Abstract: Removable catheter cap, and applications thereof, for delivering medical tubes in bodily passages. Removable catheter cap covers flexible medical tube (e.g., catheter) distal tip during delivery in a body lumen. Catheter cap includes: cap body removably connectable to, for capping, catheter distal tip, and transformable into a predefined constituent part freely passable through catheter lumen; and cap releasing member extending through catheter proximal end when catheter cap is connected to the catheter, and manipulatable for transforming cap body into constituent part or/and for withdrawing constituent part from catheter distal tip through catheter lumen.

Abstract: A catheter insertion system includes a housing extending along a longitudinal axis. A needle extends distally from a distal end of the housing. The needle has a longitudinal passage coaxially aligned with the housing. A catheter has a length and is sized and shaped to be advanced from a retracted position within the longitudinal passage of the needle to an extended position with at least a portion of the catheter length extending beyond a distal tip of the needle. The needle is typically configured to be retracted back into the housing after the catheter has been advanced, thus providing an integrated catheter and catheter insertion apparatus. After needle retraction, the housing may be taped to the patient's skin while the needle remains protected within the housing. A luer on the catheter may then be connected to a fluid or other source in an otherwise conventional manner.

Abstract: Cardiac interventional devices are fitted with sensors coupled to an electrophysiology (EP) mapping system. The sensors can be in the form of electrodes and/or magnetic field sensors which are placed strategically upon the interventional devices. The interventional devices can thus be visualized on the EP mapping display when the interventional devices are being routed through various pathways adjacent to the heart of a patient. The interventional devices can include sheaths, and especially two part sheaths with a base separate from a tube, which base can be separated from the tube at an interface. Other interventional devices include an exoskeleton attachable to a lead, needles, guide wires, dilators, J wires and luminal catheters.

Abstract: Some embodiments relate to a catheter system having a changeable or adjustable working length. The catheter system can comprise a proximal end, a distal end, and a first axial lumen configured to receive a guidewire formed through at least a portion of the catheter body. A first opening can be formed through a portion of the catheter body and be in communication with the first lumen. The sheath can be rotatable, axially movable, or otherwise changeable from at least a first position to a second position, wherein the sheath can substantially cover the first opening in the catheter body in the first position, and can substantially expose the first opening in the catheter body in the second position.

Abstract: An introducer assembly includes an elongate sheath sized for insertion into a blood vessel of a patient and a hub. The hub can be coupled to a proximal portion of the sheath and can include a first hub portion and a second hub portion. The hub can include various features to facilitate breaking apart or separating the introducer assembly from a patient. For example, the first hub portion can have a first notch which can facilitate breaking, splitting, or fracturing the hub. The second hub portion can partially surround the first hub portion and can include two wings and an opening disposed above the first notch. The first hub portion can be formed from a first material and second hub portion can be formed from a second material. In some embodiments, the second material can be stiffer than the first material to facilitate fracturing the hub.

Abstract: Percutaneous access systems, including trocars, for accessing desired locations within a subject's body through the subject's skin or other tissues that are configured to minimize incision sizes are disclosed. Such a percutaneous access system includes a cannula and an obturator. The cannula includes a passageway with a tapered section and an expandable section at its distal end. The expandable section may include leaves that are configured to extend radially outward as an elongated instrument that has an outer diameter that exceeds a minimum relaxed inner diameter of the tapered section of the passageway is forced through the tapered section. Methods for using such a percutaneous access system, including medical procedures, are also disclosed.

Abstract: The present invention relates to peripheral intravenous catheters, and in particular to an integrated peripheral intravenous catheter having a low profile securement platform, a needle hub having an interior compartment and further comprising a paddle grip, and an extension tube coupled to the catheter and stored within the interior compartment of the needle hub prior to catheterization.

Abstract: Hub assemblies that include a first hub and a second hub can be used to selectively couple and uncouple medical device components to and from each other without rotating the first hub relative to the second hub. Some hub assemblies can include a dilator that includes a dilator hub and an introducer sheath that includes an introducer sheath hub.

Abstract: A neurosurgical kit includes a catheter and a guide tub. The catheter includes a distal section of tubing having a distal end with a port or ports for delivering fluid to a target site within the brain. The distal section of tubing has an outer diameter that is smaller than an internal diameter of the guide tube. The catheter and guide tube are arranged such that, when the catheter is inserted into the guide tube to locate the port or ports at the target site, a recess is provided in a distal end section of the guide tube between the guide tube and the distal section of tubing of the catheter.

Abstract: According to the present invention, there is provided an artificial tendon-forming auxiliary instrument in which a valve cusp of a cardiac valve and a papillary muscle can be joined together with an artificial tendon through an easy procedure and the artificial tendon can be finished so as to have a desired length. According to an aspect of the present invention, an auxiliary instrument (100) is used for joining a valve cusp (210) of the cardiac valve and a papillary muscle (212) with an artificial tendon (200). A pair of end-portion support portions (20) and (21) respectively supporting the valve cusp (210) and the papillary muscle (212) is provided at both ends in a longitudinal direction. The auxiliary instrument (100) includes first and second tendon insertion ports through which the artificial tendon (200) is inserted, a tendon guide portion (30), and an instrument holding portion (40).

Abstract: Systems and methods for deploying a paddle neurostimulation lead configured to provide DRG stimulation within a patient. A DRG therapy system includes a delivery tool includes a delivery tube including a first linear segment, a second linear segment, and an arcuate segment coupled between the first and second linear segments, the first and second linear segments having an angle therebetween and the second linear segment defining an elongated opening. The delivery tool further includes a stylet positioned within an interior of the delivery tube, and a handle coupled to the delivery tube and including a stylet actuation mechanism configured to selectively advance and retract the stylet between a deployed position and a retracted position, wherein the stylet extends across the elongated opening in the deployed position to engage an engagement member of the paddle neurostimulation lead.

Abstract: An introducer assembly includes an elongate sheath sized for insertion into a blood vessel of a patient and a hub. The hub can be coupled to a proximal portion of the sheath and can include a first hub portion and a second hub portion. The hub can include various features to facilitate breaking apart or separating the introducer assembly from a patient. For example, the first hub portion can have a first notch which can facilitate breaking, splitting, or fracturing the hub. The second hub portion can partially surround the first hub portion and can include two wings and an opening disposed above the first notch. The first hub portion can be formed from a first material and second hub portion can be formed from a second material. In some embodiments, the second material can be stiffer than the first material to facilitate fracturing the hub.

Abstract: A tubular sheath for enclosing an expandable balloon attached to the distal portion of a catheter encloses and protects the expandable balloon. The tubular sheath is configured to be slidable and removable from the catheter. The tubular sheath may include a longitudinal splitting element that is removable as a result of a force applied to the longitudinal splitting element. The longitudinal splitting element is configured to split the wall of the tubular sheath in response to the force. Alternatively, the tubular sheath may include a gripping portion that has relatively poor cohesive strength to adjacent portions of the tubular sheath. The tubular sheath is configured to be removable in response to a force applied to the gripping portion.

Abstract: A method of controlling intravascular sheaths including the steps of: a) obtaining a guide assembly having a body with a tubular wall bounding a passageway, the body having a length between axially spaced ends and an outer surface that tapers towards each of the spaced ends, the body flexible at each of the spaced ends to allow the spaced ends to bend transversely to the length of the body; b) directing the guide assembly into an operative state within a human body vessel; c) obtaining a first sheath having a tubular body extending around a passageway; and d) relatively moving the guide assembly body and first sheath to thereby direct the guide assembly body into the passageway on the first sheath and thereafter guidingly sliding the first sheath lengthwise against the outer surface of the guide assembly body to: a) advance the first sheath into the human body vessel; or b) withdraw the first sheath.

Abstract: An electrical stimulation device comprises a stimulation lead with an adjustable length tension sleeve to prevent induction of an electrical current when the electrical stimulation device is in the presence of a magnetic field generated by a device such as an MRI machine. The tension sleeve is shaped to organize excess length of the stimulation lead while providing a variable length between a distal end of the stimulation lead and an electrical source. The shape of the tension sleeve avoids coils and may utilize combinations of straight and curved legs that lie substantially in a common plane to both organize excess length of the stimulation lead and prevent electrical induction.

Abstract: A slotted cannula for endoscopic surgical procedures is disclosed. The slotted cannula has a tubular body having a distal end, a proximate end, an open slot extending longitudinally from the beginning of the proximate end to the proximity of the distal end, and a pair of wings integrally formed on the proximate end. The tubular body is made from a transparent material and has an inner diameter large enough to accommodate an endoscope.

Abstract: A medical device delivery system includes a sock removal mechanism, which also locks a deployment handle. The ability to lock the handle allows a medical device to be safely and effectively deployed to a treatment site without prematurely deploying a medical device. The sock can cover and/or restrain the medical device. The sock removal mechanism can release and retract the sock when separated from the handle.

Abstract: A sheath introducer for a catheter includes a sheath having a lumen, a hub positioned on a proximal end of the sheath, and a housing positioned on the hub. The hub can include a splittable penetration member having a port in fluid communication with the sheath lumen. The housing can include a valve having a closed upper surface and a channel surrounding the splittable penetration member. Movement of the housing with respect to the hub can expose the port of the splittable penetration member for insertion of the catheter.

Abstract: Apparatus for delivery of bone includes a syringe body and a plunger. The syringe body includes a tip at a bottom thereof, a funnel-shaped top at the top thereof, and a tubular section having a generally cylindrical interior wall defining a passageway extending from the funnel-shaped top to the tip. The plunger includes an elongate piston, a press head, and a handle. The piston extends between the press head at a lower end of the plunger, and the handle at an upper end of the plunger. The plunger is removably received within the passageway, with an extent of the plunger extending out of the funnel-shaped top away from the syringe body. The syringe body may be loaded with one or more bone pellets or cartridges containing bone.

Abstract: A catheter and method of making it are disclosed. The catheter includes a swellable inner element and a non-swellable outer sleeve covering an outer wall of the inner element. The inner element absorbs liquid from infusate administered through the catheter and swells in size. Outward swelling of the inner element is restrained by the non-swellable outer sleeve. The inventive catheter can be substituted for a conventional catheter that is used in an insulin infusion system.

Abstract: A method of treating lower leg ischemia in a patient includes advancing a wire guide upstream through a vascular access sheath extending into an artery of the patient at a percutaneous entry point in the lower leg, and increasing a downstream flow of blood through the artery at least in part by dilating a constriction in the artery with a treatment mechanism guided into the constriction via the wire guide. A low profile balloon may be used as the treatment mechanism, and is advanced through the artery while the vascular access sheath protects the artery from irritation such that spasm of the artery is less likely to occur. Reduced risk of spasm advantageously enables retrograde access to chronic total occlusions such that multiple entry points into a patient's body are not necessary.

Abstract: A catheter system and corresponding methods are provided for accessing a blood vessel true lumen from a sub-intimal plane of the vessel. The catheter includes components that are symmetric about the longitudinal axis and allow for reentry without the need to ensure a correct orientation of the cannula.

Abstract: Catheters, assemblies, and methods for delivering and recovering embolic protection devices. Catheters are provided that can be advanced over single length guide wires and which can be retracted over single length wire shafts of distal embolic protection devices. One catheter is a two-port catheter having two sidewall ports, a distal end port, and a proximal end port. The two-port catheter can be advanced over a guide wire threaded between the distal end port and the distal sidewall port. An embolic protection device wire shaft can be back loaded into the distal end port and out the proximal sidewall port. A three-port catheter includes a distal end port, and distal, intermediate, and proximal sidewall ports. The distal sidewall port can be dimensioned to accept passage of a filter body through the port. The distal end port can be dimensioned to accept only a guide wire to provide a smooth transition from the guide wire to the small profile distal end.

Abstract: A delivery apparatus is provided for inserting catheters and/or cannulae into a patient's blood vessel or body cavity either with or without the use of ultrasound imaging. The apparatus is used for the delivery of central venous catheters (CVCs) for creating a central line. The invention also relates to uses of the apparatus, and to methods for inserting catheters or cannulae (e.g. a CVC) into a patient.

Abstract: In various examples, an apparatus is configured for subcutaneously inserting an implantable device within a patient. The apparatus includes a dilator portion including a dilator including a dilator length. The dilator portion is configured to separate tissue to create a subcutaneous pocket within the patient sized and shaped to accommodate an implantable device within the subcutaneous pocket. A sheath portion includes a sheath sized and shaped to accommodate the dilator within a sheath lumen. The sheath is configured to accommodate an antenna of the implantable device with the dilator removed from within the sheath. The sheath includes a sheath length that is at least substantially as long as an antenna length. The sheath is configured to separate to allow removal of the sheath around the implantable device to remove the sheath from and leave the implantable device within the subcutaneous pocket within the patient.

Abstract: This invention generally relates to a medical device assembly for facilitating a sealed working channel into a pressurized body cavity, and methods of use thereof, In certain embodiments, devices of the invention include a hollow body that is splittable along its length and being configured to move between an open configuration for operably coupling with a surgical instrument and a closed configuration, in which in the closed configuration, the device provides a seal that prevents gas leakage from an incision site of a body cavity while the instrument is in the body cavity.

Abstract: The present invention relates to a cannula for puncturing body cavities, comprising an inner and an outer longitudinally cut sleeve with proximal and distal ends. The inner sleeve is arranged within the outer sleeve so as to be longitudinally displaceable and rotatable within the outer sleeve such that the longitudinal cut of the inner sleeve is covered by the outer sleeve in a first rotational position and the longitudinal cuts of the inner and outer sleeves are placed on top of each other in a second rotational position. The distal end of the inner sleeve is provided with a puncture tip that is completely retracted into the outer sleeve if the inner sleeve is in the second rotational position, wherein the inner and outer sleeves and/or the two handle portions are, preferably unreleasably, locked to one another.

Abstract: A sacrificial catheter assembly and method of use for placing a functional catheter within the body of a patient, such as into the patient's vasculature, is disclosed. In one embodiment, the sacrificial catheter assembly comprises a sacrificial catheter including an elongate body that defines a longitudinally extending lumen. A stylet is removably received within the lumen of the sacrificial catheter such that the catheter and stylet can be advanced together to a target destination within the body of the patient. The sacrificial catheter is configured so as to then be proximally slid over the stylet to remove the sacrificial catheter from the body while the stylet remains in place at the target destination. A functional catheter can then be distally slid over the stylet to place the functional catheter at the target destination. The stylet can then be removed from the body of the patient.

Abstract: Methods and devices incorporating a guidewire entry port subassembly for use in rapid exchange catheters. The use of a subassembly allows for stronger quality control and simpler fabrication of a rapid exchange device. In several embodiments, methods of making a molded guidewire entry port using a mold, often in conjunction with one or more mandrels, are disclosed. Several device embodiments include a separate molded guidewire port as well as molded guidewire ports which are attached, during a molding step, to segments of a catheter.

Abstract: Seal systems and devices for delivering a biologic construct repair for shoulder and joint surgery into an arthroscopic workspace, including a pinch to open seal that uses fluid pressure to self-seal against a curved surface when closed.

Abstract: Devices, systems, and methods for performing injections with lowered likelihood of infection include catheters and other injection means with protective coverings. The protective covering can protect the catheter or other injection means before, during, or before and during insertion of the catheter into an insertion site. The protective covering includes two or more parts of interlocking protrusions and channels that allow for sliding motion of the parts relative each other but that resist separation of the parts in the direction perpendicular to the long axis of the two or more parts.

Abstract: A stent delivery system can include an elongate core member sized for insertion into a blood vessel. The core member can be configured to advance a stent toward a treatment location in the blood vessel. The core member can include a longitudinally extending tube having a helical cut extending along the tube. The helical cut can have an axial length of at least 50 cm and be continuous along the axial length.

Abstract: Apparatuses of the type broadly applicable to numerous medical applications in which it is desirable to insert one or more steerable or non-steerable catheters or similar devices into a working channel of an associated device, such as an endoscope, catheter, etc., or passageway of a patient, are disclosed. The apparatuses may include catheters having a dedicated guide wire channel and one or more of the following: viewing capabilities, a working channel, and auxiliary channels, such as insufflation/irrigation channels. The catheters may include a guide wire channel that is configured to provide the catheter or other device with rapid exchange capabilities.

Abstract: The present disclosure describes a sleeve comprising a conical frustum having first and second end profiles and a lumen there through for covering and constraining an expandable device, and assemblies comprising an expandable device and a sleeve having a frustoconical shape when the expandable device is at least partially expanded. The present disclosure further describes methods for deploying an expandable device in a patient comprising releasing a releasable seam disposed on a sleeve and everting the sleeve while retracting it from the expandable device.

Abstract: A method and apparatus provide techniques for stenting ostial legions and other restenosis in vessels through a stenting apparatus that includes both a guidewire and a separate marker wire. In some examples, the marker wire is threaded through a tubular body of the stenting apparatus and in other examples, the marker wire may be threaded externally through the tubular body. In both such examples, the marker wire may be aligned with a radiopaque marker of the apparatus to guide marker wire positioning.

Abstract: An improved splittable medical device introducer designed to introduce a medical device such as a lead or catheter, into a patient's vasculature without loss of blood or introduction of air is described. The introducer assembly is designed with a notch provided at the proximal end of the introducer housing. The notch, which may comprise a multitude of cross-sectional geometries, is designed to reduce the force required to separate the housing and the introducer sheath, thereby minimizing the possibility of unintentional dislodgement during separation. The notch also increases the repeatability and consistency of the amount of force required to separate the introducer housing and sheath.

Abstract: This invention generally relates to a medical device assembly for facilitating a sealed working channel into a pressurized body cavity, and methods of use thereof. In certain embodiments, devices of the invention include a hollow body that is splittable along its length and being configured to move between an open configuration for operably coupling with a surgical instrument and a closed configuration, in which in the closed configuration, the device provides a seal that prevents gas leakage from an incision site of a body cavity while the instrument is in the body cavity.

Abstract: Tear-away sheath introducers for catheters, methods for making such introducers, and methods for using such introducers are described. A splittable sheath introducer may include a sheath, a hub disposed at a proximal end of the sheath, a valve included with the hub, and a valve actuator movable from a first position to a second position, the valve actuator opening the valve when in the second position. The valve actuator may include a retaining feature that interacts with the hub to connect the retaining member to the hub.

Abstract: A dual lumen cannula includes a first tube defining a return lumen and having a proximal end, a mid-portion and a distal end, wherein the distal end includes a return aperture. A second tube is coaxial with the first tube and has a proximal end and a distal end, wherein the distal end of the second tube is fixedly attached to the mid-portion of the first tube and wherein the distal end of the second tube includes a drainage aperture. A drainage lumen is defined by a space between the first tube and the second tube. A connector is attached to the proximal end of the second tube. The connector includes a reservoir for receiving a fluid from the proximal end of the second tube. The first tube extends through the connector and does not attach directly with the second tube at the connector, and the first tube remains substantially coaxial with the second tube throughout a length of the second tube.

Abstract: The present invention provides a puncture needle set for combined spinal-epidural anesthesia comprising an epidural needle with a small guiding conduit on the pin and a groove on the outer wall and a spinal needle with a beaked tip. During anesthesia, first the epidural needle is punctured into the epidural space, then the epidural catheter is placed, afterwards the spinal needle is guided to enter into the groove on the needle peduncle by the small conduit on the pin of the epidural needle and slide into the epidural space, then let it go ahead deep into subarachnoid space. After medicine is injected, the spinal needle and the epidural needle are withdrawn in turn, at the same time the epidural catheter is left back.

Abstract: The present disclosure describes an assembly comprising a catheter, an expandable device in a collapsed configuration on the catheter, a first releasable sleeve coaxially covering a proximal portion of the device, and a second releasable sleeve coaxially covering a distal portion of the device, wherein first and second sleeves overlap and are rotatably constrained relative to each other, and wherein the second sleeve is rotatably constrained relative to the catheter. During deployment, rotation of the catheter causes rotation of the second sleeve and the device for angular radial orientation. After deployment, the first sleeve may remain implanted in the patient.

Abstract: The present invention generally provides methods and devices for removing fluid from a surgical instrument. Surgical access devices and seal systems are generally provided having one or more valves or seal assemblies to create a closed system between the outside environment and the environment in which the surgical access device is being inserted. In one embodiment, a seal assembly is provided and can include a seal having an opening configured to receive a surgical instrument therethrough and a fluid remover in the form of a sorbent element, a scraper element, a wicking element, or any combination thereof can be associated with the seal and configured to remove fluid from the opening and/or a surgical instrument.

Abstract: An apparatus for delivery of an elongate member into the lumen of a trans-dermal catheter. In a preferred embodiment, the apparatus comprises a protective sheath configured to at least substantially surround an elongate member; and slidable member configured to travel along the protective sheath, the slidable member operatively coupled to the elongate member; wherein the elongate member is insertable into a lumen of a trans-dermal catheter by moving the slidable member along at least a part of the length of the protective sheath.

Abstract: A stretchable-diameter inserter, for hemodynamic studies and related operations, is characterized in that it comprises an inserter tube, a hemostatic valve designed for preventing blood from exiting the patient toward the operator, a side line including a faucet, adapted to be used for performing blood taking and infusion operations and two dilatators: a first dilatator having a smaller cross-section and a second dilatator having a larger cross-section.

Abstract: The present invention generally relates to intraocular shunts, and in particular, to intraocular shunts configured to form a drainage pathway between the anterior chamber and the intra-scleral space.

Abstract: An assembly and method for percutaneous placement of a catheter comprising an elongated hollow catheter having a distal end and a reduced cross-section portion at a proximal end thereof. An introducer needle is slidably mounted over said catheter. The introducer needle has an elongated slit adapted to slide over the reduced cross-section portion to separate the needle from the catheter. A syringe may be attached to the proximal end of the catheter. Also, a valve may be attached to the catheter to permit easy collection of fluid.

Abstract: A modular hemostatic valve includes a splittable valve body. The splittable body defines a passageway. A sealing element is positioned in the passageway. The sealing element is configured to facilitate the passage of a first medical device, and the splittable valve body is configured to engage a second medical device.

Abstract: A catheter (100, 200) for insertion into a human and/or animal hollow organ, comprising a catheter shaft (110, 210) with a lumen (120, 220), which opens into a front opening at a distal end (112, 212) of the catheter shaft (110, 210), wherein the catheter shaft (110, 210) has at least a first lateral opening (130, 230a) that is at a distance from the distal end (112, 212) and opens into the lumen (120, 220), is distinguished by virtue of the fact that there is at least a first insertion device (140, 240a), arranged on an external side (114, 214) of the catheter shaft (110, 210) in a region of the first lateral opening (130, 230a), for a wire-like element (300, 400, 500) that should be inserted into the first lateral opening (130, 230a) from the outside.

Abstract: Guidewire exit ramp members that may be placed over a tubular member having a guidewire lumen, which longitudinally extending and laterally accessible, and methods of use. The guidewire exit ramp member can be placed to force a guidewire loaded through the lumen in a first direction to be forced out of the lumen via an opening, slit or channel. The guidewire exit ramp member, in an illustrative embodiment, takes the form of a relatively short member having a proximal portion and a distally extending flap. The flap may be designed to enter and remain in a longitudinally accessible guidewire lumen. Combinations of such ramp members and device shafts having longitudinally extending laterally accessible guidewire lumens are also disclosed, as are methods for securing such combinations together. A method of backloading a guidewire into a catheter while causing lateral exit of the guidewire at a desired location is also shown.

Abstract: A rail-guided epidural-spinal needle, which includes an epidural needle including a base and a needle shaft connected to the base, the needle shaft having a groove that is formed on an outer surface of the needle shaft and extends along an axis of the needle shaft, the base having an elevated spinal needle inlet disposed thereon, the spinal needle inlet having a conduit formed therein, the conduit being of an acute angle with the groove in a side view of the epidural needle, and being in alignment with the groove in a top view of the epidural needle. The rail-guided epidural-spinal needle also includes a spinal needle having a tip with a unilaterally curved conformation down one side, such that, when the spinal needle is inserted into the conduit of the spinal needle inlet, and pushed forward, the tip thereof reaches the groove and slides along the groove.