Abstract: A device for controlling fluid flow through an indwelling catheter assembly. The device includes a septum that is closed by default but that may be defeated temporarily by either exerting a force on a contact surface of the septum, or by biasing the septum with a probe.

Abstract: A surgical access apparatus includes an access member defining a longitudinal axis and having a longitudinal passageway for reception and passage of a surgical object and an access housing mountable to the access member. The access housing includes a diaphragm mounted thereto. The diaphragm is adapted for rotational movement about the longitudinal axis relative to the access housing. The diaphragm defines at least one internal pocket and has a seal assembly disposed within the internal pocket. The seal assembly has an interface seal member adapted for establishing a fluid tight seal about the surgical object. The seal assembly is adapted for selective movement within the pocket about multiple axes in response to manipulation of the surgical object.

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: A treatment tool for an endoscope including: an insertion section inserted from a mouth ring provided at the base-end portion of a channel of the endoscope to the inside of the channel; an operation section provided at the base end of the insertion section; a rigid guide member having a tubular shape, externally fitted around the insertion section at the base end of the insertion section, and fixed to the operation section; and a fixing section that is externally fitted around the guide member, firmly attaches between the inner wall of the mouth ring or the channel and the guide member, and fixes the guide member to the inner wall of the mouth ring or the channel.

Abstract: The present disclosure relates to a valve or seal of the type adapted to allow the introduction of an instrument or object therethrough. In particular, the valve disclosed herein is adapted to maintain a substantially fluid-tight seal with a surgical instrument and is used during a minimally invasive surgical procedure. The valve disclosed herein incorporates one or more bladder members adapted to retain a fluid therein that are associated by one or more interstitial members.

Abstract: An access assembly includes a housing defining a longitudinal axis and having a longitudinal opening therethrough, a cannula extending distally from the housing and in fluid communication with the longitudinal opening and a seal member mounted within the longitudinal opening of the housing. The seal member is configured to receive an instrument therethrough in substantial sealed relation therewith. The housing is adapted to move in at least a radial direction with respect to the longitudinal axis whereby the seal member maintains the substantial sealed relation relative to the instrument as the instrument in manipulated. The housing may be flexible and capable of deflection relative to the longitudinal axis. The housing may comprise an elastomeric material in whole or in part. The seal member may be integrally formed with the housing. The housing may include at least one flexible ring portion and possibly a plurality of ring portions.

Abstract: An access assembly is provided.

Abstract: A surgical access assembly including a base and an elongated member extending from the base. The base defines a central axis and has an opening for receipt of a surgical instrument. The elongated member defines a passageway for passage of at least a portion of the surgical instrument and is adapted to assume a substantially rolled configuration in a normal unstressed condition thereof. When in the rolled configuration, the elongated member is rolled transverse to the central axis.

Abstract: A catheter includes a pressure actuated seal within a manifold. A catheter body is coupled with the manifold, and a manifold lumen and a catheter lumen are configured to receive pressurized fluids. The pressure actuated seal includes a pressure actuated seal element having a seal element lumen. The seal element lumen is in communication with the manifold and catheter lumens. The pressure actuated seal element is deformable between an open configuration and a sealed configuration. In the sealed configuration, the pressurized fluids in the manifold press on the pressure actuated seal element along a first seal face. The pressure actuated seal element compresses inwardly around the seal element lumen according to a pressure of the pressurized fluids. In the open configuration, the pressure actuated seal element relaxes in an absence of the pressurized fluids, and the seal element lumen is open and configured to allow passage of an instrument.

Abstract: A hemostatic valve apparatus used in medical procedures that provides rapid activation of a sealing mechanism resulting in lower blood loss during use of the sealing device. The valve apparatus incorporates an actuator and two mechanisms that counter-rotate opposite ends of a sealing tube.

Abstract: An adapter assembly including a manifold and a valve assembly. The valve assembly includes a seat and a valve body having a circular base and a wall. The wall extends from a trailing side of the base to form a dome-like shape terminating at an end at which a slit is formed, with the wall defining opposing sealing edges at the slit. The seat has an upper circumferential surface and a lower circumferential surface. The upper surface engages a leading side of the base, whereas the lower surface engages a trailing side. At least one of the upper and lower surfaces forms a segment of increased height. Upon final assembly, the valve body is disposed across a passageway of the manifold, with the slit providing a selectively openable path. A force imparted by the segment of increased height flexes the base and biases the sealing edges into engagement.

Abstract: The present disclosure relates to a catheter insertion device, which comprises a catheter hub in which a check valve is arranged, and a catheter, which is in fluid communication with the catheter hub, wherein a support element is attached to the catheter, and a flexible buffer element is provided between the support element and the catheter hub.

Abstract: A surgical seal assembly, includes a seal housing defining a longitudinal housing axis and having a longitudinal opening therethrough, a seal having an inner seal portion defining a passage and being adapted to form a substantial seal about a surgical instrument disposed within the passage and a guide mounted to the seal housing. The guide has an inner guide portion proximal of the inner seal portion of the seal and spaced therefrom. The inner guide portion defines a channel adapted to generally direct the surgical instrument toward the inner seal portion of the seal upon entry of the surgical instrument within the longitudinal opening of the seal housing. The inner guide portion is relatively compliant to accommodate initial offset or angled entry of the surgical instrument.

Abstract: A hemodialysis catheter assembly with a flexible catheter lead that can control blood flow at a hemodialysis access site even under high blood pressures encountered at such sites. Flexible tubing extends through the hollow interior of a housing having opposite, open ends. The assembly includes components to alternately occlude or not occlude the lumen of the flexible tubing. In a first embodiment, spring clips press against the tubing, but insertion of a hollow sleeve into the lumen thereof retracts the clips and provides a flow path. In a second embodiment, a pinch bar can be manually moved into and out of engagement with the flexible tubing to occlude or open a flow path. In a third embodiment, the housing has a screw cap. A spring-loaded pinch bar presses against, and occludes the lumen of, the collapsible tubing when the screw cap is screwed into a threaded cutout in the housing, and provides a flow path through the tubing when the screw cap is removed.

Abstract: The invention provides improved apparatuses and related methods for the detection of needle penetration into negative pressure corporal spaces such as the epidural space. In one aspect, the invention provides a negative pressure indicator apparatus, either integrated with a needle hub or attachable thereto, which accommodates insertion of a stylet into the needle hub and needle thereof while the negative pressure indicator apparatus remains in its operable position.

Abstract: A surgical seal system is adapted for use with a cannula assembly having a cannula housing and a cannula sleeve extending from the cannula housing. The surgical seal assembly includes a seal assembly and an adapter assembly. The seal assembly is mountable to the cannula housing. The seal assembly includes a seal housing and a seal defining inner portions adapted to form a substantial seal about an instrument with a first cross-sectional dimension. The adapter assembly includes an adapter body adapted for releasably coupling to the seal housing of the seal assembly. The adapter body has an adapter seal and a tether. The adapter seal is adapted to form a substantial seal about an instrument with a second cross-sectional dimension less than the first cross-sectional dimension. The tether is mountable to the cannula sleeve thus securing the adapter assembly to the cannula.

Abstract: An infusion system for delivery of therapeutic fluids from a remote source into a patient's body. The system has an infusion assembly, a rotating pivot joint member, a fluid connector assembly, and a sealing assembly retained within the infusion assembly between the housing of the infusion assembly and the rotating pivot joint member. The seal reduces leakage of fluids. The rotating joint may be pivoted to three distinct positions to allow for emplacement on the patient, delivery of the therapeutic fluid to the patient, and protected, sealed closure of the fluid channels to avoid patient fluid backflow.

Abstract: A surgical access apparatus includes an access member defining a longitudinal axis and having a longitudinal passageway for reception and passage of a surgical object and an access housing mountable to the access member. The access housing includes a diaphragm mounted thereto. The diaphragm is adapted for rotational movement about the longitudinal axis relative to the access housing. The diaphragm defines at least one internal pocket and has a seal assembly disposed within the internal pocket. The seal assembly has an interface seal member adapted for establishing a fluid tight seal about the surgical object. The seal assembly is adapted for selective movement within the pocket about multiple axes in response to manipulation of the surgical object.

Abstract: A seal assembly establishes sealing engagement with a plurality of differently dimensioned instruments passing through a trocar. The seal assembly is a caged seal assembly movably disposed within the trocar and includes at least two seal segments disposable into and out of a sealing orientation relative to the instrument. A cage structure of the seal assembly includes at least two cage segments each connected to a seal segment, a biasing assembly connected to the cage structure and disposed and structured to normally bias the seal segments into sealing orientation.

Abstract: A surgical access device includes a seal housing and a roller disposed in the housing and defining a working channel. The roller may be stationary or movable within the seal housing to form both a zero seal in the absence of an instrument, and an instrument seal in the presence of an instrument. Rotation of the roller is contemplated and low-friction surfaces are discussed to reduce instrument insertion forces. Multiple rollers, wiper elements, low-friction braid, pivoting elements and idler rollers are contemplated. The rollers will typically be formed of a gel material in order to facilitate the desired compliance, stretchability and elongation desired.

Abstract: A trocar seal comprising an elastomeric membrane having an opening adapted to receive a surgical instrument. The membrane is configured with a plurality of pleats circumscribing the opening and extending laterally from opening. The pleats comprise a plurality of pleat walls increasing in height as the pleats extend laterally from the opening. In one embodiment, the pleats are conically arranged.

Abstract: A system and method for assembling a catheter device, wherein a septum actuator is positioned within the lumen of a catheter adapter to provide a pathway through a septum component, an introducer needle being inserted through the septum via the septum actuator thereby preventing damage to the septum, the septum actuator thereafter being withdrawn from the septum and positioned within a rearward chamber of the catheter adapter lumen.

Abstract: The haemostatic valve assembly (10) includes a housing (14) with a chamber (16) therewithin. A flexible valve element (26) is located in the chamber (16) and supported by the housing (14). A resilient element (21), for example of foam, is located in the chamber (16) and applies a constant closing force on the valve element (26). The valve (10) can be opened by aspirating fluid held within the chamber (16), for example by means of a pump or syringe, thereby to create a vacuum therein which compresses the resilient element (21). Removal of the vacuum allows the resilient element (21) to expand again and to close the valve (10).

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 sheath can include a sheath body and a sheath hub. The sheath body can have a generally flexible tubular structure, a proximal end, and a distal end. The sheath body can further define a longitudinal axis. The sheath hub can attach to the proximal end of the sheath body and define a longitudinal axis generally aligned with the axis of the sheath body. The sheath body and sheath hub can also form a central cavity along their respective axes. The sheath hub can include two plates: a flexible plate and a rigid plate. The rigid plate can have a relief generally centered on the sheath body's axis. Advantageously, the flexible plate and rigid plate can overlap to substantially seal the central cavity.

Abstract: A sheath introducer for use with a catheter, has a hub and a tube through which the catheter extends, and a lock assembly which has a rotational knob that actuates a plurality of prongs arranged in a radial pattern around a hole in the hub that receives the catheter, wherein the prongs synchronously rotate in one direction to grip the catheter or in the other direction to release the catheter.

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 trocar assembly for creating a pneumatic seal during a minimally-invasive surgical procedure. The trocar assembly including an elongated body having a lumen extending therethrough. The proximal end portion of the body defining a housing. A fluid supply plenum is defined in the housing configured to deliver pressurized insufflation fluid to a nozzle. The nozzle configured for directing pressurized fluid into the lumen and creating a pneumatic seal. A fluid return plenum is defined in the housing configured to collect spent insufflation fluid from as patient's abdominal cavity. The fluid return plenum including a plurality of axially and radially oriented elongate vanes configured to permit spent insufflation fluid to proceed between the vanes and direct spent insufflation fluid back to the fluid return plenum.

Abstract: Methods and devices are provided to allow for easy customization of a surgical access device by an end user. In one exemplary embodiment a surgical access device is provided that includes a plurality of elongate seal elements that are configured to form a sealed configuration between a surgical site and an outside environment. The seal elements can be disposed in a surgical opening and can mate directly to each other with the outermost seal elements mating directly to tissue of the opening. The seal elements can include one or more mating elements to provide the desired mating. The seal elements can also include sealable openings that are configured to receive surgical instruments for use at the surgical site. The sealable openings maintain the desired seal throughout the course of a surgical procedure. Exemplary methods for providing custom configurations on location are also provided.

Abstract: An infusion set has a retraction dial that can be removably assembled with the infusion set and access a threaded needle hub contained therein such that the dial can be used to advance or retract a needle hub and an inserted needle to a more precisely controlled insertion depth to deliver insulin or other medicament intradermally (i.e. to the upper 3 mm of skin surface). Position of the inserted needle can be maintained by providing a separated and isolated needle hub, main base and main hub of the infusion set that can isolate the inserted needle from external forces such that the needle can be maintained at a depth to deliver content to the upper 3 mm of skin surface during normal use.

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 variable hemostasis valve is disclosed that may be used during medical procedures to prevent blood loss while permitting the percutaneous introduction, operation, and removal of medical instruments. A flexible tubular seal element is disclosed that is disposed within the variable hemostasis valve to provide a fluid-tight, adjustable seal. After insertion of a medical instrument into the valve through at least a portion of the flexible tubular seal element, a proximal portion of the valve housing may be rotated to cause the tension of the flexible tubular seal element to increase over the inserted medical instrument and engage the valve in a closed position. The proximal portion of the valve housing may then be rotated in an opposite direction to release the seal and return the tubular seal element to a relaxed lumen open position.

Abstract: A medical instrument includes a housing with a passage through which a catheter is received. A valve body is mounted in the passage, and, as the catheter penetrates through the valve body, the valve body conforms to the outer wall of the catheter to maintain a fluid tight seal between the valve body and the catheter. When the valve body is unstressed before being mounted in the passage, the valve body has a first planar dimension and a second planar dimension that is less than the first planar dimension.

Abstract: A seal is provided for effectively inhibiting the egress of fluids from the working channel of an endoscope when an elongate device having a region with a non-circular cross-sectional shape is disposed therein. The seal has a body portion with a proximal end adapted for insertion of the elongate device, a distal end adapted for connection to the proximal end of the endoscope, and a wall defining a lumen adapted to receive the elongate device and to provide access to the working channel of the endoscope. The seal includes a sealing element for sealing the region of the elongate device with a non-circular cross-sectional shape. The sealing element conforms to the profile of the non-circular region.

Abstract: New devices, systems, and methods are disclosed for preventing, treating, and/or at least minimizing ischemia and/or reperfusion injury by restoring and/or modulating blood flow, particularly in the cerebral vasculature where blood vessels are narrow and tortuous. These devices, systems, and methods make it possible for a clinician to adequately and systematically restore blood flow to ischemic tissue while simultaneously modulating the blood flow to minimize reperfusion injury. New thrombectomy devices and systems, which, for example, expand with greater radial force, further enable improved binding with clots and restoration of blood flow.

Abstract: The present invention generally relates to skin-mountable devices. A device in accordance with the invention comprises a skin-mountable unit having a mounting surface comprising adhesive for adhering the unit to the skin of a subject, and a handling unit releasably attached to the skin-mountable unit. The handling unit comprises an interior space at least partially accommodating the skin-mountable unit and has an opening through which the skin-mountable unit can be moved when detached from the handling unit, the handling unit having a portion surrounding the opening. A seal member is releasably attached to the circumferential portion, providing a closed space for the skin-mountable unit. The device allows for easy handling. The user can grip the handling unit and handle the combined device during operation. The handling unit can be designed and optimized for ease of use during manipulation of the skin-mountable unit.

Abstract: A trocar seal comprising an elastomeric membrane having an opening adapted to receive a surgical instrument. The membrane is configured with a plurality of pleats circumscribing the opening and extending laterally from opening. The pleats comprise a plurality of pleat walls increasing in height as the pleats extend laterally from the opening. In one embodiment, the pleats are conically arranged.

Abstract: A seal is provided for effectively inhibiting the egress of fluids from the working channel of an endoscope when an elongate device having a region with a non-circular cross-sectional shape is disposed therein. The seal has a body portion with a proximal end adapted for insertion of the elongate device, a distal end adapted for connection to the proximal end of the endoscope, and a wall defining a lumen adapted to receive the elongate device and to provide access to the working channel of the endoscope. The seal includes a sealing element for sealing the region of the elongate device with a non-circular cross-sectional shape. The sealing element conforms to the profile of the non-circular region.

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

Abstract: A seal assembly for reception of an elongated surgical instrument is provided which includes a body having at least one opening configured and dimensioned to permit entry of an elongated surgical instrument and defining a central longitudinal axis; a seal member formed of a resilient material and defining an aperture therein, the aperture being configured and dimensioned such that insertion of the surgical instrument into the aperture causes the resilient material defining the aperture to resiliently contact the outer surface of the surgical instrument in a substantially fluid tight manner; and a fabric layer juxtaposed relative to the resilient material. A coating may be applied to the seal member to reduce friction between the seal member and surgical instrumentation inserted therein. The coating is preferably a hydrocyclosiloxane membrane prepared by plasma polymerization process.

Abstract: A valve apparatus device provides surgical instruments with sealable access to an inlet port of an endoscope instrument channel. The valve has a hollow body with a distal end that releasably attaches to the inlet port, and a flexible diaphragm seal dividing the body into a proximal chamber and a distal chamber. An instrument opening extends through the diaphragm seal for the passage of instruments therethrough, and connects the chambers together. The diaphragm seal is configured to seal with a surgical instrument inserted into the instrument opening. At least one fluid transfer member is provided to fluidly interconnect the proximal chamber to the distal chamber when the surgical instrument is sealed within the instrument opening.

Abstract: In order to improve a surgical sealing element holder for holding a surgical sealing element of a surgical sealing system comprising a trocar with a trocar sleeve, the sealing element having an insertion opening which can be widened, such that a sealing element of the sealing system can be replaced in a simple and reliable manner and it is ensured that sealing in relation to a channel of the trocar sleeve is perfect at all times it is suggested that a holder sealing element be provided for sealing the sealing element holder with respect to an inner wall surface of the trocar sleeve. In addition, an improved surgical sealing system is provided.

Abstract: A medical device is provided having a hemostatic valve system that allows substantially leak-free passage of one or more medical interventional devices, such as a catheter, for insertion into a body vessel. The medical device comprises a hemostatic valve system and an elongate tubular member. The hemostatic valve system comprises a body, one or more pouches, and one or more disks.

Abstract: Devices and methods are provided for removing fluid from a surgical access device and/or from surgical instruments passed therethrough, and for preventing such fluid from accumulating. For example, in one embodiment, an exemplary device can include a body defining a working channel that is configured and sized to allow for passage of a surgical instrument therethrough. A number of seals can be disposed in the working channel so as to contact the inserted surgical instrument. One or more outlets can be oriented to direct gas, such as air or an insufflation gas, into the working channel so as to remove fluid on the seals, or other parts of the surgical access device, as well as the surgical instruments themselves. In some embodiments, constant flows of gases can be arranged to act as shields to help prevent fluid from accumulating on the surgical access device and/or surgical instruments.

Abstract: A surgical access assembly including a base and an elongated member extending from the base. The bass defines a central axis and has an opening for receipt of a surgical instrument. The elongated member defines a passageway for passage of at least a portion of the surgical instrument and is adapted to assume a substantially rolled configuration in a normal unstressed condition thereof. When in the rolled configuration, the elongated member is rolled transverse to the central axis.

Abstract: A surgical access port comprises a valve or instrument seal that separates the instrument contact function from the instrument conforming function. Embodiments of the instrument seal comprise in instrument contact element that extends through an opening in a compression element, thereby defining an instrument orifice that seals with an instrument extending therethrough. Embodiments of the instrument contact element comprise a non-distensible membrane or film, for example, as a tube or cylinder.

Abstract: An intravenous catheter inserter device comprising a catheter threader body on which is slidably attached a septum activator, a catheter threader, and a needle hub. Some embodiments further include a safety bar that is configured to assist in coordinating the movement of the various components of the device during a catheterization procedure. In general, the septum activator provides a pathway through a septum of a Luer adapter. The Luer adapter comprises a wedge seal that is configured to receive a base portion of a catheter that is inserted into the Luer adapter by the catheter threader. Accordingly, the device of the present invention simultaneously accesses the vasculature of a patient while assembling the catheter into the Luer adapter. The final configuration provides an integrated unit that is attached to the patient and in fluid communication with patient's vascular system.

Abstract: An infusion set preferably for use with an inserter is disclosed. The infusion set includes a septum cap that encapsulates an upper resilient septum and a lower resilient septum of a base, and includes at least one radial port to receive insertion of a blunt cannula when an extension set hub is engaged with the infusion set in a direction substantially parallel to the skin surface. The extension set hub is configured to provide a snap-fit engagement with the septum cap, wherein the blunt cannula of the extension set hub is guided through the radial port of the septum cap and penetrates the interface between the upper septum and the lower septum. The extension set hub and the septum cap can be rotated in a 360 degree manner about the base of the infusion set.

Abstract: Systems and methods to provide an intravenous device having flashback capabilities and features to permit a flashback notch of an introducer needle to bypass a septum of the device without incurring an undesirable contact between the flashback notch of the introducer needle and a related contact surface of the septum.

Abstract: An exemplary infusion system for accessing an implanted device is disclosed comprising an insertion assembly, a hub comprising a sealable path configured to receive at least a portion of the insertion assembly, a flexible catheter attached to the hub and configured to receive at least a portion of the insertion assembly, and an extension tube attached to the hub. The hub may comprise a manifold element configured to provide fluid communication between the flexible catheter and the extension tube. The hub may also comprise a septum configured to seal the sealable path upon removal of the insertion assembly from the flexible catheter. The extension tube may also be configured to receive at least a portion of the insertion assembly. Exemplary methods of providing a fluid communication path to an implanted device are also disclosed.