Patent Application
20210268203
The present invention relates to medical device connectors and related systems.
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 “LuerJack” system typically uses a pivoting disconnecting member, e.g. lever member, to separate the needle hub from the syringe. By utilizing 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. However, the “LuerJack” system has been designed for standard Luer connections and it is now appreciated that Luer-type connections do not represent the full range of clinical procedures that may benefit from one-handed operation.
Conventional needle hubs are usually standard Luer parts and many fluid transfer devices have been designed in the past to include a Luer-type connector. More By utilizing a lever member the practitioner can, in a one-handed operation, more easily disconnect recently, however, the ISO 80369 series of small-bore connector standards for fluid connectors in healthcare applications has been expanded to define a number of distinct connector types for different clinical applications. In the present ISO 80369 series: a Luer connector is compliant with ISO 80369-7 for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories; an ENFit connector is compliant with ISO 80369-3 for connections on enteral medical devices and accessories; and an NRFit connector is compliant with ISO 80369-6 for connections in neuraxial applications. The aim of this series of standards is to prevent misconnections between fluid transfer lines for different clinical uses, e.g. between enteral feeding tubes and IV lines. This series of standards may be further expanded in future.
These different standard connectors generally require a two-handed operation to achieve connection or disconnection e.g. by screwing together or unscrewing the male and female parts. There is no convenient, one-handed way of disconnecting a standard medical device connector which is also designed to prevent misconnections between different connector types.
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 medical device connector for connecting, in use, to a hub, the medical device connector comprising: a fluid transfer tip comprising a tapered surface for creating a friction fitting between the fluid transfer tip and a hub connected to the fluid transfer tip in use; a separable collar, comprising at least a first arcuate segment and a second arcuate segment, which extend at least partially around the fluid transfer tip, wherein the first segment is arranged in a fixed position relative to the fluid transfer tip and the second segment is moveably mounted relative to the fluid transfer tip and the first segment; wherein the second segment comprises an engagement feature for engaging with a corresponding engagement feature of a hub connected to the fluid transfer tip in use; the separable collar having a closed configuration in which the second segment is positioned relative to the fluid transfer tip so as to extend around a hub connected to the tip in use and to engage with the hub by engagement between the engagement feature of the second segment and the corresponding engagement feature of the hub, and an open configuration in which the second segment is moved relative to the fluid transfer tip and the first segment, so as to allow disengagement of the engagement feature from the corresponding engagement feature; and a moveable disconnection member arranged such that movement of the disconnection member moves the second segment of the separable collar from a first position, corresponding to the closed configuration of the separable collar, to a second position, corresponding to the open configuration of the separable collar, and wherein movement of the disconnection member also releases the friction fitting between the fluid transfer tip and the hub by advancing the hub along the tapered surface of the fluid transfer tip.
It will be appreciated that such a medical device connector can be made compatible with any one of the ISO 80369 series of small-bore connector standards by appropriate choice of dimensions for the fluid transfer tip and separable collar. In particular, as is described below, the medical device connector is preferably compatible with one of the standards selected from ISO 80369-3, ISO 80369-6 or ISO 80369-7. A user will only be able to connect those hubs that meet the same standard and hence the device inherently prevents misconnections. In addition, the device provides the advantages of one-handed operation by enabling a user to operate the disconnection member in a single action that moves the separable collar into the open configuration to disengage the hub and releases the friction fitting between the fluid transfer tip and the hub.
The device is made relatively simple by having the first arcuate segment arranged in a fixed position relative to the fluid transfer tip. The disconnection member then only has to operate to move the second arcuate segment relative to the fluid transfer tip and the first segment. Furthermore, the Applicant has recognized that it is advantageous for the first segment to be fixed as this maintains a fixed dimensional relationship with the fluid transfer tip even when the separable collar is in the open configuration. Thus, even in the open configuration, a user is generally prevented from misconnecting the wrong type of hub to the fluid transfer tip. This can be contrasted with a collar that completely separates in all directions, leaving an exposed fluid transfer tip to which a user might be able to misconnect a hub even though the collar would likely not be able to move properly back to its closed configuration. This is important for avoiding user confusion.
A benefit of the separable collar comprising at least first and second arcuate segments, rather than more localized engagement features, is that the collar has a certain angular extent. Firstly, this means that the collar (at least in its closed configuration) looks the same as, or similar to, the collar of a standard connector despite the fact that the collar is separable. Secondly, the arcuate extent of the first and second segments can contribute to the stiffness of the collar. This can be important for ensuring that a user is not able to forcibly misconnect the wrong type of hub. The arcuate extent of the second segment can also make the engagement feature(s) more robust. This will be described in more detail below.
It will be appreciated that, in at least some embodiments, the first and second arcuate segments extending at least partially around the fluid transfer tip means that the first and second arcuate segments are arranged concentrically relative to the fluid transfer tip. The first arcuate segment may be arranged at a first radial distance from the fluid transfer tip and the second arcuate segment may be arranged at a second radial distance from the fluid transfer tip. In at least some embodiments, the first and second radial distances may be substantially the same. The collar may therefore appear symmetrically arranged about the fluid transfer tip.
It will also be appreciated that, while the first and second arcuate segments are generally arcuate in shape, it is not necessary for the first and second arcuate segments to have an outer profile that is constantly curved. In some embodiments, the first and/or second arcuate segments may have an outer profile that is curved, for example an outer profile at a fixed radius from the fluid transfer tip. In some embodiments, the first and/or second arcuate segments may have an outer profile that is partly curved and partly straight. For example, at least one of the first and second arcuate segments may have an outer profile that is generally U-shaped or J-shaped. In one set of embodiments, the second arcuate segment is U-shaped and the first arcuate segment sits inside the U-shaped second segment in the closed configuration. In such embodiments, the first and second arcuate segments may not mate together in the closed configuration. The second arcuate segment may have a much larger angular extent than the first arcuate segment, which can help to ensure the second arcuate segment is stiff and holds its shape when moved between the closed and open configurations of the collar.
In addition to the arcuate extent of the first and second segments, the arrangement of the first and second segments around the fluid transfer tip can help to prevent misconnections. In at least some embodiments, the fluid transfer tip extends along an axis that is surrounded by the separable collar, for example the separable collar may be coaxial with the fluid transfer tip, and the fluid transfer tip extends no further than an outer surface of the separable collar. This means that a compatible hub must be dimensioned to fit inside the collar before it can connect onto the fluid transfer tip. If the hub is not suitably dimensioned, then it will come into contact with an outer surface of the collar and be prevented from reaching the fluid transfer tip.
In at least some embodiments, in addition or alternatively, the fluid transfer tip extends along an axis that is surrounded by the separable collar, for example the separable collar may be coaxial with the fluid transfer tip, and the separable collar extends substantially all the way around the fluid transfer tip in the closed configuration. In such embodiments, the first and second arcuate segments may mate together in the closed configuration so as to form a closed collar extending substantially all the way around the fluid transfer tip. In other words, the separable collar may appear as a complete 360° collar in the closed configuration. This helps to prevent user confusion and attempted misconnections, and can make the collar stiff in its closed configuration so that any attempt to misconnect the wrong type of hub is resisted by the 360° angular extent of the first and second segments.
In embodiments where the first and second arcuate segments mate together in the closed configuration, this may be achieved in a number of ways. For example, the first and second arcuate segments may be arranged to interlock. In at least some embodiments, one of the first arcuate segment or second arcuate segment comprises a tongue portion extending therefrom, and the other of the first arcuate segment or second arcuate segment comprises a receiving portion shaped to receive the tongue portion such that, in the closed configuration, the first arcuate segment and second arcuate segment form a closed collar extending substantially all the way around the fluid transfer tip. In at least some embodiments, at least one of the first and second arcuate segments comprises a latching feature or detent arranged to latch onto or hold the other of the first or second arcuate segments when in the closed configuration. As will be appreciated, this will also achieve an interlocking arrangement as described above. Such a latching feature or detent may assist in holding the first and second arcuate segments together in the closed configuration. This may further help to prevent misconnections by preventing a user from being able to forcibly separate the first and second arcuate segments when attempting to attach a non-compatible hub. The other of the first and second arcuate segments may comprise a cooperating feature onto which the latching feature or detent may engage. Such a latching feature or detent may comprise a protrusion extending from at least one of the first and second arcuate segments arranged to engage with a corresponding feature, for example in the form of a recess provided on the other first or second arcuate segment.
In some other embodiments, the separable collar may not extend substantially all the way around the fluid transfer tip in the closed configuration. In such embodiments, the first and second arcuate segments may be spaced from one another in the closed configuration so as to form a partially open collar extending around the fluid transfer tip. In at least some embodiments, in addition or alternatively, at least one of the first arcuate segment or second arcuate segment may comprise multiple portions that are spaced from one another along an arcuate extent of the segment. Even in the closed configuration, the separable collar may appear as a broken rather than continuous collar. However, it will be appreciated that the arrangement of the multiple portions around the fluid transfer tip can still act to prevent an incompatible hub from being misconnected onto the tip, as it is the overall spacing between the collar and the tip that determines whether a hub can be accommodated to form a connection.
The Applicant has recognized that it is most important for the first arcuate segment to have a set spacing from the fluid transfer tip as the first segment is arranged in a fixed position and this spacing always ensures that the wrong type of hub cannot be misconnected onto the tip. Thus, in a preferred set of embodiments, at least the first arcuate segment is arranged in a fixed position having a predefined spacing from the tapered surface of the fluid transfer tip. Furthermore, in at least some embodiments, the second arcuate segment is arranged at a predefined spacing from the tapered surface of the fluid transfer tip when the collar is in the closed configuration. The spacing between the first/second arcuate segment and the tapered surface may be predefined to accommodate a specific type of hub, for example predefined in accordance with one of the ISO 80369 series of small-bore connector standards mentioned above.
In some embodiments, the predefined spacing may be compliant with ISO 80369-7 for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. The standard ISO 80369-7:2016 specifies dimensions and requirements for the design and functional performance of Luer connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. These Luer connectors have a standard 6% tapered surface to provide a so-called Luer Slip connection, and optionally include a threaded collar to provide a standard Luer Lock connection. Although standard Luer Slip or Luer Lock connections use a male tapered tip that fits inside a female hub or adaptor, it is envisaged that this could be reversed and the fluid transfer tip could be a female part having an internal taper to create the friction fitting with a corresponding male hub.
In some other embodiments, the predefined spacing may be compliant with ISO 80369-3 for connections on enteral medical devices and accessories. Compatible enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports. For example, ENFit connectors may comprise a male connector tip and a coaxial connection collar. The male connector tip may have a tapered lead-in portion. The coaxial connection collar may be internally threaded. Such ENFit connectors are dimensioned to prevent misconnections with Luer connectors. Some examples of such ENFit connectors are disclosed in US 2016/0279032 and US 2017/0014616, the contents of which are hereby incorporated by reference.
In some other embodiments, the predefined spacing may be compliant with ISO 80369-6 for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anesthesia delivery, and other regional anesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes. For example, NRFit connectors may comprise a male tapered tip surrounded by a coaxial collar that is internally threaded. Such NRFit connectors are dimensioned to prevent misconnections with Luer connectors.
In addition to the arrangement of the separable collar around the fluid transfer tip, the one or more engagement features provided by the second segment can be designed for compatibility with a specific type of hub. In some embodiments, it may be desirable for the engagement feature(s) to engage with the different corresponding engagement features of multiple hubs, even hubs compliant with different ones of the ISO 80369 series of small-bore connector standards. This can reduce the variation between devices intended for use with different standard hubs. For example, the engagement feature(s) may comprise at least one latch member. A latch member may be able to generally engage with the different corresponding engagement features of multiple hubs. A latch member may be able to grip onto a corresponding engagement feature in the form of a flange or thread of a hub. The latch member may take the form of a tooth or hook.
However, as will be appreciated from the disclosure above, a Luer Lock hub, an ENFit hub or an NRFit hub made in compliance with one of the ISO 80369 series of small-bore connector standards is dimensioned to connect onto the fluid transfer tip while engaging with a coaxial collar that is threaded. Thus, for ease of connection and to avoid user confusion, the separable collar is preferably designed to provide a threaded engagement with a hub connected in use. A user may need two hands to screw the hub into threaded engagement with the medical device connector, but operation of the disconnection member can provide for convenient one-handed release of the hub.
Furthermore, the Applicant has realized that a threaded engagement feature may be able to positively engage with a flange of a hub as well as with a corresponding threaded engagement feature as found in ISO80369-compliant hubs. In one or more embodiments, the second segment comprises an engagement feature comprising at least one threaded portion for engaging with a corresponding threaded portion or flange of a hub connected to the fluid transfer tip in use. The at least one threaded portion may comprise a helical thread. The threaded portion may be continuous or discontinuous. Whether the threaded portion is continuous or discontinuous, the nature of a threaded portion means that a user may need to twist or screw a hub into engagement with the second segment when the separable collar is in its closed configuration.
In at least some embodiments, the threaded portion comprises one or more threads protruding from an internal surface of the second segment. As is conventional, the second segment may comprise a cylindrical internal surface and one or more threads may protrude from a portion of the cylindrical internal surface.
More generally, the second segment may comprise any engagement feature or set of engagement features in a helical arrangement extending around the fluid transfer tip. Such a helical arrangement may effectively function like a threaded portion by engaging with a corresponding threaded portion or flange of a hub connected to the fluid transfer tip in use. Thus, in one or more embodiments, the second segment comprises one or more engagement features in a helical arrangement extending around the fluid transfer tip. The helical arrangement may require a user to twist or screw a hub into engagement with the second segment when the separable collar is in its closed configuration. The helical arrangement may be continuous or discontinuous.
The threaded portion or helical arrangement may extend fully across an internal surface of the second segment, or the threaded portion or helical arrangement may only extend partially across an internal surface of the second segment. Thus, as compared to the threaded collar of a standard connector, the threaded portion or helical arrangement may have a reduced extent, which can assist with disengagement when the second segment is moved to its second position corresponding to the open configuration of the separable collar. In at least some embodiments, the engagement feature(s) are static relative to the second arcuate segment. For example, the engagement feature(s) may comprise at least one fixed thread. This can ensure a robust engagement, especially for threaded engagement.
In at least some other embodiments, the engagement feature(s) are displaceable at least relative to the second segment. For example, the engagement feature(s) may comprise at least one displaceable latch member. This can assist with a push-on type of engagement.
Regardless of the form of the engagement feature(s), e.g. a latch member or threaded portion, the second segment may define an internal surface extending around the fluid transfer tip, e.g. coaxial with the tip, and the engagement feature(s) may protrude or project from the internal surface towards the fluid transfer tip. In at least some embodiments, the engagement feature(s) may project radially from the internal surface.
As mentioned above, in at least some embodiments the engagement feature(s) may comprise at least one latch member. A latch member is any member protruding from an internal surface of the second segment to positively engage with (e.g. grip onto) a corresponding engagement feature of a hub in use. In a hybrid set of embodiments, the second segment comprises one or more latch members in a helical arrangement extending around the fluid transfer tip. Such arrangements combine a gripping function from the latch member(s) with a screw function from the helical arrangement. As before, the helical arrangement may require a user to twist or screw a hub into engagement with the second segment when the separable collar is in its closed configuration.
In at least some other embodiments, it may be desirable to avoid the need for a user to twist or screw a hub into engagement with the second segment. The open configuration of the separable collar may be exploited so that a user connects a hub to the fluid transfer tip while the second segment is moved away from the fluid transfer tip. When the second segment is moved to bring the collar into its closed configuration, the engagement feature(s) may then be brought into positive engagement with the corresponding engagement feature(s) of the hub. Without the engagement feature(s) being in a helical arrangement, it may still be beneficial for the engagement feature(s) to have an angular extent around the fluid transfer tip in order to provide secure engagement. In one or more embodiments, the engagement feature comprises one or more arcuate portions extending from a surface of the second segment. The arcuate portion(s) may be arranged concentrically around the fluid transfer tip.
As mentioned above, the engagement feature(s) may protrude to latch onto a corresponding engagement feature of a hub. In some embodiments such a latching engagement may be reversed, for example the corresponding engagement feature(s) of the hub may comprise a latch member and the second segment may comprise an engagement feature comprising a latch keeper. More generally, it will be appreciated that the engagement feature(s) may not protrude outwardly from an internal surface of the second segment but may instead be imprinted or impressed into an internal surface of the second segment. For example, the engagement feature(s) may comprise at least one groove.
In addition to providing for engagement with a hub connected to the fluid transfer tip in use, the Applicant has recognized that the engagement feature(s) of the second segment may also be arranged to provide a deceleration effect when the separable collar is moving between its closed and open configurations upon operation of the disconnection member. The dual function of the disconnection member is not only to open the separable collar but also to advance the hub along the tapered surface of the fluid transfer tip to thereby release the friction fitting. As the disconnection member is pushing the hub along the fluid transfer tip, the hub may be forcibly released and there is a risk that the hub shoots away from the device in an uncontrolled manner. This can be mitigated by the separable collar at least partially resisting advancement of the hub along the fluid transfer tip. Thus, in a preferred set of embodiments, the separable collar comprises a deceleration feature. In some embodiments, this deceleration feature may be provided by the engagement feature(s) of the second segment. For example, a threaded portion may be arranged on an internal surface of the second segment so as to at least partially resist advancement of the hub at the same time as disengaging from the corresponding threaded portion of the hub.
As discussed above, the primary purpose of the first arcuate segment being in a fixed position is to define a fixed spacing from the fluid transfer tip that prevents misconnections. However, the Applicant has appreciated that it may be better for the first segment to provide a deceleration effect than the second segment, so that deceleration is decoupled from the disengagement that occurs when the separable collar is moving between its closed and open configurations upon operation of the disconnection member. Thus, in at least some embodiments, the first segment comprises a deceleration feature. This may be instead of, or in addition, to any deceleration feature provided by the engagement feature(s) of the second segment. The deceleration feature is any suitable feature arranged to interact with the hub so as to at least partially resist advancement of the hub along the fluid transfer tip.
In such embodiments, the deceleration feature may comprise at least one protrusion extending from the first segment in a direction towards the fluid transfer tip such that it interacts with a hub as it is advanced along the fluid transfer tip by the disconnecting member. The protrusion(s) may comprise a high friction material such as rubber or silicone. In some embodiments, the deceleration feature comprises multiple protrusions extending from the first segment. The multiple protrusions may be spaced apart along the fluid transfer tip, for example resulting in multiple deceleration stages as a hub is advanced along the tip.
In such embodiments, in addition or alternatively, the deceleration feature may be at least partially deformable such that as the hub is advanced across the deceleration feature, the deceleration feature deforms to allow the hub to advance along the fluid transfer tip. In such embodiments, in addition or alternatively, the deceleration feature may be at least partially displaceable such that as the hub interacts with the deceleration feature, the deceleration feature displaces to allow the hub to advance along the fluid transfer tip. The first segment, albeit in an overall fixed position relative to the fluid transfer tip, may comprise a displaceable portion that acts as the deceleration feature.
The Applicant has recognized that a collar providing a deceleration effect is advantageous in its own right, regardless of whether there is also provided a positive engagement between the collar and a hub connected to the fluid transfer tip in use. Thus, when viewed from a second aspect, the present invention provides a system comprising a hub and medical device connector; wherein the hub comprises: a connection feature arranged at a first end of the hub for connecting the hub to the medical device connector; and wherein the medical device connector comprises: a fluid transfer tip comprising a tapered surface for creating a friction fitting between the fluid transfer tip and the connection feature on the hub when the hub is connected to the medical device connector; a collar arranged to extend at least partially around the fluid transfer tip, and around at least part of the hub when the hub is connected to the fluid transfer tip, and wherein the collar comprises a deceleration feature; and a disconnection member arranged such that when the hub is connected to the fluid transfer tip, movement of the disconnection member from a first position to a second position advances the hub along the fluid transfer tip so as to release the friction fitting between the fluid transfer tip and the hub and wherein the advancement of the hub along the fluid transfer tip is at least partially resisted by an interaction between the deceleration feature and the hub.
It will be recognized that, in at least some embodiments, the collar may be a fixed collar rather than a separable collar and there may be no engagement between the collar and the hub. This means that the disconnection member, which may allow for one-handed operation, solely acts to release the friction fitting between the fluid transfer tip and the hub. However, the presence of the collar is still important as the predefined spacing between the collar and the tip can prevent user confusion and misconnections from occurring. An advantage of the absence of engagement features is that a standard Luer Slip hub can be connected onto the tip and take advantage of one-handed disconnection with deceleration.
In other embodiments, the collar is separable, comprising first and second arcuate segments with the features as described above. Thus, in at least some embodiments of this second aspect, the collar is a separable collar, comprising at least a first arcuate segment and a second arcuate segment, which extend at least partially around the fluid transfer tip. Preferably the first segment is arranged in a fixed position relative to the fluid transfer tip and the second segment is moveably mounted relative to the fluid transfer tip and the first segment. In some preferred embodiments: the second segment comprises an engagement feature for engaging with a corresponding engagement feature of a hub connected to the fluid transfer tip in use; the separable collar having a closed configuration in which the second segment is positioned relative to the fluid transfer tip so as to extend around a hub connected to the tip in use and to engage with the hub by engagement between the engagement feature of the second segment and the corresponding engagement feature of the hub, and an open configuration in which the second segment is moved relative to the fluid transfer tip and the first segment, so as to allow disengagement of the engagement feature from the corresponding engagement feature; and the moveable disconnection member arranged such that movement of the disconnection member moves the second segment of the separable collar from the first position, corresponding to the closed configuration of the separable collar, to the second position, corresponding to the open configuration of the separable collar.
There will now be described some features of the disconnection member that are generally applicable in embodiments of either of the first or second aspects of the invention.
In one or more embodiments, the disconnection member is resiliently biased into the first position. This can help to ensure that the default state of the medical device connector is one in which the disconnection member is not interfering with the friction fitting, and optionally the positive engagement, with a hub connected to the fluid transfer tip in use. A user must actively operate the disconnection member to overcome the resilient bias and cause the hub to be released.
The disconnection member may be resiliently biased by a spring member or by a natural resilient bias, for example resulting from the disconnection member being deformed from a relaxed state. In at least some embodiments, the disconnection member is moveably mounted such that movement of the disconnection member from the first position to the second position deforms the disconnection member so as to result in a resilient bias that tends to return the disconnection member to the first position. For example, the medical device connector may comprise a body member and the disconnection member may be moveably mounted to the body member with features operating between the disconnection member and the body member which interact to inhibit the disconnecting member from moving until a force is applied to the disconnecting member by a user to deform the disconnection member and overcome the interaction. This is described in more detail in the Applicant's published application WO 2016/162571, the contents of which are hereby incorporated by reference in their entirety.
In one or more embodiments, the disconnection member is locked in the first position until actively released. For example, the medical device connector may comprise a body member and the disconnection member may be prevented from moving out of the first position by a locking interaction between the disconnection member and the body member. In such embodiments, the device may further comprise a release member arranged to release the disconnection member from being locked in the first position. In addition, the release member may also operate to move the disconnection member out of the first position. Optionally, in some further embodiments, the release member is further arranged to drive movement of the disconnection member from the first position to the second position. This may be achieved, for example, through an interaction between lugs or side legs on the release member and side walls of the disconnection member. In a set of embodiments, the release member comprises deformable side legs which extend towards and rest on an outer surface of the body member and arranged such that, as the release member is pressed down towards the body member, the side legs are forced to splay outwards around the body member to contact the disconnection member and further operation of the release member thereby drives movement of the disconnection member.
The release member may be any manually operable member that operates to overcome the locking interaction between the disconnection member and the body member. The Applicant has recognized that it is desirable to prevent accidental operation of the release member, so that the disconnection member is locked in the first position until intentionally released by a user. The release member may comprise a resiliently-biased button, so that a user has to apply sufficient force to over the resilient bias before the button operates. This has the advantage of tactile feedback when a user rests a digit on the button and makes an active decision to apply a pressing force. Thus, in at least some embodiments, the medical device connector comprises a body member and the release member is mounted to the body member in a pre-stressed state. This may be achieved, for example, by the release member comprising deformable side legs which extend towards and rest on an outer surface of the body member and arranged such that, as the release member is initially pressed down towards the body member, the side legs are forced to splay outwards around the body member to put the release member in a pre-stressed state and the disconnection member comprising a latch arranged to hold the release member in the pre-stressed state.
In one or more embodiments, the disconnection member comprises a disconnection portion arranged to advance along the tapered surface of the tip to advance and push off the hub from the friction fitting. The disconnection portion may be forked, comprising a pair of fork legs extending either side of the fluid transfer tip. This can help to ensure a balanced disconnection force is applied to a hub connected to the tip in use. At least in embodiments wherein the first segment is fixed in position, the first segment may comprise two grooves for receipt of the fork legs. During movement of the disconnection member, the two grooves may receive the fork legs.
In some embodiments, the disconnection portion may be provided by a threaded portion. For example, as described above, the second segment may comprise at least one threaded portion for engaging with a corresponding threaded portion of a hub connected to the fluid transfer tip in use. When the second segment is moved between the first and second positions, the threaded portion may advance along the tapered surface of the fluid transfer tip to at least partially act as a disconnection portion. Even if the second segment is part of disconnection member in the form of a pivoting lever member, the threaded portion may act as a disconnection portion during pivotal movement to achieve the open configuration of the collar.
In one or more embodiments, the disconnection member is a pivotally mounted lever member, e.g. pivotally mounted to a body member of the medical device connector. The lever member may comprise a rearward portion that can be pivoted down towards the body member. In at least some embodiments, the rearward portion comprises a pair of side walls arranged to pivot down and around the body member. The side walls may be connected by an upper wall comprising the release member already described above. In these and other embodiments, the release member may be formed in the upper wall of the lever member by a living hinge. The release member may therefore be operable to move towards the body member independently of the side walls. In at least some such embodiments, the lever member may comprise one or more side walls linked by a bridge section that passes across the body member. Furthermore, the release member may be arranged to extend over the bridge section, such that the release member must be operated in an initial stage to move towards the body member before contacting the bridge section to start transferring a force to the lever member. In a further stage, further movement of the release member towards the body member also drives movement of the rearward portion of the lever member towards the body member. This provides for a particularly intuitive mode of two-stage operation, as a user cannot easily access the bridge section to apply a force without using the release member that extends over the bridge section. This means that the release member is intuitively operated first to actively release the disconnection member when it is locked in the first position.
In such embodiments, the device may comprise a body member to which the lever member is pivotally mounted. The lever member may comprise a disconnecting portion arranged to move at least partially along an axis of the fluid transfer tip away from the body member, thereby acting on the hub to advance it along the fluid transfer tip. In such embodiments, the lever member may further comprise a rearward portion extending away from the disconnecting portion, the rearward portion arranged to interact with the body member such that the lever member is locked in the first position, as described generally above. In such embodiments, the device may further comprise a release member arranged to deform the rearward portion around the body member so as to release the lever member from the first position. This may be achieved, for example, by deforming one or more walls of the lever member outward relative to the body member. In a set of embodiments, the release member comprises deformable side legs which extend towards and rest on an outer surface of the body member and arranged such that, as the release member is pressed down towards the body member, the side legs are forced to splay outwards around the body member to contact one or more walls of the lever member and further operation of the release member thereby drives pivotal movement of the lever member. During such pivotal movement, the rearward portion may move towards the body member while the disconnecting portion moves away from the body member and along the fluid transfer tip. Optionally, the device may include a latch on side walls of the lever member which interacts with the side legs of the release member to pull the lever member back up.
In one or more other embodiments, the disconnection member is a sliding member. The sliding member may be mounted to slide along a body member of the device from a first position over the body member to a second position over the fluid transfer tip. As described above, the sliding member may be integrated with the collar. Movement of the sliding member may cause the second segment to move as described hereinabove. In embodiments where the second segment comprises a threaded portion, the threaded portion may act as a disconnection portion that advances along the fluid transfer tip.
The first aspect of the present invention extends to a system comprising a hub and medical device connector as described herein, wherein the hub comprises the corresponding engagement feature, preferably arranged at a first end of the hub, for engaging with the engagement feature of the second segment. There has already been described a second aspect of the present invention wherein engagement between the hub and the collar is optional but the collar comprises a deceleration feature. The Applicant has now appreciated that even in the absence of a deceleration feature, or any engagement features, a separable collar operated by the disconnection member may be desirable as the collar can prevent misconnections at least in its closed configuration. Thus, when viewed from a third aspect, the present invention provides a medical device connector for connecting, in use, to a hub, the medical device connector comprising: a fluid transfer tip comprising a tapered surface for creating a friction fitting between the fluid transfer tip and a hub connected to the fluid transfer tip in use; a separable collar, comprising at least a first arcuate segment and a second arcuate segment, which extend at least partially around the fluid transfer tip, wherein at least one of the first and second segments is moveably mounted relative to the fluid transfer tip, and wherein each of the first and second segments comprises a surface facing the fluid transfer tip that is devoid of engagement features; the separable collar having a closed configuration in which the second segment is positioned relative to the fluid transfer tip so as to extend around a hub connected to the tip in use, and an open configuration in which the first and/or second segment is moved relative to the fluid transfer tip; and a moveable disconnection member arranged such that movement of the disconnection member moves the first and/or second segment of the separable collar from a first position, corresponding to the closed configuration of the separable collar, to a second position, corresponding to the open configuration of the separable collar, and wherein movement of the disconnection member also releases the friction fitting between the fluid transfer tip and the hub by advancing the hub along the tapered surface of the fluid transfer tip.
It will be understood that the surface facing the fluid transfer tip being devoid of engagement features means that the first and second segments of the separable collar do not include any threaded portion, or other engagement feature such as a latch or otherwise. The separable collar may therefore be viewed as a passive “dummy” collar that provides a visual indicator to users to avoid confusion and misconnections.
Preferably the first segment is arranged in a fixed position relative to the fluid transfer tip and the second segment is moveably mounted relative to the fluid transfer tip and the first segment, as is described above.
A medical device connector as described herein may take the form of a fluid transfer connector or a fluid transfer device, such as a syringe. The medical device connector may be a pre-filled syringe. Instead of a hub being connected to the fluid transfer tip in use, a cap may be connected to seal the syringe. Furthermore, the Applicant has appreciated that it can be particularly convenient to connect a disinfecting cap to the fluid transfer tip, not only to seal a pre-filled syringe, but more generally to provide a medical device connector that can be supplied to a user with the disinfecting cap pre-connected rather than loose in a kit. This can help to promote aseptic procedures.
Thus, in one or more embodiments of any aspect of the invention, there is provided a system comprising a medical device connector and a disinfecting cap, wherein the disinfecting cap comprises: a connection portion comprising a tapered internal surface and an external engagement feature for connecting the cap to the medical device connector; and wherein the medical device connector comprises: a fluid transfer tip comprising a tapered surface for creating a friction fitting between the fluid transfer tip and the tapered internal surface when the cap is connected to the medical device connector; and a separable collar, comprising at least a first arcuate segment and a second arcuate segment, which extend at least partially around the fluid transfer tip, wherein at least one of the first and second segments comprises an internal engagement feature for engaging with the external engagement feature of the cap connected to the fluid transfer tip in use.
The collar may be manually separable, but preferably the medical device connector further comprises a moveable disconnection member arranged such that movement of the disconnection member moves the first and/or second segment of the separable collar from a first position, corresponding to a closed configuration of the separable collar (in which least one of the first and second segments is positioned relative to the fluid transfer tip so as to extend around a cap connected to the tip in use and to engage with the cap by engagement between the internal and external engagement features) to a second position, corresponding to the open configuration of the separable collar (in which least one of the first and second segments is moved relative to the fluid transfer tip, so as to allow disengagement of the internal and external engagement features), and wherein movement of the disconnection member also releases the friction fitting between the fluid transfer tip and the cap by advancing the cap along the tapered surface of the fluid transfer tip.
In such a system, the medical device connector may further comprise any of the features already described above. For example, the first segment may be arranged in a fixed position relative to the fluid transfer tip and the second segment may be moveably mounted relative to the fluid transfer tip and the first segment. The medical device connector may be a pre-filled syringe.
Such a disinfecting cap is also considered novel in its own right, and thus when viewed from a further aspect the present invention provides a disinfecting cap comprising a connection portion comprising a tapered internal surface and an external engagement feature for connecting the cap to a medical device connector. The external engagement feature may comprise one or more of: a circumferential flange, a screw thread, a spline, or a latch. One or more such external engagement features may be present. In addition to the connection portion, the disinfecting cap may comprise any of the standard feature of a disinfecting cap, such as a chamber containing disinfecting liquid.
Some embodiments of the present invention will now be described, by way of example only, and with reference to the accompanying drawings, in which:
The second segment 16 comprises a tongue 22 at each edge of the arcuate segment 16 and the first segment 14 comprises a receiving portion 24 for receiving the tongue 22.
The lever member 18 of this particular embodiment is formed in a three-dimensional shell shape which comprises side walls 26 which engage with locking ledges (not shown in this Figure) on the fluid transfer chamber 4 so as to inhibit movement of the lever member 18. A release member 28 is provided which is connected to the lever member 18 via a living hinge 30. The release member 28 is therefore able to pivot relative to the lever member 18. The release member 28 functions to release the side walls 26 of the lever member 18 from the locking ledges on the fluid transfer chamber 4, as will be described later with reference to
The syringe 2 further comprises a deceleration feature 38 which comprises an arm 40 and a protrusion 42 extending therefrom towards the fluid transfer tip 4. The deceleration feature 38 divides the first segment 14 of the collar 12 into two portions: a first portion 14a and a second portion 14b. The first portion 14a and second portion 14b each comprises a slot 44a, 44b respectively for receiving a forked disconnection portion (not visible in this Figure) of the lever member 18.
With the separable collar 12 in the closed configuration as seen in
Furthermore, the syringe 2 may also prevent misconnection of an incorrect hub even when the collar 12 is in an open configuration, i.e. when the second segment 16 is pivoted away from the fluid transfer tip 4. In this instance, whilst the second segment 16 may be pivoted away and thus it does not provide the specific spacing around the fluid transfer tip 4 which is suitable for a specific type of hub, the first segment 14 remains fixed relative to the fluid transfer tip 4 and thus still provides a fixed space between the first segment 14 and the fluid transfer tip 14. Accordingly, whilst the entire collar 12 may not provide the defined space 68 as seen in
Once the release member 18 has been depressed by a sufficient amount, the side legs 46 will force the side walls 26 outwards.
Once the lever member 18 has been released from the locking ledge 50 as described above, depression of the release member 28 may further act to pivot the lever member 18. This is achieved by the transfer ledge 32 acting on the upper edge 34 of the side walls 26 of the lever member 18. As the release member 28 is pressed, the transfer ledge 32 acts on the upper edge 34 and forces the lever member 18 to pivot. This can be seen in
Although a hub is not seen in
In the embodiment described above, once a user removes the applied force, e.g. releases their thumb, from the release member 28, the release member 28 and lever member 18 may automatically move back to the position seen in
The medical device connectors described herein, such as the syringe 2 seen in
As can be seen by comparison of
Operation of the syringe 302, specifically the lever member 318 and release member 328, will now be described with reference to
Once the lever member 318 has been unlocked as described above, the lever member 318 may then be pivoted. This can be seen in
Starting from the default position described above, a user may apply a force to the release member 428 in order to release the lever member 418 from its first, locked position, and thereby pivot the lever member 418 into a second position, corresponding to the collar 412 being in an open configuration. This may be, for example to release a hub from the syringe 402. Following this operation, a user may subsequently release the force applied to the release member 428, e.g. by removing their thumb, or other finger from the release member 428. When a user releases the force on the release member 428, due to the resilient bias provided as a result of the side legs 446 splaying, the release member 428 will tend to move towards the position seen in
The Applicant has recognized that the arrangement described above comprising the ledges 476 and hooks 478 which act to link the lever member 418 and release member 428 in the manner described may be applied to any embodiments comprising a pivotally mounted lever member and associated release member.
The syringe further comprises a release member 528 which extends from a rear portion of the sliding member 518. The release member 528 comprises a front edge 582 that, at least in the position seen in
When a user wishes to disengage a hub (not shown in
Once released, a user may apply a lateral force to the release member 528 in order to push the sliding member 518 forwards. This can be seen in
Once the friction fit between the hub 162 and the fluid transfer tip 504 has been overcome and the second segment 516 has been advanced sufficiently such that it provides an open configuration allowing the engagement to be released, the hub 162 may freely fall away, for example under gravity. This is depicted in
In the embodiments seen in
In other embodiments, the pre-filled syringe 1402 may of course be sealed by a regular cap connected to the tip. In any of these embodiments, one-handed operation of the lever member is advantageous for convenient cap removal prior to a flushing procedure.
With reference to
Additionally, as can be seen in
This particular embodiment seen in
As can also be seen in
In order to separate the second arcuate segment 1516 from the first arcuate segment 1514, the first latching feature 1569a and second latching feature 1569b must first be disengaged. In this particular embodiment, the first arcuate segment 1514 and second arcuate segment 1516 are slight deformable, at least in the portion proximal to the first and second protrusions 1571a, 1571b and first and second recesses 1573a, 1573b. As will be appreciated, when a user applies a force to the lever member, e.g. by depressing the lever member 1518, the lever member 1518 will transfer and amplify the applied force which will initially go towards deforming the first and second arcuate segment 1514, 1516 such that the first and second latching features 1569a, 1569b are disengaged. Continued application of a force by the user to the lever 1518 will then cause the lever member 1518 to pivot thereby moving the second arcuate segment 1516 away from the first arcuate segment 1514.
With reference to both
As will be appreciated by those skilled in the art, any of the embodiments described above may be modified in an appropriate manner such that they are suitable for connection with a specific type of hub, e.g. a Luer Fit, NRFit or ENFit hub. For example, this may involve providing a specific fluid transfer tip and/or collar.
While the invention has been described with reference to exemplary embodiments and applications scenarios, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the claims. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed, but that the invention will include all embodiments falling within the scope of the appended claims and can be applied to various application in the industrial as well as commercial field.
| Number | Date | Country | Kind |
|---|---|---|---|
| 1812698.7 | Aug 2018 | GB | national |
| 1816395.6 | Oct 2018 | GB | national |
This application is entitled to the benefit of, and incorporates by reference essential subject matter disclosed in PCT Application No. PCT/EP2019/071056 filed on Aug. 5, 2019, which claims priority to GB Patent Appln. No. 1812698.7 filed Aug. 3, 2018 and GB Patent Appln. No. 1816395.6 filed Oct. 8, 2018, which are hereby incorporated by reference in their entireties.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2019/071056 | 8/5/2019 | WO | 00 |
