GB2568319A

GB2568319A - Fluid transfer devices

Info

Publication number: GB2568319A
Application number: GB1718836.8A
Authority: GB
Inventors: Mide Christian; Gidö Schön Jimmy
Original assignee: Conceptomed AS
Current assignee: Conceptomed AS
Priority date: 2017-11-14
Filing date: 2017-11-14
Publication date: 2019-05-15
Anticipated expiration: 2037-11-14
Also published as: WO2019096864A1; GB201718836D0; GB2568319B

Abstract

The device 2 comprises a first connector 4a comprising a connector tip 6 surrounded by an internally threaded collar 8 which is separable into first and second arcuate threaded parts 8a, 8b. A second connector 4b has a fluid channel 5 between the first and second connectors. The device has first and second lever members 10, 14, the first lever member 10 comprising a first actuator part 12a and a first driven part 12b carrying the first arcuate threaded part 8a, and the second lever member 14 comprising a second actuator part 16a and a second driven part 16b carrying the second arcuate threaded part 8b. The lever members 10, 14 have a default position in which the arcuate threaded parts 8a, 8b are closed together and an actuated position in which the arcuate threaded parts 8a, 8b are separated from one another (Fig 3a). The device further comprises a transmission 18 arranged to transmit a force applied to the actuator parts to the driven parts such that the lever members 10, 14 both pivot simultaneously between the default and actuated position.

Description

The present invention relates to fluid transfer devices and fluid connection system, in particular devices having a connector part comprising a connector tip surrounded by an internally threaded collar.

The Applicant has previously devised solutions for easily disconnecting a contaminated needle from a syringe (or other fluid transfer device) using one hand as disclosed in WO 2013/164358, WO 2014/020090, WO 2015/014914 and WO 2016/162571. The Applicant’s system uses a pivoting disconnecting member, e.g. lever member, to separate the needle hub from the syringe. By utilising a lever member the practitioner can, in a one handed operation, more easily disconnect the needle hub from the syringe and reduce the risk of needlestick injuries.

The Applicant has previously devised solutions compatible with standard tapered friction fit (Luer Slip) and screw fit (Luer Lock) connectors. The Applicant has realised that its fluid transfer connections may find use in any situation where fluid is being transferred using devices or lines connected by tapered (e.g. Luer-type) connector parts. In medical settings, “Luer” connectors are standardised friction fittings using a 6% taper to make leak-free connections between a tapered male tip and its mating female part. These standard tapered connector parts comprise a tapered male connector tip providing a friction fitting with a corresponding female connector part. Luer Slip connector parts provide a friction fitting alone. Luer Lock connector parts comprise a tapered male connector tip surrounded by an internally threaded collar providing a screw fit, in addition to a friction fitting, with a corresponding female connector part.

In many fluid transfer situations for medical purposes, a tapered connector tip is standard for forming a fluid-tight connection between different parts, for example when connecting a cannula or catheter to flexible hosing for the delivery or extraction of fluids. For enteral feeding systems, male and female ENFit connectors conforming to the standard ISO 80369-3 may be used. As seen for example in US 2017/014616, an ENFit coupling may comprise a male connector tip having a tapered lead-in portion, surrounded by coaxial connection collar having an internally threaded annular surface. For intravenous (IV) therapy, a typical IV kit comprises flexible tubing that is used to convey fluid under gravity from a bag to the infusion site, the flexible tubing being attached and detached by male and/or female connector parts.

When preparing an IV line, it is necessary to connect the flexible tubing to the bag and clamp the tubing while the line is filled with fluid. A needle or cannula is inserted into a patient's vein and usually carries a female connector hub. It is a two-handed operation to connect/disconnect a male connector part to/from the hub as the parts must be screwed together. Typically the male connector part is provided at one end of a flexible hose and a syringe is connected to a female connector part at the other end of the hose for an initial fluid injection. To disconnect the syringe from the hose, the connection is unscrewed and then the IV line can be connected to the hose instead. However, the twisting required to disconnect the syringe from the female connector part can inadvertently loosen the screw fit connection at the other end of the line. It is problematic if the female connector hub becomes exposed at the insertion site as it cannot easily be cleaned. The only way to deal with contamination is to remove the cannula from the patient and insert a new one, causing pain, unnecessary venous damage and risk of contamination.

Once the IV line is connected to the female connector part at the back end of the hose, the tubing is unclamped so that fluid can flow down to the cannula. At various times it may be necessary to replace the IV line, which involves first clamping the line and then disconnecting the male connector part at one end of the flexible tubing. Multiple steps are involved. If a user forgets to manually clamp the line then fluid can escape. It is a two-handed operation to disconnect the male connector part from a female connector hub, as they need to be rotated relative to one another to release the screw fit. The conventional disconnection and connection of tapered connector parts bring a person's hands into close contact with the connector parts and carries a risk of contamination.

WO 2015/014914 discloses some disconnection mechanisms for a standard Luer Lock connection for which it is no longer necessary to rotate the connector parts when connecting or disconnecting. The screw fit is released when a lever member is pressed down. This provides the ease of one-handed operation. However, such disconnection mechanisms can still be improved to ensure that the screw fit is released uniformly and in a reliable manner.

The Applicant has realised that Luer Lock connections, and other tapered fluid connections comprising a threaded connection collar, are typically chosen as they are trusted to remain secure throughout the administration process of a certain medical treatment. It is therefore important that any disconnection mechanism for such tapered connector parts can also be trusted to avoid inadvertent disconnection.

Furthermore, the Applicant has realised that, in any situation wherein a fluid-tight connection is made between two connector parts using a screw fit, it may be desirable to release the screw fit without requiring relative rotation between the connector parts. Such connector parts may form a fluid-tight seal without relying on a tapered connector tip. A fluid transfer device having an improved disconnection function may find use in medical settings and beyond.

The present invention aims to address or at least mitigate one or more of the problems outlined above.

When viewed from a first aspect, the present invention provides a fluid transfer device comprising:

a first end connector part comprising a connector tip surrounded by an internally threaded collar, wherein the internally threaded collar is separable into first and second arcuate threaded parts;

a second end connector part and a fluid transfer channel between the first and second end connector parts;

a pair of first and second lever members mounted to pivot relative to the connector tip, the first lever member comprising a first actuator part and a first driven part carrying the first arcuate threaded part, and the second lever member comprising a second actuator part and a second driven part carrying the second arcuate threaded part, wherein the first and second lever members have a default position in which the first and second driven parts are positioned such that the first and second arcuate threaded parts are closed together to form the internally threaded collar and an actuated position in which the first and second driven parts are positioned such that the first and second arcuate threaded parts are separated from one another to open the internally threaded collar; and a transmission arranged between the first and second lever members to transmit a force applied to the first actuator part of the first lever member and/or to the second actuator part of the second lever member to both of the first and second driven parts of the first and second lever members such that the first and second lever members both pivot simultaneously relative to the connector tip between the default position and the actuated position in response to an applied force.

Such a fluid transfer device provides a new approach to disconnecting a connector part comprising a connector tip surrounded by an internally threaded collar, by releasing the screw fit between the internally threaded collar and a corresponding connector part using a pair of lever members. The transmission between the first and second lever members ensures that the screw fit is released uniformly and in a reliable manner. For example, the first and second arcuate threaded parts may be separated from one another symmetrically. Furthermore, the first and second arcuate threaded parts being moved apart by the first and second lever members means that no hinging is required for the arcuate threaded parts. The arcuate threaded parts can be made rigid and form a secure screw fit when closed together to form the internally threaded collar. The transmission also makes it possible for the device to control how the applied force is applied to move the lever members between the default and actuated positions. For example, a typical force applied by a user may be too large and/or applied with a large impulse that would tend to jerk the first and second arcuate threaded parts apart. The transmission can reduce the level of the force and/or smooth the force transmission so as to controllably separate the first and second arcuate threaded parts from one another.

It will be appreciated that the first and second arcuate threaded parts are separated from one another to open the internally threaded collar and thus disrupt the threads that form the screw fit with a corresponding connector part. This operation is achieved by applying a force to one or both of the lever members, meaning that a user's hand and fingers do not come close to touching the connector tip during disconnection. This reduces the risk of contamination.

In order to maintain the integrity of the screw fit connection, it is preferable for the device to include means to lock the first and second lever members in the default position in which the first and second arcuate threaded parts are closed together to form the internally threaded collar. For example, the device may comprise a locking arrangement that acts on the first lever member and/or the second lever member and/or the transmission. In some embodiments, the transmission may be locked to prevent the first and second lever members from pivoting relative to the connector tip between the default position and the actuated position in response to an applied force. The device may comprise a manual actuator arranged to unlock the transmission. In some embodiments, alternatively or in addition, the first and/or second lever member may be locked in the default position. In one or more embodiments, the first and/or second lever member is blocked from pivoting relative to the connector tip. The device may comprise a manual actuator arranged to unlock or unblock the first and/or second lever members.

In one or more embodiments the locking arrangement comprises a moveable locking member that is resiliently biased into a locked position in which the first and/or second lever member is locked in the default position. By providing a moveable locking member that is dedicated to the function of locking the first lever member or second lever member alone, or both lever members in combination, in the default position, inadvertent disconnection can be avoided as a user must purposefully move the locking member against the resilient bias before the lever members can be pivoted from the default position. Preferably the locking member is moveable relative to the first and/or second lever member independently of pivotal movement of the first and/or second lever member relative to the connector tip. In some embodiments, the locking member may be laterally moveable relative to the first and/or second lever member e.g. in a direction along the connector tip. In some embodiments, the locking member may be moveable sideways relative to the first and/or second lever member e.g. in a direction radial to the connector tip. Once the locking member is released from the locked position, pivotal movement of the lever members may require a force to be applied tangentially e.g. in a different direction relative to the connector tip. This means that a force must be applied in two different directions to carry out the acts of unlocking the first and/or second lever member in the default position and then pivoting the lever members between the default position and the actuated position. Requiring a user to actively apply a force in two distinct stages makes it highly unlikely that the first end connector part becomes disconnected accidentally, for example if a patient were to roll over and lie on the device.

The moveable locking member may be resiliently biased into the locked position by a spring member. Preferably the actuator part comprises the spring member. In some embodiments, the spring member is a compression spring or leaf spring arranged to resiliently bias the moveable member into the locked position. In embodiments wherein the locking member is laterally moveable relative to the first and/or second lever member, e.g. in a direction along the connector tip, there may be a compression spring arranged laterally in the first and/or second actuator part. In embodiments wherein the locking member is moveable sideways relative to the first and/or second lever member, there may be a leaf spring arranged between the first and/or second actuator part and the fluid transfer channel.

In one or more embodiments the locking arrangement further comprises a blocking part arranged to prevent the first and/or second lever member from pivoting out of the default position. The moveable locking member may engage with the blocking part in the locked position. In such embodiments the locking member may be manually moveable from the locked position to an unlocked position, in which the locking member is disengaged from the blocking part and the first and second lever members are released to pivot between the default position and the actuated position in response to an applied force.

As discussed above, the locking member can be moved against the resilient bias into an unlocked position in which the first and/or second lever member is released to pivot between the default position and the actuated position. Because the locking member is resiliently biased into a locked position, the locking member must be actively moved by a user against the resilient bias into an unlocked position and also held in the unlocked position while applying a force to pivot the lever members. Preferably the moveable locking member is resiliently biased to automatically return to the locked position, e.g. when a user lets go of the locking member. The automatic return can be at any stage during pivotal movement of the first lever member. This means that the locking member always returns to the locked position.

When a force is applied to the first and/or second actuator part of the first and/or second lever member, the transmission causes both the first and second lever members to pivot between the default position and the actuated position. In some examples, the force applied to the first and/or second actuator part can be manual e.g. a manual force applied to pivot the lever members from the default position to the actuated position. In addition, or alternatively, in some examples the force applied to the first and/or second actuator part can be an internal bias e.g. an internal force applied to pivot the lever members from the actuated position back to the default position. The Applicant has recognised that such an internal bias, in particular a resilient bias, can be helpful for automatically returning the first and second lever members to the default position in which the first and second arcuate threaded parts are closed together to form the internally threaded collar. In various embodiments, a resilient bias may be created by the first and/or second lever member having a material and/or geometrical form that results in elastic deformation from a relaxed stated in the default position to a stressed state in the actuated position. The lever members then tend to return to the relaxed state in the absence of an applied force.

In one or more embodiments, at least one of the first and second lever members is resiliently biased to return from the actuated position to the default position. In some examples, one or both of the lever members may be resiliently biased by comprising an elastic material form that is deformed upon pivotal movement so as apply a resilient bias tending to return the lever members to the default position. In some potentially overlapping examples, one or both of the lever members may be resiliently biased by a spring member such as a leaf spring arranged in the device.

In some embodiments the locking arrangement comprises a moveable locking member acting on the first actuator part of the first lever member and the device comprises a leaf spring acting on the second actuator part of the second lever member. This has the advantage that the leaf spring does not interfere with the moveable locking member and vice versa. The Applicant has realised that the resilient bias acting on the second lever member may beneficially be shared between two leaf springs, thereby reducing the spring stiffness required for each leaf spring. Thus, in some embodiments, the device comprises a first leaf spring acting on the second actuator part of the second lever member and the second actuator part comprises a second leaf spring acted on by the first leaf spring. The second leaf spring may be integrated with the second actuator part. For example, the second actuator part may be formed of a plastics material with the second leaf spring formed as a cut-out spring tongue. Advantageously the two leaf springs act together to provide the resilient bias acting to return the second lever member to the default position, so each leaf spring can undergo less deflection and hence there is less risk of spring fatigue. The transmission between the lever members transmits this return force from the second lever member to the first lever member. This makes the device very reliable in automatically returning to the default position when a user stops applying a force to the first and/or second lever member.

During operation, it will be appreciated that in many embodiments a user must overcome two stages of resilient bias in order to move the lever members from the default position to the actuated position - a first resilient bias to move the locking member and a second resilient bias to pivot the lever members. Furthermore, the device must be actively held with the lever members in the actuated position. As soon as a user lets go, the lever members are biased to return to the default position in which the first and second arcuate threaded parts are closed together to form the internally threaded collar. The device therefore provides a strong and reliable screw fit connection by default.

In some embodiments, alternatively or in addition, the first and/or second lever member may be locked or blocked in the actuated position. The device may comprise a locking arrangement that acts on the first lever member and/or on the second lever member and/or on the transmission to lock the first and second lever members in the actuated position. This function could be provided by the same locking arrangement as described above, or another locking arrangement. Optionally the device may further comprise another manual actuator arranged to unlock or unblock the first lever member and/or the second lever member and/or the transmission. This manual actuator could be the same moveable locking member described above, or a different unlocking member. A benefit of locking the lever members in the actuated position is that a user is free to release his/her grip on the device, for example to connect a different hub to the first end and/or second end connector part of the device.

The lever members function to separate the first and second arcuate threaded parts in a controlled way. The first and second arcuate threaded parts are carried by the first and second driven parts, respectively, in any way that achieves this function. The first and second arcuate threaded parts could be separate parts in the device that are acted on by the first and second driven parts, but preferably the first and second arcuate threaded parts are integrated with the first and second driven parts. For example, the first and second arcuate threaded parts may be integrally formed with the first and second driven parts. Each lever member, including the actuator part, driven part and arcuate threaded part, is preferably a monolithic structure.

It will be appreciated that the first and second arcuate threaded parts are moveable relative to the connector tip of the first end connector part. The connector tip may therefore be considered the stationary part of the first end connector part. Preferably the connector tip, the second end connector part and the fluid transfer channel are all formed in the same device body structure. The lever members pivot relative to this device body structure.

For ease of manufacture, the first and second lever members may have the same lever body structure. In some embodiments, only the first lever member may have a locking member as described above added to this lever body structure.

The pair of first and second lever members is preferably mounted to pivot symmetrically relative to the connector tip. The first and second lever members may each be mounted to a suitable pivot axle in the device body structure, preferably a pivot axle on a common axis. The position of the pivot axle(s) may be chosen to achieve a desired range of movement for the first and second lever members. In some examples the first lever member comprises the first actuator part on one side of a pivot axle and the first arcuate threaded part on an opposite side of the pivot axle. In some examples the second lever member comprises the second actuator part on one side of a pivot axle and the second arcuate threaded part on an opposite side of the pivot axle.

The device may comprise any suitable transmission arranged between the first and second lever members to transmit a force applied to the first and/or second actuator part to both of the first and second lever members. The transmission may comprise, for example, a gear arrangement, a cam and follower arrangement, a rack and pinion arrangement, a belt drive, or any other mechanical transmission arrangement. In some examples, the transmission comprises a cogged gear arrangement as a simple and effective way of transmitting torque between the lever members.

The first end connector part may have a standard design of a connector tip surrounded by an internally threaded collar, except that the internally threaded collar is separable into first and second arcuate threaded parts. In at least some embodiments, preferably the internally threaded collar extends 360° around the tapered connector tip. The first and second arcuate threaded parts may have different angular extents, e.g. the first arcuate threaded part extending 150° around the tapered connector tip and the second arcuate threaded part extending 210° around the tapered connector tip. However, it is preferable that the first and second arcuate threaded parts each extend 180° around the tapered connector tip. This makes the device symmetrical when releasing the screw fit and also helps with manufacture as the lever members can have the same body construction.

In at least some embodiments, preferably the internally threaded collar is coaxial with the connector tip. The connector tip may be aligned with the fluid transfer channel inside the device. The internally threaded collar may have an annular e.g. cylindrical threaded surface facing radially inwards towards the connector tip. The internally threaded collar may comprise continuous helical threads when the first and second arcuate threaded parts are closed together.

The first end connector part, comprising a connector tip surrounded by an internally threaded collar, can be used to form a fluid-tight connection between two connector parts. In some embodiments, the connector tip may comprise a gasket for forming a sealing connection with another connector part, in addition to the screw fit provided by the internally threaded collar. In some embodiments, additionally or alternatively, the connector tip may be a male tapered connector tip for forming a friction fit with a corresponding female connector part. In these embodiments the male tapered connector tip may be inserted into the corresponding female hub of a female connector part to form the friction fit. The male tapered connector tip may be compliant with a standard design, such as ENFit or Luer Lock. For example, the first end connector part may be ISO 80369-3 compliant, wherein the connector tip is a male connector tip having a tapered lead-in portion and the internally threaded collar is a coaxial connection collar. Some examples of such ENFit connector parts are disclosed in US 2016/0279032 and US 2017/0014616, the contents of which are hereby incorporated by reference. In other examples, described in more detail below, the first end connector part may be ISO 80369-7 compliant, wherein the connector tip is a male connector tip having a standard 6% taper, i.e. a luer lock male connector part. The corresponding female luer lock connector part may comprise a female socket surrounded by an outer thread or lugs to form a screw fit with the internally threaded collar.

A standard Luer Lock connection includes not only the screw fit provided by the internally threaded collar but also a friction fitting between the tapered connector tip and a corresponding socket in a female connector part. After opening the internally threaded collar to release the screw fit, a user may manually release the friction fitting by pulling the fluid transfer device away from the corresponding female connector part. However, this is likely to require two hands. Ideally the fluid transfer device acts to release both the screw fit and the friction fitting. It is preferable for this to happen at the same time as the internally threaded collar is separated into the first and second arcuate threaded parts.

In some embodiments, the arcuate threaded parts may push against the corresponding female connector part as they separate, thereby helping to release the friction fitting. Thus, in some embodiments, at least one of the first and second arcuate threaded parts pushes along the male tapered connector tip to release the friction fit with a corresponding female connector part as the lever members pivot towards the default position. Taking a fixed reference point on one of the arcuate threaded parts, corresponding to a reference point on the corresponding female connector part, it will be appreciated that the male tapered connector tip effectively retracts from the friction fit as the lever members pivot towards the default position, i.e. before the internal threads of the surrounding collar have completely released their screw fit with the female connector part. This is beneficial as any shoot-out of the female connector part is avoided. The movement of the lever members can give the user improved axial control during disconnection of a needle or catheter connected to the connector tip. There is added clinical value as catheter tips may be dislodged and cause damage due to the sharp bevel at the tip.

In some embodiments, the arcuate threaded parts pushing against the corresponding female connector may interfere with a reliable release of the screw fit. Thus, in some embodiments, at least one of the first and second lever members comprises a pushoff member arranged to move along the male tapered connector tip to release the friction fit with a corresponding female connector part as the lever members pivot towards the default position. The Applicant has realised that this push-off member can be given a larger range of movement than the first and second arcuate threaded parts. In some embodiments the tapered connector tip extends along a central axis with the first arcuate threaded part extending through a semicircle up to 180° around the central axis and the second arcuate threaded part extending from 180° up to 360° through an opposed semicircle around the central axis. Preferably the push-off member extends from the semicircle of one of the arcuate threaded parts into the semicircle of the other arcuate threaded part. In other words, the push-off member extends across the central axis from one half of the device to the other. The central axis may be aligned with the fluid transfer channel. When the lever members pivot to open the internally threaded collar, the push-off member follows an arc passing across the central axis and therefore continuously provides a tangential force acting along the central axis to push the tapered connector tip out of its friction fitting.

In some embodiments, the device may further comprise a female connector part connected to the male tapered connector tip by a friction fit in addition to a screw fit provided by the internally threaded collar. The female connector part may provide an adaptor enabling the device to be connected to any standard medical device comprising another corresponding male connector part, e.g. using ENFit or Luer Lock connector parts. For example, the female connector part may be used to connect the device to a section of flexible tubing or a syringe.

In some embodiments, alternatively or in addition, the second end connector part may comprise a female hub. The second end connector part may therefore enable the corresponding male connector part of another medical device to be connected to the fluid transfer device e.g. using standard ENFit or Luer Lock connector parts. The second end connector part may comprise a tapered socket and an outer thread or one or more lugs.

The present invention extends to a fluid connection system comprising a male tapered lock connector device as described above, and one or more sections of flexible tubing attached to the connector device. In some examples, a section of flexible tubing may be permanently attached in fluid communication with the connector tip, for example welded or glued onto the device. In some examples, a section of flexible tubing may be removably attached in fluid communication with the connector tip, for example by a tapered part, for example a male or female tapered lock connector part. In some embodiments, to ensure compatibility with existing systems, a section of flexible tubing attached at one end to the connector device comprises a female tapered lock connector part at its other end.

In some embodiments a section of flexible tubing attached to the connector device comprises a clamping device, e.g. as is generally known. Such a clamping device may be operated independently of the fluid transfer device. In other embodiments, the fluid transfer device may itself provide a clamping function. The device may further comprise a section of flexible tubing connected to the second end connector part and a clamping arrangement to interrupt the fluid flow in the section of flexible tubing when the lever members are in the actuated position. In some examples, the clamping arrangement comprises a clamping member formed on the first actuator part of the first lever member and/or a clamping member formed on the second actuator part of the second lever member. This provides a particularly convenient way to integrate clamping into a fluid transfer device benefiting from a one-handed disconnection mechanism.

As an alternative or additional function to clamping a section of flexible tubing, the fluid transfer device may comprise a valve member arranged to interrupt fluid communication though the fluid transfer channel (i.e. between the first and second end connector parts) when the lever members are in the actuated position. The valve member may act to partially or completely block the fluid transfer channel when the lever members are in the actuated position. The fluid transfer device can therefore act as a stopcock at the same time as disconnecting the first end connector part. Such embodiments do not rely on flexible tubing to enable interruption of the fluid communication through the device. Any suitable kind of valve member may be integrated with the device and at least one of the lever members may be arranged to operate the valve member when the lever members pivot between the default and actuated positions.

The present invention extends to a syringe comprising a fluid transfer device as described above. In some embodiments the connector tip may be the tip of the syringe, for example by pivotally mounting the first and second lever members directly to the syringe. In some embodiments the connector tip may fit over the existing tip of the syringe, for example by retrofitting the device to the syringe. In some embodiments the second end connector part may comprise a female connector part that is used to connect the device to the existing male connector part (e.g. tapered male connector tip) of the syringe. In these various embodiments, the fluid transfer device may be made to meet the relevant medical standard(s), for example ISO 7886 for sterile hypodermic syringes. The syringe may have a volume of 2 ml, 5 ml, 10 ml, or 20 ml.

In any of the embodiments discussed herein, the fluid transfer device may be used to transfer any fluid, i.e. liquid and/or gas, between the first end connector part and second end connector part. Such devices may find particular use as medical devices. According to the U.S. Food and Drug Administration (FDA), a medical device can be defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (FFDCA) as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: (1) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them; or (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. The CDRH classification database contains a list of all products considered by the FDA to be medical devices. For example, the fluid transfer device may comprise one or more of: a hypodermic syringe; a pre-filled syringe; an autoinjector; an insulin pen injector; an implant injector; a catheter; a catheter connector or valve; an IV delivery device; an enteral feeding connector; a fluid transfer tube; a blood collection tube; a Luer connector; an ENfit coupling; a fluid vial; or any related accessory.

Some preferred embodiments of the present invention will now be described, by way of example only, and with reference to the accompanying drawings, in which: FIG. 1A is a perspective view of a fluid transfer device, according to one or more embodiments, in a locked default position;

FIG. 1B is a side view of the fluid transfer device of FIG. 1A in the locked default position;

FIG. 2A is a perspective view of the fluid transfer device, according to one or more embodiments, in an unlocked default position;

FIG. 2B is a partial side sectional view of the fluid transfer device of FIG. 2A in the unlocked default position;

FIG. 3A is a side view of the fluid transfer device, according to one or more embodiments, in an actuated position;

FIG. 3B is a side sectional view of the fluid transfer device of FIG. 3A in the actuated position;

FIGS. 4A and 4B are sides views of the fluid transfer device, illustrating how the arcuate threaded parts move relative to the connector tip between the default and actuated positions;

FIG. 5A is a perspective view of a fluid transfer device, according to other embodiments, in a locked default position;

FIG. 5B is a perspective view of the fluid transfer device of FIG. 5A in an actuated position;

FIG. 6A is a perspective view of a fluid transfer device providing a clamping function, according to one or more embodiments, in a locked default position;

FIG. 6B is a perspective view of the fluid transfer device of FIG. 6A in an actuated position;

FIG. 7 is a perspective view of a fluid transfer device, according to one or more embodiments, connected to a flexible tubing line;

FIG. 8 is a perspective view of another fluid transfer device, according to one or more embodiments, connected to a flexible tubing line;

FIG. 9A is a perspective view of the fluid transfer device of FIG. 8 in a locked default position when connected to a fluid delivery line;

FIG. 9B is a perspective view of the fluid transfer device of FIG. 8 in an actuated position when disconnected from a fluid delivery line; and

FIG. 10 is a side view of a fluid transfer device, according to one or more embodiments, connected to a syringe.

There is seen in FIGS. 1 to 4 a first embodiment of a fluid transfer device 2 comprising a first end connector part 4a and a second end connector part 4b with a fluid transfer channel 5 arranged between them. The first end connector part 4a has the standard design of a Luer Lock tapered connector tip 6 surrounded by an internally threaded collar 8, but in this device 2 the internally threaded collar 8 is separable into first and second arcuate threaded parts 8a, 8b. In order to controllably separate the first and second arcuate threaded parts 8a, 8b from one another, the device 2 comprises a pair of first and second lever members 10, 14 mounted to pivot relative to the connector tip 6. The first lever member 10 comprises a first actuator part 12a and a first driven part 12b carrying the first arcuate threaded part 8a. The first actuator and driven parts 12a, 12b are either side of a pivot axle 13. The second lever member 14 comprises a second actuator part 16a and a second driven part 16b carrying the second arcuate threaded part 8b. The second actuator and driven parts 16a, 16b are either side of a pivot axle 15.

As seen in FIGS. 1 and 2, the first and second lever members 10, 14 have a default position in which the first and second arcuate threaded parts 8a, 8b are closed together to form the internally threaded collar 8. As seen in FIG. 3, the first and second lever members 10, 14 have an actuated position in which the first and second arcuate threaded parts 8a, 8b are separated from one another to open the internally threaded collar 8. The device further comprises a transmission 18 arranged between the first and second lever members 10, 14 to transmit a force applied to the first actuator part 12 of the first lever member 10 and/or to the second actuator part 16 of the second lever member 14 such that the first and second lever members 10, 14 both pivot simultaneously relative to the connector tip 6 between the default position and the actuated position in response to an applied force.

As shown by FIGS. 1 and 2, the device 2 has a locked default position and an unlocked default position. This is dictated by the position of a moveable locking member 20 in the first actuator part 12. The moveable locking member 20 is resiliently biased into a locked position in which the first lever member 10 is held in the locked default position (FIGS. 1A and 1B). In this embodiment, the moveable locking member 20 is resiliently biased into the locked position by a compression spring 22 arranged laterally in the first actuator part 12. The moveable locking member 20 and the compression spring 22 can be integrally moulded as a single piece, as seen in FIG. 1A. As can be seen from FIGS. 2A and 2B, the locking member 20 is laterally moveable relative to the first lever member 10 by applying a backwards force to compress the spring 22. When the locking member 20 is moved against the resilient bias into an unlocked position, the first lever member 10 is released to pivot between the unlocked default position (FIGS. 2A and 2B) and the actuated position in response to an applied force (FIGS. 3A and 3B).

As is seen most clearly from FIGS. 1B and 2B, the device 2 comprises a blocking part 24 arranged to prevent the first lever member 10 from pivoting out of the default position. The locking member 20 engages with the blocking part 24 in its locked position (FIG. 1B). When the locking member 20 is moved laterally backwards, as seen in FIG. 2B, it no longer engages with the blocking part 24 in the unlocked position. From this unlocked position, the first lever member 10 is now able to pivot out of the default position. This is shown in FIGS. 3A and 3B.

In this embodiments the two lever members 10, 14 have the same lever body structure. For example, the lever members 10, 14 may be manufactured as the same piece (e.g. using injection moulding or additive manufacturing techniques such as 3D printing). The first lever member 10 includes a first built-in leaf spring 26 that is constrained by the locking member 20 such that it does not function. The second lever member 14 includes a second built-in leaf spring 28that is not constrained. In order to resiliently bias the second lever member 14 to return from the actuated position to the default position, the device 2 comprises a further leaf spring 30 arranged to act on the .second leaf spring 28, the two leaf springs 28, 30 being undeformed in the default position seen in FIG. 1B and deformed in the actuated position seen in FIGS. 3A and 3B.

Operation of the device 2 will now be described in more detail with reference to FIGS. 1 to 4. Starting from the locked default position seen in FIGS. 1A and 1B, the device 2 is operated by a user first pulling backwards on the locking member 20 to compress the spring 22. The first lever member 10 is then unlocked and free to pivot towards the second lever member 14, as the locking member 20 is now clear of the blocking part 24. Of course the blocking mechanism could instead, or additionally, be arranged to act on the second lever member 14 and/or the cogged transmission 18. Gripping the device 2 in one hand, the user squeezes together the first and second actuator parts 12a, 16a so as to separate the first and second arcuate threaded parts 8a, 8b carried by the first and second driven parts 12b, 16b. The lever members 10, 14 are pivoted from the unlocked default position seen in FIGS. 2A and 2B to the actuated position seen in FIGS. 3A and 3B. Due to the resilient bias of the deformed leaf springs 28, 30, the user must hold the lever members 10, 14 in this position to keep the collar 8 open. However it is envisaged that another locking arrangement (not shown) could be included in the device to lock the lever members 10, 14 in this actuated position and allow a user to release his/her grip.

FIGS. 4A and 4B demonstrate in more detail how the first and second arcuate threaded parts 8a, 8b are driven apart when the lever members 10, 14 are pivoted. Taking a fixed reference point on the collar part 8a, shown as a star, it will be understood that a female connector part (not shown) in contact with the thread at this point is pushed forwards along the connector tip 6 as the first and second arcuate threaded parts 8a, 8b are separated from one another. If the female connector part is held in a fixed position, as shown by the dotted line passing through the stars, then the connector tip 6 is seen to effectively retract backwards from its friction fit. This means that the friction fit can be at least partially released before the lever members 10, 14 reach the fully actuated position of FIG. 4B and the screw fit is completely released. The device 2 therefore provides a controlled disconnection without shootout of the female connector part.

FIGS. 5A and 5B depict another embodiment of a fluid transfer device 102 comprising a first end connector part 104a and a second end connector part 104b with a fluid transfer channel 105 arranged between them. As before, the internally threaded collar 108 is separable into first and second arcuate threaded parts 108a, 108b. The first and second lever members 110, 114 have a default position (FIG. 5A) in which the first and second arcuate threaded parts 108a, 108b are closed together to form the internally threaded collar 108. As seen in FIG. 5B, the first and second lever members 110, 114 have an actuated position in which the first and second arcuate threaded parts 108a, 108b are separated from one another to open the internally threaded collar 108. The device 102 further comprises a transmission 118 arranged between the first and second lever members 110, 114 so that they both pivot simultaneously between the default position and the actuated position in response to an applied force.

The device 102 of this embodiment operates basically in the same way as described in relation to FIGS. 1 to 4, except that the locking member 120 is now provided on a side of the device, arranged as a blocking part between the first and second lever members 110, 114. The locking member 120 is resiliently biased into a locking position (FIG. 5A) by a leaf spring 122. The leaf spring 122 pushes the locking member radially outward from the fluid channel 5 so that it engages against an edge 124 of the first and second lever members 110, 114. When a user pushes in the locking member 120, against the resilient bias of the leaf spring 122, the first and second lever members 110, 114 are free to pivot towards one another and the first and second arcuate threaded parts 108a, 108b are separated from one another to open the internally threaded collar, as seen in the actuated position of FIG. 5B. The device includes a leaf spring 130 acting on the second lever member 114 to provide a resilient bias to automatically return the lever members 110, 114 from the actuated position to the default position when the user releases his/her grip.

FIGS. 6A and 6B schematically show how a section of flexible tubing 150 can be connected to the second end connector part 4b, 104b in either of the devices 2, 102 described above. In such embodiments, the first and/or second lever member includes a clamping member 152, 154 at its rear end. When the lever members are pivoted from the default position (FIG. 6A) to the actuated position (FIG. 6B), the clamping members 152, 154 squeeze against the flexible tubing 150 to interrupt flow into/out of the device. Such an integrated clamping function can remove the need to use a separate clamping device on the tubing 150.

FIG. 7 shows an example of a fluid connection system wherein the device 2 has a section of flexible tubing 50 permanently attached to the second end connector part 4b, for example press fitted, welded or glued into attachment. A separate clamping device 52 is provided on the tubing 50. The other end of the tubing 50 carries a standard male/female connector part 54 for connection to other components.

FIG. 8 shows an example of a fluid connection system wherein the device 2 has a section of flexible tubing 50 removably connected to the second end connector part

4b, for example by a male connector part 60 carried at the end of the tubing 50. A separate clamping device 52 is provided on the tubing 50. The other end of the tubing 50 carries a standard male/female connector part 54 for connection to other components.

FIG. 9A shows the fluid connection system of FIG. 8 with a female connector part 70 connected to the first end connector part at the front of the device 2. In the default position seen in FIG. 9A, the female connector part 70 is held with a fluid-tight connection provided by the friction fit of the tapered connector tip and the screw fit of the surrounding collar 8. When the device 2 is operated as described above to open the collar 8 in the actuated position seen in FIG. 9B, the female connector part 70 is disconnected from the device 2. This is a one-handed operation with precise control over the disconnection force.

Finally, FIG. 10 provides an overview of a syringe 80 having a device 2 (as described above) connected to its tip. The device 2 provides a fluid transfer extension with its fluid transfer channel in fluid communication with the fluid chamber of the syringe. Using the device 2 to one-handedly disconnect a female hub can be advantageous compared to the standard technique of unscrewing a female hub (e.g. carrying a needle) from a Luer Lock connector tip.

Although the first and second end connector parts 4a, 4b have been illustrated as Luer Lock connectors in these embodiments, it will be recognised that the devices described herein may equally be used to release the screw fit for any other type of connector part comprising a tapered or untapered connector tip surrounded by an internally threaded collar, for example an ENFit coupling or other e.g. gasket-based coupling.

Claims

1. A fluid transfer device comprising:

a pair of first and second lever members mounted to pivot relative to the connector tip, the first lever member comprising a first actuator part and a first driven part carrying the first arcuate threaded part, and the second lever member comprising a second actuator part and a second driven part carrying the second arcuate threaded part, wherein the first and second lever members have a default position in which the first and second driven parts are positioned such that the first and second arcuate threaded parts are closed together to form the internally threaded collar and an actuated position in which the first and second driven parts are positioned such that the first and second arcuate threaded parts are separated from one another to open the internally threaded collar; and a transmission arranged between the first and second lever members to transmit a force applied to the first actuator part of the first lever member and/or to the second actuator part of the second lever member to both of the first and second driven parts of the first and second lever members such that the first and second lever members both pivot simultaneously relative to the connector tip between the default position and the actuated position in response to the applied force.

2. The fluid transfer device of claim 1, comprising a locking arrangement that acts on the first lever member and/or on the second lever member and/or on the transmission to lock the first and second lever members in the default position.

3. The fluid transfer device of claim 2, wherein the locking arrangement comprises a moveable locking member that is resiliently biased into a locked position in which the first and/or second lever member is locked in the default position.

4. The fluid transfer device of claim 3, wherein the locking member is moveable relative to the first and/or second lever member independently of pivotal movement of the first and/or second lever member relative to the connector tip.

5. The fluid transfer device of claim 3 or 4, wherein the locking member is laterally moveable relative to the first and/or second lever member.

6. The fluid transfer device of claim 5, wherein the locking member is resiliently biased into the locked position by a compression spring arranged laterally in the first and/or second actuator part.

7. The fluid transfer device of any of claims 3-6, wherein the locking member can be moved against the resilient bias into an unlocked position in which the first and second lever members are released to pivot between the default position and the actuated position in response to an applied force.

8. The fluid transfer device of any of claims 3-7, wherein the moveable locking member is resiliently biased to automatically return to the locked position.

9. The fluid transfer device of any of claims 3-8, wherein the locking arrangement further comprises a blocking part arranged to prevent the first and/or second lever member from pivoting out of the default position, and wherein the moveable locking member engages with the blocking part in the locked position.

10. The fluid transfer device of claim 9, wherein the locking member is manually moveable from the locked position to an unlocked position, in which the locking member is disengaged from the blocking part and the first and second lever members are released to pivot between the default position and the actuated position in response to an applied force.

11. The fluid transfer device of any preceding claim, wherein at least one of the first and second lever members is resiliently biased to return from the actuated position to the default position.

12. The fluid transfer device of any preceding claim, comprising a locking arrangement that acts on the first lever member and/or on the second lever member and/or on the transmission to lock the first and second lever members in the actuated position.

13. The fluid transfer device of any preceding claim, wherein the first and second lever members have the same lever body structure.

14. The fluid transfer device of any preceding claim, wherein the pair of first and second lever members is mounted to pivot symmetrically relative to the connector tip.

15. The fluid transfer device of any preceding claim, wherein the transmission comprises a cogged gear arrangement.

16. The fluid transfer device of any preceding claim, wherein the first and second arcuate threaded parts each extend 180° around the tapered connector tip.

17. The fluid transfer device of any preceding claim, wherein the internally threaded collar is coaxial with the connector tip.

18. The fluid transfer device of any preceding claim, wherein the connector tip is a male tapered connector tip for forming a friction fit with a corresponding female connector part.

19. The fluid transfer device of claim 18, wherein the first end connector part is a luer lock male connector part.

20. The fluid transfer device of claim 18 or 19, wherein at least one of the first and second arcuate threaded parts pushes along the male tapered connector tip to release the friction fit with a corresponding female connector part as the lever members pivot towards the default position.

21. The fluid transfer device of claim 18, 19 or 20, wherein at least one of the first and second lever members comprises a push-off member arranged to move along the male tapered connector tip to release the friction fit with a corresponding female connector part as the lever members pivot towards the default position.

22. The fluid transfer device of any of claims 18-21, further comprising a female connector part connected to the male tapered connector tip by a friction fit in addition to a screw fit provided by the internally threaded collar.

23. The fluid transfer device of any preceding claim, further comprising a valve member arranged to interrupt fluid communication through the fluid transfer channel when the lever members are in the actuated position.

24. The fluid transfer device of any preceding claim, further comprising a section of flexible tubing connected to the second end connector part and a clamping arrangement to interrupt the fluid flow in the section of flexible tubing when the lever members are in the actuated position.

25. The fluid transfer device of claim 24, wherein the clamping arrangement comprises a clamping member formed on the first actuator part of the first lever member and/or a clamping member formed on the second actuator part of the second lever member.

26. A fluid connection system comprising the fluid transfer device of any preceding claim, and at least one section of flexible tubing attached to the fluid transfer device.

27. The fluid connection system of claim 25, wherein the flexible tubing comprises a clamping device.

28. A syringe comprising the fluid transfer device of any of claims 1-23.