Abstract: A method and system for estimating calibration parameters of a medical fluoroscope and more particularly a method and system which automatically determines intrinsic and distortion correction parameters of a fluoroscopy device.

Abstract: A system includes determination of a first sub-matrix of a projection matrix which describes a geometrical relationship between points of a three-dimensional coordinate system of the imaging system and points of a two-dimensional coordinate system of an image detector, determination of a second sub-matrix of the projection matrix, where the first and second sub-matrixes comprise a decomposition of the projection matrix, conversion of a first point of the two-dimensional coordinate system to a first point of the three-dimensional coordinate system based on the first and second sub-matrixes, determination of an updated first sub-matrix of an updated projection matrix, where the updated projection matrix describes a second geometrical relationship between points of the three-dimensional coordinate system and points of the two-dimensional coordinate system, and conversion of a second point of the two-dimensional coordinate system to a second point of the three-dimensional coordinate system based on the updated fi

Abstract: An evaluation aid is used as a phantom (imitation lesion) when a digital X-ray dynamic image thereof is taken and evaluated for image qualities for X-ray absorption parts having different X-ray absorption ratios. The evaluation aid contains a fixed plate (plate-like body) including a plurality of regions having different X-ray absorption ratios; a rotating disk (movable body) having a plurality of wires (wire rods), the rotating disk capable of rotating (moving) with respect to the fixed plate so that the plurality of wires traverse X-ray with which the fixed plate is irradiated; and a driving motor (driving portion) which rotates (moves) the rotating disk with respect to the fixed plate. It is preferred that thicknesses and/or constituent materials of the plurality of regions of the fixed plate are different from each other, so that these regions have the different X-ray absorption ratios.

Abstract: Disclosed herein too is a positron emission tomography calibration system comprising a positron emission tomography scanner having a ring detector that comprises at least one bin for receiving radiation; a patient that is placed at approximately the center of the ring detector where the patient is irradiated with at least one dose of a treatment radiation beam; a crystal efficiency calibration system that performs the following: measures activity generated by the at least one defined radiation dose in the at least one bin; takes projection data of the measured activity; calculates crystal efficiency from the projection data; re-estimates the measured activity of each bin based on the calculated crystal efficiency; and calibrates the detector based on the re-estimated measured activity.

Abstract: A method of correlating sonic activity with electric activity in an entity of interest includes interrogating, via a sonic sensor device, the physical structure, shape and/or form of an object in the entity of interest, interrogating, via an electric field sensor, the electric and/or magnetic potential associated with the object or the physical displacement of the geo-electric field by the object while avoiding resistive contact with other portions of the entity of interest, and linking results from the sonic sensor device to results from the electric field sensor.

Abstract: Provided are an ultrasonic probe capable of forming an image without degradation even when the frequency band of a photoacoustic wave and the frequency band of an ultrasonic wave used in ultrasonography are separated from each other, and an inspection object imaging apparatus including the ultrasonic probe. The ultrasonic probe includes a first array device capable of transmitting and receiving an ultrasonic wave; and a second array device capable of receiving a photoacoustic wave. The first array device includes plural electromechanical transducers arranged in a direction perpendicular to a scanning direction, the second array device includes plural electromechanical transducers arranged in a two-dimensional manner, and the first array device and the second array device are provided on the same plane and in the scanning direction.

Abstract: Systems and methods for image processing based on ultrasound data. The system may include an IVUS catheter configured to collect data vectors including ultrasound data and an imaging engine configured to process the ultrasound data of the data vectors. The imaging engine may receive the data vectors and divide the data vectors into different sets. The ultrasound data of each respective set may be averaged and then an envelope of each set may be detected. The envelopes of each set may then be averaged to generate an enhanced data vector which may be used to generate an image.

Abstract: An ultrasound diagnostic device for measuring a carotid artery wall property includes a transmission-reception processor, a transverse cross-sectional image generator, a transverse cross-sectional image selector, and a relative angle calculator. The transmission-reception processor performs transmission and reception processing of ultrasound with respect to the carotid artery. The transverse cross-sectional image generator generates transverse cross-sectional images based on reception signals for carotid artery cross-sections at different positions. Each generated image depicts a carotid artery transverse cross-section perpendicular to a longitudinal direction. The transverse cross-sectional image selector selects a specific image among the generated images that depicts ICA and ECA cross-sections.

Abstract: A tray (100) for accommodating a coiled medical device, such as a catheter assembly (700), includes a first compartment (101), a second compartment (102), and a third compartment (103). The catheter assembly (700) and devices associated with a catheterization procedure, such as syringes (701,702) containing sterile water and lubricating jelly and a specimen container (703) can be disposed within the tray. Printed instructions (1001) can be included with the tray (100). One or more layers of wrap material (2200) can be folded about the tray (100) to enclose the tray (100) and other items, such as an additional layer of wrap material (2701), packaged liquid hand sanitizer (2401), and packaged gloves (2402). When a health care services provider (3101) unfolds the wrap material, the same can be used to create a sterile field beneath a patient (3201).

Abstract: The present invention is directed to tissue removal devices and methods. A tubular element having an open distal end is advanced into tissue so that tissue enters the tubular element. The tissue, which entered the tubular element is cut to separate the tissue from the surrounding tissue. The tissue is then transported proximally by the cutting element or a separate transport element.

Abstract: A tissue removal device includes an outer tubular member coupled to a housing and a having a tissue resection window, an inner tubular member slidably disposed within the outer tubular member, a tissue trap having a sealed interior in fluid communication with a vacuum chamber, an open proximal end of the inner tubular member being disposed within the tissue trap interior, and an actuator moveably coupled to the housing and operatively connected to a movable piston in the vacuum chamber, such that movement of the actuator relative to the housing generates a vacuum in the tissue trap.

Abstract: This invention relates to an operation device especially intended to proceed with an operation inside the body of a living being. This device (10) comprises a control handle and a flexible element (12) provided with a proximal end connected to this control handle. The flexible element (12) comprises at a distal end (14), a steerable area comprising a rigid head. The control handle comprises a control lever arranged for controlling said steerable area (17) of this flexible element. The device of the invention is characterized in that the flexible element (12) comprises at its distal end (14), a retractable tool (21), and this retractable tool being arranged to be operated by said control handle.

Abstract: A surgical apparatus providing access to an underlying body cavity through a tissue tract articulates a flexible surgical object inserted therein. The surgical apparatus includes a tube member defining a longitudinal axis and a lumen therethrough to receive the flexible surgical object. The tube member includes a proximal member, a middle member connected to the proximal member at a first joint, and a distal member connected to the middle member at a second joint. The surgical apparatus also includes articulation mechanisms to articulate the tube member.

Abstract: The present disclosure generally relates to a retractor device for retracting soft tissue to provide access to a surgical site. The retractor device includes a plurality of blades movable from a first, substantially closed position to a second, substantially open position. Related methods of using the retractor device are also described.

Abstract: A tissue retractor device within the scope of the present invention generally includes a frame, an actuating mechanism, and a plurality of blades. The actuating mechanism generally includes at least one cam that encourages automatic toe-out of the blades. The tissue retractor eliminates the need for bulky secondary blade mechanisms to prevent undesired blade deformation at the surgical site. The toe-out motion occurs simultaneously along with the opening of the blades. The present invention further provides for depth adjustment of the blades by means of an adjustable screw assembly.

Abstract: A method of performing an operation, e.g. a spinal operation, on a patient using a retractor comprising a pair of blade assemblies which are adapted to open about a set of axes that are not parallel to a third spatial axis, and further comprising a pair of arms, which are adapted to move the pair of blade assemblies apart from one another in the third spatial axis. In the method, the blade assemblies are closed to assume a low profile, inserted into a relatively small incision, and stretched apart from each other, thereby stretching the skin about the incision to form an aperture longer than the incision. The blade assemblies are then opened by rotating the blades about the set of axes, stretching the skin around the incision in a second direction that is substantially perpendicular to the first direction (i.e. the direction of the incision).

Abstract: A device useful for accessing the left atrium is provided. The device comprises an elongated tubular body and a dilating tip. The tubular body has an axis, a proximal end, a distal end and a lumen longitudinally extending therethrough. The dilating tip is slidably mounted on the distal end of the tubular body. The dilating tip comprises a segmented surface that is generally transverse to the axis of the tubular body, and a generally rigid tube extending distally from the segmented surface and having a sharp distal end. Distal movement of the tubular body relative to the dilating tip exerts a force on the segmented surface to thereby open the segmented surface.

Abstract: Knotless, adjustable anchor systems that allow for knotless tensioning of tissue (such as the rotator cuff) after anchor implantation. The knotless, adjustable anchor system includes knotless anchors (for example, swivel and/or screw-in suture anchors and/or push-in suture anchors) that are modified to carry a self-locking, adjustable construct (for example, a suture assembly with a spliced suture loop) and to position the self-locking, adjustable construct at the repair site. The system allows for knotless tensioning of the tissue after the knotless anchors have been implanted. The medial row anchors are implanted and passed through tissue in a similar fashion as the current Corkscrew® or SwiveLock® C anchors are. The lateral row anchors are similar to a knotless SutureTak® but modified to accommodate a larger suture to hold a larger load. The suture is interconnected to the medial row and returned back to the lateral row for loading into the splice.

Abstract: A suture passer instrument is disclosed that contains two opposing needles positioned adjacent to each other on the end of a hollow handle. The needles are at least partially hollow and the hollow in the needles is of a sufficient size so that a suture can be passed through an entry point near the tip of the needles through the hollow of the needles to the hollow in the handle of the instrument. Two suture ports are located toward the sharp end of the needles such that when the needle pierces through tissue the suture can be grasped and its end pulled through the hollow central chamber of the device.

Abstract: In a meniscus reattachment device, with at least one needle and at least one implant, the implant is intended to have at least one extensible subsidiary surface.

Abstract: A suture device includes: a longitudinal member extended along a longitudinal axis; a first grasping member and a second grasping member provided at a distal portion of the longitudinal member and configured to enable opening-closing movement; an opening-closing mechanism configured to open and close the first grasping member and the second grasping member; a delivery mechanism configured to deliver a distal member between the first grasping member and the second grasping member, the distal member to which a suture thread is fixed; and an engage portion supported by one of the first grasping member and the second grasping member so as to protrude from a distal end of at least one of the first grasping member and the second grasping member and having an engaging-surface capable of engaging the suture thread.

Abstract: An apparatus and a method for surgical suturing with thread management. An illustrative apparatus for tissue suturing includes a cartridge having a suturing needle having a pointed end and a blunt end, the suturing needle capable of rotating about an axis, a reciprocating needle drive, and an actuator capable of releasably engaging the needle drive to rotate the needle. A method for suturing tissue is provided that includes placing a suturing device having a cartridge containing a suturing needle to span at least one tissue segment, activating an actuator to cause rotational movement of the suturing needle through the at least one tissue segment, and deactivating the actuator to stop an advancing movement of the suturing needle to cause a suturing material to be pulled through the at least one separated tissue segment forming a stitch.

Abstract: A staple is provided having a backspan and a first and second legs extending distally from the backspan. Each of the first and second legs includes a bend dividing each leg into a traversing leg portion and a substantially linear clenching leg portion. A staple plate is positionable over the first and second legs between the backspan and the first and second clenching leg portions. An anvil assembly has first and second movable members which move toward to one another to engage outer surfaces of the first and second clenching leg portions. There is further disclosed a method of forming the staple through tissue.

Abstract: A surgical buttress for use in a surgical stapling apparatus is provided and includes an elongate rectangular body portion defining a width; a neck portion integrally formed with and extending from a distal end of the body portion, the neck portion defining a width; a head portion integrally formed with and connected to a distal end of the neck portion, the head portion defining a width; and a tail portion integrally formed with and extending from a proximal end of the body portion, the tail portion defining a width. The width of the tail portion is less than the width of the body portion.

Abstract: An anvil assembly is provided. The anvil assembly includes an anvil center rod, a head assembly pivotally secured to the anvil center rod assembly from an operative position to a tilted position, and a sleeve slidably disposed about the anvil center rod. The sleeve is associated with the head assembly such that movement of the head assembly from the operative position towards the tilted position effects proximal movement of the sleeve about the anvil center rod.

Abstract: An apparatus comprises a body, a shaft assembly, an end effector, and an articulation joint. The end effector is operable to manipulate (e.g., staple) tissue. The articulation joint couples the end effector with the shaft assembly and permits the end effector to deflect away from the longitudinal axis of the shaft assembly. The articulation joint comprises a locking assembly, which is operable to selectively lock the angular position of the end effector relative to the longitudinal axis of the shaft assembly; and an unlocking feature. The unlocking feature is operable to selectively unlock the locking assembly. The shaft assembly further comprises a first movable member, which is operable to selectively drive articulation of the end effector at the articulation joint; and a second movable member, which is operable to selectively drive the unlocking feature. The second movable member is movable independently relative to the first movable member.

Abstract: A surgical fastener applying apparatus (10) including a cartridge supporting section (200), an anvil supporting section (100) having a longitudinal axis and including a distal anvil portion (104) and a proximal handle portion (102), including a first longitudinally extending slot (109) extending therealong. A clamping lever (300) having a proximal portion and a distal portion is movable from an undamped position to a clamped position to releasably secure the anvil supporting section in close approximation with the cartridge supporting section. A firing assembly (500) includes a firing knob (552), the firing knob movable within the longitudinally extending slot from a first proximal position to a second distal position to fire fasteners (402) supported in the cartridge supporting section.

Abstract: A wound closure device using magnets to draw skin together. When two skin adhering magnets are placed on opposite sides of a wound in a polar opposite configuration, the magnets attract each other, thus drawing the skin underneath the magnets together and reapproximating wound edges. The device includes a removable sheet having an elongated partition member that separates the first magnet from the second magnet. When the removable sheet and elongated partition member are removed from the magnets, the removal allows the magnets to draw in close together to reapproximate wound edges. To prevent slippage of the magnets, the inner edges of each magnet may have complementary notches and protrusions that align with each other, thereby preventing longitudinal movement of the magnets along their inner edges.

Abstract: A staple cartridge is disclosed which includes a cartridge body, a plurality of staples removably stored, at least partially, within the cartridge body, and an implantable layer. The implantable layer can include a first portion, a second portion spaced apart from the first portion, and a third portion intermediate the first portion and the second portion, the third portion including a pressed region.

Abstract: A banding apparatus and method. One embodiment is a unitary or integrated hemorrhoidal single hand-held and single hand-operated ligator, which can, in some embodiments, enable direct visualization and release of multiple bands. The ligator has a gun-shaped handle extending from a vacuum generating trigger tube, with a fixed band bearing barrel extending from the vacuum generating trigger tube. A vacuum generating tube extends through the band bearing barrel from the rear of the gun ligator to the band bearing barrel end of the ligator gun, and is in air movement communication with the vacuum generating tube and band bearing barrel end of the ligator gun. A band actuating barrel is threadably mounted to surround a portion of the band bearing barrel, and rotation of the barrel cause the barrel to move laterally and force one or more ligating bands along and off of the band bearing barrel end. A light source can be included to illuminate the band bearing barrel end.

Abstract: In one embodiment, a ligator adapted for use with an endoscope includes a ligator body adapted to mount to a body of the endoscope, a barrel adapted to mount to a distal tip of a shaft of the endoscope, the barrel supporting multiple elastic bands that can be sequentially deployed onto internal tissue, and an activation mechanism supported by the ligator body, the activation mechanism including a rotatable activation knob, a rotatable cord winding ring, an activation cord, and a stop element that limits rotation of the activation knob to rotation between a start position and an end position beyond which no further rotation is possible.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a system for use in occluding an opening in the tissue of a body includes a handle, a catheter coupled with the handle and a medical device disposed within a lumen of the catheter. The medical device includes an anchor system having a plurality of anchor segments coupled with an anchor hub. The medical device further includes an occluder system having a plurality of occluder segments coupled with an occluder hub. A first actuator is configured to displace the occluder hub independent of, and relative to, the anchor hub to deploy the occluder system from a refracted state to an expanded state while the anchor system remains in a retracted state.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a medical device includes an occluder portion and an anchor portion, the anchor portion hingably coupled to the occluder portion. With this arrangement, the anchor portion actuates and pivots relative to the occluder portion between an anchor deployed position and an anchor non-deployed position while the occluder portion is in an occluder deployed position.

Abstract: A method for positioning a bone cutting guide on a tibia may begin with coupling a bone cut positioning apparatus with a tibia. The method may also include adjusting the positioning apparatus in a varus/valgus orientation to shine a light emitted by a light emitter approximately along a midline of an anterior surface of the tibia, swinging a pivoting arm about a pivot joint to direct the emitted light along a medial surface of the tibia, adjusting the positioning apparatus in an anterior/posterior orientation to shine the light approximately along a midline of the medial surface, contacting a stylus with a proximal end of the tibia to select a cutting depth for a bone cut to be made on the tibia, and attaching the bone cutting guide to the tibia in a position determined by the positioning apparatus.

Abstract: The invention features a glenoid (shoulder socket) implant prosthesis, a humeral implant prosthesis, devices for implanting glenoid and humeral implant prostheses, and less invasive methods of their use for the treatment of an injured or damaged shoulder.

Abstract: A device for use in total hip arthroplasty surgery including a first guide member having a substantially semi-circular ring having a top surface and a bottom surface, a plurality of first guide legs protruding vertically downward from the lower surface of the semi-circular ring, the first guide legs including a contact area disposed on the open end of the first guide leg; a plurality of holes disposed on the ring, a plurality of protrusions extending vertically upward from a top surface of the ring. The device also includes a second guide member having an arc having an arc of curvature substantially similar to the semi-circular ring, the arc having a top surface and bottom surface, first and second horizontal brackets connecting ends of the arc and being connected thereto at a termination point, a plurality of second guide legs protruding vertically from either the lower surface of the arc, first or second horizontal brackets; and means for connecting the second guide member to the first guide member.

Abstract: A method for repairing a soft tissue or bone defect can include selecting one of a plurality of sizing guides having a base perimeter size corresponding to a size of the defect, where each base has a different perimeter size and a plurality of apertures spaced apart a predetermined distance from each other, with the predetermined distance being the same for each of the sizing guides. The selected sizing guide base can be positioned against a distal end of the femur relative to the defect. A plurality of guide wires can be positioned through the plurality of apertures in the sizing guide base and the guide wires can be fixed to the femur such that the guide wires are parallel to each other. A first guide can be positioned over the guide wires and against the distal end of the femur to guide a first cutting member relative to the femur.

Abstract: An apparatus and method for performing an open wedge osteotomy. The apparatus includes devices for forming an open wedge osteotomy in bone, including a keyed-wedge implant. The method includes the steps of forming a cut in a bone, forming a keyhole in the bone surface at the proximal end of the cut, and positioning a keyed wedge-shaped implant into the cut formed into the bone.

Abstract: A system for performing a resection of a selected portion of an anatomy with a resection instrument. The system includes a first member, a first movement defining portion defined by the first member, a second member, and a second movement defining portion of the second member. The first member is fixable to the selected portion of the anatomy. The second member is configured to cooperate with the first member. The first movement defining portion and the second movement defining portion are operable to allow the second member to be moveable relative to the first member from a first position to a second position. The resection instrument is positionable relative to the second member in the first position and in the second position to form a selected resection of the selected portion of the anatomy.

Abstract: An aspiration device can be used to aspirate an obstruction from a blood vessel. The aspiration device is configured to allow controlled one-handed aspiration yet maintain a syringe plunger feel of vacuum. The aspiration device also allows one-handed injection to empty the device when needed. Furthermore, mechanisms enable one-handed locking of a plunger position of the device to maintain vacuum when the user releases the device.

Abstract: A surgical instrument for removing a gallbladder is provided. The surgical instrument includes a handle assembly, an elongated body portion extending distally from the handle assembly, and a capture portion operably mounted on a distal end of the elongated body portion. The capture portion defines a tissue receiving opening when in an open configuration and is configured for receipt through an incision when in the capture portion is in a closed configuration. The capture portion includes at least one sharpened member for cutting tissue received within the tissue receiving opening as the capture portion moves from the open configuration to the closed configuration. Also provided is a method of removing a gallbladder using a surgical instrument.

Abstract: A tunneling device for creating a pathway in subcutaneous tissue of a person's body. The tunneling device includes a member having two ends, where each of the ends defines an insertion surface that facilitates the insertion of the ends into the subcutaneous tissue of the person's body. The tunneling device includes an interchangeable handle connectable to each of the ends. The handle defines a grasping surface and an opening. The opening is configured to receive either of the ends. The grasping surface enables a user to securely hold the handle with one hand to forcibly move the member through the subcutaneous tissue of the person's body to create the pathway in the subcutaneous tissue, and pull a cable of an implant device through the created pathway.

Abstract: An ultrasonic medical treatment device has a probe, a transducer for mechanically vibrating the probe at an ultrasonic frequency, a voltage source for energizing the transducer, and another electrical voltage source for feeding to the probe a high-frequency alternating waveform of limited current and limited voltage to be conducted into a patient through the operative tip of the probe after placement of the operative tip into contact with the patient. The alternating waveform has a current and a voltage so limited as to prevent damage to organic tissues while stimulating nerves to reduce or suppress pain.

Abstract: In a width dimension decrease portion forming a distal end of an ultrasonic probe, a width dimension decreases from a proximal direction toward a distal direction, so that a sectional area perpendicular to a longitudinal axis decreases from the proximal direction toward the distal direction. An intermediary portion continuous between a probe body portion and the width dimension decrease portion includes a width dimension increase portion in which the width dimension increases and a thickness dimension decreases from the proximal direction toward the distal direction at the same time. In the intermediary portion, the sectional area perpendicular to the longitudinal axis does not increase and does not decrease at a higher decrease rate than in the width dimension decrease portion toward the distal direction.

Abstract: In one embodiment of the invention, a replaceable electrosurgical end effector cartridge is provided to couple to a mechanical wrist of a surgical instrument for a robotic surgical system. The replaceable electrosurgical end effector cartridge includes two end effectors, a fastener to rotatably couple the two end effectors together, and a cam mechanism. At least one of the two end effectors is a moveable end effector having a jaw portion, an off-center portion, and a base portion. The cam mechanism is coupled to the base portion of the at least one moveable end effector to pivot it about the fastener to open and close the jaw portion of the at least one moveable end effector with respect to the other.

Abstract: A medical device for minimally invasive removal of tissue from a body lumen, can include: a sheath having a proximal and a distal end; and a tool configured to pass through the sheath and configured to transition from a crimped state to a deployed state and to a closed state, wherein the tool forms an aperture at a distal end, the distal end of the tool having at least one tube loop and at least one wire loop, wherein the tool is configured to dissect tissue in the deployed state.

Abstract: An atherectomy device with an exchangeable drive shaft is disclosed, having a drive shaft gear at a distal end of the exchangeable drive shaft for meshing engagement with a prime mover gear on the output shaft of the prime mover. The exchangeable drive shaft is inserted into an opening at the distal end of the handle housing and moved axially in a proximal direction. Surface features on at least the prime mover housing and the engageable drive shaft help to align the drive shaft gear with the prime mover gear for meshing engagement.

Abstract: A scalpel handle sheath includes a body defining a handle-receiving cavity open to a first end of the body through a narrowed sleeve region, the body further defining a flexible arm adjacent the first end with a first boss extending inwardly therefrom adjacent the sleeve region. The sheath further includes a shield coupled with the body and slideable between a retracted position and a removal position. The shield defines an edge applying an inward force on the flexible arm during movement of the shield from toward the retracted position to the removal position and a removal flange extending within the shield and passing the first end of the body during movement of the shield from the toward retracted position to the removal position.

Abstract: A tool introducer is configured for introduction in an elongated body including a straight tube, wherein the tube encloses a tube lumen opened at its distal end with a tube opening. The tool introducer includes locking means to selectively lock or unlock an interchangeable surgical tool to the tube from displacing axially and/or rotationally in the tube lumen, the locking means being configured such that, at the locking, a tool connector of the tool projects towards the tube opening and is distanced therefrom by at least 3 cm. A method includes positioning the surgical tool introducer such that a distal portion thereof projects in a body cavity, manipulating and/or extending the tool introducer to reach and engage an elongated shaft introduced percutaneously into the body cavity; and inserting the elongated shaft into the tube lumen via the tube opening and connecting the tool to the elongated shaft.

Abstract: Systems and methods for aligning hair follicle are provided. The systems may include at least one piercing member. The piercing member may be configured to pivot about a pivot axis. The piercing member may be operable to translate along a chosen axis, wherein the chosen axis may intersect with the pivot axis. The translation of the piercing member in a first direction may enable the piercing member to pierce through an external surface of a skin, and translation of the piercing member in a second direction may enable the piercing member to retract out of the skin.