Abstract: The present invention relates to a composition comprising a biocompatible matrix and a substantially pure mesenchymal stem cells population. The present invention also relates to its use for treating soft tissue injuries.

Abstract: A diseased site where an anterior segment tissue is partly or entirely damaged or deficient can be treated using a corneal epithelium forming cell sheet that will adhere well to the anterior segment tissue. To attain this objective, a corneal epithelium forming cell sheet is produced by a process comprising the steps of cultivating under specified conditions corneal epithelium forming cells on a cell culture support comprising a substrate having its surface covered with a temperature responsive polymer of which the hydrating force varies in a temperature range of 0° C.-80° C., optionally stratifying the layer of cultured cells, and thereafter, (1) adjusting the temperature of the culture solution to either above an upper critical dissolution temperature or below a lower critical dissolution temperature, (2) bringing the cultured corneal epithelium forming cells into close contact with a carrier, and (3) detaching the sheet together with the carrier under specified conditions.

Abstract: The present invention relates to a method for preparing a nerve conduit containing cells, more particularly to a method for preparing a porous nerve conduit containing cells, having micropores formed in microchannels, wherein the nerve conduit containing cells prepared according to the present invention can be usefully used in in-vitro and in-vivo researches on nerves.

Abstract: An implantable therapy delivery device that includes a porous pouch and a cell encapsulation device configured to fit inside the porous pouch. The porous pouch may include a bio-absorbable material and/or a vascularization promotor, and the porous pouch may be packaged separately from the cell encapsulation device.

Abstract: A sheath introducer facilitates the insertion of a catheter into a peripheral artery. The sheath introducer comprises longitudinally extending exterior and interior surfaces, the interior surface defining a lumen in which blood flow occurs. The sheath introducer exterior surface has a hydrophilic material at least partially coated thereon and at least one biologically active agent disposed on the sheath introducer exterior surface. The at least one biologically active agent can be selected from the group consisting of an anticoagulant agent, an antiplatelet agent, an antiproliferative agent, an antibiotics agent, an anti-inflammatory agent, and an antivasospasmodic agent. In a preferred embodiment, the at least one biologically active agent comprises first, second and third biologically active agents, where the first biologically active agent is an antiproliferative agent, the second biologically active agent is an anticoagulant, and the third biologically active agent is an antivasospasmodic agent.

Abstract: Antimicrobial compositions for use in locking catheters and other devices are provided. In some embodiments, the composition includes at least one alcohol, at least one biocidal agent which is not an alcohol, and one or more poloxamers; in other embodiments, the composition comprises at least one poloxamer and at least one alcohol. The composition can provide long-lasting antimicrobial activity. Methods of using the composition are also provided.

Abstract: Radiopaque polymer compositions and methods for making the compositions are provided. These radiopaque polymer compositions include polymer compositions comprising a crosslinked polymer network, the network comprising a first repeating unit derived from a monofunctional monomer and a second repeating unit derived from a multifunctional non-iodinated monomer wherein neither of the two monomers is fluorinated. Devices formed from radiopaque polymer compositions are also provided.

Abstract: The presently-disclosed subject matter includes a compound comprising a first monomer, which is allyl-functionalized and crosslinkable, and a second monomer, which is not crosslinkable. In some embodiments the compounds are photocrosslinkable, and in certain embodiments are photocrosslinkable by ultraviolet light. Also provided are shape memory vascular grafts comprised the of present compounds that can transition from a temporary shape to an original shape when heated above a melting temperature of the graft. Still further provided are methods for treating vascular conditions that utilize embodiments of the present grafts.

Abstract: Devices prepared from polyetherimide resins are disclosed. In one aspect, the article can be medical device configured for use in a body or relating to a medical operation.

Abstract: The invention provides methods, devices, and reagents for treating a disease or a condition in a blood vessel, such as a venous or arterial disease or condition.

Abstract: In one embodiment, system for real time monitoring of catheter aspiration includes a housing having a first port adapted for connection to a vacuum source and a second port adapted for connection with an aspiration catheter, a pressure sensor in fluid communication with an interior of the housing, a measurement device coupled to the pressure sensor and configured for measuring deviations in fluid pressure, and a communication device coupled to the measurement device and configured to generate an alert signal when a deviation in fluid pressure measured by the measurement device exceeds a pre-set threshold. In another embodiment, the system for real time monitoring of catheter aspiration further includes a vacuum source for connection to the first port and an aspiration catheter having an aspiration lumen for connection to the second port.

Abstract: A surgical hand piece is described that maintains a vacuum pressure within the hand piece at a selected level. A check valve is provided substantially near an inlet of an integrated aspirating pump. The check valve opens to introduce fluid into the hand piece to maintain the vacuum pressure within the hand piece at or above the selected level so as to prevent or substantially reduce post-occlusion flow.

Abstract: Apparatus and a method for the provision of TNP therapy to a wound are described, the apparatus comprising: a sealing membrane (504) for covering a wound to form a wound cavity (500); one end of an aspirant conduit (522) operably associated with the wound cavity, vacuum means (524) provided at a distal end of the aspirant conduit for applying a vacuum to the wound cavity; and, air bleed means (510) in fluid communication with the wound cavity. Various embodiments of air bleed port members are also described.

Abstract: A system for hands-free nursing and breast pumping includes a breast compression system that uses moldable chambers filled with air inside the cups of a nursing bra or attached to the flange of a breast pump to apply pressure and massage patterns to a breast while using a breast pump. This compression or pressure is radially applied on the surface of the breast, and its rhythm and strength may be adjusted by the user through the use of a controller in order to mimic the best practices of manual compression. These bra cups with the compression device have openings over the nipples so that a breast pump flange can be inserted through them and used in a typical manner for the extraction of breast milk, thus increasing the amount of milk expressed.

Abstract: A wristwatch wirelessly connected to an implanted medical device such as a VAD is a component of a coplanar energy transfer system. The wristwatch monitors the operation and performance of the VAD or its battery and provides alerts to potentially dangerous situations. The watch can receive signals related to, for example, the current status of the implant (e.g., operating metrics, energy demand, etc.) and current status of the internal battery (e.g., remaining useful life of battery, battery faults, etc.). The wristwatch serves as a redundant external controller of the implanted VAD. The user can interface with the wristwatch to send commands to the VAD and control its performance, power, or charging characteristics with the push of a button. The wristwatch also includes alarm features, which indicate to the user when a fault has occurred or whether there is some situation that requires medical attention.

Abstract: One aspect of an intravascular ventricular assist device is an implantable blood pump where the pump includes a housing defining a bore having an axis, one or more rotors disposed within the bore, each rotor including a plurality of magnetic poles, and one or more stators surrounding the bore for providing a magnetic field within the bore to induce rotation of each of the one or more rotors. Another aspect of the invention includes methods of providing cardiac assistance to a mammalian subject as, for example, a human. Further aspects of the invention include rotor bodies having helical channels formed longitudinally along the length of the body of the rotor where each helical channel is formed between peripheral support surface areas facing radially outwardly and extending generally in circumferential directions around the rotational axis of the rotor.

Abstract: A detachable module for optionally recharging sorbent materials, including zirconium phosphate, with an optional bypass and conduits for a sorbent cartridge. The sorbent cartridge can have one or more modules contained therein having connectors connecting each of the modules. One or more of the modules can be reusable and the sorbent materials therein recharged.

Abstract: A dialysis system includes a filtration system capable of filtering a water stream, a water purification system capable of purifying said water stream in a non-batch process, a mixing system capable of producing a stream of dialysate from mixing one or more dialysate components with the water stream in a non-batch process, and a dialyzer system. The dialyzer may be a microfluidic dialyzer capable of being fluidly coupled to the stream of dialysate and a blood stream.

Abstract: Systems and methods for monitoring oxygenator performance in extracorporeal circuit systems or the like. More particularly, the disclosure relates to systems and methods including a controller programmed to determine oxygenator apparatus flow impedance as a function of an inlet pressure measurement, an outlet pressure measurement and a blood flow rate measurement. The systems and methods may include a communication device that receives signals from the controller to communicate information regarding oxygenator apparatus performance.

Abstract: A medicated apparatus including a medicated patch for use onto a subject undergoing peritoneal dialysis is disclosed, according to an embodiment of a present invention. The patch includes a medication layer containing a medication therein, and a backing film disposed on one side of the medication layer. The patch also includes a skin adhesive layer disposed beneath the medication layer; and a protective liner disposed beneath the skin adhesive layer. The patch is placed on a catheter by applying pressure to skin of a subject after insertion of the catheter therein, thereby holding the catheter and the medication diffusing into the skin prevents an exit site of infection.

Abstract: The present invention relates to a cytopheretic cartridge for use in treating and/or preventing inflammatory conditions that affect myocardial function and to related methods. The cartridge can be used in treating a subject with myocardial dysfunction, such as a subject with chronic heart failure and/or acute decompensated heart failure.

Abstract: The present disclosure describes a novel therapeutic apheresis system and, more specifically, methods and an apparatus for performing therapeutic apheresis. The present disclosure provides highly efficient methods for therapeutic apheresis that modulate the immune system, thereby resulting in treatment of one or more underlying immunological disease processes. In some embodiments, the disclosed methods return at least a portion of blood from an extracorporeal circuit to a patient in pulsatile flow, where the portion of blood that is returned is augmented. In other embodiments, the disclosed methods and apparatus use the central arterial system to exchange volumes of plasma to immunomodulate disease processes. The disclosed methods combine concepts of intermittent flow and continuous flow therapeutic apheresis with established cardiovascular concepts.

Abstract: This invention relates to dialysis systems and methods. In some implementations, a method includes applying vacuum pressure to a device of a dialysis system, and then determining, based on a detected fluid level or measured pressure, whether the device is functioning properly.

Abstract: A monitoring system (9) performs a method for detecting a disruption of a fluid connection between a first fluid containing system and a second fluid containing system. The monitoring system generates a monitoring signal (M1) which is representative of a fluid pressure in respect of the first fluid containing system and which is responsive to the disruption of the fluid connection, and a tracking signal (T1) which corresponds to and is more smoothed over time than the monitoring signal (M1). The monitoring system (9) further sets a detection range (M1L, M1H) in a given relation to the tracking signal (T1) so that the detection range (M1L, M1H) follows changes in the tracking signal (T1), and detects a condition indicative of the disruption by comparing a current pressure value of the monitoring signal (M1) to the detection range (M1L, M1H).

Abstract: A device for nasal lavage is described. The device ejects a gentle flow of fluid under pressure. The fluid stream provides a high quantity of fluid at low pressure. The low pressure fluid stream is more comfortable for a user than a high pressure fluid stream that is delivered by some types of pressurized cans of solution.

Abstract: The present specification describes a portable system and method for storing environmentally sensitive medicines. In an embodiment, the system comprises an insulated container with an open side, where the insulated container is configured to hold one or more medicines, an insulated lid covering the open side of the insulated container, and an electronic circuit comprising a data acquisition unit, a processor in communication with the data acquisition unit, and a communication interface connected to the processor.

Abstract: A syringe packaging system that includes a tube and a cap for enclosing a pre-filled syringe is disclosed. The tube includes a tube cut flange and the cap includes a cut skirt. With a syringe barrel contained within the tube, a syringe barrel cut flange is aligned with the tube cut flange. With the pre-filled syringe enclosed within the tube and the cap, the cut skirt of the cap surrounds the syringe barrel cut flange. In one embodiment, a film is securable to a portion of the tube and a portion of the cap to connect the tube and the cap with the pre-filled syringe enclosed within the cap and the tube.

Abstract: A supporting structure for supporting a plurality of sealed medical cartridges is disclosed, comprising a planar supporting plate having a plurality of receptacles for accommodating the sealed cartridges. Retaining protrusions are formed at the bottom ends of the receptacles protruding inward, which are mated with the shoulder portions of the sealed cartridges in such a manner that the shoulder portions of the sealed cartridges are supported on the retaining protrusions of the receptacles and that the upper ends of the sealed cartridges protrude from the upper ends of the receptacles at an upper side of the planar supporting plate, when the sealed cartridges are accommodated upside-down in the receptacles. The inventive nest will be suitable for any nested liquid filling machine without much changes in filling table and general settings.

Abstract: A real-time embedded server system for controlling, in real-time, at least one infusion pump. The embedded server system includes an embedded server including a memory and a processor electrically coupled to the memory and configured to implement a control engine configured to issue control commands to at least one infusion pump, a messaging engine configured to issue messages to and receive messages from at least one infusion pump, an aggregation engine configured to aggregate data related to the operation of the at least one infusion pump, and a networking engine configured to control network access of the embedded server and the at least one infusion pump. A patient care system including at least one embedded server controlling device configured to make patient-specific care decisions and an associated network of devices operably coupled to a patient and configured to be controlled by the at least one controlling device.

Abstract: Ratchet-based drive systems for more reliable and safer drug delivery are provided. The ratchet-based drive systems restrict angular movement and/or linear movement of components that cause a plunger to expel a liquid drug from a drug container. Movement of the components can be restricted to correspond to a predetermined or desired portion of the liquid drug. In the case that control of the drive system is lost or fails, the maximum amount of drug that could be delivered is limited to a known amount, thereby reducing the likelihood of an overdose.

Abstract: Described is a medicament cartridge comprising a housing having open proximal and distal ends, a first coupling mechanism, and a syringe slidably disposed in the housing. The syringe includes a needle and has a retracted position in which the needle is covered by the housing and an extended position in which the needle is exposed. A delivery device comprises the medicament cartridge, an actuator comprising a plunger, a motor adapted to translate the plunger, a second coupling mechanism adapted to detachably engage the first coupling mechanism, and a control button adapted to actuate the motor. A carrier comprises a first slot for at least partially containing the actuator, a second slot for at least partially containing the medicament cartridge, a user interface adapted to provide at least one a visual signal and an audible signal.

Abstract: A belt clip assembly is disclosed. The belt clip assembly includes a device retainer having a first retainer defined to retain a clip pin. The belt clip assembly further includes a clip coupled to the device retainer via the clip pin and the clip includes a detent and the clip is further defined to retain a tab pin. A tab is coupled to the clip via the tab pin, the tab being rotatable about the tab pin. Wherein the device retainer is initially rotatable about the clip pin independent of rotation of the tab about the tab pin. Additionally, the rotation of the device retainer about the clip pin results in a finite displacement of the device retainer.

Abstract: A penis erection stimulation system comprising a fully implantable drug delivery device for delivering a drug in relation to a penis to achieve erection of the penis.

Abstract: An infusion and blood collection device allows clean blood collections into a collection tube via a previously installed angiocatheter without interrupting the administration of intravenous therapies after initial installation. The device optionally includes passive control of the blood collection flow rate to prevent contamination of the collected blood draw with the IV therapy fluid being simultaneously infused through the angiocatheter. A blood collection method uses an infusion and blood collection device to draw a clean blood sample from a patient and into a collection tube via a previously installed angiocatheter without interrupting the administration of intravenous therapies.

Abstract: A method for providing blood glucose data is provided. In response to a suspension of a continuous basal insulin delivery, by an insulin delivery pump, the method identifies a condition indicating continuing hypoglycemia that continues when basal insulin delivery is suspended; and performs an action, by the insulin delivery pump, based on identifying the condition.

Abstract: Systems and methods are disclosed that provide smart alerts to users, e.g., alerts to users about diabetic states that are only provided when it makes sense to do so, e.g., when the system can predict or estimate that the user is not already cognitively aware of their current condition, e.g., particularly where the current condition is a diabetic state warranting attention. In this way, the alert or alarm is personalized and made particularly effective for that user. Such systems and methods still alert the user when action is necessary, e.g., a bolus or temporary basal rate change, or provide a response to a missed bolus or a need for correction, but do not alert when action is unnecessary, e.g., if the user is already estimated or predicted to be cognitively aware of the diabetic state warranting attention, or if corrective action was already taken.

Abstract: Systems and methods for treating nerve agent exposure in a person are disclosed. Specifically, systems and methods for detecting with sensor(s) the presence of a nerve gas in the vicinity of a person and/or symptoms in a person as a result of exposure to nerve gas, followed by actuation of an alarm and automatic initiation of a programmed injection sequence comprising at least one injection of a nerve gas antidote comprising at least one of atropine, an anticholinesterase reactivator such as 2-PAM and an anti-convulsant such as diazepam.

Abstract: A portable auto-injector configured to store a liquid component in a first chamber separately from a dry medication in a second chamber, wherein a first actuation mechanism opens a valve allowing for the initiation of a mixing step prior to injection. An extendable needle guard is provided over the delivery assembly which prevents premature injection as well as inadvertent sticks or other cross contamination of a needle. The needle guard can also form part of a secondary trigger mechanism which injects the mixed components after the mixing stage is complete.

Abstract: A medicant injection device includes a compressible body, a tip, and an outer luer body. The compressible body has a proximal end, a distal end, and a plurality of bellows, and defines an inner cavity for holding a liquid medicant. The tip is positioned at the proximal end of the compressible body. The outer luer body includes internal threads, and is positioned over and engaged with the tip to form a first fitting therewith. The first fitting is configured to be connected with a second fitting. A medicant injection device includes a compressible body having first and second arms, a receptacle interconnected with the compressible body and defining an inner cavity, and a first fitting configured to engage a second fitting. The compressible body is configured to be compressed by forcing the distal end of the first and second arm toward each other.

Abstract: The present Invention relates to a kit for applying a liquid composition on or in the skin, comprising an injection device and one or more cartridges, provided with a container appropriate for receiving a liquid composition, in which the injection device is provided with means for receiving a cartridges, characterized in that the container is provided with a movable body. The cartridge is provided with a peripheral edge, that allows the safe removal of a used cartridge out of the device, In a second aspect, the invention relates to a method for applying a liquid composition onto the skin.

Abstract: The present invention relates generally to a needleless drug delivery system. More particularly, the present invention relates to a needleless drug delivery system, in which durability of a membrane that partitions a space to fill a drug is enhanced by reinforcing a weak portion of the membrane or by forming a double membrane.

Abstract: The present invention relate to a method and corresponding apparatus for just in time mixing of a solid or powdered formulation and its subsequent delivery to a biological body. In some embodiments, a powdered formulation is maintained in a first chamber of a plurality of chambers. A plurality of electromagnetic actuators are in communication with the plurality of chambers. The actuators, when activated, generate a pressure within at least the first chamber. The pressure results in mixing of the powdered formulation and a diluent in time for delivering into the biological body.

Abstract: A closure piece for a powder syringe is proposed, having a main body, a sealing element, which is disposed on the main body such that it rests in a sealing manner against a distal opening of a powder syringe, when the closure piece is disposed in the closing position thereof on the powder syringe, and a channel, which passes through the main body and the sealing element and has a proximal and a distal end. The closure piece is characterized by a retaining element, which is configured and/or can be disposed such that, prior to an activation of the powder syringe, any powder from a chamber of the powder syringe is at least substantially, preferably completely, prevented from penetrating the channel, when the closure piece is disposed in the closing position thereof on the powder syringe.

Abstract: Medicament delivery devices for administration of opioid antagonists are described herein. In some embodiments, an apparatus includes a housing, a medicament container disposed within the housing and an energy storage member disposed within the housing. The medicament container is filled with a naloxone composition that includes naloxone or salts thereof, a tonicity-adjusting agent, and a pH-adjusting agent, whereby the osmolality of the naloxone composition ranges from about 250-350 mOsm and the pH ranges from about 3-5. The energy storage member is configured to produce a force to deliver the naloxone composition.

Abstract: An adjustable injection device for administering a substance includes a housing with an array of fastening points and at least two housing-like shells, each having at least one holding device and at least one blocking device for attaching to the housing. The holding device of a first shell can be attached to a fastening point, and the holding device of a second shell can be attached to a further fastening point. The holding device of the first shell is prevented from disengagement therefrom by the blocking device of the second shell, and the holding device of the second shell is prevented from disengagement therefrom by a blocking device of a further shell, or, in the event that the injection device has only two shells, is prevented from disengagement from the further fastening point by a blocking device of the first shell whereby the shells are non-detachably connected to the housing.

Abstract: The present disclosure describes an extended finger flange that facilitate use of syringe systems. The extended finger flange increases the surface area available for an end user's fingers thereby allowing a more secure grip on the device and providing greater control during administrations of the medication.

Abstract: Plunger rod stops attach to existing syringes to limit the range of motion of the plunger, thereby to precisely control the amount of liquid that can be expelled from the syringe when the plunger rod stop is in place. In some embodiments, plunger rod stop devices generally include a body configured to attach to the plunger, and a stand-off extending from the body, configured to contact the finger flange when the plunger is depressed. In other embodiments, the plunger rod stop attaches to the finger flange or other fixed component of the syringe and the stand-off is configured to contact the plunger or plunger rod. Methods of the invention involve using the devices to interfere with the range of motion of the plunger, then reconfiguring or removing the device to allow the plunger to be moved a predetermined length, which corresponds to a precise dosage amount.

Abstract: Flush syringe assemblies capable of creating pulsatile movement of the plunger rod as it moves in the distal direction within a syringe barrel, while preventing overpressurization of the catheter are provided. An exemplary flush syringe assembly includes a syringe barrel with a first pulsing element and a chamber with flush solution, a plunger rod with a stopper and a second pulsing element that interacts with the first pulsing element to provide an engagement force that causes pulsatile movement of the plunger rod and a thumb press slidably attached to the plunger rod with a pulse control element. The pulse control element is compressible to create a compression force that is greater than the engagement force of the first pulsing element and the second pulsing element.

Abstract: A drug delivery device includes a housing, a mechanical assembly which is at least partially accommodated in the housing and a retaining member for retaining the mechanical assembly in the housing wherein the retaining member is engaged with the housing such that the device is configured to be damaged when the mechanical assembly or parts thereof are forcefully separated from the housing.

Abstract: A rotary sensor assembly comprises an indicator member adapted to rotate and having first and second axial positions, input means adapted to be actuated by movement of the indicator member, and a processor adapted to receive input from the input means. The indicator member comprises a plurality of actuator structures, and the input means comprises one or more switches adapted to be actuated by an actuator structure. Zero or more switches is/are actuated when the indicator member is moved from the first to the second axial position, this corresponding to a first switch pattern, and zero or more switches is/are actuated when the indicator member is moved from the second to the second axial position, this corresponding to a second switch pattern. Based on input from one or more switches corresponding to the first and second switch patterns, the processor is adapted to determine rotational movement of the indicator member.