Abstract: The present invention relates to a surgical access device comprising an elongate tubular member having a working channel and a proximal end and a distal end, a septum seal integrally formed at the distal end of the tubular member, and a zero seal disposed at the distal end of the tubular member and distal to the septum seal, the zero seal being sized and configured to seal when no instrument is in place within the working channel of the tubular member, and the zero seal being coupled to the septum seal The zero seal may be a duckbill seal having opposing lip portions separated by a slit portion. The opposing lip portions are coated with or attached to a soft or occlusive material.

Abstract: A surgical access device includes a surgical sleeve defining a central longitudinal axis and having a longitudinal passageway to permit passage of a surgical object, and a diameter reduction assembly operably couplable to the surgical sleeve. The diameter reduction assembly includes a structure foundation and at least three stand-off elements mounted to the structure foundation. Each stand-off element is positioned to engage the surgical object and is independently movable relative to the remaining stand-off elements. The at least three stand-off elements are normally biased to a first position which urges the surgical object into general alignment with the central longitudinal axis, and are adapted for distal pivotal movement from the first position to a second position to facilitate passage of the surgical object, and for proximal pivotal movement from the first position to a third position to facilitate withdrawal 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 an absorbent 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 phacoemulsification irrigation sleeve includes an elongated, resilient, tubular body section configured to surround a portion of a shaft of a phacoemulsification needle, the tubular body section having a distal end and a proximal end, and an inner surface and an outer surface. An enlarged section formed on the proximal end of the tubular body portion surrounds a hub of the phacoemulsification needle and connects the irrigation sleeve to a phacoemulsification handpiece. The irrigation sleeve further comprises at least one slitted irrigation port formed adjacent to the distal end of the body section and configured to splay in response to a drop in pressure between the inner surface and the outer surface.

Abstract: A valve comprises a first housing including a first lumen extending therethrough and defining a first disk-facing surface and a second housing including a second lumen extending therethrough and defining a second disk-facing surface, the second housing being mated to the first housing so that the second disk-facing surface faces the first disk-facing surface in combination with a flexible disk gripped between gripping portions of the first and second disk-facing surfaces, the disk including a slit extending therethrough which, when acted upon by a fluid pressure of at least a predetermined threshold level opens to permit fluid flow between the first and second lumens and which, when acted upon by a fluid pressure less than the threshold level remains sealed preventing fluid flow between the first and second lumens and a relief well between opposing portions of the first and second housings radially outside the gripping portions, a width of the relief well exceeding a width of a radially outer portion of the f

Abstract: A seal assembly for use with an access device during a surgical procedure includes a housing having a passageway therethrough dimensioned to permit passage of a surgical instrument and being adapted for mounting to a trocar device, and a seal comprising a gel material and being mounted to the housing across the passageway. The seal includes inner seal portions defining an access channel dimensioned to form a substantial sealing relation with an object therethrough and substantially close in the absence of the surgical instrument. The seal preferably comprises a second material having a hardness greater than a hardness of the gel material. The gel material may be selected from the group consisting of urethane gel, silicone gel.

Abstract: There is disclosed a tri-leaflet valve (100) in which the leaflets (102) extend for substantially the entire length of the valve (100). The valve (100) is provide with a waist (106). An element (16) inserted in the tri-leaflet valve (100) can be sealed by closure of the valve (100), for example by pressurization or twisting. The seat is more effective then prior art seals.

Abstract: A vascular access device may include a body and a layer of the body that communicates with a pathogenic environment to discourage adhesion of a pathogen to the layer and thus repress pathogenic activity. A method of repressing pathogenic activity in a vascular access device includes providing the device with a body, and coating the body with a layer that discourages adhesion of a pathogen to the layer.

Abstract: An indwelling needle assembly includes a stylet having a sharp needlepoint at an end thereof, a stylet hub secured to a base end of the stylet, a hollow outer needle in which the stylet is inserted, an outer needle hub secured to a base end of the outer needle, an opening formed at the base end or at a side of the outer needle hub to communicate with the inner cavity of the outer needle, a seal fitted onto the outer needle hub and in which a hole or slit is provided for insertion of the stylet therein, the hole or slit being formed to become closed when the inserted stylet is extracted, an operating part installed on the outer needle hub to move the stylet and outer needle along the longitudinal direction when the stylet is inserted into the outer needle, and a movement suppresser for stopping or suppressing moving the stylet relative to the seal when the operating part is operated.

Abstract: Kit for providing an artificial stomach entrance, comprising a trocar with a trocar sleeve for penetrating the abdominal wall into the stomach and a PEG tube with a distal extension insertable into the stomach in the form of a balloon made of a flexible material if need be with slight stretchability, which has at least one opening and a proximally connecting tubular area, wherein a feeding channel extends from a proximal feeding opening of the tubular area through the tubular area up to the at least one opening and the balloon is connected with a fill channel, which extends along the tubular area up to the proximal end and has a fill opening with a seal.

Abstract: A tearaway sheath assembly (100) having a splittable sheath tube (102) a splittable hub (110), a splittable valve (150) and a split cap (180). The valve (150) is of the elongated duckbill type and having a slit (158) almost completely across the distal end wall (154) such that two diverging sides (156) of the distal valve portion may be moved apart during insertion therethrough of a dilator or a catheter. A two-part cap (180) is affixed to the hub proximal end (120) and traps a seating flange (168) of the valve between itself and a seating groove (136) of the hub. Pairs of opposed gaps (184,122) of the cap (180) and the hub (110) are aligned with frangible sections or seams (108) of the sheath tube (102) and frangible sections (172) and slits (166) of the valve, facilitating splitting of the assembly (100) when desired by the practitioner to peel it away from the inserted catheter.

Abstract: The present disclosure provides substrates having a lubricious coating thereon. The substrate may be flexible and include, in embodiments, a medical device. The lubricious coating, in embodiments, is applied in a pattern so that the coating avoids delamination and/or fracturing which might otherwise occur as the substrate flexes and/or stretches.

Abstract: A hemostasis valve for a vascular introducer includes a valve body having a seal region with opposed first and second end surfaces and a central axis extending through the seal region perpendicular to the first and second end surfaces. The first end surface of the seal region has a first grouping of cut lines formed on the first end surface and extending radially outward from the central axis. The second end surface of the seal region has a second grouping of cut lines formed on the second end surface and extending radially outward from the central axis. The first circumferential grouping of intersecting cut lines is axially aligned with and angularly offset from the second circumferential grouping of cut lines. A pair of planar slits extend angularly away from each cut line in the first end surface, through the valve body, to a respective pair of oppositely adjacent cut lines in the second end surface.

Abstract: A male adaptor is provided with a nose for penetrating into a housing of the female connector. A septum is disposed over the nose of the male adaptor to maintain a seal with the female connector during coupling and uncoupling. Upon coupling, the septum dilates to allow the nose to pass through. The female connector may have a septum that also dilates to allow penetration of the nose of the male adaptor. Alternatively, the septum of the female connector may be retractable under the force of the nose of the male adaptor.

Abstract: A surgical portal apparatus includes a portal member dimensioned to access tissue and having a longitudinal passageway therethrough to permit access to underlying tissue, and defining leading and trailing ends, a seal housing associated with the portal member and a seal mount at least partially disposed within the seal housing. The seal mount is adapted for rotational movement within the seal housing. The seal mount includes an instrument seal adapted to establish a substantial sealed relation with a surgical object introduced within the longitudinal passageway and a closure valve adapted to substantially close the longitudinal passageway in the absence of the object.

Abstract: A surgical access device, such as a trocar, includes a pendent valve having an elongate structure extending from a proximal end to a septum valve disposed at a distal end. In operation, the elongate structure follows the angle of the instrument to pre-position the septum valve into the path of the instrument where it is not significantly challenged during instrument insertion or manipulation. The pendant valve can be made to float at both the proximal end and the distal end of the elongate structure, to further reduce the vulnerability of the septum valve. Since the valve is less vulnerable to instrument insertion, it can be formed to minimize friction and maximize the functional range of the access device.

Abstract: A breakaway hemostasis hub for a catheter or introducer sheath includes a splittable or separable housing, a seal within the housing, an actuator partially slidably disposed within the housing, a pair of spring retainer members in the housing each adapted to receive at least one spring, and a pair of actuator retainer members adapted to retain the seal, the actuator, and the spring retainer members in the housing. The actuator is operable to assume a closed position and an open position and includes a dilator member configured to dilate the seal when the actuator is in the open position. The hub is splittable or separable into two generally symmetrical sub-assemblies to facilitate cutting the catheter for retraction from the patient's body without displacing its payload.

Abstract: A seal for use in a trocar, particularly for a trocar for eye surgery, having a seal element, with a seal opening, and an instrument opening. The instrument opening extends along a center axis on both sides of the seal element all the way through the seal. The seal also has a clamp element for establishing a form-fit connection to an instrument that is inserted at least partially into the instrument opening and through the seal opening.

Abstract: A valve body is formed from an elastic member in the form of an elliptic or circular film (disk shape) having an upper face and a lower face. The valve body has an opening and closing section which is opened and closed in response to insertion and pulling out of a dilator and is formed from a first slit, a second slit, a second concave portion and two third concave portions. A pair of ribs and six projections are formed on the lower face side of the valve body. The ribs are disposed in opposing relationship to each other with the second slit interposed therebetween and extend along the lower face. Further, the projections are disposed such that they are positioned on the inner side of the ribs and are opposed to each other with the second slit interposed therebetween.

Abstract: The present disclosure relates to a seal assembly for a cannula. The cannula includes a housing having a proximal portion and a distal portion. The seal assembly is located in the proximal portion of the housing and includes a first seal including a first tri-slit, a second seal disposed co-axially and proximal to the first seal and including a second tri-slit, and a third seal disposed co-axially to the first seal and the second seal and including a central opening. A cap is coupled to the proximal portion of the housing and adjacent the third seal and includes a plurality of suture retaining features, such as tabs, for management of sutures during surgery. Fluid leakage out of the cannula, during surgery, is substantially reduced due to the leakage being limited to a channel defined by the first tri-slit, the second tri-slit, and the central opening.

Abstract: A multifunction adaptor for an open-ended catheter that allows placement of the catheter without risk of air embolism or blood loss through the open (proximal) end of the catheter body. The present design allows passage of a standard guidewire for “over the guidewire” placement techniques and a connection for catheter flushing using a standard syringe.

Abstract: A vascular guidewire introducer device (10) having a needle (52), a bulb (16), and a valve subassembly (100) through which a guidewire (14) is insertable for vascular guidewire insertion into a blood vessel (12) of a patient. The valve subassembly (100) includes a proximal fitting (102), a proximal cap (106), and a valve arrangement (104) disposed within a valve seat (118) defined by one of the fitting and the cap. The valve arrangement includes distal and proximal disc-shaped valve members (122,126) having centered slits (124,128) therethrough, and a spacer (130) disposed between the valve members. A method is disclosed for precisely centering the slits of the valve members during assembly and for retaining the valve members in their precisely centered positions in the valve seat. The valve arrangement permits use with a wide range of guidewire diameters.

Abstract: An extravascular system may include a fluid path and a gas vent in communication with the fluid path. A method of venting a medical device may include providing a closed extravascular system having a fluid path, providing a gas vent in communication with the fluid path, venting gas from the extravascular system through the gas vent, and maintaining closure of the extravascular system during and after venting.

Abstract: An introducer for providing access to the interior of the heart generally includes a valve, a shaft, and a piercing element. The valve has a substantially closed state in the absence of an instrument inside the valve and an open state in the presence of the instrument inside the valve. The shaft has first and second ends. The piercing element is located at the first end of the shaft. The shaft is removably positioned inside the valve in an assembled condition. The valve is dimensioned to receive the instrument therein upon removal of the shaft from the valve.

Abstract: Two-way, three-position and one-way, two-position slit valves in cardiovascular access catheters with closed distal ends have slit geometries configured to overcome adhesion between opposed abutting slit faces, when pressure differentials are applied between the interior and the exterior of the catheter. Portions of the slit are oriented at a non-zero angle relative to the longitudinal axis of the catheter causing shear forces to be generated in abutting slit faces. Shear forces arise from tangential, radial, or longitudinal stresses generated in the catheter body. Slit geometries are planar or curved or include multiple end-to-end connected slit subsections. If a slit partially circumscribes a portion of the adjacent outer wall of the catheter body, restraint to outward and inward movement on that portion is reduced. Slit valves are configured to open inwardly to aspirate fluids, to open outwardly to infuse fluids, or both.

Abstract: A vascular guidewire introducer device (10) having a needle (52), a bulb (16), and a valve subassembly (100) through which a guidewire (14) is insertable for vascular guidewire insertion into a blood vessel (12) of a patient. The valve subassembly (100) includes a proximal fitting (102), a proximal cap (106), and a valve arrangement (104) disposed within a valve seat (118) defined by one of the fitting and the cap. The valve arrangement includes distal and proximal disc-shaped valve members (122,126) having centered slits (124,128) therethrough, and a spacer (130) disposed between the valve members. A method is disclosed for precisely centering the slits of the valve members during assembly and for retaining the valve members in their precisely centered positions in the valve seat. The valve arrangement permits use with a wide range of guidewire diameters.

Abstract: A releasably locking dilator and sheath assembly and methods for releasing the dilator from the sheath and longitudinally splitting the sheath are provided. The assembly includes a dilator having a dilator hub and a sheath having a sheath hub. The sheath hub has a valve and two opposing winged tabs, each tab having a perpendicular portion and an angled portion as well as a female threaded portion. The dilator hub has a male threaded portion designed to engage the female threaded portion of the sheath hub. The dilator is released from the sheath by rotating the dilator 90° in relation to the sheath and pulling the dilator out of the sheath. The sheath is longitudinally split by creating a couple on each of the winged tabs thereby forcing the sheath and the sheath hub to split longitudinally. With the sheath and sheath hub split longitudinally, the sheath is removed from around a catheter while leaving the catheter in place.

Abstract: A mucous suction device, comprising in combination, a longitudinally elongated, generally tubular, one-piece plastic body, the body having an axially elongated tapered, first portion extending toward an inlet proximate one end of the body, the body having an axially elongated second portion extending toward an outlet proximate an opposite end of the body, radially outwardly extending annular retention rings in said body second portion, said rings having sharp annular peripheries and said rings being axially resiliently flexible and axially spaced apart, and there being body side porting between said body first and second portions, said side porting being manually controllable to control suction exertion.

Abstract: A surgical access apparatus includes an access member having a longitudinal passageway providing access to a tissue site. An elongated seal member mounted to the access member has an orifice with a variable inner dimension. The elongated seal member establishes a sealing relation about an instrument and is associated with a powered adjustment mechanism for adjusting the variable inner dimension of the orifice. The powered adjustment mechanism includes trailing and leading hubs longitudinally spaced and adapted for relative rotation about an axis defined by the access member. A plurality of spokes extends between the hubs and defines first and second minimum internal dimensions when in first and second conditions respectively upon relative rotation of the hubs. The spokes are arranged about the elongated seal member to adjust the variable inner dimension of the orifice upon relative rotation of the hubs. A powered motion generator effects relative rotation between the hubs.

Abstract: A surgical portal apparatus is provided. The surgical portal apparatus includes a portal member defining a longitudinal axis and having a longitudinal opening therethrough for receiving a surgical object, a seal member positioned along the longitudinal opening for receiving a surgical object in a sealing manner, and a centering mechanism maintained within the portal member, wherein the centering mechanism including a pair of rollers arranged in general diametrical opposed relation, the rollers movable relative to the longitudinal axis from a radial inward position to a radial outward position to permit passage of the surgical object, the rollers being biased toward the radial inward direction to correspondingly bias the surgical object in general alignment with the longitudinal axis.

Abstract: A valve body formed from an elastic member in the form of an elliptical or circular film (disk shape) has upper and lower surfaces. A first concave portion is formed on the upper surface side of the valve body. The valve body further has an opening and closing section which is opened and closed in response to insertion and pulling out of a dilator and is formed from a first slit, a second slit, a second concave portion and two third concave portions. The second concave portion is formed at a portion of the concave surface side of the valve body corresponding to an intersecting portion, and the third concave portions are formed at the opposite end portions of the first slit. The second concave portion extends, in a thickness wise direction of the valve body, to an intermediate portion of the first slit but not to the second slit.

Abstract: A luer hub connector comprises a hub having a cylindrical bore extending there through. The hub is adapted to have a luer device connected at one end. A cap having a hollow nozzle extending therefrom is formed at the other end of the hub. A cylindrical spring-like member is positioned within the bore in the hub, and a septum membrane closes the end of the spring-like member. A sliding, hollow sleeve member is received in the bore of the hub member, with a hollow nozzle extending from the sleeve member into the bore of the spring-like member. When a luer device is threaded onto the end of the hub, it contacts and drives the sleeve member towards the septum. The end of the hollow nozzle is pushed through the septum, and the spring-like member is also compressed. When the luer device is removed, the spring-like member pushes the sleeve member back, and the hollow nozzle withdraws out of contact with the septum. The septum then closes and seals.

Abstract: An apparatus for the reception of an instrument inserted through a surgical portal apparatus includes a valve mount, a major opening through the valve mount, a primary valve for selectively sealing the major opening, a minor opening through the primary valve, and a secondary valve for selectively sealing the minor opening. Components of both the major valve and the minor valve may be displaced to permit passage of a broad instrument, while components of only the secondary valve may be displaced to permit passage of a narrow instrument.

Abstract: Methods and systems for transvenously accessing the pericardial space via the vascular system and atrial wall, particularly through the superior vena cava and right atrial wall, to deliver treatment in the pericardial space are disclosed. A steerable instrument is advanced transvenously into the right atrium of the heart, and a distal segment is deflected into the right atrial appendage. A fixation catheter is advanced employing the steerable instrument to affix a distal fixation mechanism to the atrial wall. A distal segment of an elongated medical device, e.g., a therapeutic catheter or an electrical medical lead, is advanced through the fixation catheter lumen, through the atrial wall, and into the pericardial space. The steerable guide catheter is removed, and the elongated medical device is coupled to an implantable medical device subcutaneously implanted in the thoracic region. The fixation catheter may be left in place.

Abstract: Seal assemblies or valves, generally for use in trocar assemblies, are provided for reducing the amount of contact between an instrument being passed into and out of a trocar assembly and an inner surface of a sealing wall of such seal assemblies or valves. In one exemplary embodiment a valve includes an activation extension that is formed on the inner surface of the sealing wall of the valve and is configured such that a distal end of the sealing wall is moved to the open position by an instrument contacting the activation extension. In one embodiment the instrument does not come into contact with the inner surface of the sealing wall during the procedure. In another embodiment a distal-most end of the activation extension can be closer to a longitudinal axis extending through the flange than the inner surface of the sealing wall.

Abstract: An intravascular valve component broadly includes a valve case and a flexible pressure-actuated flow control valve. The valve case includes attached proximal and distal case portions that present respective spaced apart fluid ports and a fluid passageway extending between the ports. The flexible pressure-actuated flow control valve is disposed within the fluid passageway and includes a slitted central valve wall and an annular flange surrounding the central valve wall. The annular flange includes a radially-extending flange wall and a projection extending axially from the flange wall, with the projection engaging one of the case portions to restrict radial movement of the flow control valve relative to the valve case.

Abstract: A medical device having a vascular access device including a rotationally activated flow control valve having, a body including a distal adapter and a proximal adapter defining a lumen extending therethrough and a septum. A method of use in which the connection of first and second medical devices results in the automatic activation of the rotational flow control valve.

Abstract: An apparatus to control blood flow through an intravenous catheter in accordance with the present invention may include an intravenous catheter adapter and a blood control valve. The blood control valve may be retained within a hollow interior region of the intravenous catheter adapter, and may include a resilient outer shell and an inner valve portion extending inwardly therefrom. The inner valve portion may include a slit configured to open, coin-purse style, upon radially compressing the resilient outer shell. In some embodiments, a compression feature may be integrated into the intravenous catheter adapter to radially compress the resilient outer shell. A Luer device, for example, may be inserted into the intravenous catheter adapter to translate the blood control valve to a position substantially corresponding to the compression feature, thereby actuating the compression feature to open the slit.

Abstract: A tearaway introducer sheath assembly (100,200) having an integrated valve (300). The valve is seated within a valve housing (222) defined by the hub portion (200) of the sheath (200). The valve (300) includes a pair of distally extending opposed side walls or flaps (324) extending to converge at a distal tip (328) having a virtual opening (334) therethrough. The valve further includes a pair of tensioners (340) along outer surfaces of the opposed side walls (324) that extend radially outwardly to engage and bear against the interior valve housing surface (230) to press the opposed side walls (324) together at the distal tip (328) for sealing, both when a dilator extends through the valve and sheath and afterward upon removal of the dilator.

Abstract: A surgical access device includes a housing; an access member extending distally from the housing and being dimensioned for positioning within tissue, and defining a longitudinal axis; and a seal assembly disposed within the housing. The seal assembly includes first and second seal components respectively having first and second seal members. Each of the first and second seal members defines a passage for passage of a surgical object in substantial sealed relation therewith. The first and second seal components are capable of relative rotation about the longitudinal axis between a first position, in which passages of the first and second seal members are in substantial alignment, and a second position where the passages of the first and second seal members are offset to inhibit the communication of fluid through the seal assembly.

Abstract: An indwelling catheter comprises a tube, a female connector and an elastically deformable hemostasis valve which can be pressed by a male connector. An opening taper portion tapered forwardly is formed in a longitudinal intermediate portion of an inner circumferential surface of the female connector. The elastically deformable hemostasis valve is provided longitudinally slidably in the opening taper portion of the female connector and an inside portion extending rearwardly from the opening taper portion. The hemostasis valve includes; a body having a hollow form opened at its front and rear ends or a tubular portion fitted over the connecting portion from a rearward direction; and an openable/closable portion being opened by elastic deformation of the body or the tubular portion.

Abstract: A surgical portal assembly includes a portal member adapted for positioning within tissue. The portal member defines a central longitudinal axis and has a longitudinal passageway for permitting passage of a surgical object. In addition, the portal member includes a seal mount. A seal member is mounted within the seal mount of the portal member. Further, the seal member has inner surface portions defining a passage for receiving the surgical object. Aside from the seal member, the surgical portal assembly contains a plurality of seal magnets mounted to the seal member. The seal magnets are arranged with respect to the passage of the seal member whereby respective poles of the seal magnets generate an attractive force to draw the inner surface portions of the seal member about the surgical object to facilitate establishing a substantial sealing relation therewith.

Abstract: A hemostasis valve for a vascular introducer includes a valve body having a seal region with opposed first and second end surfaces and a central axis extending through the seal region perpendicular to the first and second end surfaces. The first end surface of the seal region has a first grouping of cut lines formed on the first end surface and extending radially outward from the central axis. The second end surface of the seal region has a second grouping of cut lines formed on the second end surface and extending radially outward from the central axis. The first circumferential grouping of intersecting cut lines is axially aligned with and angularly offset from the second circumferential grouping of cut lines. A pair of planar slits extend angularly away from each cut line in the first end surface, through the valve body, to a respective pair of oppositely adjacent cut lines in the second end surface.

Abstract: A slit valve 10 for use with an inflatable medical device having a flange surface 12 with an opening therein. The slit valve 10 has a valve body 14 connected to the flange surface 12 and a chamber formed in the valve body 14 for accepting an inflation tube 34 inserted through the opening in the flange surface 12. The slit valve 10 has a concave section at one or both ends, which are connected by a slit 24 formed in the valve body 14.

Abstract: A tearaway sheath assembly (100) having a splittable sheath tube (102) a splittable hub (110), a splittable valve (150) and a split cap (180). The valve (150) is of the elongated duckbill type and having a slit (158) almost completely across the distal end wall (154) such that two diverging sides (156) of the distal valve portion may be moved apart during insertion therethrough of a dilator or a catheter. A two-part cap (180) is affixed to the hub proximal end (120) and traps a seating flange (168) of the valve between itself and a seating groove (136) of the hub. Pairs of opposed gaps (184,122) of the cap (180) and the hub (110) are aligned with frangible sections or seams (108) of the sheath tube (102) and frangible sections (172) and slits (166) of the valve, facilitating splitting of the assembly (100) when desired by the practitioner to peel it away from the inserted catheter.

Abstract: A trocar system for endoscopic surgery, cap assembly, and related methods are provided. The cap assembly includes a housing with an opening formed in line with an axis of the housing. The cap assembly also includes a variable opening flexible sealing gland having a stack of valve body sections each including a valve extension extending from a valve ring and having a valve opening and a slit extending between a valve opening and the valve ring. The combination of the individual valve body sections forms a substantially conically shaped iris diaphragm portion of the sealing gland. The iris is positioned to individually and separately receive elongate tools so that when any one of the elongate tools is positioned through the valve opening, a seal is maintained between peripheries of the seal gland surrounding the iris and outer peripheries of the inserted elongate tool.

Abstract: A tearaway sheath assembly (100) having a splittable sheath tube (102) a splittable hub (110), a splittable valve (150) and a split cap (180). The valve (150) is of the elongated duckbill type and having a slit (158) almost completely across the distal end wall (154) such that two diverging sides (156) of the distal valve portion may be moved apart during insertion therethrough of a dilator or a catheter. A two-part cap (180) is affixed to the hub proximal end (120) and traps a seating flange (168) of the valve between itself and a seating groove (136) of the hub. Pairs of opposed gaps (184,122) of the cap (180) and the hub (110) are aligned with frangible sections or seams (108) of the sheath tube (102) and frangible sections (172) and slits (166) of the valve, facilitating splitting of the assembly (100) when desired by the practitioner to peel it away from the inserted catheter.

Abstract: A valve body is formed from an elastic member in the form of an elliptic or circular film (disk shape) having an upper face and a lower face. The valve body has an opening and closing section which is opened and closed in response to insertion and pulling out of a dilator and is formed from a first slit, a second slit, a second concave portion and two third concave portions. A pair of ribs and six projections are formed on the lower face side of the valve body. The ribs are disposed in opposing relationship to each other with the second slit interposed therebetween and extend along the lower face. Further, the projections are disposed such that they are positioned on the inner side of the ribs and are opposed to each other with the second slit interposed therebetween.

Abstract: Methods and systems for transvenously accessing the pericardial space via the vascular system and atrial wall, particularly through the superior vena cava and right atrial wall, to deliver treatment in the pericardial space are disclosed. A steerable instrument is advanced transvenously into the right atrium of the heart, and a distal segment is deflected into the right atrial appendage. A fixation catheter is advanced employing the steerable instrument to affix a distal fixation mechanism to the atrial wall. A distal segment of an elongated medical device, e.g., a therapeutic catheter or an electrical medical lead, is advanced through the fixation catheter lumen, through the atrial wall, and into the pericardial space. The steerable guide catheter is removed, and the elongated medical device is coupled to an implantable medical device subcutaneously implanted in the thoracic region. The fixation catheter may be left in place.

Abstract: A valve body formed from an elastic member in the form of an elliptical or circular film (disk shape) has upper and lower surfaces. A first concave portion is formed on the upper surface side of the valve body. The valve body further has an opening and closing section which is opened and closed in response to insertion and pulling out of a dilator and is formed from a first slit, a second slit, a second concave portion and two third concave portions. The second concave portion is formed at a portion of the concave surface side of the valve body corresponding to an intersecting portion, and the third concave portions are formed at the opposite end portions of the first slit. The second concave portion extends, in a thickness wise direction of the valve body, to an intermediate portion of the first slit but not to the second slit.