Abstract: A hemostasis cannula unit including a valve housing, a cap, and a hemostasis valve, wherein the hemostasis valve includes a proximal valve gasket and a distal valve gasket compressed against the valve gasket by the valve housing, wherein the proximal valve gasket is the same shape as the distal valve gasket.

Abstract: A valve assembly. The valve assembly can include valve members with passageways partially non-overlapping. A compression member can be, provided adjacent the valve members. The valve assembly can be incorporated into a medical access device.

Abstract: A valve assembly is provided for permitting the introduction of a surgical instrument into a patient's body while providing a substantial seal about the instrument. The valve assembly includes a sealing gasket assembly providing a fluid tight seal before instrument insertion, and is configured and dimensioned for accommodating an instrument and providing a substantial fluid tight seal after insertion of an instrument. The valve assembly may further include a deformable sealing member having a substantially central aperture for accommodating the instrument. The sealing member provides a substantial seal about the instrument when the instrument is passed therethrough impeding the egress of fluids and gasses through the valve assembly.

Abstract: An improved vascular introducer sheath having a hemostasis valve assembly which provides tailored distribution of compressive forces along one of the top and bottom edges of each slit to avoid puckering of the slit(s) and to provide balanced performance in terms of bi-directional sealing effectiveness and device movement therethrough.

Abstract: The catheter and introducer needle assembly of this invention includes a catheter adapter at its proximal end having a hollow septum disposed therein. The septum preferably is hollow to minimize drag as the introducer needle is removed therefrom. If desired a gel or lubricious material may be disposed in the cavity.

Abstract: A surgical implement for forming an opening in the skin of a patient comprises two bodies: a first for application to one side of the skin and a second, having an incision element, for application to the other side of the skin to co-operate with the first body. The opening in the skin is formed simply and safely by placing the first and second bodies either side of the skin and moving the incision element.

Abstract: In an embodiment, a slit valve catheter has a generally tubular catheter body with an exterior surface exposed to an environment and an interior surface defining a lumen. The catheter further includes a valve which has a protuberance projecting radially from the catheter body.

Abstract: An indwelling catheter has a hollow catheter body, a catheter tube fitted to a front end of the catheter body, an elastic valve fitted inside the catheter body, and a hollow plug slidably fitted inside the catheter body. The catheter tube, the elastic valve, and the plug are aligned in this order. A connector inserted from a proximal end of the catheter pushes the plug, and the plug presses the elastic valve open.

Abstract: A site for access to the inside of a channel (1) comprises a receptacle (2), communicating with the inside of the channel (1), in order to hold a plug (4) made of an elastic material and intended to form a leaktight barrier between the inside of the channel (1) and the outside. The plug (4) has a thickness on a longitudinal axis, an inner surface (5) oriented towards the inside of the channel (1), and an outer surface (6) facing away from the inner surface (5).

Abstract: A valve (10) useful as a fluid flow check valve or as a self-sealing, penetrable, hemostatic valve for sealing a catheter introducer (12) includes a seal (26) which is highly resistant to tearing and leakage, yet is capable of accepting repeated penetrations by devices of a wide variety of diameters. The seal (26) is disk-shaped and is composed of a thermoplastic styrenic elastomer, such as a styrene-ethylene/butylene-styrene block copolymer, of very low durometer (a hardness of no more than about 30 Shore A). The seal (26) is preferably contained in a valve body (40) and is disposed between a valve seat (48) in the valve body (40) and a cap (56) connected to the valve body (40) and becomes deflected upon assembly of the valve. The seal (26) includes at least one perforation (34) closed by such deflection.

Abstract: An obturator prevents the tips or flaps of a duck-bill valve from self-adhering during storage or during sterilization procedures. The obturator holds the tips apart until the end-user is ready to use the valve. The duck-bill valve is used as an air outlet valve in blood reservoirs.

Abstract: A medical fluid flowline connector comprised of axially aligned relatively rotatable parts preferably comprising a male Luer and a female Luer and an axially compressed elastomeric valve element therebetween includes an elastomeric swabbable stopper permanently positioned in the female Luer, the stopper having a head urged by spring force outwardly of the female Luer when the spring is compressed and also being retained therein by the spring. The spring may comprise an axially compressible resilient portion of the stopper or it may comprise a separate compressible element.

Abstract: A hemostasis cannula unit including a valve housing, a cap, and a hemostasis valve, wherein the hemostasis valve includes a proximal valve gasket and a distal valve gasket compressed against the valve gasket by the valve housing, wherein the proximal valve gasket is the same shape as the distal valve gasket.

Abstract: According to the present invention, improved methods and apparatus are provided for regaining hemostasis or otherwise minimizing leakage during endoluminal, surgical or percutaneous intraluminal procedures, and for providing a seal during laparoscopic surgical procedures where there is leakage of the CO2 insufflation, when the primary means of hemostasis or pneumatic CO2 seal is compromised or fails. More particularly the present invention relates to devices having a front hub and a rear hub, one or other of which is adapted to retain a compression seal such that when the front and rear hub are matingly engaged, axial and radial pressure is applied to the compression plug and any devices located therebetween, thereby achieving a seal. The compression device can be applied while a guidewire or additional devices remain within the leaking sheath or trocar, thereby allowing the physician to maintain hemostasis or adequate CO2 insufflation, without exchanging the introducer sheath or laparoscopic port.

Abstract: A splittable medical valve is disclosed that is configured with a interfacing region that permits the valve to be placed over or inside of a tubular medical device, such as a splittable introducer sheath, to prevent loss of bodily fluids and/or reduce ingress of air-borne pathogens. The valve further includes a sealing element configured to accept passage of a medical device, such as a catheter, sheath, pacemaker lead, or other ancillary device therethrough, whereby the valve body is split along one or more lines or fissure to allow removal of the valve from around the ancillary device.

Abstract: A hemostasis cannula comprising a housing having a passage therethrough sized to receive a catheter and a valve body mounted in the passage. The valve body includes an opening therethrough which forms a seal around a catheter enclosed within the cannula. In one embodiment, a ring of raised material surrounds the opening. In another embodiment, a ring of raised material surrounds the hole, and an internal ring of material lines at least a portion of the interior of the opening. The valve body is compressed within the cannula housing. When the catheter is removed, the valve body closes thus blocking air flow into the patient's blood vessel and also blocking blood flow out of the patient's blood vessel. The cannula housing also includes a side port for introducing fluids into the patient's blood vessel.

Abstract: A vascular introducer sheath including a tubular shaft and a hemostasis valve assembly connected to the proximal end thereof. The hemostasis valve assembly includes a hub, a cap and a normally-flat gasket disposed therebetween. Both the hub and the cap include continuous curved contact surfaces facing the top and bottom surfaces of the gasket. The continuous contact surfaces may be flat or gently curved and may be smooth or include a means to grip the gasket. At least one of the contact surfaces is formed at an angle to cause the gasket to become convex or concave in response to compression between the hub and the cap. The continuous contact surfaces uniformly distribute forces onto the perimeter of the gasket to avoid stress concentration points that may compromise gasket integrity. In addition, the continuous contact surfaces reduce the amount of pressure necessary to impart the curved shape of the gasket.

Abstract: A valve (10) useful as a fluid flow check valve or as a self-sealing, penetrable, hemostatic valve for sealing a catheter introducer (12) includes a seal (26) which is highly resistant to tearing and leakage, yet is capable of accepting repeated penetrations by devices of a wide variety of diameters. The seal (26) is disk-shaped and is composed of a thermoplastic styrenic elastomer, such as a styrene-ethylene/butylene-styrene block copolymer, of very low durometer (a hardness of no more than about 30 Shore A). The seal (26) is preferably contained in a valve body (40) and is compressed between a valve seat (48) in the valve body (40) and a cap (56) connected to the valve body (40). The seal (26) includes at least one perforation (34) closed by such compression. This compression also provides the seal (26) with a proximal or upstream concave surface (30), making it highly resistant to inversion during repeated removals and manipulations of interventional devices passing through the valve (10).

Abstract: Disclosed is an elongate flexible microcatheter, for diagnostic and or therapeutic applications. The microcatheter is provided with a small outside diameter and high degree of flexibility, to facilitate negotiation of small, tortuous vessels such as those encountered in intercranial catheterizations. The catheter is formed from a composite of a series of tubular elements, each extending axially for a different distance along the tubular body. A distal section on one or more of the tubular components is provided with a spiral cut, to modify the flexibility properties of the finished catheter. The catheter may also be provided with an inflatable balloon, and a valve to permit the use of a single lumen for both receiving a guidewire and for conveying inflation media.

Abstract: A bleed back control assembly and method-for controlling blood loss during catheterization procedures includes a side arm body connected at the proximal end to a seal body. The side arm body comprises one or more branches, each having a lumen, and a finger rest on the exterior of at least one branch. The seal body comprises a cap assembly and a seal assembly. The seal assembly comprises a clamp seal and a bleed back seal, both made of elastomer and held by a seal holder. The cap assembly comprises a threaded cap and a funnel cap. The threaded cap is connected to the seal holder. Rotation of the threaded cap causes the clamp seal to open or close. The funnel cap comprises a dilator, and pressing the funnel cap causes the dilator to open an aperture in the bleed back control seal. A spring, wound around the dilator, returns the funnel cap to its original position, thus closing the bleed back seal. The bleed back seal self-sizes to devices introduced through its aperture.

Abstract: A blood seal having a spring-biased septum is provided for preventing the leakage of blood during the placement and use of vascular catheters and similar devices. The structure of the blood seal includes a housing with an internal channel. A spring-biased septum is placed securely within the channel such that it substantially blocks blood flow through the channel. The spring-biased septum includes an elastic plug having a pre-slit or pre-molded hole and a biasing element disposed about the elastic plug. A needle or other object may be withdrawn through the slit or hole, after which the biasing element forces the hole closed, preventing blood leakage.

Abstract: A blood seal having a spring-biased septum is provided for preventing the leakage of blood during the placement and use of vascular catheters and similar devices. The structure of the blood seal includes a housing with an internal channel. A spring-biased septum is placed securely within the channel such that it substantially blocks blood flow through the channel. The spring-biased septum includes an elastic plug having a pre-slit or pre-molded hole and a biasing element disposed about the elastic plug. A needle or other object may be withdrawn through the slit or hole, after which the biasing element forces the hole closed, preventing blood leakage.

Abstract: An inflatable balloon catheter having a guide wire lumen, an inflation lumen, and a one-way valve disposed within the inflation lumen, the one-way valve allowing fluid flow from the guide wire lumen into the inflation lumen and balloon. One method for preparing the catheter for use includes blocking the guide wire lumen proximal port and injecting inflation fluid into the guide wire lumen distal port. The injected fluid flows through the one-way valve into the inflation lumen and exits through the inflation lumen proximal port. One catheter includes a proximal switchable valve having bleed and inflation positions. This catheter provides a small distal profile and allows for bleeding the catheter while inflation equipment is attached to the catheter.