Abstract: An apparatus for and method of manufacturing an improved wire-reinforced plastic tubing for medical and other applications is disclosed. A plurality of spaced-apart wire segments may be wound onto successive portions of a long segment of plastic tubing which portions are supported for rotation to wind coil wire thereon by rotating the plastic tubing while a supply of coil wire is wound onto the plastic tubing. When multiple winding segments have been wound on the long segment of plastic tubing, the segments may be separated into individual wire-reinforced tubing products each having one or more wire windings thereupon.

Abstract: The present invention discloses a task specific robot for the procedure of endoscopic submucosal dissection (ESD). This robot has two arms with nine degrees of freedom (DOF), and the capability of tissue elevation and dissection. An optimal design of these robot arms requires the use of shape memory alloy (SMA) wire and steel wire actuators to develop an improved actuation mechanism, which enables force to be transmitted to the distal tip of the robot arms for an efficient tissue elevation and dissection.

Abstract: High flow rate catheters, and related methods, are useful in dialysis and other procedures. A catheter according to the invention comprises a hub and a generally elongated conduit. The conduit has a substantially continuous and smooth wall. The conduit also defines at least one lumen and has a length extending from a proximal end to a distal end of the conduit. The proximal end is coupled to a hub and the distal end has an opening in communication with the lumen. The conduit has a conical shape which tapers along the length.

Abstract: An implantable prosthesis is provided for repairing a fistula, such as an anal fistula. The prosthesis or fistula repair device may include a body with a shape configured for placement in the fistula. The prosthesis may also include an anchor or base that is located at one or both ends of the body to facilitate anchoring the prosthesis in position. The prosthesis may include one or more channels to create one or more pathways for drainage and/or irrigation of the fistula. The channel may have a relatively uniform dimension along its length or a tapered shape that increases along its length. The prosthesis may have an adjustable length for accommodating fistula tracts of varying lengths. The prosthesis may include elongated body segments that provide a wicking or capillary function to facilitate drainage of the fistula tract.

Abstract: An apparatus for performing a nerve block procedure, the apparatus being composed of an echogenic needle or an echogenic soft tissue tunneling device and an echogenic catheter configured for controlled delivery of a medication. The apparatus may further include a sheath such that at least one of the needle or tunneling device and sheath is echogenic. The present invention also encompasses a system for performing a nerve block procedure, the system includes introducing an echogenic needle in the general area of a nerve bundle, positioning the echogenic needle adjacent the nerve bundle utilizing sonic imaging techniques, introducing an echogenic catheter configured for controlled delivery of a fluid through the echogenic needle, withdrawing the echogenic needle, positioning the echogenic catheter adjacent the nerve bundle utilizing sonic imaging techniques, and delivering fluid to the nerve bundle through the echogenic catheter.

Abstract: A deployment system for a self expanding stent includes a catheter assembly with a tip attached to a distal end segment of an elongate tube. The tip includes a proximal portion molecularly joined to a distal portion, which has a lower durometer hardness than the proximal portion. The proximal portion includes an anchor surface in contact with the distal portion, and oriented perpendicular to a central axis of the elongate tube. The elongate tube may be formed from a thermosetting polyimide, and the overmolded tip may be made from two different colored and different hardnesses of polyether block amide material. The tip is overmolded onto an untreated external surface of the elongate tube.

Abstract: An over-tube was developed for receiving and guiding endoscopic instruments into a patient's anus, through the colon, and into the peritoneum. The over-tube has a flexible sheath adapted for insertion into the anus through the colon and out the peritoneum of a patient. A stiffened region is used to protect the colonic wall from injury during insertion of medical instruments through the patient's lower gastrointestinal tract. The proximal end of the over-tube is surrounded by two narrow inflatable balloons on either side of the colotomy to keep the device in place with its lumen open into the peritoneum and further prevent leakage of insufflation. The device may comprise two channels, one for duel channel endoscopes and larger medical instruments or single lumen endoscopes, and an additional channel for surgical instruments. A distal valve prevents insufflation leakage, making the device especially useful in NOTES surgeries.

Abstract: A method for automated segmentation of a blood vessel of a head and neck of a subject in a medical image, the method comprising: identifying the location of anatomical landmarks in the medical image; identifying regions of interest in the medical image based on the landmarks; segmenting segments of blood vessels in the medical image; classifying at least one of the segments as defining the blood vessel based on its position relative to the landmarks within the regions of interest to create a classified blood vessel; identifying a starting seed for the blood vessel from the classified blood vessel; identifying an ending seed for the blood vessel from the classified blood vessel; segmenting the blood vessel between the starting seed and the ending seed; and defining a path between the starting seed and the ending seed.

Abstract: The present invention provides a flexible catheter system and method for providing easier access and delivery of therapeutics and or devices via the human vasculature. The flexible catheter system comprises a luer connector attached to a flexible catheter body by a proximal shaft. The method includes the steps of providing a patient in need of an interventional procedure, obtaining a flexible catheter system, inserting the flexible catheter system into the patient through the right radial artery located in the right arm of the patient, and tracking the flexible catheter body from the right radial artery to the heart of the patient.

Abstract: The present invention is an electrophysiology, RF ablation, or similar catheter (i.e., catheter or sheath) that includes an actuator that significantly increases the length of travel (i.e., steering travel) of the actuation wires, as compared to the length of travel provided by prior art actuators. The catheter includes a hollow flexible tubular body, a pair of actuation wires disposed in a side-by-side relationship in the body, a handle attached to a proximal end of the body, an actuator pivotally mounted to the handle, an arcuate internal gear rack disposed on the actuator, one or more pulleys pivotally mounted on the handle and coaxially coupled to a pinion gear engaged with the gear rack, and a guide block mounted within the handle. The one or more pulleys include a first channel in which the first actuation wire resides and a second channel in which the second actuation wire resides. The actuation wires pass through holes in the guide block, which aligns the wires into their respective channels.

Abstract: A urinary catheter includes a tube and a tip. The tube has a tube wall defining a lumen extending between a distal tube end and a proximal tube end, with an opening formed in the tube wall. The tip extends from the proximal tube end to a closed proximal tip end. An inside diameter of the lumen increases constantly along an entire length of the tube from a first inside diameter measured at the proximal tube end to a second inside diameter measured at the distal tube end, where the first inside diameter is smaller than the second inside diameter such that the lumen is formed in a conical shape that diverges from the proximal tube end to a wider cross-sectional opening at the distal tube end.

Abstract: An assembly includes a prosthetic heart valve and a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve of a patient. The prosthetic heart valve has a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent. The delivery apparatus has a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first and second shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, and a nose piece coupled to the distal end portion of the second shaft.

Abstract: A system for redistributing interstitial fluid within a mammal is disclosed. The system comprises an implantable accumulation chamber, a confined flow passageway such as a catheter in communication with the accumulation chamber, and a liquid transfer pump for dispensing accumulated interstitial fluid from the accumulation chamber to a predetermined body site via the confined flow passageway.

Abstract: A dual lumen cannula is provided for conveying a fluid into an injection site through an inner lumen of the cannula. Fluid pressure is relieved from the injection site via a plurality of egress ports located along an outer lumen of the cannula.

Abstract: An electrode array assembly with a frame that is foldable or bendable on which electrodes are disposed. The frame includes laterally spaced apart bridges. Tabs extend laterally outwardly from the bridges Electrodes are disposed on the tabs. Beams, also part of the frame, extend between the laterally adjacent bridges. The frame can be folded around the beams so as to cause the laterally spaced bridges to at least partially overlap. When the beams are so bent, the electrode array can be disposed in an access cannula that has a diameter less than the width of the unfolded array.

Abstract: A male luer medical connector includes a needle having a distal portion with a hole opening and contained in the cavity of a resilient seal. The needle has, apart from its distal portion, an additional hole. The seal and needle are shaped so that when the connector is connected, the compressed seal forms with the needle, immediately upstream of the upper level of the additional hole, a sealed cavity for receiving by way of passage in the additional hole a part of the fluid contained in the needle; and when the seal is released the cavity contains fluid when the lateral hole opening into the needle is sealed, and the portions of the seal, downstream and upstream of the cavity respectively, as well as the additional hole, are shaped so the downstream portion closes a lateral hole while the same cavity continues to discharge the fluid into the needle.

Abstract: Systems, methods, and devices are provided for the treatment of edema. In one aspect a method for implanting an indwelling catheter within a vein of a patient is provided. The catheter can extend from a position upstream of at least one outflow port of a duct of the lymph system to a terminal position downstream of the at least one outflow port. In use, a first restriction can be created within the vein proximal to a distal region of the catheter. The first restriction can define a localized low pressure zone distal of the restriction and within a portion of the vein housing the catheter. The low pressure zone can be adjacent to the at least one outflow port to enable fluid to pass from the at least one lymph duct outflow port into the vein.

Abstract: A stent delivery device has a handle and a sliding body, the sliding body is slidable with respect to the handle. The handle has a grip and a guide. The sliding body has at least two flange portions extending from the sliding body. The flange portions are offset from one another along the length of the sliding body. The operator can thereby deploy a relatively long stent by first gripping the nearest flange portion and pulling the sliding body toward the handle; subsequently, the operator can reposition his/or finger on the next-nearest flange portion and continue deployment of the stent by pulling the sliding body further toward the handle.

Abstract: A surgical instrument includes an elongated shaft having a distal portion and a proximal portion coupled to a housing. An inner shaft member extends at least partially through the elongated shaft and is selectively movable in a longitudinal direction. An end effector is supported by the distal portion of the elongated shaft. The end effector includes upper and lower jaw members pivotally coupled to the distal portion of the elongated shaft about a pivot axis and including a pair of laterally spaced flanges. The pairs of flanges of the jaw members are arranged in an offset configuration such that one flange of the upper jaw member is positioned on a laterally exterior side of a corresponding flange of the lower jaw member, and the other flange of the upper jaw member is positioned on a laterally interior side of the other flange of the lower jaw member.

Abstract: An agent delivery catheter including a first hollow tube and a second hollow tube that protrudes from a distal opening of the first hollow tube and defines an agent delivery lumen extending along the entire length of the catheter. The distal end of the first tube is coupled to the second tube to form an annular cavity between the first tube and the second tube, the annular cavity provided for accommodating a retractable stylet shaft. An adapting member is disposed on and coupled to a proximal end of a ceramic member and for receiving a distal end of the stylet shaft.

Abstract: A luer medical connector having a male luer body for connection with a female luer assembly which includes a female luer body, a fluid channel insert within the female luer body, an elastomeric seal between the female luer body and the male luer body, and an elastomeric stopper at a proximal end of the female luer body.

Abstract: A vascular access device, for implantation at least partially below the skin of a patient to provide an arteriovenous fistula, includes a graft portion coupled to a catheter portion. The graft portion is sutured to an opening in an artery while the catheter portion is inserted into a vein so that its end lies within the vein downstream from the point of entry into the vein. The device may be comprised of ePTFE with an outer polyurethane coating or the graft portion may comprise ePTFE with an outer polyurethane coating and the catheter portion may comprise polyurethane. There may also be an inner polyurethane coating. Alternatively, the device may be comprised entirely of polyurethane.

Abstract: An inspectable joint in a medical device is disclosed that includes at least one medical-grade tube having an end, a medical-grade fitting having at least one joining surface configured to accept the end of the tube, and a joining material disposed between the tube and the joining surface. The joining material includes a first component configured to couple the tube to the fitting and a second component configured to provide observable evidence of the presence of the joining material between the tube and the joining surface.

Abstract: An intravascular intervention system can include a manipulation member sized for insertion into a blood vessel and an intervention member coupled to the manipulation member. The manipulation member can include a longitudinally extending tube having a helical cut extending along the tube. The helical cut can have an axial length of at least 50 cm and be continuous along the axial length. The intervention member can be compressible to a collapsed configuration for delivery to an endovascular treatment site through a catheter and be self-expandable from the collapsed configuration to an expanded configuration.

Abstract: Embodiments relate to a dilator and catheter introducer systems. The dilator system includes a dilator including a dilator lumen, and one or more cores for positioning in the dilator lumen. The catheter introducer systems further include a sheath including a sheath lumen operable to receive at least a portion of the dilator therein. Each core imparts a curvature to the dilator; modify the bending resistance of the dilator, or a combination thereof.

Abstract: A lead for navigating small vessels and a catheter system for implantation of leads into small vessels. Veins that return blood to the heart against the force of gravity often have valves in them to prevent backflow of deoxygenated blood. Leads and catheter systems in accordance with embodiments of the invention allow cannulation and lead implantation in small, tortuous, obstructed, and difficult to access veins enabling a range of stimulation and sensing applications.

Abstract: A gastrointestinal implant device is anchored in the duodenum and extends beyond the ligament of Treitz. All food exiting the stomach is funneled through the device. The gastrointestinal device includes an anchor for attaching the device to the duodenum and an unsupported flexible sleeve. The anchor can include a stent and/or a wave anchor and is collapsible for catheter-based delivery and removal.

Abstract: The present disclosure is directed to template devices and methods for using the same in aortic arch reconstruction.

Abstract: A delivery system for percutaneously delivering and deploying a stented prosthetic heart valve. The delivery device includes a delivery sheath slidably disposed over an inner shaft, and a capture assembly. The capture assembly includes a spindle and a biasing member. The spindle is attached to the inner shaft and defines slot. The biasing member is disposed within the slot and self-transitions from a deflected condition to a normal condition. In a delivery state, the delivery sheath retains the prosthesis over the inner shaft and coupled to the spindle via the capture slot, including a portion of the prosthetic valve being engaged within the slot and the biasing member forced to the deflected condition. In a deployment state, the delivery sheath is proximally withdrawn and the biasing member self-transitions toward the normal condition to eject the prosthetic valve from the capture slot.

Abstract: A tool for facilitating insertion of a speech valve with a flexible retention flange into a fistula between the trachea and the esophagus of a human patient. The tool has a wall curved to define a passage having opposed open first and second passage ends and an axis extending therebetween. The wall has an external surface insertable into a fistula between the trachea and esophagus and defining a slot which extends from the passage to the external surface of the wall. The slot has an opening at the first passage end extending from the first passage end to at least a part of the way to the second passage end and at least a portion of the slot progresses angularly around the axis.

Abstract: A deployment system for vascular repair of a transected body vessel is provided. The system can include a prosthesis, an inner sheath, and an outer sheath. The inner sheath can be configured to selectively retain a first portion of the prosthesis in the compressed configuration, leaving a remaining portion of the prosthesis uncovered by the inner sheath. The outer sheath can be configured to retain the remaining portion of prosthesis in the compressed configuration and the first portion of the prosthesis within the inner sheath. The outer sheath is removable from the prosthesis to allow an expansion of the remaining portion of the prosthesis to the expanded configuration at a first opening in the transected vessel. The inner sheath is removable from the prosthesis first portion to allow an independent expansion of the first portion to the expanded configuration at a second opening in the transected vessel.

Abstract: Embodiments herein include devices and methods directed toward creating reverse flow within a vessel and thereby providing protection against embolic debris. Embodiments comprise a catheter and a plurality of occluders that are expandable and adjustable within a lumen to create low-pressure areas that reroute blood flow and embolic debris therein.

Abstract: A catheter tunneling adapter including a longitudinal body having a distal end and a proximal end and a passageway extending from an entrance at the proximal end to an exit at the distal end. The passageway has a first hemisphere and a second hemisphere with the first hemisphere defining a generally unobstructed first passageway portion from the entrance to the exit. A guide ramp is positioned within the second passageway and tapers towards the first hemisphere moving from the proximal end to the distal end. The ramp defines a longitudinal notch therethrough such that a second passageway portion extends from the entrance to the exit.

Abstract: Elongate, flexible catheter includes a shaft having a proximal end, a distal end, and a lumen extending therein. The shaft has an inner layer comprising an amorphous polyamide having a Shore D durometer value of greater than 78, and an outer layer comprising a semi-crystalline polyamide or copolyamide having a Shore D durometer value of less than 76. The outer layer is thinner than the inner layer. The shaft has an increased resistance to kinking as compared to a similar shaft of a single layer of the amorphous polyamide having a Shore D durometer value of greater than 78.

Abstract: A capsule assembly for an endograft introducer is disclosed. The assembly comprises: a capsule and a capsule plug. The capsule has a cavity for receiving an end of a stent graft and a capsule wall terminating in a distal end. The capsule plug comprises: a tip portion having a lead-in surface and an abutment surface; and a tail portion having an external surface engageable with an inside surface of the capsule wall. The capsule is slideably movable with respect to the capsule plug from a first position in which the distal end of the capsule wall surrounds an opening into the cavity to a second position in which the distal end of the capsule wall is positioned proximally with respect to the abutment surface, whereby movement of the tip portion into the capsule is resisted by abutment between the distal end of the capsule wall and the abutment surface.

Abstract: A method is provided including introducing a delivery device through a vessel wall to a treatment site within one of a peri-adventitial space or a pericardium adjacent a coronary blood vessel and delivering a treatment agent through the delivery device. The treatment agent is delivered through the delivery device according to conditions that hydraulically dissect tissue planes within the peri-adventitial space. A kit is provided including a delivery device having a needle to be advanced through one of an epicardium of a heart and a wall of a coronary blood vessel into a peri-adventitial space and a treatment agent comprising particles having an average diameter on the order of 15 microns or more to be delivered through the delivery device into the peri-adventitial space.

Abstract: The instant invention relates generally to catheters and to introducer catheters used to help deliver catheters or other medical devices to locations within the human body. In particular, the instant invention relates to large diameter catheters and introducer catheters having a torque transfer layer that includes at least two flat wires braided into a wire mesh. The flat wires have a width of at least about 0.007 inches and a depth of at least about 0.003 inches. The lumen diameter of the catheter is at least about 6 French. The torque transfer layer provides increased strength, flexibility, and kink resistance.

Abstract: A steerable laser probe may include a handle having a handle distal end and a handle proximal end, a flexible housing tube having a flexible housing tube distal end and a flexible housing tube proximal end, an actuation mechanism control of the handle, and an optic fiber disposed within an inner bore of the handle and within the flexible housing tube. An actuation of the actuation mechanism control may be configured to gradually curve the flexible housing tube. A gradual curving of the flexible housing tube may be configured to gradually curve the optic fiber. An actuation of the actuation mechanism control may be configured to gradually straighten the flexible housing tube. A gradual straightening of the flexible housing tube may be configured to gradually straighten the optic fiber.

Abstract: The present invention concerns a flexible stapling device (1). More particularly, this invention concerns a flexible endovascular stapling device (1) for an intravascular procedure such as patent foramen ovate closure, which is designed to avoid open heart surgery by permitting the closure of the defect utilizing a stapling means (26) which is positioned by using a flexible shaft/guidewire system.

Abstract: A cannula comprising a polymeric material which is phthalate-free, yet retains flexibility, workability and elongation properties so as to avoid kinking when bent. Also disclosed is a method of manufacturing a cannular device comprising extruding a flexible, biocompatible, phthalate-free polymeric composition through a round die into a tube, pulling the tube through a water bath at a rate established according to a predetermined function, and cutting the tube to for a cannular device, wherein the predetermined function periodically modulates a pulling rate.

Abstract: The invention is directed to eluting medical devices that enable consistent “on-demand” delivery of therapeutic agents to a vessel. The medical device of the current invention comprises an expandable member, a hydrophilic coating comprising at least one therapeutic agent about the expandable member or structural layer and an outer sheath with a variably permeable microstructure. The design and methods disclosed herein ensures that therapeutic agent delivery occurs essentially only during expansion of the expandable member, minimizing coating and/or therapeutic agent loss to the bloodstream and providing controlled delivery to the treatment site.

Abstract: A balloon catheter having a multilayer catheter shaft is formed to have an inner layer and an outer layer, where the inner layer and outer layer are selected from materials that enhance the pushability of the catheter while preserving the flexibility. Using a combination of a high Shore D duromater value material and a lower Shore D duromater value material, various combinations of multilayer catheter shafts are disclosed utilizing different glass transition temperatures and block copolyamides to obtain the desired characteristics.

Abstract: A tunneling system for use with a catheter includes an elongate tunneling member defining a longitudinal axis along at least a portion of a longitudinal length thereof. The elongate member has a first end and a second end. The tunneling system further includes a connector configured for releasably engaging the second end of the elongate tunneling member to the catheter.

Abstract: A bi-directional catheter with nearly double the throw in its catheter tip deflection defines a puller wire travel path having a U-turn a pulley which minimizes the offset angle between the puller wire and the longitudinal axis of the control handle while maximizing the travel distance of that puller wire for any given distance traveled by the pulley drawing the puller wire. In particular, the control handle of the catheter which includes a steering assembly having a lever arm carrying a pair of pulleys for drawing corresponding puller wires to deflect the tip section of the catheter. The pulleys are rotatably mounted on opposing portions of the lever arm such that one pulley is moved distally as the other pulley is moved proximally when the lever arm is rotated.

Abstract: An intravascular catheter for peri-vascular or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, or such as nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system may also controls the depth of penetration of the ablative fluid into and beyond the tissue of the vessel wall. The catheter may also include structures which provide radial and/or lateral support to the guide tubes so that the guide tubes expand uniformly and maintain their position against the interior surface of the vessel wall as the sharpened injection needles are advanced to penetrate into the vessel wall.

Abstract: A method of treating an intravascular site in a patient includes spraying jets of treatment fluid out of spray orifices formed in an elongate catheter body, and changing an impingement pattern of the treatment fluid on material within the intravascular site in response to a torque induced by a back pressure of the jets. A thrombolysis catheter includes an elongate catheter body having a plurality of spray orifices formed in a body wall, and communicating with a fluid lumen longitudinally extending in the elongate catheter body. The plurality of spray orifices define a torque inducing spray jet pattern, whereby a back pressure of spray jets exiting the spray orifices induces a torque on the elongate catheter body.

Abstract: An implant delivery system for delivering a sheet-like implant is disclosed. The implant delivery system includes a distal guidewire port for receiving the proximal end of guidewire after the guidewire distal end has been affixed to a first point on bone or other tissue. The implant delivery system is tracked over the guidewire to a selected position defined by the guidewire attachment. The device includes an implant spreader assembly disposed proximate the distal end of a delivery shaft. The implant spreader assembly includes a first arm and a second arm. The arms are coupled to the delivery shaft such that the first arm and second arm are moveable between a closed position and an open position. When pivoting to the open position the distal end of each arm travels in a generally transverse direction to spread a sheet-like implant.

Abstract: A coil for transmitting torque comprises a wire having a longitudinal axis and first and second longitudinal edges extending along the longitudinal axis, wherein the first longitudinal edge is formed with a first pattern and the second longitudinal edge is formed with a second pattern complementary to the first pattern, the first and second patterns being configured to interlock with one another when the wire is wound into a helical shape.

Abstract: The instant invention relates generally to catheters and to introducer catheters used to help deliver catheters or other medical devices to locations within the human body. In particular, the instant invention relates to large diameter catheters and introducer catheters having a torque transfer layer that includes at least two flat wires braided into a wire mesh. The flat wires have a width of at least about 0.007 inches and a depth of at least about 0.003 inches. The lumen diameter of the catheter is at least about 6 French. The torque transfer layer provides increased strength, flexibility, and kink resistance.

Abstract: The CSF shunt valve includes an elongate, hollow housing and a valve unit disposed within the housing. A plurality of exit ports are formed along the wall of the housing, and a plurality of bleeder ports are formed on the bottom of the housing. The valve unit includes at least one regulating mechanism disposed within the housing. Each regulating mechanism includes an obstructing member operatively attached to a spring. The spring is compressible within a predefined range of fluid pressure. The obstructing member compresses the attached spring in response to fluid pressure acting thereon, opening the exit ports for fluid being drained. The spring-biased obstructing members facilitate self-adjustment for drainage flow. Although arranged in series, the range limits are not continuous with subsequent springs, which safeguards against transient spikes in fluid pressure and ensures independent compression of subsequent springs in response to the predefined limits of pressure for that spring.