a patient. The connector has a frame that can be positioned about a surface on the housing of the needle assembly and a pair of wings that pivot toward one another to provide a gripping surface.

Abstract: Apparatus for use with tissue (22) of a subject, including a substance (24) configured to be injected into the tissue, and first and second tissue-squeezing surfaces (20) configured to be placed on first and second sides of the tissue, to exert pressure on the tissue by being moved toward each other in response to a squeezing force (F), and to facilitate injection of the substance into the tissue by releasing the substance in response to application of the squeezing force.

Abstract: An infusion catheter system comprises a surgical needle and an infusion catheter. The infusion catheter has an internal bore; and the needle has a protrusion extending from its proximal end. The protrusion is adapted to mate with the internal bore of the infusion catheter. Through this innovative connection method, the needle can take the same diameter as the catheter. Therefore the puncture marks caused in the patient will have a smaller diameter than with conventional “introducer needles”, reducing pain, leakage and the chances of infection. Furthermore, the catheter may be introduced subcutaneously, further reducing the risk of infection by eliminating the risk of skin bacteria being drawn into the wound cavity.

Abstract: A medical fluid delivery system is provided including a steerable, guide catheter, a delivery catheter adapted for deployment at a targeted tissue site using the steerable guide catheter, the delivery catheter including a proximal port, a distal port, and a lumen extending between the proximal and distal ports; a distal fixation element coupled to the delivery catheter so as to position the distal port adjacent the targeted tissue site; and a flexible hollow needle adapted to be advanced through the delivery catheter lumen, the flexible needle including a tissue-piercing distal tip for extending from the distal port of the delivery catheter for advancement into the targeted tissue site and a proximal end for extending from the proximal port of the delivery catheter through which a medical fluid is delivered.

Abstract: A microneedle or microneedle device includes a microneedle body extending from a base to a penetrating tip formed from a silk fibroin based material, which is easy to fabricate and highly biocompatible. The microneedle device can include one or more microneedles mounted to a substrate. The silk fibroin can include active agents to be transported into or across biological barriers such as skin, tissue and cell membranes. The silk fibroin microneedles can be fully or partially biodegradable and/or bioerodible. The silk fibroin is highly stable, affords room temperature storage and is implantable. The silk fibroin structure can be modulated to control the rate of active agent delivery.

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 system and method for a patch-like, self-contained substance infusion device which can be attached to a skin surface via an adhesive contact surface. A push button activation assembly can then be used to remove an interlock, allowing a disk or Belleville spring assembly to apply an essentially even and constant pressure to the contents of a fluid reservoir assembly. This allows the release of one or more spring-loaded patient needles into the skin surface, and establishes a fluid communication path between the patient needles and the pressurized fluid reservoir contents thereby delivering an infusion into the skin. The push button activation assembly further allows the release of one or more improved safety mechanisms after use.

Abstract: Methods and compositions for treating post-myocardial infarction damage are herein disclosed. In some embodiments, a carrier with a treatment agent may be fabricated. The carrier can be formulated from a bioerodable, sustained-release substance. The resultant loaded carrier may then be suspended in at least one component of a two-component matrix system for simultaneous delivery to a post-myocardial infarction treatment area.

Abstract: Methods and compositions for treating post-myocardial infarction damage are herein disclosed. In some embodiments, a carrier with a treatment agent may be fabricated. The carrier can be formulated from a bioerodable, sustained-release substance. The resultant loaded carrier may then be suspended in at least one component of a two-component matrix system for simultaneous delivery to a post-myocardial infarction treatment area.

Abstract: A pen needle assembly is provided herein which includes: a hub having a body with a transverse wall; an arrangement for mounting the hub onto an injector; a first needle cannula extending distally from the transverse wall, the first needle cannula terminating at a distal end, formed for insertion into a patient, with a first lumen extending proximally from the distal end, the first needle cannula being of a first gauge; and, a second needle cannula extending proximally from the transverse wall, the second needle cannula extending from a distal end and terminating at a proximal end with a second lumen extending distally from the proximal end. The first and second lumens are in communication. Further, the second needle cannula is of a second gauge, the second gauge defining a larger external cross-section than the first gauge.

Abstract: Sealing connectors for use in connecting tubing to tubing, tubing to needles or other implements, syringe to tubing, or syringe to needles or other implements that provide reduced turbulence and sharp transitions are described herein.

Abstract: A device and method for accessing a pericardial space of the heart includes a shaft having a cavity at a distal end, a suction lumen terminating in a distal port within the cavity and a hollow needle having a distal tip extending into the cavity. The cavity may be a recess in the shaft into which the distal tip of the needle fixedly protrudes. In other embodiments, the cavity is formed by an inflatable member positioned at the distal end of the shaft and the needle is slidable relative to the shaft. Suction is applied at the cavity to draw a pericardial bleb. The needle pierces the pericardial bleb for accessing the pericardial space and also facilitates delivery of payloads into the pericardial space.

Abstract: A surgical access system comprises a trocar, an insufflating optical obturator slidably insertable into the trocar, and a laparoscope slidably insertable into the obturator. A distal end of the obturator comprises a tip, at least a portion of which comprises a wall with a generally uniform thickness comprising a transparent material. At least one vent hole disposed at the obturator tip is fluidly connected to a gas flow channel defined by an interior surface of the obturator and the laparoscope, which is fluidly connected to an insufflation gas inlet disposed at a proximal end of the trocar. Improved optical characteristics of the trocar system permit precise and accurate visual placement thereof into a body cavity. Accordingly the access system is suitable as a first entry surgical access system. Embodiments of the trocar access are also useful for drug delivery, and/or for fluid and/or tissue aspiration.

Abstract: An infiltration cannula and method of using the infiltration cannula during a tumescent infiltration procedure are disclosed herein. The infiltration cannula may have an outwardly flaring hub which may be wedged into an adit of a patient to minimize leakage of fluid being infiltrated into the patient. Also, the infiltration cannula may be utilized to hydrate a dehydrated patient by a medically untrained person. The infiltration cannula may also be used to deliver an antibiotic/vasoconstrictive drug solution to minimize surgical site infections.

Abstract: The present invention relates to injectable compositions comprising biocompatible, swellable, hydrophilic, non-toxic and substantially spherical microspheres useful for tissue bulking. The invention also relates to methods of tissue bulking, particularly for the treatment of Gastro-esophageal reflux disease, urinary incontinence, or urinary reflux disease, using the injectable compositions.

Abstract: Transvascular access devices and methods for transvascular access are provided. The transvascular access devices can include a guidewire lumen and a guide tube and stylet disposed in a second lumen. The guide tube can be used to control the orientation of the stylet and provide additional support for the stylet. The methods include providing a second entry point in a vessel of a patient remote from a first entry point. A vascular catheter can enter the vascular system of a patient at a first entry point and be advanced to a second entry point. A guide tube can be advanced out the second lumen of the vascular catheter with a stylet advanced out of the guide tube to pierce the vessel wall and skin of the patient at the second entry point. A catheter can be introduced to the vascular system at the second entry point.

Abstract: A regional anesthesia catheter used with a guide such as for example a needle cannula has a distal portion integrally connected to a main portion of the catheter by a junction portion that has a cross-sectional profile different from the distal and main portions, so as to predispose the distal portion of the catheter to move in a given direction when the distal portion is not guided by or constrained by the needle cannula. The cross-sectional profile of the junction portion may be configured in a particular shape, or be constructed to have a flexibility that predisposes the distal portion to bend, curve or move toward a given direction.

Abstract: Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The distal end of the sheath is maintained in the first, low cross-sectional configuration and expanded using a radial dilatation device. In an exemplary application, the sheath is utilized to provide access for diagnostic or therapeutic procedures such as ureteroscopy, cardiac electrophysiology, gastroenterology, and spinal access.

Abstract: The invention presented is a needle system to access a subcutaneous port primarily for the administration of chemotherapy, designed to protect the health care worker from inadvertent needle injury by isolation of the needle tip within base and tower components. A rotating collar is designed to keep the needle immobile until access of the port is desired when it can be rotated to align a cut out with a corresponding cut out of the tower that houses the needle for advancement of the needle downward into the port. On retraction, the collar can be rotated, locking the needle back into a retracted position within the tower.

Abstract: In one embodiment, the present invention provides a device and method for treating recurrent corneal erosion. In one embodiment, the method includes the steps of contacting an epithelium layer of a cornea with an array of glass micro-rods including a plurality of sharp features having a length that penetrates a Bowman's layer of the eye, wherein the plurality of sharp features of the array of glass micro-rods produces a plurality of punctures in the Bowman's layer of the eye that are of micro-scale or less. In another embodiment, the present invention provides a method and device for drug delivery. In one embodiment, the device includes an array of glass micro-rods, wherein at least one glass micro-rod of the array of glass micro-rods includes a sharp feature opposite a base of the array of glass micro-rods, wherein the sharp feature includes a treated surface for delivering a chemical compound to the eye.

Abstract: Fluid delivery systems, methods and devices for delivering a therapeutic fluid to the body of the patient are disclosed. A fluid delivery device for delivering fluid to the body of the patient includes a housing having an upper wall, a lower wall, and an opening. The device includes a well-arrangement mechanism disposed inside the housing. The well-arrangement mechanism includes a tubular member having a bore disposed between the wall openings. The device also includes a penetrating cartridge for delivery of therapeutic fluid to the body of the patient. The cartridge is configured to engage the bore following its insertion through the opening such that the therapeutic fluid can be delivered through the tubular member into the penetrating cartridge, and into the body of the patient, when the penetrating cartridge engages the bore.

Abstract: A needle assembly including a positive flush mechanism for use with a vascular access port. The needle assembly is configured to supply fluid to the port and to provide a positive flush to overcome negative pressures in the port that can potentially occur during withdrawal of the needle from the port.

Abstract: Provided are a microneedle and a microneedle array which have both aspects of safety and easiness to use and can administer a predetermined dose of a medical agent without causing a pain by smoothly running into the skin surface layer of a patient, the microneedle comprising a frustum and a forward end portion thereon, having a forward end apex angle in the range of 15 to 60° and a forward end diameter in the range of 1 to 20 ?m and satisfying the following expression (1), H/D?5??(1) (H: Height of the whole, D: Diameter of bottom surface of the frustum).

Abstract: A device for automatically delivering a drug to a user and method thereof are disclosed. The device (10, 20, 70, 110) provides a connector to which a vial (12, 50, 60, 100, 130, 202) containing the drug is removably connected and situated thereto in a substantially inverted position. When commanded by the user, the device (10, 20, 70, 110) starts a reconstitution process to automatically create a reconstituted drug, and provides an indication that the reconstitution process is complete such that the vial (12, 50, 60, 100, 130, 202) may be removed from the connector (22, 72,112). After disposing the device (10, 20, 70, 110) on the user, the device (10, 20, 70, 110) can automatically deliver the reconstituted drug to the user when further commanded by the user.

Abstract: A drug delivery assembly for use in association with an outlet port of an injection device, the assembly including a connector for association with the outlet port of the injection device, a skin interface element including a fluid flow channel in fluid connection with at least one hollow penetrating element deployed for penetrating into a biological barrier and a shield deployed to prevent inadvertent contact with said hollow penetrating element prior to use. The shield being retained in engagement with at least one of the connector and the skin interface element. The skin interface element is mechanically engaged with the connector so as to be displaceable relative to the connector between an inactive position and an active position. The motion of the skin interface element relative to the connector from the inactive position to the active position is effective to disengage retention of the shield.

Abstract: Sympathetic nerves run through the adventitia surrounding renal arteries and are critical in the modulation of systemic hypertension. Hyperactivity of these nerves can cause renal hypertension, a disease prevalent in 30-40% of the adult population. Hypertension can be treated with neuromodulating agents (such as angiotensin converting enzyme inhibitors, angiotensin II inhibitors, or aldosterone receptor blockers), but requires adherence to strict medication regimens and often does not reach target blood pressure threshold to reduce risk of major cardiovascular events. A minimally invasive solution is presented here to reduce the activity of the sympathetic nerves surrounding the renal artery by locally delivering neurotoxic or nerve-blocking agents into the adventitia. Extended elution of these agents may also be accomplished in order to tailor the therapy to the patient.

Abstract: The present invention provides a multi-directional needle assembly for injecting substance into at least one injection site of a patient's body, comprising: a. an elongated member having a distal end; said distal end having a plurality of openings disposed therein; b. a plurality of needles disposable at least partially within said elongated member, adapted to be reconfigured from a FOLDED configuration to a DEPLOYED configuration; said FOLDED configuration being characterized by the position of said needles within said elongated member; said DEPLOYED configuration being characterized by the protrusion of said needles out of said openings; the disposition of said openings is provided according to a predetermined scattering pattern such that (i) at least two separated areas within said distal end are provided for injection of said substance into at least two different injection locations at said injection site; and, (ii) a DEAD AREA between said two separated areas is obtained.

Abstract: The current techniques provide a system for monitoring a physiological parameter of a patient using microneedles that are coupled to an optical system, allowing spectroscopic measurements to be made immediately below the outer layer of the epidermis. In embodiments of the present invention, the results of the spectroscopic measurements are used to control the administration of a drug through an intravenous tube. In other embodiments, the microneedles may be coated with a drug for administration to the patient. In other embodiments, the microneedles may be mounted in a probe, wherein an actuator is used to move the needles into contact with the skin, and a drug delivery system is used to infuse the drug into the patient. A method for making needles is also provided.

Abstract: A mechanism for aligning a hypodermic needle or other probe with a predetermined location within a patient has a radio-transparent guide with a lengthwise slot for accommodating the needle. A pair of radiopaque rings spaced at opposite ends of the guide enables the surgeon to align the needle with the predetermined location and advance the needle in a continuous and steady movement toward the predetermined location in spite of the intermittent activation and deactivation of a two-dimensional x-ray apparatus. A slot in each of the rings, moreover, forming gaps in alignment with the lengthwise guide slot permit the guide to be removed as the needle approaches the predetermined location.