The present disclosure relates to devices and methods for performing isotachophoretic concentration of analytes using a porous matrix, for example, for use in diagnostic assays such as lateral flow assays. For example, the disclosure provides a method of concentrating an analyte in a sample. The method includes providing a device comprising a porous matrix having a first fluid pathway having a first end and extending to a second end, a first electrode, and a second electrode; introducing to the first pathway a first fluid comprising a trailing electrolyte, a second fluid comprising a leading electrolyte and the analyte; and applying a voltage across the first electrode and the second electrode for a time sufficient to provide an ITP plug. As described herein, the devices and methods described herein can be used in conjunction with lateral flow assay techniques to detect and quantify a variety of biochemical and biological analytes, such as nucleic acids, proteins, cells and metabolites.

The present invention provides a system including: a protein having a domain that binds a membranal component; an inlet for sample flow, an Isotachophoresis (ITP) system and a flow generating means connected or coupled to the aqueous parts of the ITP. The invention also provides a method for detecting and or sorting cells with this system.

An assembly is provided for interfacing with a microfluidic chip having at least one microscopic channel configured to receive a liquid sample for analysis. The assembly includes a chip carrier, an electronics module, an optical module, and a mechanical module. The chip carrier includes a base and a cover defining a cavity to receive the microfluidic chip. The electronics module includes a signal generator which applies at least one electrokinetic signal electrode(s) of the chip. The optical module includes an excitation radiation source which causes excitation radiation to impinge on the sample, and an emission radiation detector which detects radiation emitted from the sample. The mechanical module includes a chip-carrier receiving structure, relatable with respect to the optical module for focus and at least one degree of translational freedom.

Provided herein is an apparatus that includes a body with a top surface and a recess in the top surface. The top surface, excluding the recess, is substantially planar. The recess is confined to an area that is defined by an inner diameter of the top surface of the body.

One embodiment is directed to a method for controllably managing pain in the afferent nervous system of a patient having a targeted tissue structure that has been genetically modified to have light sensitive protein, comprising: providing a light delivery element configured to direct radiation to at least a portion of a targeted tissue structure, a light source configured to provide light to the light delivery element, and a controller operatively coupled to light source, wherein the targeted tissue structure comprises a sensory neuron of the patient; and automatically operating the controller to illuminate the targeted tissue structure with radiation such that a membrane potential of cells comprising the targeted tissue structure is modulated at least in part due to exposure of the light sensitive protein to the radiation.

The present invention relates to scaffolds composed of a protein backbone cross-linked by a synthetic polymer. Specifically, the present invention provides PEGylated-thiolated collagen scaffolds and PEGylated albumin scaffolds and methods of generating and using same for treating disorders requiring tissue engineering.

A method and device are provided for simultaneously or near-simultaneously diagnosing and treating tension pneumothorax and/or hemothoraxA Veress-type needle portion includes a hollow needle for puncturing the chest wall over a blunt hollow probe biased by one or more springs to extend distally into the pleural cavity. Openings in the blunt hollow probe connect via a pathway to an automatic check valve, which permits the flow of air and/or fluid only in a proximal direction. Pressure from within the pleural cavity is transmitted to the interior surface of a pressure documenter. If pressure greater than atmospheric pressure is present in the pleural cavity, the pressure documenter will be automatically urged proximally to simultaneously allow air and/or fluid to escape from the pleural space through the device, thus treating the tension pneumothorax and/or hemothorax, as well as providing a stable indicator to positively document the diagnosis of increased pressure.

In one example embodiment, a system for treating a tissue site is disclosed comprising a dressing adapted to contact the tissue site and provide a fluid seal between a therapeutic environment and a local external environment, and a solution source fluidly coupled to the dressing and adapted to deliver an antimicrobial solution comprising a peroxy α-keto carboxylic acid, such as peroxy pyruvic acid, to the tissue interface. The system may further comprise a negative-pressure source fluidly coupled to the dressing and adapted to provide negative pressure to the therapeutic environment after delivery of the antimicrobial fluid to the therapeutic environment. In another example embodiment, a method for treating a tissue site is disclosed comprising positioning a tissue interface to contact the tissue site, covering the tissue interface and the tissue site with a drape to provide a fluid seal between the therapeutic environment and the local external environment, and delivering an antimicrobial solution comprising peroxy α-keto carboxylic acid to the therapeutic environment before providing negative pressure to the therapeutic environment.

The present invention relates to a breast pump (10) for extracting milk (30) from a human breast, comprising:—a first breast receiving funnel (16) for receiving a first breast (28) of a user;—a vacuum pump (20) for generating an underpressure within the first breast receiving funnel (16); and—a control unit (22) for controlling the vacuum pump (20); wherein the control unit (22) is configured to operate the vacuum pump (20) in at least two different modes, an attachment mode (48) and a milk extraction mode (50); wherein in the attachment mode (48) the control unit (22) is configured to control the vacuum pump (20) to generate a constant underpressure within the first breast receiving funnel (16) allowing the user to attach the first breast receiving funnel (16) to the first breast (28); and wherein in the milk extraction mode (50) the control unit (22) is configured to control the vacuum pump (20) to generate a time-variable underpressure profile within the first breast receiving funnel (16) for extracting milk (30) from the first breast (28).

A renal failure blood therapy system includes a renal failure blood therapy machine, concentration levels for each of a plurality of solutes removed from a patient's blood at each of the multiple times, a display device configured to display for selection at least one removed blood solute from the plurality of removed blood solutes, and a device programmed to (i) estimate at least one renal failure blood therapy patient parameter using the determined concentration levels for the at least one selected removed blood solute, (ii) determine a plurality of acceptable renal failure blood therapy treatments that meet a predetermined removed blood solute clearance for the at least one selected removed blood solute using the at least one renal failure blood therapy patient parameter, and (iii) enable selection of at least one of the plurality of acceptable renal failure blood therapy treatments for operation at the renal failure blood therapy machine.

An automated peritoneal dialysis system provides various features including prescription-driven dialysis fluid preparation, an integrated disposable fluid circuit, and sensor capabilities that allow accurate filing and draining control with high safety margins. Features include a peritoneal fluid circuit with a pressure sensor at either end and methods and devices for using the pressure signals. Other features and embodiments are disclosed.

An insert for a catheter system can include an insert housing which defines a portion of a fluid pathway of the catheter system, a cartridge positioned within the insert housing in a manner to allow fluid flow along the fluid pathway such that fluid contacts the insert during the fluid flow, and an active agent associated with the cartridge. The active agent and the cartridge can be adapted to release active agent from the cartridge during the fluid flow.

Exemplary embodiments provide wearable automatic injection devices for providing an injection of a therapeutic agent into a patient. The wearable automatic injection device includes a housing having a patient contact portion securable to the patient, an injection needle for insertion into the patient, and a prefilled syringe assembly for holding the therapeutic agent. The prefilled syringe assembly includes a distal stopper and a proximal stopper penetrated by a penetrating needle. The penetrating needle is in fluid communication with the patient injection needle.

Valves, valved fluid transfer devices and ambulatory infusion devices including the same.

Valves, valved fluid transfer devices and ambulatory infusion devices including the same.

A detection section is used in such a manner that it is inserted into a living body by being guided by an insertion needle to be stuck and inserted into the living body. The detection section includes a first region, a second region, and a third region. The first region is provided in a tip end portion of the detection section and includes an electrode layer (detection electrode). The third region includes a wiring section and has a smaller width than the width of a slit of the insertion needle. The second region is provided between the first region and the third region and has the same width as the width of the third region by gradually decreasing from the width of the first region.

An infusion pump system providing therapy to a patient in a closed-loop or semi-closed loop mode can safely automatically revert to open-loop therapy. The system stores a default open-loop basal rate profile in memory. The system also continually tracks the insulin on board for the patient over a plurality of closed-loop therapy intervals. When an error or event occurs requiring reversion to open-loop therapy, the system automatically provides therapy according to the open-loop basal rate profile and the tracked insulin on board amount.

Described herein are syringe devices, systems and methods. In general, the syringe may include a first chamber and a cartridge movable within the first chamber. The cartridge may include a cartridge chamber and a valve in fluid communication with the cartridge chamber and the first chamber and having an open configuration and a closed configuration. The valve may allow movement of a liquid out of the cartridge chamber while in a open configuration. The cartridge may also include a second end, movable within the cartridge chamber, and a locking mechanism having a locked configuration and an unlocked configuration, the locking mechanism preventing movement of the second end within the cartridge chamber while in the locked configuration.

The invention relates to an arrangement for determining a position (x) of a stopper relative to a container in a drug delivery device, comprising an acoustic source configured to emit an acoustic signal and an acoustic sensor configured to detect an acoustic signal, a processing unit for controlling the acoustic source and processing the detected acoustic signal for determining characteristics of the acoustic signal correlated with the position (x) of the stopper. Furthermore, the invention relates to a method for determining a position (x) of a stopper relative to a container in a drug delivery device, the method comprising the steps of emitting an acoustic signal from an acoustic source, detecting an acoustic signal caused by the emitted acoustic signal by means of an acoustic sensor, and processing the detected acoustic signal for determining characteristics of the acoustic signal correlated with the position (x) of the stopper by means of a processing unit.

An injection device, method, and system for drug delivery includes a primary container for storing a drug, the container having a stopper movably disposed in the container for expelling the drug, an injection drive mechanism comprising a plunger for acting on the stopper and an energy source for exerting a force on the plunger to cause the plunger to act on the stopper to expel the drug, the force causing the plunger to accelerate to a velocity prior to acting on the stopper, and a damping mechanism for reducing the velocity of the plunger prior to acting on the stopper. The damping mechanism can include a dashpot or an energy absorbing material associated with the plunger. Alternatively or additionally, the damping mechanisms can include absorbing material disposed between support members of an outer casing of the injection device and the primary container.

An expanding plunger rod for a syringe is configured to transition from a packaged configuration to an expanded configuration for operation. The rod includes a substantially cylindrical outer sleeve having a closed-off bottom end and an open upper end, and an inner rod having a lower end and an upper end. The inner rod is slidably disposed coaxially within the outer sleeve. In the packaged configuration, the inner rod is nested within the outer sleeve. In the expanded configuration, the inner rod is disposed substantially axially above the outer sleeve, and the inner rod locks axially in place to prevent transition from the expanded to the packaged configuration.

An assembly for a drug delivery device (1) is proposed, comprising a housing (13) having a proximal end and a distal end, a dose member (23) which is displaceable in the proximal direction with respect to the housing for setting of a dose of a drug, a clutch member (28) which is displaced in the proximal direction with respect to the housing when setting the dose, and a stop member (30) configured to define a clutch stop position for the proximal displacement of the clutch member with respect to the housing, with the clutch member, when in the clutch stop position, being prevented from further displacement in the proximal direction with respect to the housing, wherein the clutch member and the dose member are configured to mechanically cooperate with one another when the clutch member is in the clutch stop position, thereby preventing further displacement of the dose member in the proximal direction with respect to the housing during setting of the dose. Furthermore, a drug delivery device (1) is proposed.

An add-on logging device (100, 300) mounted to a drug delivery device is turned on when the cap is removed. After a given amount of time in inactivity the sensor means of the add-on device is turned off automatically to save energy. If the user takes a dose of drug this is not detected as the add-on device is only turned on when the cap is removed. According to the present invention a warning message is provided when the cap is re-mounted after the sensor means has been turned off automatically, the warning message indicating to a user that an expelled dose may not have been detected.

The invention is directed to a dose indicating mechanism for drug delivery device (1) configured for the delivery of a medicament contained in single medicament cartridge (2), the medicament comprising at least one first drug and one second drug, wherein the dose indicating mechanism comprises a body (3), a dose dial component (7) configured to move relative to the body (3) during dose setting and first dose indicator means (10) configured to display a set dose of the medicament and/or of first drug in dependence of the displacement of dose dial component (7) during dose setting. In order to provide the user with further information, a second dose indicator means (15) is provided that is configured to display a set dose of the second drug during dose setting. The invention is also directed to a respective drug delivery device.

In some embodiments, an adjunct device for tracks time and/or dosage of a medicine. The device may include a connector for mounting the device to a deposable pen injector. The device may be configured to allow use of the native controls and injectors of the injector. For example the device may include a view port for viewing a dose indicator of the injector. The device may include one or more vibration sensors. A processor may be configured to differentiate increasing a dose, decreasing a dose and/or discharging the medicine based on the output of the sensors. Optionally a display of the device may be positioned for simultaneous viewing with the dosage indicator of the injector. For example a user may verify the accuracy of the adjunct device before performing a discharge.

To enable a user to readily determine the gauge of the needle of a needle assembly that has a base and a needle protective housing pivotably attached thereto, the needle assembly is injection molded from a color coded molding material which color was preassigned to correspond to the gauge of the needle. As a result, both the base and the protective housing of the needle assembly have—the same specific color, and reflect or provide an indication of the given gauge of the needle. The needle sheath that covers the needle prior to use may be made of a plastics material that may be clear, or have the same or a different color than that of the needle assembly. The gauge of the needle of a fixed needle syringe could also be ascertained by its color coded needle protective housing. Color coded markings that correspond to the gauge of the needle may also be printed onto the syringe barrel of the fixed needle syringe.

A drug delivery device is provided herein, the device including a reservoir for containing a medicament. The medicament includes a suspension of solids in a liquid carrier. The device also includes a needle having a distal end for injection into a patient, a proximal end in communication with the reservoir, and a lumen extending between the distal and proximal ends. A path is defined from the reservoir to the distal end of the needle through the lumen, the path having an inner diameter that decreases in a proximal to distal direction along at least a portion thereof. Advantageously, with the subject invention, a flow path may be defined which provides a more gradual transition in diameter from the reservoir to a distal tip of the needle. In this manner, changes in velocity of the suspension may be less abrupt than in the prior art, thus better maintaining solid particles in the suspension.

A medical treatment system including a treatment chamber, a source of an aqueous mist containing a medication, a source of an oxygen-enriched gas, and a control system adapted to alternately surround a human body part with a mist containing a medication and the oxygen enriched gas, which can be used to treat various skin disorders including infected lesions, bacterial infections such as acne (i.e. Propionibacterium acnes), fungal infections such as Athlete's foot (i.e. fungal genus Trichophyton), conditions associated with hair loss including alopecia as well as ulcerations and frostbite resulting from poor circulation. A method of treating skin disorders is also disclosed, that includes providing a mist containing a medication and enriched oxygen gas to the site being treated as well as providing oxygen to the patient during treatment.

A closed loop catheter useable for heat exchange is manufactured by forming a plurality of generally transverse bore holes though a flexible, multilumen catheter body, lacing a tube trough the bore holes so that loops of the tube protrude from the catheter body, connecting one end of the tube to an inflow lumen of the catheter and connecting the other end of the tube to an outflow lumen of the catheter. A heated or cooled heat exchange medium may then be circulated through the tube while the catheter is inserted in the vasculature of a subject, thereby resulting in heat exchange between the subject's flowing blood and the heat exchange medium being circulated through the tube.

An introducer configured with a first curve having a first angle that traverses space of an atrial appendage, a central atrium, caudad to the coronary sinus, and a second curve that has an angle sufficient to align the introducer with an intrinsic curvature of the coronary sinus of a subject.

The invention includes novel devices and methods for inhibiting or preventing colonization of fluid flow networks by bacteria that have upstream surface motility. In certain aspects, the devices and methods of the invention prevent or minimize undesirable bacterial colonization of medical devices and/or treat or prevent bacterial infections.

Medical devices, methods and kits are described. An exemplary medical device comprises a catheter that has a catheter wall and defines a catheter lumen, a bend, and a coil disposed distal to the bend. The catheter defines one or more apertures that extend through the catheter wall and are in communication with the catheter lumen.

Disclosed herein are methods for treating solid mass tumors with direct delivery of an anti-tumor immunotherapeutic agent to the tumor site. In one aspect, this invention encompasses methods of treating solid mass tumors by direct microinjection via a microcatheter of an anti-tumor immunotherapeutic agent into the microvasculature leading into tumor thereby providing high levels of contact with the tumor while minimizing the degree of systemic buildup of the immunotherapeutic agent.

Vascular access system embodiments can be configured to remove gas and a piercing member from a catheter assembly. In some embodiments, vascular access systems can remove gas and at least a portion of a piercing member concurrently or simultaneously. In some embodiments, vascular access systems can remove gas before removing at least a portion of a piercing member. In several embodiments, a vascular access system can include a first barrel configured to remove gas and a second barrel configured to retract a piercing member.

A sheath introducer for a catheter includes a sheath having a lumen, a hub positioned on a proximal end of the sheath, and a housing positioned on the hub. The hub can include a splittable penetration member having a port in fluid communication with the sheath lumen. The housing can include a valve having a closed upper surface and a channel surrounding the splittable penetration member. Movement of the housing with respect to the hub can expose the port of the splittable penetration member for insertion of the catheter.

Pressure sensing guidewires are disclosed. The pressure sensing guidewires may include a tubular member having a proximal portion and a distal portion. The distal portion may have a plurality of slots formed therein. The distal portion may have a first wall thickness along a first region and a second wall thickness smaller than the first wall thickness along a second region. A pressure sensor may be disposed within the distal portion of the tubular member and housed within the second region. An anti-thrombogenic coating may be disposed on an inner surface, an outer surface, or both of the second region of the distal portion of the tubular member.

A catheter includes a catheter body having a proximal end, a beveled distal end, and a lumen therethrough. The beveled distal end defines an elliptical port for releasing contrast or other media through the lumen and from the elliptical port. The catheter may also be used delivering devices or for aspirating or extracting materials from the vasculature or other body lumens. A fixed guidewire extends distally from the distal end of the catheter body, typically from the distal-most edge of the elliptical port. The fixed wire is typically malleable so that it can be manually formed into a desired shape. The elliptical port may be flat or concave.

A medical balloon of a balloon catheter assembly includes a balloon wall formed of at least two layers. The first layer is made of an impervious polymeric material. The second layer, which is integral with the first layer is made of a radiopaque and/or echogenic material and a polymeric material. In the preferred embodiment, there is provided 60 to 80% by weight of radiopaque material in the second layer. It has been found that these concentrations of radiopaque material provide good visibility of the balloon under ultrasonic imaging.

A drug delivery balloon apparatus is disclosed herein, comprising: (a) at least two lumens, comprising a first lumen and a second lumen, (b) a balloon inflation port in fluid communication with the first lumen, (c) a drug delivery port in fluid communication with the second lumen, (d) a guidewire port in fluid communication with the second lumen, wherein the second lumen is configured to receive both a guidewire and a drug solution, (e) an occlusion balloon, (I) a drug delivery balloon, where the occlusion balloon and the drug delivery balloon are in fluid communication with the first lumen, (g) one or more drug delivery channels extending the length of the second lumen, and (h) one or more drug delivery ducts extending from the one or more drug delivery channels to an exterior surface of the second lumen.

Systems and methods for longevity, anti-aging, fatigue management, obesity, weight loss, weight management, delivery of nutraceuticals, and treating hyperglycemia, Alzheimer's disease, sleep disorders, Parkinson's disease, Attention Deficit Disorder and nicotine addiction involve synchronizing and tailoring the administration of nutraceuticals, medications and other substances in accordance with the body's natural circadian rhythms, meal times and other factors. Improved control of blood glucose levels, extended alertness, and weight control, and counteracting of disease symptoms when they are at their worst are possible. An automated, pre-programmable transdermal administration system is used to provide pulsed doses of medications, pharmaceuticals, hormones, neuropeptides, anorexigens, pro-drugs, stimulants, nutraceuticals, phytochemicals, phytonutrients, enzymes, antioxidants, essential oils, fatty acids, minerals, vitamins, amino acids, coenzymes, or other physiological active ingredient or precursor. The system can utilize a pump, pressurized reservoir, a system for removing depleted carrier solution, or other modulated dispensing actuator, in conjunction with porous membranes or micro-fabricated structures.

A transdermal drug delivery device comprises: a reservoir for holding a drug; and at least one microneedle in fluid communication with the reservoir through which the drug can be delivered transdermally, wherein the transdermal drug delivery device is concealed from view during operation thereof.

A device for delivery of material or stimulus to targets within a body to produce a desired response, the targets being at least one of cells of interest, cell organelles of interest and cell nuclei of interest. The device includes a number of projections for penetrating a body surface, with the number of projections being selected to produce a desired response, and the number being at least 500. A spacing between projections is also at least partially determined based on an arrangement of the targets within the body.

An ultrasound catheter with a lumen for fluid delivery and fluid evacuation, and an ultrasound source is used for the treatment of intracerebral or intraventricular hemorrhages. After the catheter is inserted into a blood clot, a lytic drug can be delivered to the blood clot via the lumen while applying ultrasonic energy to the treatment site. As the blood clot is dissolved, the liquefied blood clot can be removed by evacuation through the lumen.

A medical device comprising a subcutaneous access port having an access port body and at least one needle having a removable needle tip and a needle shaft defining a needle lumen; the at least one needle housed within the access port body, the at least one needle extendable and retractable relative to the access port body; and a needle shift mechanism operable such that the at least one needle is extendable from and retractable into the access port body at a plurality of positions of the access port body.

The present disclosure is directed to a medical port drainage assembly that includes a port component and a replaceable catheter. The port component includes a tube having a proximal end, a distal end, and tube walls defining a catheter access lumen. A head component is located on a proximal end of the tube and an assembly retention element is located on a distal end of the tube. The head component is deployed outside the patient's body and defines an opening to the catheter access lumen. The assembly retention element is deployed within a lumen of the patient's body. The port component includes a valve assembly which may be a single valve (e.g., a duckbill valve) or a system of valves. The port component also includes a connector for coupling and decoupling the replaceable catheter to the port component.

Devices, systems, and methods for disinfecting catheters used during in line catheter connections are provided. A disinfection device including one or more LED UV sources comprises a small volume kill zone. The disinfection device is configured to effectively disinfect fluid within the kill zone.

A connector for a fluid path set for delivery of a fluid to a patient during a procedure is described. The connector includes a magnetic check valve for limiting fluid flow to one direction through the fluid path. The magnetic check valve is configured to open in response to one or more of fluid pressure and change in value of magnetic force in the check valve.

Disclosed herein is a fluid infusion device of the type that delivers medication fluid to the body of a patient. The device includes or cooperates with a fluid reservoir, and the device has a sealing assembly to receive and form a fluid seal with the fluid reservoir. A retractable sealing element surrounding a hollow fluid delivery needle may be used to seal a port of the fluid reservoir. The port may include a pressure vent that is sealed by the retractable sealing element. In one variation, the reservoir includes a moving valve sleeve that holds a septum. The septum moves to allow the reservoir to vent, and to form a seal with the port when the needle pierces the septum. In another variation, the device includes a needleless sealing assembly. In yet other variations, the device uses a needled fluid reservoir.

The present invention relates, inter alia, to dermal systems comprising at least one light source and at least one pharmaceutically and/or cosmetically active ingredient. The dermal systems can be employed in order to enhance the penetration and action of the pharmaceutically and/or cosmetically active ingredient.

The present invention discloses a system and method for monitoring an infusion pump capable of intelligently easing pain. Each infusion pump control terminal is connected with a monitoring server through a wireless AP and a local area network respectively; each human body vital sign sensor is connected with the signal input end of a field programmable gate array FPGA through a sensor interface circuit respectively, an infusion control device is connected with the control signal output end of the field programmable gate array FPGA, the field programmable gate array FPGA is in communication with an ARM processor in a bus coding mode, and the ARM processor is in communication connection with the wireless AP through a WIFI communication module. By means of the system and method for monitoring infusion pump capable of intelligently easing pain, a plurality of basic vital sign data of a patient is collected in real time, corresponding infusion schemes are generated through analysis of the data, the infusion pump is controlled to achieve automatic infusion, monitoring and pain-easing infusion are combined together for coordinative work, and infusion control is more scientific and reliable; patient online perception and feedback is supported, self-improvement of a system is facilitated, and more accurate and reliable infusion schemes can be acquired.