Abstract: The invention provides novel amphiphilic drug-drug conjugates useful as cancer therapeutics, and compositions and methods thereof.

Abstract: Provided herein are compositions and related methods for delivering an IgG-decoy receptor to the CNS. The methods include systemic administration of a bifunctional decoy receptor-BBB receptor antibody fusion antibody comprising a receptor extracellular domain (ECD) covalently linked to an antibody to a receptor expressed on the surface of the blood-brain barrier (BBB receptor). In some embodiments, the compositions described herein are administered to treat a subject suffering from a CNS condition.

Abstract: The present invention relates to a prodrug or a pharmaceutically acceptable salt thereof, comprising a drug linker conjugate D-L, wherein D being a biologically active moiety containing an aliphatic amine group is conjugated to one or more polymeric carriers via dipeptide-containing linkers L. Such carrier-linked prodrugs achieve drug releases with therapeutically useful half-lives. The invention also relates to pharmaceutical compositions comprising said prodrugs and their use as medicaments.

Abstract: The invention provides immunotherapeutic and prophylactic bacteriophage viral-like particle (VLPs) which are useful in the treatment and prevention of human papillomavirus (HPV) infections and related disorders, including cervical cancer and persistent infections associated with HPV. Related compositions (e.g. vaccines), nucleic acid constructs, and therapeutic methods are also provided. VLPs and related compositions of the invention induce high titer antibody responses against HPV L2 and protect against HPV challenge in vivo. VLPs, VLP-containing compositions, and therapeutic methods of the invention induce an immunogenic response against HPV infection, confer immunity against HPV infection, protect against HPV infection, and reduce the likelihood of infection by HPV infection.

Abstract: Described herein are compositions of antibodies and carrier proteins and methods of making and using the same, in particular, as a cancer therapeutic. Also described are lyophilized compositions of antibodies and carrier proteins and methods of making and using the same, in particular, as a cancer therapeutic.

Abstract: The present invention relates to imaging agent compositions comprising radiolabelled c-Met binding peptides suitable for positron emission tomography (PET) imaging in vivo. The c-Met binding peptides are labelled with the radioisotope 18F. Also disclosed are pharmaceutical compositions, methods of preparation of the agents and compositions, plus methods of in vivo imaging using the compositions, especially for use in the management of cancer.

Abstract: There is described In another of its aspects, the present invention provides a radiation source assembly comprising: (i) an elongate radiation source; (ii) a positioning element connected to a proximal portion of the elongate radiation source; and (iii) a connecting portion secured to a proximal portion of the positioning element and configured to engage a support element to maintain a distal portion of the elongate radiation source in a cantilevered position. The present radiation source assembly is configured such that the distal portion of the radiation source is cantilevered with the respect to the distal portion of the protective sleeve in which it is disposed. This feature obviates the need to use spacers, stops, springs and the like in a distal portion of the protective sleeve to maintain correct position of the radiation source within the protective sleeve.

Abstract: A surgical sterilizing container tub is provided on which a sterilizing container lid is adapted to be detachably fitted for formation of a surgical sterilizing container for holding surgical instruments for sterilization. The sterilizing container tub has a bottom and a container wall projecting from the bottom. The sterilizing container tub defines a set-down plane, and the bottom forms a fluid collection area for collecting fluid. In order to provide such a surgical sterilizing container tub and such a surgical sterilizing container with which fluid to be removed can be effectively conducted to the fluid collection area, the bottom has a fluid drainage surface which is inclined relative to the set-down plane and is in fluid connection with the fluid collection area for draining fluid in the direction of the container wall. A surgical sterilizing container is also provided.

Abstract: A tonometer tip disinfection apparatus for disinfecting and rinsing a tonometer tip includes a first basin configured to hold a disinfecting solution, a second basin configured to hold a rinsing solution, a holding platform configured to receive at least one tonometer tip, a tonometer tip support arm configured to support a tonometer tip having a tip end in an orientation allowing the tip end to reside at least in part within the first and second basins, and a transportation assembly configured to automatically move the tonometer tip support arm between the first and second basins and the holding platform.

Abstract: Aerosols that include ceragenin compounds (i.e., ceragenin-containing aerosols), methods for delivering such aerosols, and devices for delivering such aerosols. Ceragenins can be used to kill a broad range of microbes (e.g., bacteria, viruses, fungi, bacterial spores, fungal spores, and the like), yet they are thought to be completely non-toxic to humans and other higher eukaryotes. Aerosols can penetrate into the nooks and crannies of a space and kill microbes that may lurk in a space. In addition, ceragenins have a extended mode of action, which allows them to continue killing microbes in a space for an extended period of time.

Abstract: A mist generator is used to deliver a high throughput extremely fine mist comprising a biocide. Flows of evaporating hot gas mix turbulently and enhance forced heat and mass transfer between the very fine droplets and the hot gas to form a well-mixed premixed evaporator, resulting in high humidity vapor formation well inside a tube. The high relative humidity vapor with elevated temperature is then condensed as it exits the tube and disperses into the volume to be decontaminated as a condensed vapor cloud, but neither as a mist nor as a pure vapor depending on temperature and humidity of room environment. The condensed vapor cloud may evaporate or settle on the volume surfaces and contents, whereby both dry vapor and condensed vapor are applied into the volume for the killing process.

Abstract: A process and system for sterilization of a product pathway of a blow-fill-seal machine. The process comprises steps of: (1) isolating a holding tank from the product pathway; (2) supplying a sterilizing agent to the product pathway of the BFS machine when the holding tank is isolated; (3) stopping the supply of sterilizing agent to the product pathway when a threshold is reached; and (4) supplying filtered compressed air to the product pathway when the supply of sterilizing agent is stopped. The process is preferably executed automatically without human intervention once initiated. Also described is a system for carrying out the process including a processor, valves and temperature and/or pressure sensors which provide information to the processor to determine when to open and close the valves to supply sterilizing agent and/or compressed air to the product pathway or holding tank.

Abstract: A volatile substance delivery system includes a volatile substance container to contain a volatile substance, an outlet to deliver a volume of the volatile substance from the volatile substance container to an ambient environment, and a manual screw pump to increase pressure within the volatile substance container and promote the delivery of the volatile substance from the volatile substance container.

Abstract: An absorbent article includes a chassis comprising a topsheet, a backsheet, and an absorbent core disposed between the topsheet and the backsheet, and at least one elastically elongatable panel joined to the chassis. The elastically elongatable panel includes a stretch laminate that has at least one cover layer, an elastomeric film attached to the cover layer, the elastomeric film having two surfaces and a skin on at least one of the surfaces, and an adhesive disposed between the skin and the cover layer. The stretch laminate has at least one anchoring zone and at least one stretch zone, the skin that is located in the anchoring zone has a plurality of wrinkles, and the wrinkles have furrows, and at least some of the adhesive is disposed in at least some of the furrows. An absorbent article including the stretch laminate is also provided.

Abstract: Ophthalmic suture materials made from biocompatible and biodegradable polymers with high tensile strength for use in drug delivery, methods of making them, and method of using them for ocular surgery and repair have been developed. The suture materials are made from a combination of a biodegradable, biocompatible polymer and a hydrophilic biocompatible polymer. In a preferred embodiment the suture materials are made from a poly(hydroxyl acid) such as poly(l-lactic acid) and a polyalkylene oxide such as poly(ethylene glycol) or a polyalkylene oxide block copolymer. The sutures entrap (e.g., encapsulate) one or more therapeutic, prophylactic or diagnostic agents and provide prolonged release over a period of at least a week, preferably a month.

Abstract: Disclosed is a matrix material comprising a pharmaceutical composition such as a matrix material with a pharmaceutical composition printed on the surface. In one embodiment the pharmaceutical composition comprises thrombin. Further disclosed is a method for making the matrix material with a pharmaceutical composition printed on the surface and use of said matrix material for promotion of hemostasis and/or wound healing. Also disclosed is a kit-of-parts comprising a matrix with a pharmaceutical composition and a container with a peelable lid.

Abstract: The invention has as its object the provision of a medicine capable of reducing a volume of emphysema-suffering pulmonary alveoli or alveolar sacs by means of a respiratory region volume inhibitor containing a coating film formation as a main component and capable of forming a coating film in a respiratory region, characterized by being used in such a way that the coating film-forming component is administered to an emphysema-suffering pulmonary alveolar parenchyma in a human-respiratory region in an amount of 0.004 to 200 g/application, preferably 0.07 to 20 g/application and more preferably 0.5 to 5 g/application on each occasion.

Abstract: A monomeric adhesive composition includes a stabilized polymerizable monomer, such as a 1,1-disubstituted monomer, including a cyanoacrylate, and a wound healing agent, wherein the wound healing agent is 5,5-disubstitutedhydantoin, including phenytoin; and a method for making said composition.

Abstract: Vascular grafts for treating, reconstructing and replacing damaged or diseased cardiovascular vessels that are formed from decellularized extracellular matrix (ECM). The vascular grafts include outer or outer and inner coatings that provide structural reinforcement.

Abstract: The invention provides compositions and methods for making and using microvascular stamps for stimulation and spatial organization of neovessels in tissue.

Abstract: The present invention relates to a gene delivery stent using titanium oxide thin film coating and a method for fabricating the gene delivery stent. The gene delivery stent according to the present invention may be loaded with a drug having anti-inflammatory and anti-thrombotic effects and simultaneously deliver a gene capable of inhibiting proliferation of vascular smooth muscle cells. Accordingly, late thrombosis and metal allergy may be reduced, and vascular restenosis in the stent region may be prevented, thereby making it possible to increase treatment effects of the bare metal stent.

Abstract: A synthetic osteoinductive porous biomaterial is provided comprising: a network of interconnected micropores, wherein the microporosity is 23% by volume or more; wherein the surface free energy of the biomaterial is 19 mJ/m or more; and the mean interconnection diameter and the mean interconnection diameter and the surface free energy are chosen to provide a permeability resulting from the micropores of 0.206 nm2 or greater and a capillary pressure difference in water of 3.7 kPa or more. The biomaterial contains hydroxyapatite and silicon.

Abstract: Apparatuses and methods for administering a hemostatic agent to the tissue surrounding an opening in a body lumen are disclosed. The apparatus can include a tissue-contacting region and an optional body lumen-penetrating region. At least one hemostatic agent is included as a component of a coating over and/or a mixture with the material of at least a portion of the tissue-contacting region.

Abstract: The present disclosure provides, inter alia, a method of producing an outer layer material for forming into a structure and that comprises an entanglement having a hydrophobic polymer host and a hydrophilic guest, including in one embodiment the steps of: intermingling cloaked hydrophilic guest complexes with the hydrophobic host; crosslinking molecules of the guest with the guest; and performing a hydrolysis reaction.

Abstract: The present invention pertains to implantable or insertable medical devices which comprise a substrate and one or more therapeutic-agent-containing regions contain one or more therapeutic agents. In various aspects of the invention, one or more characteristics of such therapeutic-agent-containing regions are controlled. Further aspects of the invention relate to methods of forming such devices and to methods of using such devices.

Abstract: Various forms of anti-clog suction tips apparatus are disclosed. An exemplary anti-clog suction tip apparatus includes a suction tip assembly having a suction tip with a suction opening at a first end thereof for removing debris through suction, a hose attachment portion for attaching the suction tip assembly to a suction source, and an ejection wire channel. The apparatus further includes an ejection wire assembly having an ejection wire extending within the channel and an ejection button integral with or connected to the ejection wire. Applying a force to the ejection button advances the ejection wire through the channel such that an end portion of the ejection wire enters the suction tip and dislodges debris clogging the suction tip. The ejection wire may include an enlarged end portion such as, for example a ball tip. One or more of the components of the apparatus may be single-use and disposable.

Abstract: A laparoscopic retractor and suction device includes a shaft including a distal end and an opposed proximal end. The shaft defines an internal suction channel extending from the distal end to the proximal end. The device includes a head attached to the distal end of the shaft and in fluid communication with the suction channel. The head is movable from a collapsed configuration to a deployed configuration.

Abstract: The invention includes a portable negative wound therapy system including a container, a wound covering, a packet and a plurality of surface cross-linked superabsorbent particles. The invention also includes a liquid solidification system for reducing gel block in NPWT systems. Methods of solidifying liquid medical waste from NPWT devices are also described and disclosed.

Abstract: A blood pump includes a hub having an axis of rotation and a generally cylindrical shape. The hub has an upstream end region, a central region, and a downstream end region, and the hub includes a magnetic material. Blades that are disposed on the downstream end region of the hub extend downstream of the hub.

Abstract: Various “contactless” bearing mechanisms including hydrodynamic, hydrostatic, and magnetic bearings are provided for a rotary pump as alternatives to mechanical contact bearings. These design features may be combined. In one embodiment, the pump apparatus includes a rotor having a bore, a ring-shaped upper rotor bearing magnet, and a ring-shaped lower rotor bearing magnet. The bearing magnets are concentric with the bore. The lack of mechanical contact bearings enables longer life pump operation and less damage to working fluids such as blood.

Abstract: A foldable, intravascularly insertable blood pump (10) comprises a foldable, radially delivering impeller (20) accommodated in a foldable housing or envelope (24). Axially before and behind the impeller a clearance (60) is provided between the impeller (20) and the front and back walls (32, 62) of the housing (24), the clearance being at least 0.2 mm. Preferably, the space defined between adjacent blades (54) of the impeller (20) is open towards the front wall (32) of the housing (24).

Abstract: The present invention provides methods and systems for a biomaterial medical implant device for treating patients with HF and/or intractable dyrhythmia. It either is implanted inside the cardiac cavity(ies), ICI, or after their removal, TAH. The embodiment consists of 2 layers. Layer 1 (16) is immobile and adherent to the basement. Layer 2 (17) reflects from layer 1 and faces the cavity. Layer 2 moves inwards (systole) and backwards (diastole) by between-layers Concertina-like elastic fibers and/or a spring (22), on-surface diagonally crossing elastic fibers (27), or sheets (29&30) of electromagnetic coils (34), that are adherent to both layers from the inside. Layer 2 moves through the electromagnetic coil causing its attraction to layer 1, when polarities are different and repulsion when polarities are similar.

Abstract: Devices, systems and methods for treating disorders characterized by low cardiac output. The devices, systems and methods use intra-aortic balloon counterpulsation in combination with hypothermia of all or a portion of a human or veterinary patient's body to improve coronary perfusion and cardiac output. To effect the hypothermia, a heat exchange catheter may be positioned in the a patient's vasculature separately from the intra-aortic balloon counterpulsation catheter. Alternatively, a combination Intra-aortic balloon counterpulsation/heat exchange catheter may be utilized. Such combination catheter comprises a) a catheter sized for insertion into the aorta, b) a counterpulsation balloon and c) a heat exchanger. A drive/control system receives temperature and electrocardiograph signals and drives the inflation/deflation of the counterpulsation balloon as well as the heating/cooling of the heat exchanger.

Abstract: An apparatus for extracorporeal blood treatment, comprising a treatment unit (2) having a first chamber (3) and a second chamber (4) separated from one another by a semipermeable membrane (5), a blood removal line (6) connected in inlet with the first chamber (3) and a blood return line (7) connected in outlet with the first chamber; an infusion line (9; 9a, 9b) of a replacement fluid and a fluid evacuation line (10) connected in outlet from the second chamber.

Abstract: A flow reversing device for performing blood treatment can include a flow reversing actuator. The flow reversing actuator can receive and engage a disposable tubing set with multiple branches that form forward and reverse blood flow paths respectively when blood the flow reversing actuator is selectively changed between forward and reverse configurations. The shape of the tubing can be such that during forward operation, dead regions of non-flowing blood are defined. The flow reversing actuator can have a controller configured to operate generally in forward mode. At first times, the controller can cause the flow reversing actuator to clear the dead regions. At second times, the controller can cause the flow reversing actuator to test for leaks by reversing the flow of blood for a period of time sufficient to cause air to be drawn into the tubing set and conveyed to an air sensor.

Abstract: Centrifugation systems and methods are provided for separating blood into its constituent parts. Inner and outer walls of a centrifuge each include a projection which extends toward the other wall. A separation chamber is received in the centrifuge between the walls, with the chamber including an inlet port for flowing blood into the chamber, a plasma outlet port for flowing plasma out of the chamber, and a red cell outlet port for flowing red blood cells out of the chamber. With the chamber received in the centrifuge between the walls, the first projection extends into the path of separated blood components flowing toward the plasma outlet port and prevents cellular blood components from flowing into the plasma outlet port. The second projection extends into the path of separated blood components flowing toward the red cell outlet port and prevents plasma from flowing into the red cell outlet port.

Abstract: A separation system for separating a multiple component material into at least two fractions. The separation system includes a separation device having a first end, a second end opposite to the first end, and a sidewall that extends between the first end and the second end to define a separation chamber having an interior volume. The system also includes a valve moveable between an open position and a closed position, the valve is mounted at a fixed location within the separation chamber at a position that is closer to the second end than to the first end and is spaced apart from the second end, the valve is operable to isolate a first fraction of the multiple component material having a first density on a first side of the valve from a second fraction having a second density on a second side of the valve that is opposite to the first side.

Abstract: Systems and methods of efficaciously washing body cavities, specifically including the nasal cavity, wherein a fluid flow is governed in at least one of degree and direction of issuance. Governing of the degree of fluid flow can involve an applicator that is affixable to a fluid source, wherein the applicator can variably constrain the degree of fluid flow being issued. Governing of the direction of issuance can involve the applicator, when affixed to the fluid source, issuing the fluid flow in a specific direction, relative to the fluid source, and an indicator of the fluid source's general orientation relative to vertical.

Abstract: The invention concerns a base part for a medication delivery device, the base part comprising a connection part and a moveable part. The moveable part, which moves relative to the connection part, is capable of guiding fluid paths from a medication delivery port to a first cannula or sensor and a second cannula or sensor. The base part also comprises guiding means which can direct each cannula or sensor to its subcutaneous position.

Abstract: A mobile medical pump has a tubular cartridge unit with a first end having an interface to an infusion line and a second, open end having a first engagement interface, with a piston inserted in the cartridge and engaging an inner diameter of the cartridge, such that translation of the piston within the cartridge will draw in or expel liquid to or from the cartridge, a case housing having an opening for inserting the cartridge and an internal second engagement interface at a depth that, with a cartridge fully inserted and the first and second engagement interfaces joined, an infusion line may be connected to the first end external to the case, and a piston rod within the case housing, the piston rod having a permanent magnet at a first end with a planar surface orthogonal to a longitudinal axis of the piston rod, and a threaded opening at an opposite end engaging a rotatable translation screw driven by a translation drive system including an electric motor.

Abstract: A device, method, and system are provided for monitoring the delivery of fluids through a drip chamber. The device includes an electromagnetic radiation (EMR) source and an EMR detector. A device body is employed to position the source and detector about the drip chamber so that the source and detector define an optical path across the drip chamber. A processor device is employed to detect fluid drops from differences between detector signal values separated by a lag time. The flow rate is determined from a drip factor and the detection of multiple drops. In the context of delivering intravenous (IV) fluids, a battery powered handheld monitoring device that includes the source, detector, device body, and processor device may be affixed to a drip chamber included in an infusion set. The device includes a user interface, including buttons, a display, and an audio speaker, for the input and output of information.

Abstract: An implantable infusion pump possesses operational functionality that is, at least in part, controlled by software operating in two processor ICs which are configured to perform some different and some duplicate functions. The pump exchanges messages with an external device via telemetry. Each processor controls a different part of the drug infusion mechanism such that both processors must agree on the appropriateness of drug delivery for infusion to occur. Delivery accumulators are incremented and decremented with delivery requests and with deliveries made. When accumulated amounts reach or exceed, quantized deliverable amounts, infusion is made to occur. The accumulators are capable of being incremented by two or more independent types of delivery requests. Operational modes of the infusion device are changed automatically in view of various system errors that are trapped, various system alarm conditions that are detected, and when excess periods of time lapse between pump and external device interactions.

Abstract: An apparatus for processing a set of data values, a data value representing a physiological measure of a body fluid at a time instant, comprising: an estimated probability function calculator for calculating an estimated probability function associated with the set of data values; a transform calculator for calculating a non-linear transform rule using a predetermined target probability function being different from the estimated probability function, so that the probability function of a set of transform data values is closer to the target probability function than the estimated probability function; and a transformer for applying the transform rule to the set of data values or to at least one further data value not included in the set of data values and sampled at the different time instant from the time instants for the set of data values to obtain at least one transformed value representing the physiological measure.

Abstract: The invention relates to an injection device including an injector and an ampoule unit for the needle-free injection of a medium. A needle-free injection device has a first chamber with an interior that opens into a nozzle, and has a second chamber with an interior that is separated from the interior of the first chamber. The interiors of the two chambers are connectable to each other, thus allowing a mixing and/or reaction of the media located in the chambers. In the first chamber, a powdery medium can be accommodated, and in the second chamber, a fluid medium is can be accommodated. The fluid medium can be transported into the first chamber for the mixing/reaction of the two media.

Abstract: The present invention relates to an automatic injection device (1) comprising: a container having a longitudinal axis A and movable between a first position and a second position, in which the needle is inserted, biasing means, for moving the container to its second position, retaining means (70, 73, 74) for maintaining said biasing means in a first stressed state, triggering means (90) for releasing said retaining means, said retaining means comprising a lever member having a pivoting part and a radial projection extending therefrom, said radial projection being in a first angular position when said retaining means is in its passive condition, said radial projection being in a second angular position, different from said first angular position, when said retaining means is in its active condition, the axis of said pivoting part being included in a transversal plane of said longitudinal axis A.

Abstract: A method and system for priming a drug delivery device are provided. The drug delivery device includes a forced priming feature that requires the user to move the dose dial sleeve (3) axially to cause the spindle (5) to pre-load a cartridge bung before a first dose can be dialed.

Abstract: A syringe device that includes a stem, container, and a plunger, the plunger having tubes with a soluble substance that maintain a seal on compounds within the container's chamber, and/or a parabolic cover held in position by a soluble substance, thus allowing a multi-cycle usage to dispense medication to patients, even while preventing further use.

Abstract: A jet injector that includes a prefilled syringe. The syringe includes a fluid chamber that contains a medicament. The syringe also has an injection-assisting needle, and a plunger is movable within the fluid chamber. A housing is configured for allowing insertion of the needle to a penetration depth. An energy source is configured for biasing the plunger to produce an injecting pressure in the medicament in the fluid chamber of between about 80 and 1000 p.s.i. to jet inject the medicament from the fluid chamber through the needle to an injection site.

Abstract: A gasket of a prefilled syringe is disclosed, which includes a gasket body and a plunger-mounting member. The gasket body has a plunger-mounting member removal prevention rib formed on an inner surface of the gasket body. The plunger-mounting member has an outer projected part, which engages the plunger-mounting member removal prevention rib of the gasket body, a plurality of elastically deformable inner projected parts which are extended obliquely from an inner portion of a proximal side of the plunger-mounting member toward a central and distal end of the plunger-mounting member, and plunger removal prevention locking parts formed at free ends of the inner projected parts. The plunger has a distal end part capable of entering the plunger-mounting member and an outer projection part which engages the plunger removal prevention locking parts of the plunger-mounting member.

Abstract: An assembly for a drug delivery device comprises a drive member which is adapted and arranged to be displaced in a dose setting direction for setting a dose of a drug and to be displaced in a dose delivery direction for delivering the set dose of the drug. The assembly comprises a piston rod which is adapted and arranged to be displaced in the dose delivery direction via mechanical interaction with the drive member for delivering the set dose. The assembly comprises at least one resilient pre-delivery element, wherein the assembly is configured such that the resilient pre-delivery element is biased when the drive member is displaced in the dose setting direction for setting the dose, the biased resilient pre-delivery element relaxes before the drive member is displaced in the dose delivery direction for delivering the dose. When the resilient pre-delivery element relaxes, the piston rod is displaced with respect to the resilient pre-delivery element in the dose delivery direction by a pre-delivery distance.