Abstract: Disclosed herein are devices, systems and methods for using such devices and systems for treating incisions and wounds. In an aspect, disclosed is a device having a generally planar tension relief module and a flexible sealant structure sized to cover the tension relief module, the flexible sealant structure comprising a lower adhesive surface. The tension relief module includes a conduit structure having a plurality of support structures on an upper surface of the conduit structure and at least one opening extending through the conduit structure from a lower surface to the upper surface. At least a portion of the conduit structure is adapted to be aligned with a longitudinal axis of the incision. The tension relief module also includes opposing adhesive structures coupled to the conduit structure. The lower adhesive surface of the flexible sealant structure and the upper surface of the conduit structure form a flow pathway.

Abstract: There is a breastfeeding device having a microprocessor having a memory embedded therein that can be pre-programmed to have a plurality of different sucking cycles interspersed with periodic pauses. These different cycles and pauses allow for an accurate modeling of a woman breastfeeding a child. In addition, this system and process can also result in a pre-programmable breastfeeding pump, which creates a preset time for initialization and a preset schedule of a series of events for breastfeeding over a period of time such as over a 24 hour or 30 hour period of time so that the user can automatically use the breast pump without having to use any of the keys on the keyboard of the device. In at least one embodiment, the device including any software which can be programmed thereon, is configured to mimic or model itself towards a suction pattern of a child.

Abstract: A blood circulation assist system comprising an inflow cannula having a lumen and an insertion device configured to be received therein and to facilitate insertion of a portion of the inflow cannula into a heart chamber. The insertion device includes a shaft having distal and proximal end portions and a plurality of lumens. A first lumen is configured to receive a guidewire and a second lumen is configured to receive a pressurized fluid. A tip connected to the distal end portion of the shaft is configured for insertion into the heart chamber. The tip has a hollow interior communicating with the first shaft lumen. An inflatable member is coupled to the distal end portion of the shaft and includes a hollow interior in fluid communication with the second shaft lumen. The inflatable member is movable between deflated and inflated configurations for releasably securing the insertion device to the inflow cannula.

Abstract: Apparatus and methods for providing extracorporeal blood circulation and oxygenation control include multi-stage deairing of blood to provide automated cardiopulmonary replacement to sustain patient life during a medical procedure such as cardiopulonary bypass graft surgery, keyhole cardiopulmonary bypass graft surgery, percutaneous angioplasty, percutaneous stent placement, and percutaneous atherectomy.

Abstract: An external functional means comprises at least one housing body, at least one chamber integrated into the housing body for receiving medical fluids, at least one passage integrated into the housing body for receiving and/or conducting a medical fluid, and at least one valve means completely or partly integrated into the housing body for controlling or regulating a fluid flowing through the external functional means. The invention further specifies a blood treatment apparatus and methods which may be carried out by means of the external functional means of the invention and by means of the blood treatment apparatus, respectively.

Abstract: Pressure measurement system (e.g., for an extracorporeal treatment system), method and pressure pod apparatus including a position sensor for use in repositioning a diaphragm that separates a liquid side cavity from a transducer side cavity (e.g., operatively connected to a pressure transducer); the liquid side cavity being in fluid communication with an inlet and an outlet.

Abstract: A system for separating and concentrating a component of a whole material is disclosed. The whole material can include a material that has more than one component, such as whole blood that can include at least red blood cells, monocytes, and plasma. The system can include a substantially single container including a separation section and a concentration section wherein a component can be moved from the separation section, after a separation, to the concentration section to be concentrated. The concentrated component can then be withdrawn from the separation and concentration container for a selected procedure.

Abstract: A novel neural injection system and related methods are herein disclosed. Various embodiments of an embodiment of a neural injection system of the present invention provide for at least one benefit of enhanced injection characteristics, increased operational efficiency, reduced cost per unit, reduced incidence of injury through intraneural/intravascular injection, reduced incidence of injury through pricking/piercing, and/or the like.

Abstract: A storage system is provided. The system may include a tray having at least one recess in which at least one syringe is disposed, the syringe including a barrel with first and second barrel ends, and a stopper fixedly disposed between the first and second barrel ends. A tool attached to the stopper through the second barrel end, the tool having a first end attached to the stopper and a second end attached to or abutting the barrel or a surface of the recess, the first end being selectively adjustable relative to the second end to vary the distance between the first and second ends of the tool. In addition or in the alternative to the tool, the system may include a motion generator attached externally to the syringe, the motion generator being one of at least a vibration generator and a rotating frame.

Abstract: A pressure sensor for use with a fluid delivery system having good sensitivity at low pressure, but also configured to remain in operating condition after being exposed to high pressures is disclosed herein. In one variation, the pressure sensor includes a fluid path set, a deformable element associated with the fluid path set and configured to deform in response to an external pressure, and a pressure transducer for monitoring deformation of the deformable element. In certain embodiments, the pressure sensor is configured to measure fluid pressure within the range of between about 0 mm Hg to about 300 mm Hg. However, the sensor pressure is also be configured to remain functional after being exposed to pressure in excess of about 60,000 mm Hg.

Abstract: A number of racks which are configured to allow a number of devices to couple thereto are provided. In some embodiments, the racks are for use with a number of medical devices. Devices may be coupled to a rack by clamps. The racks may include a number of connectors which provide power and/or a network connection to devices coupled thereto. The racks may include a clamp which allows the racks to couple to a supporting structure such as a pole.

Abstract: A device for securing and organizing tubing, such as medical venous access lines, includes a tray; a fastener attached to the tray, the fastener designed to attach the tray to another object, such as a post from an IV unit or a patient's bed; at least one tube slot built into the tray, the tube slot sized to accommodate a portion of a tube; a first strap attached to the tray proximate to the fastener; and a second strap attached to the tray proximate to the end of the tray distal from the fastener, wherein the first strap and the second strap are designed to secure the tube within the tube slot without impeding flow through the tube. The device may further include label tabs extending upwardly from the tray proximate to each tube slot.

Abstract: An insertion apparatus and a method for use with a device for delivery of a therapeutic fluid into a body of a patient and/or for sensing of a bodily analyte are disclosed. The apparatus includes a housing adapted for loading therein at least one cannula cartridge unit having a protective member. The protective member accommodates at least one penetrating cartridge having a subcutaneously insertable element and a penetrating member. The apparatus includes a displacement mechanism capable of protracting the penetrating cartridge towards the body of the patient, where protraction of the penetrating cartridge results in insertion of the subcutaneously insertable element into the body of the patient.

Abstract: There is provided a cassette unit that is suitable for use with an auto-injector having an electrically powered drive unit. The cassette unit has a housing defining a cassette unit housing cavity and a needle projection aperture. The cassette unit housing cavity is arranged for receipt of a syringe that is suitable for use in the injected delivery of drug to a patient. The cassette unit includes a removable cap that fits over and thereby, acts such as to close off, the needle projection aperture; and connecting to the removable cap, a needle cover defining a needle sheath for sheathing of the needle tip of the syringe. The removable cap is provided with a finger-grip feature that is sized and shaped for gripping by the finger of a user to allow for removal of the removable cap and needle cover from the cassette unit housing.

Abstract: There are disclosed devices and methods for protecting a user from a sharp tip of a medical needle. In an embodiment, a device includes a central body portion, a medical needle having a sharp tip, a pair of wings in attachment to the central body portion, and a hook-and-loop fastening system disposed on at least one of the wings, and configured to selectively attach the wings together with the medical needle positioned between the wings so as to protect a user from the sharp tip of the medical needle. In another embodiment, a method includes withdrawing a sharp tip of a medical needle from a patient, closing a pair of wings with the medical needle positioned between the wings, and fastening the wings together with the medical needle positioned between the wings so as to protect a user from the sharp tip of the medical needle.

Abstract: The present invention relates to a device, system and a method for optimizing syringe based drug delivery profile with a treatment element and in particular, to such a device, system and method in which optimization is based on a plurality of data that directly and/or indirectly affect the optimization of the drug delivery profile. The device facilitating syringe based drug delivery, by optimizing drug delivery of the injected drug, records user's activity, and data relative to drug injections, comprising a disposable unit configured for a single use period and a rechargeable reusable unit having electronics comprising a sensor module.

Abstract: A dispensing device which disperses medicate through a needle across a zone within a body. The device includes a needle which is, during use, becomes encapsulated within a tubular needle-receiving member, a reservoir in fluid communication with the needle, positioned within the housing, and in communication with the needle, a second reservoir, a reservoir-connecting conduit in communication with the reservoir, a fluid drive in communication with the fluid in the second reservoir and in communication with the reservoir-connecting conduit, and a linear drive attached to the needle or to the needle-receiving member. The fluid drive impel fluids from the second reservoir to the reservoir-connecting conduit and thus drives the therapeutic agent from the reservoir during the linear displacement of the needle towards the housing. Fluid communication from the therapeutic agent reservoir to the needle is maintained by the tubing during operation of the linear drive.

Abstract: Embodiments disclosed herein are directed to systems and methods for protecting needleless injector units from one or more contaminants. In an embodiment, a needleless injector system includes a needleless injector unit and an auxiliary unit. The needleless injector unit has a nozzle portion and a supply of one or more substances for injection. The needleless injector unit is configured to inject the one or more substances from the nozzle portion through a skin surface of a subject. The auxiliary unit is coupleable to the needleless injector unit. The auxiliary unit includes a source of one or more protectants and is configured to emit the one or more protectants in a region between the nozzle portion of the needleless injector unit and the skin surface of the subject.

Abstract: The invention relates to a medicament delivery device comprising a locking mechanism (5) for locking a plunger rod (4). The locking mechanism (5) comprises a locking wheel (6) and locking means (7), said locking means (7) being moveable between an active position where the locking means (7) prevent the locking wheel (6) from rotation and an inactive position where the locking means (7) allow the locking wheel (6) to rotate, wherein said plunger rod (4) extends through an opening in the locking wheel (6); and a resilient member (8) arranged at the moveable locking means (7) and being arranged to act on the moveable locking means (7) to displace said movable looking means (7) towards the inactive position where the locking means (7) allow the locking wheel (6) to rotate.

Abstract: An injection device includes a housing, a plunger, a drive gear and a release trigger. The plunger includes a leadscrew and a cap attached thereto where, in use, the cap engages a bung of a cartridge containing medicament. The drive gear within the housing engages with the leadscrew such that rotation of the drive gear around the leadscrew drives the plunger axially through the housing towards the bung. The trigger includes a locking ring having generally axially extending teeth for engaging with corresponding teeth on the drive gear. The trigger is generally axially movable between an engaged position where the teeth are engaged and prevent rotation of the drive gear, and a disengaged position where the teeth are disengaged and enable rotation of the drive gear. Movement of the trigger between the disengaged and engaged position causes counter-rotation of the drive gear and retracts the plunger away from the bung.

Abstract: An injector (10) for injecting a medicament into a patient. The injector includes a container (18) defining a first chamber (22), which contains a fluid therein, and a second chamber (23). The injector also includes an injection conduit (126) configured for directing the fluid fired from the container into the patient. A transfer mechanism is operable by a user to transfer the fluid from the first chamber to the second chamber in a first stage of operation, and a firing mechanism is operable by the user for firing the fluid from the second chamber through the injection conduit in a second stage of operation. An energy source (62) is in powering association with the firing mechanism to drive firing mechanism in the first and second stages.

Abstract: A percutaneous medication device, comprising a syringe to be filled with medical liquid and a needle formation attached to a leading-end of the syringe is provided. The needle formation comprises a needle formation body, from the surface of which a needle projects and a cover portion covers a leading-end of the needle formation body. The needle is inserted into a through-hole formed at the leading-end of the needle formation body and fixed by a fixation member. The needle formation body is mated to the cover portion, a space is formed between an inner surface of the cover portion and the leading-end of the needle formation body, and the needle projects from the leading-end surface of the cover portion through a needle insertion hole formed at the leading-end of the cover portion.

Abstract: An elastic cap detachably mountable to a barrel tip portion of a barrel so as to seal a tip of a needle hole includes a cylindrical receiving hole configured to receive at least part of a barrel tip portion and a puncture needle of a barrel. The receiving hole includes a first inner diameter portion having a smaller diameter than an outer diameter of the annular head; a stopper portion provided at an end of the first inner diameter portion; and a second inner diameter portion that is formed from the stopper portion to a bottom wall provided at an end of the second inner diameter portion, the second inner diameter portion having a smaller diameter than the first inner diameter portion.

Abstract: A drug delivery device for administering a dose of a medicament by way of injection is disclosed, the device including a housing to receive a cartridge at least partially filled with a medicament and being sealed with a piston slidably disposed therein, a drive mechanism having a piston rod to be displaced in a distal direction to operably engage with the piston of the cartridge, a dose button operably engaged with the drive mechanism for at least one of preparing or initiating a dose dispensing action of the drive mechanism, and a protective member adapted to impede actuation of the dose button, wherein the protective member is releasably connected to the housing via a breakable seal.

Abstract: Systems, methods, and devices can detect a dangerous or adverse condition or anticipated condition that indicates an undesirable amount of electric current in a patient-connected tube providing fluid to a patient. The fluid flow to the patient is stopped responsive to the detection. Stoppage of fluid flow to the patient can reduce or prevent electric current in the fluid from reaching a patient, flowing through the patient to ground, and/or continuing to flow through the patient.

Abstract: An inhaler includes a main body having a canister housing, a medicament canister retained in a central outlet port of the canister housing, and a dose counter having an actuation member for operation by movement of the medicament canister. The canister housing has an inner wall, and a first inner wall canister support formation extending inwardly from a main surface of the inner wall. The canister housing has a longitudinal axis X which passes through the center of the central outlet port. The first inner wall canister support formation, the actuation member, and the central outlet port lie in a common plane coincident with the longitudinal axis X such that the first inner wall canister support formation protects against unwanted actuation of the dose counter by reducing rocking of the medicament canister relative to the main body of the inhaler.

Abstract: An oscillating positive respiratory pressure apparatus and a method of performing oscillating positive respiratory pressure therapy. The apparatus includes a housing having an interior chamber, a chamber inlet, a chamber outlet, an exhalation flow path defined between the inlet and the outlet, and a restrictor member rotatably mounted within the interior chamber. The restrictor member has an axis of rotation that is substantially perpendicular to the flow path at the inlet, and includes at least one blocking segment. Rotation of the restrictor member moves the at least one blocking segment between an open position and a closed position. Respiratory pressure at the chamber inlet oscillates between a minimum when the at least one blocking segment is in the open position and a maximum when the at least one blocking segment is in the closed position. By exhaling into the apparatus, oscillating positive expiratory pressure therapy is administered.

Abstract: A respiratory mask assembly includes a rigid mask frame and a cushion. A clip secures the cushion to the frame.

Abstract: The invention relates to a method and device for carrying out a signal-processing viewing of a measurement signal that is correlated with the respiratory activity of an individual, for example, of a measurement signal that is correlated with the respiratory gas. The aim of the invention is to provide solutions with which an improved electronic analysis of the signals that are representative with regard to respiratory activity can be achieved. To this end, the invention provides that viewing results are obtained within the scope of a signal-processing viewing of said measurement signal and make a differentiation between obstructive and central respiratory disorders possible. The viewing results are determined, in particular, while taking into account changes of selected breathing characteristics such as, for example, the change in the ratio of inhalation time to exhalation time.

Abstract: Systems and methods for triggering inspiration and/or cycling exhalation with a ventilator are described herein. In particular, systems and methods for synchronizing ventilator breath delivery with patient breath demand utilizing a digital sample counting trigger mode are described herein. The digital sample counting triggering mode characterizes digital samples taken from a measured or estimated parameter during the patient inhalation/exhalation period to synchronize breath delivery with patient breath demand.

Abstract: A nebulizing catheter for bronchial therapy includes a catheter having a sheath defining an interior space and an open tip. A nebulizer is positioned in the interior space and located adjacent the open tip. The nebulizer includes a piezoelectric device. A liquid mixture is provided and placed in flow communication with the piezoelectric device for nebulizing a portion of that liquid mixture into small droplets for use in the bronchial therapy.

Abstract: Nasal cannula apparatus, includes in an inlet tubular fitting sized and configured to directly endwise connect to a source of oxygen, or oxygen and air. The fitting defines an inlet flow passage area A, having a 15 mm external diameter. A pair of tubular prongs is operatively connected with the inlet fitting, and receivable in an infant's nostrils to deliver oxygen, or oxygen and air flow to the infant, the prongs each having flow passing area A3, and A1>>A3.

Abstract: A flow regulation vent for use in controlling a vent flow of washout gas in a system for supplying breathable gas pressurized to within a therapeutic pressure range above atmospheric pressure to a patient in the treatment of a sleep disordered breathing condition is disclosed. The flow regulation vent may include a housing having at least one vent orifice and at least one fixed bleed orifice; and a flap configured to regulate the vent flow of washout gas through the at least one vent orifice, wherein the at least one fixed bleed orifice is not covered by the flap in any position and the flow regulation vent provides a minimum vent flow independent of the position of the flap.

Abstract: Medical devices and methods for making and using the same. An example medical device may include a tubular member and a liner disposed within the tubular member. The tubular member may have a plurality of slots formed therein. A space may be defined between the tubular member and the liner. One or more bonding members may be disposed in the space.

Abstract: A tray (100) for accommodating a coiled medical device, such as a catheter assembly (700), includes a first compartment (101), a second compartment (102), and a third compartment (103). The catheter assembly (700) and devices associated with a catheterization procedure, such as syringes (701,702) containing sterile water and lubricating jelly and a specimen container (703) can be disposed within the tray. Printed instructions (1001) can be included with the tray (100). When a CSR wrap (1000) is disposed about the tray (100), the printed instructions can be placed atop the CSR wrap (1000) but beneath an outer sterile wrap (1002). The printed instructions (1001) can include a patient portion (1202) that is detachably coupled to a health care services portion (1201) such that it can be taken home with the patient after the procedure.

Abstract: The present invention is directed to a novel shape-transferring cannula system, which provides access to tortuous and unsupported paths. The shape-transferring cannula system and method enables exploration of hollow body structures, and creates a custom-contoured access port for insertion and removal of, for example, diagnostic, surgical, or interventional instruments to and from a site within the body to which the physician does not have line-of-sight access.

Abstract: A flexible tip dilator is disclosed. The flexible tip dilator includes a hollow elongated tubular member with a proximal region and a tapered distal region. The tapered distal region has three regions with a first region made from at least a first material but not a second material and a third region made from at least the second material but not the first material. The second region is includes both the first and second materials overlapping one another.

Abstract: A catheter system utilizing one or more sensors is described. The catheter can be used as part of an embolic coil system, guidewire system, or combined embolic coil/guidewire system where the devices interact with the catheter system. A variable detachment embolic coil system and guidewire system are also described.

Abstract: The present application discloses a handle configured to receive a catheter. The handle comprises a port that communicates with a lumen of the catheter and a mechanism is provided that moves the end of the catheter for positioning. The guide wire traverses a reservoir located in the handle. In particular, the handle comprises an enclosure with a conduit and a reservoir, where the conduit extends through the enclosure from the left side to the right side and the reservoir space has a curved or concave base. The bottom side and top side of the handle converge into a tapered point on the left side.

Abstract: Devices and methods are provided for sealing a catheter insertion site to maintain sterility. In one embodiment, a catheter dressing is provided that includes an adhesive plate configured for attachment to the skin of a patient and a flexible sheath that extends proximally from the adhesive plate. The sheath can be capable of longitudinal extension from a compressed to an extended state and can be configured in its extended state to surround an external segment of a catheter implanted in the patient and circumferentially seal to a portion of the external segment at a distance from the adhesive plate. The dressing can also be configured to restrict longitudinal movement of the catheter while at the same time permitting non-longitudinal movement. One-piece rigid or semi-rigid dressing bodies are also disclosed, as are various methods and devices for facilitating removal and or replacement of a catheter dressing.

Abstract: A needle retraction apparatus comprising a body having a forwardly projecting needle, a needle retraction mechanism seated inside the body and biasing the needle rearwardly relative to the body, a slide member attachable to the body and having an opening communicating with a needle retraction cavity projecting away from the body, and an actuator rotatable relative to the slide member to reposition the slide member from a first position preventing needle retraction to a second position permitting needle retraction. An IV catheter introducer comprising the subject needle retraction apparatus is also disclosed.

Abstract: A medical instrument includes a first elongated member including: a fluid lumen through which a fluid is flowable, an aperture opening located in a distal end surface of the first elongated member; a second elongated member including: an insertion lumen in which the first elongated member is insertable, and a discharge section through which the fluid can be discharged; and a movement section configured to form a seal between the first elongated member and the second elongated member in a state where the first elongated member is disposed in the insertion lumen of the second elongated member, the movement section being configured to allow the first elongated member and the second elongated member to move relative to each other such that the discharge section of the second elongated member is positionable on a distal side of the aperture of the first elongated member.

Abstract: A guide wire includes a wire main body that has a plate-like portion in a distal end portion of the wire main body and a reinforcement portion that is provided on at least one surface of the plate-like portion and reinforces the plate-like portion. The reinforcement portion is made up of two wire rods, and both end portions of the reinforcement portion are fixed to the plate-like portion. The plate-like portion is formed in a ribbon shape, and the reinforcement portions are diagonally provided on the same plane of the plate-like portion, and intersect each other. The guide wire has a coil that covers the plate-like portion and the reinforcement portion.

Abstract: In various embodiments, a device is provided comprising a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being the same or greater than the first pressure. In various embodiments, a method comprising fabricating a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being at or greater than the first pressure, disposing the balloon on an elongate member having a lumen, placing the lumen in fluid communication with an interior volume of the balloon.

Abstract: The present invention relates to a valve system for an inflatable portion of an indwelling medical device and more particularly to a valve system for fluid regulation of a catheter comprising a fluid inflatable portion that undergoes pressure changes within the body during use.

Abstract: In one aspect, an implantable shunt system is disclosed that, in one example implementation, includes a resilient member and a connected fluid regulating device. The fluid regulating device selectively permits fluid flow through an opening valve of an implantable shunt according to an adjustable opening pressure. The opening pressure is proportional to an amount of tension on the resilient member. One or more tension sensors that are connected to the resilient member measure an amount of tension on the resilient member. The tension sensors generate tension data that corresponds to the measured amount of tension. The system further includes a communication unit with a transmitting unit that transmits the measured data over a communication link. The system also includes a reading unit that receives the transmitted tension data over the communication link. The reading unit includes a connector that electrically connects the reading unit to the transmission unit.

Abstract: A delivery device including a substrate formed in a coil comprising a plurality of loops, an active agent deposited between an inner surface and an outer surface of the substrate formed in the coil, and a pair of end caps, each end cap disposed on a corresponding end of the coil.

Abstract: The invention provides a patch and a patch preparation having an adhesive layer with a high adhesive force, wherein the hydrophobic adhesive layer does not bloom even when an organic fluid component having high polarity is contained therein. The patch contains a support and an adhesive layer on at least one surface of the support, wherein the adhesive layer contains a synthetic rubber having a viscosity average molecular weight of 500,000-1,600,000, an organic fluid component having high polarity, a tackifier, and magnesium aluminometasilicate. In the patch preparation, the above-mentioned adhesive layer further contains a drug.

Abstract: According to an aspect of the present invention, a medical device is provided, which comprises the following: (a) a hollow elongate body (e.g., a elongate cylinder, such as a needle) having distal and proximal ends; and (b) a rotatable member comprising a tissue morselizer and an elongate shaft (e.g., an auger-like tissue-drilling bit). In the devices of the present invention, the elongate shaft is disposed within the hollow elongate body and cooperates with the hollow elongate body to (i) advance material (e.g., morselated tissue) toward the proximal end of the hollow elongate body when the shaft is rotated in a first direction, and (ii) advance material (e.g., a therapeutic agent and/or a bulking agent) toward the distal end of the hollow elongate body when the shaft is rotated in a second direction that is opposite the first direction.

Abstract: Embodiments of the invention include methods of tissue/wound treatment and associated devices and systems, including devices for breaching bio-films contained in and around wounds, devices for maximizing moisture vapor transmission rate, and tissue dressings with added barrier features for permeable surfaces.