Abstract: The present disclosure relates to guidewire devices having shapeable tips and effective torquability. A guidewire device includes a core having a proximal section and a tapered distal section. A tube structure is coupled to the core such that the tapered distal section of the core extends into and distally beyond the tube structure. The portion of the core extending distally beyond the tube forms a shapeable tip. One or more coils also extend distally beyond the tube. The tip is configured to reduce the tendency of resilient forces from the tube structure to disrupt a customized shape of the tip.

Abstract: An automated therapy system having an infusion catheter; a sensor adapted to sense a patient parameter; and a controller communicating with the sensor and programmed to control flow output from the infusion catheter into a patient based on the patient parameter without removing fluid from the patient. The invention also includes a method of controlling infusion of a fluid to a patient. The method includes the following steps: monitoring a patient parameter with a sensor to generate a sensor signal; providing the sensor signal to a controller; and adjusting fluid flow to the patient based on the sensor signal without removing fluid from the patient.

Abstract: A wire guide includes a solid core mandrel that is initially received in a flat wire coil that has a rest inner diameter that is greater than a uniform diameter of the solid core mandrel. The flat wire of the flat wire coil is in tension between a proximal location and a distal location so that the flat wire coil has a reduced inner diameter that is smaller than its rest inner diameter. The tension in the flat wire is introduced by torquing the mandrel relative to the flat wire coil as part of attaching the coil to the mandrel.

Abstract: A medical fluid probe includes a heat spreader structure that defines therein a fluid chamber that is in fluid communication with an external environment around the probe, and a thermal energy source in thermal communication with the heat spreader structure. The heat spreader structure functions as both temperature-control elements and structural elements. A variety of separate structure elements, such as the heat pipes, may combine to form the heat spreader structure. The thermal energy source may be used to maintain the temperature of the heat spreader structure, such as by heating and/or cooling the heater spreader structure.

Abstract: Described herein are atherectomy catheters, systems and methods that include a distal tip region that may be moved laterally so that its long axis is parallel with the long axis of the main catheter body axis. Displacing the distal tip region laterally out of the main catheter body axis exposes an annular blade and opens a passageway for cut tissue to enter a storage region within the catheter. The annular blade may be internally coupled to a drive shaft that rotates the blade, and thus the exposed blade edge may have the same crossing profile (OD) as the rest of the distal end region of the catheter. Also described herein are gear-driven atherectomy devices that may use a cable drive shaft to actuate the annular blade. Both push-to-cut and pull-to-cut variations are described, as are methods for cutting tissue and systems including these atherectomy catheters.

Abstract: A method of making a medical guidewire including providing a wire having a length that includes a proximal length and a distal length. The method further includes applying cold work to the distal length and not applying cold work to the proximal length, thereby imparting to the distal length a diameter that is smaller than the proximal length diameter; and applying a reducing process to the wire whereby the proximal length is reduced to have an outer diameter that is the same as the outer diameter of the distal length. The proximal length has an inner diameter and the distal length has an inner diameter that is less than the inner diameter of the proximal length.

Abstract: A retrieval catheter operable by a single clinician that will neither displace a deployed stent nor cause undue trauma to the vascular lumen or lesion. The retrieval catheter may be sized to accommodate both a guidewire and a balloon wire. The retrieval catheter is easy to navigate through tortuous passageways and will cross a previously deployed stent or stent-graft easily with minimal risk of snagging on the deployed stent or stent graft. The sheath and dilator are adapted to allow a guidewire or balloon wire to pass through the walls of both and to allow the sheath and dilator to move axially with respect to each other.

Abstract: Retrieval of material from vessel lumens can be improved by use of a distal element comprising an expandable mesh, a treatment device includes an elongated member having a proximal portion and a distal portion configured to be positioned within a blood vessel at a treatment site at or near a thrombus. A distal element comprising an expandable mesh is coupled to the distal portion of the elongated member via a connection assembly. In an expanded state, at least a portion of the mesh is configured to be in apposition with the blood vessel wall at the treatment site to anchor or stabilize the elongated member with respect to the blood vessel. The distal element can be electrically coupled to an extracorporeal current generator.

Abstract: A catheter assembly and/or an introducer may include one or more features configured to guide a probe and/or a catheter distally through a septum. The catheter assembly may include a catheter adapter and the septum. The catheter adapter may include a distal end, a proximal end, and a lumen extending therebetween. In some embodiments, the septum may be disposed within the lumen. The septum may include a proximal surface that is tapered inwardly in a distal direction such that the proximal surface of the septum is configured to guide the probe and/or the catheter distally through the septum. The catheter assembly may be configured to receive an introducer, which may include an introducer element. A proximal end of the introducer element may include another proximal surface that is tapered inwardly in the distal direction such that the other proximal surface is configured to guide the probe or the catheter distally through the septum.

Abstract: A medical device system is provided herein which has an elongated, flexible hollow member with an expandable infusion segment attached at the most distal end of the device. The device has a plurality of fluid infusion ports on the expandable infusion segment for delivering an intended fluid to a target site in a body lumen. Additionally, a method is provided herein for infusing an intended fluid to a target site within a body lumen.

Abstract: A tunneling tool is used to create a subcutaneous tunnel for passage of a lead extension. The lead extension is transported from a proximal incision site to a distal incision site and as a result the proximal connector of the lead extension does not pass through the subcutaneous tunnel. The tunneling tool may carry the lead extension during the tunneling procedure. The tunneling tool may include a tool body that contains the lead extension as the lead extension is being carried to the distal incision site. The tunneling tool may further include a tracker tube that is present within the tool body, and the lead extension is contained in and carried by the tracker tube.

Abstract: A method of manufacturing a needle-equipped outer tube includes a preheating step comprising heating a distal end connecting section to a temperature at or below a softening point of a material forming an outer tube member with a joint member inserted in a distal end connecting section of the outer tube member, and with a needle being inserted or inserted and fixed in the needle insertion hole; and a joint member welding step, performed after the preheating step, comprising thermally welding the joint member to the distal end connecting section of the outer tube member with a distal end portion of the joint member pressed toward the proximal end of the joint member by a pushing member with a pressing force in a range of 4 N to 30 N.

Abstract: An intravascular catheter is disclosed that includes an elongated shaft defined by a wall including at least one port extending through the wall into a lumen. At least one channel may be defined between layers of polymer making up the catheter shaft. The channel extends along at least a portion of the shaft and is in fluid communication with the port. Outer and inner diameters of the catheter may be substantially constant along the length of the catheter.

Abstract: An access device for placing a medical article within a body space includes a needle, a dilator, and a sheath. The dilator can be coaxially and slideably disposed about the needle, and the sheath can be coaxially and slideably disposed about the dilator. The access device can further include a inner member coaxially disposed between the needle and dilator. The needle can include a fenestration in fluid communication with a space between the needle and inner member. When the needle punctures a blood vessel, the fenestration allows blood to flow into the space between the needle and inner member to provide a visual indicator to a physician or healthcare professional that the needle is in a vessel.

Abstract: The invention provides a disposable endometrial biopsy device comprising an elongated blunt-end catheter with distally placed tissue acquisition side-hole and proximally attached aspiration syringe with spring-loaded plunger having latching mechanism to release plunger for induction of aspiration. The device has a pin-hole channel or filter acting as a tissue trap between the catheter channel and the syringe in order to prevent aspiration of tissue into the body of the syringe.

Abstract: Apparatuses and methods for electrokinetic transport of fluids to patients. Drug-containing solutions may be placed in vial-like reservoir, which is connected to an apparatus such as a traditional catheter or other device capable of holding a drug-containing solution. Instead of a vial-like reservoir, a doped infusion pad or a gel may be used as a source of the drug-containing solution. The reservoir and apparatus may thus be the same component. The methods and apparatuses disclosed herein may also be used to transport fluid alone to achieve a clinical effect. The apparatus is placed at the point of drug delivery. The counter-electrode may be placed in or on a patient. Current is passed from the reservoir to the counter-electrode. Through electrokinetic transport, drug-containing solution is delivered along a current path from the drug source to the counter-electrode. A hollow fiber catheter for use in electrokinetic transport is also disclosed.

Abstract: A method for introducing an elongate medical instrument with a shaped portion into the body of a subject includes at least partially straightening the shaped portion from an exterior of the elongate medical instrument. A retention element may then be introduced into an interior of the shaped portion to maintain the shaped portion in an at least partially straightened configuration as the external force is removed from the shaped portion. With the retention element in place, the shaped portion may be introduced to a desired location within a hollow interior of an internal organ. The retention element may then be removed to enable the shaped portion to return to its desired shape. A straightening apparatus includes the retention element, as well as an external element that at least partially straightens the shaped portion of the elongate medical instrument from the outside. A system includes the elongate medical instrument and the straightening apparatus.

Abstract: A system and a method of positioning a wire guide are provided. The method includes inserting a wire guide in a first configuration into a lumen of a catheter, distally advancing the wire guide to a distal portion of the lumen so that a distal end of the wire guide is distal to an opening in a wall of the catheter and advancing a distal portion of the wire guide through the opening by distally advancing the distal portion relative to the catheter so that the distal end remains in the lumen as the distal portion of the wire guide extends out of the opening. The method includes advancing the distal portion of the wire guide further out of the opening so that the distal end exits through the opening so that the distal portion is distal to the distal end of the wire guide in a second configuration.

Abstract: Therapeutic agents, diagnostic agents and other compositions can be effectively delivered to target tissues using ultrasonic dispersion. For example, a therapeutic agent in solution may be injected subcutaneously in the vicinity of a target tissue in a patient. External ultrasound is used to disperse the therapeutic agent in the target tissue. The disclosed methods provide increased concentrations of therapeutic agents in tissue relative to traditional delivery methods, thereby improving therapeutic outcomes while reducing costs. In addition the methods can be used to deliver effective concentrations of therapeutic agents to tissues with limited blood supply.

Abstract: A method and apparatus for closing a vascular wound includes an apparatus that can be threaded over a guidewire into place at or adjacent the wound. The apparatus includes a chamber that encloses a hemostatic material therein. When the apparatus is positioned adjacent the wound as desired, the hemostatic material is deployed from the chamber. Blood contacts the hemostatic material, and blood clotting preferably is facilitated by a hemostatic agent within the material. Thus, the vascular puncture wound is sealed by blood clot formation.

Abstract: A transluminal device may include an elongate section extending between a proximal end and a distal end of the device. The elongate section may be configured to be inserted into a body cavity. The device may include a balloon within the elongate section between the proximal end and the distal end.

Abstract: A tissue access site system is provided. In one embodiments, the system includes a tissue cutting element designed for generating a tissue access site through a tissue, the tissue access site being surrounded by tissue edge portions of a predetermined geometry; and a tissue closure device being for attaching at least one closure element to the tissue at a region corresponding to at least one of the tissue edge portions.

Abstract: A self-illuminating endogastric tube which simplifies the correct placement of the distal end of the endogastric tube within the gastrointestinal tract of a patient. A self-illuminating stylet which simplifies the correct placement of the distal end of an endogastric tube within the gastrointestinal tract of a patient. A method of placing the distal end of an endogastric tube within the gastrointestinal tract of a patient that does not expose the patient to radiation, or that limits the amount of radiation exposure to less than the amount associated with standard methods of placing the distal end of an endogastric tube within the gastrointestinal tract of a patient. A method of confirming the correct placement of an endogastric tube that does not expose the patient to radiation, or that limits the amount of radiation exposure to less than the amount associated with standard methods of placing an endogastric tube.

Abstract: Catheters assemblies having structural configurations operable to reduce backflow along the catheter assembly track, and methods of making and using such catheter assemblies. Catheters assemblies in accordance with embodiments of the present invention find use in various applications including the treatment of acute and chronic medical conditions. An exemplary catheter assembly includes, in one illustrative embodiment, a flexible proximal catheter body portion, and a distal portion of a smaller diameter than the body portion. The distal portion includes a sealed distal tip or end and one or more side flow openings to permit flow of therapeutic substance from the catheter along an axis that is different than, e.g., skewed relative to, a longitudinal axis of the distal portion of the catheter assembly.

Abstract: A medical apparatus which comprises a sharpened outer needle and a blunt inner needle slidingly disposed within the outer needle is provided. The apparatus also contains a position indicator to indicate the position of the inner needle within the outer needle, so that the user knows whether the inner needle is in a protective or a non-protective position. The position indicator may be a mechanical visual indicator, an electronic visual indicator, a tactile indicator, an audible indicator or any combination of the above.

Abstract: Surgical access systems and obturators for or used in surgical access systems are provided. The obturator is configured to operate or accommodate the use of at least two different sized trocars. The outer diameter of the adaptable obturator when inserted into a trocar compresses from an initial condition to a compressed condition to match the inner diameter of the trocar.

Abstract: A system for convection enhanced delivery of therapeutic comprises one or more flexible, biocompatible microcatheters that are directed to a target location to deliver a therapeutic agent. The microcatheter is releasably coupled to a guide tube and directed to the desired location. The microcatheters are small and flexible in order to reach the target areas, minimize trauma at the injection site, and minimize reflux of the injectable therapeutic.

Abstract: Disclosed is a shaped electrode and dissecting tool configured to aid in controlling the path of an electrode as it is moved into its intended position within the epidural space of a patient. The shaped electrode and dissecting tool is configured with a contoured leading edge having at least one concavity that aids in moving the electrode and dissecting tool through the intended tissues within the patient's body. A variety of concavity contours may be provided and used for particular surgical applications.

Abstract: The devices and methods shown provide for the minimization of extravasation during arthroscopic surgery. The anti-extravasation surgical portal plug allows a surgeon to drain excess fluids from the soft tissue surrounding the surgical field during arthroscopic surgical procedures.

Abstract: Catheters assemblies having structural configurations operable to reduce backflow along the catheter assembly track, and methods of making and using such catheter assemblies. Catheters assemblies in accordance with embodiments of the present invention find use in various applications including the treatment of acute and chronic medical conditions. An exemplary catheter assembly includes, in one illustrative embodiment, a flexible proximal catheter body portion, and a distal portion of a smaller diameter than the body portion. The distal portion includes a sealed distal tip or end and one or more side flow openings to permit flow of therapeutic substance from the catheter along an axis that is different than, e.g., skewed relative to, a longitudinal axis of the distal portion of the catheter assembly.

Abstract: An anti-clogging catheter includes a tubular cannula defining a fluid passageway and shaped and tipped to removably insert within and be removed from a human body, where the cannula has a proximal end with a first interior surface defining a first interior diameter and a distal end with a second interior surface defining a second interior diameter that is smaller than the first interior diameter. A stylet is movable within the fluid passageway between the proximal end and the distal end and has an outer diameter substantially equal to the second interior diameter.

Abstract: An apparatus includes a catheter for an intrathecal drug delivery system and a stylet having a curved forward end. Preferably, the curved forward end has a shape in the form of a “J” or a “C.” Also preferably, the catheter has a distal end that conforms to the curved forward end of the stylet. Thus, the present invention provides a catheter having a blunt forward end that minimizes the risk of penetrating the substance of the spinal cord. Additionally, the curved forward end of the stylet can be formed of a springy material so that it straightens out during the processes of insertion through a guide needle and retraction from the needle.

Abstract: Catheters assemblies having structural configurations operable to reduce backflow along the catheter assembly track, and methods of making and using such catheter assemblies. Catheters assemblies in accordance with embodiments of the present invention find use in various applications including the treatment of acute and chronic medical conditions. An exemplary catheter assembly includes, in one illustrative embodiment, a flexible proximal catheter body portion, and a distal portion of a smaller diameter than the body portion. The distal portion includes a sealed distal tip or end and one or more side flow openings to permit flow of therapeutic substance from the catheter along an axis that is different than, e.g., skewed relative to, a longitudinal axis of the distal portion of the catheter assembly.

Abstract: Systems and methods for using a trocar system are disclosed. The system generally comprises a trocar, a magnet, and a magnetizable cannula. The trocar has a first end and a second end. The magnetizable cannula has a central opening sized to receive the trocar. The magnet is positioned adjacent the second end of the trocar and its magnetic field releasably secures the magnetizable cannula in a position adjacent the second end of the trocar.

Abstract: Methods for installing a flexible spinal needle assembly and methods of delivering a fluid may include inserting a distal end of a flexible spinal needle assembly into a subject and, thereafter, disposing an anti-restriction member at least partially within an inner flow path of the flexible spinal needle to substantially prevent fluid occlusion caused by bending or kinking of the flexible spinal needle.

Abstract: A flow element for use with flexible needles and flexible needle assemblies to minimize flow occlusion within a flexible needle is provided. The flow element is particularly suited for uses with a flexible needle for minimizing incidence of post-dural puncture headache. The flow element includes a body having an internal flow path for conducting a fluid through a flexible needle, and an anti-restriction member. The anti-restriction member includes an elongated body, a proximal end coupled to the body within the internal flow path, and a distal end for disposing at least a portion of the elongated body within a flexible needle. A flexible spinal needle assembly for minimizing flow occlusion through an internal flow path of a flexible needle by unintended kinking that is potentially caused by ligament or muscle layer movements is also provided.

Abstract: A medical apparatus which comprises a sharpened outer needle and a blunt inner needle slidingly disposed within the outer needle is provided. The apparatus also contains a position indicator to indicate the position of the inner needle within the outer needle, so that the user knows whether the inner needle is in a protective or a non-protective position. The position indicator may be a mechanical visual indicator, an electronic visual indicator, a tactile indicator, an audible indicator or any combination of the above.

Abstract: Catheter systems and methods for facilitating the delivery of a therapeutic agent directly to the interior of a body organ, and/or the extraction of material from said organ. The catheter distal end is placed within the body organ to be treated. The catheter may carry a fixation device near the catheter distal end. When implanted, the fixation device retains the catheter distal end in the organ despite normal patient activity. The fixation device may include porous material to promote soft tissue ingrowth for anchoring the catheter distal end within the organ.

Abstract: A surgical access port for insertion into a body cavity can have an elongate tubular body extending along an axis between a proximal end and a distal end, and a tip at the distal end of the tubular body for penetrating through a body wall and into the body cavity. The distal tip moves from a first, penetrating position to a second, retaining position when the body wall has been traversed. The surgical access port may further comprise a seal housing connected to the proximal end of the tubular body, the seal housing having an access port providing an opening into the tubular body to allow passage of surgical instruments. The distal tip may be sharp, pointed or bladed. The distal tip may also be substantially blunt or have a conical surface. The access port may further comprise a retention member for connecting the tubular body and the distal tip.

Abstract: A safety syringe adapted consists of an outer casing that supports a conventional hypodermic needle and an inner casing which supports a blunt cannula that is disposed inside the inner lumen of the hypodermic needle. The inner casing is keyed to the outer casing by one or more pins that engage helical tracks formed along the inner surface of the outer casing. Rotation of the inner casing relative to the outer casing advances the inner casing so that the blunt cannula is moved from a retracted position within the needle to an extended position in which the blunt end of the cannula extends beyond the tip of the needle.

Abstract: Device and method are provided for diagnosing and treating diseases and injuries to the spine by injecting drugs into the diseased or injured area. The device and method of the subject invention provide improvements to patient and operator safety, along with ease-of-use and convenience improvements over conventional techniques.

Abstract: An apparatus includes a catheter for an intrathecal drug delivery system and a stylet having a curved forward end. Preferably, the curved forward end has a shape in the form of a “J” or a “C.” Also preferably, the catheter has a distal end that conforms to the curved forward end of the stylet. Thus, the present invention provides a catheter having a blunt forward end that minimizes the risk of penetrating the substance of the spinal cord. Additionally, the curved forward end of the stylet can be formed of a springy material so that it straightens out during the processes of insertion through a guide needle and retraction from the needle.

Abstract: A trocar system for providing access across a body wall includes a trocar and an anchor provided in the form of a first helix. The anchor is adapted for placement in an operative position wherein the anchor extends at least partially through the body wall. A second helix formed on the trocar is size and configured to engage the first helix of the anchor so that rotation of the trocar relative to the anchor moves the second helix along the first helix. In this manner, the trocar is drawn into the anchor as it moves into the body wall. A proximal force applied to the anchor resists tenting of the abdominal wall. The anchor also holds the layers of the body wall together thereby resisting peritoneal separation.

Abstract: A blood collection set including a non-patient needle assembly interconnected with an intravenous needle assembly through tubing is provided. The non-patient needle assembly includes a hub assembly adapted for mounting with a blood collection set, and an internal blunting member including a blunted tip. The non-patient needle assembly further includes an external cannula concentric with the internal blunting member and including a non-patient puncture tip adjacent the blunted tip. The external cannula is axially displaceable with respect to the hub assembly between a first retracted position in which the non-patient puncture tip extends beyond the blunted tip and a second activated position in which blunted tip extends beyond the non-patient puncture tip.

Abstract: A tube clamp is disclosed for optional opening and closing of tubes such as infusion tubes, an infusion pump, an infusion tube set and the combination thereof, the tube clamp comprising means for opening or closing the tube clamp which interacts with a part of the infusion pump which is a lever for locking and unlocking a door in the pump, wherein an automatic opening and closing of the tube clamp can be realized without a relative movement of the tube clamp and the tube.

Abstract: A device for preventing excessive insertion of a rod-like member when the rod-like member is inserted into a gastrostomy catheter, and to a medical instrument provided with the same. The device comprises a reference position establishment part which can be installed at a base end opening side of the gastrostomy catheter, a mobile part which can be fixed to the endoscope, and a linking part. The linking part can change the gap between the reference position establishment part and the mobile part within a range no greater than a set length, and links the reference position establishment part and the mobile part. Furthermore, a bending instrument for bending the tip end of the endoscope when said tip end portion projects a prescribed length outwards from a through-hole of a stomach-internal fixed part is fitted to the tip end of the endoscope.

Abstract: A transseptal needle includes an elongate needle body having a distal end and a proximal end and a cannular needle tip located proximate the distal end of the needle body. The needle tip has a distal segment, a proximal segment, and a longitudinal axis. An inner surface of the needle tip defines a passageway spanning at least a portion of the needle tip, and an outer surface of the needle tip defines a wall with the inner surface. The distal segment of the needle tip also includes a wedge surface and a dome-shaped region. The wedge surface forms a wedge angle of other than 90 degrees relative to the longitudinal axis. The dome-shaped region, which intersects the wedge surface, includes at least two bevels that intersect the wedge surface and that intersect each other at one or more points on the needle tip.

Abstract: Medical devices and methods for manufacturing and using medical devices. An example medical device includes a core member, a tubular member coupled to the core member, and a tip member coupled to the tubular member. The tubular member may include a first section having a first outer diameter and a second section having a second outer diameter that is smaller than the first outer diameter.

Abstract: To provide a gastrostomy tube extension device which can facilitate insertion or removal of a gastrostomy tube by making the degree of extension of the gastrostomy tube constant. [Means for Resolution] A gastrostomy tube extension device 20 used for inserting and taking out a gastrostomy tube 10 into/from a hole 33 formed on a patient's abdomen, the gastrostomy tube 10 including an outer fixing member 10a to be installed on the skin surface side, an inner fixing member 10c installed on the inner surface side of the stomach wall, and a tube member 10b for connecting the outer fixing member 10a and the inner fixing member 10c, and the gastrostomy tube extension device comprising a rod 21 and an engaging member 22. The rod 21 has a rod-shaped member which can push the center of the distal end of the inner fixing member 10c with its distal portion toward the distal end, and with a plurality of engaging step portions 24a are formed on the proximal portion.

Abstract: Apparatus and methods for percutaneously performing myocardial revascularization are provided using a catheter having an end region that is directable to contact a patient's endocardium at a plurality of positions. A cutting head is disposed within a lumen of the catheter and coupled to a drive tube that rotates and reciprocates the drive shaft. One or more stabilizing elements are disposed on the distal end to retain the catheter in position when the cutting head is actuated. The cutting head and drive tube include a lumen through which severed tissue is aspirated. Mechanisms and methods are provided for providing the operator with information to assess the desirability of treating a proposed site. Mechanisms also are provided for controlling the maximum extension of the cutting head beyond a distal endface of the catheter, independent of the degree of tortuosity imposed on the catheter.