Guidewire safety device

Abstract

A guidewire safety device having, a main body component 1 located between a first connector 3 component and a second connector component 4, wherein the second connector component is for connection to

Description

The present invention relates to a guidewire safety device. The device has particular application in preventing retained guidewire events. Background of the Invention When treating patients having a variety of medical conditions it is often necessary to insert a catheter through the patient's skin into a blood vessel or a body cavity to facilitate delivery of treatment (drugs via a catheter into a central vein, draining of an abscess in the abdomen or chest etc.), and / or achieve accurate monitoring of the patient's physiology (central venous pressure measurements, arterial pressure measurements, cardiac output measurement etc.). The standard procedure for inserting this sort of catheter is a known as the Seidinger technique. In this procedure a needle is used to puncture the target blood vessel or body cavity, and a soft ended guidewire threaded through the needle into the blood vessel or body cavity so that part of the guidewire is in the patient, and the remaining part of the guidewire is outside the patient. The needle is then withdrawn over the guidewire leaving the guidewire in the blood vessel or body cavity. A catheter is then threaded over the wire which guides the catheter into the blood vessel or body cavity. Finally, the guidewire is withdrawn, leaving the catheter in the desired body location. The known Seidinger technique is shown in the Figure 19 (courtesy of Shah R and www.slideshare.net). Although the Seidinger technique is the 'gold standard' for percutaneous insertion of a catheter into a blood vessel or body cavity, the procedure is associated with a risk of guidewire retention in the patient which can cause serious complications. In the case of central venous catheter insertion, retained guidewires have been reported to cause cardiac arrhythmias, thrombosis, cardiac perforation and cardiac tamponade, with a reported mortality rate of up to 20% (1, 2). This is a commonly performed procedure with an estimated 5 million central venous catheters inserted per annum in the US, and an estimated incidence of retained guidewire events of approximately 1 in every 3000 procedures (3). Given the serious consequences, retained guidewire events have been designated as a "Never Event" in both the US and UK. A "Never Event" is a serious, preventable patient safety incident that should not occur. Despite this, there were 30 reports of retained guidewires following Seidinger procedures in the UK between 1st April 2019 and 29th February 2020, of which 14 were following insertion of a central venous catheter(4). The primary reason for retained guidewire events following catheter insertion using the Seidinger technique is human error. The literature describes operator inattention, distraction, and inexperience, together with inadequate supervision, high workloads, and staff fatigue as potential causes (5-7). Despite systems being put in place to address these issues such as better training, adequate supervision, checklists and equipment checks following the procedure, the incidence of retained guidewires continues to rise. This is largely because removal of the guidewires still relies on the human operator to remember to do so, and solutions that rely solely on the operator preventing mistakes are unlikely to be completely effective. Retained guidewires during the central venous catheter placement occur at a "critical point" in the Seidinger procedure. This is when the catheter is placed over the guidewire (8). It is at this point that clinicians can forget that the guidewire has not been removed and, without realizing this, continue to advance the catheter and finish the procedure by securing the catheter in place. Retention of the guidewire is then only discovered on or after a check X-ray. It is likely that the 'critical point' for guidewire retention during other types of Seidinger procedures is the same as for central venous catheter insertion. A number of strategies have been developed and / or proposed to reduce or prevent retained guidewire events. Based on the concept of safety engineering, these have focused on either amending the Seidinger procedure by introducing additional steps to increase safety, or modifying the equipment used to perform catheter insertion. For example, Venner's WireSafe is an engineered solution which prevents completion of the central venous catheter insertion procedure without removing the guidewire. This consists of a locked box which contains the suture, suture holder, and antimicrobial dressing required to secure the central venous catheter. The box can only be opened using the guidewire as a key. It is inserted into the lock, and remaining inside the lock, is used as a handle to open the lid of the locked pack to allow the operator to access the suture, suture holder, and antimicrobial dressing. Therefore, the only way in which the operator can access the contents to complete the procedure is by first removing the guidewire from the patient after the "critical point". This ensures that clinicians remember to remove the guidewire because they are unable to complete the procedure without doing so. However, Venner's WireSafe suffers from the problems that it introduces additional steps to the Seidinger procedure which adds time to the procedure, and an additional step for clinicians. It still relies on the operator to adhere to the procedure protocol and has therefore not completely removed the element of human error from the procedure. It would not prevent guidewire retention in a clinical situation where two or more catheter packs are opened. This happens in two scenarios. The first is where there is a planned insertion of multiple central venous catheters within the same procedure, with the use of multiple kits. The second is where there has been difficulty in catheter insertion with the first kit, and a second kit is opened. Venner's WireSafe also has considerable cost implications. In view of this, alternative solutions have been sought these are divided into 2 main groups: Firstly, there are publications which describe different ways the guidewire could be modified to prevent its retention. These include different shaped wires, and wires that have some form of impediment structure such as a collapsible shape along its length, both of which would theoretically prevent migration of the guidewire into the patient if it was retained in the catheter. However, modifying the shape of the guidewire presents usability and safety issues because a bend in a guidewire is likely to make the wire more difficult to handle during a surgical procedure. In addition, a bend in the wire such as spiral is likely to result in the end of the guidewire rotating as the catheter is advanced over the wire. The rotating end of the wire is in the patient, and rotation of the guidewire tip could damage surrounding tissues and cause significant complications. Secondly, there are publications which describe other locking mechanisms. For example, US8992480 describes a locking mechanism on the end of a central venous catheter, and outlines a number of different designs for achieving this. The document discloses a locking mechanism which must be activated by the operator i.e., with finger compression or other means. However, this manual control of the locking mechanism enables bidirectional travel of the guidewire through their device, and relies on the operator to activate the device to lock the guidewire in place. WO2022 / 090736 discloses another locking mechanism, which provides the advantage of automatically gripping a guidewire allowing only unidirectional wire movement through the mechanism. Movement of the guidewire into the patient is prevented by a self-activating mechanism which is triggered by movement of the wire itself. However, the mechanism prevents adjustment of the position of a catheter relative to the guidewire and this can be important for finely adjusting the position in a patent. In view of the above, there is a need for a new guidewire safety device which will assist in negating retained guidewire events and which will allow fine adjustment of the position of a catheter relative to a guidewire when necessary. Remarkably, this has now been achieved by a device incorporating a guidewire locking mechanism together with a releasing mechanism at the external end of a catheter. The device can be attached (for example, by a manufacturer of a catheter) to the end of a catheter channel that transmits the guidewire during insertion, but detachable from the catheter once a surgical procedure has been completed. Summary of the Invention In accordance with a first aspect of the present invention there is provided a guidewire safety device which comprises a main body component located between a first connector component and a second connector component, wherein the second connector component is for connection to a catheter and the main body component houses a means for gripping a guidewire and a separate means for releasing the guidewire. Preferably, the means for gripping a guidewire includes a gripper. Preferably, the gripper is moveable between a first, engaged configuration and a second, disengaged configuration. In the engaged configuration, the gripper allows free movement of a guidewire outwards towards the first connector component from the second connector component, but it grips the guidewire preventing movement of the guidewire through the device in the opposite direction. In the disengaged configuration, the gripper allows free movement of a guidewire through the device outwards towards the first connector from the second connector component as well as in the opposite direction. Preferably, in the engaged configuration, the gripper is biased to grip a guidewire without requiring operator intervention if the guidewire is pulled or pushed through the device from the first connector component towards the second connector component. In addition, preferably, in the engaged configuration the gripper is biased to release the guidewire without requiring operator intervention if the guidewire is pulled or pushed through the device from the second connector component towards the first connector component. Therefore, in the engaged configuration, the gripper allows only unidirectional travel of the guidewire, whereas in the disengaged configuration the gripper allows free travel of the guidewire through the device in either direction. In other words, in use, in the engaged configuration, the gripper allows free movement of a guidewire away from a patent relative to the device, but the gripper is capable of gripping the guidewire restricting its movement relative to the device if the guidewire is moved through the device towards a patent relative to the device. Preferably, in the engaged configuration, the gripper is biased to grip a guidewire automatically locking onto the guidewire and preventing movement of the guidewire through the device only in the direction towards the second connector from the main body component. Preferably, this is achieved by the gripper exerting force on the guidewire at all times. Preferably, the force is minimal when the guidewire is stationary relative to the device or when the guidewire is moved through the device towards the first connector from the main body component. Preferably, friction between the gripper and the guidewire automatically results in the gripper being placed in an engaged configuration when the guidewire is moved through the device only in the direction towards the second connector from the main body component. Preferably, the gripper is selected from a clamp ball, a collet, one or more barbs, a cam lock and a blade. Most preferably, the gripper is a clamp ball. Preferably, a single gripper is provided. For example, one embodiment of the invention includes only one clamp ball. Preferably, in the engaged configuration, the gripper locks automatically onto a guidewire if the guidewire is moved in the direction of a patient relative to the device. This provides the advantage of removing any reliance on the operator prevent guidewire retention i.e. removing human error. Preferably, in the engaged configuration, the gripper is capable of effectively locking onto central venous catheter guidewires having different diameters without any modification to the gripper. Preferably, in the engaged configuration, the gripper is capable of effectively locking movement of a guidewire relative to the device regardless of orientation of the device. Preferably, in the engaged configuration, the gripper is capable of effectively locking movement of a guidewire relative to the device even if the guidewire or gripper are coated in saline, blood or other body fluid. Preferably, the gripper can be modified (scaled) to effectively lock movement of any guidewire used in any Seidinger procedure, not just central venous catheter insertion. Preferably, the means for releasing the guidewire includes a releaser. Preferably, the releaser is moveable between a first inactive, configuration and a second, active configuration. Preferably, in the inactive configuration the releaser does not act on the gripper and the gripper is in an engaged configuration. Preferably, in the active configuration the releaser acts on the gripper to place it in a disengaged configuration thereby disengaging the gripper and allowing free movement of a guidewire through the device outwards towards the first connector component from the second connector component as well as in the opposite direction. Preferably, the releaser is selected from a rotary collar, a longitudinal slider, a radial slider, a tapered post, a cam, and a pin. In this regard, preferably, the releaser selected depends on the selection of the gripper. Preferably, if the gripper comprises a clamp ball, the releaser comprises a rotary collar or a longitudinal slider, which are capable of disengaging the clamp ball from a guidewire. Preferably, if the gripper comprises a collet, the releaser comprises a radial slider which is capable of pushing against the collet and disengaging it from a guidewire. Preferably, if the gripper comprises one or more barbs, the releaser comprises a tapered post, which is capable of pushing against the barbs and disengaging the barbs from a guidewire. Preferably, if the gripper comprises a first cam, the releaser comprises a second cam, which is capable of pushing against the first cam and disengaging it from a guidewire. Preferably, if the gripper comprises a blade, the releaser comprises a pin for pushing against the blade and disengaging it from a guidewire. In one embodiment, the gripper comprises a clamp ball and the releaser comprises a rotary collar. Preferably, the rotary collar comprises an annular body and a flange which projects radially inwardly from the body. Rotation of the collar about the longitudinal axis of the body to a first position places the releaser in an inactive configuration wherein the flange does not act on the clamp ball and the clamp ball is placed in an engaged configuration capable of gripping a guidewire. Rotation of the collar about the longitudinal axis of the body to a second position places the releaser in an active configuration wherein the flange acts on the clamp ball and the clamp ball is placed in a disengaged configuration allowing free movement of the guidewire through the device. In a second embodiment, the gripper comprises a clamp ball and the releaser comprises a longitudinal slider. Preferably, the longitudinal slider comprises a member which defines a channel around the clamp ball. Movement of the longitudinal slider longitudinally to a first position places the releaser in an inactive configuration wherein the slider does not act on the clamp ball and the clamp ball is placed in an engaged configuration capable of gripping a guidewire. Movement of the longitudinal slider longitudinally to a second position places the releaser in an active configuration wherein the slider acts on the clamp ball and the clamp ball is placed in a disengaged configuration allowing free movement of the guidewire through the device. In a third embodiment, the gripper comprises a collet and the releaser comprises a radial slider. Preferably, the radial slider comprises a member having a ramped surface. Movement of the radial slider radially to a first position places the releaser in an inactive configuration wherein the ramped surface does not act on the collet and the collet is placed in an engaged configuration capable of gripping a guidewire. Movement of the radial slider to a second position places the releaser in an active configuration wherein the ramped surface acts on the collet and the collet is placed in a disengaged configuration allowing free movement of the guidewire through the device. In a fourth embodiment, the gripper comprises one or more barbs and the releaser comprises a tapered post. Preferably, the barbs are formed on the radially inner surface of a first connector component, which is capable of a bayonet interaction with the main body of the device. In this regard, a seal, which is preferably a Z seal, is located longitudinally between the main body of the device and the first connector component. A flange extends radially outwardly from the first connector component which interacts with a member projecting longitudinally from the main body of the device. Radial rotation of the first connector component relative to the main body of the device to a first radial position results in the flange abutting the member and the releaser is placed in an inactive configuration wherein the barbs are placed in an engaged configuration capable of gripping a guidewire. Rotation of the first connector component about the longitudinal axis of the device to a second position allows the releaser to be placed in an active configuration wherein the member does not interact with the flange, the seal between the first connector component and the main body of the device is capable of being compressed and a tapered post acts on the barbs opening the barbs apart thereby placing the barbs in a disengaged configuration allowing free movement of the guidewire through the device. In a fifth embodiment, the gripper comprises a first cam and the releaser comprises a second cam. Rotation of the second cam to a first position places the releaser in an inactive configuration wherein the second cam does not act on the first cam and the first cam is placed in an engaged configuration capable of gripping a guidewire. Rotation of the second cam to a second position places the releaser in an active configuration wherein the second cam on the first cam and the first cam is placed in a disengaged configuration allowing free movement of the guidewire through the device. In a sixth embodiment, the gripper comprises a blade and the releaser comprises a pin. Preferably, the blade comprises a stainless steel insert in the form of a substantially planar member. Preferably, the pin has a first radially inward end and a second radially outward end defining a button. Preferably, between the first end and the second end, the pin is supported by an arm which extends from the main body of the device and the pin is angled relative to the blade and the axis of the device so that the first end of the pin is capable of pushing against the blade. Movement of the pin to a first position places the releaser in an inactive configuration wherein the pin does not act on the blade and the blade is placed in an engaged configuration capable of gripping a guidewire. Movement of the pin radially inwardly relative to the main body to a second position places the releaser in an active configuration wherein the pin acts on the blade and the blade is placed in a disengaged configuration allowing free movement of the guidewire through the device. Preferably, the main body is manufactured by injection moulding or ultrasonic welding of a plastics material. Preferably, the plastics material is selected from ABS, polypropylene or polycarbonate. Preferably, it is colourless or clear. Advantageously, this allows the user to have full visibility of the guidewire and procedural fluids. Preferably, the main body has longitudinal length between the first connector component and the second connector component of about 20mm to about 25mm. Preferably, the main body has a maximum outside diameter of about 8mm. Preferably, the main body has an internal empty volume of about 20mm3 to about 136mm3. Preferably, an end of the main body adjacent to the second connector component has a shallow external inclusive angle about 3.4° of the outside profile. Advantageously, this provides a secure leak free taper fit to a mating catheter. Preferably, the first connector component comprises a Luer hub component for connection to a Luer hub. Preferably the first connector component is manufactured by injection moulding plastics materials such as polypropylene, polycarbonate or ABS. Preferably, the first connector component has a longitudinal length of about 10mm to about 15mm. Preferably, the first connector component has a maximum outside diameter of about 8mm. Preferably, the first connector component is bonded to the main body component by either press fit retention, or using one or more bonding adhesives. Preferably, the first connector component has an end for connection to a syringe. In this regard, preferably, the first connector component has an internal taper feature (which conforms to syringe manufacturing standards) that allows connection to a standard syringe, and / or a locking screw feature on the top of the first connector component (conforming to syringe manufacturing standards) which allows a syringe to be screwed to the component. Preferably, the first connector component is compatible with both locking and slip style syringes. Preferably, the first connector component has a lumen having a diameter of about 0.8mm to about 1mm, which is greater than that of the guidewire which allows for free unrestricted movement of the guidewire through the component. Preferably, the second connector component comprises a locking sleeve component for connection to a catheter. The second connector component is preferably manufactured by injection moulding plastic materials such as polypropylene, polycarbonate or ABS. Preferably, the second connector component has a longitudinal length of about 10mm to about 15mm, more preferably about 12.7mm. Preferably, the second connector component has a maximum outside diameter of about 10mm to about 12mm, more preferably 11mm. Preferably, the second connector component is press fitted on to the main body component, and is preferably retained by a barb feature which is present on the main body component. Preferably, the second connector component moves freely in a rotational direction around the main body. Advantageously, this allows for securing to the catheter without causing rotation movement of the assembly. Preferably, an internal thread is present in the internal bore of the second connector component (manufactured in line with syringe manufacturing standards) which allows for a secure screw connection to a catheter. Preferably, the device defines at least one lumen which extends through the main body component, first connector component and second connector component for allowing flushing fluid through the device. The lumen allows free passage of fluids through the device. This provides the advantage of enabling a catheter with the device attached to be used to administer fluids, or drain effluent. In one embodiment, preferably the lumen comprises a plurality of fenestrations between the gripper and an inner wall of the main body. Advantageously, in the engaged configuration, the gripper allows a guidewire to move freely through it in one direction, but automatically grips and locks the guidewire if it is moved in the opposite direction. This allows the catheter to be threaded over the guidewire and freely advanced into the blood vessel or body cavity in the patient. It also allows withdrawal of the guidewire from the catheter and out of the patient once the catheter is in position. However, once the external end of the guidewire has been threaded through the gripper, it is not possible for the guidewire to be accidentally pushed back into the patient, nor would it be able to migrate into the patient if accidentally left in the lumen of the catheter at the end of the procedure. In addition, advantageously, in the disengaged configuration, the gripper allows a guidewire to move freely through the device in either direction. This allows an operator to finely adjust the position of a guidewire relative to a catheter in either direction if necessary. In use, after finely adjusting the position of a guidewire relative to a catheter, the gripper can be returned to the engaged configuration. The invention provides the advantages of an engineered safety solution thereby removing the potential for human operator error as the locking mechanism activates automatically. In addition, the invention provides the advantage of enabling an operator to finely adjust the position of a guidewire relative to a catheter in either direction. The device of the invention is relatively easy to engineer and manufacture; it has a low cost; it is safe in scenarios when multiple catheter packs are open; it has a single locking mechanism design, a single release mechanism design, and size can be used with all current diameters of central venous catheter guidewire; and the device can be modified for use on all catheters (not just central venous catheters) inserted using the Seidinger technique to prevent accidental guidewire retention events. The present invention provides the advantage of allowing only unidirectional guidewire movement relative to the device when the gripper is in the engaged configuration. In this configuration, in all embodiments of the invention, movement of the wire into the patient is prevented by a self-activating and self-releasing mechanism which is triggered by movement of the wire itself. No separate mechanical switch is required. In the event that an operator forgets to remove a guidewire once a catheter or drain has been put in place it provides the advantage of mitigating risk to the patient. Brief Description of the Drawings The invention will now be further described with reference to the accompanying drawings in which: Figures 1 to 3 show views of a first embodiment of the invention; Figure 1 shows a side view of this embodiment showing the gripper in the engaged configuration and the releaser in the inactive configuration and sectional views of A-A and B-B identified in the side view; Figure 2 shows a side view of this embodiment showing the gripper in the disengaged configuration and the releaser in the active configuration and sectional views of C-C and D-D identified in the side view; Figure 3 shows perspective and exploded views of this embodiment; Figures 4 to 6 shows a second embodiment of the invention; Figure 4 shows a side view of this embodiment showing the gripper in the engaged configuration and the releaser in the inactive configuration and sectional view of A-A in the side view; Figure 5 shows a side view of this embodiment showing the gripper in the disengaged configuration and the releaser in the active configuration and sectional view of B-B identified in the side view; Figure 6 shows perspective and exploded views of this embodiment; Figures 7 to 9 show views of a third embodiment of the invention; Figure 7 shows a side view of this embodiment showing the gripper in the engaged configuration and the releaser in the inactive configuration and sectional views of A-A and B-B identified in the side view; Figure 8 shows a side view of this embodiment showing the gripper in the disengaged configuration and the releaser in the active configuration and sectional views of C-C and D-D identified in the side view; Figure 9 shows perspective and exploded views of this embodiment; Figures 10 to 12 show views of a fourth embodiment of the invention; Figure 10 shows a side view and a perspective view of this embodiment showing the gripper in the engaged configuration and the releaser in the inactive configuration and sectional view of A-A identified in the side view; Figure 11 shows a side view and a perspective view of this embodiment showing the gripper in the disengaged configuration and the releaser in the active configuration and sectional view of B-B identified in the side view; Figure 12 shows perspective and exploded views of this embodiment; Figures 13 to 15 show views of a fifth embodiment of the invention; Figure 13 shows a top view and a side view of this embodiment showing the gripper in the engaged configuration and the releaser in the inactive configuration and sectional views of A-A, B-B and C-C identified in the top and side views; Figure 14 shows a top and a side view of this embodiment showing the gripper in the disengaged configuration and the releaser in the active configuration and sectional views of D-D, E-E and F-F identified in the top and side views; Figure 15 shows perspective and exploded views of this embodiment; Figures 16 to 18 show views of a sixth embodiment of the invention; Figure 16 shows a top and a side view of this embodiment showing the gripper in the engaged configuration and the releaser in the inactive configuration and sectional views of A-A and B-B identified in the top and side views; Figure 17 shows a top and a side view of this embodiment showing the gripper in the disengaged configuration and the releaser in the active configuration and sectional views of C-C and D-D identified in the side and top views; Figure 18 shows perspective and exploded views of this embodiment; Figure 19 shows the known Seidinger technique. Detailed Description of the Invention It will be appreciated that aspects, embodiments and preferred features of the invention have been described herein in a way that allows the specification to be written in a clear and concise way. However, unless circumstances clearly dictate otherwise, aspects, embodiments and preferred features can be variously combined or separated in accordance with the invention. For example, features of the second and third embodiments described below can be combined. In this regard, for example, a collet mechanism can be combined with barbed arms at the collet / wire interface. This can reduce the force needed to push the wire through the device in the non-locking direction as a larger central hole through the collet can be provided. A combination of barbs gripping the wire and a collet being pulled back into a ramped part of a housing so that the collet exerts a radially inward force on the wire results in stopping movement of the wire relative to the device in an inward direction (towards the patient). Within the context of this specification, the word "about" preferably means plus or minus 20%, more preferably plus or minus 10%, even more preferably plus or minus 5%, most preferably plus or minus 2%. Within the context of this specification, the word "comprises" means "includes, among other things" and should not be construed to mean "consists of only". Within the context of this specification, the word "substantially" means preferably at least 90%, more preferably 95%, even more preferably 98%, most preferably 99%. Within the context of this specification, the term "gripper" is used interchangeably with the term "locking mechanism". Within the context of this specification, the term "releaser" is used interchangeably with the term "releasing mechanism". Within the context of this specification, the term "biased" is preferably interpreted to mean one or more of prearranged, predisposed, weighted, skewed, tending towards, inclined. For example, the term can mean spring-loaded. This can be due to compression of a spring, or compression of a material itself. With reference to figures 1 to 3, in one embodiment, the gripper comprises a clamp ball [2] and the releaser comprises a rotary collar

[13] . The rotary collar

[13] comprises an annular body

[15] and a flange

[14] which projects radially inwardly from the body

[15] . Rotation of the collar

[13] about the longitudinal axis of the body [1] to a first position places the releaser in an inactive configuration wherein the flange

[14] does not act on the clamp ball [2] and the clamp ball [2] is placed in an engaged configuration capable of gripping the guidewire [5]. Rotation of the collar

[13] about the longitudinal axis of the body [1] to a second position places the releaser in an active configuration wherein the flange

[14] acts on the clamp ball [2] and the clamp ball [2] is placed in a disengaged configuration allowing free movement of the guidewire [5] through the device. Between the first position and the second position the rotary collar

[13] moves through an angle in the range of about 45° to about 90° with an optimum movement of about 70°. When the gripper is in an engaged configuration, the guidewire [5] is restricted from moving in the inwards direction by progressively increasing the clamping force provided by a clamp ball on the guidewire via a taper activation method. According to this embodiment, the device is designed to function to its intended use in all orientations including, upright, lay flat or inverted, positions as well as any other orientation in between. As an assembled product, the device is about 31mm in length and securely connects to the Luer hub of a standard catheter, or other catheter connector. When the gripper is placed in an engaged configuration, the device has a central lumen which allows free and unrestricted movement of a guidewire through the centre of the device in one direction (free movement), but the clamp ball automatically grips and locks the guidewire in place preventing movement of the guidewire through the device in the opposite direction (lock). This gripping effect automatically releases on changing the direction of the guidewire movement to outwards. In both the configurations of the embodiment, the design of the device enables bidirectional free flow of fluid through the device. The main body [1] component is preferably manufactured by injection moulding, or ultrasonic welding, of plastics materials such as ABS, polypropylene or polycarbonate. Preferably, the main body component is colourless or clear. Preferably, it has a length of about 22mm and a maximum outside diameter of about 010mm. Preferably, the main body component [1] is translucent, more preferably colourless. Preferably, the main body component [1] has an internal empty volume [6] of about 38.88mm3 which allows a user to have full visibility of the guidewire and procedural fluids though the main body component [1]. The main body component also has an internal shallow convex radius [7] of between about 10mm and 50mm that forms a ramp feature necessary to stop movement of the guidewire towards a patient relative to the device via a direct interaction between the ramp feature and the guidewire, when a force is exerted on the guidewire by the clamp ball. The clamp ball and guidewire are each located in separate adjoined channels

[10] ,

[11] that advantageously prevent the clamp ball entering the guidewire channel. A single channel

[12] receives both the guidewire and the clamp ball. Alternatively, the guidewire is located in guidewire channel

[10] and the clamp ball is located in clamp ball channel

[11] . The clamp ball channel has an adequate size to allow the clamp ball to axially travel along the length of the clamp ball channel. These adjoined channels may have a circular, ovoid or a polygon shape, or any combination of these. The open interface between the two channels has a width of between about 0.5mm to about 2mm. The guidewire channel

[10] and clamp ball channel

[11] have an open interface. The ramp feature may have a smooth or textured surface finish. For example, the texture can be provided by projections and / or indents in the surface of the ramp feature. Advantageously, a textured surface finish promotes friction between the ramp and guidewire. At the lower end of the main body, the body is tapered. A shallow external inclusive angle of about 3.44° of the outside profile is manufactured to provide a secure leak free taper fit to the mating catheter. The clamp ball component [2] is preferably manufactured from plastic materials such as polypropylene, polycarbonate and ABS, or stainless 304 or 316 materials. Preferably a single clamp ball is provided. The clamp ball is housed inside the main body of the device, where it is free to move within a channel

[11] in the main body. The clamp ball has an external diameter of about 1mm to about 3mm and remains in contact with the guidewire in both the locked and unlocked configurations. The clamp ball has a smooth or textured surface finish to enhance friction with the guidewire. For example, the texture can be provided by projections and / or indents in the surface of the clamp ball. The surface of the clamp ball may be textured to promote friction between the clamp ball, the guidewire and the convex ramp feature. In use, when the gripper is in an engaged configuration and when the guidewire is pushed or pulled through the Luer hub in an outwards direction (away from the patient relative to the device) it is directed through a channel though the main body. The clamp ball lightly grips the guidewire via its critically controlled outside diameter but does not provide any resistance to wire movement [8]. In contrast, if the guidewire is pushed in an inwards direction (towards the patient relative to the device), the critically controlled outside diameter of the clamp ball means that the clamp ball lightly grips the guidewire and the guidewire is pulled into the ramp of the main body of the device. On contact with the ramp feature [7] of the main body [1] of the device, the shallow radius of the main body of the ramp feature and the clamp ball component combine to tighten the grip of the clamp ball [2] on the guidewire [5] and this stops movement of the guidewire [5] in the inward direction relative to the device [9]. A first connector component comprises a Luer hub component [3], which is preferably manufactured by injection moulding a plastics material. Preferably the plastics material is selected from polypropylene, polycarbonate or ABS. Preferably, it has a length of about 15mm and a maximum outside diameter of about 10mm is bonded to the main body component by either press fit retention, ultrasonic welding or using bonding adhesives. At its lower end, the Luer hub component [3] has a channel there through having a diameter of about 1mm to about 2mm which is greater than that of the guidewire [5]. This allows for free unrestricted movement of the guidewire through the Luer hub component. The Luer hub component [3] has an internal taper feature (which conforms to syringe manufacturing standards) that allows connection to a standard syringe, and a locking screw feature on the top of the upper end of the Luer hub component [3] (conforming to syringe manufacturing standards) which allows a syringe to be locked to the component. It is intentional that the Luer Hub component is compatible with both locking and slip style syringes. The second connector component comprises a locking sleeve component [4], which is preferably manufactured by injection moulding a plastics material. Preferably, the plastics material is selected from polypropylene, polycarbonate or ABS. Preferably, it has a length of about 12.7mm and a maximum outside diameter of about 11mm is press fitted on to the main body component, and is retained by a barb feature which is present on the main body component [1]. The locking sleeve [4] is able to move freely in a rotational direction around the main body [1] allowing for securing to the catheter without causing rotation movement of the assembly. There is an internal thread present in the internal bore of the locking sleeve (manufactured in line with syringe manufacturing standards) which allows for secure screw connection to the catheter. The device defines at least one lumen

[12] which extends through the main body component, Luer hub component and locking sleeve component for allowing flushing fluid through the device. The lumen

[12] allows free passage of fluids through the device. This provides the advantage of enabling a catheter with the device attached to be used to administer fluids, or drain effluent. In addition, in the event that an operator forgets to remove the device once a catheter or drain has been put in place it provides the advantage of mitigating risk to the patient. Preferably, the lumen

[12] comprises a plurality of fenestrations in the main body. Advantageously, when the gripper is in an engaged configuration, the clamp ball [2] effectively locks the guidewire [5] and stops it from moving in an inward direction (towards the patient) even if the guidewire or clamp ball are coated in saline, blood or other body fluids. Preferably, this embodiment comprises only one clamp ball [2]. Preferably, this embodiment defines separate channels through the device, one channel

[10] for the guidewire and a separate channel

[11] for the clamp ball. This provides the advantage of preventing the clamp ball from obstructing the passage of the guidewire through the device. In addition, the separate channels provide the advantage that the clamp ball moves freely within its recessed channel and is always in contact with the guidewire. The device incorporates a specific taper on the guidewire channel [7], namely a convex curved internal wall, which improves the contact and force between the walls of the main body [1], the ball [2], and the wire [5]. Advantageously, the surface of the ball [2] and sidewalls of the channels in which the ball and guidewire [5] are provided are configured to improve friction between the ball [2] and wire [5] and between the wire [5] and sidewall [7]. With reference to Figures 4 to 6, in a second embodiment the gripper comprises a clamp ball [2] and the releaser comprises a longitudinal slider

[20] . The longitudinal slider [20 ]comprises a member

[21] which defines a channel

[22] around the clamp ball [2], Movement of the longitudinal slider

[20] longitudinally to a first position places the releaser in an inactive configuration wherein the slider

[20] does not act on the clamp ball [2] and the clamp ball [2] is placed in an engaged configuration capable of gripping a guidewire [5]. Movement of the longitudinal slider

[20] longitudinally to a second position places the releaser in an active configuration wherein the slider

[20] acts on the clamp ball [2] and the clamp ball [2] is placed in a disengaged configuration allowing free movement of the guidewire [5] through the device. The slider

[20] travel between the first position and the second position is in the range of about 3.5mm to about 8mm with an optimum travel of about 6.0mm. The slider

[20] is accessible to the user at any time apart from the short time that a flushing syringe is attached. When the gripper is in an engaged configuration, the guidewire [5] is restricted from moving in the inwards direction by progressively increasing the clamping force a ball [2] applies on the guidewire via a taper activation method. The device is designed to function to its intended use in all orientations including, upright, lay flat or inverted, positions as well as any other orientation in between. As an assembled product, the device is about 31mm in length and securely connects to the Luer hub of a standard catheter, or other catheter connector. When the gripper is in an engaged configuration, the device has a central lumen which allows free and unrestricted movement of a guidewire [5] through the centre of the device in one direction (free movement), but automatically grips and locks the guidewire in place preventing movement of the guidewire through the device in the opposite direction (lock). This gripping effect automatically releases on changing the direction of the guidewire [5] movement to outwards. In both the configurations of the device, the design of the device enables bidirectional free flow of fluid through the device. The main body [1] component is preferably manufactured by injection moulding, or ultrasonic welding, of plastics materials such as ABS, polypropylene or polycarbonate. Preferably, the main body component is colourless or clear. Preferably, it has a length of about 22mm and a maximum outside diameter of about 8mm. The main body component has an internal empty volume [6] of about 38.88mm3 which allows the user to have full visibility of the guidewire and procedural fluids. The main body component [1] defines a single channel in which the guidewire and clamp ball are located. The main body component also has an internal shallow radius [7] of about 32mm that forms the ramp feature necessary to activate the clamp ball component. At the lower end of the main body, the shallow external inclusive angle of about 3.4° of the outside profile is manufactured to provide a secure leak free taper fit to the mating catheter. The clamp ball [2] component is manufactured plastic materials such as polypropylene, polycarbonate or ABS, or stainless 304 and 316 materials, and is housed inside the main body of the component, where it will be free to move in a forward and backward direction along the ramp feature in the main body during use. Preferably, a single clamp ball [2] is provided. The clamp ball [2] has a diameter configured so that it remains in contact with the guidewire in both the lock and unlock modes. When the gripper [2] is in an engaged configuration, and when the guidewire [5] is pushed or pulled through the Luer hub [3] in an outwards direction (away from the patient) it is directed through the central hole of the main body [1]. The clamp ball [2] lightly grips the guidewire [5] via its critically controlled outside diameter but does not provide any resistance to wire movement [8]. If the guidewire [5] is pushed in an inwards direction (towards the patient), the critically controlled outside diameter means that the clamp ball [2] will lightly grip the guidewire [5] and be pulled into the ramp [7] of the main body [1] of the device. On contact with the ramp feature [7] of the main body [1] of the device, the shallow radius of the main body of the ramp feature [7] and the clamp ball component [2] combine to tighten the grip of the clamp ball [2] on the guidewire [5] and this stops the movement of the guidewire [5] in the inward direction [9]. The first connector component [3] comprises a Luer hub component [3], which is preferably manufactured by injection moulding a plastics material. Preferably the plastics material is selected from polypropylene, polycarbonate or ABS. Preferably, it has a length of about 11mm and a maximum outside diameter of about 8mm is bonded to the main body component by either press fit retention, or using bonding adhesives. At its lower end, the component has a hole diameter of about 1mm to about 2mm, which is greater than that of the guidewire which allows for free unrestricted movement of the guidewire through the component. The Luer hub component [3] has an internal taper feature (which conforms to syringe manufacturing standards) that allows connection to a standard syringe, and a locking screw feature on the top of the upper end of the component (conforming to syringe manufacturing standards) which allows a syringe to be locked to the component. It is intentional that the Luer Hub component [3] is compatible with both locking and slip style syringes. The second connector component comprises a locking sleeve component [4], which is preferably manufactured by injection moulding a plastics material. Preferably, the plastics material is selected from polypropylene, polycarbonate or ABS. Preferably, it has a length of about 11mm and a maximum outside diameter of about 12.7mm is press fitted on to the main body component, and is retained by a barb feature which is present on the main body component. The locking sleeve [4] is able to move freely in a rotational direction around the main body [1] allowing for securing to the catheter without causing rotation movement of the assembly. There is an internal thread present in the internal bore of the locking sleeve [4] (manufactured in line with syringe manufacturing standards) which allows for secure screw connection to the catheter. The device defines at least one lumen

[12] which extends through the main body component [1], Luer hub component [3] and locking sleeve component [4] for allowing flushing fluid through the device. The lumen

[12] allows free passage of fluids through the device. This provides the advantage of enabling a catheter with the device attached to be used to administer fluids, or drain effluent. In addition, in the event that an operator forgets to remove the device once a catheter or drain has been put in place it provides the advantage of mitigating risk to the patient. Advantageously, when the gripper [2] is in an engaged configuration, the clamp ball [2] effectively locks the guidewire [5] even if the guidewire or clamp ball are coated in saline, blood or other body fluids. With reference to figures 7 to 9, in a third embodiment, the gripper comprises a collet [30 ]and the releaser comprises a radial slider

[31] . The radial slider

[31] comprises a member

[32] having a ramped surface

[33] . Movement of the radial slider

[31] radially to a first position places the releaser in an inactive configuration wherein the ramped surface

[33] does not act on the collet

[30] and the collet

[30] is placed in an engaged configuration capable of gripping a guidewire [5] . Movement of the radial slider

[31] to a second position places the releaser in an active configuration wherein the ramped surface

[33] acts on the collet

[30] and the collet

[30] is placed in a disengaged configuration allowing free movement of the guidewire [5] through the device. The ramped surface

[33] is inclined to the longitudinal axis of the device at an angle of about 10° to about 30°, with an optimum of angle of about 20°. When the gripper

[30] is in an engaged configuration, the guidewire [5] is restricted from moving in the inwards direction by progressively increasing the compression force acting on the guidewire via a collet and taper activation method. According to this embodiment, the device is designed to function to its intended use in all orientations including, upright, lay flat or inverted, positions as well as any other orientation in between. As an assembled product, the device is about 34mm in length and securely connects to the Luer hub of a standard catheter, or other catheter connector. When the gripper

[30] is in an engaged configuration, the device has a central lumen

[12] which allows free and unrestricted movement of a guidewire [5] through the centre of the device in one direction (free movement), but automatically grips and locks the guidewire [5] in place preventing movement of the guidewire through the device in the opposite direction (lock). This gripping effect automatically releases on changing the direction of the guidewire [5] movement to outwards. In both the configurations of the collet

[30] (free movement or locked), the design of the device enables bidirectional free flow of fluid through the device. The main body [1] component is preferably manufactured by injection moulding, or ultrasonic welding, of plastics materials such as ABS, polypropylene or polycarbonate. Preferably, the main body component is colourless or clear. Preferably, it has a length of about 25mm and a maximum outside diameter of about 8mm. The main body component has an internal empty volume [6] of about 136mm3 which allows the user to have full visibility of the guidewire and procedural fluids. The main body component also has an internal shallow angle [7] which tapers at an inclusive angle of about 16° and forms a ramp feature necessary to activate the collet component. The ramp feature [7] is preferably linear, concave, convex or a combination thereof. In the case of a concave or convex ramp feature, the radius of curvature is preferably about 10mm to about 50mm. Advantageously, by providing a ramp feature [7] having a concave or convex face, a shorter clamping response time can be achieved. In a preferred embodiment, the ramp feature [7] has a linear, conical ramp face on the inner wall of the main body [1]. The ramp face [7] is tapered at an inclusive angle of about 16°. The radiused face of the collet

[30] abuts this ramp face and as the collet

[30] is forced to move longitudinally through the main body, force applied by the tapering ramp face of the inner wall of the main body forces causes the collet to grip the guidewire. At the lower end of the main body, the body has a shallow external inclusive angle of about 3.4° of the outside profile is manufactured to provide a secure leak free taper fit to the mating catheter. The collet

[30] component is manufactured by injection moulding plastic materials such as polypropylene, polycarbonate and ABS, and is housed in a specific orientation inside the main body of the component, where it will be free to move in a forward and backward direction during use. The collet has a length of about 4.2mm and a maximum outside diameter of about 5.8mm and has preferably 3 to 5, more preferably 3, leg features equally spaced in a round construction, separated by preferably 3 to 5, more preferably 3, empty spaces of similar size and connected to each other at one or other end of the collet component. A hole of equal or smaller diameter to the specific guidewire, and with a diameter of about 0.5mm is present through the centre of the component. The outside profile of the collet

[30] , has an activation radius of about 9mm. Alternatively, the outside profile of the collet

[30] , has an activation radius of about 2mm. When the gripper is in an engaged configuration, and when the guidewire is pushed or pulled through the Luer hub in an outwards direction (away from the patient) it is directed through the central hole of the collet

[30] . The collet

[30] lightly grips the guidewire [5] via its critically controlled central hole but does not provide any resistance to wire movement. In contrast, if the guidewire is pushed in an inwards direction (towards the patient), the critically controlled central hole means that the collet will lightly grip the guidewire and be pulled into the ramp of the main body of the device. On contact with the ramp feature [7] of the main body [1] of the device, the angle of the main body of the ramp feature [7] and the radius of the collet component

[30] combine to further close the central hole of the collet

[30] . This closing effect tightens the grip of the collet

[30] on the guidewire [5] and stops the movement of the guidewire in the inward direction. The first connector component comprises a Luer hub component [3], which is preferably manufactured by injection moulding a plastics material. Preferably the plastics material is selected from polypropylene, polycarbonate or ABS. Preferably, it has a length of about 11mm and a maximum outside diameter of about 8mm is bonded to the main body component by either press fit retention, or using bonding adhesives. At its lower end, the Luer hub component has a hole diameter of about 1mm to about 2mm, which is greater than that of the guidewire which allows for free unrestricted movement of the guidewire through the Luer hub component. The Luer hub component has an internal taper feature (which conforms to syringe manufacturing standards) that allows connection to a standard syringe, and a locking screw feature on the top of the upper end of the Luer hub component (conforming to syringe manufacturing standards) which allows a syringe to be locked to the Luer hub component. It is intentional that the Luer hub component is compatible with both locking and slip style syringes. The second connector component comprises a locking sleeve component [4], which is preferably manufactured by injection moulding a plastics material. Preferably, the plastics material is selected from polypropylene, polycarbonate or ABS. Preferably, it has a length of about 12.7mm and a maximum outside diameter of about 11mm is press fitted on to the main body component, and is retained by a barb feature which is present on the main body component. The locking sleeve is able to move freely in a rotational direction around the main body allowing for securing to the catheter without causing rotation movement of the assembly. There is an internal thread present in the internal bore of the locking sleeve (manufactured in line with syringe manufacturing standards) which allows for secure screw connection to the catheter. The device defines at least one lumen

[12] which extends through the main body component [1], Luer hub component [3] and locking sleeve component [4] for allowing flushing fluid through the device. The lumen

[12] allows free passage of fluids through the device. This provides the advantage of enabling a catheter with the device attached to be used to administer fluids, or drain effluent. In addition, in the event that an operator forgets to remove the device once a catheter or drain has been put in place it provides the advantage of mitigating risk to the patient. The lumen

[12] comprises a plurality of fenestrations between the collet

[30] and an inner wall of the main body [1]. Advantageously, when the gripper

[30] is in an engaged configuration, the collet

[30] effectively locks the guidewire [5] even if the guidewire or collet are coated in saline, blood or other body fluids. In this embodiment, a single mobile element (the collet

[30] ) is located within a fixed main body [1]. That is to say that the collet [5] is movable in relation to the main body [1]. When the gripper

[30] is in an engaged configuration, interactions between the inner wall of the main body [1] and the outer wall of the collet

[30] result in inward radial forces that alter the force between the inner wall of the collet [30 ]and a guidewire [5]. This force is biphasic in that it automatically increases if the wire [5] is moved towards the patient, gripping the wire [5] and so preventing movement in a direction towards the patient, but reduces when the wire [5] is moved out of the patient and allows free movement of the wire [5]. The embodiment requires multiple features working together to allow this automated release and grip of the guidewire [5]. These include: a. The collet

[30] defines a central aperture that allows passage of wire whilst always maintaining 'light' contact with the wire [5] so that the collet always moves in the direction of the wire [5]. The design of the central aperture and the inner wall of the collet

[30] is such that the wire [5] is freely directed up the collet

[30] and can freely move within the collet

[30] , but that resistive forces between the inner wall of the collet

[30] and wire [5] are maximised when the gripper is in an engaged configuration. b. The inner wall of the main body [1] and the outer wall of the collet

[30] are tapered (linear, concave, convex or any combination thereof) in the direction of the patient. This provides the advantage of causing the collet

[30] to grip the wire [5] when the wire [5] is moved towards the patient relative to the device when the gripper is in an engaged configuration. c. The collet

[30] has a plurality of legs which are pivoted at one end or the other of the collet. Movement of the collet

[30] into the taper provides a radial force onto the legs which then deforms the collet to compress the guidewire within the central aperture - the strength of this force is proportional to the degree of movement of the collet into the taper. Movement of the collet out of the taper releases the legs and thus the guidewire [5]. The stiffness and flexibility of the collet are designed to maximise the activation and release of these compressive forces. d. Advantageously, when the gripper

[30] is in an engaged configuration, the above gripping mechanism is self-activating and self-releasing. No separate switch or mechanism are required. e. Advantageously, the collet

[30] is fenestrated to allow fluids to pass there through and to allow the device to be flushable before use. With reference to Figures 10 to 12, in a fourth embodiment, the gripper comprises one or more barbs

[40] and the releaser comprises a tapered post

[41] . The barbs

[40] are formed on the radially inner surface of a Luer component [3], which is capable of a bayonet interaction with the main body [1] of the device. In this regard, a Z seal

[42] , is located longitudinally between the main body [1] of the device and the first connector component [3]. A flange

[43] extends radially outwardly from the first connector component [3] which interacts with a member

[44] projecting longitudinally from the main body [1] of the device. Radial rotation of the first connector component [3] relative to the main body [1] of the device to a first radial position results in the flange

[43] abutting the member

[44] and the releaser is placed in an inactive configuration wherein the barbs

[40] are placed in an engaged configuration capable of gripping a guidewire [5]. Rotation of the first connector component [3] about the longitudinal axis of the device to a second position allows the releaser to be placed in an active configuration wherein the member

[44] does not interact with the flange

[43] , the seal

[42] between the first connector component [3] and the main body [1] of the device is capable of being compressed and a tapered post

[41] acts on the barbs

[40] opening the barbs

[40] apart thereby placing the barbs

[40] in a disengaged configuration allowing free movement of the guidewire [5] through the device. Rotation of the first connector component [3] and barbs

[40] together from the first position to the second position to allow the seal

[42] to be compressed is in the range of about 15° to about 60° with an optimum angle of about 25°. Axial travel of the first connector component [3] and barbs [together] is in the range of about 0.4mm to about 2.0mm with an optimum distance of about 0.7mm. The inclusive angle of the tapered post

[41] has a range of about 15° to about 40° with an optimal inclusive angle of about 25°. The radius on the end of the tapered post

[41] has a range of about 0.5mm to about 2.0mm with an optimal of about 1.0mm. The inclusive angle of each barb

[40] is in a range of about 25° to about 45° with an optimal inclusive angle of about 36°. When the gripper is in an engaged configuration, the guidewire [5] is restricted from moving in the inwards direction by the injection moulded protruding barbs biting into the guidewire. The device is designed to function to its intended use in all orientations including, upright, lay flat or inverted, positions as well as any other orientation in between. As an assembled product, the device is about 30.7mm in length and securely connects to the Luer hub of a standard catheter, or other catheter connector. When the gripper is in an engaged configuration, the device has a central lumen

[12] which allows free and unrestricted movement of a guidewire [5] through the centre of the device in one direction (free movement), but automatically grips and locks the guidewire [5] in place preventing movement of the guidewire through the device in the opposite direction (lock). This gripping effect automatically releases on changing the direction of the guidewire movement to outwards. In both the configurations of the barb features

[40] , the design of the device enables bidirectional free flow of fluid through the device. The main body [1] component is preferably manufactured by injection moulding, or ultrasonic welding, of plastics materials such as ABS, polypropylene or polycarbonate. Preferably, the main body component is colourless or clear. Preferably, it has a length of about 21.7mm and a maximum outside diameter of about 8mm. The main body component has an internal empty volume [5] of about 90mm3 which allows the user to have full visibility of the guidewire and procedural fluids. At the lower end of the main body, the shallow external inclusive angle about 3.4° of the outside profile is manufactured to provide a secure leak free taper fit to the mating catheter. The first connector component [3] comprises a Luer hub component [3], which is preferably manufactured by injection moulding a plastics material. Preferably the plastics material is selected from polypropylene, polycarbonate or ABS. Preferably, it has a length of about 14mm and a maximum outside diameter of about 8mm is bonded to the main body component by either press fit retention, or using bonding adhesives. At its lower end, the component preferably has about 4 to about 6 barbed features

[40] set at about 50° to about 70° from the centre line of the component. The 4 or 6 barb features

[40] come together to create a hole of equal or smaller diameter to the specific guidewire [5] and with a target hole diameter of about 0.8mm. When the gripper is in an engaged configuration, the barbs

[40] create a light grip on movement of the guidewire [5] in the outwards direction, and these barbed features

[40] deflect out to allow free movement of the guidewire [5]. When the gripper is in an engaged configuration, if the guidewire [5] is pushed in an inwards direction (towards the patient), the barb features bite in to the guidewire [5] which tightens the grip of the barbs

[40] on the guidewire [5] and stops the movement of the guidewire [5] in the inward direction. The angle, shape, thickness and / or flexibility of the barbs

[40] is such that the optimum resistance is applied to the guidewire [5]. The Luer hub component [3] has an internal taper feature (which conforms to syringe manufacturing standards) that allows connection to a standard syringe, and a locking screw feature on the top of the upper end of the component (conforming to syringe manufacturing standards) which allows a syringe to be locked to the component. It is intentional that the Luer hub component [3] is compatible with both locking and slip style syringes. The second connector component [4] comprises a locking sleeve component [4], which is preferably manufactured by injection moulding a plastics material. Preferably, the plastics material is selected from polypropylene, polycarbonate or ABS. Preferably, it has a length of about 12.7mm and a maximum outside diameter of about 11mm is press fitted on to the main body component, and is retained by a barb feature which is present on the main body component. The locking sleeve is able to move freely in a rotational direction around the main body allowing for securing to the catheter without causing rotation movement of the assembly. There is an internal thread present in the internal bore of the locking sleeve (manufactured in line with syringe manufacturing standards) which allows for secure screw connection to the catheter. The device defines at least one lumen

[12] which extends through the main body component [1], Luer hub component [3] and locking sleeve component [4] for allowing flushing fluid through the device. The lumen

[12] allows free passage of fluids through the device. This provides the advantage of enabling a catheter with the device attached to be used to administer fluids, or drain effluent. In addition, in the event that an operator forgets to remove the device once a catheter or drain has been put in place it provides the advantage of mitigating risk to the patient. The lumen

[12] comprises a plurality of fenestrations between the barbed moulding

[40] and an inner wall of the main body [1]. Advantageously, when the gripper is in an engaged configuration, the barbed moulding

[40] effectively locks the guidewire [5] even if the guidewire [5] or barbed moulding

[40] are coated in saline, blood or other body fluids. In this embodiment, a plurality of barbs

[40] , preferably three or more, are positioned around a central channel through which a guidewire [5] can pass. The barbs

[40] are directed away from the patient, and they always maintain light contact with the guidewire [5]. When the gripper

[40] is in an engaged configuration, the guidewire [5] can move freely out of the patient but movement into the patient relative to the device results in a resistive radial force on the wire which prevents further movement. The mechanism is self-activating and releasing. The embodiment requires multiple features working together to allow this automated release and grip of the guidewire [5]. These include: a. Remarkably, the mechanism is made using a single moulding. b. The barb angles, shapes, and flexibility are designed to maximise contact between the barbs

[40] and guidewire [5] when the gripper is in an engaged configuration,, and to provide adequate and rapid grip when the wire moves towards the patient relative to the device when the gripper is in an engaged configuration. c. The design of the barbs

[40] is such that they cannot be inverted by normal clinical forces. d. Advantageously, fenestrations between arms / barbs

[40] are provided to allow fluids to pass there through thereby allowing the device to be flushable before use. e. When the gripper

[40] is in an engaged configuration, and when the wire [5] is moved in one direction (against the arms / barbs

[40] ) the arms / barbs

[40] grip the wire [5], and the stiffness of the material prevents inversion of the arms / barbs

[40] so the wire [5] cannot move. Advantageously, the barbs

[40] are self-activating. No separate switch or mechanism is required. f. Movement of the wire [5] relative to the device in the direction away from the patient opens (or everts or deflects out) the arms / barbs and the wire is released and can move freely. Advantageously, the barbs

[40] are self-releasing. No separate switch or mechanism is required. With reference to Figures 13 to 15, in a fifth embodiment the gripper comprises a first cam

[50] and the releaser comprises a second cam

[51] . Rotation of the second cam

[51] to a first position places the releaser in an inactive configuration wherein the second cam

[51] does not act on the first cam

[50] and the first cam

[50] is placed in an engaged configuration capable of gripping a guidewire [5]. Rotation of the second cam

[51] to a second position places the releaser in an active configuration wherein the second cam

[51] acts on the first cam

[50] and the first cam

[50] is placed in a disengaged configuration allowing free movement of the guidewire [5] through the device. When the gripper is in an engaged configuration, the guidewire [5] is restricted from moving in the inwards direction by progressively increasing the clamping force the cam lock

[50] applies on the guidewire via an involute form moulded on to the sprung Cam

[50] , The device is designed to function to its intended use in all orientations including, upright, lay flat or inverted, positions as well as any other orientation in between. As an assembled product, the device is about 30.2mm in length and securely connects to the Luer hub of a standard catheter, or other catheter connector. When the gripper is in an engaged configuration, the device has a central lumen

[12] which allows free and unrestricted movement of a guidewire [5] through the centre of the device in one direction (free movement), but automatically grips and locks the guidewire [5] in place preventing movement of the guidewire [5] through the device in the opposite direction (lock). This gripping effect automatically releases on changing the direction of the guidewire [5] movement to outwards. In both the configurations of the device, the design of the device enables bidirectional free flow of fluid through the device. The main body [1] component is preferably manufactured by injection moulding, or ultrasonic welding, of plastics materials such as ABS, polypropylene or polycarbonate. Preferably, the main body component is colourless or clear. Preferably, it has a length of about 21.2mm and a maximum outside diameter of about 8mm. The main body component [1] has an internal empty volume of about 40.5mm3 which allows the user to have full visibility of the guidewire and procedural fluids. The main body component [1] also has an internal radius of about 3.2mm that forms the spring housing feature necessary to activate the cam component. At the lower end of the main body [1], the shallow external inclusive angle of about 3.4° of the outside profile is manufactured to provide a secure leak free taper fit to a mating catheter. The cam

[50] component is manufactured plastic materials such as polypropylene, polycarbonate and ABS, and is housed inside the main body of the component, where it is attached by bonding adhesive or press fit in to the internal radius of the main body. Once situated in place, the cam will be free to move in a forward and backward radial motion pivoting from the top of the spring section of the cam. This forward and backward pivoting motion, coupled with the involute radius shape of about 1.4mm situated on the front of the cam has the effect of adjusting the through hole diameter in which the guidewire will run through during use. When the guidewire is pushed or pulled through the first connector component [3] in an outwards direction (away from the patient) it is directed through the central hole

[12] of the main body [1]. The cam component

[50] lightly grips the guidewire [5] on the involute radius via its critically controlled spring pressure, but does not provide any resistance to wire [5] movement. When the gripper

[50] is in an engaged configuration, if the guidewire [5] is pushed in an inwards direction (towards the patient), the involute radius of the cam

[50] means that the it will lightly grip the guidewire [5] and be pulled in a downward rotating motion, where the increasing diameter of the involute radius and the pivot feature of the component

[50] combine to tighten the grip of the cam

[50] on the guidewire [5] and stops the movement of the guidewire [5] in the inward direction. The first connector component [3] comprises a Luer hub component [3], which is preferably manufactured by injection moulding a plastics material. Preferably the plastics material is selected from polypropylene, polycarbonate or ABS. Preferably, it has a length of about 12.7mm and a maximum outside diameter of about 8mm is bonded to the main body component by either press fit retention, or using bonding adhesives. At its lower end, the component has a hole diameter of about 1mm to about 2mm, which is greater than that of the guidewire which allows for free unrestricted movement of the guidewire [5] through the component [3]. The Luer hub component [3] has an internal taper feature (which conforms to syringe manufacturing standards) that allows connection to a standard syringe, and a locking screw feature on the top of the upper end of the component (conforming to syringe manufacturing standards) which allows a syringe to be locked to the component. It is intentional that the Luer Hub component [3] is compatible with both locking and slip style syringes. The second connector component comprises a locking sleeve component [4], which is preferably manufactured by injection moulding a plastics material. Preferably, the plastics material is selected from polypropylene, polycarbonate or ABS. Preferably, it has a length of about 12.7mm and a maximum outside diameter of about 11mm is press fitted on to the main body component, and is retained by a barb feature which is present on the main body component. The locking sleeve [4] is able to move freely in a rotational direction around the main body allowing for securing to the catheter without causing rotation movement of the assembly. There is an internal thread present in the internal bore of the locking sleeve [4] (manufactured in line with syringe manufacturing standards) which allows for secure screw connection to a catheter. The device defines at least one lumen

[12] which extends through the main body component [1], Luer hub component [3] and locking sleeve component [4] for allowing flushing fluid through the device. The lumen

[12] allows free passage of fluids through the device. This provides the advantage of enabling a catheter with the device attached to be used to administer fluids, or drain effluent. In addition, in the event that an operator forgets to remove the device once a catheter or drain has been put in place it provides the advantage of mitigating risk to the patient. Advantageously, when the gripper

[50] is in an engaged configuration, the cam component

[50] effectively locks the guidewire [5] even if the guidewire [5] or cam component

[50] are coated in saline, blood or other body fluids. With reference to Figures 16 to 18, in a sixth embodiment the gripper comprises a blade

[60] and the releaser comprises a pin

[61] . The blade

[60] comprises a stainless steel insert in the form of a substantially planar member

[62] . The pin

[61] has a first radially inward end

[63] and a second radially outward end

[64] defining a button

[65] . Between the first end

[63] and the second end

[64] , the pin

[61] is supported by an arm

[66] which extends from the main body [1] of the device and the pin

[61] is angled relative to the blade

[60] and the axis of the device so that the first end

[63] of the pin

[61] is capable of pushing against the blade

[60] . The angle between the longitudinal axis of the pin

[61] and the longitudinal axis of the device is in the range about 45° to about 80° with an optimum angle of about 65°. Movement of the pin

[61] to a first position places the releaser in an inactive configuration wherein the pin

[61] does not act on the blade

[60] and the blade

[60] is placed in an engaged configuration capable of gripping a guidewire [5]. Movement of the pin

[61] radially inwardly relative to the main body [1] to a second position places the releaser in an active configuration wherein the pin

[61] acts on the blade

[60] and the blade

[60] is placed in a disengaged configuration allowing free movement of the guidewire [5] through the device. The distance of travel of the pin

[61] from the first position to the second position is in the range of about 0.4mm to about 1.2mm with an optimum distance of about 0.8mm. When the gripper is in an engaged configuration, the guidewire [5] is restricted from moving in the inwards direction by a blade

[60] in the form of a stainless steel insert

[62] biting in to the guidewire [5]. The device is designed to function to its intended use in all orientations including, upright, lay flat or inverted, positions as well as any other orientation in between. As an assembled product, the device is about 30.2mm in length and securely connects to the Luer hub of a standard catheter, or other catheter connector. When the gripper is in an engaged configuration, the device has a central lumen

[12] which allows free and unrestricted movement of a guidewire [5] through the centre of the device in one direction (free movement), but automatically grips and locks the guidewire [5] in place preventing movement of the guidewire through the device in the opposite direction (lock). This gripping effect automatically releases on changing the direction of the guidewire movement to outwards. In both the configurations of the clamp, the design of the device enables bidirectional free flow of fluid through the device. The main body [1] component is preferably manufactured by injection moulding, or ultrasonic welding, of plastics materials such as ABS, polypropylene or polycarbonate. Preferably, the main body component is colourless or clear. Preferably, it has a length of about 21.2mm and a maximum outside diameter of about 8mm. The main body component has an internal empty volume of about 23.75mm3 which allows the user to have full visibility of the guidewire and procedural fluids. At the lower end of the main body [1], the shallow external inclusive angle of about 3.4° of the outside profile is manufactured to provide a secure leak free taper fit to a mating catheter. The blade

[60] is in the form of a steel insert component

[62] which is manufactured by stamping and forming metal materials such as stainless steel grades 304 and 316, and is securely housed through either press fit of adhesive bonding in a specific orientation inside the main body [1] of the device. The steel insert

[62] has a height of about 3mm and a component width of about 1.5mm. The angle of the steel insert

[62] to the main body [1] of the device is critically controlled to create a gap between the main body component [1] and steel insert

[62] which is less than that of the diameter of the specific guidewire [5]. The material thickness (about 0.5mm) of the steel insert is finely tuned to act as a spring on the guidewire [5]. When the guidewire is pushed or pulled through the first connector component [3] in an outwards direction (away from the patient) it is directed through the gap feature between the steel insert

[62] and the main body [1]. The steel insert

[62] lightly grips the guidewire [5] via its finely tuned material thickness but does not provide any resistance to wire movement [7]. When the gripper is in an engaged configuration, if the guidewire [5] is pushed in an inwards direction towards the patient, then the finely tuned steel insert

[62] will lightly bite in to the guidewire [5]. When the gripper is in an engaged configuration, this biting effect tightens the grip of the steel insert

[62] on the guidewire [5] and stops the movement of the guidewire in the inward direction. The first connector component [3] comprises a Luer hub component [3], which is preferably manufactured by injection moulding a plastics material. Preferably the plastics material is selected from polypropylene, polycarbonate or ABS. Preferably, it has a length of about 13.7mm and a maximum outside diameter of about 8mm is bonded to the main body component by either press fit retention, or using bonding adhesives. At its lower end, the component [3] has a hole diameter of about 1mm to about 2mm, which is greater than that of the guidewire [5] which allows for free unrestricted movement of the guidewire through the component [3]. The Luer hub component [3] has an internal taper feature (which conforms to syringe manufacturing standards) that allows connection to a standard syringe, and a locking screw feature on the top of the upper end of the component [3] (conforming to syringe manufacturing standards) which allows a syringe to be locked to the component. It is intentional that the Luer hub component is compatible with both locking and slip style syringes. The second connector component [4] comprises a locking sleeve component [4], which is preferably manufactured by injection moulding a plastics material. Preferably, the plastics material is selected from polypropylene, polycarbonate or ABS. Preferably, it has a length of about 12.7mm and a maximum outside diameter of about 11mm is press fitted on to the main body component, and is retained by a barb feature which is present on the main body component [1]. The locking sleeve [4] is able to move freely in a rotational direction around the main body [1] allowing for securing to the catheter without causing rotation movement of the assembly. There is an internal thread present in the internal bore of the locking sleeve

[40] (manufactured in line with syringe manufacturing standards) which allows for secure screw connection to a catheter. The device defines at least one lumen

[12] which extends through the main body component [1], Luer hub component [3] and locking sleeve component [4] for allowing flushing fluid through the device. The lumen

[12] allows free passage of fluids through the device. This provides the advantage of enabling a catheter with the device attached to be used to administer fluids, or drain effluent. In addition, in the event that an operator forgets to remove the device once a catheter or drain has been put in place it provides the advantage of mitigating risk to the patient. Advantageously, when the gripper is in an engaged configuration, the steel insert component

[62] effectively locks the guidewire [5] even if the guidewire [5] or steel insert component

[62] are coated in saline, blood or other body fluids. The above described embodiments have been given by way of example only, and the skilled reader will naturally appreciate that many variations could be made thereto without departing from the scope of the invention. References 1) Williams, TL, Bowdle, AT, Winters, BD, Pavkovic, SD, Szekendi, MK . Guidewires unintentionally retained during central venous catheterization. J Assoc Vase Access 2014; 19:29-34 2) Evans, LV, Dodge, KL . Simulation and patient safety: Evaluative checklists for central venous catheter insertion. Qual Saf Health Care 2010; 19(Suppl 3):142-46 3) Vannucci, A, Jeffcoat, A, Ifune, C, Salinas, C, Duncan, JR, Wall, M . Retained guidewires after intraoperative placement of central venous catheters. Anaesth Analg 2013; 117:102-8 4) NHS England and NHS Improvement. Provisional publication of Never Events reported as occurring between 1 April 2019 and 29 February 2020. Published 30th March 2020. 5) Schummer, W, Schummer, C, Gaser, E, Bartunek, R . Loss of the guidewire: Mishap or blunder? Br J Anaesth 2002; 88:144-6 [Article] [PubMed] 6) Anwari, JS, Imran, S . Retention of central line guidewire. Saudi J Anaesth 2014; 8:443-5 [Article] [PubMed] 7) Pokharel, K, Biswas, BK, Tripathi, M, Subedi, A . Missed central venous guidewires: A systematic analysis of published case reports. Crit Care Med 2015; 43:1745-56 [Article] [PubMed] 8) Mariyaselvam, M, Walters, H, Callan, C, Mathew, K, Jackman, S, Young, P . Guidewire retention: Reported incidence, location and timing of error. Eur J Anaesthesiol 2017; 32(suppl 53):16AP02-12

Claims

1. A guidewire safety device which comprises a main body component located between a first connector component and a second connector component, wherein the second connector component is for connection to a catheter and the main body component houses a means for gripping a guidewire and a separate means for releasing the guidewire.

2. The guidewire safety device of claim 1, wherein the means for gripping a guidewire includes a gripper.

3. The guidewire safety device of claim 2, wherein the gripper is moveable between a first, engaged configuration and a second, disengaged configuration, wherein in the engaged configuration, the gripper allows free movement of a guidewire outwards towards the first connector component from the second connector component, but it grips the guidewire preventing movement of the guidewire through the device in the opposite direction, and in the disengaged configuration, the gripper allows free movement of a guidewire through the device outwards towards the first connector component from the second connector component as well as in the opposite direction.

4. The guidewire safety device of claim 3, wherein in the engaged configuration, the gripper is biased to grip a guidewire without requiring operator intervention if the guidewire is pulled or pushed through the device from the first connector component towards the second connector component.

5. The guidewire safety device of any one of claims 2 to 4, wherein the gripper is selected from a clamp ball, a collet, one or more barbs, a cam lock and a blade.

6. The guidewire safety device of any one of claims 2 to 5, wherein the gripper effectively locks the guidewire even if the guidewire or gripper are coated in saline, blood or other body fluids.

7. The guidewire safety device of any one of the preceding claims, wherein the means for releasing a guidewire includes a releaser.

8. The guidewire safety device of claim 7, wherein the releaser is moveable between a first, inactive configuration and a second, active configuration.

9. The guidewire safety device of claim 8, wherein in the inactive configuration the releaser does not act on the gripper and the gripper is in an engaged configuration.

10. The guidewire safety device of claim 7 or claim 8, wherein in the active configuration the releaser acts on the gripper to place it in a disengaged configuration thereby disengaging the gripper and allowing free movement of a guidewire through the device outwards towards the first connector component from the second connector component as well as in the opposite direction.

11. The guidewire safety device of any one of claims 7 to 10, wherein the releaser is selected from a rotary collar, a longitudinal slider, a radial slider, a tapered post, a cam, and a pin.

12. The guidewire safety device of any one of claims 7 to 11, wherein (a) the gripper comprises a clamp ball and the releaser comprises a rotary collar or a longitudinal slider capable of disengaging the clamp ball from a guidewire; (b) the gripper comprises a collet and the releaser comprises a radial slider which is capable of pushing against the collet and disengaging it from a guidewire; (c) the gripper comprises one or more barbs and the releaser comprises a tapered post, which is capable of pushing against the barbs and disengaging the barbs from a guidewire; (d) the gripper comprises a first cam and the releaser comprises a second cam capable of pushing against the first cam anddisengaging it from a guidewire; or (e) the gripper comprises a blade and the releaser comprises a pin for pushing against the blade and disengaging it from a guidewire.

13. The guidewire safety device of any one of the preceding claims, wherein the main body component is manufactured by injection moulding or ultrasonic welding of a plastics material such as ABS, polypropylene or polycarbonate, which is optionally colourless or clear.

14. The guidewire safety device of any one of the preceding claims, wherein the main body component has length of about 20mm to about 25mm.

15. The guidewire safety device of any one of the preceding claims, wherein the main body component has a maximum outside diameter of about 8mm.

16. The guidewire safety device of any one of the preceding claims, wherein the main body component has an internal empty volume of about 20mm3 to about 136mm3.

17. The guidewire safety device of any one of the preceding claims, wherein an end of the main body component adjacent to the second connector component has a shallow external inclusive angle about 3.4° of the outside profile.

18. The guidewire safety device of any one of the preceding claims, wherein the first connector component comprises a Luer hub component for connection to a Luer hub.

19. The guidewire safety device of any one of the preceding claims, wherein the first connector component is manufactured by injection moulding plastics materials such as polypropylene, polycarbonate or ABS.

20. The guidewire safety device of any one of the preceding claims, wherein the first connector component has a length of about 10mm to about 15mm.

21. The guidewire safety device of any one of the preceding claims, wherein the first connector component has a maximum outside diameter of about 8mm.

22. The guidewire safety device of any one of the preceding claims, wherein the first connector component is bonded to the main body component by either press fit retention, or using one or more bonding adhesives.

23. The guidewire safety device of any one of the preceding claims, wherein the first connector component has an end for connection to a syringe.

24. The guidewire safety device of any one of the preceding claims, wherein the first connector component has an internal taper feature that allows connection to a standard syringe, and / or a locking screw feature on the top of the first connector component which allows a syringe to be screwed to the component.

25. The guidewire safety device of any one of the preceding claims, wherein the first connector component has a lumen having a diameter of about 0.8mm to about 1mm, which is greater than that of the guidewire which allows for free unrestricted movement of the guidewire through the component.

26. The guidewire safety device of any one of the preceding claims, wherein the second connector component comprises a locking sleeve component for connection to a catheter.

27. The guidewire safety device of any one of the preceding claims, wherein the second connector component is preferably manufactured by injection moulding plastic materials such as polypropylene, polycarbonate or ABS.

28. The guidewire safety device of any one of the preceding claims, wherein the second connector component has a length of about 10mm to about 15mm.

29. The guidewire safety device of any one of the preceding claims, wherein the second connector component has a maximum outside diameter of about 10mm to about 12mm.

30. The guidewire safety device of any one of the preceding claims, wherein the second connector component is press fitted on to the main body component, and is optionally retained by a barb feature which is present on the main body component.

31. The guidewire safety device of any one of the preceding claims, wherein the second connector component moves freely in a rotational direction around the main body.

32. The guidewire safety device of any one of the preceding claims, wherein an internal thread is present in the internal bore of the second connector component which allows for a secure screw connection to a catheter.

33. The guidewire safety device of any one of the preceding claims, wherein the device defines at least one lumen which extends through the main body component, first connector component and second connector component for allowing flushing fluid through the device.

34. The guidewire safety device of claim 33, wherein the lumen allows free passage of fluids through the device.

35. The guidewire safety device of claim 33 or 34, wherein the lumen comprises a plurality of fenestrations between the gripper and an inner wall of the main body.A

Images