Abstract: A variable hydraulic resistor for use with implantable pumps is disclosed. The variable hydraulic resistor according to the present invention is particularly useful in varying the flow rate of a medication fluid from an otherwise constant flow implantable pump. An implantable pump is also disclosed, which does not require a complicated clinching system or the like, and which may include an undulating membrane and chamber design to reduce the height of the pump.

Abstract: Safety intravenous catheters (IVCs) are disclosed herein having a catheter hub with a catheter tube, a needle with a needle hub, and a needle guard. The needle guard is configured to be positioned at least partially within an interior space of the catheter hub and is retained thereto by mechanical engagement between the two. Following removal of the needle from the catheter hub, the needle guard is configured to disengage from the catheter hub and attach over a tip of the needle to shield the needle tip from inadvertent needlesticks. The needle guard having an angled end section configured with a length and a width to retain the needle tip within a tip holding space behind the angled end section.

Abstract: A medical device (e.g., an implantable medical device) including a sealing apparatus (sealing element, e.g., a grommet for securing a lead to the device) that includes an element (e.g., a body) having a plasma-treated surface and methods (e.g., methods of making the device).

Abstract: The syringe is intended for one-off use and has a syringe barrel (1), a barrel stopper (12) which can be displaced in the syringe barrel (1) by means of a plunger rod (11) and a needle unit (25) accommodated in the syringe barrel (1). The plunger rod (11) and the needle unit (25) are connected to one another by coupling means (20, 40) in order to retract the needle unit (25) into the syringe barrel (1) after the injection. As proposed by the invention, the needle unit (25) comprises a needle holder (26) made from plastic surrounding an injection needle (27) made from stainless steel along part of its length, which is closed off from an interior of the syringe barrel (1) containing an injection solution (50) by means of a seal insert (36) made from pharmaceutical rubber through the injection needle (27) extends from the rear end. As a result of this feature, an injection solution (50) contained in the syringe is in contact exclusively with permitted materials and the syringe can therefore be stored pre-filled.

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: An enteral feeding system for use with a syringe or extension tubing, such as an enteral feeding syringe or tubing, is provided. The system has features to balance the pressure within the tubing.

Abstract: The device comprises an injection system, which is made up of a rigid external tubular body (1) that enables it to be inserted into the abdominal cavity of a sow. This body is, in turn, covered by a sterile sleeve (2) that enables it to be used in different animals. A flexible duct (3) runs coaxially and its distal end connects with a bevelled needle (4) that permits insertion in the oviduct (12) at an angle of 45°. The proximal end of the flexible tube connects with a device (6) that includes a sheath (7) closed at the other end by a piston (8) that slides along the inside of the sheath and that enables the precision insertion of low-volume liquids.

Abstract: The present disclosure relates to compositions, methods, systems, computer-implemented methods, and computer program products thereof that relate to biological cells for delivery of at least one therapeutic agent to a biological tissue or subject.

Abstract: A needle (1, 100, 110) for precision filling of dosage containers, such as vials, ampoules etc. is provided. The needle ideally comprises an elongate plastics body (2) having a through channel (5) extending between inlet (3) and outlet (4) openings. A tip portion (7b) at the outlet opening (4) has a chamfer (8) tapering towards the outlet opening (4) and an end surface (9) around the opening so that the tip portion (7b) is frusto-conical. The surface area of the end surface (9) is sufficiently smaller than the area of the cross-section of the needle body (2) so that in use the needle (1) is capable of providing for formation of smaller droplets of liquid at the outlet (4) compared to needles without such body thickness reduction at the time when the liquid flow through the needle is shut off. The end surface (9) may be so narrow as to take the form of a sharp rim.

Abstract: A cap assembly is disclosed for use with a lock solution delivery device. The cap assembly includes a housing defining a receptacle and having an inlet end and an outlet end. A plunger is movable axially within the receptacle from a retracted position to an advanced position and is rotatably supported within the receptacle from a first position to a second position. The plunger includes an axial extension configured to non-rotatably engage a syringe connected to the inlet end of the housing. The plunger is positioned to move from the first position to the second position in response to rotatable detachment of a syringe from the inlet end of the housing.

Abstract: A gland member within a medical valve is configured to have a substantially consistent or enlarging internal volume as the valve transitions from a closed mode to an open mode. To that end, the valve has a housing forming an interior containing a flow path, and a stationary post member within the interior. The post member has a lumen that is a part of the flow path. The lumen has an opening to the interior of the housing. The valve further includes a gland member circumscribing the post member to produce a variable volume region formed at least in part between the gland member itself and the post member. In addition, the variable volume region is a part of the flow path, while the gland member occludes the post lumen opening when in the closed mode. The variable volume region has an open volume (i.e., when the valve is in the open mode) that is no less than its closed volume (i.e., when the valve is in the closed mode).

Abstract: Needleless access port valves are generally discussed herein with particular discussions extended to needleless access port valves having a pliant valve housing interacting with an inlet connector assembly. The pliant valve housing has an integrally formed valve stem and one or more ports. The valve stem cooperates with a nozzle on the inlet connector assembly to form a slip port, which can open when exerted by force to permit flow or closes when the force is removed.

Abstract: Methods and apparatus for positioning a elongate hollow member at a desired location in a body in a medical procedure are provided. A position marker is removably disposed within a sheath. The sheath may be disposable. The sheath and enclosed position marker may be inserted into a lumen of a member to be positioned. The position in space of the position marker may be monitored by a position sensor to provide real-time information regarding a position of the member. The spatial relationship between the position marker and member may be fixed by securing the mounting member to the sheath and securing the sheath to the member.

Abstract: Novel outdwelling normally closed bulbous medical bidirectional slit valves and outdwelling slit valve assemblies for influent and effluent fluid flow into and from a medical patient are disclosed, as well as related methods.

Abstract: A nasal passage washing device includes a pliable body including an open top; and an applicator cap removably attached to the pliable body to cover and uncover the open top. The applicator cap includes an applicator tip having a substantially frustoconical configuration sized and shaped for receipt at least partially within a nostril of a user for sealing engagement therewith, the applicator tip including a hole to transfer washing solution there through, a washing solution transfer tube in communication with the hole of the applicator tip and a bottom of an inside of the pliable body to transfer washing solution from the bottom of the inside of the pliable body to the hole of the applicator tip, and a one-way air valve that only allows air flow into the pliable body through the one-way air valve and does not allow air flow and washing solution flow out of the pliable body through the one-way air valve.

Abstract: The present invention is directed to an automatic reconstitution drug delivery device. The inventive device effects simple and automatic reconstitution of a dry drug. To effect reconstitution, a user displaces a release button which causes first and second chambers of a drug cartridge to communicate, resulting in automatic mixing of a diluent and dry drug to effect reconstitution of the dry drug. The user then simply sets the dose volume using a dose-setting mechanism, and administers the injection in a manner typical of self-injection drug delivery devices. Whole or partial automatic priming can be also achieved by the device.

Abstract: A hub for a sheath, catheter, or other tubular device includes a first hub portion including a first hub lumen sized for receiving a medical device therethrough, and a second hub portion including a second hub lumen, the second hub portion coupled to the first hub portion such that the first and second hub lumens are aligned with one another and the first and second hub portions are spaced apart from one another to define a gap. A valve is secured within the gap between the first and second hub portions that includes a valve passage therethrough, e.g., for accommodating receiving a medical device through the first and second hub lumens into the tubular device, while providing a substantially fluid tight seal. For example, the valve passage may include a bore extending partially from a first end of the valve towards a second end of the valve, and a slit that extends from the end of the bore to the second end of the valve.

Abstract: Certain embodiments disclosed herein include, but are not limited to, at least one of compositions, methods, devices, systems, kits, or products regarding rejuvenation or preservation of germ cells or gametes. Certain embodiments disclosed herein include, but are not limited to, methods of modifying germ cells or gametes, or methods of administering modified germ cells or gametes to at least one biological tissue.

Abstract: A medical valve has an open mode that permits fluid flow, and a closed mode that prevents fluid flow. To that end, the medical valve has a housing having an inlet and an outlet, and a resilient member within the housing. The resilient member has a body portion with a free state when undeformed by external mechanical forces and a deformed state when the valve is in the closed mode. The body portion is formed to return toward the free state as the valve transitions from the closed mode to the open mode and defining at least part of a fluid path through the valve.

Abstract: An infusion set, patch pump, or elements thereof, having an exemplary catheter (14) provided with one or more channels, grooves and coatings (24, 34, 44), configured and arranged to provide a degree of strength and flexibility. The catheter (14) can also have an exemplary flexible union with the hub (12) having at least one of a ball-and-socket joint (66, 68), a sliding plate (86), and a flexible bushing (106), and which is sealed to allow even further movement of the catheter (14) while preventing leakage of medication through the junction. In doing so, a number of benefits associated with the use of rigid materials in catheter construction can be provided while at the same time, benefits associated with the use of flexible materials in catheter construction and/or flexible engagement with the hub can also be provided.

Abstract: A cassette (1) that is insertable into an infusion pump for delivery of a fluid to a subject that has a housing with two ends for holding flexible tubing (75) through which the fluid is directed. The housing has an open area exposing the tubing, which engages a pumping mechanism when inserted into an infusion pump. An anti-flow valve mechanism (100) associated with the tubing or the cassette and present either in, on or near the housing is made up of a piston (103/105) and spring (110), where the spring biases the piston against the tubing to prevent fluid flow.

Abstract: A pressure activated two-way slit valve assembly is designed to be used in combination with, but not limited to, a high flow rate catheter to prevent accidental ingestion of air or loss of blood if the closure cap comes off during non-use of the catheter. In addition, the potential for occlusion of the catheter due to blood clots in the catheter and catheter related infection is substantially reduced. The pressure activated two-way slit valve assembly includes a first end, a second end, a wall defining a dumbbell shaped channel, and a flexible, thin disk having a slit and positioned within the pressure activated two-way slit valve assembly to reside within the dumbbell shaped channel. The slit and the dumbbell shaped channel are sized to enable the slit to deform in response to a predetermined pressure differential across the slit to allow fluid to pass therethrough.

Abstract: A disposable unit for a therapeutic fluid delivery device. The disposable unit includes a base portion comprising a reservoir cavity and a fluid path, the reservoir cavity including a reservoir port and a septum, the fluid path including a fluid channel from the reservoir port to a cannula port. The disposable unit also includes at least one flexible membrane portion attached onto said base portion and forming a top of said reservoir cavity and a top of said fluid channel and a tubing connected to said base portion at said cannula port, said tubing in fluid communication with said reservoir cavity.

Abstract: An ear medication delivery device for delivering a treatment liquid and retaining the treatment liquid within an ear canal of a patient including a unitary, one piece earplug formed of a soft resilient material including an ear canal engaging portion and an external portion and defining a single internal passage therethrough. The external portion includes a major disk and an annular medication applicator receiving portion in fluid communication with the internal passage. The ear canal engaging portion includes at least two minor disks of progressively different size extending outwardly in a generally radial direction. The ear canal engaging portion defines a molded resilient valve unitary with the earplug that is shiftable from a closed position to an open position in either direction under a preselected fluid pressure and that resiliently returns to the closed position below the preselected fluid pressure.

Abstract: A fill and purge system for a drug reservoir is disclosed. The fill and purge system comprises a positive pressure source, a negative pressure source, a first valve, a second valve, and a delivery channel. The positive pressure source is fluidly connected to the first valve. The negative pressure source is fluidly connected to the second valve. The first and second valves are fluidly connected to the delivery channel. A method of filling and purging a drug reservoir is also disclosed.

Abstract: A device for regulating the flow rate of a medical liquid includes a body provided with elements associated with corresponding parts connected together but torsionally free, at least one of the parts including a plurality of recesses acting as flow regulator able to modify the flow rate of the liquid directed towards the patient by rotating the parts about a common axis of rotation. Between the parts a seal element enables the recesses to be selectively connected together via communication elements, so achieving flow rate regulation. Transverse sealers are provided between the seal element and at least the second part of the parts which are interconnected but torsionally free. The transverse sealers preventing the escape of liquid from the recesses and from the body of the device following a relative movement or misalignment between the parts in a plane perpendicular to the axis of rotation or along this latter during flow regulation or following any angular misalignment of the parts relative to the axis.

Abstract: A needle can include a fluid directing portion comprising a U-shaped lateral orifice extending between the exterior and interior surfaces and a corresponding U-shaped diverter adjacent to the U-shaped lateral orifice. A diverter can be disposed within a lumen of a needle and transverse to a central axis within the lumen.

Abstract: A dialysis valve includes a tube attached between an artery and a vein which, when elongated, simultaneously narrows in diameter at least one location. The narrowed portion of the tube decreases the volume and velocity between the arterial and venous side of the patient to prevent damage or intimal hyperplasia on the venous side between dialysis treatments. When the valve is opened for dialysis, an unrestricted blood flow exists between the arterial and venous side, permitting a controlled, open blood flow during dialysis.

Abstract: The present invention concerns a housing for supporting the proximal inlet ports of at least two isolated lumens, for use in a patient fluid administration system, wherein each of the lumens further comprises a distal outlet for connecting to at least one patient fluid administration member, and wherein the housing further comprises an integral unit, wherein the unit comprises a distal frame layer, a female connector layer, for connecting to at least one of the fluid peripheral elements and at least one intermediate gasket layer for providing sealing between each of the isolated lumens.

Abstract: Compositions, systems and methods utilizing engineered surgical irrigants providing delivery of components with therapeutic or other secondary benefits. Engineered irrigants provide targeted delivery of desired agents, including agents for propulsion of nano-devices, agents including molecular probes, gene expression agents, magnetically orientable agents, agents for discrete tissue temperature detection and tissue regeneration agents.

Abstract: An upstream hole is formed at the upstream end of a detector main body of a liquid flow detector for detecting liquid flow, and a downstream hole is formed at the downstream end, with a liquid flow channel comprising a liquid flow detection channel, discharge channel, and, optionally, intermediate flow channel, being formed between the upstream hole and downstream hole. A mobile body which is optionally, spherical, moves with the flow of liquid, and is arranged inside the liquid flow channel. The diameter of the liquid flow detection channel is smaller than the diameter of the discharge channel, and the diameter of the mobile body is slightly smaller than the diameter of the liquid flow detection channel. The shape of the peripheral edge part of the upstream hole and the downstream hole is optionally elliptical.

Abstract: A flow control manifold includes a valve housing having first and second inlets and an outlet. The valve housing defines a cavity sized to slideably engage a valve having a first position and a second position. The flow control manifold may further include a first flow path defined within the valve and a second flow path defined within the valve such that the first flow path fluidly couples the first and second inlets to the outlet along the second flow path when the valve is in the first position.

Abstract: The present invention provides devices, systems, and methods for delivery of an active agent into the eye of a subject. In one aspect, for example, an ocular active agent delivery device (10) can include an active agent reservoir (14) disposed in an annular housing (12), the annular housing (12) being configured to fit inside of a lens capsule and at least partially encircling a line of sight of an intraocular lens within the lens capsule. The device (10) can further include a semipermeable membrane (16) operatively coupled to the active agent reservoir (14), where the semipermeable membrane (16) is configured to allow diffusion of an active agent from the active agent reservoir (14). Additionally, a valve (18) can be operatively coupled to the active agent reservoir (14), where the valve (18) is configured to allow filling of the active agent reservoir (14) with an active agent.

Abstract: A medical connector for use in a fluid pathway includes a substantially transparent housing having a proximal end with a proximal opening and a distal end with a distal opening, and a cavity extending therebetween. The connector provides a substantially visible fluid flow path extending through a substantial portion of the connector.

Abstract: A pressure actuated flow control valve for an infusion catheter permits gravity flow of a liquid through the catheter and into a patient while resisting back flow of blood from the patient and into the catheter. The valve has a hemispherical body with an outstanding circumferential flange and a normally closed, diametric slit. The slit is longer on the convex outer surface than on the concave inner surface. Dome thickness diminishes in the area adjacent the slit, reducing total apical deflection upon collapse of the slit toward the concave surface. An inner orthogonal rib biases the slit closed. Upon application of a predetermined pressure, the slit opens toward the concave surface to permit forward fluid flow. At lower pressures, the slit closes to check fluid flow. Greater reverse pressure is required to collapse the slit toward the concave surface to permit reverse fluid flow.

Abstract: In a body fluid analyzer, a body fluid extracting unit for holding medicine to promote discharge of body fluid and collecting body fluid is arranged at a lower surface of a body fluid collecting chip. A body fluid discharge promoting medicine storage unit is connected to a medicine injecting hole formed in the body fluid collecting chip. A test unit is arranged in the body fluid collecting chip, and the body fluid extracting unit and the test unit are connected by a body fluid feeding path. A discarding body fluid storage unit is connected to the exit of the body fluid feeding path. A medicine supplying mechanism including a pump is operatively connected.

Abstract: A device for priming and venting a hazardous drug within an intravenous administration set. The device includes various access ports and fluid channels to permit direct injection of a hazardous drug into the fluid reservoir, while eliminating the possibility of undesirable exposure to the hazardous drug. The device further includes priming and flushing ports to enable flushing of a hazardous drug from the system following an infusion procedure.

Abstract: A valve mechanism for use with a feeding set includes a reservoir of liquid and a metering device. The valve mechanism includes a valve body including a reservoir port adapted to be fluidly connected to the reservoir, a metering port adapted to be fluidly connected to the metering device, a feeding port adapted to be in fluid communication with the patient, and a priming port in fluid communication with atmosphere. A valve member in the valve body is adapted to selectively fluidly connect the reservoir port to the priming port, to fluidly connect the reservoir port to the metering port, and to fluidly connect the metering port to the feeding port.

Abstract: An injection device (1) for injecting a dose of drug, e.g. insulin for diabetes treatment, in which energy is stored in a spring member (9, 24) during dose setting. The stored energy is released and used for driving an injection mechanism during injection of a previously set dose. The injection device (1) further comprises means for electronically detecting the amount of a set dose and/or means for electronically detecting the amount of an injected dose. The electronic detecting means allows storage and/or logging of data relating to injections performed using the injection device (1).

Abstract: A fluid titration system has an optical sensor, a physiological monitor, a titration controller and an infusion device. The optical sensor transmits multiple wavelengths of light into a tissue site of a person and detects the optical radiation after attenuation by pulsatile blood flowing within the tissue site. The physiological monitor receives a resulting sensor signal and derives a plethysmograph that corresponds to the pulsatile blood flow. The monitor also calculates a plethysmograph variability measure that is responsive to changes in perfusion at the tissue site. A titration controller generates a fluid control output according to the variability measure. The infusion device administers a liquid solution via an intravenous (IV) connection to the person according to the fluid control output so as to regulate at least one of a fluid flow start, rate and stop.

Abstract: A surgical fluid transfer apparatus for passage of fluids includes a hub defining a longitudinal axis and having an internal chamber, an elongated member extending from the hub and a closure valve disposed within the internal chamber. The closure valve is adapted for movement between a first position substantially sealing the internal chamber to prevent passage of fluids and a second position establishing a fluid passage within the hub to permit passage of fluids therethrough. The closure valve includes a valve housing and a seal member. The seal member has an open condition establishing an internal passage different than the fluid passage to permit passage of an access instrument through the closure valve and a closed condition in the absence of the access instrument. The inner wall portions of the valve housing cooperate with the seal member to permit the seal member to assume the closed condition thereof.

Abstract: A valve connector for medical infusion lines including an external tubular body with an inlet end and an outlet end, an internal hollow spike and an intermediate sealing member including a head with pre-slit and an elastic hollow element formed with fluid-tight members in contact with the hollow spike and with an elastic thrust means, which tends to maintain the elastic head in a closed condition. The elastic thrust means comprises a base part joined to the elastic hollow element of the sealing member through a generally transverse annular wall, which, during axial displacement of the elastic head from the closed condition to the open condition, bends within an annular chamber defined between the base part and a portion with conical surface of the hollow spike.

Abstract: A one-way valve comprises a seat and a membrane having an inner portion that is stretched over the seat, wherein, in use, the inner membrane portion is selectively deflected from the seat such that a fluid path is created from one side of the membrane to the other so as to open the valve, and wherein an outer peripheral portion of the membrane is stiffer than the inner portion such that the membrane deflection is substantially restricted to only the inner portion. The one-way valve may be used in a pump for an infusion system.

Abstract: An infusion assembly is provided having a first outlet conduit adapted to be in fluid communication with a delivery site of a patient. The assembly further includes at least first and second fluid inlet conduits adapted to be in fluid communication with at least a first and second fluid reservoir, and an infusion switching device, including a housing and an internal valve assembly. The internal valve assembly is adapted for selective manipulation by a patient or caregiver. The valve assembly includes an off-setting, and first infusion setting, for initiating an infusion of a first fluid from a first fluid reservoir to a delivery site, and a second infusion setting for initiating an infusion of a second fluid from a second fluid reservoir to a delivery site.

Abstract: A fluid control device for directing fluid flow comprising a needleless access device for transferring fluids and methods of directing fluid flow. The fluid control device may have a first port, a second port, a third port and a connecting portion joining the first, second and third ports. A first valve element may be positioned within the first port and a fluid director may be positioned within the connecting portion. The first valve element may move between an opening position, where fluid may flow past the first valve element, and a closed position, where fluid may be prevented from flowing past the first valve element. The fluid director may have at least one passageway for connecting at least two of the first, second and third ports such that fluid may flow therebetween. An actuation mechanism may be used to orient the fluid director and, consequently, the at least one passageway within the connecting portion.

Abstract: A valve may include (a) a housing defining a valve lumen adapted for fluid connection with a lumen of a catheter; (b) a substantially conical valve member coupled to the housing and extending across the valve lumen to control flow therethrough; (c) a plurality of slits extending through the valve member and separated from one another circumferentially around the valve member; and (d) a ramp formed within a distal end of the valve lumen extending proximally from a distal tip of the valve member toward a ramp vertex separated from the distal tip by a predetermined distance.

Abstract: A self-sealing male Luer connector attaches to any standard female Luer valve to open a flow channel between the two. The self-sealing male Luer connector includes a rigid housing having a distal end with a rigid male Luer connector and a proximal end at which a proximal seal is formed. The distal end of the housing includes a valve seat. Located within the housing is a resilient biasing member that biases an actuator into contact with the valve seat to prevent fluid flow through the male connector. Upon engagement with a female connector, the actuator is moved in the proximal direction to open the distal valve and then the proximal seal. A partial vacuum is formed within the male connector upon disengagement with the female connector that draws any fluids on the external surface of the distal end of the male Luer connector into the male tip.

Abstract: Disrupting tissue and devices and systems for disrupting tissue. The disclosure describes ways to deliver moieties to a target tissue, where the target tissue in general is not at the point of introduction, in such a way that minimal damage is produced in the tissue at the point of introduction. In some embodiments this is accomplished by jetting fluid at high velocity into the target tissue. The disclosure further describes novel agents deliverable in such systems for use in remodeling tissues. Some of these agents comprise a liquid while others do not. Additionally, although not specifically described in detail much of the disclosure may additionally be used in the delivery of therapeutic drugs.

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 dosing unit for an ambulatory infusion device and a method of operation are disclosed. The dosing unit includes a stationary member, a movable member, and a plunger. The movable member and the stationary member, together, make a charging valve and a discharging valve. The plunger is located, at least in part, in a metering cavity of the movable member and the movable member is adapted to selectively couple and decouple a driving unit, such that, by operating the driving unit with the movable member being coupled with the driving unit, the movable member moves with the plunger to maintain a position of the plunger relative to the movable member along a displacement axis, and by operating the driving unit with the movable member being decoupled from the driving unit, the plunger is displaced while the position of the movable member is maintained.