Abstract: An insertion set system includes a base configured to be secured to a patient, and a flexible tubing on the base. The flexible tubing has a distal end portion forming a cannula to be inserted into the patient. An inserter having a needle is received by the base. The needle has a channel in which the distal end portion of the flexible tubing is received. The needle is able to slide relative to the flexible tubing, to selectively withdraw the needle off of the distal end portion of the flexible tubing. The base may include a passage for fluid flow arranged transverse to the axial dimension of the distal end portion of the flexible tubing.

Abstract: A pre-assembled, telescoping elongate system comprising an outer elongate member surrounding a finer gauge inner elongate member which, after percutaneous penetration by the outer elongate element, extends to penetrate an intervertebral disc into which a sensing element and/or an injectable may be delivered.

Abstract: Drug delivery devices are described that provide hybrid forms with gripping and stability functionalities, such as a grip portion on a skin contact surface. In some versions, the drug delivery devices can include a cep having a release liner such that removal of the cap exposes the grip portion. In some versions, the drug delivery devices include a retractable needle guard having the grip portion extending therearound.

Abstract: The present invention relates to a nasal catheter to prevent a negative pressure, and more particularly, to a nasal catheter that prevents a negative pressure which includes a tube body which is connected to one end of a shaft of an aspirator that suctions rhinorrhea or secretions, and is made up of a cone part whose diameter increases from a distal end toward a rear end of the conduit and an extension part that forms a passage extending from the cone part, and is inserted into the nasal cavity; and a ventilation part in which a ventilation hole penetrating from the distal end of the cone part toward the rear end is formed to allow outside air to flow into the nasal cavity.

Abstract: Systems, methods and devices are described including a medical device subassembly including a magnetic feature. Systems include such a catheter adapter subassembly or needle subassembly or guidewire introducer subassembly and a wire including a magnetic feature, and relative movement of the catheter adapter subassembly or needle subassembly or guidewire introducer subassembly and the wire can be determined using a magnetometer.

Abstract: The present invention provides devices to access the suprachoroidal space or sub-retinal space in an eye via a minimally invasive transconjunctival approach. The devices may also be used after a partial dissection, for example after dissection of the outer scleral layer of the eye, and using the device within the dissection to access the suprachoroidal space or the sub-retinal space.

Abstract: A transseptal needle or punch. The transseptal punch includes a stylet with a tube with a side window and a cutting wire disposed within the tube, with a sharp cutting segment disposed proximate the window. The sharp cutting segment can be expanded radially outwardly from the window by translation of the cutting wire proximal end within the tube.

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: A chest tube insertion device includes a semi-rigid curvilinear sheath body having a distal end and a proximal end, a lumen defined axially through the sheath body from the distal end to the proximal end, the lumen including a distal end opening at the distal end and a proximal end opening at the proximal end, and a tapered pneumostatic tube clamp at the distal end of the sheath body, the tube clamp including one or more clamp tabs angled radially inward toward the distal end opening. The chest tube insertion device is supported during insertion into the chest cavity by a stylet. The chest tube insertion device is also removable from a chest tube when a free end of the chest tube is positioned in the chest cavity of a patient.

Abstract: In some embodiments, disclosed herein are systems and methods of treating a patient that can include the steps of accessing the sphenopalatine fossa, and cannulating the inferior orbital fissure from the sphenopalatine fossa to access the retro-orbital space. The sphenopalatine fossa can be accessed via various routes, including percutaneously. Accessing the sphenopalatine fossa can include the step of inserting a needle-catheter system into the sphenopalatine fossa. Integrated needle-catheter systems as described herein can also be configured to access the trigeminal ganglion, epidural space, intrathecal space, and other desired anatomical locations.

Abstract: Devices for detecting microorganism strains or target cellular analytes are provided. The device includes a filter holder, the filter holder comprising a tip portion; a nonwoven article disposed on the tip portion of the filter holder; and an adaptor attacked to the filter holder, the adaptor defining an aperture. Methods of detecting microorganisms and/or cellular analytes in a fluid sample using the devices are also provided. The method includes obtaining the device; placing a lumened or cannulated device in fluid communication with the device; and passing a fluid sample suspected of containing at least one microorganism strain or target cellular analyte from the lumened or cannulated device through the device and contacting the nonwoven article. The method further includes contacting the nonwoven article with at least one detection reagent and detecting the presence of the at least one microorganism strain or target cellular analyte concentrated by the nonwoven article.

Abstract: Devices used to capture sutures are described. More particularly, suture capture devices described herein include an elongate cannulated tool having a first end with a sharpened point configured to pierce tissue, and an elongate hook member positioned within a hollowed center region of the elongate cannulated tool that has a hook on a first end of the elongate hook member proximate the sharpened point of the elongate cannulated tool. The elongate hook member is capable of advancing and retracting within the elongate cannulated tool. The devices further include a handle positioned on a second end of the elongate cannulated tool that includes a trigger that advances the hook into or out of the first end of the elongate cannulated tool when pushed in a first or second direction. Methods of capturing a suture using such a device are also described.

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: The invention provides improved devices and apparatuses and related methods for sensing differences in pressure or other parameters in the environment of the body of a patient during passage of the device through one or more tissues. In one aspect, the devices and apparatuses of the invention are configured to sense differences in the environment of the body of the patient as the device passes through tissue adjacent to the epidural space to tissue of the epidural space. In one aspect, a dual cannula device comprising one or more sensors connected to a signaling component is provided for sensing passage into of the device into the epidural space and positioning therein. Methods of using same are also provided.

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: 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: A transseptal needle or punch is described wherein the distal end of the transseptal needle is able to articulate laterally out of the longitudinal axis of the steerable transseptal needle. The transseptal needle includes a blunted distal end configuration that is minimally traumatic. Under control by the user or a computer, the transseptal needle can be articulated to generate various curves with high bending force. The transseptal needle is configured for use with an introducer which can also include side windows.

Abstract: There is disclosed, among other things, embodiments of a biopsy needle for taking a full core sample through soft tissue. In the illustrated embodiments, the needle includes a single monolithic tubular member having a notch cut part-way through a distal portion of the tubular member to form an arch-shaped finger. At least a portion of the finger is bent toward the notch and into the lumen of the tubular member. Methods for using these embodiments are also described.

Abstract: A method and device are provided for simultaneously or near-simultaneously diagnosing and treating tension pneumothorax and/or hemothoraxA Veress-type needle portion includes a hollow needle for puncturing the chest wall over a blunt hollow probe biased by one or more springs to extend distally into the pleural cavity. Openings in the blunt hollow probe connect via a pathway to an automatic check valve, which permits the flow of air and/or fluid only in a proximal direction. Pressure from within the pleural cavity is transmitted to the interior surface of a pressure documenter. If pressure greater than atmospheric pressure is present in the pleural cavity, the pressure documenter will be automatically urged proximally to simultaneously allow air and/or fluid to escape from the pleural space through the device, thus treating the tension pneumothorax and/or hemothorax, as well as providing a stable indicator to positively document the diagnosis of increased pressure.

Abstract: A laser atherectomy device includes a light delivery catheter equipped with sensors for monitoring physical characteristics at a laser application site. An integrated control unit utilizing data from said sensors is provided to optimally adjust laser energy parameters and to provide for safe and efficacious ablation of the blood vessel occlusion.

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: 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: 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 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: 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: 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: 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.