Abstract: Intervertebral discs are avascular. Oxygen, nutrients and bicarbonate diffuse from capillaries in cartilaginous endplates into discs to feed and maintain disc cells. As we age, calcified layers form at the endplates, blocking and occluding capillaries. Diffusion zones of oxygen and nutrients in disc become shallow. Cells in mid-layer of the disc suffer chronic anaerobic and starving conditions. Lactic acid is produced. Disc cells die from starvation, causing disc degeneration and forming fissures in annulus. Lactic acid leaks from fissures to the outer annulus of the disc to cause irritation, inflammation and persistent pain. Spirals of filament are implanted into the painful and degenerating disc to draw oxygen, nutrients and bicarbonate from the shallow diffusion zones of the cartilaginous endplates into the mid-layer of the degenerating disc.

Abstract: The present disclosure relates to drug eluting devices, and their uses. The drug eluting devices can allow for perfusion during deployment. The coatings the may contain bioactive materials which elute once deployed in a patient and can have anti-proliferative, anti-inflammation, or anti-thrombotic effects. Sol gel technology can be used to coat the devices.

Abstract: Electromechanical substance delivery devices are provided which implement low-power electromechanical release mechanisms for controlled delivery of substances such as drugs and medication. For example, an electromechanical device includes a substrate having a cavity formed in a surface of the substrate, a membrane disposed on the surface of the substrate covering an opening of the cavity, and a seal disposed between the membrane and the surface of the substrate. The seal surrounds the opening of the cavity, and the seal and membrane are configured to enclose the cavity and retain a substance within the cavity. An electrode structure is configured to locally heat a portion of the membrane in response to a control voltage applied to the electrode structure, and create a stress that causes a rupture in the locally heated portion of the membrane to release the substance from within the cavity.

Abstract: An ambulatory infusion pump can include a maximum bolus override procedure. When a bolus amount greater than a maximum bolus amount is requested, the pump can provide an alert indicating that the amount requested exceeds the maximum bolus amount. If the user confirms the request in response to the alert, the bolus amount can be delivered to the user. The amount delivered in response to the confirmation can be a first portion of the bolus amount. A reminder can then be provided that a second portion of the bolus amount that is a remaining portion of the requested bolus amount was also requested. If a second confirmation is received in response to the alert, the second portion of the bolus amount can also delivered to the user.

Abstract: A safety needle device comprising a body piece including a rear end connected to a cannula and a front end having a needle for connecting to a patient, a sliding gap at the front end of the body piece, a lock button at a rear end of the body piece, a sliding piece adopting a locked position wherein the sliding piece is folded and locked onto the body piece and a sliding position wherein the sliding piece is unfolded and unlocked from the body piece; retaining flaps at a bottom of the sliding piece for receiving the fingers of a hand of a user when the needle device must be disconnected from the patient, and locking parts in the sliding piece to lock the sliding piece and the body piece in a position wherein the needle is removed from the patient and protected by walls of the sliding piece.

Abstract: Described herein are methods for implanting cells into a host comprising the steps of implanting into the host a device comprising a cell encapsulation chamber with at least one seal, allowing the device to vascularize, and loading the device with a human embryonic stem (hES) cell-derived pancreatic progenitor cell population.

Abstract: The invention provides an implantable component which is connectable to a manipulating device in a self-retaining manner by means of a coupling device, which provides a first coupling element and a second coupling element. The implantable component can thus be really positioned by the manipulating device which can, for example, already be connected to the implantable component before a therapeutic procedure and can be separated therefrom again after the surgical procedure. This is in particular advantageous with minimally invasive procedures.

Abstract: A stent retriever assembly having a proximal end and a distal end, and including a mesh tube having a distal and proximal end, and being connected to a first wire. Also, a blood-porous fragment guard is at the distal end of the mesh tube, the fragment guard including spokes joined at a central hub and extending radially and proximally from the central hub, and wherein a second wire is connected to the central hub so that when the second wire is pulled proximally relative to the first wire, the hub is pulled proximally, causing the spokes to spread out and causing the fragment guard to widen.

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: A surgical apparatus for positioning within a tissue tract accessing an underlying body cavity is adapted to articulate instruments inserted therein. The surgical apparatus includes an anchor member configured to form a sealing relation with a tissue, a balloon member and a plurality of articulating arms extending distally from the anchor member. Inflating and/or deflating the balloon member effectuate articulation of the articulating arms.

Abstract: Interventional procedures on the carotid arteries are performed through a transcervical access while retrograde blood flow is established from the internal carotid artery to a venous or external location. A system for use in accessing and treating a carotid artery includes an arterial access device, a shunt fluidly connected to the arterial access device, and a flow control assembly coupled to the shunt and adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state. The flow control assembly includes one or more components that interact with the blood flow through the shunt.

Abstract: The invention provides a method for alleviating discogenic pain by administering a therapeutic agent that disrupts neuronal and/or vascular elements in the disc, which is typically a degenerated disc. Disruption of neuronal elements in the disk includes destroying nerve endings without substantially affecting the central body of the nerve, suppressing activation of the nerve endings, and inhibiting the growth of nerve endings into the disk. Disruption of vascular elements includes causing the vascular extensions to retract from the disk, or suppressing the formation of such extensions. The therapeutic agent may be administered locally via an interbody pump, a bolus or a depot, or may be administered systemically.

Abstract: The present invention relates to methods for encapsulating pancreatic progenitors in a biocompatible semi-permeable encapsulating device. The present invention also relates to production of human insulin in a mammal in response to glucose stimulation.

Abstract: A supplemental device for use with an injection device, the supplemental device comprising: a plurality of light sources each being configured to illuminate a surface portion of an injection device, in use, with light of a different wavelength; at least one sensor for generating sensor outputs indicative of the respective intensities of light of different wavelengths reflected from the surface portion; and a processor for: controlling the plurality of light sources to illuminate the surface portion with light of first to third different wavelengths; obtaining first to third values for sensor outputs corresponding to the first to third different wavelengths respectively; performing one or more calculations using at least the first and second values to provide one or more further values; and using the third value and the or each further value, but not the first and second values, to determine a property of the injection device.

Abstract: Two part laparoscopic tools and surgical methods using such tools are presented. The tools and methods enable use of multiple surgical tools each having wide tool heads to be used in a body cavity using a single wide trocar and one or more narrow incisions, thereby reducing surgical risk and enhancing patient comfort and shortening recovery time. Additional instruments for facilitating laparoscopic surgery are also presented.

Abstract: An embolus trap device is provided. The embolus trap device consists of an outer catheter, an inner catheter, a plurality of filter baskets, and a plurality of basket collapse wires. The filter baskets are of different radius and are positioned along the inner catheter in order of increasing radius from the proximal to the distal end. The filter baskets increase in radius so that any embolic fragment that flows past each basket has a chance to be caught and secured by a filter basket distal to it. The filter baskets are separately collapsible by the plurality of collapse wires and are collapsed in proximal-to-distal fashion with the largest basket being closed last in order to capture embolic fragments that may emerge from the smaller baskets because of disruptions as they are closed.

Abstract: An automatic process of predictive determination of the position and movements of the skin of a subject in a zone of interest, with the subject breathing freely or in an assisted manner, includes preliminarily acquiring multiple configurations of the skin profile in axial planes, at given successive times, in different respiratory positions, and for each axial plane, constructing at least one deformable digital model starting from different skin profiles, then noting, in a repetitive manner, the actual position of a point on the skin at the level of each axial plane, whose position is significantly modified during inhalation and exhalation phases, and providing, essentially in real time, a simulation of the skin profile in each axial plane, as a function of the actual position noted, and an evolving three-dimensional representation of the skin at the level of the zone of interest, by interpolation between the different axial planes.

Abstract: A medical device including a medical device body that includes a first support structure, the medical device further comprising a first fixation anchor that includes a first anchor body extending between a first end and an opposing second end, and a hook portion extending from the first end, wherein the first anchor body engages the first support structure, and wherein the first fixation anchor is fabricated separate and apart from the medical device body. A method of making a medical device is disclosed.

Abstract: Apparatus and methods for treating conditions such as rhinitis are disclosed herein where a distal end of a probe shaft is introduced through the nasal cavity where the distal end has an end effector with a first configuration having a low-profile which is shaped to manipulate tissue within the nasal cavity. The distal end may be positioned into proximity of a tissue region having a post nasal nerve associated with a middle or inferior nasal turbinate. Once suitably positioned, the distal end may be reconfigured from the first configuration to a second configuration which is shaped to contact and follow the tissue region and the post nasal nerve may then be ablated via the distal end. Ablation may be performed using various mechanisms, such as cryotherapy, and optionally under direct visualization.

Abstract: The Body Cavity Cancer Treatment System achieves extremely uniform temperatures inside the tissue of the body cavity thereby realizing optimal efficacy in enhancing operation of the chemotherapy agent while avoiding harm or pain to the patient. This is accomplished by the inclusion of “target particles”, such as nano-particles, into the body cavity along with the chemotherapy agent to enable the use of an externally generated energy field to cause heating of the chemotherapy agent and the surrounding tissue of the body cavity by the activation of the nano-particles. The proper selection of the applied energy field enables precise control of the heat generated by the movement of the nano-particles.

Abstract: The invention relates to a valve prosthesis for replacing an atrioventricular valve of the heart, comprising an annular body, to which heart valve leaflets are attached and which can be inserted in the valve annulus of the heart, and further comprising at least one anchoring part, which protrudes from the annular body on the ventricle side and can be anchored in tissue.

Abstract: A method including percutaneously positioning a delivery device in a blood vessel; locally introducing a treatment agent from the delivery device into the blood vessel upstream of an infarcted area or distressed area; and following introducing the treatment agent, occluding the blood vessel for a dwell time sufficient to allow the treatment agent to flow into targeted capillaries in or adjacent to the infarcted area. A system comprising a delivery device suitable for percutaneous insertion into a blood vessel of a patient, the delivery device comprising an occluding portion and a delivery cannula having a lumen therethrough; a controller coupled to a proximal portion of the delivery device comprising instruction logic to perform a method including introducing a treatment agent into the delivery cannula; and occluding a blood vessel following a predetermined delay time after introducing the treatment agent.

Abstract: Methods, system and apparatus for relieving pressure in an organ such as, but not limited to, the eye are disclosed. The method includes implanting a bioabsorbable channel into the selected area of the organ using a delivery apparatus.

Abstract: A method for treating arthritis of a joint includes identifying a bone lesion in a bone adjacent to the joint; and implanting in the bone a reinforcing member in or adjacent to the bone lesion. A kit for conducting the method includes: (a) at least one reinforcing member having a proximal face adapted to face the joint, a distal face adapted to face away from the joint, and a wedge-shaped edge adapted to pierce bone, wherein the at least one reinforcing member is planar and sterile; and (b) a container adapted to maintain the at least one reinforcing member sterile. Another kit includes: (a) a sterile fluid; (b) a syringe for injecting the fluid into a bone; (c) a curing agent adapted to cure the fluid to polymerize and/or cross-link; and (d) a container adapted to maintain the sterility of contents of the container.

Abstract: This disclosure relates to diagnostic testing for subjects with or at risk of dementia and methods related thereto. In certain embodiments, the disclosure relates to methods of diagnosing a frontotemporal lobar degeneration subtype comprising measuring total Tau and Tau phosphorylated at threonine 181 in a sample from a subject, calculating a ratio of Tau phosphorylated at threonine 181 to total Tau, and making a diagnosis of the subtype based on said ratios. Typically, the sample is of cerebrospinal fluid and the frontotemporal lobar degeneration subtypes are selected from frontotemporal lobar degeneration with immunoreactive lesions to Tau and frontotemporal lobar degeneration with immunoreactive lesions to TAR DNA binding protein of 43 kD.

Abstract: A system and method are provided for assessing the compliance of internal patient tissue for purposes of catheter guidance and/or ablation procedures. Specifically, the system/method provides for probing internal patient tissue in order to obtain force and/or tissue displacement measurements. These measurements are utilized to generate an indication of tissue elasticity. In one exemplary embodiment, the indication of elasticity is correlated with an image of the internal tissue area and an output of this image including elasticity indications is displayed for a user.

Abstract: A drive mechanism for a drug delivery device is presented that can be switched between a normal operation mode and a reset mode. A piston rod is displaced in a distal direction to deliver a dose in a normal operation mode and is displaced in the proximal direction in a reset mode. The drive mechanism also has a drive member that is rotationally moveable with respect to the housing, wherein in the normal operation mode, the drive member is coupled with the piston rod so that rotational movement of the drive member in the rotation direction with respect to the housing is converted into movement of the piston rod in the distal direction with respect to the housing, and wherein, in the reset mode, the piston rod is decoupled from the drive member.

Abstract: A closure element applying medical device for repairing a fistula is described. The closure element applying medical device can be configured for repairing any type of fistula that provides an abnormal channel from one body part to another body part (e.g., organ to organ, organ to vessel, and/or vessel to vessel). Examples of fistulas that can be repaired with the present invention include anorectal fistulas, enteroenteral fistulas, enterocutaneous fistulas, vesicovaginal fistulas, arteriovenous fistulas, perilymph fistulas, rectovaginal fistulas, ureterocolon fistulas, and the like. The medical device can include a closure element, a shaft, a carrier assembly, and controller systems. The medical device can also include a locator assembly. Additionally, the closure element applying medical device can include endoscope components so as to function also as an endoscope.

Abstract: A connector for coupling to a base of an indwelling device equipped with a circular hub having a radius, a top surface, a side surface, and a circumferential recess defined in the side surface. The connector has a resilient assembly including a plurality of release buttons extending from the resilient assembly and may include a conduit defining a fluid pathway through the connector. Each release button has a finger contact zone and a catch. The catch is configured to releasably engage the circumferential recess. The connector is coupled by positioning the connector on the circular hub and depressing the connector until the catches engage the circumferential recess such that the connector is configured to rotate completely about the circular hub. The connector is decoupled from the hub by pressing the release buttons to reversibly displace the respective catches radially to disengage from the circumferential recess.

Abstract: A syringe includes a holding portion that accommodates an injection objective substance, a driving portion that applies injection energy, and a nozzle portion that includes a passage for injection, with these portions being loaded into a housing independently, whereby a state where the injection objective substance can be injected is established. The syringe includes a regulating means for regulating a loading position of the holding portion and the driving portion within the housing so that a loading state, where the holding portion and the driving portion are always loaded in the same order into the housing, is established for injection of the injection objective substance. Due to this, it is possible to facilitate injection of injection liquid ideal for various purposes and to improve user's convenience.

Abstract: A digital circuit configuration for generating a pulse-width modulated signal, particularly for regulating an analog electrical variable using pulse-width modulation, is described in which an actual value of the analog variable present at the input of an A/D converter is converted to a digital output variable, the digital output variable of the A/D converter being provided or supplied to a comparator unit, which compares the output variable to an upper threshold value and to a lower threshold value; at the output of the comparator unit, a signal being present which indicates whether the output variable of the A/D converter lies above the upper threshold value or below the lower threshold value; and it being particularly provided that the output of the A/D converter is connected to a digital timer, using which the pulse-width ratio of a generated pulse-width modulated signal is settable.

Abstract: Devices and tissue fasteners for approximating and fastening tissue using minimally invasive techniques are disclosed. Methods for approximating and fastening tissue by application of one or more tissue fasteners are also provided. In one embodiment, spaced apart tissue locations are engaged by tissue penetrating members of a deformable fastener, one of more of the engaged tissue locations is moved toward another engaged tissue location to approximate the spaced apart locations, and the deformable fastener is deployed to secure the approximated tissue locations. These methods may be used in laparoscopic plication gastroplasty procedures for forming an invaginated tissue fold, to close holes in the gastrointestinal lumen, and in a variety of interventional procedures.

Abstract: A medicated module includes (i) a rotatable reservoir body comprising (a) a flow path and (b) a medicament-reservoir profile and (ii) a pin feature disposed in the rotatable reservoir body, the pin feature comprising a medicament-cavity profile. The medicated module also includes a second medicament, wherein the second medicament is held in a reservoir formed at least in part by the medicament-reservoir profile and the medicament-cavity profile, and wherein, prior to dispense, the second medicament is filled to at least the proximal end of the medicament-cavity profile.

Abstract: A balloon is inflated from a collapsed configuration, then deflated. A polymeric stem is then disposed over the deflated balloon and the stent crimped to the balloon.

Abstract: The present technology is directed to methods of soft tissue emulsification using a mechanism of ultrasonic atomization inside gas or vapor cavities, and associated systems and devices. In several embodiments, for example, a method of non-invasively treating tissue includes pulsing ultrasound energy from the ultrasound source toward the target site in tissue. The ultrasound source is configured to emit high intensity focused ultrasound (HIFU) waves. The target site comprises a pressure-release interface of a gas or vapor cavity located within the tissue. The method continues by generating shock waves in the tissue to induce a lesion in the tissue at the target site. The method additionally includes characterizing the lesion based on a degree of at least one of a mechanical or thermal ablation of the tissue.

Abstract: Disclosed are a patch, system, and method for delivery of a permeant composition into a subject via at least one formed pathway through a biological membrane of the subject. The patch comprises a matrix, at least one hydrophilic permeant disposed within the matrix, wherein at least a portion of the permeant can dissolve in biological moisture received from the subject, and at least one permeability enhancer disposed within the matrix. Also disclosed are systems and methods for delivery of a permeant composition into a subject via at least one formed pathway through a skin layer of the subject.

Abstract: Provided is a device for capturing debris in blood vessels, which enables a filter member to be smoothly recovered, and has a simple structure leading to an easy operation. For this purpose, provided is an elastic steel wire that, in a folded state, extends in a direction toward a base of a slide tube from a fore end part of a holding part in a ringlike elastic wire rod along an outer side of the slide tube.

Abstract: Methods and apparatus are provided for treating contrast nephropathy, e.g., via a pulsed electric field, via a stimulation electric field, via localized drug delivery, via high frequency ultrasound, via thermal techniques, etc. Such neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such neuromodulation is performed in a bilateral fashion. Bilateral renal neuromodulation may provide enhanced therapeutic effect in some patients as compared to renal neuromodulation performed unilaterally, i.e., as compared to renal neuromodulation performed on neural tissue innervating a single kidney.

Abstract: Surgical instruments for dissection and retraction, providing suction to remove fluids, smoke and debris at the site of a surgical procedure. A surgical dissector/retractor having a handle and head with a suction channel passing within the dissector/retractor. The dissector/retractor includes a smooth leading edge and a suction port on a top surface of the head.

Abstract: A system and method for restoring (e.g., replacing) a defective heart valve of a patient. A delivery system is manipulated to percutaneously deliver and implant a stented prosthetic heart valve to a native heart valve. A post-dilatation balloon is percutaneously delivered to the implantation site, and a compliant segment thereof is arranged within a region of the implanted prosthesis. The balloon is inflated such that the compliant segment expands and contacts the prosthesis, expanding a remodeling region of the prosthesis to a remodeled state. With these and related techniques, remodeling of an implanted, stented prosthetic heart valve to better match the native valve shape is possible, providing many benefits such as reducing the risk of paravalvular leaks.

Abstract: Disclosed are collection devices for collecting and stabilizing whole blood or a component thereof, which include a first end and a second end and at least one interior wall defining a reservoir, wherein the reservoir contains a stabilization agent that includes a lysophospholipase (LysoPLA) inhibitor. Also disclosed are methods for making and using the devices.

Abstract: A medical device for wound closure, including an elongate body with a plurality of portions and a perforated region disposed therebetween. The medical device may also include an alignment member. The wound plug may also have a first position for insertion, the portions being mechanically coupled to each other, and a second position where one or more of the portions are spatially separated.

Abstract: Microbial growth inhibiting solutions and methods of employing the microbial growth inhibiting solutions in flushing and coating medical devices are disclosed. In alternative embodiments, the microbial growth inhibiting solutions include combinations of a chelating agent with a C4-C9, C10 or C12 carboxylate antimicrobial agent, for example, such as n-capric, n-lauric, or n-octanoic acid. Methods of using these microbial growth inhibiting solutions for coating a medical device and for inhibiting catheter infection are also disclosed.

Abstract: Microbial growth inhibiting solutions and methods of employing the microbial growth inhibiting solutions in flushing and coating medical devices are disclosed. In alternative embodiments, the microbial growth inhibiting solutions include combinations of a chelating agent with a C4-C12 carboxylate antimicrobial agent, for example, such as n-capric, n-lauric, or n-octanoic acid. Methods of using these microbial growth inhibiting solutions for coating a medical device and for inhibiting catheter infection are also disclosed. Methods of using these microbial growth inhibiting solutions, or portions thereof, as leaching treatment solutions to treat polymer syringes and the treated syringes are also disclosed.

Abstract: The drive mechanism comprises a drive member inside a housing, a rotation member and a dose member. The drive member is rotatable with respect to the housing. The rotation member is also rotatable and unidirectionally rotationally engaged with the drive member. The dose member is able to move along a set/deliver path between a first axial position and a second axial position in either direction or to move along a cancel path from the second axial position to the first axial position. An engagement of the dose member with the rotation member causes the rotation member to rotate when the dose member is moved along the set/deliver path. The drive member is not rotated when the dose member is moved along the cancel path. A button in/out spline can be provided for the set/deliver path and a cancel spline for the cancel path.

Abstract: A high-volume peripheral intravenous (IV) catheter and method includes an elongate stylet removably disposed in the lumen of an elongate catheter with the stylet having a beveled distal end forming a piercing tip that protrudes from the outlet port of the catheter. The catheter has a proximal cylindrical shape from the inlet port transitioning at a transition to an inner lumen conical taper terminating at the outlet port, and having a larger internal diameter at the inlet port and a tapering smaller internal diameter between the transition and the outlet port. A plurality of side outlet ports is formed laterally through the catheter in the inner lumen conical taper. A cross-sectional area of the outlet port and the side outlet ports together is equal or greater than a cross-sectional area of the inlet port.

Abstract: There is provided a compound of Formula (I) and salts thereof, where R1 is an oxime or an alkylated oxime; the alkylated oxime comprises a linear or branched alkyl group of length C1 to C5; and R2 are each independently (a) an unsubstituted or substituted linear or branched alkyl group of chain length C1-7, (b) an aryl substituted alkyl group, where the aryl group is substituted, (c) an alkoxy substituted alkyl group, where the alkoxy group is substituted by a methoxy group or an alkoxy group substituted with an alkoxy group, or (d) an H atom, where the substituents in (a) and (b) are hydroxy, alkoxy, acyloxy, alkoxycarbonyloxy, amino, aryl, nitro, oxo or fluoro groups. The compounds may be used as a medicament.

Abstract: A valvuloplasty catheter comprises a balloon or other expansible shell which carries a plurality of scoring elements, typically formed in an elastic, self-closing metal cage. The expansible shell and scoring elements are positioned inside an aortic or other cardiac valve, and the shell expanded to engage the scoring elements against stenotic material which covers the valve leaflets and valve annulus. The scoring elements uniformly distributed force to break up the stenotic material, and the cage further contributes to rapid balloon deflation allowing shortening of the treatment time.

Abstract: Systems, methods, and articles for providing an antimicrobial composition to the proximal elements of a trans-dermal catheter and into the lumen of the transdermal catheter are disclosed. In an embodiment, an antimicrobial composition on an interior surface of a cap element transfers antimicrobial to the proximal end of the transdermal catheter. The system comprises an elongate member configured for insertion into a lumen of a catheter, the elongate member containing an antimicrobial.

Abstract: A self-dilating cannula for introduction into a patient's vasculature includes an elongate body and an atraumatic tip. The elongate body has a proximal end, a distal end, and a fluid-flow lumen extending therebetween. The atraumatic tip is positioned at the elongate body's distal end and has a blunted end and a conical shape. The atraumatic tip includes a plurality of fluid-flow openings proximal to the blunted nose that are configured to disperse fluid from the fluid-flow lumen in a plurality of directions with respect to the atraumatic tip. The atraumatic tip also includes an opening in the blunted nose that is sized to a guidewire.