Abstract: A blood regurgitation preventing puncture and guidance device without skin dilation is provided. The puncture and guidance device mainly includes a needle tube, a dilation tube, a sheath, and a deceleration and stop device. A hydrophilic ultrasound developing coating is provided on a surface of the sheath to lay a foundation for visual puncture. The sheath and the dilation tube contain X-ray developing particles, and are provided with a transition section.

Abstract: A guide wire for guiding a dilator to be inserted into a living body includes: a flexible elongated shaft portion; a puncture portion at a distal end portion of the shaft portion to form a hole in biological tissue; and an elastically deformable cover portion covering the puncture portion. The cover portion includes a sparse pitch portion that has a wire member wound in a spiral shape and axially contractible, and a distal end cover located on a distal end side of the sparse pitch portion and covering at least a part of the puncture portion. The puncture portion includes a first contact portion. The distal end cover includes a second contact portion configured to contact the first contact portion from a proximal end side, so that relative axial movement of the first and second contact portions is restricted by the first contact portion contacting the second contact portion.

Abstract: A pericardial access device includes a first tube, a second tube coupled to the first tube, and a biasing mechanism coupled to the second tube. The pericardial access device is moveable between an expanded configuration and a contracted configuration. The biasing mechanism biases the pericardial access device towards the expanded configuration, and the pericardial access device moves towards the contracted configuration when a force is applied to the second tube.

Abstract: An access device for placing a medical article within a body space includes a needle, a dilator, and a medical article. The needle can include an elongated needle body with a distal end and a hub from which the needle body extends. The elongated needle body can include at least one side fenestration and an outer diameter. The dilator can be slideably disposed on the needle body and include a dilator hub and an elongated dilator shaft that extends from the dilator hub. The dilator shaft can include at least one side fenestration in communication with the needle side fenestration. The dilator shaft can also include an inner diameter that is less than the outer diameter of the needle. The medical article can include a tubular section and a hub. The tubular section can be disposed on the dilator and define a space between the medical article and the dilator in communication with the needle side fenestration through the dilator side fenestration.

Abstract: The device includes a dilator having a locking mechanism configured to limit a distance a guidewire can be advanced out of a distal end of the dilator.

Abstract: An introducer apparatus includes an outer sleeve and an inner cannula received within the lumen of the outer sleeve. The outer sleeve has a profile such that at least a portion of the distal end of the outer sleeve tapers in the distal direction at an angle not exceeding about 2° relative to a longitudinal axis of the apparatus. The distal open end of the outer sleeve has a wall thickness not exceeding about 0.003 inch. The inner cannula includes a tapered distal end portion. The tapered distal portion of the inner cannula extends distal to the distal open end of the outer sleeve, such that a generally smooth diametrical transition is provided between the outer sleeve tapered portion and the open distal end of the inner cannula.

Abstract: Embodiments of the present invention provide for a catheterization system and related methods. The systems and methods provide for the initial placement of a smaller diameter catheter within a patient, the catheter being expandable to a larger diameter by the implementation of a dilator, wherein the dilator is configured to contact and expand a lumen of the catheter as it is inserted therethrough.

Abstract: A split dilator aspiration system is disclosed. The system includes a catheter, having an elongate, flexible tubular body with a proximal end, a distal end, a side wall defining a central lumen, and a handle on the proximal end. A dilator is advanceable through the central lumen, the dilator having an elongate body, cannulated to receive a guidewire, and an axially extending split along at least a portion of the elongate body, configured to allow removal of a portion of the dilator laterally from the guidewire.

Abstract: A body cavity irrigation and drainage system and a related method. The body cavity irrigation and drainage system may include two pigtail catheters that are coupled together so that when in a use state the tail portions of the two pigtail catheters curl in opposite directions. The two pigtail catheters may be coupled together so that they are maintained in a fixed relative orientation. The system may also include a sheath having a cavity within which both of the two pigtail catheters are positioned during an insertion process. The sheath may be a peel-away type sheath such that the sheath can be torn and removed from the body cavity while the two pigtail catheters remain in the body cavity.

Abstract: Intravenous access is achieved by introducing a catheter over an access needle which is initially present in the catheter. A tapered dilating element is positioned over the needle and provides a transition between the needle and a larger catheter lumen.

Abstract: Embodiments discussed herein are directed to devices, systems and methods for effectively treating post endovascular procedure complications such as endoleaks within an aneurysm sac. Some embodiments may include a delivery system with an integral aneurysm sac conduit configured for the introduction of materials which may be useful for treating endoleaks or the like.

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: One embodiment is directed to a method for creating translumenal vascular access, comprising utilizing a dilator adaptor to assist with forming a substantially atraumatic geometric outer junction between a dilator member/introducer member assembly and a guidewire which may be somewhat undersized relative to a lumen formed through the dilator member, thereby creating a geometric fit gap which may be suboptimal from a tissue interfacing perspective. The dilator adaptor may be interposed between the guidewire and dilator member to assist in remedying this fit mismatch, and in generally providing a preferred outer instrument interface for insertion through a small defect in a vessel to gain access to a lumen defined through the vessel.

Abstract: A self-dilating cannula for introduction into a patient's vasculature includes an elongate body and an atraumatic tip. The elongate body has a proximal end, a distal end, and a fluid-flow lumen extending therebetween. The atraumatic tip is positioned at the elongate body's distal end and has a blunted end and a conical shape. The atraumatic tip includes a plurality of fluid-flow openings proximal to the blunted nose that are configured to disperse fluid from the fluid-flow lumen in a plurality of directions with respect to the atraumatic tip. The atraumatic tip also includes an opening in the blunted nose that is sized to a guidewire.

Abstract: Intravenous access is achieved by introducing a catheter over an access needle which is initially present in the catheter. A tapered dilating element is positioned over the needle and provides a transition between the needle and a larger catheter lumen. The access needle is hollow and has a port which allows blood to flash back through a lumen of the catheter so that flashback can be observed on a catheter hub or the catheter itself.

Abstract: Tissue dilation systems are disclosed. The present systems provide percutaneous access to one or more target structures located in a patient's body. The tissue dilation systems include two or more tissue dilation tubes telescopically arranged and moveable relative to each other. The tissue dilation tubes can be preassembled prior to use by utilizing a dilation tube retention assembly which can maintain the dilation tubes in a substantially fixed position and release the tubes therefrom in order to dilate a patient's tissue. Methods of producing the present systems and using the present systems in surgical procedures are also disclosed.

Abstract: The present invention provides for devices and methods for providing endovascular therapy, including facilitating establishment of vascular access, placement of endovascular sheaths, catheter tip localization, and administration of vascular occlusion. The inventions includes a vessel cannulation device, an expandable sheath, an occlusion catheter, and a localizer each of which may be provided separately or used as part of a system.

Abstract: A composite wire, such as a guide wire, may include a principal section with a relatively large outer diameter, as well as one or more reduced sections with smaller outer diameters. The relatively small outer diameter of each reduced section may be defined by an inner element of the composite wire, while the relatively large outer diameter of the principal section may be defined by one or more outer elements that reside on, and may surround, the inner element. The inner and outer elements may be formed from materials that impart the composite wire with one or more desired characteristics, such as a stiffness, hardness and flexibility. In specific embodiments, the inner element may comprise a standard, small diameter guide wire, while the outer element comprises a tube formed from polyether ether ketone (PEEK). Each outer element may be secured to the inner element at one or more locations.

Abstract: An elastic percutaneous elastic introducer sheath is disclosed which can locally expand and reduce to accommodate a transcatheter medical device. The elastic introducer sheath includes a non-circumferentially continuous elastic frame, a liner, and a jacket.

Abstract: The invention generally relates to devices for fastening a hernia mesh. The invention provides a surgical fastening device that includes a shaft with a fastener carrier disposed at least partially within the shaft, in which the carrier is configured to accept fasteners of a plurality of different sizes. Different sized fasteners can be preloaded in interchangeable carriers or even mixed together within a carrier in the fastening device. The device can deliver the fasteners to different depths in a patient's tissue.

Abstract: Intravenous access is achieved by introducing a catheter over an access needle which is initially present in the catheter. A tapered dilating element is positioned over the needle and provides a transition between the needle and a larger catheter lumen. The access needle is hollow and has a port which allows blood to flash back through a lumen of the catheter so that flashback can be observed on a catheter hub or the catheter itself.

Abstract: A cannula tool in combination with other tools is used to provide multiple instruments necessary for surgical procedures. The cannula tool is used in combination with a piercing tool to form a dilator instrument to access a treatment site and in combination with a plunger tool to deliver biological or grafting material to a treatment site. Each of the plunger and piercing tools includes a guide lumen to track the tools over a K-wire or other guide device for placement at the treatment site. The application discloses asymmetrical piercing and plunger tools for placement proximate to a facet joint for treatment.

Abstract: The present invention relates to a rotary blood pump with a double pivot contact bearing system with an operating range between about 50 mL/min and about 1500 mL/min. The rotary blood pump is part of a blood pump system that includes blood conduit(s), a control system with optional sensors, and a power source. Embodiments of the present invention may include elements such as wear resistant bearing materials, a rotor back plate for magnetic attraction of the rotor to reduce bearing pivot bearing forces and wear, a rotor size and shape and a bearing gap that combine to create a hydrodynamic bearing effect and reduce bearing pivot bearing forces and wear, improved intravascular conduits with increased resistance to thrombosis, conduit insertion site cuffs to resist infection, and conduit side ports amenable to the easy insertion of guidewire and catheter-based medical devices.

Abstract: The present invention provides a combination cannula positioned targeting guide adapted for angular receipt and support of a surgical instrument, the combination including an endoscopic portal having an enlarged membrane chamber having a rear port and an elongated portal cannula extending towards a portal tip, the rear port and the portal cannula being axially aligned; a portal stand extending from a substantially rectangular body towards an arcuate channel in communication with the enlarged membrane chamber; and the endoscopic portal being rotationally secured to the portal stand.

Abstract: Vascular needle system for visualization of blood has a vascular needle and a tube having a beveled distal end and a proximal end and between the ends a tubular wall having an external surface and an axial cavity for the passage of a fluid between said ends, the needle being provided with at least one lateral aperture and a proximal base-body, the vascular needle system also having a plastic transparent tubular cannula having an internal surface and overlying at least partially the needle.

Abstract: A dilator system includes a series of sequential dilators. A first dilator has an elongated body having a major axis and a minor axis, the minor axis being substantially normal to the major axis. A second dilator has an elongated body having a major axis and a minor axis, the minor axis of the second dilator being substantially normal to the major axis of the second dilator. A bore of the second dilator is configured to matingly receive the first dilator in such a way that the major axis of the second dilator is aligned with the minor axis of the first dilator and the minor axis of the second dilator is aligned with the major axis of the first dilator.

Abstract: A medical device is provided, configured to access a target site within a patient body. The device may be provided as a kit including pre-assembled components. Embodiments of the device include an elongate flexible access needle including a needle lumen disposed through at least a longitudinal length of the needle; an elongate wire guide pre-loaded into at least a lengthwise portion of the needle lumen and extending to at least near a distal end of the needle end; and a needle sheath including a longitudinal sheath lumen through which the access needle is disposed; where the distal needle end comprises a piercing tip configured for penetrating tissue to access a target site. A method of use is provided where the needle may be withdrawn over the pre-loaded wire guide after it has been directed to a target site and the sheath as been advanced over the needle's distal end, in a manner freeing the wire guide for further guidance or direction, and for introduction of another device along the wire guide.

Abstract: A dialysis catheter having a first portion having a first diameter, an elongated distal portion having a second diameter smaller than the first diameter, and a transition portion between the first portion and distal portion. The first portion includes first and second independent longitudinally extending blood withdrawal lumens and the transition portion has first and second opened areas separated by a rib, the first opened area forming a first terminal opening for the first withdrawal lumen and the second opened area forming a second terminal opening for the second withdrawal lumen. A longitudinally extending blood delivery lumen configured to deliver blood terminates in a delivery opening in the distal portion of the catheter.

Abstract: An introducer is configured to distinguish an introducer provided with a sheath tube whose wall thickness is reduced, from an introducer provided with a sheath tube whose wall thickness is not reduced, and to recognize the relationship between the inner diameter and the outer diameter for the sheath tube in which the wall thickness is reduced. An introducer includes an introducer sheath and a dilator. The introducer further includes a first information piece on at least one of the introducer sheath and the dilator and has an inner diameter dimension of the sheath tube as an index. Furthermore, a second information piece having an outer diameter dimension of the sheath tube as an index is on at least one of the introducer sheath and the dilator.

Abstract: Utilizing the technology and methods disclosed, the characteristics of flexibility and rigidity for intralumenal devices, including coaxial two piece devices such as stylet and needle sets, can be adapted by a physician or device manufacturer according to the type of procedure, the patient size and unique anatomical challenges of a given procedure. Rigidity and flexibility are actively controlled by the operator at predefined portions of a device through rotating the stylet within the cannula to bring about alignments of customized notches to impart target flexibility or rigidity profiles at specific spots on the device. The device operator is able to alter the relationship and orientation of specific notched and non-notched segments of either or both the stylet and cannula that are strategically located at said critical points along the length of the device.

Abstract: An access device for placing a medical article within a body space includes a needle, a dilator, and a medical article. The needle can include an elongated needle body with a distal end and a hub from which the needle body extends. The elongated needle body can include at least one side fenestration and an outer diameter. The dilator can be slideably disposed on the needle body and include a dilator hub and an elongated dilator shaft that extends from the dilator hub. The dilator shaft can include at least one side fenestration in communication with the needle side fenestration. The dilator shaft can also include an inner diameter that is less than the outer diameter of the needle. The medical article can include a tubular section and a hub. The tubular section can be disposed on the dilator and define a space between the medical article and the dilator in communication with the needle side fenestration through the dilator side fenestration.

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

Abstract: An introducer is configured to distinguish an introducer provided with a sheath tube whose wall thickness is reduced, from an introducer provided with a sheath tube whose wall thickness is not reduced, and to recognize the relationship between the inner diameter and the outer diameter for the sheath tube in which the wall thickness is reduced. The introducer includes an introducer sheath which includes an elongated hollow sheath tube and a sheath hub at the proximal side of the sheath tube and provided with a dilator insertion port. A first information piece having an inner diameter dimension of the sheath tube as an index is shown on at least one of the sheath tube and the sheath hub. Furthermore, a second information piece having an outer diameter dimension of the sheath tube as an index is shown on at least one of the sheath tube and the sheath hub.

Abstract: In some embodiments, an apparatus includes a handle and an elongate member coupled to the handle. The elongate member has a first portion, a second portion and a third portion. The first portion of the elongate member extends from the handle and defines a first longitudinal axis. The second portion of the elongate member extends from the first portion and defines a second longitudinal axis. The first longitudinal axis and the second longitudinal axis define a first angle and a first plane. The third portion of the elongate member extends from the second portion of the elongate member and defines a third longitudinal axis. The third longitudinal axis and the second longitudinal axis define a second angle and a second plane. The second plane is non-parallel with the first plane.

Abstract: Devices and methods are provided for performing a medical procedure using a trans-septal approach. The device includes a dilator including a proximal end, a distal end terminating in a distal tip, and a lumen extending between the dilator proximal and distal ends, and a needle device including a proximal end, a distal end sized for introduction into the dilator lumen and terminating in a sharpened distal tip. The needle is movable relative to the dilator to selectively expose the needle device distal tip distally from the dilator lumen and advance the dilator relative to the needle device. The dilator may have a complex tapered shape on its distal tip, e.g., including first and second tapered regions. The needle device may include an inner needle including the sharpened distal tip and an outer tube including a substantially blunt distal end that slidably receives the inner needle.

Abstract: An access device places a medical article within a body space of a patient. The device has a needle that includes an elongated body and a needle hub. The device further includes a dilator disposed on and slideable along the elongated body of the needle and a medical article. The medical article is disposed on and slideable along the dilator. A track extends in a proximal direction from the dilator. The needle hub slides along at least a portion of the track between a first position and a second position. The device further includes a locking mechanism operably disposed between the track and the needle hub so as to inhibit further axial movement of the needle in the proximal direction when the needle hub is in the second position.

Abstract: Devices, systems and methods wherein a dilator, such as a balloon or other expandable member, is positionable within the frontal sinus ostium and adjacent frontal recess and useable to dilate the frontal sinus ostium and substantially all of the frontal sinus recess without requiring repositioning and repeated re-expansion of the dilator. One balloon catheter device of the invention comprises a catheter body that is less than about 50 cm in length (and in some embodiments less than 25 cm in length and a semi-compliant or non-compliant balloon on the catheter body. The balloon may have a working length of about 12 mm to about 30 mm and a width at its widest point when fully inflated of about 2 mm to about 7 mm. Such balloon may be constructed to withstand inflation pressures of about 12 atmospheres. In some embodiments, the dilator is advanced through or over a guide (e.g., guidewire or guide catheter) that has a preformed shape.

Abstract: An insertion device for applying an infusion set to the body of a patient, wherein the device has two actuation members which have to be actuated simultaneously to trigger an insertion movement by which a cannula of the infusion set is introduced into the body and wherein, in some embodiments, one of the actuation members is a securing slide including a contact face to be placed on the body of the patient, the securing slide being actuated by the insertion device being pressed, via the contact face, against the body of the patient.

Abstract: A method and apparatus for preparing an access site on a patient for insertion of a catheter into one of the patient's veins. The method includes the steps of: providing a tract forming assembly having a leading cutting edge and a dilating body defining a trailing dilating portion, with the cutting edge and dilating body together defining a tract forming unit; advancing the tract forming unit into skin at the access site so that: a) the cutting edge progressively forms a tract through the patient's skin and subcutaneous tissue towards the one vein; and b) the dilating body follows the cutting edge and dilates the tract; and removing the tract forming unit from the dilated tract so that no component resides in the dilated tract to allow a catheter to be directed through the dilated tract and into the one vein.

Abstract: A device for the medical treatment is provided which includes not only a function for applying turning force to a guide wire but also a function for inserting an end portion of the guide wire into an opening of a catheter and therefore is excellent in workability. In one form, a device for the medical treatment includes a guide wire connecting section capable of being connected to a guide wire to apply turning force to the guide wire, and a catheter connecting section to which a catheter can be connected and which can relatively move toward and away from the guide wire connecting section.

Abstract: A cannula is placed in an enlarged opening through a bladder wall and an abdominal wall by applying pulling tension to a placement guide extending through a small pathway to hold an inflated placement balloon in sealing contact with the bladder wall. The seal confines distension fluid in the bladder to establish sufficient reactive resistance to enlarge the opening through the bladder wall with blunt force dilation from an obturator.

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: A device for threading a conduit into a communication with a vein or artery beneath the skin of a patient, during insertion of components such as a PICC line is provided. Surfaces of a hollow needle, dilator, and sheath included in kit, and which are anticipated to contact the skin of a patient during the procedure are provided with an antimicrobial surface area formed thereon. The surface area so positioned prevents bacteria and other pathogens from occupying the contacting surfaces and thereby being communicated into the tissue below the patient's skin.

Abstract: The various embodiments of the present inventions provide stabilization devices and methods for use of the stabilization devices with minimally invasive gynecological procedures such as methods of preventing pregnancy by inserting intrafallopian contraceptive devices into the fallopian tubes.

Abstract: Intravenous access is achieved by introducing a catheter over an access needle which is initially present in the catheter. A tapered dilating element is positioned over the needle and provides a transition between the needle and a larger catheter lumen. The access needle is hollow and has a port which allows blood to flash back through a lumen of the catheter so that flashback can be observed on a catheter hub or the catheter itself.

Abstract: A cannula assembly for directing blood from the heart of a patient and a minimally invasive method of implanting the same. The cannula assembly includes a flexible cannula body having a proximal end and a distal end with a receiving portion, and a transseptal tip having a distal end and a proximal end with an engaging portion. First and second anchors are coupled to the transseptal tip and configured to be deployed from a contracted state to an expanded state. The engaging portion of the transseptal tip is operable to removably engage the receiving portion of the flexible cannula body in vivo.

Abstract: A dilator includes a first section, a second section, a third section, and a fourth section which have different diameters and are adjacent to each other in an axial direction, an angle formed by an outer peripheral surface of the first section with respect to the axial direction is smaller than an angle formed by an outer peripheral surface of the second section with respect to the axial direction, the angle formed by the outer peripheral surface of the second section with respect to the axial direction is larger than an angle formed by an outer peripheral surface of the third section with respect to the axial direction, and the angle formed by an outer peripheral surface of the third section with respect to the axial direction is smaller than an angle formed by an outer peripheral surface of the fourth section with respect to the axial direction.

Abstract: Methods and devices described herein facilitate improved treatment of body organs.

Abstract: Devices and methods for guidewire assisted placement of catheters into blood vessels are described. Some of the devices and methods relate to automated or partially automated or assisted insertion and placement of an intravenous catheter into a vein or artery of a patient. Other of the devices are blood draw devices and methods for insertion and placement of an intravenous device into a vein or artery of a patient or to withdraw a blood sample from the patient. The devices also provide for guide wire tip inspection after use.

Abstract: A tissue retractor device suitable for spinal surgery. The device includes base apparatus to which three blades are circumferentially hinged, the blades closing upon each other in default position from spring bias. A pusher mechanism is threadably connected to the base which spreads the blades by rotating the pusher in its threads relative to the base, which converts rotational motion to translational motion to angular motion of the blades about their respective hinges. One blade is longer than the others to present a multipurpose tip to the user of the device, such a tip being useful in avoiding nerve roots or other anatomy obstructing the surgical path. A dilator is threadably connected to the pusher, the dilator having a long hollow tube connected to a hollow tip extending beyond the blades to slide over guide-wire and initially position the device at the operative site, prior to using the pusher to retract patient's tissue.