Abstract: Methods and devices treating an autonomic nervous system associated disease condition in a subject are provided. Aspects of the invention include inducing one or more physiological response selected from the group consisting of sweating, gastric emptying, enhanced heart rate variability and enhanced quantitative sensory test responsiveness in a manner sufficient to modify the autonomic nervous system so as to treat the subject for the disease condition. The methods and devices find use in a variety of applications, e.g. in the treatment of subjects suffering from conditions arising from disorders of the autonomic nervous system.

Abstract: The present invention provides a radiation-shielding container for a radiopharmaceutical that allows or a product fluid to be dispensed from a base component thereof.

Abstract: The present invention relates to methods for treating obstructive sleep apnea (OSA), alleviating a negative OSA symptom, reducing snoring, or improving quality of life in a subject, comprising administering to the subject an effective amount of a pharmaceutical composition comprising pyridostigmine before sleep. Also provided are related medicaments as well as methods for preparing the medicaments.

Abstract: The invention provides methods for decellularizing bone, e.g., human bone.

Abstract: A syringe with a syringe cylinder and a syringe, with a seat for the syringe cylinder and an axially displaceable piston seat for the syringe piston. There is an encoding on the syringe cylinder with encoding elements as protrusions and deepenings (depressions) at seven encoding positions, checking elements in the form of further protrusions and further deepenings at seven checking positions, each being disposed between two encoding positions. The encoding elements and the checking elements have six protrusions in total, and a guiding structure to align the syringe on a further guiding structure with each encoding element and with each checking element to a sensing element, said further guiding structure being disposed in the seat of the metering device and having a certain position with respect to an annular sensing device for sensing the encoding by sensing elements of the metering device that are across the circumference.

Abstract: Devices and methods for treating a target site in a body lumen are provided. A medical device includes a stent-like structure including a plurality of scoring and non-scoring filaments interwoven with one another. Generally, the stent-like structure will have more non-scoring filaments than scoring filaments to provide greater structural support and to focus the scoring forces on only a few select areas. The stent-like structure is expanded within the target site to score the target site and to provide temporary structural support while the target site is infused with a therapeutic agent. Such therapeutic agent infusion occurs with the use of a drug eluting or drug coated balloon disposed within the stent-like structure or by occluding the target site and introducing a drug into the occluded target site to sit for a period of time.

Abstract: A system and method for vessel catheterization is provided, having an introducer sheath and a catheter. The introducer sheath can include a handle and a sheath body extending from the handle. An access lumen is provided in the introducer sheath, and can include a tapered portion that is sized to receive a tapered outer surface of the catheter. The catheter may be a central venous catheter, such as a peripherally inserted central catheter, including a hub, a catheter body with at least one lumen extending distally from the hub, and at least one tube extending proximally from the hub. The introducer sheath is preferably a splittable sheath. The catheter can be inserted into the access lumen, and translated until confronting surfaces of the tapered outer surface of the catheter body and the tapered portion of the introducer sheath contact one another. This arrangement can inhibit buckling and/or kinking of the catheter during insertion, and improve initial catheter tip positioning.

Abstract: There is provided an enteral feeding assembly having a base and a connector. The base has a catheter with a lumen for communication with a body lumen. The base also has an opening with a predetermined shape on its proximal side that also communicates with the catheter lumen. The connector has a key configured to complement the predetermined shape of the opening in the base, which occurs desirably in one position only, so that the connector and base may be joined together. The connector is also connected to a feeding tube that provides a nutrient solution from a replaceable feeding bag. Once the connector is in position in the base, liquid may from the bag to the body lumen. Once in position, the connector may rotate 360 degrees relative to the base before being again in the installation/removal position.

Abstract: A method of constructing a sensor includes depositing a first material in a predetermined arrangement to form a structure. The depositing results in at least one void occurring within the structure. The method further includes depositing a second material within the voids. The second material may have electrical properties that vary according to deformation of the second material. The method also includes providing electrical access to the second material to enable observation of the one or more electrical properties. A sensor includes a structure that has one or more voids distributed within the structure. The sensor also includes a material deposited within the one or more voids. The material may be characterized by one or more electrical properties such as piezoresistivity. The sensor includes a first contact electrically coupled to a first location on the material, and a second contact electrically coupled to a second location on the material.

Abstract: A drug delivery device is presented comprising of a housing, a plurality of contacts, a rod disposed within the housing, and an encoded member configured to be rotatably supported inside the housing, to engage with the rod and to be rotatable with respect to the rod, and to be axially constrained with respect to the housing such that axial advancement of the rod in a first direction relative to the housing causes rotation of the encoded member, wherein the outer surface of the encoded member is provided with a plurality of tracks together forming an encoder, each track comprising conductive segments and non-conductive segments and wherein the encoded member is supported in the housing such that each track is engaged by a respective one of the plurality of contacts.

Abstract: A drug delivery device is presented comprising of a housing, a plurality of contacts, and a cylindrical member configured to be rotatably supported inside the housing, wherein the outer surface of the cylindrical member is provided with a plurality of tracks together forming an encoder, each track comprising conductive segments and non-conductive segments, and wherein the cylindrical member is supported in the housing such that each track is engaged by a respective one of the plurality of contacts.

Abstract: Described herein is a positioning tool having an elongate portion for carrying a medical implant. Also described is a method of positioning a medical implant using an elongate positioning tool. One form of the method includes positioning a medical implant on a distal portion of an elongate positioning tool, inserting the positioning tool with the implant thereon into a body cavity manipulating the positioning tool to position the implant into contact with tissue at an attachment location, attaching the implant to surrounding tissue at the attachment location, separating the implant from the positioning tool, and withdrawing the positioning tool from the body. In a preferred embodiment, the position of the implant is visually confirmed using an endoscope before the implant is attached to surrounding tissue. In one embodiment, the implant is a satiation device and the body cavity is the esophagus and/or stomach.

Abstract: An implantable drug delivery system including: a biocompatible or bio-inert housing containing a drug infusion pump, a drug chamber from which a liquid drug is dispensed when the pump applies a force to the drug chamber, and an internal controller actuating the pump; a delivery catheter extending from the housing to one or more drug delivery treatment sites in a target tissue, wherein the catheter includes a lumen having an inlet to receive a drug pumped from the drug chamber and an outlet are positioned at the target tissue, wherein the drug flows through the outlet to the target tissue, and wherein the internal controller stores and executes an automatic periodic flow regimen which commands the pump and drug chamber to periodically dispense an intermittent bolus or pulse of the liquid drug, wherein the periodic flow regimen provides a prophylactic treatment for granuloma.

Abstract: Occlusions in a delivery line of an infusion pump can be detected by measuring pressure differentials in the pump over short periods of time in order to minimize the effects of long term systematic sensor changes. In a delivery mode such as basal insulin delivery where a small portion of a volume of fluid is delivered, pressure readings can be obtained before and after the motor move to deliver each portion and compared. The differentials after one or more motor moves can be compared to determine whether an occlusion is present. In a delivery mode such as bolus insulin delivery in which an entire volume of fluid is delivered, pressure differentials can be obtained for consecutive deliveries at a common point in the delivery cycle of each delivery. Comparison of these pressure values can be used to determine whether an occlusion is present.

Abstract: The preset invention provides a liquid injector in which, when an injection time period and an injection rate are entered as an injection condition, a condition image having a horizontal width corresponding to the injection time period and including the injection rate as text data is displayed in a condition screen with its vertical axis representing the injection rate and its horizontal axis representing the injection time period at a vertical position in association with the injection rate and a horizontal position in association with the injection time period. The operator easily understands instinctively the injection condition from the horizontal width and the position of the condition image, and since the condition image includes the injection rate as text data, the operator can check quickly the numerical values. Thus, the liquid injector can be provided which allows simple entry and review of the injection condition.

Abstract: Improved methods and devices for performing an endoscopic surgery are provided. Systems are taught for operatively treating gastrointestinal disorders endoscopically in a stable, yet dynamic operative environment, and in a minimally-invasive manner. Such systems include, for example, an endoscopic surgical suite. The surgical suite can have a reversibly-expandable retractor that expands to provide a stable, operative environment within a subject. The expansion can be asymmetric around a stabilizer subsystem to maximize space for a tool and an endoscope to each be maneuvered independently to visualize a target tissue and treat the target tissue from outside the patient in a minimally invasive manner.

Abstract: The present invention provides a pseudo-tissue for accuracy control comprising a nucleic acid or cells, a holding body for holding the nucleic acid or cells, and a protecting body for covering at least a part of the surface of the holding body so as to protect the holding body. A method for controlling accuracy by using the pseudo-tissue, and a method for manufacturing the pseudo-tissue are also disclosed.

Abstract: The invention relates to a method for the amplification of DNA and apparatus for such amplification. The method comprises steps typically found in amplification methods but utilizes an optical procedure to detect denaturation of DNA or attainment of the desired denaturation temperature. The apparatus (1) comprises a temperature controllable chamber (2) including a rotor (3) for holding a plurality of reaction vessels (see 7 for example) for reaction mixtures including DNA, a drive means for the rotor, a heater (8) within the chamber for transiently supplying infrared energy to the reaction vessels, and an optical system (12-16) for determining denaturation of at least a reference DNA or for detecting attainment of a desired denaturation temperature in at least a reference reaction vessel.

Abstract: An implantable lumen filter (100) is described. The implantable lumen filter includes a proximal portion (103a) having a generally-tapered outer surface defined by a plurality of outer struts (106).The implantable lumen filter may also include a distal portion (103b) having a generally-tapered outer surface defined by a plurality of outer struts (106b) coupled together at the distal end (102b) of the distal portion. The implantable lumen filter may also include an apex (105) comprising the connection between the proximal and distal portions. The apex may define an outer dimension of the implantable lumen filter. The outer surface of the proximal portion is dimensioned to direct particulates towards the outer dimension.

Abstract: A device, system, and method for providing access to, and sealing of, a body organ includes an implant device. An implant device has a main body having an internal access lumen, with a plurality of prongs extending from a distal end of the main body. The main body can include two lumens, one slidable within the other, to form a single continuous lumen with an adjustable length. The main body has an expanded configuration with an expanded diameter, and an unexpanded configuration with an unexpanded diameter. The prongs have a generally straight configuration where they extend distally of the distal end of the main body, and a bent configuration where the prongs bend around so that their tips extend proximally of the distal end of the main body. The device may include a hemostatic barrier to prevent fluid leakage therethrough when the main body is in the unexpanded configuration.

Abstract: The present invention relates to topical compositions containing choline alfoscerate for use in maintaining and restoring the integrity of the mucous membranes.

Abstract: An improved elastomeric pump for an infusion assembly. The pump includes a generally cylindrical mandrel body with first end, an opposed second end, a length, an outer diameter corresponding to a first radius (Rmandrel), a central bore extending through the length, a first port extending from the outer diameter to the bore to provide a fluid passageway, a fill port and an exit port in fluid communication with the bore. The pump includes an inflatable elastomeric tube disposed concentrically about the mandrel, the tube being sealingly secured on the mandrel near the respective ends of the tube and having an original inner diameter that corresponds to a second radius (r) so that it approximately matches the outer diameter of the mandrel (Rmandrel), a length (L) less than the length of the mandrel, a wall thickness (t) such that: (0.4225×r)<t?(0.660×r).

Abstract: A vaccination system for delivering a vaccine substance to avian pullets is provided. Such a system includes a vaccine delivery assembly configured to perform a vaccine delivery procedure for delivering a vaccine substance to the avian pullets. A plurality of positioning devices is provided, with each positioning device receiving an avian pullet for presentation to the vaccine delivery assembly. Each positioning device is transported to individually mate with the vaccine delivery assembly to deliver the vaccine substance during the vaccine delivery procedure. Associated methods, devices, and assemblies are also provided.

Abstract: A flow control system may include an inner nosecone having an inner nosecone distal end and an inner nosecone proximal end, an outer nosecone having an outer nosecone distal end and an outer nosecone proximal end, an aperture of the outer nosecone, a gasket having a gasket distal end and a gasket proximal end, a gasket aperture of the gasket, a gasket seal of the gasket, a flow control mechanism having a flow control mechanism distal end and a flow control mechanism proximal end, and a control aperture of the flow control mechanism. A rotation of the flow control mechanism about the gasket may be configured to decrease an aspiration flow rate. A rotation of the flow control mechanism about the gasket may be configured to increase an aspiration flow rate.

Abstract: The invention provides compositions and methods for the treatment and/or reversal of an edema, e.g., including a central nervous system (CNS) edema, e.g., a brain or a spinal edema, edema in a burned or an injured tissue such as skin, or any tissue edema. In alternative embodiments, the invention provides compositions and methods for a direct treatment and reversal of an edema, e.g., CNS, brain or spinal edema, including a membrane transport device, in vitro and in vivo characterization of edema, and the sensitive early optical detection of the edema, e.g., tissue, CNS or cerebral edema.

Abstract: In one aspect, the present disclosure is directed to a method for treating a bladder within a body of a subject, including inserting one or more heaters into the bladder wall of a subject, and selectively heating the one or more heaters by a remote device.

Abstract: The disclosed medical dressing includes multiple adhesives. A first adhesive can strongly secure to the medical device, while a gentle adhesive secures to skin. Therefore, the medical device is secure, while the skin is in contact with a gentle adhesive. Selection of the adhesive, as well as the positioning of the adhesive on the medical dressing disclosed result in a medical dressing that effectively secures a medical device to a patient, while gently securing to skin.

Abstract: Described are devices and methods related to the needleless injection of fluid into tissue of the lower urinary tract, such as the urethra and prostate.

Abstract: A method for delivering permeant substances transdermally into a membrane of an animal includes forming at least one delivery opening in the skin tissue, with the at least one delivery opening having a mean opening depth of between about 40 and about 90 microns.

Abstract: Systems and methods are disclosed herein that generally involve CED devices with various features for reducing or preventing backflow. In some embodiments, CED devices include a tissue-receiving space disposed proximal to a distal fluid outlet. Tissue can be compressed into or pinched/pinned by the tissue-receiving space as the device is inserted into a target region of a patient, thereby forming a seal that reduces or prevents proximal backflow of fluid ejected from the outlet beyond the tissue-receiving space. In some embodiments, CED devices include a bullet-shaped nose proximal to a distal fluid outlet. The bullet-shaped nose forms a good seal with surrounding tissue and helps reduce or prevent backflow of infused fluid.

Abstract: Devices, systems, and techniques for transitioning between different drug delivery sources or different drug concentrations may account for diffusion and mixing of drug within the fluid. In one example, a method may include determining a flow rate for a fluid to be delivered to a patient via a drug pump and a catheter in fluid communication with a reservoir of the drug pump. The fluid includes a drug. The method also includes determining a concentration profile of the drug delivered via the catheter, wherein the concentration profile identifies a volume of delivered fluid needed to achieve a target transition dose of the drug. The method further includes determining, by a processor and based on the flow rate and the concentration profile, an initial delivery period required to achieve the target transition dose by delivering the fluid at the flow rate.

Abstract: An implantable device includes at least one solid structure having an external surface and a volume beneath the surface. One or more of a first conductor or set of conductors is disposed externally and/or internally on or within the structure and an array of elongate electrically conductive elements are disposed radially outwardly within the volume. A breach is detected when a conductive fluid intrudes into the volume through the surface.

Abstract: An apparatus and method are disclosed for providing a continuous and controlled flow of a fluid and/or gas or combination of them when using an irrigation system; said system comprises: a reservoir system comprising a plurality of containers of fluid; said containers in said reservoir system are disposed in a predetermined configuration; a fluid transfer system in fluid connection with said reservoir system, said fluid transfer system comprising: at least one fluid transfer head, adapted to transfer fluid from one of said plurality of containers to an external tubing system; wherein each of said fluid transfer heads is characterized by a mechanism adapted to radially or linearly move each of said fluid transfer heads.

Abstract: A method and system for improved storage of suction catheters are disclosed. The new method and system result in a new suction catheter that has been removed from its packaging prior to use or a used suction catheter being stored in a way that eliminates or reduces the opportunity for cross contamination. The holder also disinfects the suction catheter while it is being stored, thus reducing or eliminating the opportunity for disease or antigens that may be on the new or used suction catheter to infect or reinfect the patient or other individual.

Abstract: Devices and methods are provided for fluid delivery. The device may include a housing having an outer surface which includes a porous membrane, a fluid reservoir disposed in the interior region of the main housing and formed at least in part by a wall structure, a puncture mechanism operable to puncture the wall structure and form a fluidic path between the fluid reservoir and one or more channels in fluid communication with the porous membrane, and a positive displacement mechanism operable, following puncture of the wall structure, to drive a fluid out of the fluid reservoir, through the one or more channels, and into the porous membrane.

Abstract: An atraumatic guidewire kit and method including a guidewire having a soft tip of increased diameter that spreads any force placed on tissue over an increased area resulting in reduced trauma to the tissue.

Abstract: Disclosed are various embodiments of medical line securing devices and methods of using the medical line securing device. According to various embodiments, the medical line securing device comprises a bandage that comprises at least one releasable locking device configured to detachably attach to at least one intravenous extension tube. In one embodiment, the intravenous extension tube may be coupled to a source intravenous line on one end and an access device on the other end. The releasable locking device may be configured to detach the intravenous extension tube when a pre-defined force is exerted on the intravenous extension tube.

Abstract: In some examples, a method including wirelessly communicating, using an external medical device, with an implantable medical device via a telemetry head device, wherein the telemetry head device includes a power source configured to supply operational power to the telemetry head device; determining a first power level of the power source while the external medical device wirelessly communicates with the implantable medical device via the telemetry head device; suspending wireless communication between the implantable medical device and the external medical device based on the determined first power level. The wireless communication may be resumed, e.g., at the point communication was suspended, upon determining that the power level of the power source has been increased after the communication was suspended.

Abstract: An improved safety occluder and method of use provides an occluder for an infusion set having a first, occluding position, a second, non-occluding position which returns to the first, occluding position when the occluder's plunger is released, and a third, non-occluding position which retains the plunger in a configuration which allows fluid flow through the infusion set. The occluder may also include a locking mechanism to prevent accidental movement of the plunger out of the first, occluding position.

Abstract: A hub assembly and methods of attaching the same to a catheter shaft. The hub assembly includes a strain relief coupled to a hub. The strain relief may be mechanically coupled to the hub. The hub assembly may be manufactured in a non-clean room environment, and subsequently connected to the catheter shaft in a clean room.

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

Abstract: A magnetic delivery system for delivering a magnetizable particle to a location in a body, the device includes a magnetizable object implanted in the body, wherein the magnetizable object includes a plurality of segments distributed throughout the magnetizable object and wherein the segments are configured to provide a magnetic gradient for attracting the magnetizable particle and an external source of a magnetic field capable of (i) magnetizing the magnetizable particle and (ii) increasing a degree of magnetization of the magnetizable object and thereby creating the magnetic gradient. A drug delivery system including the magnetic delivery system and a magnetizable particle associated with a therapeutic agent and/or a cell. A cell delivery system based on the magnetic delivery system and a magnetizable particle associated with a cell. A method of using the magnetic delivery system for delivery of a therapeutic agent and/or a cell to a targeted location in a body.

Abstract: An apparatus, systems, and methods related to determining an identity and a concentration of an intravenous fluid. The apparatus, the systems, and the methods described herein may provide near real-time monitoring and/or determination of an identity of components of the intravenous fluid. A concentration and the identity of all of the components of the intravenous fluid may be identified simultaneously.

Abstract: A method and apparatus for manipulating a surgical guidewire. The apparatus comprises a chuck for selectively coupling motive force to a surgical guidewire and an actuator, coupled to the chuck, for imparting an axial motive force to the chuck. Embodiments of the invention further comprise a method of using the apparatus.

Abstract: This invention is related to the use of polyurethane-based polymer as a drug delivery device to deliver biologically active compounds at a constant rate for an extended period of time and methods of manufactures thereof. The device is very biocompatible and biostable, and is useful as an implant in patients (humans and animals) for the delivery of appropriate bioactive substances to tissues or organs.

Abstract: Methods for producing a composite bone graft material that can regenerate bony defects in the body are provided. Also, methods, kits and delivery systems for a minimally invasive delivery of a composition for regenerating bone at or near the site of a bony defect that include, the composition for regenerating bone comprising collagen and bioactive glass are provided.

Abstract: An apparatus comprising a controller. The controller includes an input/output (I/O) module and a rule module. The I/O module is configured to present a question for a patient when communicatively coupled to a user interface and receive patient information in response to the question via the user interface. The rule module is configured to apply a rule to the patient information and generate a suggested insulin pump setting from application of the rule. Other devices, systems, and methods are disclosed.

Abstract: A method of conducting biological materials to soft tissue. The method includes loading a conduit device onto a delivery shaft of an inserter, inserting at least a portion of the delivery shaft into soft tissue, expelling the conduit device from the delivery shaft into the tissue, and delivering biological material through an access port of the inserter into at least one outer longitudinal channel of the conduit device.

Abstract: A dispensing device and the method of making same for dispensing medicaments to a patient that includes a housing, a first assembly connected to the first end of the housing that includes a body portion, and a penetrating sub-assembly. The first assembly also includes a rate control chip of novel construction that is connected to the penetrating sub-assembly and functions to control the rate of flow of medicinal fluid to the patient. Disposed within the housing is a second assembly that includes a shuttle, a collapsible container carried by the shuttle and a plurality of variable force springs that function to thrust the collapsible container into penetrating engagement with the penetrating member of the penetrating assembly and then to collapse the collapsible container to deliver the medicinal fluid to the patient. Connected to the second end of the housing is a novel third assembly that includes an operating member that functions to controllably move the shuttle forwardly of the housing.

Abstract: A needleless injector including a body at a proximal end, a shaft extending distally from the body, at least one injection orifice at a distal end of the shaft in fluid communication with a fluid chamber at the proximal end, a pressure source in communication with the fluid chamber, and a tissue tensioner located at the distal end of the shaft proximal to the injection orifice, wherein the distal end including the tissue tensioner and injection orifice is positionable within a urethral lumen so that when the tissue tensioner is deployed, tissue of the urethra is tensioned at a location for injection of fluid from the injection orifice into the tissue of the urethra.