Abstract: Wound dressings, systems, and methods are presented for treating a wound on a patient's limb, such as a venous leg ulcer. The dressings, systems, and methods involve creating airflow within the dressing to vaporize and remove liquid. The airflow may begin when the dressing becomes saturated. The dressings may be used to provide compression and reduced pressure to the wound. Other systems, methods, and dressings are presented herein.

Abstract: Methods and apparatuses for detecting full waste canister and/or fluid flow path blockage conditions are disclosed. Also disclosed are methods and apparatuses for controlling a pump. In some embodiments, flow of fluid can be restricted in a portion of the fluid flow path. A controller can be configured to compare a difference in pressure values upstream and downstream of a fluid flow restrictor to a pressure difference threshold, and determine based on the comparison whether to activate an alarm indicating the full waste canister condition or the fluid flow path blockage condition. The controller can be additionally or alternatively configured to determine a fluid flow using a flow meter, open a selectable valve in response to a comparison of the fluid flow with a fluid flow threshold, determine fluid flow after opening the valve, and determine based on the fluid flow after opening the valve whether to activate the alarm.

Abstract: A hand piece having an irrigation portion and an aspiration portion that are releasably coupled is disclosed. In an assembled configuration, the irrigation portion and the aspiration portion are coupled such that the hand piece may be manipulable by a user as a single unit. In a separated configuration, the irrigation portion and the aspiration portion may be utilized separate from each other. The irrigation portion and the aspiration portion may be freely moved between the assembled configuration and the separated configuration.

Abstract: Disclosed herein are several embodiments of a wound treatment apparatus employing a fluidic connector for negative pressure wound therapy and methods of using the same. Some embodiments are directed to improved fluidic connectors for connecting to a wound site, for example a fluidic connector including a reinforcement, and methods of using the same.

Abstract: A hollow fiber membrane module is capable of producing washed platelets having a low total protein amount and a high total platelet count from a platelet suspension. The hollow fiber membrane module for washing platelets by removal of impurities from a platelet suspension includes a housing having a platelet suspension inlet, washed platelet outlet, and filtrate outlet; and a hollow fiber membrane for filtering the platelet suspension, wherein pores through which the platelets do not pass, while the impurities pass, are formed, which hollow fiber membrane is arranged inside the housing; wherein the capacity of the inlet-side space which communicates with the platelet suspension inlet and stores the platelet suspension before being filtered through the hollow fiber membrane in the housing is 30 to 400 mL, and the module water permeability is 50 to 300 mL/Pa/hr.

Abstract: Various systems and methods relating to two-dimensional materials such as graphene. A membrane include a cross-linked graphene platelet polymer that includes a plurality of cross-linked graphene platelets. The cross-linked graphene platelets include a graphene portion and a cross-linking portion. The cross-linking portion contains a 4 to 10 atom link. The cross-linked graphene platelet polymer is produced by reaction of an epoxide functionalized graphene platelet and a (meth)acrylate or (meth)acrylamide functionalized cross-linker.

Abstract: To provide a blood treatment filter device capable of efficiently utilizing a blood treatment filter. A blood treatment filter device 20 has a filter sheet 26 through which a specific component among components forming blood is harder to pass than other components and a spacer sheet 27 through which the specific component is easier to pass than through the filter sheet 26. The filter sheet 26 has filter through-holes 39 disposed at intervals. The filter sheet 26 and the spacer sheet 27 are spirally wound in an overlapped state. The filter device 20 has seals 31 sealing both end portions in the longitudinal direction of a wound body 25 formed by the filter sheet 26 and the spacer sheet 27 which are spirally wound in a fluid-tight manner. The outer peripheral surface of the wound body 25 is formed by the filter sheet 26.

Abstract: Systems and methods are disclosed for performing hemodialysis that include fluid handling systems that provide accurate control over the type and level of hemodialysis being performed. The system includes a first pump for pumping dialysate into a dialyzer and a second pump for pumping dialysate out of the dialyzer. The system also includes a third pump that provides improved control of a level of ultrafiltration, hemodiafiltration, or both.

Abstract: A device (1) for the extracorporeal oxygenation of the blood of a patient, comprising a containment casing (2) which has at least an inlet port (4) of the venous blood and at least an outlet port (5) of the arterial blood, at least an inlet channel (6) and at least an outlet channel (7) of a work gas intended to provide oxygen to blood and/or to remove CO2 from the same, at least a bundle of hollow fibres (8) arranged within the casing (2) and placed between the inlet channel (6) and the outlet channel (7), the hollow fibres being in communication with the inlet and outlet channels (6, 7) and being intended to be crossed by the relative work gas, at least a first and at least a second filtering elements (12, 13) arranged inside the bundle of hollow fibres (8) and spaced apart the one from the other, the filtering elements (12, 13) being able to trap any air bubbles present in the treated blood, where the first and second filtering elements (12, 13) define a relative open profile and where the hollow fibres (8

Abstract: An oxygenator comprising a hollow-fibre film bundle is surrounded at least in certain areas by a bubble-retaining filter. In order to ensure an optimal function of the hollow-fibre film bundle and the bubble-retaining filter, it is proposed that a gas-permeable retaining structure is arranged between hollow-fibre film bundle and bubble-retaining filter.

Abstract: Methods (300), devices, and systems of processing blood are described. The method (300) comprises the steps of: obtaining (312) blood from a patient coupled to a single blood processing device to form a closed loop between the patient and the blood processing device; collecting (314) bulk mononuclear blood cells from the blood by leukapheresis implemented using the blood processing device in the closed loop; and enriching (316) concurrently target cells separated from non-target cells in the bulk mononuclear blood cells using the blood processing device in the closed loop.

Abstract: A trans-anal irrigation (TAI) system adapted for self-use includes an irrigation head supplied with water from a reservoir by a pump or by gravity feed. The irrigation head has either internal or external structures for releasably retaining the head in a user's rectum during the water flow portion of a TAI process. A guide member arm may be provided for manipulating the irrigation head for both insertion and removal. The irrigation head is reliably attached to the guide member arm. The guide member arm may include an integral manual pump.

Abstract: Embodiments relate generally to drug delivery infusion profiles that can be transferred and executed on infusion pumps without the need for loading new firmware. Particularly, embodiments relate to integrating and/or editing delivery profiles for execution infusion systems. Such systems can include target-controlled infusion systems. Advantages of such embodiments include enabling healthcare providers and medical device companies to respond quickly to changes in infusion pump technology, drug development, and pharmacokinetics by providing the ability to create, edit, integrate, and store delivery profiles to accommodate these changes.

Abstract: Described is novel system for delivering medication to a patient via an infusion pump. The infusion pump includes mechanical means for delivering medication that are locked and unlocked via a remote control device. The remote control device is configured to be programmed with a desired dosage of medication and to unlock the infusion device to permit the patient, user, or healthcare provider to mechanically deliver only the desired amount of medication by turning a dial. Once the desired dosage of medication has been manually delivered, the remote control locks the infusion device.

Abstract: A mechanical infusion pump device for injecting medication into a patient's IV, includes an IV reservoir and a syringe communicated to the IV reservoir and having a syringe plunger connected to a filling plunger that is moved with the syringe plunger in a first syringe-filling direction to fill the syringe with fluid medication. Biasing weight(s) is/are provided on the filling plunger for exerting bias or force from gravity on the filling plunger and the syringe plunger in a second syringe-discharging direction to dispense medication from the syringe into the patient's IV when the filling plunger is released. Only a calibrated amount of medicine can be discharged to the patent's IV over time as determined by calibration of the biasing weights and the metering element located between the syringe and the patient's IV for a given viscosity of the medication.

Abstract: A therapeutic product delivery device is described which comprises a device body and a cartridge for holding a therapeutic product. An engagement structure is provided for releasably engaging the cartridge with the device body. A fault detector is provided for detecting a fault in the delivery of the therapeutic product from the cartridge. A release trigger is responsive to the detection of a fault to cause the engagement structure to release the cartridge from the device body. In this way, a fault causes the cartridge to be released from the device body, which will prevent any further delivery of the therapeutic product to the patient. This solution is strongly preferable to a solution in which a product delivery mechanism (e.g. a pump) is merely paused or stopped, since when the cartridge separates then no further delivery is possible at all, until the cartridge is reattached (or more probably replaced with a new cartridge in case the fault is with the cartridge).

Abstract: Apparatus are provided for infusion devices and related systems and operating methods. An exemplary system includes a motor, a sensing arrangement coupled to the motor to provide output indicative of a detected characteristic of the motor when the sensing arrangement is enabled, and a module coupled to the sensing arrangement to periodically enable the sensing arrangement while the motor is idle and detect potential unintended motion of the motor based on the output from the sensing arrangement while periodically enabling the sensing arrangement. In some embodiments, the motor includes a rotor configured such that its rotation provides translational displacement of a plunger in a fluid reservoir, and the sensing arrangement includes one or more sensors configured to provide output indicative of a detected magnetic field of the rotor magnet.

Abstract: A user-wearable patch pump system for delivery of insulin or other medicament can include a patch pump having a reusable drive unit and a replaceable and refillable cartridge. The cartridge can selectively attach to and be detached from the drive unit. The cartridge can initially be inserted onto the drive unit in a first orientation at an angle to the drive unit and then be rotated to align the cartridge with the drive unit and lock the cartridge in place on the drive unit to form the patch pump.

Abstract: A method of constructing an infusion set, patch pump, or element thereof, comprising the steps of mixing at least two of a solvent, an anesthetic, and a lubricant, applying said mixture as a coating to at least one surface of an infusion set, patch pump, or element thereof, and substantially removing said solvent after coating to provide at least one of an anesthetic layer and a lubricant layer upon said infusion set, patch pump, or element thereof.

Abstract: A therapeutic product delivery device is described, which comprises a circuit layer, an actuator layer carrying an actuator, an occlusion detection layer (118), and a valve layer, through which a therapeutic product is conveyed by the action of the actuator. A plurality of conductive pins (155) extend from the circuit layer through or to each of the actuator layer, the occlusion detection layer and the valve layer, the conductive pins aligning the layers with each other. The occlusion detection layer comprises a plurality of contacts, each electrically connected to a respective one of the conductive pins, the contacts being provided at a detection region at which the therapeutic product is deposited in the event of a blockage. A blockage inhibiting the therapeutic product from being conveyed to the patient is detected when therapeutic product deposited in the detection region provides an electrical connection between the contacts.

Abstract: Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device to deliver fluid to a body of a user involves autonomously operating the infusion device to deliver a variable rate of infusion of the fluid in a first operating mode, determining a residual amount of active fluid in the body of the user based at least in part on the variable rate of infusion delivered by the infusion device in the first operating mode, and in response to identifying a change in operating mode from the first operating mode, generating a user notification based at least in part on the residual amount of active fluid. The residual amount represents infused fluid that exceeds a nominal amount corresponding to a reference rate of infusion for maintaining a physiological condition in the body of the user at a desired level.

Abstract: A communication method of managing communications to and from a handset device controlling a therapeutic product delivery device is described. The method comprises transmitting, to a server, at least part of a unique identifier for a handset device for controlling a therapeutic product delivery device, and patient information regarding a user to be associated with the handset device, and at the server, associating the handset device with the patient information, generating a handset specific code, and transmitting the handset specific code to the user. At the handset device, a manual input of the handset specific code is received, and the future transmission of data from the handset device to the server carried out in association with the handset specific code.

Abstract: A system and method for automatically administering insulin based on a feedforward control. The automatic insulin delivery system may include a computing device comprising a processor, machine readable non-transitory media which stores the coupled-model of the invention, and a monitoring system. The machine readable transitory media may be configured to receive one or more inputs and the coupled-model may utilize a feedforward control to parameterize the inputs and generate an output that can be translated to a type and amount of insulin to be administered by the system. The input(s) received by the machine readable non-transitory media may be created by a user or received from one or more sensors. The method may include providing a model that is stored on a machine readable non-transitory media and administering insulin based on the output provided by the model.

Abstract: The present invention relates to a drug delivery device for setting and dispensing of a dose of a medicament is presented comprising a housing to accommodate a cartridge filled with the medicament, an electrically operated drive mechanism to be operably engaged with the cartridge to expel a predefined dose of the medicament from the cartridge, and at least one dose element displaceably arranged relative to the housing to set and/or to dispense the dose of the medicament, wherein the dose element and the drive mechanism are mechanically decoupled from each other.

Abstract: The invention relates to a device for inserting needles, including a body defined by a proximal end and a distal end, a mounting movably mounted inside the body, at least one needle secured to the mounting, a drive means suitable for driving the mounting towards said distal end, said mounting comprising a distal surface onto which the needle projects, said distal end comprising a contact area intended for contacting the tissue, the mounting being configured so as to reach a position, after activating the driving means, in which the distal surface thereof, relative to said proximal end, is more distant than said contact area, wherein the device is further configured so as to enable a gradual passive return movement of the mounting once said position has been reached.

Abstract: A mounting arrangement for a drug-delivery device is proposed, the mounting arrangement comprising: a plug element with a longitudinal axis (L) and a housing part having a recess with a side wall which is adapted to receive the plug element. At least one of the plug element or the side wall of the recess are provided with a protrusion for fixing the plug element in a given position relative to the housing part by a force-fit engagement. Furthermore, a coupling assembly is proposed, the coupling assembly comprising the plug element and the housing part being mechanically coupled to each other.

Abstract: An injection device includes a housing and a setting part configured to, in relation to said housing, rotate in a first rotational direction when an amount of injection fluid to be dispensed is being set. The setting part rotates in a second rotational direction counter to the first rotational direction when the injection fluid is pressed out of the injection device. A latching unit defines at least one latching position of the setting part and acts between the setting part and the housing. The latching unit is active at least when the amount of injection fluid to be dispensed is set and each of the latching positions has an unequivocal rotational position of the setting part in relation to the housing assigned thereto.

Abstract: Described is a medicament delivery device (1), comprising a piston rod (11), and a container carrier (7) for retaining a medicament container, such as a syringe (8), within the body (2). At least one longitudinal rib (2.2) associated with the piston rod (11) is arranged to engage the carrier (7). At least one of the carrier (7) and the at least one rib (2.2) comprises a resilient material adapted to be deformed by the engagement between the carrier (7) and the at least one rib (2.2).

Abstract: An injector for bone regeneration is provided, including: a syringe; a needle having an embedding portion for embedding the needle in the syringe, an injecting portion integrally connected to the embedding portion and protruding from the syringe, and a channel penetrating through the embedding portion and the injecting portion for receiving an inducible bone regeneration material; and a pushing element having a rod that is less in diameter than the channel of the needle, slidably and axially disposed in the channel of the needle, for pushing the inducible bone regeneration material to move through the injecting portion and be injected into a bone portion of a patient, when the rod in the channel of the needle is pushed toward the injecting portion. The injector has a reduced size, and is beneficial for treatment of bone defects.

Abstract: Devices having male connectors for preventing connection to non-compatible female connectors are described. An exemplary male connector includes an elongate tip and a collar disposed coaxially around the elongate tip including a plurality of ribs disposed on either an inside surface or an outside surface of the collar for preventing entry of a non-compatible female connector into a channel formed between the elongate tip and the collar. One or more embodiments pertain to a device with a male connector and a compatible female connector including a threaded portion for engaging a corresponding threaded portion of the male connector.

Abstract: A method for lubricating an injection needle when used multiple times at a single occasion to penetrate a support, the method including the steps of: a) depositing a layer of a lubricating composition on the support; b) penetrating multiple times the layer of the lubricating composition deposited in step a) with the injection needle, thereby providing a lubricated injection needle having a deposited layer of the lubricating composition thereon.

Abstract: A skin adhesive device is described that can be used in conjunction with a variety of medical devices that are held against a skin surface and/or that puncture the skin during a medical procedure. The device can be adhered to the skin and can hold the skin taut during a procedure so as to maintain the skin against a medical device and/or to prevent compression of subdermal structures during a procedure. Following use, the device can be simply removed from the skin surface and discarded.

Abstract: The invention relates to the field of aerosolization by wet nebulizers, and in particular aerosols made by vibrating membranes. A capture chamber moderates the aerosol particle distributions with the primary effect on the larger particles.

Abstract: A portable nasal irrigator houses an airflow regulating system, instead of external bulky, heavy components, to power and automate the atomization of fluid for irrigation of nasal passages or for the delivery of drugs. The airflow regulating system is made up of a pump, a motor to drive the pump, a filter for filtering air, and a programmable circuit board to control the motor and regulate and maintain a power supply. The airflow regulating system is configured, via the programmable circuit board, to limit a number of actuations performed by the airflow regulating system over a predetermined dispensing period. Alternatively, the airflow regulating system is configured to limit a run time for each actuation of the airflow regulation system.

Abstract: A cannula assembly includes a cannula and an obturator. The cannula includes an elongated shaft dimensioned to access tissue. The elongated shaft has a lumen extending therethrough. The elongated shaft includes a first shaft segment having a first pre-determined configuration and a second shaft segment having a second pre-determined configuration different from the first pre-determined configuration. The obturator includes an elongated body adapted for insertion through the lumen of the elongated shaft. The elongated body includes a first body segment having a configuration in general accordance with the first pre-determined configuration of the first shaft segment and a second body segment selectively adaptable to conform to the second pre-determined configuration of the second shaft segment upon insertion through the lumen of the elongated shaft.

Abstract: A compliance monitoring module for a breath-actuated inhaler comprising: a miniature pressure sensor, a sensor port of said sensor being pneumatically coupled to a flow channel through which a user can inhale; a processor configured to: receive a signal originating from a dosing mechanism of the inhaler indicating that medication has been released; receive data from a sensing element of the sensor; and based on said signal from said dosing mechanism and said data from said sensing element, make a determination that inhalation of a breath containing medication through said flow channel complies with one or more predetermined requirements for successful dosing; and a transmitter configured to, responsive to said determination, issue a dosing report

Abstract: The present invention relates to systems and methods for multi-frequency oscillatory ventilation (MFOV). The system uses a broadband flow waveform more suitable for the heterogeneous mechanics of the lung. The system provides more efficient gas exchange and enhanced lung recruitment at lower airway pressures.

Abstract: A head mounted breathing apparatus is provided with an air cylinder filled with pressurized air; a head mount including a band, a fastening member on one side of the band for fastening the air cylinder, and a hook and loop fastener on the band; and a hose assembly including a hose, a connector at one end of the hose for attaching to the air cylinder and having a switch, and a sleeve put on the other end of the hose and having two openings. A person may wear the breathing apparatus when walking, jogging, or running. Further, the person may position the openings to be in close proximity to the nostrils and turn on the switch when he or she has difficulties of breathing. Furthermore, fresh air flows from the air cylinder to the nose via the hose assembly.

Abstract: A blower assembly is configured to deliver a flow of breathable gas at a continuously positive pressure with respect to ambient air pressure to a patient interface in communication with an entrance to a patient's airways including at least an entrance of the patient's nares, while the patient is sleeping, to ameliorate sleep disordered breathing. The blower assembly includes a motor having a shaft that extends from opposite sides of the motor. The blower assembly also includes an impeller and a circuit board. The impeller is attached to the shaft on a first side of the motor and is structured to rotate in close proximity to a volute wall. The circuit board is configured to control power supplied to the motor and is configured to disable the motor when the impeller is closer than a predetermined distance from the volute wall.

Abstract: An air-way tube holder includes a face plate having a v-shaped tube-receiving surface that aligns with one side of an opening through the face plate, and a holding block, which is disposed near a second side of the opening. The holding block receives a thumb screw and an engagement arm, the latter including a clamping head, which directly opposes the tube-receiving surface. The thumb screw is adapted to move the clamping head toward the tube-receiving surface to immobilize an airway tube therebetween, either by sliding the thumb screw (gross adjustment) or turning the thumb screw (fine adjustment). The thumb screw/clamping head is releasable by actuating a quick-release mechanism.

Abstract: A mask assembly for therapy of Sleep Disordered Breathing may include: a cushion having a seal forming portion that is structured to form a seal with only the patient's nose in use, the cushion defining at least in part an interior chamber; a shell assembly including a generally rigid shell, the generally rigid shell having a port that opens into the interior chamber, the generally rigid shell including an exhalation vent for venting exhaled gas, an air inlet tube in fluid communication with the cushion to supply breathable gas from a pressurized supply to the interior chamber; and a swivel and an elbow attached to the air inlet tube, the swivel and the elbow configured to be attached to an air supply conduit, wherein the swivel and the elbow are positioned superior to the patient's head in use, and wherein the mask assembly does not contact the patient's forehead in use.

Abstract: A sealing cushion (16) for a respiratory mask assembly (10) has a patient interface portion (18) having a resiliently deformable membrane (24) for engagement with a patient's face, and an aperture (26) formed therein for receiving a nasal and/or mouth region of a patient's face. An inner surface of the membrane has a plurality of projections (32, 34, 36, 38, 40). The projections (32, 34, 36, 38, 40) are arranged such that each projection (32, 34, 36, 38, 40) is engageable with an adjacent projection (32, 34, 36, 38, 40) on deformation of the membrane (24) during engagement of the membrane (24) with the patient's face, in use, thereby providing the membrane (24) with an increased resistance to deformation in a deformed configuration.

Abstract: A gas delivery device includes a nitric oxide generating system. The system has a medium including i) a source of nitrite ions, or ii) a source of nitrite ions and a Cu(II)-ligand complex. A working electrode is in contact with the medium, wherein i) when the medium includes the source of nitrite ions, the working electrode is a copper containing conductive material or a base material coated with a copper containing conductive material, or ii) when the medium includes the source of nitrite ions and the Cu(II)-ligand complex, the working electrode is platinum, gold, carbon, a carbon coated material, and/or mercury. A reference/counter electrode is in contact with the medium and electrically isolated from the working electrode. An inlet conduit is to deliver oxygen gas to the medium, and an outlet conduit is to transport a stream of oxygen gas and nitric oxide from the medium.

Abstract: An apparatus for use in administering a particulate medicament to a biological subject's airway, the apparatus including an inlet that in use is in fluid communication with a supply of positive pressure gas, an outlet that in use is in fluid communication with the subject's airway to deliver the positive pressure gas thereto and a medicament supply that provides a dose of particulate medicament so that the particulate medicament is entrained in a gas flow from the inlet to the outlet, thereby delivering the particulate medicament to the subject's airway.

Abstract: A disposable nasal air moisturizing device is removably attached to a nasal cannula to release a moisturizing liquid into a breathing gas and a patient's nasal airway. The intranasal sponges and moisturizing liquid prevents and treats both abrasions from the nasal cannula and excessive drying of the mucosa. This reduces the incidence of nosebleeds in patients using supplemental nasal oxygen.

Abstract: Methods of an apparatus determine a quantity of a body of water in a humidifier such as by indirect measurement. The quantity of water may be determined by measuring one or more properties or characteristics, from which the quantity of water may be inferred. Characteristics of a flow of air, the humidifier, and/or the body of water may be measured. The characteristics may be, for example, pressure, flow rate, noise, vibration, temperature, electrical or mechanical. These may be measured by one or more sensors, which may be located in the humidifier, RPT device, air circuit or the patient interface. The methods described may have advantages, for example in being able to detect the quantity of water without requiring sensors to be present in a disposable component, and in some cases, without introduction of additional sensors.

Abstract: A respiratory assistance device used by a patient having a breathing problem. Specifically, the respiratory assistance device includes a blower for taking in gas and sending out the gas into the respiratory tract of the patient, an upstream-side humidifier for humidifying the gas to be introduced into the blower on the upstream side of the blower, and a downstream-side humidifier for humidifying the gas sent out from the blower on the downstream side of the blower.

Abstract: A gas-powered, pneumatic ventilator (1) is driven by compressed air from a compressor (2) and its outlet (11) is connected via corrugated tubing (30) to a patient valve (34) and face mask or the like. A source (4) of pure oxygen, such as from an oxygen cylinder (40), is connected via small bore tubing (38) to a gas inlet (37) adjacent the air inlet (33) of the patient valve (34) so that supplementary oxygen is mixed with the air. The patient valve (34) closes and a patient dump valve (16) in the ventilator opens during the exhalation phase to allow oxygen supplied to the patient valve (34) to fill the corrugated tubing (30) from the patient end (32) and displace air in the tubing out of the patient dump valve (16) so that a volume of oxygen is collected in the tubing and is dispensed to the patient during the next inspiratory phase.

Abstract: Methods and apparatus for providing circadian-friendly LED light sources are disclosed. A light source is formed to include a first LED emission (e.g., one or more LEDs emitting a first spectrum) and a second LED emission (e.g., one or more LEDs emitting a second spectrum) wherein the first and second LED emissions are combined in a first ratio and in a second ratio such that while changing from the first ratio to the second ratio the relative circadian stimulation is varied while maintaining a color rendering index above 80.

Abstract: Balloon catheter includes an outer shaft having a hypotube and a monolithic single-layer distal outer member, a balloon in fluid communication with an inflation lumen, and an inner tubular member having a guidewire lumen defined therethrough. The outer shaft has the inflation lumen defined therethrough. The monolithic single-layer distal outer member is necked to a reduced diameter along an entire length thereof. A proximal end of the monolithic single-layer distal outer member is coupled to the hypotube. A distal section of the hypotube comprises a skive defined by a first angled cut, an axial cut, and a second angled cut. The balloon has a proximal balloon shaft coupled to a distal end of the monolithic single-layer distal outer member. The inner tubular member extends distally from a proximal port in the monolithic single-layer distal outer member through at least a portion of the balloon.