Abstract: A drainage system, the drainage system comprising a container having an interior and a mouth, the mouth comprising an outer surface and an opening, a frangible seal covering the opening, a cap secured to the mouth and in fluid communication with a drainage line, the cap having an inner surface configured to engage with the outer surface of the mouth, an O-ring located at least partially between the outer surface of the mouth and the inner surface of the cap and configured to form a fluid seal between a space defined by the cap and the space located externally of the drainage system, and a retaining ring circumferentially engaging the cap.

Abstract: A filter assembly for use with a surgical suction tool for removing fluid and debris from a surgical site includes a conical filter element with a plurality of orifice arrays spaced along the length of the conical body with successively decreasing orifice diameters. The filter element includes an annular flange at the mouth of the filter element that is clamped between a container and a cap. The container includes conically tapered wall to define a radial space between the container and the filter element to permit fluid flow around the filter element and through the container to an outlet tube fitting. A cap covers the mouth of the container with a threaded interface defined between the cap and the container. The threaded interface includes a dual pitch triple lead thread with a coarse lead-in pitch and a fine trailing pitch.

Abstract: An ultrasonic surgical handpiece includes a motor having a transducer assembly along a central axis of the surgical handpiece. The motor is configured for operative connection to a power source. A surgical attachment has a proximal end detachably connected to the motor and a distal end defining a working plane for engagement with biological tissue. A housing has a housing distal end, a housing proximal end, and a cavity configured to receive the motor and the surgical attachment. An irrigation path of the housing is configured to communicate irrigation fluid. The irrigation path has an inlet proximate the housing proximal end operatively connected to an irrigation fluid source, and an outlet proximate to the working plane. The irrigation path is separated from the housing cavity to prevent contact between the irrigation fluid and an operational portion of the surgical attachment.

Abstract: A snivel suction apparatus includes a suction mechanism and an air extraction mechanism. The air extraction mechanism is connected to the suction mechanism. The air extraction mechanism includes a pump, a piston, a communicating tube, a first check valve and a second check valve. The piston is arranged on the pump. One side of the communicating tube is connected to the pump. The other side of the communicating tube is connected to the suction mechanism. The first check valve is arranged in the pump and at one side of the communicating tube. The second check valve is arranged on the pump.

Abstract: A needle drawing assistance apparatus. The apparatus includes a first planar member defining a first end and a second end and a second planar member having a proximal end and a distal end. The second planar member is secured to the first end of the first planar member at the proximal end of the second planar member via a hinge. The hinge is configured to allow the needle assistance apparatus to be freely movable between an active position and an inactive position. The inactive position is defined where the first planar member rests parallel and in contact with the second planar member. The active position is defined where the first planar member defines an angle greater than zero degrees with the second planar member.

Abstract: A surgical tip device for coupling to a suction source. The surgical tip extending from a proximal end to a distal end and defining a cavity for the passage of suction flow through the device. The tip includes a probe movably received within the cavity and capable of manipulation from an exterior of the device to remove obstructions from both the distal end, the proximal end, and within the cavity.

Abstract: The present disclosure provides an apical connector for use in a heart wall. The apical connector may include a port defining an aperture therethrough, an anchoring device extending distally from the port and configured for advancing at least partially through the heart wall, and a cannula configured for advancing through the aperture of the port and at least partially through the heart wall. The cannula may include a locking tab configured to engage the port and lock the cannula with respect to the port.

Abstract: An implantable system includes a ventricular assist device and a cuff for attachment to a heart. The ventricular assist device includes an inlet cannula. The cuff defines an opening for insertion of the inlet cannula into the opening. The cuff includes an annular fastening member and an attachment member. The annular fastening member is configured to be sutured to heart tissue. The attachment member includes flexible extensions. Each of the flexible extensions is configured to interface with the inlet cannula during insertion of the inlet cannula into the opening so as to cause the flexible extension to flex outward to accommodate passing of the inlet cannula along the opening. Each of the flexible extensions is configured to interface with the inlet cannula to impede extraction of the inlet cannula from the opening.

Abstract: A method for providing a treatment recommendation to a physician for treating a patient is disclosed. The method comprises determining, from a processor in communication with a patient data repository, a first treatment recommendation based on a combination of selected patient demographics from the patient data repository applicable to the patient, and operational parameters of a plurality of ventricular assist devices (VADs) suitable for treating the patient, the first treatment recommendation having a first survival rate and comprising the use of a first VAD. The method then obtains a first signal from using the first VAD on the patient. The method then determines a second treatment recommendation based on the first signal and the first treatment recommendation, the second treatment recommendation having a second survival rate. The method then provides the second treatment recommendation to the physician if the second survival rate is higher than the first survival rate.

Abstract: The invention relates to a device for extracorporeal blood treatment, having a hydraulic system B which comprises multiple lines (7), (9) for providing dialysate for a dialyser (3) and having a control system (15) which comprises multiple electrical components (17A), (17B), (17C). The invention also relates to a method for operating a device for extracorporeal blood treatment which has a hydraulic system which comprises multiple lines for providing dialysate for a dialyser and a control system which comprises multiple electrical components, wherein the dialysate is produced using a liquid supplied to the device for extracorporeal blood treatment. The extracorporeal blood treatment device is a blood treatment device which has a central connection (11) to allow a liquid, in particular permeate (pure water), to be supplied to the machine.

Abstract: Extracorporeal blood flow circuit devices can be used during medical procedures such as on-pump open-heart surgery. For example, extracorporeal heat exchange and oxygenation devices can be used to facilitate surgical procedures such as coronary artery bypass grafting. In some embodiments, such an oxygenation device can include an integrated air removal structure. In particular embodiments, the air removal structure can comprise one or more porous hollow fibers.

Abstract: A blood purification system is provided that is capable of effectively utilizing accumulated histories stored during blood purification treatment and that helps quickly and accurately grasp whether the current transition of a particular parameter is normal when compared with a transition of the particular parameter that is estimated from the histories.

Abstract: A drainage catheter with retractable internal drains for fluid drainage and irrigation. The drainage catheter with retractable internal drains generally includes a primary catheter for insertion within a subject, a lumen within the primary catheter for conducting fluid flow between a source of fluid drainage or irrigation and the subject, and a plurality of selectively retractable and deployable drains in fluid communication with the lumen. Retraction and deployment of the drains within a subject is accomplished remotely via a specially shaped stylet and common drain connector within the primary catheter. The plurality of drains are enclosed within the primary catheter in the retracted state and extend radially outwardly from the primary catheter in the deployed state. In the retracted state, insertion and location of the primary catheter in a subject are facilitated. In the deployed state, expanded and improved drainage and irrigation area and a plurality of fluid flow paths and locations are provided.

Abstract: A syringe including a barrel having an interior surface defining an interior extending along a longitudinal axis between an open end and a closed end opposite the open end. The closed end has an orifice that opens to a nozzle extending from the closed end. The syringe includes a plunger including a support and a seal attached to the support. The seal defines a selectively variable volume hollow cavity within the interior of the barrel. A receiver extends longitudinally from a connector face of the support. The receiver includes multiple jaws spaced for receiving an injector fastener having an insertion end and a retention land. Each jaw has an elastically deformable arm and a catching surface for engaging a retention land of the injector fastener when the injector fastener is seated between the jaws.

Abstract: A microsurgical system with an integrated substance chamber is provided herein for delivering substance (e.g., a drug, retina patch, dye, etc.) to a surgical site through a tool component of the microsurgical instrument, such as a tissue removal component. The system may include a tissue removal handpiece having a tissue cutter disposed at a distal end. The system may further include a first fluid conduit and a second fluid conduit. The first fluid conduit may couple a fluidics subsystem to the tissue removal handpiece to permit removal of cut tissue. The second fluid conduit may couple a substance chamber to the tissue removal handpiece. The system may additionally include a control system that enables or facilitates selective control of fluid through the tissue removal handpiece to introduce substance from the substance chamber to a surgical site through a port in the tissue cutter.

Abstract: A therapeutic device for treating an acute medical condition of a patient such as cardiac arrest is provided. The device includes one or more sensors that monitor parameters such as heart rhythm that relate to the patient's medical condition. The device also includes a plurality of medication reservoirs, each reservoir including a conduit, wherein each reservoir holds a predetermined medication that may be used to treat the condition. A manifold is connected with the reservoirs via their respective conduits. A delivery line is connected with the manifold to deliver fluids from the manifold to the patient intravenously. One or more medication pumps are in fluid connection with respective ones of the reservoirs. A processor is connected with the sensors. The processor includes a memory that stores processing instructions to interpret the parameters and to determine a recommended medication to deliver to the patient based on the parameters, the recommended medication being one of the predetermined medications.

Abstract: A multi-IV set retention device for retaining flexible lines (e.g., medical fluid lines, such as IV sets) comprises a retention body having a normal axis, and a plurality of retention slots that removably receive and retain flexible lines, and a plurality of openings to facilitate insertion of a flexible line into an associated retention slot. The retention slots are radially arrayed about the normal axis of the retention body, such that the plurality of flexible lines is movable as a unitary body. The flexible lines can be radially bundled as a collection of flexible lines that define a center of mass about a central portion of the retention device, so that the flexible lines move and act as a single flexible line. One or more of such multi-IV set retention devices can be coupled along a length of one or more flexible lines, thus fanning an IV set retention system. A method of making the multi-IV set retention device, and a method of retaining flexible lines, is provided.

Abstract: A therapeutic substance delivery device includes a fluid path having a reservoir needle, a body needle, a body needle injection mechanism, and a pumping assembly (a) configured to pump the substance from the reservoir to the subject, (b) shaped to define a pump chamber, and (c) including a plunger disposed within the pump chamber. The plunger moves back and forth through a plurality of discrete motion phases. A first motion phase of the plunger actuates a first operation from a group of operations including (a) driving the reservoir needle to penetrate the reservoir, (b) advancing the body needle into the body of the subject, (c) withdrawing the substance from the reservoir, (d) pumping the substance into the subject, and (e) retracting the body needle. A second motion phase of the plunger actuates a second operation from the group of operations. Other applications are also described.

Abstract: A syringe includes a body and a plunger movably disposed within the body. The syringe may be used with an injector including a drive member. The drive member preferably includes at least one pin adapted to form a retractable abutting connection with an interior of a plunger to enable the drive member to retract the plunger with the body of the syringe.

Abstract: Methods and systems for utilizing co-simulation of a physical model and a self-adaptive predictive controller using hybrid automata are described. For example, there is disclosed a self-adaptive predictive control system to generate an initial patient model with initial patient model settings (k1, k2, . . . , kn) and execute a program that takes as input, the initial patient model settings as configuration parameters that specify at least a plurality of initial states. Such a system further receives new patient inputs and generates hybrid automata as a variation of the initial states by applying the new patient inputs to the initial patient model. The system further derives reachable states from the hybrid automata and outputs all reachable states computed. The system further detects changes and responsively generates a new patient predictive model with new parameter settings (k?1, k?2, . . . , k?n), iteratively repeating until a termination criterion is satisfied. Other related embodiments are disclosed.

Abstract: The embodiments described herein may relate to methods and systems for adjusting insulin delivery. Some methods and systems may be configured to adjust insulin delivery to personalize automated insulin delivery for a person with diabetes. Some methods and systems may be configured to adjust insulin delivery to a person with diabetes according to one or more conditions of an insulin delivery device. Some methods and systems may be configured to enable a lock-out mode where adjustment to insulin delivery to personalize automated insulin delivery is restricted.

Abstract: An autoinjector is described that includes an outer body, a first trigger, an output needle, and a first compartment. The first compartment is positioned within the outer body and includes (i) a main body, (ii) a first biasing member coupled to the first trigger, and (iii) a protrusion positioned at a distal end of the main body. The autoinjector further includes a second compartment positioned in the outer body and in fluid communication with the first compartment and the output needle. The autoinjector also includes a second biasing member coupled to a second trigger. The first biasing member is configured to, upon application of force to the first trigger, automatically move an ampule in a distal direction relative to the main body to force the ampule against the protrusion, so as to break the ampule and allow a medicament to flow from the ampule to the second compartment.

Abstract: An autoinjector comprises a housing, a product container, a displaceable needle protection sleeve, a plunger rod displaceable by a preloaded discharge spring, a dose setting element with at least two different rotational positions relative to the housing, and a dosing sleeve. The dosing sleeve or the plunger rod has a dose selection stop, and the other has at least one dosing stop. By rotating the dose setting element, the dosing sleeve or the plunger rod is rotated relative to the other. Upon displacement of the needle protection sleeve, the spring displaces the plunger rod, whereby, if the dose setting element is in the first rotational position, the dose selection stop and the first dosing stop strikes against each other, and, if the dose setting element is in the second rotational position, one of the dose selection stop and the first dosing stop is or can be moved past the other.

Abstract: Devices and methods for intraocular fluid injection are disclosed. A device can include a surgical instrument for an ophthalmic procedure. The surgical instrument can include a handle. A fluid compartment can be coupled to the handle and configured to hold a substance. A tool can be coupled to the distal end of the handle and have a lumen configured to convey the substance into an intraocular site of a patient. A piston can be in the handle and configured to reciprocate along the longitudinal axis of the handle to draw the substance from the fluid compartment and eject the substance through the lumen of the tool. A push button can be on the lateral side of the housing and configured to engage the piston via a sloped surface to actuate a forward stroke of the piston towards the distal end of the handle.

Abstract: The invention may include a knife having a syringe hub remover. In one embodiment, the invention may include a hub slot that may be integral to the knife tang and that may further be configured to be positioned over a syringe hub and allow for an improved leveraged torque force to be applied thereby twisting and ultimately assisting in the removal of the syringe hub.

Abstract: A needle ejection and retraction mechanism (10) comprises a needle (12), a needle hub (14) connected to the needle (12) and adapted to be displaced in a distal direction and in a proximal direction, a first spring mechanism (16) compressed to exert a force in the distal direction on the needle hub (14) and adapted to cause the needle (12) to eject in the distal direction, a second spring mechanism (18) compressed to exert a force in the proximal direction on the needle hub (14) and adapted to cause the needle (12) to retract in the proximal direction after it has been ejected in the distal direction, and an actuator (20) which is adapted to activate the exertion of the force in the distal direction on the needle hub (14) and the exertion of the force in the proximal direction on the needle hub (14).

Abstract: A needle protection system, adapted to protect a tip of a hypodermic needle connected or connectable to a syringe. The system comprises a shield to shield the tip of the needle; a needle hub engaged to the hypodermic needle and having an exterior surface including at least one slot. The slot includes at least three surfaces corresponding to three operative orientations of said shield. The needle hub is connected to the shield such that the shield can move axially, but cannot rotate, relative to the needle hub. The three operative orientations include a storage operative orientation, an injection operative orientation, and a needle protection operative orientation. The system also includes a locking sleeve, at least one biasing element, a needle sheath, and at least one tab in the slot to prevent undesired movement between said surfaces.

Abstract: Disclosed herein is an auto injector assembly comprising an auto injector for dose injection of medicament and a protective casing covering the auto injector, the auto injector having a recap prevention cap with one or more recap prevention springs and a housing partly protruding through the recap prevention cap. The housing is for accommodation of a syringe with a needle, a plunger rod, a plunger rod, a syringe driver, and a plunger rod driver.

Abstract: An apparatus includes a first member coupled to a second member. The first member defines a chamber containing a dry powder and includes a chamber wall that forms an outer boundary of the chamber. The second member includes a surface covering the chamber and defines an intake channel and an exit channel. The exit channel is fluidically coupled to the chamber via an exit opening. The intake channel is fluidically coupled to the chamber via an intake port. A center line of the intake channel is tangential to a portion of the chamber wall such that a portion of an inlet airflow conveyed into the chamber via the intake channel has a rotational motion. The intake port is defined at least in part by an intake ramp. The intake ramp includes a transition surface that forms an exit angle with respect to the surface of less than 105 degrees.

Abstract: An inhalation component generating device includes: a power supply; a load that evaporates or atomizes an inhalation component source by power from the power supply; and a control circuit that performs control based on an output of a temperature sensor. The control circuit performs: a process (a) of calculating power supply temperature on the basis of the output of the temperature sensor; and a process (b1) of determining whether the power supply temperature is in a first temperature range, and performing deterioration diagnosis on the power supply only in a case where the power supply temperature is in the range.

Abstract: Therapy gas delivery systems that provide run-time-to-empty information to a user of the system and methods for administering therapeutic gas to a patient. The therapeutic gas delivery system may include a gas pressure sensor attachable to a therapeutic gas source that communicates therapeutic gas pressure data to a therapeutic gas delivery system controller, a gas temperature sensor positioned to measure gas temperature in the therapeutic gas source that communicates therapeutic gas temperature data to the therapeutic gas delivery system controller, at least one flow controller that communicates therapeutic gas flow rate data to the therapeutic gas delivery system controller, at least one flow sensor that communicates flow rate data to the therapeutic gas delivery system controller, and at least one display that communicates run-time-to-empty to a user of the therapeutic gas delivery system.

Abstract: Systems and methods for novel ventilation that allows the ventilator to detect a patient intention to cycle exhalation are provided. Further, systems and methods for cycling exhalation based on a muscle pressure are provided.

Abstract: The present invention relates generally to medical suction catheter devices, and specifically to catheter devices for aspiration of trachea-bronchial secretions and/or cleaning of tracheal ventilation tubes. Embodiments of the invention disclose an apparatus for use with a tracheal ventilation tube and/or a ventilator. In some embodiments, the apparatus comprises a cleaning catheter and a manifold. Related methods are also disclosed herein.

Abstract: An exemplary embodiment provides a tracheal tube system, comprising a tracheostomy tube holder and a cover. The tracheostomy tube holder for affixing a tracheal tube to a patient, the tracheostomy tube holder comprising a first end, a second end, and a connector for attaching the first end to the second end. The cover configured to surround at least a portion of the connector to thereby inhibit access to the connector.

Abstract: A respirator mask includes a facepiece configured to create a seal with a face of a user and a mask frame coupled with the facepiece. A port assembly is coupled with the mask frame and an inhalation path including a filter, a first valve seat and a first valve member, the filter and first valve member coupled with the first valve seat on opposed sides. An exhalation path includes a second valve seat and a second valve member, the second valve member surrounding the first valve seat.

Abstract: A breathing assistance apparatus is designed for use with delivery of respiratory gases to a patient. The breathing assistance apparatus includes a patient interface, having a body section adapted to cover the nose, or nose and mouth of a patient and a sealing interface. The sealing interface includes at least an outer sealing member. The outer sealing member (201) is adapted to attach to the body section in a sealing manner and has a substantially thin section (203) in at least its nasal bridge region. The thin section is substantially thinner than the rest of the outer sealing member.

Abstract: A respiratory mask can have a frame supporting a sealing arrangement. Various features of the frame and sealing arrangement can improve comfort and reduce the occurrence of pressure sores. The frame can include cheek supports that have a large surface area configured to spread loads over a greater area of the patient's face and therefore reduce the forces applied to the face and the occurrence of point loads. The seal can have a main body that includes a spring with a silicone skin, wherein the spring applies a substantially constant force to the face and/or nares of the patient.

Abstract: Described herein are methods and devices for selectively applying fluids (particularly anesthetics) to a target tissue from within a blood vessel while minimizing the amount of fluid applied to non-target tissue. The injection catheters described herein may include an elongate body, a directional injector, and one or more holdfasts for securing the catheter before extending the injector. The methods of selectively applying anesthetic to a target structure generally include the steps of inserting an injection catheter into a body vessel, positioning the injection catheter within the body vessel near the target structure, anchoring the injection catheter before extending a directional injector from the injection catheter, and applying anesthetic from the injection catheter to the target structure.

Abstract: A system and method for prostate cancer treatment under local anesthesia includes creating a superficial skin and subcutaneous block in a perineal area of a patient by administering a first anesthetizing agent; creating a deep nerve block under ultrasound guidance by administering a second anesthetizing agent, the second anesthetizing agent infiltrating cavernosal nerve bundle tissue and periprostatic space; and ablating prostate tissue. The office-based method, statistical models and computer generated treatment plans identify and ablate prostate tissue containing cancer through or via the perineum while preserving prostate function, and critical anatomical structures.

Abstract: An intravascular device (200) comprising an active member (202) for reversibly expanding a radial extension of the intravascular device inside a luminal extension of the vessel and comprising a reversibly deformable active membrane (206) that is arranged and configured to change its shape against a variable intravascular fluid pressure exerted on the active membrane in an inserted state by an intravascular fluid, an intravascular pressure compensation cavity (208), which is fluidicly sealed from the intravascular fluid and which includes a first chamber (208.1) that is covered by the active membrane (206), and a second chamber (208.2) that is covered by a compensation membrane (210), which is reversibly deformable in response to the variable intravascular fluid pressure, wherein the first chamber (208.1) and the second chamber (208.2) are in pressure communication with each other and, via the active membrane (206) and the compensation membrane (210), with the intravascular fluid.

Abstract: A smart obturator assembly includes a hub forming a central passage. The hub is configured to couple to a proximal end of a device that forms a lumen such that the central passage is in fluid communication with the lumen. A collar on the hub includes electronic circuitry in signal communication with remote reception circuitry. An obturator is movably positionable within the lumen. The obturator is movable within the lumen between a first position and a second position. The obturator includes a distal end and a sensor at the distal end. The sensor is configured to sense an environmental characteristic within a patient's blood stream, generate a signal representative of the environmental characteristic, and transmit the signal to the electronic circuitry. The electronic circuitry is configured to receive the signal and transmit the signal to the remote reception circuitry.

Abstract: Disclosed herein are embodiments of stabilizers for use in delivering a replacement heart valve. The stabilizers can receive a portion of a delivery system, such as a handle, to prevent unwanted motion of the delivery system. The stabilizer can include a linear actuator for adjusting a position of the delivery system once held within the stabilizer.

Abstract: A medical device drive apparatus for inserting an elongated medical device into a blood vessel includes a sub-drive unit that enables fine movement of the elongated medical device and a main drive unit that enables long distance movement of the elongated medical device, in which the sub-drive unit includes a sub-drive unit body and a sub-movable portion movable with respect to the sub-drive unit body, and information on minute force applied to the elongated medical device is calculated based on information on acceleration of the sub-movable portion.

Abstract: A device configured to move in a viscoelastic media, the device comprising: a main-body comprising a first material, configured to respond to a first threshold of a stimulus field; and one or more memory shaped elements comprising a second material, configured to respond to a second threshold of a stimuli field; wherein the first material is selected to enable manipulation of the main-body's direction in the viscoelastic media; and wherein second material is selected to enable manipulation of the configuration of the memory shaped element.

Abstract: A uni-directional, plunger-type electrophysiology catheter handle is designed to reduce the input force a user must apply to deflect the distal end of the catheter. A force amplifier is operatively coupled to a deflection actuator of the handle. The force amplifier can be a pulley or a system of gears. The force amplifier can increase the output force of deflection actuator by the same factor as that by which the user input force is reduced. A variable-friction autolocking system can also be used to reduce the input force a user must apply during initial deflection as compared to later deflection of the catheter.

Abstract: The present disclosure relates to fluoride ion batteries and structures of metal based electrode materials for various fluoride ion batteries. The structures of the metal based electrode materials comprise one or more shells or interfaces, enabling the electrodes to operate at room temperature with a liquid electrolyte.

Abstract: A catheter insertion device (10) is provided for positioning and inserting a catheter (14), particularly a midline catheter into a patient. The insertion device (10) includes an introducer needle (18) that extends from the distal end of the catheter during insertion. A manually operated actuator assembly (20) is movable with respect to a housing for deploying the catheter (14) over the distal end of the introducer needle (18). A step-wise movement of the actuator (20) advances the catheter (14) in stages over the introducer needle (18). A shuttling or indexing mechanism (60, 76) advances the catheter and prevents retraction of the catheter once deployed.

Abstract: A delivery sheath includes an outer tubular layer and an initially folded inner tubular layer. When an implant passes therethrough, the outer tubular layer expands and the inner tubular layer unfolds into an expanded lumen diameter. The sheath may also include selectively placed longitudinal support rods that mediate friction between the inner and outer tubular layers to facilitate easy expansion, thereby reducing the push force needed to advance the implant through the sheath's lumen.

Abstract: Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on the substrate, wherein the coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphology and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein substantially all of pharmaceutical agent and/or active biological agent remains within the coating and on the substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of the medical device in the body of the subject a portion of the pharmaceutical agent and/or active biological agent is delivered at the intervention site along with at least a portion of the polymer and/or a at least a portion of the pharmaceutical carrying agents.

Abstract: The present disclosure is directed to a device. The device may include a distal shaft defining a central lumen and an orienting element comprising at least one inflatable member. Wherein a first portion of the orienting element extending from the shaft in a first direction and a second portion of the orienting element extending from the shaft in a second direction. Further, wherein the second direction is substantially opposite the first direction.