Abstract: An introducer assembly for introducing a catheter into a patient, includes a sheath having a distal end and a proximal end with a hollow lumen extending between the distal end and proximal end. The assembly also includes a coupler having a distal end operatively coupled to the proximal end of the sheath, the coupler having an internal passage in fluid communication with the hollow lumen. The assembly further includes a connector having a distal end operatively coupled to the coupler proximate the distal end of the coupler.

Abstract: A Coude catheter insures proper drainage and reduces tissue damage by using a loop section having an open passageway positioned on a proximal end of the catheter to adjust the catheter.

Abstract: A system and method for cutting soft tissue with a retractable surgical cutting device (10). The device (10) includes a handle (12) having a first channel (24) extending therethrough and a switch (18) located thereon. The switch (18) is movable between a retracted position and an extended position. An actuator (26) with a blade (16) extends through the first channel (24) and connects to the switch (18) within the handle (12). An outer sheath (14) is connected to the handle (12) and surrounds the actuator (26) and at least a portion of the blade (16). A drive mechanism (28) is connected to the switch (18) within the handle (12) such that when the switch (18) moves from the retracted position to the extended position, the actuator (26) moves from a retracted position to an extended position. In the retracted position, the blade (16) can be entirely within the outer sheath (14) and in the extended position, at least a portion of the blade (16) is positioned outside of the outer sheath (14).

Abstract: The invention provides biodegradable implants for treating sinusitis. The biodegradable implants have a size, shape, density, viscosity, and/or mucoadhesiveness that prevents them from being substantially cleared by the mucociliary lining of the sinuses during the intended treatment period. The biodegradable implants include a sustained release therapeutic, e.g., an antibiotic, a steroidal anti-inflammatory agent, or both. The biodegradable implants may take various forms, such as rods, pellets, beads, strips, or microparticles, and may be delivered into a sinus in various pharmaceutically acceptable carriers.

Abstract: A surgical access assembly is disclosed. The surgical access assembly comprises an outer sheath and an obturator. The outer sheath is defined by an open distal end and an open proximal end and includes a hollow body portion therebetween. The obturator is defined by a distal end and a proximal end and the distal end further comprises a tapered distal tip member that terminates in a closed radiused distal tip. The obturator is configured to be received within the outer sheath such that the tapered distal tip member protrudes from the open distal end of the outer sheath when the obturator is in an introducing configuration.

Abstract: A stylet for use in guiding a distal tip of a catheter to a predetermined location within the body of a patient. In one embodiment the stylet is configured for use within a lumen of the catheter and comprises a core wire, an ECG sensor, and a magnetic assembly. The ECG sensor senses an ECG signal of a patient when the stylet is disposed within the lumen of the catheter and the catheter is disposed within the body of the patient. The magnetic assembly includes at least one element capable of producing a magnetic or electromagnetic field for detection by a sensor external to the patient. In another embodiment, the stylet includes a pre-shaped distal segment that is deflected with respect to a more proximal portion of the stylet, which in turn causes a distal segment of the catheter to be deflected when the stylet is received within the lumen.

Abstract: A small gauge surgical instrument assembly is shown with advantages such as diminished “play” at the tip. A surgical instrument assembly is also shown with support along a length of the instrument that can be selected by the surgeon. In particular, very small and flexible instruments for vitreous surgery are shown with selectable stiffness, thus providing control as well as access to all parts of the vitreous cavity. Embodiments as shown are safer, and increase the variety of cases for which these instruments can be used.

Abstract: A surgical access assembly and method of use is disclosed. The surgical access assembly comprises an outer sheath and an obturator. The outer sheath and obturator are configured to be delivered to an area of interest within the brain. Either the outer sheath or the obturator may be configured to operate with a navigational system to track the location of either device within the brain.

Abstract: The disclosure provides examples of a surgical needle for entering a joint space through tissue, such as the hip joint. The surgical needle includes a stylet movable within a hollow body. The hollow body has at one end, a tip of a bevel for cutting tissue and at another end, a feedback member providing a surgeon with tactile feedback. The stylet has at one end, a resistance reducing member that when positioned a preset distance from the bevel reduces the resistance of the surgical needle through tissue. At the other end of the stylet is a stylet hub. In some examples of the surgical needle, the stylet hub includes a proximal stop, stylet locking member and/or locking member. The surgical needle advantageously provides tactile feedback, reduces resistance, and minimizes or prevents damage to delicate structures.

Abstract: A device (100) for creating a tunnel through soft tissue, comprises an elongated insertion member including a lumen extending therethrough to a distal opening, the elongated insertion member being sized to be inserted into the body via an opening of no more than 35 mm diameter and a tunneling member (108) received in the lumen for movement between an insertion configuration in which a tissue penetrating distal tip is received within the lumen and a tunneling configuration in which the distal tip extends distally from the distal opening by a desired distance in combination with a handle (104) coupled to a proximal end of the insertion member, the handle remaining outside the body and including a first actuator (106) for moving the tunneling member between the insertion and tunneling configurations.

Abstract: An electrosurgical apparatus for treating tissue comprises an elongate shaft including a proximal region, a distal region having an electrically conductive region and one or more lumens through the shaft. A stylet is located within one of the lumens for obturating at least a portion of an opening defined by a distal end of the elongated shaft. The stylet distal end has a sensor and may include an occluding component substantially surrounding and affixed to it. The elongated shaft and the stylet can possibly be configured to allow passage of fluid through the lumen while the stylet is located within the lumen. Related stylet configurations are also disclosed.

Abstract: A ball-tipped mandrel, separate or integrated on a device delivery assembly, can be used to ease delivery and/or retrieval of an ancillary device within a body vessel having tortuous anatomy. A ball-tipped mandrel can be moved through a catheter as a part of a preparation procedure prior to insertion into a body vessel of a patient. A ball-tipped mandrel can be moved through a catheter during or after insertion into a body vessel of a patient in preparation for delivery of an ancillary device. A ball-tipped mandrel can be integrated onto the distal portion of a device to produce dilation during device delivery.

Abstract: Medical device delivery systems and methods of using the same are disclosed. Some of the delivery systems may include a catheter having a proximal end, a distal end, and a sheath. A bifurcated gripping member may be disposed on the proximal end of the catheter and the bifurcated gripping member may include a first gripping prong and a second gripping prong. A deployable prosthesis may be disposed on the distal end of the catheter.

Abstract: A surgical access assembly and method of use is disclosed. The surgical access assembly comprises an outer sheath and an obturator. The outer sheath and obturator are configured to be delivered to an area of interest within the brain. Either the outer sheath or the obturator may be configured to operate with a navigational system to track the location of either device within the brain.

Abstract: Transluminal access system includes a stent delivery catheter having a handle control mechanism. The catheter comprises a number of components for establishing an initial penetration between adjacent body lumens and subsequently implanting a stent or other luminal anchor therebetween. Manipulation of the stent components is achieved using control mechanisms on the handle while the handle is attached to an endoscope which provides access to a first body lumen.

Abstract: In accordance with various embodiments, an intraocular manipulator is disclosed which uses negative pressure to grasp and/or manipulate an intraocular object, for example, an IOL, a crystalline lens, or an intraocular foreign body. The device comprises a tip, a stem, and a suction source. The device may be a handheld device with the negative pressure controlled by a foot pedal. Similarly, the device may be used in conjunction with other intraocular devices.

Abstract: A surgical grooved director including a fixed or removable handle with a tubular member having a lumen extending therethrough with an aperture at its proximal end and a blunt dissecting distal tip. An access window is formed through the wall of the tubular member in a distal portion of the instrument and is in communication with the lumen. An integral side rail is integrally mounted on the tubular member and defines a linear groove adapted to receive and allow slideable movement of a knife.

Abstract: Epidural catheters include a tubular member and at least one bend indicator located proximate a distal end of the tubular member to provide a reference point for a user to bend the catheter. Catheter assemblies may include such catheters. Methods of inserting an epidural catheter having a bent distal end into a patient include bending a catheter at a location proximate at least one bend indicator formed proximate a distal end of the catheter and inserting at least a portion of the catheter into a patient. Methods of making an epidural catheter include forming a tubular member having a proximal end and a distal end and forming at least one bend indicator on the catheter proximate the distal end of the tubular member to provide a reference point for a user to bend the catheter.

Abstract: A transseptal needle assembly comprised of a cannula, a handle assembly and a stylet is described. The cannula of the needle assembly is of a uniform body construction such that the cannula main portion and needle portion are fluidly connected in one-piece. The handle assembly comprises a handle housing, a handle sleeve and a handle slug. The handle slug provides ballast which improves tactile feel of the needle assembly. In addition, the stylet comprises a stylet housing having a hinged designed that allows for easier control of the stylet.

Abstract: The present invention relates to methods of transvascular retrograde access placement and to devices that facilitate these methods. For purposes of the present invention, transvascular retrograde access placement generally comprises the insertion of a vascular catheter into a central blood vessel through the puncturing of the central blood vessel from the inside of the central blood vessel with a needle or other similarly configured device, or a needle-tipped guidewire of the present invention, and exiting that needle from the patient through the skin rather than the traditional approach of inserting a needle from the outside of the skin surface to the inside of a blood vessel.

Abstract: The female urethral catheterization device may include an insertion portion configured for insertion into a urethra. The insertion portion having an opening for receiving a bodily fluid. The catheterization device may include an elongated portion configured for receiving a guiding input. The guiding input may be relayed from the elongated member to the insertion portion for guiding the insertion portion. The catheterization device may include a curved portion connecting the elongated portion and the insertion portion. The curved portion may have a drain for draining the bodily fluid.

Abstract: In one instance, a catheter for replacing or adding a guide wire into a patient is provided. The catheter includes a first rapid exchange lumen, a second rapid exchange lumen, and a releasable wire-securing device. A second guide wire is placed in the second rapid exchange lumen and secured into position. The catheter is then advanced along the first guide wire until in position, and then the second guide wire is released from the wire-securing device and advanced into the desired position. The catheter is then removed. Other catheters and methods are also disclosed.

Abstract: The invention is directed to a bladeless trocar obturator to separate or divaricate body tissue during insertion through a body wall. In one aspect, the obturator of the invention comprises a shaft extending along an axis between a proximal end and a distal end; and a bladeless tip disposed at the distal end of the shaft and having a generally tapered configuration with an outer surface, the outer surface extending distally to a blunt point with a pair of side sections having a common shape and being separated by at least one intermediate section, wherein each of the side sections extends from the blunt point radially outwardly with progressive positions proximally along the axis, and the shaft is sized and configured to receive an optical instrument having a distal end to receive an image of the body tissue. With this aspect, the tapered configuration facilitates separation of different layers of the body tissue and provides proper alignment of the tip between the layers.

Abstract: An access assembly is provided.

Abstract: A stylet for use with a medical catheter has a lumen blocking portion and a shaft, where the shaft has a smaller effective diameter than the lumen blocking portion. The lumen blocking portion has an outer surface that is approximately flush with the catheter lumen in a working area of the catheter. The lumen blocking portion has a length capable of covering at least one side hole of the catheter.

Abstract: Devices and methods for transplanting tissue for the purpose of regeneration, for treating a patient having injured myocardial tissue, and/or for improving cardiac function through cell regrowth. More specifically, the devices and methods obviate the need for cellular alteration. The devices comprise a hollow tube with a sharp distal end, a stylet that is disposed and movable within the hollow tube, and a stopping device that constrains movement of the stylet. The methods comprise removing intact tissue from a first region of a mammalian organ and implanting the tissue in a second region of the same organ.

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 surgical access assembly and method of use is disclosed. The surgical access assembly comprises an outer sheath and an obturator. The outer sheath and obturator are configured to be delivered to an area of interest within the brain. Either the outer sheath or the obturator may be configured to operate with a navigational system to track the location of either device within the brain.

Abstract: A surgical access assembly and method of use is disclosed. The surgical access assembly comprises an outer sheath and an obturator. The outer sheath and obturator are configured to be delivered to an area of interest within the brain. Either the outer sheath or the obturator may be configured to operate with a navigational system to track the location of either device within the brain.

Abstract: A surgical system comprising a cannula assembly and an obturator assembly for penetrating tissue is disclosed. A cover of the cannula assembly is mounted to a cannula housing and has a cover aperture therethrough. The cover has a trailing end face defining a predetermined geometrical configuration, at least a portion of the trailing end face is obliquely arranged relative to a longitudinal axis and terminates in, and leads toward the cover aperture to facilitate guiding of the surgical object through the cover aperture. The obturator assembly includes an obturator housing and an obturator member. The obturator housing has a housing base defining a leading end face, which defines a predetermined geometrical configuration corresponding to the predetermined geometrical configuration of the trailing end face of the cover to mate therewith upon assembly of the obturator assembly with the cannula assembly.

Abstract: An apparatus and corresponding method for providing convection enhanced delivery of bioactive agent to a tissue site. The apparatus involves the use of semipermeable membranes, typically in the form of one or more hollow fibers, together with a source and conduit of solution containing the bioactive agent to be delivered. The use of hollow fiber technology provides an optimal combination of features, including delivery kinetics and distribution, as compared to conventional (e.g., standard needle) type delivery devices.

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: An inexpensive, endo-tracheal intubation device is disclosed. Methods of making and using the inexpensive, endo-tracheal intubation device are also disclosed.

Abstract: An infusion flow guidewire system and method of use. The infusion flow guidewire system includes a delivery sheath and an infusion flow guidewire. The minimal cross section flexible infusion flow guidewire includes a flexible tip having a closed distal end, a coil, a core wire and at least one distally located jet orifice for infusion of fibrinolytics and for introduction of high pressure fluids for maceration and rearwardly directed flow of thrombus debris located in tortuous small sized vessels. Apparatus, some of which is removably attachable, is provided for grasping members of the invention for rotational torqueing and for longitudinal actuation along and within the vasculature.

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: 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 method of introducing a catheter 38 into an umbilical artery 14. The artery 14 is dilated with an introducer 22. A cannula 30 is introduced into the end of the artery 14, and a catheter is introduced through the cannula 30, with the distal end of the catheter 38 not engaging with the cut end of the artery 14.

Abstract: A method for positioning a guide element in a patient and a kit for use in the method. In one embodiment, the method involves transorally inserting an endoscope into a patient's stomach. An incision site is externally indicated by transilluminating the stomach and abdominal walls of the patient from within the stomach. Next, a scalpel incision is made at the indicated incision site, and an access needle is inserted into the incision, the proximal end of the access needle remaining external to the patient and the distal end of the access needle extending into the patient's stomach. The stylet of the access needle is then removed from the patient while keeping the cannula in place. Next, the distal end of a grasping tool is inserted through the cannula and into the patient's stomach. The looped leading end of a pullwire is then inserted through the endoscope and into the stomach. The tool is then manipulated until a distal hook on the tool catches the looped leading end.

Abstract: The present disclosure relates to a surgical access system that includes a cannula assembly adapted for removable positioning within a percutaneous tissue tract, and an obturator assembly removably positionable within the cannula assembly. The cannula assembly includes a cannula housing, a cannula sleeve, and first engagement structure, and the obturator assembly includes an obturator housing, an obturator sleeve, and second engagement structure. The first engagement structure and the second engagement structure are correspondingly dimensioned such that rotation of the obturator assembly in a first direction effectuates corresponding rotation of the cannula assembly to facilitate advancement of the cannula assembly through tissue.

Abstract: A surgical access apparatus for providing access inside a body includes a housing having a first port, a tubular member extending distally from the housing and defining a longitudinal axis therealong, wherein the tubular member includes a lumen extending therethrough. a shaft insert disposed in the lumen of the tubular member, wherein the shaft insert forms first, second, and third passageways extending along the lumen of the tubular member, wherein each of the first, second, and third passageways is adapted to receive a surgical instrument; and a first seal assembly covering the first port of the housing and defining a first passage disposed in communication with the first passageway defined by the shaft insert in the tubular member, wherein the first seal assembly is adapted to form a seal around the surgical instrument inserted through the first passage of the first seal assembly.

Abstract: A stylet instrument is positionable within a catheter to facilitate placement of the catheter during a surgical procedure. The stylet instrument has application in a hemodialysis procedure where the catheter is positioned via a subcutaneous tunneling technique. The stylet instrument includes a hub, first and second stylet members extending from the hub and operatively connected to permit positioning within corresponding lumens of a catheter, and securing means associated with the hub to releasably secure the catheter to the hub. The securing means includes at least one locking detent.

Abstract: A monitor-driven intracranial catheter assembly including dual lumen catheter for monitoring intracranial pressure via a pressure sensor located in one lumen while simultaneously draining cerebrospinal fluid through another lumen. A third lumen can also be provided with a side port for receiving a stylet. The stylet is used as a stiffening agent to aid in advancing the catheter into the patient's brain. The pressure sensor is preferably a spectral modulation sensor that communicates with a photodetector apparatus by means of a single optical fiber, thus minimizing the diameter of the catheter. The photodetector is self-correcting for signal errors caused by temperature change, changes in intensity of the input light, and transmission losses within the optical apparatus.

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 stylet is provided which has improved stiffness and buckling strength and can be easily manufactured at low cost. The stylet is comprised of a covering and a core, each of which have different mechanical properties. In one embodiment, the stylet is comprised of an outer tube and an inner rod with a circular cross-section, wherein the rod is inserted inside the tube. The tube can be made from a material which is more resistant to permanent deformation than the inner rod. The inner rod is made from a stiffer material which provides buckling strength. The combination of the stylet and associated stimulation lead may be used to make multiple insertions into body tissue.

Abstract: A medical instrument for suction and irrigation comprises an elongate shaft with a first channel serving as suction channel and with a second channel serving as irrigation channel, the shaft having a first tube which is closed in cross section and in which one of the channels is present. The shaft has a second tube which is open in cross section along its length and is placed with its open lengthwise side on an outside face of the first tube and secured sealingly thereon, the other channel being formed in the space between the outside face of the first tube and an inside face of the second tube. A method for production of the instrument is also described.

Abstract: A surgical obturator comprising an elongate shaft extending along an axis between a proximal end and a distal end, and a bladeless tip disposed at the distal end of the shaft having a conical surface forming proximally into an outer surface, the outer surface extending distally to a blunt point and having a pair of side sections. The side sections extend from the blunt point radially outwardly with progressive positions proximally along the axis. The conical surface facilitates insertion of the obturator with a reduced penetration force and minimizes tenting of the body wall. The conical surface further facilitates separation of different layers of the body wall and provides proper alignment of the tip between the layers. The surgical obturator may be constructed from a disposable or reusable material such as a metal or an autoclavable polymer.

Abstract: A method for inserting a multi-lumen catheter into a patient is disclosed. The catheter includes an elongated, central, multi-lumen tube portion having a proximal end and a distal end. A distal branch portion includes a plurality of single-lumen distal extension tubes. The proximal first end of each distal extension tube is connected to the distal end of the central tube portion such that the single lumen of each distal extension tube is in fluid communication with one of the plurality of lumens of the central tube portion. A proximal branch portion includes a plurality of single-lumen proximal extension tubes. The distal first end of each proximal extension tube is connected to the proximal end of the central tube portion such that the single lumen of each distal extension tube is in fluid communication with one of the plurality of lumens of the central tube portion.

Abstract: A catheter kit for a burrow having a catheter and an obturator and excellent in operability. The catheter comprises a tube having, inside, a nutrient passage leading nutrition or chemicals from the outside of a body to the inside of a stomach and extending along the wall surface of the burrow and a non-balloon type endodwelling member fitted to the tip part of the tube, normally placed in an expanded state and reduced in diameter less than that in the expanded state when an external force acts thereon by the obturator, and indwelled in the stomach in a buried state in a living body. The obturator comprises a guide wire passage detachably engaged with the catheter and allowing a guide wire installed in the obturator ranging from the tip to the midway thereof to be inserted therein and an operation part for transmitting the external force to the endodwelling member fitted to the rear end thereof. The rear end part of the guide wire passage and the operation part are arranged in a separated state.