Abstract: A disposable fluid flow assembly for operation in connection with a fluid pump configured to provide a flow of fluid to the disposable fluid flow assembly is provided. The disposable fluid flow assembly includes an elongated flexible tube, a needle hub connected with the flexible tube, a pressure sensor for sensing fluid pressure, and an identification circuit embedded connected with the pressure sensor. The identification is configured to provide a plurality of signals to the central controller of the fluid pump when the disposable needle assembly is connected with the fluid pump. The plurality of signals may include various signals, such as a signal to identify physical characteristics of the assembly, a signal to ensure that the assembly is authentic, a signal to ensure that the disposable assembly is not re-used, and/or a signal to ensure that the pressure signal is connected and operating properly.

Abstract: The present invention relates to an optical blood detector system that rapidly detects the presence of blood due to a blood leak in a system. The blood detector system contains a reusable blood sensor that is able to accurately detect the presence of blood in, for example, an extracorporeal blood treatment system by optically sensing light from a sensing region and determining if the light came from a leaked blood. The blood sensor may be responsive to reflected light or light emitted from blood due to bio-fluorescence excited by a light source in the blood detector system. The blood detector system can be placed against absorbent material adjacent to an intravenous needle injection site and quickly detect any blood wicked into the absorbent material. The blood detector system can eliminate the need for medical personnel to continuously inspect numerous patients visually for potentially fatal blood leaks due to needle dislodgement.

Abstract: Devices, systems, and techniques for programming drug delivery are described. Such techniques may account for diffusion and mixing of drug within the fluid or allow for more flexible programming options. In one example, a method may include determining one or more fluid delivery parameters (e.g., volume, flow rate, or period of time) for a fluid that is a mixture of two other fluids. The determination may be based on one or more fluid delivery parameters of the two other fluids and/or a concentration profile representing the mixing between the two other fluids. In other examples, drug delivery programming may be facilitated by the selection of various patterns and steps of drug delivery. The system may track volume of delivered fluid to maintain desired dosing of the patient.

Abstract: Apparatuses and methods for training users of ambulatory medical devices. The methods relate to improving user interactions with the touchscreens of devices. In one embodiment there is an operating mode that records all user interactions along with various device parameters and allows the clinician to review the patient's performance for the initial use period. Automated analysis software may be employed to analyze the data generated by the device. The results of the analysis may be used by the clinician to improve the patient and device interaction.

Abstract: The present invention relates in part to multi-chambered vessels comprising a first chamber a second chamber and a seal comprising a first member and a second member, wherein the first member and the second member are engageable with one another to form a barrier separating the first chamber and the second chamber. The first member and the second member are disengageable from one another to open a channel between the first chamber and the second chamber. Vessels of the invention allow a user to establish communication between the first chamber and the second chamber at a desired time, for example in order to contact components contained within the chambers or in order to sequentially release components or doses of components from the vessel. Also provided is a kit comprising a seal of the invention.

Abstract: The present invention relates to an autoinjector device (10) for use in combination with a syringe (30), said syringe comprising a movable plunger; a needle; and a tubular needle shield (34). The claimed autoinjector device (10) comprises: an elongated housing having a proximal (11) and a distal end (12); a drive mechanism; a syringe holder (40) in order to support the fragile syringe and to prevent damage to the syringe. The invention furthermore relates to a method for assembly of the autoinjector device according to the invention.

Abstract: The present disclosure relates an elongated housing for an injection device for delivery of a liquid medicament, the housing comprising: a tubular-shaped cartridge holder to accommodate a cartridge filled with the medicament and comprising a proximal connecting end, a body to accommodate a drive mechanism operably engageable with a piston of the cartridge, wherein the body comprises a distal connecting end connectable to the proximal connecting end, wherein one of the proximal connecting end and the distal connecting end comprises an insert section, wherein the other one of the proximal connecting end and the distal connecting end comprises a receptacle to axially receive the insert section, wherein the insert section comprises at least one fastening element to positively engage with a complementary-shaped fastening element of the receptacle to provide an axial interlock of the cartridge holder and the body, wherein the fastening elements of the insert section and the receptacle comprise at least one pair

Abstract: The present disclosure relates to a cartridge holder of an injection device, the cartridge holder comprising a tubular shaped elongated sleeve extending in an axial direction to accommodate a cartridge filled with a medicament, wherein the sleeve (29) comprises: a proximal connecting end to connect with a distal connecting end of a body of the injection device, which body is configured to accommodate a drive mechanism of the injection device and which drive mechanism is operably engageable with a piston of the cartridge, a flange section extending radially outwardly from an outside surface of the sleeve and having a proximally facing abutment face to axially abut with a distal end face of the distal connecting end of the body, at least three protrusions located distally from the flange section, extending radially outwardly from the outside surface of the sleeve and being distributed around the circumference of the sleeve.

Abstract: The present invention provides a piston washer (1, 51) for a drug delivery device, the piston washer (1, 51) comprising a central portion (2, 72) arranged about a centre axis, a peripheral portion (3, 73), and an axially pliable structure (8, 78) connecting the central portion (2, 72) and the peripheral portion (3, 73). The axially pliable structure (8, 78) is preconfigured to undergo permanent deformation in response to a difference between a first resultant force acting on the peripheral portion (3, 73) and a second resultant force acting on the central portion (2, 72) exceeding a threshold level.

Abstract: The present invention relates to an information provider assembly to be used with a medicament delivery device for providing status information of the medicament delivery device, which medicament delivery device is provided with a medicament dose setting mechanism, the information provider assembly comprising a housing designed to be releasibly connectable to said medicament delivery device, the information provider assembly further comprising a measuring unit capable of measuring the position of a measuring surface on said medicament delivery device, which measuring surface is moved as the medicament dose setting mechanism is operated.

Abstract: Drug delivery device adapted to expel a set dose, comprising an expelling mechanism with a drive spring, a dose setting mechanism with first and second dose setting ratchet parts, a bias spring as well as control means. The control means is adapted to rotate the second ratchet part in a first direction to thereby set a dose when rotating the dose setting member in the first direction, and move the ratchet parts axially out of engagement with each other when the dose setting member is rotated in the opposite direction. When the first and second ratchet parts have been axially disengaged, the drive spring will rotate the second ratchet part in the second direction to thereby reduce the set dose, the bias spring moving the ratchet parts axially into engagement with each other again, this resulting in the set dose being reduced corresponding to one tooth of the ratchet mechanism.

Abstract: Embodiments described herein generally relate to devices, systems and methods for measuring a volume or number of doses remaining in a drug delivery device that is used for delivering a dose to a patient. In some embodiments, a dose measurement system for measuring the liquid volume in a container includes a light guide disposed and configured to reflect electromagnetic radiation toward the container. The dose measurement system also includes a light guide disposed and configured to emit electromagnetic radiation into the light guide. A plurality of sensors are located in the apparatus that are optically coupleable to the light guide and are disposed and configured to detect the electromagnetic radiation emitted by at least a portion of the light guide. The apparatus also includes a processing unit configured to receive data representing the portion of the detected electromagnetic radiation from each of the plurality of sensors.

Abstract: A dispensing device for dispensing medication from a medication container. The dispensing device includes a housing, a drive member engageable with the medication container, at least one first ramp surface fixed relative to the housing, a driver movable within the housing to move the drive member for forcing medication from the medication container, the driver including at least one second ramp surface, and a plunger including at least one push module movable relative to the housing from a ready position to a plunged position.

Abstract: According to the invention there is provided a needle assembly for mounting on an injection device. The needle assembly comprises a body configured to be removably attached to an injection device in use; a double ended needle supported by the body and extending from a forward tip to a rearward tip; and a needle shield coupled to the body. The needle shield is arranged for relative axial movement with respect to the body. The needle assembly has an injection configuration, in which the shield is positioned such that the forward tip of the needle projects beyond a forward end of the shield. The needle assembly also has a shroud configuration, in which the shield is positioned such that the forward end of the shield extends beyond the forward tip of the needle. The needle assembly further comprises a needle support fixed to the needle. The needle support is captive between the body and the shield. The needle support is fixed relative to the body when the needle assembly is in the injection configuration.

Abstract: The disclosure relates to a needle assembly adapted to couple with a medicament delivery device including a needle having a proximal tip and a distal tip, a needle hub coupled to the needle, a body adapted to engage the needle hub, a removable needle cap adapted to cover the distal tip, and a removable sealing element. The sealing element is adapted to seal an open proximal end of a compartment of the body, including the proximal tip, in such a manner that the proximal tip is housed in a sealed environment before use of the needle. The disclosure further relates to a medicament delivery device including such a needle assembly.

Abstract: A medical needle is provided with a needle body and a protector including a housing space which houses the needle body after venipuncture by the needle body by relative movement of the needle body in an axial direction. The protector has an annular recess in the entire circumference in the circumferential direction of an inner face in the housing space so as to accumulate blood that spatters from the needle body.

Abstract: A delivery tool connectable with a syringe can be used to deliver a viscoelastic solution. The tool includes a first segment, a second segment and an inner lumen defined by the first and second segments. A distal portion extends from the second segment in a curved manner.

Abstract: A surgical device that provides a suction force against a patient's body. The device includes a handle and a suction head pivotally attached to the handle. The suction head includes an open-ended suction chamber having a rim positioned to engage the patient's skin. An actuator on the handle operates a pump to draw a negative pressure in the suction chamber, causing the rim to seal against the patient's skin via the suction force. Once the suction force is initiated, the user may lift the handle away from the patient's body to lift tissue. The lifted tissue provides a site for insertion of a trocar or Veress needle for a laparoscopic procedure in some embodiments. A gimbal disposed between the handle and the suction head provides at least two degrees of freedom such that the handle can be rotated and pivoted to optimize the direction of applied lifting force.

Abstract: Systems for managing pressure in a fluid reservoir chamber of a fluid infusion device are provided. For example, a fluid infusion device comprises a housing having a reservoir chamber that receives a fluid reservoir and a pump chamber. The fluid infusion device also includes a drive system contained within the pump chamber, and the drive system includes a slide that is movable relative to the fluid reservoir. The slide includes a proximal slide end that cooperates with a portion of the fluid reservoir to dispense fluid, and the proximal slide end has a projection. The fluid infusion device includes a pressure management system defined in the projection of the slide. The pressure management system includes at least one bore defined through the projection. The at least one bore is spaced a distance apart from a perimeter of the projection to vent air from the reservoir chamber into the pump chamber.

Abstract: A transition adapter component of a ventilator aerosol delivery system for delivering an aerosol to a patient, includes a housing having a proximal end and a distal end, the proximal end having an aerosol passage for receiving an aerosol produced by a heated capillary and a gas connection port for receiving carrier gas from a ventilator, which is in communication with a plurality of gas entry ports within the transition adapter. An inner cavity of the transition adapter receives the aerosol from the heated capillary and the streams of carrier gas from the plurality of gas exit ports within the transition adapter and directs the streams of carrier gas at least partially encircling and in parallel with the aerosol. An exit port on the distal end of the transition adapter housing delivers an entrained aerosol to an aerosol delivery connector.

Abstract: Methods for reducing the risk of a thromboembolic event, and a related drug delivery system are provided. In some embodiments, a dose of acetylsalicylic acid can be provided in powder form to a patient using a dry powder inhaler. The dose can be effective to reduce a risk of a thromboembolic event in a patient. A dry powder inhaler used for the method can have a mouthpiece, a reservoir for receiving the dose of acetylsalicylic acid, and an actuation member for making available the dose of acetylsalicylic acid for inhalation by a patient through the mouthpiece.

Abstract: An inhalation therapy device includes an atomizer for atomizing a drug which is advantageously present in the form of a fluid into an atomization chamber so that an aerosol or mist is provided in the atomization chamber. The patient or user can inhale the aerosol produced by the atomizer from the atomization chamber via a mouthpiece. The ampoule is inserted into an ampoule holder holding the fluid-containing ampoule. The inhalation therapy device also includes an opening unit for opening the fluid-containing ampoule. The ampoule holder advantageously includes a first part, disposed displaceably in relation to the opening unit, thereby allowing an ampoule present in the ampoule holder to be displaced in the direction of the opening unit.

Abstract: An intra-nasal clip device may include a retainer having a first arm and a second arm. A first chamber housing may be coupled to the first arm, and the first chamber housing may include a first chamber and a first contact surface. Preferably, the first chamber and the first contact surface may be positioned on opposing sides of the first chamber housing. A second chamber housing may be coupled to the second arm, and the second chamber housing may include a second chamber and a second contact surface. Preferably, the second chamber and second contact surface may be positioned on opposing sides of the second chamber housing. The first contact surface and second contact surface may be orientated towards each other and configured to contact and grip portions of the nose so that a chamber, optionally containing an aromatic compound, may be positioned within a nostril of the nose.

Abstract: A rescue device for a heart attack victim and a method of rescuing a heart attack victim is provided. The device includes a first tube that is configured to be inserted into the victim's mouth so as to assist in performing CPR and restoring normal breathing by creating a high-pressure environment within the victim's mouth and thus inflating the victim's lungs. The device further includes a second tube that is configured to allow a rescuer to create the high-pressure environment in the victim's mouth by blowing into a second tube of the device. A filter is positioned between the first and second tubes to reduce sanitary concerns and to prevent foreign objects from traveling between mouths of the victim and the rescuer.

Abstract: A blower includes a housing including a proximal opening and a distal opening that are co-axially aligned, a stator component) provided to the housing, an impeller positioned between the proximal opening of the housing and the stator component, and a motor adapted to drive the impeller. The impeller includes a plurality of impeller blades. The stator component includes a plurality of air directing grooves along its exterior surface. The leading edge of the air directing grooves extend tangentially outwards from the outer tips of the impeller blades and are configured to collect the air exiting the impeller blades and direct it from a generally tangential direction to a generally radial direction by dividing the air from the impeller and directing the air along a curved path towards the distal opening so that airflow becomes substantially laminar.

Abstract: Devices, systems and methods for improved placement of endotracheal tubes which have particular application for awake or sedated intubation, are described. An intubation scope having a handle, a flexible probe, and an articulatable tip where the handle has a control lever to cause and control articulation of the tip of the intubation scope. The system has a locking mechanism to hold the ET tube in desired position over and along the flexible probe during the intubation process. Specific methods of using this system for improvement of the intubation techniques are described.

Abstract: A flexible tube holding device includes a handle having a groove along a length of a back side thereof, the groove being sized to at least partially accept a desired flexible tube, such as an endotracheal tube, such that the handle is fully back side open. The device is generally J-shaped from the side, and further includes a blade connected to the handle, the blade having a proximal blade section connected to the handle and having an opening along a back side thereof, and a tube retention section connected to the proximal blade section at an end thereof opposite the handle and along the opening. The tube retention section is sized to accept at least most of a cross-section of a tip portion of the flexible tube when present and shaped to retain the tip portion.

Abstract: A patient interface includes a sealing arrangement adapted to provide an effective seal with the patient's nose, an inlet conduit arrangement adapted to deliver breathable gas to the sealing arrangement, and a cover that substantially encloses the sealing arrangement and/or the inlet conduit arrangement.

Abstract: The disclosure relates to a nasal cannula comprising a port configured for delivery of a medicament into a flow of a fluid being delivered by the nasal cannula to a user and/or configured for interfacing with a medicament delivery device or an instrument. The disclosure also relates to a nasal cannula comprising an asymmetric profile to reduce an amount of occlusion of one nare of a user to provide access for an instrument to the nare with the nasal cannula in use.

Abstract: A nasal pillow system for treating sleep apnea is disclosed that may include a nasal pillow. The pillow has a cavity wall that defines a cavity, and two nasal interface structures connected to and extending away from the cavity wall. The nasal interface structures are in fluid communication with cavity. Each nasal interface structure includes a conical nasal interface, a cylindrical trunk structure connected to conical nasal interface and an annular relief pocket connected to the cylindrical truck structure and the cavity wall. The connection between the annular relief pocket and the cavity wall defines substantially a plane, and a first portion of the annular relief pocket extends away from the plane and a second portion extends towards the plane.

Abstract: A nasal interface device configured to be positioned about a user's nose includes an air supply interface body including an air supply opening, at least one nasal opening, and first and second side slots and first and second elastic members extending through the first and second side slots, respectively, on the air supply interface body. Each of the first and second elastic members includes first and second adhesive means on an outer end thereof distal from the air supply interface body. The nasal interface device includes a bendable metallic member including a bridge portion between first and second ends, wherein the first and second elastic members attach to the first and second ends of the bendable metallic member, respectively.

Abstract: Luer connector including a primary Luer male connector, having a secondary female section extending from a top distal part of the primary Luer male connector back towards a proximal part thereof, the primary Luer male connector including a first inner fluid flow channel extending from a proximal end thereof to the secondary female section, the primary Luer male connector being configured to mate with a primary Luer female connector having a secondary male section including a second inner fluid, flow channel.

Abstract: The present invention includes systems and methods of using real-time neurofeedback to improve the correspondence between first-person experience and specific brain activation patterns in a manner that minimally affects the experience itself. The present invention provides meditators the ability to enhance their control over their own brain activity, such as posterior cingulate cortex (PCC) activation. The present invention also provides methods for treating a disease or disorder of a subject by measuring the subject's brain activity via fMRI, presenting a representation of the measured brain activity to the subject, and instructing the subject to reduce the represented brain activity by altering their meditative state. The present invention also provides a system and method of using fMRI neurofeedback to directly correlate subjective experience with neural activation.

Abstract: Apparatus, system, and method for creating a curvature on a medical device during a medical procedure, for example, selecting a curvature from a curve database, customizing the curvature for a specific patient anatomy, and applying the curvature to the medical device during the medical procedure.

Abstract: A medical cannula system comprises a conduit; an endoscope comprising a distal steerable tip, wherein the endoscope is inside the conduit, and wherein the distal steerable tip of the endoscope extends out of the conduit; a tip liner surrounding the distal steerable tip of the endoscope; and a wiper link surrounding the tip liner at a close tolerance.

Abstract: A sphenocath including a sheath assembly including a sheath hub with a sheath tube extending therefrom with a passage extending from a proximal end of the sheath hub to a distal end of the sheath tube; a catheter assembly including a catheter hub with a catheter tube extending therefrom with a passage extending from a proximal end of the catheter hub to a distal end of the catheter tube; wherein the catheter assembly passes through the sheath assembly with a portion of the catheter hub engaging a portion of the sheath hub to limit relative rotation between the hubs while permitting relative axial movement such that in an initial non-extended position the distal end of the catheter tube is proximate to the distal end of the sheath tube. A system further including a guidewire is also provided.

Abstract: A renal flow system injects a volume of fluid agent into a location within an abdominal aorta in a manner that flows bi-laterally into each of two renal arteries via their respectively spaced ostia along the abdominal aorta wall. A local injection assembly includes two injection members, each having an injection port that couples to a source of fluid agent externally of the patient. The injection ports may be positioned with an outer region of blood flow along the abdominal aorta wall perfusing the two renal arteries. A flow isolation assembly may isolate flow of the injected agent within the outer region and into the renals. The injection members are delivered to the location in a first radially collapsed condition, and bifurcate across the aorta to inject into the spaced renal ostia. A delivery catheter for upstream interventions is used as a chassis to deliver a bilateral local renal in assembly to the location within the abdominal aorta.

Abstract: A neuromodulation catheter includes an elongate shaft and a neuromodulation element. The shaft includes two or more first cut shapes and two or more second cut shapes along a helical path extending around a longitudinal axis of the shaft. The first cut shapes are configured to at least partially resist deformation in response to longitudinal compression and tension on the shaft and torsion on the shaft in a first circumferential direction. The second cut shapes are configured to at least partially resist deformation in response to longitudinal compression on the shaft and torsion on the shaft in both first and second opposite circumferential directions.

Abstract: A device including a catheter (14) and a medical instrument (12). The catheter includes an inner portion (16) and one or more unlocking features (18). The medical instrument includes one or more locking features (24). When the medical instrument is in the inner portion of the catheter, the one or more unlocking features engage the one or more locking features so that the medical instrument can bend in the catheter. When the medical instrument is outside the catheter, the one or more unlocking features disengage from the one or more locking features so that the medical instrument is restricted from bending.

Abstract: Systems, devices, and methods are provided for transseptal access of septa within a patient. The device can be advanced to a septum, e.g., towards a fossa ovalis. Instead of applying positive pressure to “tent” the septum, a negative pressure is applied to a lumen within a sheath, e.g., within an elongated member slidable within the sheath, via a negative pressure source such as a syringe on the proximal end of the sheath. This results in the septum pulling inward. The sheath employs a stationary needle-like central core component contained within the lumen of the sheath that punctures the septum when the same is pulled passed it by the negative pressure. The stationary needle-like central core component may be hollow and may form a portion of the elongated member or may be coupled to a distal end thereof.

Abstract: An apparatus for deflecting a distal portion of a catheter, a sheath, a medical device, or other flexible elongate member may generally include a handle portion, a pair of adjusting knobs, and deflection wires. The adjusting knobs may be rotatably coupled to the handle portion and operably coupled to the deflection wires. The deflection wires may be in further communication with the distal portion of the flexible elongate member. Rotation of the adjustment knobs may translate or otherwise displace particular deflection wires with respect to the rest of the flexible elongate member, thereby causing the distal portion of the flexible elongate member to deflect. Further, the deflection wires may be oriented such that the distal portion of the flexible elongate member may be deflected in a multitude of directions.

Abstract: A rapid exchange catheter comprises a guide wire lumen including a substantially sealed portion in which a lumen wall extends around an entire periphery thereof and a channel portion including a channel opening the lumen to an exterior of the catheter, wherein a width of the channel is less than a maximum width of the channel portion. A guide wire ramp extends into the channel portion, with the ramp extending further into the lumen of the channel portion as a distal end of the ramp is approached.

Abstract: This invention provides devices and methods for insertion of a catheter into a vessel. The devices include coaxial slidably mourned needle, dilator and catheter components. The methods include piercing a vessel with the needle component, dilating the pierced hole with the dilator component, retraction of the needle component, insertion of the catheter and withdrawal of the dilator.

Abstract: A guidewire includes a core shaft, a coil body disposed around an outer periphery of the core shaft, and a resin layer. The resin layer includes a proximal end part disposed around an outer periphery of the coil body; a distal end part located between the core shaft and the coil body distal to the proximal end part and having an outer diameter that is smaller than an outer diameter of the proximal end part; and a tapered part located between the proximal end part and the distal end part and having an outer diameter that decreases in the distal direction. The distal end part of the coil body is not covered with the resin layer. The guidewire has improved rotation performance (operativity) while maintaining insertability, and a risk that a distal end the resin layer will detach from the guidewire is reduced.

Abstract: A guidewire that is specifically designed for performing an intracardiac transseptal puncture procedure is described. A piercing head for the guidewire has a conically-shaped section that tapers to a cutting section comprised of three tapered facets extending to a pointed tip. The three facets form three cutting edges that each provide for smooth cutting of body tissue, for example, cutting of the septum wall. The cut tissue does not tend to close or relax as readily as if the tissue had been punctured with a conically-shaped piercing tip, for example, one that has a structure similar to a pencil tip, This helps with subsequently moving a catheter and similar medical device through the pierced body tissue. Consequently, the faceted piercing head leaves an opening having a diameter that is substantially similar to the maximum outer diameter of piercing head.

Abstract: Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: A multi-layered balloon is provided where each layer is formed such that each layer is made from tubing that optimizes the inner wall stretch thus providing maximum balloon strength. The high pressure, multi-layer balloon is provided with layers that allow for slipping, such that the balloon has a very high pressure rating and toughness, yet excellent folding characteristics. Methods for producing such multi-layer balloons using existing balloon forming equipment are also provided. The multi-layer balloons can have alternating structural and lubricating layers, or layers with low-friction surfaces. The multi-layer balloons are preferably manufactured using a variety of methods including nesting, co-extrusion, or a combination of nesting and co-extrusion. The multi-layer balloons have balloon layers having substantially similar, or the same, high degree of biaxial orientation of their polymer molecules such that each balloon layer of the multi-layer balloon will fail at approximately the same applied pressure.

Abstract: A medical tube 10 (drain tube 10) includes a main shaft tube 20, a flow path opening/closing mechanism 40, and a branch tube 30. The main shaft tube 20 internally has a main shaft side distal opening 21a and a main shaft lumen 21. The flow path opening/closing mechanism 40 brings the main shaft lumen 21 into a communicating state by applying pressure smaller than predetermined pressure, and brings the main shaft lumen 21 into a blocked state by applying pressure equal to or greater than the predetermined pressure. The branch tube 30 promotes a pancreatic juice pj to flow into a branch lumen 31, based on the applied pressure which is equal to or greater than the predetermined pressure.

Abstract: Systems and methods are provided herein that generally involve shunting fluid, e.g., shunting cerebrospinal fluid in the treatment of hydrocephalus. Self-cleaning catheters are provided which include split tips configured such that pulsatile flow of fluid in a cavity in which the catheter is inserted can cause the tips to strike one another and thereby clear obstructions. Catheters with built-in flow indicators are also provided. Exemplary flow indicators include projections that extend radially inward from the interior surface of the catheter and which include imageable portions (e.g., portions which are visible under magnetic resonance imaging (MRI)). Movement of the flow indicators caused by fluid flowing through the catheter can be detected using MRI, thereby providing a reliable indication as to whether the catheter is partially or completely blocked.