Abstract: A device for one-handed insertion of a guidewire into a vessel or cavity is provided. The device has a body, an actuator carriage, a guidewire feed, and a syringe. The body has a handle, a guideway, and a clip to retain the syringe. The syringe has a barrel and a plunger with a flange and a guidewire passage. The actuator carriage has a trigger and a clip to grasp the syringe plunger flange. The actuator carriage slides along the body guideway. The guidewire feed has a wire feed surface. The thumb engages wire at the wire feed surface to advance and retract the wire through the guidewire passage and a finger moves the trigger to move the syringe plunger rearwardly and/or forwardly, while the remaining fingers of the one hand grasp the handle. The device allows the user to sense resistance encountered by the tip of the wire.

Abstract: A fluid vessel insertion device (10), typically for medical use, comprises a puncture member (18) arranged for locaton within a sleeve (20), and a retraction mechanism (44, 48, 60) for retracting the puncture member relative to the sleeve. The puncture member (18) is retractable in use between a first condition in which an end (18A) of the puncture member protrudes beyond an end (24) of the sleeve and a second condition in which the end of the puncture member is within the sleeve (20). The retraction mechanism (44, 48, 60) actuates the puncture member between the first and second conditions in response to fluid pressure at the end (18A) of the puncture member. The device may be used during positioning of the sleeve in a desired fluid vessel, such as, for example, during intravenous cannulation.

Abstract: An intravascular access system for facilitation of intraluminal medical procedures within the neurovasculature through an access sheath. The system includes an aspiration or support catheter having a flexible, distal luminal portion having an inner diameter defining a lumen extending between a proximal opening at a proximal end of the luminal portion and a distal opening at a distal end of the luminal portion. The catheter has a rigid spine coupled to at least the proximal end of the luminal portion and extending proximally therefrom. The system includes a dilator having a flexible, distal dilator portion sized to be received within the lumen of the luminal portion. Associated systems, devices, and methods of use are also described.

Abstract: Systems, methods and compositions relating to delivering synthetic polymer formulations to the body are described, which can be used by a range of medical personnel including those with minimal experience and training. Under some embodiments, the present invention relates to systems and devices for delivering polymer formulations to a body cavity (e.g. peritoneal cavity) to reduce or stop bleeding. Under some embodiments, an initial percutaneous access pathway is first formed using a delivery device with a probe and needle mechanism that automatically stops the advance of the device upon insertion into a body cavity or space, thus minimizing user error and improving patient safety. The hollow probe then allows transmission of polymer, mixed with gas and/or additional substances, from a holding chamber or canister to flow through the device and hollow probe into the patient's anatomic cavity or space of interest, stopping expansion when the device senses the appropriate pressure.

Abstract: A device for creating intravascular access and guidewire placement includes a main body having a lumen and a piercing member disposed in the lumen. The piercing member moves distally out of the lumen and pierces tissue while moving. A needle guide is provided for guiding the piercing member, the needle guide having a distal end which comprises a first alignment member. A guidewire has a distal tip with a second alignment member disposed on the guidewire distal tip. The first alignment member may comprise a magnetic attachment, at least one magnetic implant, a proximity sensor, an ultrasonic sensor, or other suitable system for alignment of devices disposed on opposing sides of opaque tissue. Similarly, the second alignment member may comprise a magnetic attachment or implant, a proximity sensor, or an ultrasonic sensor.

Abstract: A catheter insertion device and method for insertion. The catheter insertion device can include a housing, a needle attached to a needle carrier, a catheter including a catheter shaft attached to a catheter hub, and a guidewire. The guidewire can include a coil tip positioned in a lumen of the needle. The method for insertion can include inserting a distal end of the needle and the catheter shaft into a blood vessel of a patient, advancing the coil tip out of the needle lumen and into the blood vessel, advancing the catheter over the guidewire, and withdrawing the guidewire and the needle from the catheter. The coil tip can include a straightened configuration and a coiled configuration. The coil tip can transition from the straightened configuration in the needle lumen to the coiled configuration in the blood vessel.

Abstract: A surgical access port and assembly are disclosed for providing access for a medical instrument into an intracorporeal cavity of a patient undergoing surgery. The access port comprises a cannula and a first passage which extends along the cannula and along which a medical instrument is arranged to pass, the passage comprising a first entrance portion disposed at a proximal region the of the cannula and a first exit portion disposed at a distal region of the cannula. The cannula further comprises a second passage which extends along the cannula and along which an electrode is arranged to pass, the second passage comprising a second entrance portion disposed at a proximal region of the cannula and a second exit portion disposed at a distal region of the cannula.

Abstract: The present invention is directed to systems, devices and methods for trans-septally delivering carbon dioxide through a minimally invasive catheter to create a gaseous pocket or emphysema between the posterior wall of the left atrium and the esophagus during cardiac ablation of the left atrium. This pocket of gas expanded tissue serves to thermally insulate and separate the esophagus from the left atrium during ablation to prevent the formation of an atrial-esophageal fistula. The system comprises a control system to precisely deliver the gas to a desired location through a needle-based catheter assembly.

Abstract: A safety catheter needle having a cannula removably inserted in a catheter and associated with a cannula holder is provided. The cannula has a proximal extremity attached to the cannula holder and a distal extremity close to a deformed part, with provision for a protection device associated with the catheter holder movably containing the cannula and moving within the catheter holder when the cannula is drawn out from the catheter. The protection device has a principal body containing a moving body rotating about an axis (M) at right angles to a longitudinal axis (W) of the cannula and capable of interacting with a fixed part of the catheter holder—while the cannula is being drawn out, bringing about rotation of the rotating moving body within the principal body and immobilizing the distal extremity of the cannula within the former.

Abstract: A plurality of individual tools is provided where each tool is uniquely configured to perform a step or a portion of a step in a novel procedure associated with the implantation of a stabilizing device (e.g., an interspinous spacer) for stabilizing at least one spinal motion segment. The tools are usable individually, or more preferably as a tooling system in which the tools are collectively employed to implant an interspinous spacer, generally in a minimally invasive manner. For example, each of the tools is arranged with coordinated markings and/or other features to ensure consistent depths of insertion, proper orientation of the tools with respect to each other or an anatomical feature of the patient, and precise delivery of the spacer to maintain safe positioning throughout the implantation procedure.

Abstract: Disclosed herein are sealing devices and methods configured for improving sealing functionality with an engaged extension member of an apparatus. More specifically, disclosed herein are methods configured for improving insufflation gas containment in relation to trocars (and/or other related type of devices) that are used for enabling a surgical instrument such, for example, a laparoscope, to gain access to an abdominal cavity (or other body cavity). By providing for such improved insufflation gas containment, sealing devices as disclosed herein are particularly advantageous, desirable and useful in view of long-standing reasons for limiting insufflation gas leakage and in view of newly recognized reasons stemming from outbreak of COVID-19 disease for limiting insufflation gas leakage.

Abstract: An access device for placing a medical article within a body space includes a syringe, a needle, and a sheath which are employed together with a guide wire. The sheath can be coaxially and slideably disposed about the needle. During insertion of the sheath over the needle, guide wire and into the body space, the syringe provides a negative pressure to ensure that any air located between the inside diameter of the sheath and the outside diameter of the needle is drawn into the needle rather than into the body space. In certain embodiments, a dilator is coaxially and slideably disposed about the needle and within the sheath.

Abstract: A plurality of individual tools is provided where each tool is uniquely configured to perform a step or a portion of a step in a novel procedure associated with the implantation of a stabilizing device (e.g., an interspinous spacer) for stabilizing at least one spinal motion segment. The tools are usable individually, or more preferably as a tooling system in which the tools are collectively employed to implant an interspinous spacer, generally in a minimally invasive manner. For example, each of the tools is arranged with coordinated markings and/or other features to ensure consistent depths of insertion, proper orientation of the tools with respect to each other or an anatomical feature of the patient, and precise delivery of the spacer to maintain safe positioning throughout the implantation procedure.

Abstract: The present invention concerns compositions and methods related to utilizing glycine and N-acetylcysteine for a variety of medical conditions (e.g., muscle loss such as sarcopenia, HIV infection and others, organ damage such as those from diabetes and insulin resistance and diabetic nephropathy, cardiac function and failure such as preventing or improving heart failure, fatty liver, cancer prevention, and others) related to reduced levels of glycine, N-acetylcysteine, and/or glutathione.

Abstract: A hub assembly for connection to a medical device. The hub assembly may comprises an outer component having a proximal end, a distal end, and a cavity extending from the proximal end to the distal end. The hub assembly may further include an insert having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end positioned at least in part within the cavity of the outer component. The insert may have a lumen extending from the proximal end to the distal end thereof. The outer component may be formed from a first material and the insert may be formed from a second material different from the first material.

Abstract: A device for penetrating tissue with reduced force and placing a guidewire is provided. The device includes a driving actuator generating reciprocating motion at less than 20 kHz. A penetrating member having a lumen dimensioned to accommodate a guidewire is provided, and may be coaxial or axially offset from the driving actuator. A coupler mechanically connects the driving actuator and the penetrating member, transferring the reciprocating motion to the penetrating member. At least one frictional member facilitates the movement of the guidewire through the lumen for placement at the target tissue. The frictional member(s) may be operated manually or by a guidewire actuator. A housing including a channel also dimensioned to accommodate the guidewire may also be provided, and may further include the frictional member(s) for facilitating movement of the guidewire. A side port may also be included at the penetrating member or coupler for introduction of the guidewire.

Abstract: Devices and methods for delivering end effectors through surgical trocars are described herein. In one embodiment, a surgical end effector loading device is provided that includes a housing having a distal-facing first portion configured to couple with a proximal end of a surgical trocar, and an elongate second portion protruding distally from the first portion. The second portion can include a lumen formed therein and can be configured to extend into a working channel of the surgical trocar when the housing is coupled thereto. The device can also include at least one mating element coupled to the housing and configured to interface with a complementary mating element of the surgical trocar to restrict movement of the housing relative to the trocar, as well as an end effector retainer coupled to the housing and configured to selectively couple a surgical end effector to the housing.

Abstract: A modular medical device catheter system comprises a parent module and an adapter module. The adapter module is configured to engage an inner lumen of a distal end of the parent module to couple the adapter module with the parent module.

Abstract: The present embodiments relate generally to applicators of on-skin sensor assemblies for measuring an analyte in a host, as well as their method of use and manufacture. In some aspects, an applicator for applying an on-skin sensor assembly to a skin of a host is provided. The applicator includes an applicator housing, a needle carrier assembly comprising an insertion element configured to insert a sensor of the on-skin sensor assembly into the skin of the host, a holder releasably coupled to the needle carrier assembly and configured to guide the on-skin sensor assembly while coupled to the needle carrier assembly, and a drive assembly configured to drive the insertion element from a proximal starting position to a distal insertion position, and from the distal insertion position to a proximal retraction position.

Abstract: A surgical access port assembly including a cannula having a diameter of less than about 3 mm and a tapered hub, capable of attachment to a laparoscopic surgical instrument, connected to the proximal end of the cannula.

Abstract: A system (5, 405) for infusing medication into a subject is provided. The system (5, 405) includes an injection system (50, 450) for controlling fluid flow from a fluid reservoir to a needle. A sensor (20) detects a characteristic indicative of fluid pressure in the needle. The injection system (50, 450) controls the flow of fluid to the needle in response to the characteristic detected by the sensor (20), which continuously detects the characteristic as the needle is inserted into the subject. The system may include a light assembly (100) connected with the injection system. The light assembly (100) may provide a continuously variable signal indicative of the fluid pressure in the needle. The system (5, 405) may further provide a mechanism that provides cues to the operator to insert the needle at a particular rate. The system may further include a conductive element (334) for providing electric nerve stimulation.

Abstract: A trocar assembly includes a trocar that includes a trocar housing and a cannula that extends distally from the trocar housing, and an integral seal system positioned within a central passageway extending axially through the trocar and engageable against a surgical tool shaft extended therethrough. The integral seal system includes an asymmetric seal and a duckbill seal arranged distal to the asymmetric seal, and the asymmetric seal defines a diaphragm that complements insertion and extraction drag forces generated by the duckbill seal against the surgical tool shaft such that total insertion and extraction drag forces generated by the integral seal system are equalized.

Abstract: A modular medical device catheter including a parent module and an adapter module. An attachment mechanism couples the adapter module to a surface of an inner lumen of the parent module. The attachment mechanism includes a coil in which a surface of the coil directly engages with the surface of the lumen of the parent module. The adapter module can include an elongated element having one or more electrical conductors.

Abstract: A trocar assembly includes a seal assembly that maintains insufflation pressure when sized seal cartridges are removed and replaced. The trocar assembly includes a housing that defines a working chamber, and a cannula distally extends from the housing and defines a lumen that communicates with the working chamber. The seal cartridge is arranged within the working chamber, and may include one or both of a proximal seal assembly and a distal seal assembly arranged distally from the proximal seal assembly, and may further include a bushing extending distally from a distal end of the seal cartridge and into the lumen. A tertiary seal may also be positioned within the working chamber distal to the seal cartridge, such that the bushing extends through the tertiary seal when the seal cartridge is received within the working chamber.

Abstract: An insert includes: an insert body that has an opening and has an inner cavity therein; a light guide member that is inserted into the inner cavity of the insert body and guides light emitted from a light source; a light emitting portion that emits light guided by the light guide member; a light absorption member that generates photoacoustic waves by absorbing the light emitted from the light emitting portion; and a proximal end portion that has an inlet of liquid and a chamber communicating with the inlet and the inner cavity of the insert body. The inner cavity has a space for flow of the liquid, and liquid injected through the inlet is capable of flowing from the opening of the insert body through the chamber and the space for flow of the liquid.

Abstract: A medical device is disclosed comprising an elongated needle assembly having a distal end, a proximal end and a longitudinal axis A, the needle assembly comprises a tubular cannula having a sharpened distal end, a proximal cannula portion, and a longitudinal bore along the longitudinal axis A, and a stylet configured to extend through the bore of the cannula, and having a blunt distal end and a proximal stylet portion. The needle assembly is provided with a spring member configured to urge the stylet in a distal direction along the longitudinal axis, such that the stylet is axially spring-biased in said distal direction.

Abstract: A tool for an endoscope comprises an elongated shaft including a proximal end and a distal end, wherein the elongated shaft comprises a tubular member with an interior channel extending from the distal end toward the proximal end and a one or more perforations in the tubular member that are spaced from the distal end, the one or more perforations providing fluid communication between an exterior of the elongated shaft and the interior channel.

Abstract: A method of securing an infusion set to a skin surface, comprising the steps of placing a needle or cannula of the infusion set in the skin surface, and controlling a minimum bend radius of the placed needle or cannula to resist deformation and fracture thereof.

Abstract: A microneedle injection apparatus comprising an inverted actuator. The apparatus can include a housing having a base and a cavity, and a microneedle array holder configured to hold a microneedle array within the cavity of the housing. The microneedle array holder can be movable between a retracted position, and an extended position. The apparatus can further include an actuator movable with respect to the housing and the microneedle array holder between a first position and a second position to cause the microneedle array holder to move from the retracted position to the extended position. At least a portion of the actuator can be located on a skin-facing side of the apparatus (e.g., adjacent the base of the housing) and can be configured to be moved from the first position to the second position in response to the apparatus being pressed toward the skin surface.

Abstract: A catheter may include a catheter body, which may include a proximal end, a distal end, and a lumen formed by an inner wall of the catheter body that extends between the proximal end and the distal end along a longitudinal axis. The distal end of the catheter body may include a distal lumen opening disposed on the longitudinal axis. The distal end may also include a leading edge. The leading edge may form the distal lumen opening and may include an upper and a lower portion. The lower portion of the leading edge may be disposed distally to the upper portion of the leading edge.

Abstract: A self-sealing catheter valve that includes a flexible tubular part having a distal opening and an opposite proximal opening, and a proximal valve part. The proximal valve part has a curved self-sealing flexible diaphragm disposed inside the flexible tubular part and has a base perimeter united with a circumferential wall of the flexible tubular part. The curved self-sealing flexible diaphragm has a concave surface facing towards the proximal opening, and a convex surface facing towards the distal opening, and a flexible diaphragm wall of the curved self-sealing flexible diaphragm has a traverse slit. The self-sealing catheter valve provides an efficient self-closing mechanism for a peripheral catheter assembly and constitutes an efficient barrier against potential contagious spread from the patient to the surrounding environment by blood born disease e.g. HIV, hepatitis and Ebola viruses.

Abstract: An introducer for insertion of a medical device into a patient's vasculature includes an elongate introducer body, a hub, and a hemostatic valve. The elongate introducer body includes a longitudinal axis, a proximal region, a distal region, and an inner lumen. The hub is coupled to the proximal region of the introducer body. The hemostatic valve is disposed within the hub and forms a liquid-tight seal across the inner lumen. The introducer includes a guide configured to guide an object towards the center of the valve during insertion of the object.

Abstract: The device includes a dilator having a locking mechanism configured to limit a distance a guidewire can be advanced out of a distal end of the dilator.

Abstract: An epidural needle assembly including an epidural needle assembly and an injection needle assembly. The injection needle assembly is slidably mounted on the needle of the epidural needle assembly between extended and retracted positions. The injection needle assembly includes an injection hub having an injection needle secured thereto which extends forwardly therefrom. When the injection needle assembly is in its retracted position, the forward end of the injection needle is positioned rearwardly of the forward end of the epidural needle. When the injection needle assembly is in its extended position, the forward end of the injection needle is positioned forwardly of the forward end of the epidural needle. When in its extended position, the injection needle is able to create a hole in the skin of a person or animal to permit the epidural needle to be inserted therein.

Abstract: Apparatus and methods for sealing a puncture through tissue includes an introducer sheath sized for introduction into a puncture, cartridge sized for insertion into the introducer carrying a sealant, and a locking element for coupling the introducer sheath to the cartridge. When the cartridge is advanced into the introducer sheath, the locking element couples the introducer sheath to the cartridge such that subsequent retraction of the cartridge causes the introducer sheath to retract, thereby deploying the sealant from the cartridge within the puncture beyond the introducer sheath.

Abstract: Provided are an apparatus for injecting a liquid into a primo-node and a primo-vascular system tracing system including the apparatus. The apparatus includes a liquid injection tube to inject a liquid into a primo-node of an object, and a suction tube to hold the primo-node to inject the liquid injection tube into the primo-node. The liquid injection tube and the suction tube are formed as one body. The liquid injection tube is inserted into an inner side of the suction tube and an edge unit of the liquid injection tube protrudes to the outside from an inner side of a suction opening of the suction tube.

Abstract: An endoscopic includes a handle, a tubular member, a control member, and an end effector assembly. The handle has a stationary member and a movable member. The movable member includes a constrained curved path for passage of the control member. The tubular member has an end coupled to the stationary member and a distal end rotatably coupled to the end effector assembly. The control member extends through the curved path, the tubular member, and is coupled to the end effector assembly. A knob is attached to the movable member and control member. Displacement of the movable member relative to the stationary member causes actuation of the end effector assembly, and rotation of the knob on the movable member causes the control member to rotate within both the constrained curved path and the tubular member, and results in rotation of the end effector assembly.

Abstract: An implant delivery system is described. The implant delivery system utilizes an implant, implant wire, delivery sheath, and a torque device. The torque device may include a cutting element to slit the delivery sheath and a clamp device to fix the position of the implant delivery wire.

Abstract: A fluid transfer device for parenterally transferring fluid to and/or from a patient includes a housing, a needle, and an occlusion mechanism. The housing defines a fluid flow path and is couplable to a fluid reservoir. The needle has a distal end portion that is configured to be inserted into the patient and a proximal end portion that is configured to be fluidically coupled to the fluid flow path of the housing, and defines a lumen therebetween. The occlusion mechanism selectively controls a fluid flow between the needle and the fluid flow path. The occlusion mechanism includes an occlusion member that is movable between a first configuration where the lumen of the needle is obstructed during insertion into the patient and a second configuration where the lumen of the needle is unobstructed after the needle has been inserted into the patient allowing fluid transfer to or from the patient.

Abstract: A medical apparatus which comprises a sharpened outer cannula and a blunt inner cannula slidingly disposed within the outer cannula is configured to allow one-hand operation by user to operate the medical apparatus. The apparatus also contains a visual position indication system adapted to indicate the position of the inner cannula.

Abstract: A method for surgically removing a tumor from a woman's breast is provided. The method can include inserting an optical trocar having a working channel and a transparent tip through a skin incision, guiding the transparent tip of the trocar through breast tissue with visualization such that the transparent tip of the trocar is placed adjacent to the tumor, insufflating gas via the working channel of the trocar to create a cavity in an operative field next to the tumor, dissecting the tumor free with a surgical instrument inserted through the working channel and removing the tumor through the trocar.

Abstract: A catheter insertion device and method for insertion. The catheter insertion device can include a housing, a needle attached to a needle carrier, a catheter including a catheter shaft attached to a catheter hub, and a guidewire. The guidewire can include a coil tip positioned in a lumen of the needle. The method for insertion can include inserting a distal end of the needle and the catheter shaft into a blood vessel of a patient, advancing the coil tip out of the needle lumen and into the blood vessel, advancing the catheter over the guidewire, and withdrawing the guidewire and the needle from the catheter. The coil tip can include a straightened configuration and a coiled configuration. The coil tip can transition from the straightened configuration in the needle lumen to the coiled configuration in the blood vessel.

Abstract: An adapter constructed to have a proximal portion that interfaces with the internal lumen of a medical device and a distal portion that modifies, augments or extends the configuration or intended use of the medical device. The proximal portion of the adapter interfaces with the internal lumen of the medical device in a manner to secure the adapter to the medical device during use. The distal portion of the adapter is generally outside the lumen of the catheter or device.

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 disclosure relates to a needle assembly for delivering a lead and methods of use. The needle assembly is configured to cut tissue and reduce the potential for cutting vulnerable bodily structures. The needle assembly includes an outer needle with a blunt tip and an inner needle with a sharp tip. The outer needle may be curved, and the inner needle may be curved. When the inner needle is rotated with respect to the outer needle, the inner needle protracts or retracts with respect to the outer needle. A stopping feature on the needle assembly may be included to resist over-rotation or over-extension. The needle assembly provides an initial path that may be further dilated for delivering a lead, such as a vagus nerve stimulation lead to a target site. The target site may be electrically tested with some embodiments.

Abstract: The invention relates to a safety needle arrangement (1) comprising a main part (2), a cannula support (6), a cannula (10), a proximal end of which is retained on a distal end (7) of the cannula support (6), an adjusting element (15) which is operatively arranged between the main part (2) and the cannula support (6), and a locking device (19) with multiple first and second locking elements (20, 21) which are engaged with one another. The first locking elements (20) are arranged in the region of a proximal end (4) of the main part (2) and are formed by projections (22) which are arranged diametrically opposite one another. The second locking elements (21) are arranged in the region of a proximal end (8) of the cannula support (6) and are formed by recesses (24) which are arranged diametrically opposite one another.

Abstract: A telescoping access cannula comprising: an outer tube; an inner tube carried by the outer tube, the inner tube being coaxial with the outer tube and longitudinally movable relative to the outer tube; and a rotatable member carried by the outer tube and connected to the inner tube, wherein rotation of the rotatable member causes longitudinal movement of the inner tube relative to the outer tube.

Abstract: An apparatus includes a cannula assembly, a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing includes an inlet port removably coupled to the cannula assembly and defines an inner volume. The fluid reservoir is fluidically coupled to the housing and configured to receive and isolate a volume of bodily fluid from a patient. The flow control mechanism is at least partially disposed in the inner volume. The actuator is operably coupled to the flow control mechanism and is configured to move the flow control mechanism between a first configuration, in which bodily fluid can flow, via a fluid flow path defined by the flow control mechanism, from the cannula assembly, through the inlet port and into the fluid reservoir, to a second configuration, in which the fluid reservoir is fluidically isolated from the cannula assembly.

Abstract: A catheter system includes an introducer sheath and a delivery catheter having an external surface. A sleeve connector is supported on and axially movable relative to the external surface of the delivery catheter. A collapsible sleeve has a first end attached to the external surface of the delivery catheter at a first attachment and a second end attached to the sleeve connector at a second attachment. The catheter system includes a medical device placement configuration in which the delivery catheter is received through the introducer sheath, the sleeve connector is removably attached to the introducer sheath, and the collapsible sleeve is positioned radially between the external surface of the delivery catheter and an internal surface of the introducer sheath.

Abstract: An infusion set, comprising a base, and an inserter pivotally connected to said base, said inserter including a catheter movable from a first catheter position to a second catheter position, an introducer needle located within said catheter and movable between a first and second introducer needle positions, and an activation button, wherein when said button is moved from a first button position to a second button position, said catheter is moved from said first toward said second catheter position, said introducer needle is moved from said first toward said second introducer needle position, and said introducer needle is thereafter moved back toward said first introducer needle position, wherein in the second button position, the inserter is configured to fold substantially entirely within said base in the second inserter position.