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: 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 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: 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: 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: 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: 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 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: 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: 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: A catheter assembly includes a catheter, an inner needle, and a deflection suppression mechanism that suppresses a deflection of the inner needle. A side flow path structure having at least one liquid passage is provided on a circumferential wall of the catheter. The deflection suppression mechanism has a sliding contact support portion that can support the catheter while sliding against the catheter when the catheter is advanced with respect to the inner needle. In an initial state, the sliding contact support portion is located to be closer to a proximal side than a liquid passage located on a most distal side in the side flow path structure.

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: A method includes receiving, from a probe that includes electrodes and is positioned inside a cavity in an organ of a patient, (i) proximity signals indicative of proximity of the electrodes to a wall of the cavity, and (ii) position signals indicative of positions of the electrodes within the cavity. Based on the proximity signals and the position signals, at least a portion of a volume of the cavity is represented by a sphere model including multiple spheres. A direction is identified along which one or more spheres are larger than one or more surrounding spheres by at least a given factor. Based on the indicated direction, a location of an opening in the wall of the cavity is estimated and presented to a user.

Abstract: An electrosurgical device capable of both: (i) generating a radiative microwave field to perform either blood coagulation or sterilization, and (ii) dispensing a liquid to a target area, e.g. adrenaline for the treatment of peptic ulcers. Using microwave energy allows controlled coagulation which is unaffected by changes in tissue impedance during coagulation, and which can achieve a high level of coagulation within a given time. The electrosurgical device comprises a probe tip having a coaxial transmission line that includes a hollow inner conductor having a dielectric material formed on an inner surface thereof. A liquid-conveying channel is located inside the dielectric material. The probe tip includes a conductive element coupled to receive microwave energy from the coaxial transmission line, the conductive element forming a radiating antenna structure for emitting a microwave EM field outwardly from the probe tip.

Abstract: A suction catheter system is described with a suction extension interfaced with a guide catheter to form a continuous suction lumen extending through a portion of the guide catheter and through the suction extension. The suction extension can be positioned by tracking the suction nozzle through a vessel while moving a proximal portion of the suction extension within the lumen of the guide catheter. The suction extension can comprise a connecting section with a non-circular cross section for interfacing with the inner lumen of an engagement section of the guide catheter. The tubular body of the guide catheter can have a reduced diameter distal section the can be useful to restrain the movement of the suction extension. Proximal fittings attached to the guide catheter can facilitate safe removal of the catheter system from the patient by allowing for the removal of some or all of a tubular extension of the suction extension from the guide catheter behind a hemostatic seal.

Abstract: One embodiment is directed to a system for deploying a device to a distal location across a vessel, comprising an elongate introducer sheath tubing member comprising open-cell fibrous wall material defining a lumen therethrough, wherein in a collapsed configuration the sheath has a first cross-sectional outer diameter and a first lumen inner diameter, and in an expanded configuration, the sheath has a second cross-sectional outer diameter and a second lumen inner diameter; and a substantially non-porous expandable layer coupled to a proximal portion of sheath and configured to prevent fluids present in the lumen from crossing the fibrous wall material.

Abstract: A stent is disclosed that has an elongated body having a proximal end, a distal end, at least one open spiral channel formed on the exterior surface of the body to provide fluid communication between the proximal end and the distal end. The stent also has a central lumen open at the proximal and distal ends of the stent for the passage of a guide wire. A method for using the stent and a kit containing the stent are also disclosed.

Abstract: A delivery tool connectable with a syringe can be used to deliver a viscoelastic solution. The tool includes a first segment, a second segment and an inner lumen defined by the first and second segments. A distal portion extends from the second segment in a curved manner.

Abstract: An actuated telescoping system for navigation within a vascular lumen and thrombectomy of a thrombus. The system includes a tubular catheter member having an open distal end defining a catheter lumen, a vacuum source, a rotational drive system, a flexible shaft having a channel coupled to the rotational drive system for rotational movement in response thereto, and an optional guidewire selectively inserted at least partially within the flexible shaft. The flexible shaft is at least partially disposed within the tubular catheter member configured for uncoupled rotational and translational motion therein and to optionally define a corkscrew motion in response to rotational driving force by the drive system that results in formation of hydrodynamic vortices within the catheter lumen.

Abstract: A method and apparatus for fluid delivery enables navigation through tortuous, spatially restricted body anatomy to access narrow diameter body lumens for the continuous delivery of fluids, including therapeutic fluids, to the lumen in an atraumatic manner that avoids damage to the body lumen. The fluid delivery device can have a flexible conduit having a proximal end, a distal end, and a lumen extending along an interior of the flexible conduit providing a fluid flow path between the proximal and distal ends, where the lumen transitions into a micro-lumen exiting through a port through which a high concentration of fluid injected into the lumen exits laterally out along an image viewable zone at the distal end of the flexible conduit. The flexible conduit has a maximum outer diameter sized sufficient to navigate narrow diameter body lumens.

Abstract: A heart pump assembly includes an elongate catheter with a proximal portion and a distal portion, a rotor at the distal portion of the elongate catheter, a driveshaft, and a bearing. The rotor can include an impeller blade shaped to induce fluid flow in a first axial direction. The drive shaft may be coupled to or integrally formed with a proximal end of the rotor and can include a pump element formed in a surface of the drive shaft. The bearing can include a bore into which the drive shaft extends. The pump element is shaped so as to induce fluid flow through the bore in a second axial direction which can be the same or opposite to the first axial direction.

Abstract: An actuated telescoping system for navigation within a vascular lumen and thrombectomy of a thrombus. The system includes a tubular catheter member having an open distal end defining a catheter lumen, a vacuum source, a rotational drive system, a flexible shaft having a channel coupled to the rotational drive system for rotational movement in response thereto, and an optional guidewire selectively inserted at least partially within the flexible shaft. The flexible shaft is at least partially disposed within the tubular catheter member configured for uncoupled rotational and translational motion therein and to optionally define a corkscrew motion in response to rotational driving force by the drive system that results in formation of hydrodynamic vortices within the catheter lumen.

Abstract: A method of manufacturing a micro-molded electrode (160) having multiple individually addressable sensors (140) along a shaft (180) can include forming a recess in a mold substrate, depositing a structural material therein, depositing a conductive material at specific locations, providing a coating (190), and removing the mold substrate. A micro-molded electrode (160) having a base (170) tapering to at least one shaft (180) can include an electrode substrate, multiple individually addressable sensors (140), and a coating (190).

Abstract: A laparoscopic flexible suction/irrigation device of the present invention encases a inner rigid cannula with an outer flexible cannula. Upon translating the distal end of outer flexible cannula beyond the distal end of the inner rigid cannula, the outer flexible cannula returns to a preexisting curvilinear shape. This curved extension can thereafter be positioned via a proximal handle to concavities within the surgical site for precise and effective fluid retraction.

Abstract: Disclosed delivery catheters have a three-dimensional curvature that facilitates reaching the RAA from the inferior vena cava, positioning the distal end of the catheter generally parallel to the plane of the pericardial space at the puncture location within the RAA, orienting the puncturing device in a direction that avoids the right coronary artery, aorta, pulmonary artery, and other structures to prevent bystander injury to such structures, and provides sufficient rigidity to puncture through a wall of the RAA into the pericardial space.

Abstract: Disclosed is a wrapping cape system which displays favorable grasping characteristics in operations for the entrapment and removal of blocking items in tubular geometries. The wrapping cape system yields a configuration that surrounds the blocking item, such as a thrombus, peripherally, thus capturing its body tangentially and allowing the operator to pull it along the surrounding tube (for instance vein or artery) by utilizing shear forces distributed along the surface of the blocking item in its axial direction. The advantage stems from the fact that the blocking item is not pushed from behind during its withdrawal, but pulled instead; also, since there is no penetration, fragmentation is avoided.

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.