Abstract: A medical manipulator includes: an end effector provided at a distal side of the medical manipulator; a proximal housing provided at a proximal side of the medical manipulator; and an elongated portion coupled to both the end effector and the proximal end. The elongated portion includes: a first elongated member coupled to both the end effector and the proximal housing; a second elongated member coupled to only either one of the end effector and the proximal housing, the second elongated member being configured to form by surrounding the first elongated member; and to be slidable in a longitudinal direction relative to the first elongated member; and a third elongated member coupled to both the end effector and the proximal housing, the third elongated member being configured to form an exterior of the elongated portion by surrounding the second elongated member.

Abstract: The subject invention provides a drug delivery device for injecting medicament which includes a tubular reservoir; a stopper slidably disposed in the reservoir; a spring for moving the stopper in the reservoir; at least one needle, the needle having a distal end for insertion into a patient, and a lumen extending proximally from the distal end, the lumen being in direct or indirect communication with the reservoir; a needle driver for displacing the needle; and an actuator. Activation of the actuator causes the spring to move the stopper and the needle driver to displace the needle. The needle moves relative to, and separately from, the reservoir with the needle being displaced. Advantageously, with the subject invention, a drug delivery device is provided wherein a needle is moved, relative to the reservoir, in being displaced for injection. This permits control of the needle displacement separate from the reservoir.

Abstract: The present disclosure relates to systems and methods for activating a circuit of an implant device. Consistent with one implementation, an implant device is provided with a sensor including a working electrode (WE) and a counter electrode (CE). The sensor may be configured to generate a first current at the CE when the implant device is implanted in a body of a subject. A sensing circuit may also be provided that is electrically coupled to the WE of the sensor. The sensing circuit may be activated based on the first current and utilize the sensor to measure one or more parameters of an individual or other subject.

Abstract: Certain embodiments provide multi-medicament or single medicament infusion systems for preventing the cross-channeling or improper delivery of medicaments. The system may include one or more of an infusion pump, medicament cartridges, cartridge connectors, a multi-channel fluid conduit, and an infusion set. The medicament cartridges may be sized and shaped differently such that the medicament reservoirs can only be inserted into the pump under selected configurations.

Abstract: An auto-injector is provided which includes a housing with a syringe slidably received therein. The syringe has a barrel with a piston movable therein and a needle extending therefrom. The piston is releasably secured to one end of a plunger which is slidably secured within a body in the housing and is operable through a bias provided by a motive source. In use, the plunger moves under the bias from a loaded condition to a discharged condition to move the syringe so that the needle extends from a tip at an injection end of the housing and to slide the piston within the barrel to expel the contents of the syringe. The plunger is held in the loaded condition against the bias by a detent extending from the body and which can be selectively released by operation of an actuator when pressure is applied to the tip.

Abstract: An extracorporeal blood treatment apparatus is provided comprising a filtration unit (2) connected to a blood circuit (17) and to a dialysate circuit (32), a preparation device (9) for preparing and regulating the composition of the dialysis fluid; a control unit (12) is configured for receiving a conductivity or sodium concentration set point for the dialysis fluid and for calculating a mass transport of a substance at an instant t of a treatment session based on said set value of the parameter for the dialysis fluid in the dialysis supply line (8).

Abstract: The present invention generally provides a device for inserting needles and alleviating the discomfort associated with needle insertion. In certain embodiments, the device is suited for injecting butterfly needles and particularly butterfly needles that are attached to infusion tubing. The patient or caregiver loads a butterfly needle with tubing attached into the base of the drive plunger. The needle with tubing attached is retracted into the housing of the device by retracting the inner plunger. Once retracted, the device is activated and ready to administer a needle into the tissue of a patient. The device is then placed on the location of the skin where injection is desired. The surface that contacts the skin may be textured and may include a contact switch that causes the device to vibrate when slight pressure is applied through contact with the skin.

Abstract: Self-righting articles, such as self-righting capsules for administration to a subject, are generally provided. In some embodiments, the self-righting article may be configured such that the article may orient itself relative to a surface (e.g., a surface of a tissue of a subject). The self-righting articles described herein may comprise one or more tissue engaging surfaces configured to engage (e.g., interface with, inject into, anchor) with a surface (e.g., a surface of a tissue of a subject). In some embodiments, the self-righting article may have a particular shape and/or distribution of density (or mass) which, for example, enables the self-righting behavior of the article. In some embodiments, the self-righting article may comprise a tissue interfacing component and/or a pharmaceutical agent (e.g., for delivery of the active pharmaceutical agent to a location internal of the subject).

Abstract: Self-righting articles, such as self-righting capsules for administration to a subject, are generally provided. In some embodiments, the self-righting article may be configured such that the article may orient itself relative to a surface (e.g., a surface of a tissue of a subject). The self-righting articles described herein may comprise one or more tissue engaging surfaces configured to engage (e.g., interface with, inject into, anchor) with a surface (e.g., a surface of a tissue of a subject). In some embodiments, the self-righting article may have a particular shape and/or distribution of density (or mass) which, for example, enables the self-righting behavior of the article. In some embodiments, the self-righting article may comprise a tissue interfacing component and/or a pharmaceutical agent (e.g., for delivery of the active pharmaceutical agent to a location internal of the subject).

Abstract: Techniques for providing therapy to a patient via electrical stimulation are described. The techniques include, for example, determining, relative to a start time of providing the electrical stimulation, one or more efficacy times that correspond to an efficacy indicator, determining, according to the efficacy times, efficacy data items for the patient, comparing the efficacy data items with the efficacy indicator, and generating, based on the comparison, a prediction of an expected response to the therapy manifesting in the patient at a prospective time.

Abstract: Improved sub-assemblies and methods of control for use in a diagnostic assay system adapted to receive an assay cartridge are provided herein. Such sub-assemblies include: a brushless DC motor, a door opening/closing mechanism and cartridge loading mechanism, a syringe and valve drive mechanism assembly, a sonication horn, a thermal control device and optical detection/excitation device. Such systems can further include a communications unit configured to wirelessly communicate with a mobile device of a user so as to receive a user input relating to functionality of the system with respect to an assay cartridge received therein and relaying a diagnostic result relating to the assay cartridge to the mobile device.

Abstract: A kit for enabling delivery of an active compound to the skin for penetration into the skin, a delivery device for delivering an active compound, and a method of delivery of an active compound are provided. An active compound delivery kit for enabling delivery of an active compound into the skin of a subject includes an arrangement for providing a pathway into a biological barrier of a subject in an application zone, an active compound provided in dry form, and a delivery device for delivery of dissolved active compound to the application zone. Provision of a pathway into the biological barrier, preferably skin, is provided and the active compound applied in optimum form within a short time frame after forming the pathway ensuring treatment of the desired skin cells is optimised.

Abstract: A needle hub (10) for a pen needle is provided with an enlarged surface for contact with the skin of a patient. The enlarged surface is provided with a surface having a dimension and shape to enable a needle or cannula to penetrate the skin to a desired depth and permit substantially the entire exposed length of the needle or cannula to penetrate the skin to the desired depth. The surface of the needle hub can be formed by an inner cone shaped member (26) forming a first contact surface with a surface area of about 1-5 mm2 and an outer ring (28) at a peripheral edge forming a second contact surface with a combined surface area of about 15 to 50 mm2.

Abstract: The invention relates to a method for inverting the diaphragm of a filled and capped container. According to the invention, the container is placed on a support ring of an inversion device, a pressing member is applied to the container and a pusher is raised through the support ring to invert the diaphragm and shape the diaphragm into an arch. While the pusher inverts the diaphragm, the seat is moved away from the upper plane of the support ring, so that when the pusher reaches the raised position, a space is opened between the seat and the support ring to enable a longitudinal expansion of the container under the combined effect of the increase in internal pressure caused by the decrease in the volume due to the inversion and the forces generated inside the container by the pusher and the support member.

Abstract: Various embodiments of bulking or cushioning agents or material and related medical devices and methods are disclosed. For example, a method of performing a medical procedure in a tract of a body may include injecting a material in a liquid phase proximate a target site between a first tissue layer and a second tissue layer, allowing the material to transition from the liquid phase to the gel phase in response to a raise in temperature of the material to approximately at or above the predetermined temperature, and performing a surgical procedure on the target site. The material may have the liquid phase at temperatures below a predetermined temperature and a gel phase at temperature approximately at or above the predetermined temperature.

Abstract: A system and method for correcting a volume of fluid delivered by a fluid injector during an injection procedure is described. The method included determining and compensating for a volume factor associated with compliance of the fluid injector system and correcting for the volume by one of over-driving the distance that the drive member travels in a fluid reservoir, under-driving the distance that the drive member travels in the fluid reservoir, or lengthening or shortening a fluid delivery time.

Abstract: The present disclosure relates to relates to systems and methods for on-demand delivery of a therapeutic agent from an eye mounted device. Particularly, aspects of the present invention are directed to a method of delivering a therapeutic agent, the method including receiving, at a controller of a therapeutic agent release and delivery device, a first command signal for delivery of a therapeutic agent based on a dosing time window. Upon receipt of the first command signal, the controller determines whether one or more compliance conditions are satisfied. When the one or more conditions are satisfied, the controller initiate a release and delivery protocol that commands a signal generator to generate and send a second command signal causing a capacitor or one or more circuits to deliver an actuation signal causing one or more therapeutic agent delivery mechanisms to open and release the therapeutic agent from one or more reservoirs.

Abstract: A medicament delivery system, including a medicament container and a delay mechanism that is activated prior to completion of medicament delivery from the medicament container. The delay mechanism automatically activates a subsystem or initiates an operation subsequent to completion of medicament delivery.

Abstract: An insertion mechanism for a drug delivery device including a trocar, a housing, and a manifold in fluid communication with a fluid pathway connector and movable relative to the housing between a first manifold position adjacent to a proximal end of the housing and a second manifold position adjacent to a distal end of the housing. A hub carrying the trocar or hollow delivery needle is removably connected to the manifold, the hub being movable relative to the housing between a first hub position adjacent to the proximal end of the housing and a second hub position adjacent to the distal end of the housing. A power source is configured to generate rotational motion. A motion conversion mechanism operatively connects the power source and the hub, and is configured to convert the rotational motion into linear motion of the hub.

Abstract: Infusion devices, systems, and related operating methods are provided. A method of detecting an anomalous condition with respect to a fluid path based on operation of an actuation arrangement configured to deliver fluid via the fluid path involves providing input power to the actuation arrangement to produce actuation of the actuation arrangement, identifying an active amount of actuation of the actuation arrangement concurrent to the input power being provided to the actuation arrangement, disabling the input power to the actuation arrangement, identifying a passive amount of actuation of the actuation arrangement after disabling the input power to the actuation arrangement, and detecting the anomalous condition based on a relationship between the active amount and the passive amount.

Abstract: Disclosed herein are several embodiments of a negative pressure apparatus and methods of using the same in the treatment of wounds. Some embodiments are directed towards improved fluidic connectors configured to transmit irrigation fluid and to apply aspiration to a wound, for example using softer, kink-free conformable layers. Some embodiments may comprise a first channel for delivering irrigation fluid to the wound and a second channel for transmitting negative pressure and removing fluid comprising irrigation fluid and wound exudate from the wound, wherein the channels comprise a flexible spacer material. Some embodiments are directed toward an irrigation manifold attachable to or incorporated as part of a distal end of an irrigation and aspiration fluidic connector.

Abstract: A method and apparatus are disclosed for an optimized transseptal procedure for providing left heart access, that reduces the number of devices that are used in order to minimize procedural time, complexity and cost. The apparatus comprises a hybrid dilator that comprises the combined functionality of a transseptal sheath and dilator assembly. The hybrid dilator comprises: a dilator shaft defining a lumen for receiving a crossing device therethrough, the dilator shaft being structured to provide support for the crossing device when the crossing device is used to create a puncture in a tissue; and a distal tip having an outer diameter which tapers down to an outer diameter of the crossing device for providing a smooth transition between the crossing device and the distal tip when the crossing device is inserted through the lumen and protrudes beyond the distal tip.

Abstract: A dispensing device is provided to dispense a designated amount of a material on every dose delivery operation. The dispensing device includes a thumb pad, a cam drum coupled to the thumb pad, and a pawl nut comprising a one-way pawl. The thumb pad may be pulled out in a direction away from a distal end of the dispensing device for setting a dose of the material to be dispensed out and may be pushed in towards the distal end for delivering the dose. The cam drum includes a plurality of linear cam profiles and a plurality of helical cam profiles that may be disposed on a surface of the cam drum. The one-way pawl may engage with a ratchet disposed at a distal end of the cam drum and may prevent a rotation of the cam drum in an undesired direction.

Abstract: A drug delivery assembly is used for delivering a medicament to a patient. The assembly includes a main body having a housing and defining a recess, with an actuator associated with the housing. An adhesive pad, configured to attach to a human body surface, is associated with a lower surface of the housing. The assembly also includes a cartridge configured to be at least partially inserted into the recess and having: a cartridge housing, a drug reservoir positioned within the cartridge housing, a stopper movably associated with the drug reservoir, and a needle movably associated with the drug reservoir. The actuator is manipulated to deploy the needle, with the actuator also engaging the cartridge to prevent removal of the cartridge from the recess during drug delivery. A rod of the body engages the stopper to move the stopper and dispense a medicament from the drug reservoir during drug delivery.

Abstract: There is described a patch pump comprising a cartridge, a power source, a pump system, a drug delivery device and a control system configured to operate in particular the pump system and the drug delivery device. The pump system comprises, on the one hand, a pump having a pump housing containing a pump piston and a valve piston and, on the other hand, a pump drive comprising a piston motor and a valve motor for driving the pump piston and the valve piston independently from each other through a first and a second transmission. The drug delivery device comprises a transdermal delivery system having a needle actuation mechanism configured for transdermal insertion of a cannula.

Abstract: The present invention provides a drug delivery system (1) comprising a drug delivery device (2, 3) carrying at least one reservoir (40a, 40b), and a needle unit (4) being attachable to the drug delivery device (2, 3) in axial extension thereof and adapted to establish a flow way between the at least one reservoir (40a, 40b) and a drug delivery site. The needle unit (4) comprises a needle structure (11) comprising a front needle portion (12) for entering the drug delivery site, and at least one back needle portion (13a, 13b) for insertion into the at least one reservoir (40a, 40b), and a needle shield (20).

Abstract: An injector device for delivering a liquid medicament comprises an injector body having a proximal end and a distal end. The injector device further includes a syringe slidably received in the injector body and moveable from a first position to a second position towards the distal end of the body. Additionally, the injector device comprises a needle holder between the syringe and the distal end of the body, and a needle held in the needle holder. The needle has a distal end extending toward an opening in the distal end of the body, and a proximal end extending toward the syringe. The injector device also comprises a syringe biasing member within the body configured to bias the syringe into the second position. The syringe is spaced from the needle in the first position and is in engagement with the proximal end of the needle in the second position.

Abstract: An assembly for a drug delivery device comprises a housing, a dose member which is displaceable in a proximal direction with respect to the housing for setting of a dose of a drug, a clutch member which is displaced in the proximal direction with respect to the housing when setting the dose, and a stop member configured to define a clutch stop position. The clutch member and the dose member are configured to mechanically cooperate with one another when the clutch member is in the clutch stop position, thereby preventing further displacement of the dose member in the proximal direction with respect to the housing during setting of the dose.

Abstract: The present invention provides for pharmaceutical preparations, devices, systems and methods for the treatment of otic diseases and conditions. In various embodiments, the preparations, devices, systems and methods enable sustained drug release for the treatment or prevention of hearing loss, infections, and other pathological conditions of cochlea and inner ear.

Abstract: A medicament delivery device includes a case, a first plunger, a second plunger arranged telescopically with the first plunger, a first drive spring biasing the second plunger relative to the case, and a second drive spring biasing the first plunger relative to the second plunger.

Abstract: A device (1) for dispensing a substance to a patient comprising a cylindrical first container (2) containing the substance and a second container (3) containing a liquid. The device further comprises an injection device (4) and transfer mechanism (5) for transferring the liquid from the second container (3) to the first container (2) and from the first container (2) to the injection device (4). The first container (2) has a connection element (7) and a plunger (9) that can be moved between the first (6) and second ends (8). By moving the plunger (9) towards the first end (6), liquid contained therein can be dispensed via the injection device (4). The injection device (4) comprises a piercing cannula (15) and an indwelling cannula (16). In an initial position, a distal end region of the piercing cannula (15) extends coaxially in the interior of the indwelling cannula (16).

Abstract: Embodiments of the present invention disclose micro-lipo needle device and methods of making and using the same.

Abstract: Inventive embodiments disclosed herein include a catheter for dilating a sinus cavity lumen. The catheter includes a guide tube, having a proximal end and a distal end, that terminates in a distal tip; a sleeve member annularly positioned over the guide tube, wherein the sleeve member is movable relative to the guide tube and is capable of being advanced over the guide tube; and a balloon coupled to the sleeve member, wherein the balloon can be extendable and inflated at or beyond the end of the guide tube.

Abstract: The present invention provides a method for generating an immune response in a subject, comprising administering to the subject's skin an immunizing composition from a SARS-CoV-2 pathogen, wherein the composition is administered with a microneedle delivery device.

Abstract: Provided are a microneedle array capable of improving the visibility of an appearance inspection, and a manufacturing method of the same. A microneedle array is a microneedle array including: a sheet portion having a first surface and a second surface which oppose each other; and a plurality of needle portions arranged on the first surface of the sheet portion, in which the second surface of the sheet portion is configured by a rough surface having peak portions and valley portions, and an average transmittance of the sheet portion in a wavelength range of 300 nm to 740 nm is 75% or less.

Abstract: A plug delivery system and method of use. The plug delivery device includes a support leg, a plunger, and an extractor. The support leg includes an internal receiving space configured to receive an implanted coaxial needle assembly through an opening in the distal end. The plunger extends at least partially through the internal receiving space of the support leg and has a longitudinally adjustable relation with respect to the support leg. The extractor is also configured to translate in a longitudinal direction with respect to the support leg and has a needle connection component configured to engage the coaxial needle assembly. The extractor can be moved distally in the longitudinal direction to engage the coaxial needle assembly and then moved distally to concurrently retract the coaxial needle assembly while the plunger remains relatively stationary to deploy the sealant plug residing in the coaxial needle assembly.

Abstract: A device for isolating a microbe or a virion includes a semiconductor substrate; and a trench formed in the semiconductor substrate and extending from a surface of the semiconductor substrate to a region within the semiconductor substrate; wherein the trench has dimensions such that the microbe or the virion is trapped within the trench.

Abstract: Subcutaneous implantation tools and methods of implanting a subcutaneous device using the same. The tool may include a tool body having a longitudinally extending recess having a distal opening and having a tunneler at a distal end of the tool body extending from the distal opening of the recess. The tool may include a plunger slidably fitting within at least a portion of the tool body recess. The recess may be configured to receive an implantable device and the tunneler preferably extends distally from the recess at a position laterally displaced from the device when the device is so located in the recess. Movement of the plunger distally within the recess advances the device distally out of the recess and alongside of and exterior to the tunneler.

Abstract: Subcutaneous implantation tools and methods of implanting a subcutaneous device using the same. The tool may include a tool body having a longitudinally extending recess having a distal opening and having a tunneler at a distal end of the tool body extending from the distal opening of the recess. The tool may include a plunger slidably fitting within at least a portion of the tool body recess. The recess may be configured to receive an implantable device and the tunneler preferably extends distally from the recess at a position laterally displaced from the device when the device is so located in the recess. Movement of the plunger distally within the recess advances the device distally out of the recess and alongside of and exterior to the tunneler.

Abstract: An electronic computing system creates a treatment plan and provides safe and accurate treatment recommendations by obtaining an input image of a face; comparing, using a pattern recognition process, one or more aspects of the input image to corresponding aspects of a plurality of reference images; obtaining, based on a result of the comparing, supplemental information associated with one or more additional characteristics of the face; and creating a treatment plan based on the input image and the additional characteristic.

Abstract: An actuating device having integrated plunger is configured to be removably mounted to an automatic mixing device for a syringe. The actuating device includes lower and upper housings, a trigger member, a lockout ring, a mixing biasing member, a delivery plunger, a plunger biasing member, and a mixing plunger. The mixing plunger is releasably engaged with the trigger member in an initially locked state and engageable with at least one seal of the mixing device. The trigger member is operable to initiate decompression of the mixing biasing member and engagement of the mixing plunger with the at least one seal of the mixing device. The delivery plunger may also be activated to expand from a first, collapsed configuration to a second, expanded configuration by actuation of the trigger member.

Abstract: An autoinjector includes a case, a needle shroud telescopically coupled to the case, a carrier slidably arranged in the case, a collar rotatably and slidably disposed in the case and coupled to the needle shroud and the carrier, and a trigger button operably coupled to the carrier. The case includes a rib. The needle shroud is movable between a first extended position, a retracted position, and a locked second extended position. The carrier is adapted to hold a medicament container and movable from a first axial position to a second axial position relative to the case. The carrier abuts the rib in the first axial position and the needle shroud is in the first extended position and disengages the rib when the needle shroud is in the retracted position and the trigger button is pressed to advance the carrier to the second axial position.

Abstract: Systems, devices and methods are provided for inserting at least a portion of an in vivo analyte sensor, such as a dermal sensor, for sensing an analyte level in a bodily fluid of a subject. An applicator is positioned against a skin surface and a force is applied to the applicator causing at least a portion of a sharp and an in vivo analyte sensor to be positioned in the body of the subject. In particular, disclosed herein are embodiments of applicators designed to prevent premature sharp withdrawal and/or reduce the likelihood of improper sensor insertion. Also disclosed are embodiments of applicators including sharp modules having an angled sharp which can be configured to create an insertion path for a sensor.

Abstract: Devices, systems, and methods useful to engage tissue using suction and to perform medical procedures during sectional engagement. The present disclosure includes disclosure of a tension apparatus, comprising an elongated portion; and a head portion at a distal end of the elongated portion, the head portion comprising one or more arms, whereby a suction lumen extending along the elongated portion and the one or more arms terminates at one or more suction openings at each of the one or more arms.

Abstract: A device and method is disclosed for assembling a container holder in a clean environment, aseptically adding a solution to a primary container, inserting the primary container into the container holder, applying a first barrier to the container holder, sterilizing the container holder comprising the primary container and the applied first barrier to provide a sterilized container holder, assembling a fluid path module in a clean environment, the assembling comprising applying a second barrier to a first end of the sterilized fluid path module, sterilizing the fluid path module to provide a sterilized fluid path module and assembling a delivery device comprising the sterilized container holder and the sterilized fluid path module.

Abstract: A device for isolating a microbe or a virion includes a semiconductor substrate; and a trench formed in the semiconductor substrate and extending from a surface of the semiconductor substrate to a region within the semiconductor substrate; wherein the trench has dimensions such that the microbe or the virion is trapped within the trench.

Abstract: Apparatuses and methods described herein relate to treating cancerous tumors using radiation therapy and chemotherapy. In some embodiments, a method of treatment includes administering radiation therapy targeting a tumor, isolating a segment of a vessel proximate to the tumor, and administering a dose of a chemotherapeutic agent to the segment of the vessel. The method can further include waiting a period of time after administering the radiation therapy before administering the dose of the chemotherapeutic agent. In some embodiments, a catheter device including first and second occluding elements can be used to isolate the segment of the vessel.

Abstract: This disclosure teaches a disposable inserter which includes a housing having arranged in a displaceable configuration an inserter assembly comprising a cannula assembly with a cannula, a manually operable member for displacing the inserter assembly from a retracted position to an advanced position in order to manually insert the cannula into the skin of a patient, a locking element for blocking or enabling displacement of the inserter assembly, and a coupling arrangement for coupling the disposable inserter to a reusable inserter for automatically displacing the inserter assembly from the retracted position to the advanced position in order to automatically insert the cannula into the skin of the patient.

Abstract: A manual injection device having a lower body (1) for a reservoir (S), a piston (P) and a needle (A); a movable upper body (2) including a piston rod (TP); and an actuator sleeve (10) including a contact end (11) and movable relative to the lower body between projecting positions and an actuated position. The actuator sleeve (10) is in a first projecting position before the manual injection device is actuated, and in a second projecting position after it is actuated. The actuator sleeve co-operates with the lower body (1) or with any element secured to the lower body to define a pricking lock. The piston rod (TP) co-operates with the reservoir or with an element secured to the reservoir to define an injection lock. The force for actuating the pricking lock is less than the force for actuating the injection lock, such that the pricking lock is actuated first.

Abstract: Systems and methods for transferring fluid to or from a subject use a set of MRI compatible components that can aspirate intrabody structure and/or fluids. The components include a device guide, a semi-rigid guide sheath configured to slidably extend through the device guide, a stylet releasable coupled to the guide sheath and extending a fixed distance out of a distal end thereof, and a cannula coupled to flexible tubing that is releasably interchangeably held in the guide sheath in lieu of the stylet.