Abstract: An irrigated ablation catheter includes a shaft and an electrode assembly affixed to a distal end of the shaft. The distal electrode assembly includes a manifold and an ablation electrode affixed together and extending along a center axis. The electrode has a distal irrigation passageway extending therethrough to an opening at a distal tip of the electrode. The opening of the irrigation passageway is offset in distance from the center axis, and allows a thermal sensor such as a thermocouple to be located in a sensor cavity in the electrode on or near the center axis. One variation involves providing a pair of distal irrigation passageways through the electrode where both of the openings of the passageways are offset from the center axis. The thermal sensor in this variation is located in the sensor cavity substantially on the center axis.

Abstract: Disclosed herein are medical device systems, and methods thereof, for automatically detecting access to a medullary cavity. Embodiments include intraosseous access systems with sensing obturators, configured to detect a change in modality, e.g. pressure, oxygen saturation, electrical impedance, etc. at a distal tip thereof. Signals can be transmitted to a control logic that can modify the activation of a driver in response. Signals can be transmitted by way of wired or wireless communication. In an embodiment, signals can be transmitted through conductive polymer material that forms the obturator and allows the obturator to be flexible enough to mitigate accidental needle stick injuries.

Abstract: The invention relates to a method for producing poly(alkylene) guanidines, comprising at least the following steps: a) providing an alkylene diamine of the formula NH2—(CH2)m-NH2 with m=4-12, in particular 6-10, in a reaction vessel and heating the alkylene diamine to a temperature greater than or equal to the melting temperature of the alkylene diamine in question, typically to a temperature in a range of 25° C. to 115° C., preferably 55° C. to 110° C.

Abstract: A trocar assembly includes a trocar including an elongated tubular member extending between a distal end configured to be inserted into a surgical site and a proximal portion including a trocar housing configured for introduction of surgical instruments into the tubular member, wherein the trocar housing includes at least one latch receptacle. The assembly includes a cap, wherein the housing of the cap is attached to the proximal portion of a trocar. The cap includes a housing configured to be removably attached to a proximal portion of a trocar. The housing includes a flow passage therethrough from a distal end of the housing to a proximal opening of the housing. A filter medium is included within the housing spanning the flow passage for filtration of flow through the flow passage.

Abstract: A cannula-catheter bonding method and apparatus can include a needle having a specifically configured connector end to reduce the risk of the connector end disengaging with an adapter (e.g., a catheter, a cannula, or a connector of a Huber needle assembly, etc.). The specifically configured needle connector end can be a formation, such as a barb, a bead, an annular structure, a rib, etc. The formation can be formed on the connector end, and may be elongated with a conical shaped nose leading to a base with a bottom. The formation can be used to prevent movement of the needle relative to the adapter. A method for producing the formation can include forming a mold for the formation in a plate, where the connector end can then be placed within the mold so that curable material can be disposed within the mold. Upon hardening of the curable material, the formation can take the shape of at least a portion of the mold.

Abstract: A lid for a medical implant has a first part, a second part and engaging means. The second part is rotatable relative to the first part such that, in use, rotation of the second part relative to the first part causes the engaging means to engage with and attach the lid to the implant.

Abstract: An implantable vascular access port has a main port body with one or more hollow internal chambers formed therein each with a floor at the base of the internal chamber. The port body has an outlet aperture formed in a sidewall there of the internal chamber. One or more parallel, lateral, or angled-access apertures, relative to the port floor and associated septa are located opposite the outlet aperture in the main port body in a sidewall there of (parallel or lateral or angled-access aperture or septum), with at least a one perpendicular-access aperture and septum located opposite the floor of the internal chamber(s). The port chamber in the area of the outlet aperture has an at least partially conical shape directionally aligned with the parallel or lateral or angled-access aperture and septum, with said outlet aperture in contiguity a reversible outlet tube or port body needle locking mechanism.

Abstract: After a prolonged period in the body, an IVC filter can be substantially absorbed by the body. When this occurs, it can be very difficult and/or dangerous for the patient if the IVC filter is forcibly removed. Thus, it is desirable to have systems and methods for safely abandoning the removal procedure of the IVC filter. Example embodiments of an apparatus for safely abandoning the removal procedure of the IVC filter can include: a sleeve having a lumen and a first hole on a wall of the sleeve; a shaft slidably disposed within the lumen of the sleeve; a flexible distal extension comprising a braid structure with a first opening; and a first lasso encircling a portion of the first opening of the braid.

Abstract: A light-emitting, antimicrobial tuber, instrument or catheter includes a thin, flexible tube having an optically transparent wall; and a light transmitter configured and arranged to emit light through the tube, which may be ultraviolet C (UVC) irradiation, photodynamic therapy (PDT), violet-blue light therapy, and other light-based therapies. In one embodiment, violet-blue light from 400-500 nm in wavelength, such as 405 nm, for instance, is used. The device is used on a patient and a therapeutic amount of light is administered to the patient, thereby reducing the risk of infections being transmitted from the instrument, tube or catheter to the patient, generally. The device may be configured for use in the urinary tract or as intravascular, and may be indwelling or temporary. Light may be administered for the duration of use or another time period effective to halt, inhibit, or reduce microbial or fungal growth.

Abstract: A ventilation tube includes a hollow main portion having an inner wall, an outer wall, a distal end and a proximal end. The outer wall defines an outer wall width dimension. At least one distal member is coupled to and extends from the distal end and has an outer end. At least one proximal member is coupled to and extends from the main portion and has an outer end. In an undeployed state, the outer end of the at least one proximal member is more greatly spaced apart from the outer wall width dimension than the outer end of the at least one distal member. In a deployed state the outer end of the at least one distal member changes in position relative to the outer wall width dimension and the outer end of the at least one proximal member remains unchanged relative to the outer wall width dimension.

Abstract: An ocular medical injector is provided for drug delivery. A method includes inserting a puncture member of the medical injector into the eye until the puncture member reaches the SCS. The puncture member defines a lumen therethrough. With the puncture member disposed within the SCS, a flexible cannula is advanced distally through the lumen of the puncture member, beyond the distal end portion of the puncture member and along the SCS towards a posterior region of the eye. The flexible cannula has an atraumatic distal tip and defines a lumen therethrough. With the distal tip of the flexible cannula disposed within the SCS beyond a distal end portion of the puncture member, a therapeutic substance is administered to the SCS.

Abstract: An apparatus is provided herein for dilating bodily tissue and for monitoring neural activity in the distracted bodily tissue. In one aspect of the invention, the apparatus includes a first dilator having a tubular body with a distal end, a proximal end, and at least one electrode mounted about a circumference thereof; and, a second dilator having a tubular body of electrically-insulative material, the tubular body having a distal end, a proximal end, and a lumen extending therebetween sized to permit the second dilator to subsequently telescopically slide over the first dilator and come into overlapping coaxial alignment with the first dilator. A discrete window is formed through the tubular body, at or near the distal end, in communication with the lumen.

Abstract: In a method for diagnosing, validating and treating a patient having lesions in both arteries of left and right lower limbs. By determining that a smaller curvature of lesion to be treated first, catheters and an operation time can be reduced is to be treated first on a priority basis based on diagnostic data, deciding that a larger lesion curvature is to be treated next, then treating the lesions substantially continuously.

Abstract: A method of making a flexible medical article or tube, for example, a sheath for a vascular access device, is provided. The method can include extruding a polymer, for example, a polycarbonate-urethane copolymer, to form a tube and annealing the extruded polymer. The method can further include cutting the extruded tube to a desired length before or after annealing, flaring one end of the annealed tube and over-molding the flared portion onto a hub, and forming the other end of the tube into a tip. A sheath formed by such a method is also provided.

Abstract: Sensor devices including dissolvable tissue-piercing tips are provided. The sensor devices can be used in conjunction with dissolvable needles configured for inserting the sensor devices into a host. Hardening agents for strengthening membranes on sensor devices are also provided. Methods of using and fabricating sensor devices are also provided.

Abstract: The use of stepped cannulas, wherein a step structure creates a backstop to reduce backflow along the cannula body, is known for convection enhanced delivery of agents to the brain and other structures within an animal. Described herein are novel and improved stepped cannula designs wherein the length of the cannula segment between the step and the dispensing outlet is variable and can be controllably adjusted inside the patient during delivery. This advantageously allows the operator to place the cannula step at the optimal position and deliver agents at one or more positions within the target structure.

Abstract: According to one embodiment, a tissue penetrating device includes an elongate shaft having a proximal end, a distal end, and a lumen extending there between. A first needle is disposed within the lumen of the elongate shaft and is extendable therefrom between a first configuration and a second configuration. In the first configuration, the first needle is disposed within the elongate shaft's lumen and is substantially aligned with an axis of the lumen. In the second configuration, the first needle extends distally of the elongate shaft's distal end and bends away from the lumen's axis. A second needle is disposed within a lumen of the first needle and is extendable therefrom when the first needle is positioned in the first configuration and when the first needle is positioned in the second configuration. The second needle may be extended from the first needle to penetrate tissue of a patient.

Abstract: Provided herein is a catheter assembly including an imaging device for identifying an anatomical structure. The catheter assembly includes a patient cannula configured to be drawn along a catheter or guide wire; a transseptal puncture catheter at least partially enclosed within the patient cannula; and an imaging catheter. The imaging catheter includes a transducer configured to emit an energy beam capable of reflecting from an anatomical structure and to detect energy reflected from the structure. The catheter assembly also includes a transmitter for conveying a signal representative of the detected energy from the transducer to a signal processor for obtaining information about the structure. An imagining system and a method for identifying a predetermined transseptal puncture location on an atrial septum are also provided herein.

Abstract: A device (100) for facilitating the positioning of a catheter for the administration of a liquid medicament to a spontaneously breathing patient. The method and system according to preferred embodiments of the present invention allows optimizing the dispensing said medicaments. In particular the system according to a preferred embodiment of the present invention allows the administration of an exogenous pulmonary surfactant to preterm patients.

Abstract: A catheter assembly includes a peripheral intravenous (“PIV”) portion that provides expedited vascular access. The catheter assembly includes an elongate catheter body defining a first lumen and includes a CVC portion, a transition portion, and a PIV portion. The PIV portion defines a relatively smaller diameter, a tapered tip, and a lumen configured to receive a needle. The needle extends through a needle access aperture, disposed through a side wall of the catheter body, through the PIV lumen, to a point beyond a distal end of the catheter body. A clinician accesses a vasculature using the needle and the PIV portion. The needle is then removed and a guidewire advanced through the lumen of the catheter body and the PIV portion into the vasculature. The CVC portion is then advanced over the guidewire into the vasculature, self-dilating the insertion site as the transition portion enters the vasculature.

Abstract: An intraosseous needle assembly includes a needle having a first cylindrical shaft. The shaft having a distal end, a proximal end, and a wall defining an inner channel. The first cylindrical shaft includes threading protruding from the wall along a proximal portion of the first cylindrical shaft. The needle further includes a needle head extending from the proximal end of the first cylindrical shaft. The needle assembly may further include a stylet, the stylet having a second cylindrical shaft having a first end and a second end and a stylet head extending from the second end. The stylet head includes a proximal surface and a distal surface, a pair of substantially parallel second side walls, a pair of rounded end sections joining the second side walls, a protrusion extending from the distal surface, and a tapered section extending from the distal surface to the second cylindrical shaft.

Abstract: A catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, a lumen extending between the distal end and the proximal end, and a side port. A septum may be disposed within the lumen of the catheter assembly. The side port may include a lumen in fluid communication with the lumen of the catheter adapter. The lumen of the side port may be distally-facing, which may facilitate flushing of fluid trapped proximate a distal face of the septum. The catheter assembly may include a catheter secured within the catheter adapter and extending distally from the catheter adapter.

Abstract: An orifice irrigation device includes a tubular component having a distal end and a proximal end and at least one bore axially extending from the proximal end to the distal end, the bore terminating at a plurality of orifices which extend at an angle from the bore; one or more flared wings coaxially positioned with respect to the tubular component, the at least one flared wing having a rim at its distal end; and one or more open flushing channels defined by the one or more flared wings, the flushing channels being defined by the side edges of the one or more flared wings.

Abstract: Disclosed is a system including an electrode and a stylet configured to steer the electrode towards its intended position during implantation, and a method for such system's use. An electrode is provided having regions with varied flexibility. A stylet having bends that are indexed to specific regions of flexibility of the electrode may be inserted into the electrode, and upon minimal radial and/or longitudinal movement of the stylet within the electrode, will cause the magnitude of the angle to which the lead is bent to either increase or decrease so as to aid the operator in placement of the electrode.

Abstract: Transradial access devices, systems, and methods. An exemplary device of the present disclosure for providing access to a vessel or other luminal organ and to prevent overperforation of the same including a needle having a needle tip and at least one current element positioned thereon or embedded therein at or near the needle tip, a sheath positioned around at least part of the needle, and a protractor in communication with the needle, whereby engagement of the protractor causes the needle tip to protract from the sheath through the aperture, and whereby release of the protractor causes the needle tip to retract through the aperture into the sheath. Activation of the at least one current element can facilitate vasodilation of the vessel or other luminal organ.

Abstract: The present disclosure provides devices and methods for the treatment of ophthalmological conditions such as dry eye. Among the devices provided are punctal plugs and devices for inserting punctal plugs. The punctal plugs may be shaped for insertion in the punctum and/or the canaliculus. They may also be coated with a bioadhesive. Methods for inserting the punctal plugs are provided, as well as methods for preparing bioadhesive-coated punctal plugs. A method is also provided to treat dryeye using a bioadhesive without use of a punctal plug.

Abstract: A tubular body includes an elongated inner layer that demarcates a main lumen; a wire reinforcing layer that is formed by winding a reinforcing wire around the inner layer; a resinous elongated sub-tube that is arranged so as to extend along a longitudinal direction of the main lumen outside the wire reinforcing layer and demarcates a sub-lumen having a smaller diameter than the main lumen; a resinous outer layer that sheaths the wire reinforcing layer and the sub-tube; and a retaining wire. An operating wire is movably inserted through the sub-lumen, and has a tip connected to a distal portion of the tubular body. An operating part is operated to pull the operating wire to bend the distal portion of the tubular body. The retaining wire is sheathed by the outer layer, and winds together the sub-tube and the wire reinforcing layer.

Abstract: An enhanced flexibility catheter shaft having an elongate flexible body with a proximal end, a distal end, and at least one lumen extending therethrough. A distal, flexible section on the body has a ribbed or corrugated tubular membrane having at least a first reinforcement structure, such as a first helical support, on a radially exterior or interior surface of the tubular membrane and optionally a second reinforcement structure, such as a second helical support, on the other of the radially interior or exterior surface of the tubular membrane.

Abstract: Methods and devices described herein facilitate diaphragm entry for posterior access of body organs.

Abstract: Devices for the diagnosis and treatment of microvascular obstruction (MVO) and other dysfunctional diseases of the microvasculature of many organs, including the heart. The present subject matter provides novel devices and methods to detect and measure or treat MVO in real time during scenarios such as invasive angiographic/therapeutic procedures. Such procedures include therapy for organ systems including the heart (acute myocardial infarction-primary percutaneous coronary intervention (PPCI)), brain stroke (CVA), bowel ischemia/infarction, pulmonary emboli/infarction, critical limb ischemia/infarction, renal ischemia/infarction, and others. Using methods of the invention, a system comprising specialized infusion and sensing catheter, diagnostic agents, therapeutic agents, and control console with specialized algorithms can both diagnose and treat MVO by eliminating the microvascular clot and debris causing the obstruction.

Abstract: Apparatus and methods for ocular treatment are provided. The apparatus can comprise a microcannula having a proximal end, a distal end, a cavity, and a central longitudinal axis. The apparatus can include a handle coupled to the proximal end of the microcannula. The apparatus can include multiple orifices extending circumferentially about the microcannula distal end, each of the orifices defining a channel extending transverse to the central longitudinal axis, and one or more grooves about a circumference of the microcannula.

Abstract: A steerable surgical needle (10) includes an elongated needle shaft (12), a beveled tip portion (14), and a flexural element (16) that connects the needle shaft (12) with the tip portion (14) and permits the tip portion to deflect relative to the needle shaft. A method for steering the surgical needle (10) through tissue includes the steps of advancing the needle in the body tissue to induce tip flexure which causes the needle to follow a curved trajectory, and rotating the needle about its longitudinal axis in place, without advancement, to remove the tip flexure.

Abstract: The invention relates surgical abdominal methods of treating obesity in a patient by implanting a volume filling device that, when implanted in a patient, reduces the food cavity in size by a volume substantially exceeding the volume of the volume filling device. Also disclosed is a laparoscopic instrument for providing a volume filling device to be invaginated in the stomach wall of a human patient to treat obesity.

Abstract: Provided is a precision variable flow rate infusion system and method for delivering a liquid from a reservoir having an initial potential outflow rate to a patient. The system includes at least a first flexible flow rate tubing having a pre-defined flow rate selected at a maximum dosage flow rate for the liquid from the reservoir, the pre-defined flow rate being less than the initial potential outflow rate of the reservoir. Also provided is an adjustable flow rate controller having an inlet and an outlet, at least one internal fluid pathway there between and a fluid pathway modifier structured and arranged to modify the internal fluid pathway from the inlet to the outlet from a closed pathway to a maximum flow pathway with a plurality of different flow rate pathways there between.

Abstract: Catheters with at least two curved portions near their distal ends are provided. The lengths and/or curvatures of the curved portions are selected so that a catheter can be advanced through a brachiocephalic or left subclavian artery (BCA or LSC) to access the ascending or descending aorta (AA or DA), withdrawn therefrom, and simply rotated to access the AA or DA. Hence, the catheters provide access to both the AA and DA through the BCA or LSC without any need to withdraw the catheter from the BCA or LSC, e.g., so a second catheter can be exchanged for it. The catheter can further be advanced through the DA into the abdominal aorta and rotated to access branch arteries including the vessels of the lower extremities. The catheters are usable for flush aortography, arteriography, and intravascular pressure measurements, and can be introduced to the BCA or LSC via radial artery access.

Abstract: A catheter assembly 10 comprises a catheter 12 including a longitudinally extending wall 16 with inner and outer surfaces. The inner surface of the wall defines a bore 22 extending longitudinally through the catheter defining a first lumen 52 and a second lumen 54. At least one of the first and second lumens communicates with an opening in the outer surface of the wall at a distal end of the catheter. An elongated separator 14 includes a longitudinally extending surface that at least partially defines the second lumen. The longitudinally extending surface of the separator is disposed asymmetrically relative to the bore when viewed in cross-section taken transverse to the longitudinal extent of the separator adjacent to a distal end of the separator. At least a portion of the separator is movable relative to the bore and the inner surface of the catheter wall.

Abstract: According to one implementation a central venous catheter is provided that includes an end emitting optical fiber that is configured to end emit bacterial disinfecting light to disinfect a conduit located inside the hub, the conduit connecting the working lumen of an infusion shaft with a working lumen of a main shaft.

Abstract: A parison for being blow molded into a medical balloon for a catheter includes a first tubular layer having a functional modification and a second tubular layer adapted for bonding with the first tubular layer to form the blow molded balloon. Related methods are also disclosed.

Abstract: The disclosure generally relates to adjustable sheath devices for insertion into the body to provide intravascular access to various medical devices, involving a dynamically expandable sheath capable of expanding within the blood vessel when a medical device is passed through the sheath and retracting back to almost its original size when the medical device is removed from the sheath. Embodiments generally comprise a rigid collar and an elongated sleeve comprising a continuous elastomeric outer layer and an expandable inner layer.

Abstract: The present disclosure relates to devices used to access the pericardial space of the heart. In particular, the present disclosure describes an apparatus to enable an operator to access the pericardial space of the heart, and deliver cardiac therapies to the pericardial space, under direct visualization through a single, small incision.

Abstract: A stretchable display device is disclosed, which is able to be operated with three states of a non-stretched state, a transition state and a stretched state, and the stretchable display device includes a stretchable substrate and a plurality of light emitting units. The plurality of the light emitting units are disposed on the stretchable substrate, and the plurality of the light emitting units are in a mode of ON or in a mode of OFF. The light emitting units being in the mode of ON are in a number of N1 while in the non-stretched state, the light emitting units being in the mode of ON are in a number of N2 while in the transition state, and the light emitting units being in the mode of ON are in a number of N3 while in the stretched state, wherein N3?N2>N1.

Abstract: A dilator tip may include an elongated tubular member defined by a circumferential wall and having a distal tip region and a proximal end, and a plurality of ribs extending longitudinally between the distal tip region and the proximal end. The plurality of ribs may extend radially outward from the elongated tubular member, and the plurality of ribs may be spaced apart circumferentially.

Abstract: A support apparatus for supporting a trocar while the trocar extends through a body wall of a patient includes an inflatable collar and a slidable abutment collar commonly connected for engagement onto the trocar following which the slide collar is released to slide along the trocar. The inflatable collar is inflated to a set size by a manually operable pump on the slidable collar operated by squeezing finger abutments together up to a latch so that threaded portion expels the inflation fluid. The abutment member is shaped to be received on an outer surface of the trocar and adjustable longitudinally of the trocar sleeve so as to be located at a selected position by a manually movable latch collar. The inflatable collar and slidably collar are held connected by a manually operable release.

Abstract: An intravascular access system for facilitation of intraluminal medical procedures within the neurovasculature through an access sheath. The system includes an aspiration or support catheter having a flexible, distal luminal portion having an inner diameter defining a lumen extending between a proximal opening at a proximal end of the luminal portion and a distal opening at a distal end of the luminal portion. The catheter has a rigid spine coupled to at least the proximal end of the luminal portion and extending proximally therefrom. The system includes a dilator having a flexible, distal dilator portion sized to be received within the lumen of the luminal portion. Associated systems, devices, and methods of use are also described.

Abstract: Methods and systems for a catheter access port cleaning, disinfection or sterilization device are disclosed. The catheter access port cleaning, disinfection or sterilization device may comprise, a first housing having a power source and control circuit; a second housing shaped to mate with a catheter and having a first ultra-violet light source mounted therein, the first housing wired to the second housing to power the light source. When activated, the ultra-violet light source emits ultra-violet radiation that is transmitted from the second housing to the catheter attached to a patient. In this way, the device provides an efficient system for cleaning, disinfecting or sterilizing an access port in the second housing while reducing patient infections.

Abstract: A plug for occluding an ocular canaliculus comprises a cylindrical body member having a first outer diameter. The cylindrical body member is provided along an external surface with at least one outwardly extending projection having a second outer diameter greater than the first outer diameter and larger than an inner diameter of an ocular canaliculus. The first outer diameter of the plug is typically less than and approximately equal to the inner diameter of the canaliculus.

Abstract: Tissue localization devices and methods of localizing tissue using tissue localization devices are disclosed. The tissue localization device can comprise a handle comprising a delivery control, a delivery needle extending out from the handle, and a localization element within the delivery needle. The localization element can be deployed out of the delivery needle or retracted back into the delivery needle when the delivery control is translated in a first direction or a second direction, respectively. The localization element can be coupled to a flexible tracking wire.

Abstract: Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a delivery system for use in occluding an opening in the tissue of a body includes an actuation assembly operatively coupled to a medical device including an anchor portion and an occluder portion. The actuation assembly is configured to move the anchor portion between a deployed state and retracted state while the occluder portion maintains a deployed state. With this arrangement, the deployed occluder portion can be visualized via imaging at a preferred position prior to deploying the anchor portion of the medical device.

Abstract: Vascular access devices, systems, and methods of their use are provided. In one embodiment, a vascular access device includes a catheter, a balloon, and an inflation lumen. The catheter includes an elongate flexible shaft having a proximal end and a distal end with a primary lumen therethrough. The balloon is disposed about the distal end of the catheter. The inflation lumen is in fluid communication with the balloon and extends toward the proximal end of the shaft of the catheter. The balloon is inflatable into a shape having a first open end, a second open end, a sidewall between the first and second open ends, and a passageway therethrough, which, when the balloon is deployed and inflated within a vessel, permits blood flowing in the vessel to flow through the passageway.

Abstract: This invention relates to local administration of a bone-forming agent and at least one anti-resorptive agent to treat osteoporosis and related disorders.