Abstract: Methods and devices for the diagnosis and treatment of microvascular dysfunction, such as microvascular obstruction (MVO) and other dysfunctional diseases of the microvasculature of many organs, including the heart. The present subject matter provides novel devices and methods to successfully diagnose, restore patency, open and preserve flow, and limit reperfusion injury in organs and cases with microvascular dysfunction. The present subject matter provides apparatus and method to detect, measure and treat microvascular dysfunction in real time during scenarios such as invasive angiographic/therapeutic procedures. Such procedures include therapy for organ systems including the heart (acute myocardial infarction—primary percutaneous coronary intervention (PPCI)), brain stroke (CVA), bowel ischemia/infarction, pulmonary emboli/infarction, critical limb ischemia/infarction, renal ischemia/infarction, and others.

Abstract: Disclosed are a sonotrode and its use for transdermal delivery of therapeutic or cosmetic compounds. The sonotrode 10 comprises a tubular neck 14 attached at a proximal end to a solid head 12 and ending at a distal end in a flared foot 16. When coupled to an ultrasonic transducer and applied to skin of a human or animal, the sonotrode enhances the delivery of compounds into the skin.

Abstract: The present invention relates to a medicament container holder (10) comprising a body (12) adapted to receive a medicament container (14), the body (12) comprising proximally directed tongues (38) at its proximal end, engagement elements (42) arranged at the proximal end of the tongues (38), directed inwards, which engagement elements (42) are arranged to engage a neck portion (46) of the medicament container (14); wherein the tongues (38) deflect radially outwards when engaged by a needle shield (16) of said medicament container (14). The invention is characterized in that said tongues (38) with said engagement elements (42), engage with said neck portion (46) of said medicament container (14) for preventing the medicament container (14) from moving in a proximal direction relative the medicament container holder (10), when disengaged with said needle shield, wherein said tongues (38) are in a stressed state when in engagement with said neck portion (46).

Abstract: A method of making a flexible medical article or tube, for example, a sheath for a vascular access device, is provided. The method can include extruding a polymer, for example, a polycarbonate-urethane copolymer, to form a tube and annealing the extruded polymer. The method can further include cutting the extruded tube to a desired length before or after annealing, flaring one end of the annealed tube and over-molding the flared portion onto a hub, and forming the other end of the tube into a tip. A sheath formed by such a method is also provided.

Abstract: Systems and methods are disclosed herein for managing access to therapy controls of an ambulatory medicament pump that provides therapy to a subject using safe access levels associated with the therapy controls. The therapy change controls may enable modification of the corresponding therapy control parameters. The disclosed systems and methods can determine the eligibility of a subject receiving therapy from the ambulatory medicament pump or a user of the ambulatory medicament pump, for a safe access level and provide access to the corresponding therapy change controls. The ambulatory medicament pump may provide access to the therapy change controls upon receiving an access signal. In some cases, the ambulatory medicament pump may receive a time-based passcode and provide access to the therapy change controls upon receiving a matching passcode from the user.

Abstract: A valve comprises a first housing including a first lumen extending therethrough and defining a first disk-facing surface and a second housing including a second lumen extending therethrough and defining a second disk-facing surface, the second housing being mated to the first housing so that the second disk-facing surface faces the first disk-facing surface in combination with a flexible disk gripped between gripping portions of the first and second disk-facing surfaces, the disk including a slit extending therethrough which, when acted upon by a fluid pressure of at least a predetermined threshold level opens to permit fluid flow between the first and second lumens and which, when acted upon by a fluid pressure less than the threshold level remains sealed preventing fluid flow between the first and second lumens and a relief well between opposing portions of the first and second housings radially outside the gripping portions, a width of the relief well exceeding a width of a radially outer portion of the f

Abstract: Methods and devices related to the fields of skin care, hair restoration and lip care wherein the systems may be used by an individual for infusing treatment media into skin or lips for cosmetic and rejuvenation purposes, hair restoration purposes or other therapeutic purposes.

Abstract: A peristaltic pump disclosed herein includes a raceway, a plunger, a motor, and a heater. The raceway is configured to retain a tube (e.g., an IV tube). The plunger acts on the tube disposed within the raceway. The motor engages the plunger to actuate the plunger. The heater is disposed in thermal-conductive contact with the tube. That is, the heater, either through direct or indirect application, heats the tube.

Abstract: An electrosurgical system can include an electrosurgical generator, a feedback circuit or controller, and an electrosurgical tool. The feedback circuit can provide an electrosurgery endpoint by determining the phase end point of a tissue to be treated. The electrosurgical system can include more than one electrosurgical tool for different electrosurgical operations and can include a variety of user interface features and audio/visual performance indicators. The electrosurgical system can also power conventional bipolar electrosurgical tools and direct current surgical appliances.

Abstract: Disclosed herein are systems and methods for mitigating the risk of insulin stacking in automated insulin delivery systems. In AID systems configured to both automatically calculate insulin delivery based on glucose levels and receive manual programming of meal boluses configured to counteract carbohydrates in a meal, insulin stacking can result if the system automatically increases insulin delivery based on a rise in glucose levels in response to consumption of a meal and the user later programs a meal bolus for the meal. The risk of such double dosing is mitigated by the systems and methods disclosed herein by enabling the system to account for recent automated insulin increases when a meal bolus is programmed.

Abstract: A handle assembly for controlling a steerable catheter includes a handle extending about a longitudinal axis from a proximal end to a distal end. A lumen extends through the handle to a distal tip extending outwardly from the distal end of the handle and a pair of control wires are interconnected to the distal end of extend the lumen. A lever assembly is disposed within the handle and includes a lever rotatable about a lever axis to control deflection of the distal end of the lumen. The lever assembly includes a first and second gear assembly disposed in opposing relationship to one another and offset relative to the longitudinal axis for allowing the lumen to pass therebetween. Each of the gear assemblies are interconnected to one of the pair of control wires to individually pull a respective one of the control wires in response to rotation of the lever.

Abstract: A disposable medical vacuum drainage bag includes a flexible enclosure made of a flexible material. The flexible enclosure is configured to define an interior chamber. The flexible enclosure has a first fluid port and a second fluid port. The flexible enclosure has a collapsed state and an expanded state. A framework is located in the interior chamber. The framework has a plurality of frame structures configured to rotate in unison about separate rotational axes between a collapsed configuration and an expanded configuration, wherein the collapsed configuration facilitates the collapsed state of the flexible enclosure and the expanded configuration facilitates the expanded state of the flexible enclosure. An actuator is coupled to the framework. The actuator is configured to rotatably transition the plurality of frame structures between the collapsed configuration and the expanded configuration.

Abstract: A drive-control system for an injection device for delivering settable doses of a pharmaceutical substance contained in a cartridge, including a tubular housing body having a longitudinal axis, a proximal end and a distal end connectable to the cartridge enclosure, a helical spring contained in the housing body and a piston rod moveable towards the distal end and blocked in translation towards the proximal end. The housing body includes a control sleeve on which the spring is mounted, which rotatable around the axis, and a setting sleeve translatable along the axis. Rotation of the control sleeve in a first direction combined with compression of the spring causes the setting sleeve to be translated towards the proximal end of the housing body, and extension of the spring causes the setting sleeve to be translated towards the distal end of the housing body and the control sleeve to be rotated in a second direction and the piston rod to be pushed towards the outside of the housing body.

Abstract: A drug self-delivery device comprising a body portion containing a drug vial and a needle assembly, where the body portion is slidably engaged to a trigger portion. When engaged by a user pressing the trigger portion against the user's flesh, the needle assembly relative to the drug vial so as to align a needle port with an integral drug delivery port connected to the drug vial thereby allowing fluid flow of medication through the needle. Seals engaged by a penetration spring prevent loss of medication and prevent the need for direct connection between the needle assembly and the drug vial.

Abstract: An intravenous catheter system including a housing, a catheter, and a guide wheel rotatably disposed in the housing and manually engageable by the user. The intravenous catheter system may also include a guidewire contained within the housing and moveable by the guide wheel into and through the catheter with roation of the guide wheel with one finger, and push off tab. The intravenous catheter system may be configured such that once the guidewire is in a vein of a body, the user may use the same finger to advance the catheter by use of the push off tab A blood flash chamber can be incorporated into the housing of the system, method or device to indicate engagement between the catheter and the vein of the patient, and indicate the timing of the use of the wheel to move the guidewire.

Abstract: A catheter for a hepatic artery introduced from an arm of a patient includes a first bent portion, a second bent portion distal of the first bent portion and bent to the same side as the first bent portion, a third bent portion disposed on a distal side of the second bent portion and bent to an opposite side from the second bent portion, and a most distal end portion disposed distal of the third bent portion, in which a minimum radius of curvature of the first bent portion is larger than a minimum radius of curvature of the second bent portion. The most distal end portion is directed to a common hepatic artery and the first bent portion comes into contact with an aorta wall on an opposite side from a celiac artery when the second bent portion contacts a blood vessel wall of the celiac artery.

Abstract: Ambulatory medical devices that provide therapy to a subject, such as blood glucose control, are disclosed. Disclosed systems and devices can transmit a request to modify blood glucose control therapy delivered to a subject. The request can be transmitted via a voice-activated control system, the ambulatory medicament pump can include a medicament reservoir, a pump controller, a wireless data interface, and/or other elements. The device can receive an indication that the request to modify therapy is approved and, in response to the indication that the request to modify the blood glucose control therapy is approved, instruct the pump controller to modify the blood glucose control therapy delivered to the subject.

Abstract: A system for performing irrigation of a body cavity includes a reservoir containing an irrigation liquid, a catheter and a controller. The catheter is configured to be at least partially inserted into the body cavity and has a flushing passage, a drain passage and a retention balloon. A waste drain valve is in fluid communication with the drain passage of the catheter and is movable between a closed configuration, where waste is retained within the drain passage, and an open configuration where waste flows through the drain passage. The controller is in fluid communication with the reservoir and the catheter, and has a pump and a valve assembly. The valve assembly is changeable between configurations where, when the pump is actuated, irrigation liquid is pumped from the reservoir to the retention balloon, from the reservoir to the flushing passage of the catheter and from the retention balloon to the reservoir.

Abstract: Certain embodiments provide multi-medicament or single medicament infusion systems for preventing the cross-channeling or improper delivery of medicaments. The system may include one or more of an infusion pump, medicament cartridges, cartridge connectors, a multi-channel fluid conduit, and an infusion set. The medicament cartridges may be sized and shaped differently such that the medicament reservoirs can only be inserted into the pump under selected configurations.

Abstract: A novel electroporation device for the delivery of vaccines that is both effective in generating a protective immune response and tolerable delivery to a subject (or near painless); and also methods of using same device to vaccinate a subject against a variety of infectious diseases and types of cancer in a near painless.