Abstract: A fibrin sealant comprises a mixture of first microparticles that comprise fibrinogen, second microparticles that comprise thrombin, and additive material. The additive material may be particulate, and may be, for instance, a biocompatible, water-absorbent, material, a biocompatible, water-swellable material, a biocompatible, water-insoluble material, a polysaccharide or silica.

Abstract: The present invention relates to A bioresorbable implant comprising: a bioresorbable porous layer including a biopolymer foam and defining first pores, a bioresorbable porous three-dimensional mesh made from a microbial cellulose and defining second pores, wherein the bioresorbable porous layer is disposed in the bioresorbable porous three-dimensional mesh. The invention also relates to a method of making a bioresorbable implant.

Abstract: Methods for treating a cardiovascular disorder comprising concomitant administration of one or more extracellular matrix (ECM) based compositions directly to damaged or diseased cardiovascular tissue associated with the cardiovascular disorder, and provision of ventricular assistance. In a preferred embodiment, the ECM based compositions include an ECM material derived from a mammalian source.

Abstract: Unitary surgical devices are disclosed. Such devices may include an elongated body extending between a proximal end and a distal end, and having one or more lumens extending through the elongated body and a tip disposed at the distal end of the elongated body. The harvesting device may further include a first gripping element disposed about the dissection tip and a second gripping element disposed about the dissection tip distally of the first gripping member. The second gripping member may be moveable with respect to the first gripping member for capturing a blood vessel between the first gripping member and the second gripping member. The blood vessel captured between first gripping member and the second gripping member may then be sealed and, subsequently, severed by a cauterizing element disposed between the first gripping member and the second gripping member.

Abstract: Embodiments include a method for promoting selective tissue attachment to medical implants. By treating implant surfaces where tissue attachment is desired with tissue attachment promoting treatments, and treating implant surfaces where tissue attachment is not desired with tissue attachment inhibiting treatments, selective tissue attachment to medical implants may be achieved. Also, embodiments include an implant with at least one tissue contacting surface and at least one secondary surface where tissue attachment is not desired, and appropriate tissue attachment promoting or inhibiting treatments on the surfaces.

Abstract: The present invention is directed to absorbable microspheres comprising a copolymer formed from greater than 88 to about 99 mole percent ?-caprolactone or p-dioxanone, and about 1 to less than 12 mole percent of a different second monomer selected from the group consisting of glycolide, p-dioxanone, trimethylene carbonate and the lactides and combinations thereof, said microspheres having a particle size ranging from about 5 to 2,000 microns. Also described herein are a method for making such microspheres and formulations comprising such absorbable microspheres.

Abstract: The object of the present invention is to provide a calcium phosphate-collagen fiber composite which has an excellent mechanical property, can induce bone replacement by rapid bone remodeling, and can be used in a high-load region. The object can be solved by a porous composite comprising a calcium phosphate crystal and a collagen fiber at a weight ratio of 80:20 to 20:80, wherein (1) a bioabsorbability of the porous composite is graded, and (2) the density of the porous composite determined by gravimetric method is 300 to 1500 mg/cm3.

Abstract: Guide wire devices fabricated from a linear pseudo-elastic Ni—Ti alloy and methods for their manufacture. The Ni—Ti alloy that includes nickel, titanium, and about 3 atomic % (at %) to about 30 at % niobium (Nb). Cold working the Ni—Ti alloy stabilizes the alloy's martensitic phase and yields a linear pseudo-elastic microstructure where reversion to the austenite phase is retarded or altogether blocked. The martensitic phase of cold worked, linear pseudo-elastic Ni—Ti—Nb alloy has an elastic modulus that is considerably higher than the comparable cold worked, linear pseudoelastic binary Ni—Ti alloy. This yields a guide wire device that has better torque response and steerability as compared to cold worked, linear pseudoelastic binary Ni—Ti alloy or superelastic binary Ni—Ti alloy.

Abstract: The disclosure provides biodegradable implantable devices such as a stent comprising a biodegradable polymeric wherein the polymeric material is treated to control crystallinity and/or Tg. The stent is capable to expand at body temperature in a body lumen from a crimped configuration to a deployed diameter and have sufficient strength to support a body lumen.

Abstract: In-vivo biodegradable medical implants, containing at least in part at least partially fine-grained metallic materials that are strong, tough, stiff and lightweight, are disclosed The in-vivo biodegradable implants are used in a number of stent applications, for fracture fixation, sutures and the like. The in-vivo biodegradable medical implants enable the reduction of implant size and weight and consequently result in reducing the release of implant degradation products into the body.

Abstract: A digitally controlled aspirator is provided with a processor that allows the user to select operating conditions including one or more default settings. The processor further includes sensors for sensing operational and environmental conditions and adjusts the operation of the aspirator to reflect the sensed conditions.

Abstract: The various embodiments herein relate to systems and methods for controlling the operation of a pulsatile heart assist device in a patient. The systems and methods include utilizing sounds and electrical signals produced by the heart to control the operation of the heart assist device.

Abstract: An IV holder includes a base for supporting the IV holder on a floor. A first end of a post extends from the base and a distal second end area of the post has an IV bag hook. The IV bag hook is positioned substantially over a center of gravity of the IV holder when the base is positioned on the floor. The post has an offset area so that the post doesn't interfere with an IV bag suspended from the IV bag hook.

Abstract: A holographic occlusion detection system has a holographic label placed onto a sensing portion of a pressure sensor connected to infusion tubing. The sensor at the sensing portion can have a relatively thin wall section and may be wider and flatter than a normal cross section of the tubing. The label is then illuminated by a polychromatic light source, and the light reflected off the holographic label is then received by a photodetector. Pressure changes within the tubing cause a change in orientation of the holographic label, thereby resulting in a shift in the peak wavelength of the light sensed by the photodetector. This wavelength shift can then be calibrated to the swelling of the sensing portion so that pressure within the line can be calculated. In another variation, monochromatic light is reflected off a holographic label, and pressure changes are detected by measuring the amplitude of the reflected light.

Abstract: A dosing unit for an ambulatory infusion device and a method of operation are disclosed. The dosing unit includes a stationary member, a movable member, and a plunger. The movable member and the stationary member, together, make a charging valve and a discharging valve. The plunger is located, at least in part, in a metering cavity of the movable member and the movable member is adapted to selectively couple and decouple a driving unit, such that, by operating the driving unit with the movable member being coupled with the driving unit, the movable member moves with the plunger to maintain a position of the plunger relative to the movable member along a displacement axis, and by operating the driving unit with the movable member being decoupled from the driving unit, the plunger is displaced while the position of the movable member is maintained.

Abstract: A system for controlling pressurized infusion and temperature of intravenous fluids according to the present invention includes a housing, a heating assembly and a flexible cover. The heating assembly is recessed within the housing and includes a generally U-shaped configuration to surround and uniformly heat fluid within a fluid container placed thereon. The cover wraps around a portion of the fluid container to secure the fluid container against the heating assembly. The cover includes a pressurization member to apply a desired pressure to the fluid container to achieve a desired flow rate of intravenous fluid from the fluid container to an infusion site on a patient. The system further includes a controller to control the heating assembly and pressure within the pressurization member in accordance with desired temperature and pressure information entered into the controller for system operation.

Abstract: An automated insertion assembly includes a first dermal perforation assembly configured to releasably engage a first subdermal device. A first actuation assembly is configured to drive the first dermal perforation assembly into a user's skin to a first depth and drive the first subdermal device into the user's skin to a second depth. The second depth is greater than the first depth.

Abstract: A method is disclosed for priming a kit for use in a therapeutic apheresis procedure with previously-collected blood prior to flowing the patient's whole blood into the inlet line of the kit, as part of a procedure in which a selected blood component is separated from a patient's whole blood, and replaced with a previously-collected blood component. The operator enters into the controller of the separation device the hematocrit value of the previously-collected blood. Then, in response to prompts by the controller, the operator enters a target hematocrit value for the previously-collected blood and an identification of the portion of the kit to be primed. The identified portion of the kit is automatically primed with the previously-collected blood. The patient is then connected to the inlet line of the kit in response to a prompt from the controller and the therapeutic procedure is commenced.

Abstract: There is provided an infusion pump system for delivering a predetermined medical solution at a preset reference infusion speed. The system comprises a medical solution container; an infusion line through which the medical solution is drawn out of the medical solution container; an infusion pump configured to discharge the medical solution via the infusion line. The infusion pump is controlled so that the discharge speed of the infusion pump is computed on the basis of a current discharge speed of the infusion pump and the infusion speed of the medical solution, the resulting discharge speed is corrected by a predefined correction coefficient, and the medical solution is discharged at the corrected discharge speed.

Abstract: A device for detecting moisture for use with a device for monitoring an access to a patient for an extracorporeal blood treatment apparatus is described. The device for detecting moisture is constituted as a two-dimensionally extending fabric to be placed on the patient's skin, having an electrically conductive structure as a moisture sensor and constituted by non-conductive and conductive warp and weft threads configured to produce in the woven fabric a defined electrically conductive structure through spatial separation of the warp and weft threads. By the use of conductive warp and weft threads, an electrically conductive structure can be constituted having sections running in different directions, thereby creating a moisture sensor exhibiting a particularly high degree of sensitivity. The electrically conductive structure is preferably terminated with a terminating resistor, preferably not a component part but rather part of a connection part of the device, so that production is simplified.

Abstract: A system and method for adjusting insulin infusion volume based on air in an infusion set tube includes inputting at least one location and length of an air bubble along the infusion set tube. An air bubble volume is determined in the infusion set tube. An insulin infusion volume is determined based on a desired insulin infusion. A determination is then made whether the desired insulin infusion would include the air bubble volume based on the inputted location and length of the air bubble. The air bubble volume is added to the insulin infusion volume to make an adjusted insulin infusion volume if the insulin infusion volume includes the air bubble.

Abstract: The subject matter disclosed herein provides a response to a dose of a substance and/or controls the administration of the dose. In one aspect, there is provided a system. The system may include a processor and at least one memory configured to provide a response determinator. The response determinator may receive therapeutic and wellness data. Moreover, the response determinator may determine a response based on the received therapeutic and wellness data. The response may represent a reaction to a substance integrated with an ingestible event marker. The determined response may be provided to, for example, a therapy controller. Related systems, methods, and articles of manufacture are also described.

Abstract: A syringe assembly having an exterior surface and defining a chamber having a stopper disposed therein is disclosed. The syringe assembly includes a plunger assembly having an elongated plunger rod and a handle portion connected thereto, the plunger rod including a depending leg and at least one hinge connecting the depending leg with the handle portion. The plunger rod is adapted to transition from a collapsed position, in which at least a portion of the depending leg extends along at least a portion of the exterior surface of a syringe barrel, to an extended position in which at least a portion of the depending leg engages the stopper. The at least one hinge maintains the depending leg substantially parallel to a longitudinal axis of the syringe barrel in both the collapsed position and the extended position.

Abstract: An injection device for use with a syringe having a syringe body, a needle coupled thereto, and a plunger moveable through the body to eject medication from the syringe through the needle, includes a housing defining an inner space for holding a syringe and facilitating movement thereof from a first position in which the needle is contained fully within the housing and a second position in which the needle projects from the housing, and a drive member located within the inner space so that in use the drive member can engage the plunger of a syringe held within the housing. The device further includes a force applicator located within the inner space for providing a force to the drive member so as to move the syringe from the first to the second position and thereafter to move the plunger through the syringe body, a trigger mechanism, and a damper.

Abstract: A safety device to be used with a vial, or capsule, has a collar dimensioned to slidably fit about the body of the vial. Extending from the collar is a neck member that has connected to its other end a housing pivotable to a position along the longitudinal axis of the vial. A latch member having a lip is integrated to the neck member and extends out from the neck member in a direction towards the center of the collar. Neck member is fabricated to have an elastic characteristic so that if it is not biased by any external force, it will return to its original position. As the collar of the safety device is moved along the body of the vial, neck member is biased away from the vial as the latch member maintains contact along the outer surface of the vial, and then the outer surface of the hub formed at the top end of the vial.

Abstract: The invention relates to an apparatus for extracorporeal blood treatment, comprising a device for detecting a tubing system to be placed in the blood treatment apparatus and a method for detecting a tubing system to be placed in an extracorporeal blood treatment apparatus. The tubing system is detected on the basis of the dependency of the flow rate Q, at which the fluid is delivered by at least one pump of the extracorporeal blood treatment apparatus in a tubing section of the tubing system, on the speed n at which the at least one pump is operated, and on the inner diameter d of the tube of the tubing section. Because the dependency of the flow rate on the pump speed and the tube cross section is known, a conclusion can be drawn as to whether a particular tubing system has been placed in the extracorporeal blood treatment apparatus.

Abstract: Systems and methods for detecting developing faults in a flow generator or ventilator during therapeutic use thereof are provided. The motor current may be measured to estimate the torque input by the motor, while the output torque from the impeller may be determined (e.g., as inferred from the motor control system model and/or by consulting a lookup table). One or more transducers may collect data useful in determining the input and output torques. A difference between the input (to the motor) torque and the output (from the impeller) torque may be calculated. The difference, optionally filtered using a low-pass filter to reduce noise, may be compared to a predetermined threshold once or over a period of time to detect gross failures and/or developing failures. Once a failure or developing failure is detected, a user may be alerted and/or the flow generator may be placed into a “service required” mode.

Abstract: A dispensing device, a storage device and a method for dispensing a formulation as a spray using a gas stream. Doses of the formulation are contained in storage members, which comprise individual atomizing device. The storage members are received in cavities, which are sealed by a common outlet seal. The outlet seal is peeled individually for each cavity to open the respective storage member and its atomizing device before the respective dose is dispensed by a gas stream flowing through the storage member.

Abstract: This disclosure describes improved systems and methods for efficiently configuring respiratory settings and/or parameters in a ventilatory system. Specifically, the present methods and user interface provide an efficient and consistent means for configuring ventilatory settings for a new patient. Specifically, the ventilator may be preconfigured with appropriate parameter settings based on an institution-specific protocol, a physician-specific protocol, or other suitable protocol or specification. Indeed, the present disclosure provides an institution and/or physician with increased control over routine ventilatory settings by pre-configuring the ventilator with these routine settings. Further, the present disclosure provides increased assurance as to the consistency of the routine ventilatory settings by eliminating repeated data entry by clinicians, decreasing the chances of error.

Abstract: A subglottic suctioning system with a tracheal tube having a ventilation lumen, a cuff inflation lumen, and a suction lumen are disclosed which may help reduce the incidence of ventilator associated (or acquired) pneumonia. The suction lumen communicates with the space in the trachea above the cuff where secretions accumulate. The suction lumen has a valve on the proximal end for connection to a source of vacuum. The valve is adapted to interrupt the supply of vacuum to the suction lumen to allow for the introduction of a rinsing fluid in its place and to automatically re-establish the connection to the source of vacuum upon completion of rinsing. The rinsing fluid aids in maintaining an open suction lumen and may include medicaments and mucolytic agents to enhance or promote healing or to alter the properties of the mucus to make removal easier. The user may easily and repeatedly alternate suction and rinsing fluid through the suction lumen, i.e.

Abstract: The present invention provides an apparatus and a corresponding method for intubating a human or non-human animal patient. In some embodiments, the present invention is used in the field of anesthesia and emergency medicine. In some embodiments, the present invention provides an intubation tube that includes an integrated Blaine Bafflex System having a plurality of blaines for sealing the trachea, wherein the intubation tube is formed from a single material. In some embodiments, the shape and outer circumference of each blaine of the system is selected according to the desired use of the intubation tube (e.g., for intubating a pediatric patient or an adult patient or for intubating a small animal or a large animal). In some embodiments, the distance between successive blaines is selected such that, when the intubation tube is inserted into the patient and the blaines bend, none of the blaines overlap with their nearest neighbor.

Abstract: An apparatus for maintaining a surgical airway and method for the same includes an elongated body insertable orally into a patient. The elongated body defines leading and trailing ends. A passageway is defined through the leading and trailing ends, such that surgical equipment may be insertable through the opening of the elongated body. A securing member may be connected to the trailing end that can hold the elongated body in a position such that an airway remains open to treat the patient, while supporting oxygen flow to the patient.

Abstract: A mask with cushion that has an outer film is disclosed. The film may be self-skinning or a film formed about or glued to the cushion body. In another form the cushion may be formed with at least a portion having a plurality of adjacent voids having a honeycomb-like structure.

Abstract: The inhalation therapy device according to the invention comprises a nebulizer chamber which accommodates an aerosol generator that emits aerosol into the nebulizer chamber. A valve that has a valve seat, a resilient valve member and a valve member positioning means is arranged at an opening of the nebulizer chamber. The valve member positioning means can be moved out of a first position and into a second position so as to position the valve member on the valve seat in such a manner that in the first position, the valve member, in a flow-free state, is positioned on the valve seat in a pre-tensioned manner and in a second position, is spaced apart from the valve seat.

Abstract: A mask system has a shroud module with headgear connectors adapted to removably attach to respective headgear straps of headgear; and a cushion module, including a frame defining a breathing chamber; and a cushion to form a seal with the patient's face in a nasal bridge region, a cheek region and a lower lip/chin region of the patient's face. The cushion is constructed of a first, relatively soft, elastomeric material and the frame is constructed of a second material that is more rigid than the cushion, and a nasal bridge portion of the cushion includes one or more folds to provide in use a higher level of adaptability or flexibility to the nasal bridge region of the cushion module relative to another region of the cushion module. The shroud module and the cushion module are configured to be removably coupleable to one another.

Abstract: A delivery device (20, 22) for and a method of delivering a substance to the nasal airway (1) of a subject, in particular the posterior region of the nasal airway, the delivery device comprising: a closure unit for causing the closure of the oropharyngeal velum of the subject; and a delivery unit for delivering a gas flow entraining a substance to one of the nostrils of the subject at such a driving pressure as to flow around the posterior margin of the nasal septum and out of the other nostril of the subject, wherein the delivery unit comprises a nosepiece (30, 40, 58, 82, 102, 132) which includes an outlet through which the gas flow is in use delivered to the one nostril and a sealing member for sealing the one nostril to the outlet such as in use to prevent the escape of the gas flow through the one nostril.

Abstract: A modular respiratory system to which different parts can be added in a convenient way enabling such upgraded respiratory system to deliver the most comfortable respiratory conditions at an acceptable cost of ownership.

Abstract: A pressure relief device comprising a valve configured to resiliently deform in response to a predetermined pressure; and a sound dampener configured to dampen a sound generated by the valve when the valve resiliently deforms in response to said predetermined pressure.

Abstract: Dilators and sheaths for use in minimally invasive vascular therapy are disclosed. In some embodiments, the dilators include a slot that accesses a guidewire lumen within the dilator. These slots facilitate rapid exchange of one dilator for another. In another embodiment, a dilator is sufficiently stiff to facilitate entry, but also designed to facilitate placement of the dilator along a tortuous path.

Abstract: A catheter comprising a sheath to be inserted into a living body, wherein the sheath includes a tubular reinforcement layer of at least one layer, which is formed with a spiral slit continuous from the distal side to the proximal side thereof; a termination end of the spiral slit is provided on the proximal side of the slit proximal portion at the site of the proximal side of the spiral slit; and at the same time, there is formed a slit termination portion in which inclination angle of the spiral slit with respect to the circumferential direction of the reinforcement layer is larger than that of the slit proximal portion.

Abstract: A catheter provided with a guidewire catheter lumen having a thin covering that is easily punctured by a guidewire at virtually any desired point along the catheter length. The thin covering may be integral with the catheter shaft, or may be a separate component that covers only the portion of the catheter shaft immediately adjacent the outer portion of the guidewire lumen, or may be a thin tubular construct that surrounds the entire catheter shaft. The covering is preferably relatively translucent, allowing for good visualization of the location of the end of the guidewire to enable puncturing of the covering at the desired location along the length of the catheter shaft. The covering is also preferably tear resistant at puncture sites. The catheter shaft is preferably made of a material having a color that provides good visibility against an operating field, and more preferably is phosphorescent either entirely or in part.

Abstract: An elongate medical device having a longitudinal axis and a surface; and a continuous, helical bi-component fiber wound around at least a portion of the surface of the medical device along its longitudinal axis, wherein the bi-component fiber has a cross-section with a generally flattened side and an inner core encased in a sheath, and wherein the inner core is aligned about the medical device.

Abstract: One possible embodiment of the invention could be a hypodermic needle that rotatably connects to a shield comprising a hypodermic needle denoted into a distal needle portion and a proximal needle portion, the distal needle portion's injection aperture continuously connected to the proximal needle portion's connection aperture; a shield that comprises at least a skin pad portion, the proximal needle portion being rotatably held within a portion of the shield in a manner that allows the distal needle portion to be moved between an operative position, wherein the distal needle portion descends downward and away from a bottom of the skin pad portion to hold the needle tip away from the skin pad portion to a stored position that has the needle tip of the distal needle portion placed proximate to the skin pad portion.

Abstract: A slitter for slitting a guide catheter has a handle and a blade assembly coupled to the handle. The blade assembly includes a shroud for receiving an elongated body of a medical device and a slitting blade having an exposed cutting edge to slit the guide catheter. The blade assembly includes a user-deflectable portion coupled to the shroud for causing the shroud to flex in response to deflection of the user-deflectable portion. The handle and the blade assembly may be assembled from piece parts in a manufacturing method.

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: A guidewire manipulation device includes a housing sized to be supported by a hand of a user, the housing having a distal end and a proximal end; a rotation member rotationally disposed within the housing; a locking assembly coupled to the rotation member, the locking assembly configured to selectively transfer rotational movement of the rotation member to rotational movement of a guidewire; a handle coupled to the housing and configured to be operable by the hand of the user; and a drive system coupled to the handle, the drive system configured to apply alternating clockwise motion and counter-clockwise motion to the guidewire by causing the rotation member to rotate.

Abstract: An apparatus for applying a substance to internal mammalian tissue is provided. The apparatus includes a member having a flexible, absorbent, porous portion connected to a non-porous portion. The apparatus may be used to treat atrial fibrillation or other non-atrial fibrillation issues with internal mammalian tissue.

Abstract: A balloon catheter is provided that may be used to dilate hardened regions of a stenosis on a vessel wall. The balloon catheter is provided with cutting elements that extend along a surface of a balloon. At least one bioactive is present, either on the cutting element, within the interior of the balloon, within the material of the balloon or on an outside surface of the balloon. The bioactive is delivered to the vessel wall upon dilation of the balloon.

Abstract: A device (100) for applying a microneedle array to a skin surface. The device comprises a base (120) defining a skin contacting plane, an array component having a skin facing side comprising a microneedle array, and at least one connecting member (140) having a first portion affixed through a first hinge (142) to the base and a second portion affixed to the array component. The connecting member has a first equilibrium position with the microneedle array in a recessed position within the device and a second equilibrium position with the microneedle array positioned so as to be able to contact a skin surface.

Abstract: An applicator assembly includes a head portion having a proximal end, a distal end, and an interior portion defining a fluid chamber; a container for containing an antiseptic solution coupled to and in fluid communication with the proximal end of the head portion; and an application member in fluid communication with the fluid chamber and comprising a foam, having a first foam layer adjacent a second foam layer, wherein the first foam layer is disposed toward the distal end of the head portion and comprises a dye impregnated therein, and the second foam layer is disposed away from the distal end of the head portion and is free from the dye, and wherein, after the antiseptic solution passes from the container through the fluid chamber, the antiseptic solution passes into the first foam layer, whereupon the dye is solubilized by and tints the antiseptic solution.