Abstract: An improved method and equipment for tissue/vessel sealing is disclosed for the sealing, coagulation and transection of tissue during surgical procedures. The improvement is accomplished through better management of heat and moisture present during tissue treatment by having tissue grasping surfaces comprised of an outer non-conducting region and an inner conductive region, and including channels in the jaw assembly to direct steam and moisture away from surrounding tissue. The outer region follows the perimeter each jaw, isolating the treatment zone and preventing steam and excess heat from leaving the tissue treatment zone, reducing thermal margins and unintended patient burns. The outer region also prevents surrounding moisture from affecting the treatment zone and allowing more consistent results.

Abstract: This invention relates to medical devices useful for infusion therapy and, more particularly, to a syringe that can be selectively used with a retractable needle or with frontal attachment devices such as luer hubs, valves or other connectors in needleless systems.

Abstract: Pen injection devices (10) and methods of using a pen injection device are disclosed. Pen injection devices include a sterile dual transfer spike assembly (150) including a dual transfer spike defining a fluidic pathway; a first cartridge assembly (12) including a first cartridge (20) containing a first substance; a second cartridge assembly (14) including a second cartridge (30) containing a second substance; a plunger rod (50) translatable in a first direction; and a biasing mechanism (60) configured to bias the plunger rod in a second direction opposite the first direction. Methods of using a pen injection device having a first container, a second container, a plunger rod, and a biasing mechanism include activating the pen injection device, thereby creating a fluidic pathway between the first container and the second container; and translating the plunger rod at least once, thereby transferring a first substance from one container to the other container to mix with a second substance.

Abstract: A catheter balloon with integral non-distending regions having a plurality of layers which wind around the balloon material and overlap to form an angle of between 45 and 90 degrees relative to each other upon inflation, and methods of making the non-distending regions are provided.

Abstract: The present invention monitors an IV bag injection port and informs the user of prior injections. The present invention employs an object and/or a sealed chamber within a transparent IV fluid bag injection port. In the case of the object, notification of prior use is achieved when the object's or IV fluid's appearance is altered. With respect to the sealed chamber, the chamber's seal is breached to allow fluid to pass between the chamber and the IV bag to change the appearance of the contents of the chamber. Since the injection port and bag walls are at least partially transparent, medical personnel are able to observe the altered appearance of either the object, IV fluid or the sealed chamber.

Abstract: A transseptal sheath defining a sheath lumen, a proximal end, and a distal end. A valve disposed within the sheath lumen proximate the distal end. The transseptal sheath defining at least one port along a portion of its periphery proximate the valve.

Abstract: A propellant pillow for use in an implantable pump is described herein. The propellant pillow generally includes a propellant bag having a septum attached thereto. In one embodiment, the pillow may further include a rigid member associated with the propellant bag to prevent piercing of the bag by an injection device inserted through the septum during a filling process. In another embodiment, the propellant pillow includes a propellant bag having a surrounding layer of resealable material encompassing the bag. The surrounding layer also serves to prevent piercing of the bag during filling of the pillow with a propellant. Methods of filling such propellant pillows with propellant as well as utilizing such pillows in connection with implantable pumps are also described herein.

Abstract: A medical injection system includes an elongate injection apparatus and an actuator apparatus. The actuator apparatus includes a fitting for coupling the actuator apparatus to a delivery catheter and a reversible gripping means to grip the injection apparatus; the gripping means is included in a plunger that is slideably engaged with the fitting and directs the injection apparatus through a fitting lumen and through a catheter lumen, when the fitting is coupled to the catheter.

Abstract: A system and method for assembling a catheter device, wherein a septum actuator is positioned within the lumen of a catheter adapter to provide a pathway through a septum component, an introducer needle being inserted through the septum via the septum actuator thereby preventing damage to the septum, the septum actuator thereafter being withdrawn from the septum and positioned within a rearward chamber of the catheter adapter lumen.

Abstract: The present invention includes a microneedle assembly having a support that includes a first surface and a second surface, the second surface further including a slanted surface. A plurality of microneedles are provided which project outwardly from the second surface of the support. A pathway through the microneedle assembly is formed and includes an aperture extending between the first surface of the support and the second surface of the support, a channel disposed on the exterior surface of at least one microneedle, the channel having a surface, the channel being in alignment with at least a portion of the aperture to form a junction through which fluids may pass.

Abstract: An insertion head for medical or pharmaceutical uses including a housing with a side that can be positioned on tissue and a penetrating device with a tip, the penetrating device carried by the housing in a protected orientation in which the housing covers the tip and a penetrating orientation in which the tip protrudes, wherein the penetrating orientation is angled relative to the protected orientation.

Abstract: An anchoring system for securing a dialysis catheter to a patient comprises an anchor pad and retainer. The anchor pad is attached to the skin of the patient by an adhesive layer on one side of the pad. The retainer is disposed upon the surface of the anchor pad opposite the adhesive layer and includes a base, a cover, and an adhesive spot. A groove upon the base is arranged to receive a Y-site portion of a dialysis catheter. A post also protrudes from the base to the cover at a position which will be disposed between the two distal branches of the dialysis catheter. The cover closes over the base, securing the Y-site between the groove and the post. Closing the cover places the catheter in contact with the adhesive spot. This contact between the retainer, adhesive spot and catheter inhibits inadvertent motion of the catheter.

Abstract: The present disclosure provide catheter anchoring devices including anchoring devices that can be used to secure percutaneous catheters to a patient. In some embodiments, a catheter anchoring device comprises a locking tab having a front surface including a first mechanical engagement material and a back surface to be adhesively secured to a catheter by wrapping the back surface around a catheter surface. The catheter anchoring device further comprises a base portion comprising a base material layer including a bottom surface for adhesive application to the skin of a patient and a top surface including a second mechanical engagement material for engagement with the first mechanical engagement material of the locking tab; and a flexible closure extending from the base material layer and including a third mechanical engagement material for engagement with the top surface of the base material layer and a through-hole sized to allow passage of a tab protrusion.

Abstract: A catheter assembly includes a catheter, a tubular structure affixed to an exterior surface of the catheter, and a stabilizing cuff affixed to, and at least partially embedded within, the tubular structure. The tubular structure may include a tapered surface extending from an end of the tubular structure to an exterior surface of the catheter. A method of manufacturing a catheter assembly may include positioning a tubular structure about a catheter, positioning a stabilizing cuff near the tubular structure, and partially embedding at least a portion of the stabilizing cuff within the tubular structure while shaping the tubular structure to form a tapered surface. A temporary sleeve may be positioned about the tubular structure prior to shaping the tubular structure. The tubular structure may also be preformed to include a tapered end prior to positioning the tubular structure about the catheter.

Abstract: A medical article securement device holds a medical article such as a catheter in position upon the body of a patient and at least inhibits longitudinal movement of the medical article. The securement device includes a retainer, a pair of hinged actuators, and a pair of engagement members coupled with the hinged actuators. Movement of the actuators causes the engagement members to grip at least a portion of a medical article placed within the retainer so as to inhibit longitudinal movement of the medical article with respect to the retainer. The shape of the retainer inhibits lateral and transverse movement of the medical article with respect to a patient's skin.

Abstract: A syringe assembly having a collapsible or pivotable plunger rod with magnification properties is provided. In a pre-use or packaged state, the plunger rod is positioned substantially parallel to a barrel of the syringe assembly resulting in the syringe assembly having a reduced length and a smaller packaging footprint. The smaller packaging footprint allows for reduced storage space of the syringe assembly. Upon removal from a packaging and/or a storage space, the plunger rod can be slid or pivoted toward a proximal end of the syringe barrel and locked into place such that the syringe assembly is ready for use. The plunger rod can be shaped to provide magnification to indicia of the syringe barrel and/or contents. Alternatively, a separate magnification member can be associated with the plunger rod and/or secured about the syringe barrel.

Abstract: A syringe needle safety apparatus comprising a syringe barrel having an open end and an opposite end adapted for a needle and a needle safety cover displaceable between a un-deployed state wherein the cover is constrained and the needle exposed, and a deployed state wherein the cover covers at least the needle tip. A plunger is slidably engaged in the syringe barrel and at least one element secures the needle safety cover in the un-deployed state. Biasing means urge the needle safety cover from the un-deployed state to the deployed state, and a housing is coupled to the opposite end of the syringe barrel, the housing comprising a corresponding securing member and a deformable member, the deformable member releasing the at least one element from the corresponding securing member upon receiving a releasing force via the plunger. During deployment, the needle safety mechanism provides for the needle safety cover to avoid contact with the needle, reducing or eliminating blood contact.

Abstract: Exemplary embodiments provide a syringe plunger formed of a polymeric material. The syringe plunger includes a pressurizer disposed at a proximal end, and a distal end bifurcated into a first plunger arm having a first conical surface and a second conical surface, and a second plunger arm having a first conical surface and a second conical surface. The distal end includes a first contact surface defined by the first conical surface of the first plunger arm and the first conical surface of the second plunger arm, the first contact surface configured to initially contact a firing engagement mechanism, the first contact surface disposed at a first angle of between about 40° and about 80° relative to a longitudinal axis of the syringe plunger.

Abstract: An injection needle assembly includes a needle having a needle point to puncture skin, a needle hub including a first member which holds the needle, and a second member in which a discharge part of a syringe is to be fitted, and an elastic member disposed inside the second member to make liquid-tight close contact with the inner surface of the second member, with the elastic member having an insertion hole in which the needle tube is inserted.

Abstract: Transfer sets are disclosed in the present patent. The transfer set provides a connection between a source of peritoneal dialysis fluid and a patient for whom peritoneal dialysis has been prescribed. The transfer sets disclosed herein are smaller and provide a more compact and convenient device by which a dialysis patient controls the flow of dialysis fluid to and from the peritoneum of the patient. The devices are more compact and convenient because they include more convenient mechanisms for starting and stopping flow of the dialysis fluid. It is also easy to determine whether the mechanism is in a closed or open configuration by simply looking at the mechanism.

Abstract: Systems for treating a vessel bifurcation comprise a bifurcated catheter having a first branch and a second branch. Each branch defining an exchange region that extends from the distal end of the shaft to the guidewire port of the shaft. The catheter has a radial alignment mechanism which provides improved radial alignment characteristics of at least the exchange region of the branches.

Abstract: Embodiments of the present invention provide a temporary tattoo, appliqué or decal and a method of using the tattoo on a patient to identify on that patient a selected operative site, wherein said operation is identified by name on said decal and wherein the accuracy of site selection may be endorsed by the patient and the responsible operator directly on the selected site in such a manner that the endorsement indicia remain legible after the decal is eradicated.

Abstract: The invention relates to the treatment of wounds. In particular, the invention relates to systems, devices, and methods enabling pulse lavage irrigation of wounds in a non-controlled setting while providing containment of contaminated irrigation fluid, thereby preventing exposure of individuals and surfaces in proximity to the patient to infectious materials.

Abstract: An absorbent article includes a fit system having fasteners and friction elements. The fasteners are located in the front waist area and the back waist area and are adapted to fasten the article about the waist of a wearer to define a waist opening, a pair of leg openings, and a pair of overlap regions. The friction elements are located in the overlap regions and are adapted to provide friction between the front waist area and the back waist area in the overlap regions. The friction elements have an upper portion oriented towards the waist opening and a lower portion oriented towards the leg opening. The upper portion and the lower portion have different concentrations of surface treatment, thicknesses, and/or surface areas.

Abstract: Stabilized glucagon solutions, methods of storing and using the stabilized glucagon solutions, and drug delivery devices containing the stabilized glucagon solutions. In some embodiments, the glucagon solutions may be alkaline, such as with a pH of at least about 9. The glucagon solutions may be resistant to aggregation of glucagon when the solutions are stored for a prolonged period, such as at least about three days, at room temperature and/or physiological temperature.

Abstract: Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing an intravascular device having a distal portion, inserting the device into the vascular lumen, positioning the distal portion in the vascular wall to at least partially surround the occlusion, and removing at least a portion of the surrounded occlusion from the lumen.

Abstract: Methods and devices are provided for targeted administration of a drug to a patient's eye. In one embodiment, the method includes inserting a hollow microneedle into the sclera of the eye at an insertion site and infusing a fluid drug formulation through the inserted microneedle and into the suprachoroidal space of the eye, wherein the infused fluid drug formulation flows within the suprachoroidal space away from the insertion site during the infusion. The fluid drug formulation may flow circumferentially toward the retinochoroidal tissue, macula, and optic nerve in the posterior segment of the eye.

Abstract: A microcatheter having a guidewire port that is positioned proximal of the distal end of the microcatheter in order to provide rapid exchange capability. The guidewire port includes provisions that permit guidewire access into a lumen of the microcatheter while providing a relatively fluid tight seal at least when the guidewire is not present in the guidewire port.

Abstract: Catheter devices having low profile shafts and laterally deployable members (e.g., cannulas, needles, etc.) that may be extended or advanced laterally from the catheter shaft. Also disclosed are methods for bypassing a vascular obstruction (e.g., a chronic total occlusion or other full or partial obstruction) wherein a guidewire is entrapped in a subintimal space adjacent to the obstruction. A catheter of the foregoing character is advanced over the entrapped guidewire and into the subintimal space. The laterally deployable member is then advanced or extended from the subintimal space back into the true lumen of the blood vessel distal to the obstruction. A second guidewire is then advanced through or along the laterally deployable member. The catheter and first guidewire are then removed and one or more working device(s) (balloons, atherectomy devices, setnts, etc.) is/are advanced over the second guidewire and used to establish a subintimal bypass channel through which blood may flow around the obstruction.

Abstract: A medical device including a shaft having an elongated inner member and an elongated tubular reinforcing member disposed over at least a portion of the inner member. In some embodiments, at least a portion of the outer surface of the inner member is spaced from the inner surface of the reinforcing member, defining a space substantially free of any other structures of the device. In some embodiments, the shaft can include a tip structure disposed on a distal portion of the inner member. In some such embodiments, the reinforcing member has a distal end, and the tip structure is disposed on the distal portion of the inner member adjacent the distal end of the reinforcing member. Additionally, in some embodiments, the reinforcing member can include a plurality of apertures defined therein, for example, to enhance the flexibility or other such characteristics of all or portions of the reinforcing member.

Abstract: A method of making a catheter having a flexible outer tube and a lubricious inner tube bonded to the flexible outer tube. The catheter is formed of a distal outer tube formed of a first, flexible material, an inner tube having a lubricious inside wall surface formed of a second, lubricious material, and an outer tube wall surface compatible with heat bonding the inner tube outside wall surface to the outer tube wall surfaces. A preferred flexible material is polyether block amide (PEBA) and a preferred lubricious material is polyethylene.

Abstract: An elongate medical device having an axis comprises an inner liner, a jacket radially outward of the liner, a braid comprising metal embedded in the jacket, a sensor, and at least one wire electrically connected to said sensor. The at least one wire is one of: embedded in the jacket and optionally disposed helically around the braid; extending longitudinally within a tube which extends generally parallel to the device axis and wherein the tube is embedded in the jacket; and disposed within a lumen, wherein the lumen extends longitudinally within the jacket.

Abstract: A luer connector assembly (100) including a luer connector body (102), a luer cap (110) and a protective flexible sleeve (120). The protective sleeve is assembled to the distal end (116) of the luer cap (110) to define a cap/sleeve subassembly (130), and the luer cap proximal end (112) is removably affixable to the distal end (106) of the luer connector (102). A prepared end (202) of a proximal catheter lumen (200) of a patient-implanted catheter assembly is inserted through the protective sleeve (120) and through and beyond the luer cap (110) to be affixed to the luer connector distal end (106). The luer cap/sleeve subassembly (130) is then slid proximally to be removably affixed to the luer connector distal end (106), whereafter the clamp (204) on the catheter lumen (200) is positionable onto and around the protective sleeve (120), to protect the catheter lumen (200) during clamping.

Abstract: A collapsible valve for use in a needleless access connector to reduce the priming volume of the needleless access connector. A needleless access connector with a small priming volume. A method of connecting a first medical device to a second medical device with a needleless access connector with a small priming volume.

Abstract: A manually operable pump for the effective removal of fluids to include blood, blood clots, fluid, and air from a body cavity of a subject is provided. The manually operable pump is adapted to be connect to a range of fluid conduits and is equipped with one-way valves that effectively permit flow of fluid through the pump in only one direction. The sensitivity of the one-way valves is such that when properly positioned, fluid can flow through the valves and out of the pump without manual compression of the pump and with the aid of gravity power alone.

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

Abstract: A drainage apparatus for an incapacitated person or ostomy patient having a urine draining device or stoma respectively, the apparatus comprising a conduit (14) having a first end having connection means suitable to attach to the urine draining device or stoma of the person or patient and a second end connected to a sewer/drainage system (20) of a dwelling (8). Such dwellings may include commercial and domestic buildings, caravans and motor homes and a portion of the conduit may be permanent in such a dwelling.

Abstract: This invention is generally related to catheters for insertion into a body cavity, duct or vessel, and more particularly to a tip or plug for a catheter. The catheter tip is constructed and arranged to form a seal on the end portion of the catheter tube, while a sleeve secured or formed integrally to the tip cooperates with the catheter tube to form a first balloon that encapsulates the tip of the catheter and a second balloon that positions the catheter within the body cavity, duct or vessel.

Abstract: A surgical instrument comprises a tool part and a grip part connected to each other via a ball and socket joint or other double-axis joint. The double axis joint allows the surgeon to work in a non-fatiguing, ergonomic and sensitive manner. The tool on the tool part can be activated e.g., mechanically by an actuation member. Additional actuation elements such as, e.g., electrical switches, can be arranged on the grip part to activate the tool. The transmission connection between the grip part and the tool can be achieved via rigid levers and connecting pieces or also via flexible elements (e.g., a traction cord), or rigid components with an integral hinge. To uncouple a pivoting movement of the grip part towards the tool part from an actuation of the tool, at least one joint of the transmission is arranged in the center of the joint.

Abstract: An apparatus and process using a high-power, short-pulsed thulium laser to output infrared laser pulses delivered through an optical fiber, for cutting and ablating biological tissue. In some embodiments, the pulse length is shortened sufficiently to keep inside the stress-confined ablation region of operation. In some embodiments, the pulse is shortened to near the stress-confined ablation region of operation, while being slightly in the thermal-constrained region of operation. In some embodiments, the laser is coupled to a small low-OH optical fiber (˜100 ?m diameter). In some embodiments, the device has a pulse duration of about 100 ns for efficient ablation; however in some embodiments, this parameter is adjustable.

Abstract: The present disclosure relates to a portable irradiating arrangement having a light source, particularly a laser diode, comprising an outer sleeve, an inner sleeve, and a radiation distributing probe, whereby the inner sleeve is mounted in the outer sleeve and the radiation distributing probe may be attached at a probe-facing end of the outer sleeve, whereby the irradiating arrangement is designed in such a way that the light source can be turned on only when the radiation distributing probe is attached to the outer sleeve. The invention relates further to a portable irradiating arrangement, in which the inner sleeve is in contact with the radiation distributing probe in such a way that the inner sleeve must be detached from the radiation distributing probe before removal of the radiation distributing probe from the outer sleeve.

Abstract: A balloon elongation apparatus includes an elongated hypotube with a distal end having a reduced inner diameter portion that is configured to radially expand when a mandrel is advanced through a lumen of the hypotube towards the reduced inner diameter portion. A medical kit includes a catheter having a distally-located balloon and the elongation apparatus disposed within a guide wire tube of the catheter. In use, the balloon is elongated following a procedure in order to facilitate retracting the balloon into a sheath. The balloon is elongated by first advancing the mandrel relative to the hypotube so that the hypotube radially expands and firmly engages an inner surface of the guide wire tube and then advancing the mandrel, hypotube, and distal end of the guide wire tube relative to the catheter body.

Abstract: A working end of a catheter includes at least one therapeutic element, such as a resistive heating element, usable to deliver energy for ligating, or reducing the diameter of, a hollow anatomical structure. In certain examples, the catheter includes a lumen to accommodate a guide wire or to allow fluid delivery. In certain embodiments, a balloon is inflated to place resistive element(s) into apposition with a hollow anatomical structure and to occlude the structure. Indexing devices and methods are also disclosed for successively treating portions of the hollow anatomical structure. In certain examples, marks along the catheter shaft provide visual verification to the physician of the relative position of the therapeutic element of the catheter. Embodiments of indexing devices may include pairs of rings and/or hinged arms that move a catheter a desired indexed position between successive treatments.

Abstract: A method for controlling an electrosurgical generator is contemplated by the present disclosure. The method includes applying an electrosurgical waveform to tissue through an electrode. The electrosurgical waveform includes one or more positive half-cycles one or more negative half-cycles. The method also includes measuring voltage and current of the electrosurgical waveform to detect a peak voltage of each of the positive half-cycles and the negative half-cycles and comparing the peak voltage of the positive half-cycles and the peak voltage of the negative half-cycles to determine generation of electrical discharges. The method further includes adjusting the current of the electrosurgical waveform to regulate the generation of the electrical discharges based on a comparison of the peak voltage of the positive half-cycles and the peak voltage of the negative half-cycles.

Abstract: The present invention encompasses apparatus and methods for mapping electrical activity within the heart. The present invention also encompasses methods and apparatus for creating lesions in the heart tissue (ablating) to create a region of necrotic tissue which serves to disable the propagation of errant electrical impulses caused by an arrhythmia.

Abstract: Embodiments of the present invention are directed to ablation catheter systems configured, for example, to ablate tissue adjacent an ostium of the pulmonary vein in a left atria of a heart. In one embodiment, an ablation catheter system includes a handle including an actuator and a catheter coupled to the handle defining a lumen extending through a length of the catheter, the catheter including a tip portion at a distal end thereof. The ablation catheter system may also include an electrode coupled to the handle with lines extending through the lumen of the catheter, the electrode being configured to be constrained within the tip portion of the catheter and configured to be deployed from the tip portion and self expand to an expanded configuration. With this arrangement, the electrode is configured to self expand to a conical configuration with a tip portion configured to be disposed within the pulmonary vein.

Abstract: The present disclosure relates to electrosurgical devices having a plurality of hand-accessible variable controls. An electrosurgical device configured for connection to a source of electrosurgical energy is provided and includes a housing; an electrical circuit supported within the housing, the electrical circuit being connectable to the source of electrosurgical energy; and a controller slidably supported on the housing, wherein the controller is configured to exert a force on each of the housing and the electrical circuit to affect a change in the electrical circuit and to provide a tactile feedback to a user of the electrosurgical device as the controller is moved relative to the housing.

Abstract: A device and method for treatment of a tissue specimen disposed in surrounding tissue has a tissue specimen isolating toot and a tissue specimen damager. The tissue specimen isolating tool isolates the tissue specimen from the surrounding tissue. The tissue specimen damager damages the tissue, with a possible end result being necrosis. The severing tool may have a cutting member that is extendable to an outwardly radially bowed position about device. The tissue specimen is isolated by rotating the cutting member about the tissue specimen. The cutting member may be functionally connected to a cutting member radio frequency generation source. The tissue specimen damager may damage the tissue specimen using ionizing radiation, cutting devices, thermal treatment devices, chemical treatment devices, or sealing an outer boundary of the tissue specimen.

Abstract: An embodiment of the invention may include a medical device. The medical device may include a flexible tube, an elongate member configured to cut tissue and extend from the flexible tube, and a cauterizing member configured to cauterize tissue and to move relative to the elongate member and the flexible tube. The cauterizing member may substantially surround at least a portion of the elongate member.

Abstract: A surgical cutting and fastening instrument. The instrument comprises an end effector, a shaft connected to the end effector, and a handle connected to the shaft. The handle comprises an electric, DC motor connected to a drive train for powering the drive train and a plurality of series-connected DC power source connected to the motor for supplying electrical power to the motor. The handle also comprises a power source selection switch for connecting, when in a first state, all of the DC power sources to the motor, and, when in a second state, a subset of the DC power sources to the motor. Also disclosed are means for actuating a RF electrode in the end effector and means for indicating actuation of the RF electrode.