Devices and methods for decoupling medical tubing connectors

Abstract

A tool for loosening a clave and a hub that are attached to each other in a seized hub-clave joint and / or for connecting a clave and hub to form a hub-clave joint. The tool has a body and one or more grip areas disposed at different positions along the body. Each grip area includes a grip liner. Some or all of the body is deformable or movable when the clave or the hub is positioned within a corresponding one of the grip areas. The grip liner is used, when the body is deformed, to engage against the clave or the hub inserted within one of the grip areas of the tool, such that a user of the tool can rotate the tool about an axis defined by the corresponding grip area to exert a torque on the clave or the hub engaged by the tool, thereby loosening the seized hub-clave joint.

Description

DEVICES AND METHODS FOR DECOUPLING MEDICAL TUBINGCONNECTORSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This patent application claims priority to U.S. Provisional Patent Application Serial Number 63 / 523,701 , filed June 28, 2023, the entire content of which is incorporated by reference herein.STATEMENT OF GOVERNMENT INTEREST

[0002] This invention was made with government support under Grant Number TR004406 awarded by the National Institutes of Health. The government has certain rights in the invention.BACKGROUND

[0003] Every year in the United States, millions of patients will receive prescribed treatments administered through, or removal / irrigation of bodily fluids extracted from, various catheters, feeding tubes, drainage tubes, or other intravenous administration sets. Nurses commonly perform these procedures; however, patients and caregivers often self-administer such treatments and / or replace such feeding or drainage tubes, at home daily or long-term care of a patient is necessary. For example, millions of catheters are used with patients every year. As an example, on average 5 million central venous catheters (CVCs) are placed every year in the United States. Caring for CVCs (or catheters, feeding tubes, etc.) can be stressful, as these patients are often critically ill and at an increased risk of, for example,bloodstream infections. Indeed, in the United States, over 400,000 bloodstream infections occur each year, of which 90% are associated with CVCs, placing these patients at an increased risk of mortality. For patients receiving repeatable infusions, such as total parenteral nutrition (TPN), they, or their at-home caregiver(s) will be required to care for the CVC and administer infusions at home in the same manner as a trained healthcare professional.

[0004] In recent decades a form of secure screw lock technology has advanced the ability to administer treatments by ensuring an air-tight fit between administration sets. For example, needleless claves are often used to provide a secure “screw lock” connection from the hub (the external port of the CVC) to needleless syringes or tubing. This air-tight fit is important as it reduces concerns about accidental disconnections that could lead to loss of medication, risk of air entry, and increased risk of infection. However, this advancement has also increased the difficulty for patients, caregivers, and clinicians in loosening such secure connections after the administration of treatments.

[0005] For infection control purposes, it is recommended that claves and administration sets be changed at regular intervals. Disinfection techniques during scheduled changing of needleless claves and administration sets have been shown to decrease contamination risk. While these techniques are effective at reducing the risk of bloodstream and other infections, additional challenges exist when the “screw lock” connection seizes between male and female ends of different sets of medical tubing, making it difficult, if not impossible, to disconnect the male and female ends from each othermanually (i.e., without the aid of tools). Guidelines are lacking on how to mitigate the challenge that arises when such “screw lock” type connections seize, making it difficult to change the clave or tubing set. This difficulty is thought to be the result of the medication that travels through the ’’screw lock” connection building up and drying in / around this “screw lock” connection, as well as to the performance of the recommended disinfection techniques on / to such “screw lock” connections. The accumulation and drying of residue from bodily fluids is also thought to play a role in the seizing of such “screw lock” connections.

[0006] At present, there are limited solutions that address this problem and current literature and guidelines regarding the challenges and workarounds are sparse. The lack of resources and the use of such workarounds can add to the stress already associated with caring for a patient with a catheter. Therefore, a need exists for providing a tool designed for disconnecting a seized “screw lock” connection that will not result in any damage to either the clave (i.e., the female connector part) or the hub (i.e., the male connector part) of a catheter, such as for example and without limitation, a CVC, which often happens at present when known workarounds are used.SUMMARY

[0007] According to an example embodiment, a tool for loosening a clave and a hub that are attached to each other in a seized hub-clave joint and / or for connecting the clave and the hub to form such a hub-clave joint is provided. This tool comprises a body and one or more grip areas disposed atdifferent positions along the body. In some or all embodiments of the tool disclosed herein, each grip area of the one or more grip areas comprises a grip liner. In some or all embodiments of the tool disclosed herein, at least a portion or more of the body is deformable or movable when the clave or the hub is positioned within a corresponding grip area of the one or more grip areas. In some or all embodiments of the tool disclosed herein, wherein the grip liner is configured such that, when at least a portion or all of the body is deformed, squeezed and / or moved, an inner diameter, defined by a distance between opposing points on an inner surface of the grip liner for each of the one or more grip areas, of the one or more grip areas is decreased. In some or all embodiments of the tool disclosed herein, as a result of the inner diameter of the corresponding grip area decreasing, the inner surface of the grip liner of the corresponding grip area directly contacts and is compressed against the clave or the hub positioned within the corresponding grip area, such that a user can rotate the tool about an axis defined by the corresponding grip area to exert a torque on the clave or the hub positioned in the corresponding grip area for loosening the seized hub-clave joint.

[0008] In some or all embodiments of the tool disclosed herein, the body comprises two arms that are attached, at a respective proximal end thereof, to a hinge, such that the two arms are pivotable about the hinge relative to each other; the body has an open end between a respective distal end of the two arms, by which the clave or the hub is positioned within the corresponding grip area; the hinge defines the body as having a closed end, opposite the open end; the one or more grip areas is a plurality of grip areas;and all of the plurality of grip areas are spaced apart from each other along a length of the body.

[0009] In some or all embodiments of the tool disclosed herein, a first grip area of the plurality of grip areas is formed at least partially within the hinge, such that the hinge extends circumferentially around the first grip area; and, optionally, all of the plurality of grip areas, other than the first grip area, are defined by recesses formed into the two arms, each of the recesses being in a shape of an arc segment.

[0010] In some or all embodiments of the tool disclosed herein, all of the plurality of grip areas are defined by recesses formed into the two arms, each of the recesses being in a shape of an arc segment.

[0011] In some or all embodiments of the tool disclosed herein, the tool comprises: a clamping ridge formed on each of the first and second arms, the clamping ridge on the first arm being coplanar with, and at a same distance from the hinge as, the clamping ridge on the second arm; the clamping ridge on the first arm and the clamping ridge on the second arm are configured, when the first arm and the second arm are pressed together by a sufficiently strong force, to deform a tube or lumen positioned between the clamping ridge of the first arm and the clamping ridge of the second arm to stop a flow of a fluid through the tube or lumen; and a lock configured to, when the first arm and the second arm have been pressed together by a force that causes the clamping ridge of the first arm and the clamping ridge of the second arm to stop the flow of the fluid through the tube or lumen, resist a separation movement of the first and second arms away from each other, such that the flow of the fluid through the tube or lumen remainsstopped until the first and / or second arms are moved in a disengagement direction to disengage the lock.

[0012] In some or all embodiments of the tool disclosed herein, the body comprises a handle region, an extension region, and a grip region; the one or more grip areas comprises an outer grip area in the grip region; the handle region comprises a first handle and a second handle, by which a user is configured to manipulate the tool; the extension region comprises a first arm and a second arm; the first arm is connected between the grip region, at a first end of the outer grip area, and the handle region, at the first handle; the second arm is connected between the grip region, at a second end of the outer grip area, and the handle region, at the second handle; the first and second handles are spaced apart from each other to define an open end of the tool; when the tool is in an undeformed state, the first arm and the second arm are spaced apart from each other to form a channel, the channel extending continuously from the open end into the outer grip area; the outer grip area has a C-shaped profile; and when the user squeezes the first and second handles together, the inner diameter of the outer grip area decreases.

[0013] In some or all embodiments of the tool disclosed herein, the tool comprises a hub grip insert that is pivotably attached to the body at an insert hinge, the hub grip insert being pivotable between an engagement position, in which the hub grip insert is positioned radially within the outer grip area, such that the hub grip insert defines an inner grip area therein, and a nonengagement position, in which the hub grip insert is positioned to that no portion of the hub grip insert is within the outer grip area, wherein: the hubgrip insert is smaller than and has a same profile shape as the outer grip area, such that the inner grip area of the hub grip insert is, when in the engagement position, concentrically located within the outer grip area; the hub grip insert comprises, on an inner surface of the inner grip area, a grip liner that comprises a same material as the grip liner of the one or more grip areas; the inner diameter of the inner grip area is substantially similar to the outer diameter of the hub when the tool is in an undeformed state; and the inner diameter of the outer grip area is substantially similar to the outer diameter of the clave when the tool is in the undeformed state.

[0014] In some or all embodiments of the tool disclosed herein, the plurality of grip areas comprises: at least one grip area that has an inner diameter that is substantially similar to an outer diameter of the clave; and at least one further grip area that has an inner diameter that is substantially similar to an outer diameter of the hub.

[0015] In some or all embodiments of the tool disclosed herein, each of the grip liners comprises silicone.

[0016] In some or all embodiments of the tool disclosed herein, each of the grip liners comprises a substantially smooth surface or a substantially ribbed surface.

[0017] In some or all embodiments of the tool disclosed herein, the tool comprises, formed in the body, a clamp that is configured to stop a flow of a fluid through a tube or catheter attached to the clave and / or the hub.

[0018] In some or all embodiments of the tool disclosed herein, the body comprises, on an outer surface thereof, a gripping portion that aids the user to grasp and manipulate the tool during use.

[0019] According to another example embodiment, a method of loosening a clave and a hub that are attached to each other in a seized hub-clave joint and / or for connecting the clave and the hub to form such a hub-clave joint is provided. The method comprises providing one or more tools, each of which comprises a body and one or more grip areas disposed at different positions along the body. For these tools, each grip area of the one or more grip areas comprises a grip liner. The method further comprises inserting the clave or the hub within a corresponding grip area of the one or more grip areas of the one or more tools and deforming, squeezing and / or moving at least some of the body of the at least one tool to grasp the clave or the hub. For each of the tools, the grip liner is configured such that, when the body is deformed, squeezed and / or moved, an inner diameter, defined by a distance between opposing points on an inner surface of the grip liner for each of the one or more grip areas, of the one or more grip areas is decreased; and, as a result of the inner diameter of the corresponding grip area decreasing, the inner surface of the grip liner of the corresponding grip area directly contacts and is compressed against the clave or the hub positioned within the corresponding grip area. The method further comprises rotating the tool about an axis defined by the corresponding grip area to exert a torque on the clave or the hub positioned in the corresponding grip area for loosening the seized hub-clave joint.

[0020] In some or all embodiments of the method disclosed herein, the body comprises two arms that are attached, at a respective proximal end thereof, to a hinge, such that the two arms are pivotable about the hinge relative to each other; the body has an open end between a respective distalend of the two arms, by which the clave or the hub is positioned within the corresponding grip area; the hinge defines the body as having a closed end, opposite the open end; the one or more grip areas is a plurality of grip areas; and all of the plurality of grip areas are spaced apart from each other along a length of the body.

[0021] In some or all embodiments of the method disclosed herein, a first grip area of the plurality of grip areas is formed at least partially within the hinge, such that the hinge extends circumferentially around the first grip area; and, optionally, all of the plurality of grip areas, other than the first grip area, are defined by recesses formed into the two arms, each of the recesses being in a shape of an arc segment.

[0022] In some or all embodiments of the method disclosed herein, all of the plurality of grip areas are defined by recesses formed into the two arms, each of the recesses being in a shape of an arc segment.

[0023] In some or all embodiments of the method disclosed herein, the tools comprise a clamping ridge formed on each of the first and second arms, the clamping ridge on the first arm being coplanar with, and at a same distance from the hinge as, the clamping ridge on the second arm. The clamping ridge on the first arm and the clamping ridge on the second arm are configured, when the first arm and the second arm are pressed together by a sufficiently strong force, to deform a tube or lumen positioned between the clamping ridge of the first arm and the clamping ridge of the second arm to stop a flow of a fluid through the tube or lumen. The tools further comprise a lock configured to, when the first arm and the second arm have been pressed together by a force that causes the clamping ridge of the first armand the clamping ridge of the second arm to stop the flow of the fluid through the tube or lumen, resist a separation movement of the first and second arms away from each other, such that the flow of the fluid through the tube or lumen remains stopped until the first and / or second arms are moved in a disengagement direction to disengage the lock.

[0024] In some or all embodiments of the method disclosed herein, the body comprises a handle region, an extension region, and a grip region; the one or more grip areas comprises an outer grip area in the grip region; the handle region comprises a first handle and a second handle, by which a user is configured to manipulate the tool; the extension region comprises a first arm and a second arm; the first arm is connected between the grip region, at a first end of the outer grip area, and the handle region, at the first handle; the second arm is connected between the grip region, at a second end of the outer grip area, and the handle region, at the second handle; the first and second handles are spaced apart from each other to define an open end of the tool; when the tool is in an undeformed state, the first arm and the second arm are spaced apart from each other to form a channel, the channel extending continuously from the open end into the outer grip area; the outer grip area has a C-shaped profile; and, when the first and second handles are moved or squeezed together, the inner diameter of the outer grip area decreases.

[0025] In some or all embodiments of the method disclosed herein, the tools comprise a hub grip insert that is pivotably attached to the body at an insert hinge, the hub grip insert being pivotable between an engagement position, in which the hub grip insert is positioned radially within the outergrip area, such that the hub grip insert defines an inner grip area therein, and a nonengagement position, in which the hub grip insert is positioned to that no portion of the hub grip insert is within the outer grip area, wherein: the hub grip insert is smaller than and has a same profile shape as the outer grip area, such that the inner grip area of the hub grip insert is, when in the engagement position, concentrically located within the outer grip area; the hub grip insert comprises, on an inner surface of the inner grip area, a grip liner that comprises a same material as the grip liner of the one or more grip areas; the inner diameter of the inner grip area is substantially similar to the outer diameter of the hub when the tool is in an undeformed state; and the inner diameter of the outer grip area is substantially similar to the outer diameter of the clave when the tool is in the undeformed state.

[0026] In some or all embodiments of the method disclosed herein, the plurality of grip areas comprises at least one grip area that has an inner diameter that is substantially similar to an outer diameter of the clave; and at least one further grip area that has an inner diameter that is substantially similar to an outer diameter of the hub.

[0027] In some or all embodiments of the method disclosed herein, each of the grip liners comprises silicone.

[0028] In some or all embodiments of the method disclosed herein, each of the grip liners comprises a substantially smooth surface or a substantially ribbed surface.

[0029] In some or all embodiments of the method disclosed herein, providing the one or more tools comprises providing at least a first tool and a second tool, the method comprising inserting the clave within acorresponding grip area of the one or more grip areas of the first tool; inserting the hub within a corresponding grip area of the one or more grip areas of the second tool; deforming, squeezing and / or moving at least some of the body of the first tool to grasp the clave; deforming, squeezing and / or moving at least some of the body of the second tool to grasp the hub; and rotating the first tool relative to the second tool to loosen the seized hubclave joint.

[0030] In some or all embodiments of the method disclosed herein, the body comprises a clamp that can stop a flow of a fluid through a tube or catheter attached to the clave and / or the hub.

[0031] In some or all embodiments of the method disclosed herein, the body comprises, on an outer surface thereof, a gripping portion that aids the user to grasp and manipulate the tool during use.BRIEF DESCRIPTION OF THE DRAWINGS

[0032] One or more example embodiments of the disclosed devices are described herein, with reference to the accompanying drawings, in which:

[0033] FIG. 1 is a schematic reference view of an example embodiment of a catheter with one or more hubs for induction of fluids into the catheter for administration to a patient.

[0034] FIG. 2 shows a hub-clave joint, which is a threaded joint for connecting a clave to a hub of a catheter in a fluid-tight manner.

[0035] FIG. 3 is an isometric view of a first example embodiment of a hub-clave tool configured to grasp and allow the application of torque toeither a hub or a clave to allow for loosening and disconnection of a seized hub-clave joint.

[0036] FIG. 4 is an isometric view of a second example embodiment of a hub-clave tool that is generally similar to the hub-clave tool shown in FIG. 3, but in which the grip liners have ridges formed on a contact surface thereof.

[0037] FIG. 5A is a side view of a third example embodiment of a hubclave tool.

[0038] FIG. 5B is an isometric view of the hub-clave tool shown in FIG. 5A.

[0039] FIG. 6A is a side view of a fourth example embodiment of a hubclave tool.

[0040] FIG. 6B is an isometric view of the hub-clave tool shown in FIG. 6A.

[0041] FIG. 7 is an isometric view showing a plurality of the hub-clave tools shown in FIG. 3 that are arranged for use unscrewing a clave from a hub at a seized hub-clave joint.

[0042] FIG. 8 is a perspective view of a fifth example embodiment of a hub-clave tool shaped similarly to scissors, at least in part.

[0043] FIGS. 9 and 10 are respective perspective views of a sixth example embodiment of a hub-clave tool shaped similarly to scissors, at least in part.

[0044] FIG. 11 is a side plan view of the hub-clave tool shown in FIGS. 9 and 10, in which the hub grip insert is in an extended position.

[0045] FIG. 12A shows the hub-clave tool shown in FIGS. 9-11 , the hubclave tool being engaged with a clave of a hub-clave joint.

[0046] FIG. 12B shows the hub-clave tool shown in FIGS. 9-11 , the hubclave tool being engaged with a hub of a hub-clave joint.

[0047] FIG. 13 is a perspective view of a seventh example embodiment of a hub-clave tool.

[0048] FIG. 14A shows the hub-clave tool shown in FIG. 13, the hubclave tool being engaged with a clave of a hub-clave joint.

[0049] FIG. 14B shows the hub-clave tool shown in FIG. 13, the hubclave tool being engaged with a hub of a hub-clave joint.

[0050] FIG. 15 is a perspective view of an eighth example embodiment of a hub-clave tool configured to be lockable in a closed position.

[0051] FIG. 16 is a side plan view of the hub-clave tool shown in FIG. 15.

[0052] FIG. 17 is a front plan view, taken along the plane 17-17 shown inFIG. 16, of the hub-clave tool shown in FIGS. 15 and 16.

[0053] FIG. 18 is a perspective view of a ninth example embodiment of a hub-clave tool configured to be lockable in a closed position.

[0054] FIG. 19 is a side plan view of the hub-clave tool shown in FIG. 18.

[0055] FIG. 20 is a perspective view of a tenth example embodiment of a hub-clave tool with catheter / tubing crimper integrally formed therein.

[0056] FIG. 21 is a side plan view of the hub-clave tool shown in FIG. 20.

[0057] FIG. 22 shows the hub-clave tool of FIGS. 20 and 21 being used to securely grasp a hub with laterally extending wings, for disconnecting the hub from the clave also shown in FIG. 22.

[0058] FIG. 23 shows the hub-clave tool of FIGS. 20 and 21 being used to securely grasp a hub with laterally extending wings, for connecting thehub to a clave (e.g., as part of performing one or more disinfection techniques).

[0059] FIG. 24 shows a side view of an eleventh example embodiment of a hub-clave tool with a retention structure provided thereon.

[0060] FIG. 25 shows a perspective partial view of a twelfth example embodiment of a hub-clave tool with a retention structure provided thereon.

[0061] The drawings are not necessarily to scale. The drawings are merely representations, not intended to portray specific parameters of the disclosure. The drawings are intended to depict example embodiments of the disclosure, and therefore are not to be considered as limiting in scope. In the drawings, like numbering represents like elements.DETAILED DESCRIPTION

[0062] Example embodiments of a hub-clave tool in accordance with the present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, in which preferred embodiments of the present disclosure are presented. The hub-clave tools presently disclosed herein may, however, be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will convey certain example aspects of such connector adapter(s) to those skilled in the art. In the drawings, like numbers refer to like elements throughout unless otherwise noted.

[0063] As used herein and throughout, the terms “clave” and “hub” are used generically to refer to any female and male connectors, respectively, ofmedical tubing sets, in which the male connector (i.e., the “hub”) is inserted or otherwise received within the female connector (i.e., the “clave”). In the “screw lock” connectors referenced elsewhere herein, the “hub” may be externally threaded and the “clave” may be internally threaded, such that the “hub” can be threaded into the “clave” and the helical engagement of the threads of the “clave” and “hub” act to resist axial disconnection of the “hub” from the “clave.” The hub-clave tools disclosed herein are not, however, limited to being used with such “screw lock” connectors. Indeed, the hubclave tools disclosed herein can be used with any male-female medical connection, including, for example, non-threaded, slip fit, or interference fit connection types in which a male connector is inserted axially into the female connector; in such connection types, it is not uncommon for the male connector to become seized within the female connector, in which case it is advantageous to use the hub-clave tools disclosed herein to apply a torque or twisting motion between the male and female connectors to break any such seizure therebetween, thus subsequently allowing the male connector to be axially removed from the female connector.

[0064] The example embodiments of the hub-clave tool disclosed herein are configured for use with (e.g., to loosen) threaded or non-threaded connections between a hub and clave of any medical tubing sets that are sized to be manipulated by these hub-clave tools. As an example, the example embodiments can be used with a catheter and a needleless clave used for administering, for example, fluids, medications, etc. Further examples of uses for the catheter and the needleless clave can include removal / irrigation of fluids. Each of the example embodiments disclosedherein works generally similarly, however, there are some differences between the different embodiments. These differences will be discussed herein with respect to the individual embodiments, however, the general overview of operation for using the hub-clave tools disclosed herein to disengage (e.g., threadably) a clave seized onto a hub of a catheter from the hub will be disclosed herein. The hub-clave tools disclosed herein can also be used to engage (e.g., threadably) a clave and a hub to form a hub-clave joint. The methods disclosed herein are capable of disconnecting a seized clave from a hub of a catheters without damaging the clave, the hub, the tubing, or the catheter.

[0065] In general, the method requires use of at least one hub-clave tool disclosed herein. In some instances, such as, for example, where a large disconnection torque needs to be applied and it is not possible to hold either the clave or the hub manually without it rotating or, otherwise, where a caregiver lacks sufficient manual strength to prevent rotation of either the hub or clave in their hand, it is advantageous for the methods disclosed herein to be practiced using two (2) of the hub-clave tools disclosed herein.

[0066] The method thus comprises providing at least one hub-clave tool, inserting a clave or a hub of the seized hub-clave joint within a grip area that is sized for (i.e., has a same or smaller inner diameter as) the hub or clave being inserted into the grip area, squeezing the portions of the body of the hub-clave tool together to compress the grip liner(s) within the grip area in which the hub or clave is inserted, and using the hub-clave tool to apply a torque to the hub or clave that is inserted within the corresponding grip area of the hub-clave tool.

[0067] FIG. 1 shows an example of a catheter with hubs attached thereto, each hub being configured for connection to a needleless clave via a fluid- tight threaded connection for transfusion of a fluid into the catheter via the hub to which such clave is fluidically connected. An example of such a hubclave joint is shown in FIG. 2, in which a hub, generally designated 2, is threadably inserted within a clave, generally designated 1. The hub 2 and the clave 1 can have a threaded or non-threaded interface. As noted elsewhere herein, it is common for the clave 1 and the hub 2 to become seized together, which otherwise prevents or resists the threaded disconnection of the clave 1 from the hub 2, such as is necessary when performing various recommended disinfection protocols, when changing a transfusion fluid, etc.

[0068] FIG. 3 shows a first example embodiment of a hub-clave tool, generally designated 100, that is configured, either alone or in conjunction with the same or a different hub-clave tool, to apply a torque to either of a clave 1 (see, e.g., FIG. 2) or a hub 2 (see, e.g., FIG. 2) that form a seized hub-clave joint, or connection. According to this example embodiment, the hub-clave tool 100 comprises a body 110 that is generally shaped like a “clothes pin.” Thus, this body 110 comprises two generally longitudinally- extending elements, or arms 112, that are interconnected by a hinge structure, generally designated 114. In this example embodiment, the hinge structure 114 is a generally C-shaped (or U-shaped) structure to which the proximal end of each arm 112 of the body 110 is rigidly connected. The arms 112 of the body 110 may be parallel to each other or inclined at an angle towards each other, in which case the distance between the externalsurfaces of the arms 112 tapers, being greatest at the proximal end of the arms 112 and smallest at the distal end of the arms 112, which is the farthest point of the arms 112 from the hinge structure 114. In some embodiments, the hinge structure 114 is semi-circular in profile. In some embodiments, the hinge structure 114 may extend circumferentially less than 180°, in which case the arms 112 of the body 110 may be splayed apart from each other, the distance between the outer surfaces of the arms 112 increasing from the proximal end to the distal end of the arms 112.

[0069] The structures of the body 110 may be formed discretely from each other and then subsequently assembled together or formed in a single piece, sometimes referred to as having a monolithic construction, such as may be readily achieved using, for example, injection molding, additive manufacturing, and other similarly suitable manufacturing techniques.

[0070] The body 110 comprises, formed therein, at least one grip area160, 161, 162 configured for grasping a generally circularly or annularly- shaped device, such as a clave 1 or a hub 2. It is advantageous for the body 110 to have at least two such grip areas 160, 161, 162 formed therein. In the example embodiment shown in FIG. 3, the body 110 has 3 grip areas 160,161, 162 formed therein, these grip areas 160, 161, 162 having different internal diameters from each other, with grip area 160 having the largest internal diameter, the grip area 162 having the smallest internal diameter, and the grip area 161 having an internal diameter that is between the internal diameters of the grip areas 160 and 162.

[0071] The first, or “large,” grip area 160 is formed partially within the hinge structure 114, a portion of this first grip area 160 being also defined onthe inner surface of the arms 112 of the body 110 at the proximal end of each such arm 112. The inner surface of this first grip area 160 advantageously extends radially over more than 180° and, in some embodiments, as much as 270°.

[0072] The second, or “medium,” grip area 161 is formed spaced apart from the first grip area 160 along the length of the arms 112 of the body 110 of the hub-clave tool 100. This second grip area 161 is defined by an arc segment formed on the inner surface of each of the arms 112 of the body 110, between the proximal and distal ends of these arms 112. The arc segment of the second grip area 161, which is formed on the inner surface of the upper (defined in the orientation shown in FIG. 3) arm 112 is a same distance from the hinge structure 114, or proximal end of such arm 112, as the other arc segment of the second grip area 161, which is formed on the inner surface of the lower arm 112. Thus, when the arms 112 of the body 110 are squeezed towards each other for gripping a circularly- or annularly- shaped structure, such as a clave 1 or hub 2, inserted therein, the arc segment of the upper arm 112 and the arc segment of the lower arm 112 can define portions of a circular profile. In the example embodiment shown, the arc segments of the second grip area 161 formed in the upper arm 112 and the lower arm 112 each extend radially or circumferentially over less than 180° of a circular profile. The arc segments of the second grip area 161 can, in some embodiments, define an entire circular profile when the arms 112 of the body 110 are squeezed together.

[0073] The third, or “small,” grip area 162 is formed spaced apart from the first and second grip areas 160, 161 along the length of the arms 112 of thebody 110 of the hub-clave tool 100. This third grip area 162 is defined by an arc segment formed on the inner surface of each of the arms 112 of the body 110, at, adjacent to, or at least closer to the distal end of each of these arms 112 than the second grip area 161. The arc segment of the third grip are 162a, which is formed on the inner surface of the upper (defined in the orientation shown in FIG. 3) arm 112 is a same distance from the hinge structure 114, or proximal end of such arm 112, as the other arc segment of the third grip area 162, which is formed on the inner surface of the lower arm 112. Thus, when the arms 112 of the body 110 are squeezed towards each other for gripping a circularly- or annularly-shaped structure, such as a clave 1 or hub 2, inserted therein, the arc segment of the upper arm 112 and the arc segment of the lower arm 112 can define portions of a circular profile. In the example embodiment shown, the arc segments of the third grip area 162 formed in the upper arm 112 and the lower arm 112 each extend radially or circumferentially over less than 180° of a circular profile. The arc segments of the third grip area 162 can, in some embodiments, define an entire circular profile when the arms 112 of the body 110 are squeezed together.

[0074] In order to advantageously conform to, and have greater surface adhesion to, a circularly- or annularly-shaped structure, such as a clave 1 or hub 2, inserted into one of the first, second, or third grip areas 160, 161, 162 designed to engage circumferentially therewith, each of the first, second, and third grip areas 160, 161, 162 comprises a grip liner 170, 171, 172 attached to the inner surface of the corresponding first, second, or third grip area 160, 161, 162. These grip liners 170, 171, 172 can be formed, for example and without limitation, out of medical-grade silicone. In the first grip area 160, thegrip liner 170 is attached to an inner circumferential surface of the hinge structure 114 and arms 112 of the body 110 that defines the contact surface of the first grip surface 160. In the second grip area 161, the grip liner 171 is attached in two pieces, each of the arms 112 having a piece of the grip liner 171 attached to an inner surface of the arm 112, within the arc segment that defines the second grip area 161, or a portion thereof. In the third grip area 162, the grip liner 172 is attached in two pieces, each of the arms 112 having a piece of the grip liner 172 attached to an inner surface of the arm 112, within the arc segment that defines the third grip area 172, or a portion thereof.

[0075] The grip liners 170, 171, 172 have a substantially smooth inner surface and are adhered to (i.e., mechanically bonded to) the body 110. The body 110 can be made of a different material from the grip liners 170, 171, 172. For example, the body 110 can be made of a material that is harder and less compressible than the material from which the grip liners 170, 171, 172 are made. During operation of the hub-clave tool 100, a hub 2 or clave 1 is inserted into whichever of the first, second, or third grip areas 160, 161, 162 is appropriately-sized to engage therewith, the arms 112 of the body 110 are pressed together (i.e., towards each other), the inner circumferential contact surface, or at least a portion thereof, of the corresponding first, second, or third grip liner 170, 171, 172 is compressed against the outer surface of the hub 2 or clave 1, and a rotary torque is exerted, through the tool by a user, on the hub 2 or clave 1 with which the hub-clave tool 100 is engaged, the axis of rotation being coaxial with a longitudinal axis of such hub 2 or clave 1. After the hub-clave joint has been sufficiently loosened, the compressiveforce acting on the arms 112 of the body 110 is released, the hub 2 or clave1 is removed from the hub-clave tool 100, and the hub 2 and clave 1 of the hub-clave joint are manually threadably disengaged, or unscrewed from each other. Alternatively, in configurations in which the hub 2 and the clave 1 are not threadably engaged with each other, after the hub-clave joint has been sufficiently loosened, the hub 2 and the clave 1 may be separated from each other by application of an axially-oriented force to the hub 2 and / or the clave 1.

[0076] Another use of the hub-clave tool 100 comprises inserting a hub 2 or clave 1 into whichever of the first, second, or third grip areas 160, 161, 162 is appropriately-sized to engage therewith, the arms 112 of the body 110 are pressed together (i.e., towards each other), the inner circumferential contact surface, or at least a portion thereof, of the corresponding first, second, or third grip liner 170, 171, 172 is compressed against the outer surface of the hub 2 or clave 1, and a rotary torque is exerted, through the tool by a user, on the hub 2 or clave 1 with which the hub-clave tool 100 is engaged, the axis of rotation being coaxial with a longitudinal axis of such hub 2 or clave 1. The torque applied to the clave 1 or the hub 2 is in the direction of engagement (e.g., threaded engagement) of the clave 1 and hub2 to form a hub-clave joint. The compressive force acting on the arms 112 of the body 110 is advantageously maintained while the torque is applied to the clave 1 or hub 2 with which the hub-clave tool 100 is engaged. After the hubclave joint has been formed by a sufficiently tight connection between the clave 1 and the hub 2, the clave 1 or hub 2 is removed from the hub-clave tool 100.

[0077] The body 110 has an open end 116, which is formed between the distal ends of the arms 116 of the body 110. This open end 116 of the body 110 allows for insertion into the hub-clave tool 100 of the clave 1 or hub 2 to be engaged by / with the hub-clave tool 100 for loosening a seized hub-clave joint.

[0078] An alternate example embodiment of the hub-clave tool, generally designated 101, is shown in FIG. 4. The hub-clave tool 101 shown in FIG. 4 is substantially identical to the hub-clave tool 100 shown in FIG. 3, with the exception being that the inner surface of the grip liners 170, 171, 172 in the hub-clave tool 101 shown in FIG. 4 have a ribbed, or ridged, outer surface (i.e., the surface that contacts the hub 2 or clave 1 inserted therein), unlike the hub-clave tool 100 shown in FIG. 3, in which the inner surface of the grip liners 170, 171, 172 is substantially smooth. Like elements, structures, features, etc. between different embodiments of the hub-clave tools 100, 102-109 described anywhere herein are not described with respect to the hub-clave tool 101 shown in FIG. 4; rather, in order to fully understand the features of the hub-clave tool 101, reference should be made to the descriptions and / or illustrations of such like elements, structures, features, etc. in relation to the other hub-clave tools 100, 102-109, described and / or shown elsewhere herein as having such like elements, structures, features, etc. that are shown for the hub-clave tool 101 in FIG. 4.

[0079] Another example embodiment of the hub-clave tool, generally designated 102, is shown in FIGS. 5A and 5B. The structures, features, and operation of the hub-clave tool 102 is largely similar to the structures, features, and operation of the hub-clave tool 100, shown in FIG. 3. However,for the hub-clave tool 102, the inner surface of the arms 112 of the body 110 have a generally wave-like profile shape, with the grip liner 190 being a continuous element that extends over the entire inner surface of the arms 112 and the hinge structure 114 of the body 110, with the exception of a portion of the inner surface of each of the arms 112 at the distal end thereof. Thus, the grip liner 190 extends substantially continuously and in an uninterrupted manner from at, or adjacent to, the distal end of one of the arms 112 of the body 110 to at, or adjacent to, the distal end of the other arms 112 of the body 110.

[0080] In the example embodiment of the hub-clave tool 102 shown in FIGS. 5A and 5B, the wave-like profile of the inner surface of the arms 112 is the same on each of the arms 112, such that the “peaks” (i.e., the portion of the wave-like profile that extends in the direction of, so as to be closest to, the other arm 112) of the wave-like profile formed on each arm 112 are aligned with each other along the length of the arms 112 and, thus, the body 110 as well, with the “valleys” (i.e., the portion of the wave-like profile that extends away from, so as to be farthest from, the other arm 112) of the wave-like profile formed on each arm 112 being aligned with each other along the length of the arms 112. Thus, the locations along the length of the body 110 between the “peaks” each define a corresponding one of the grip areas 180, 181, 182, 183, 184. In the example embodiment shown in FIGS. 5A and 5B, the hub-clave tool 102 has five (5) grip areas 180, 181, 182, 183, 184 formed therein, with the largest, first grip area 180, being formed within the hinge structure 114, similarly to the example embodiments of the hubclave tools 100, 101 shown in FIGS. 3 and 4, and each of the secondthrough fifth grip areas 181, 182, 183, 184 being positioned progressively further from the proximal end of the arms 112 of the body 110 and each of the second through fifth grip areas 181, 182, 183, 184 having a smaller diameter than the preceding grip area.

[0081] Thus, for example, in the hub-clave tool 102, the first grip area 181 has a diameter that is larger than each of the second, third, fourth, and fifth grip areas 181, 182, 183, 184; the second grip area 182 has a diameter that is smaller than the first grip area 181, but larger than each of the third, fourth, and fifth grip areas 182, 183, 184; the third grip area 182 has a diameter that is smaller than each of the first and second grip areas 180, 181, but larger than each of the fourth and fifth grip areas 183, 184; the fourth grip area 183 has a diameter that is smaller than each of the first, second, and third grip areas 180, 181, 182, but larger than the fifth grip area 184; and the fifth grip area 184 has a diameter than is smaller than each of the first, second, third, and fourth grip areas 180, 181, 182, 183.

[0082] In some embodiments, the opposite arrangement for the wave-like profile may be true, in which case the first grip area 181 would have a diameter that is smaller than each of the second, third, fourth, and fifth grip areas 181, 182, 183, 184; the second grip area 181 would have a diameter that is larger than the first grip area 180, but smaller than each of the third, fourth, and fifth grip areas 182, 183, 184; the third grip area 182 would have a diameter that is larger than each of the first and second grip areas 180, 181, but smaller than each of the fourth and fifth grip areas 183, 184; the fourth grip area 183 would have a diameter that is larger than each of the first, second, and third grip areas 180, 181, 182, but smaller than the fifthgrip area 184; and the fifth grip area 184 would have a diameter than is larger than each of the first, second, third, and fourth grip areas 180, 181, 182, 183. Like elements, structures, features, etc. between different embodiments of the hub-clave tools 100, 101, 103-109 described anywhere herein are not described with respect to the hub-clave tool 102 shown in FIGS. 5A and 5B; rather, in order to fully understand the features of the hubclave tool 102, reference should be made to the descriptions and / or illustrations of such like elements, structures, features, etc. in relation to the other hub-clave tools 100, 101, 103-109, described and / or shown elsewhere herein as having such like elements, structures, features, etc. that are shown for the hub-clave tool 102 in FIGS. 5A and 5B.

[0083] FIGS. 6A and 6B show an example fourth embodiment of a hubclave tool, generally designated 103. The hub-clave tool 103 is an alternate embodiment of the hub-clave tool 102, shown in FIGS. 5A and 5B. For the hub-clave tool 103, the outer surface of the arms 112 of the body 110 has the same wave-like profile as the inner surface of the arms 112 described in the hub-clave tool 102, shown in FIGS. 5A and 5B. Forming the hub-clave tool 103 to have this a wave-like profile formed on the outer surface of the arms 112 has been found, at least in some instances, to advantageously provide added gripping surface on the hub-clave tool 103 for a user to prevent the user’s hand from slipping on the outer surface of the arms 112 of the body 110 of the hub-clave tool 103, since this wave-like, oscillating outer surface of the arms 112 can allow the user’s fingers to be engaged within one of the pluralities of recessed areas formed on the outer surface of the hub-clave tool 103. These recessed areas are generally formed betweenadjacent grip areas 180, 181, 182, 183, 184 Like elements, structures, features, etc. between different embodiments of the hub-clave tools 100-102, 104-109 described anywhere herein are not described with respect to the hub-clave tool 103 shown in FIGS. 6A and 6B; rather, in order to fully understand the features of the hub-clave tool 103, reference should be made to the descriptions and / or illustrations of such like elements, structures, features, etc. in relation to the other hub-clave tools 100-102, 104-109, described elsewhere herein as having such like elements, structures, features, etc. that are shown for the hub-clave tool 103 in FIGS. 6A and 6B.

[0084] Referring now to the hub-clave tools 102, 103, shown in FIGS. 5A- 6B, the wave-like profile of the inner and / or outer surfaces of the arms 112 of the body 110 may have a shape such that the diameters of the grip areas 180, 181, 182, 183, 184 does not increase or decrease progressively (e.g., continuously) along the length of the body (e.g., towards or away from the hinge structure 114), meaning that the diameters of the grip areas 180, 181, 182, 183, 184 can be arranged in any sequence or order along the length of the arms 112 and, thus, of the body 110. By way of example, the first grip area 180 may have a working diameter of about 10 mm, the second grip area 181 may have a working diameter of 14 mm, and the third grip area 182 may have a working diameter of 7 mm. The same is also true for the hubclave tools 100, 101. The term “working diameter” is used herein to describe the diameter of the object (e.g., the clave 1 and / or the hub 2) with which the grip liner(s) 170, 171, 172, 190 of each grip area 160, 161, 162, 180, 181, 182, 183, 184 are designed to circumferentially interface with (e.g., compressively grasp) while the hub-clave tool 100, 101, 102, 103 is in use.

[0085] FIG. 7 is an example arrangement for two (2) of the hub-clave tools 100, shown and described elsewhere herein in relation to FIG. 3, can be arranged for unscrewing a clave 1 that is seized to a hub 2 at a hub-clave joint. The first hub-clave tool 100 is used for gripping the hub 1 of the hubclave joint within the third grip area 162. The second hub-clave tool 100 is used for gripping the clave 2 of the hub-clave joint within the first grip area 160. In this example embodiment, the third grip area 162 of both of the hubclave tools 100 is configured to engage with and apply a torque to the hub 2, which can have, for example, an outer diameter of about 7 mm; the first grip area 160 of both of the hub-clave tools 100 is configured to engage with any apply a torque to the clave 1, which can have, for example, an outer diameter of about 14 mm. The second grip area 161 of each of the hub-clave tools 100 can have any suitable diameter; however, in the example embodiment shown, the second grip area 161 has a diameter that is smaller than the diameter of the first grip area 160 and larger than the diameter of the third grip area 162.

[0086] In the example arrangement of the hub-calve tools 100 shown in FIG. 7, a hub 2 of a hub-clave joint is inserted within the third grip area 162 of the first hub-clave tool 100 and a clave 1 of the same hub-clave joint is inserted within the first grip area 160 of the second, or other, hub-clave tool 100. The user grasps both of the first and second hub-clave tools 100, applying a compressive force between the arms 112 of the body 110 of both of the first and second hub-clave tools 100, to apply a compressive force to the hub 2 and clave 1, respectively, of the hub-clave joint with which the first and second hub-clave tools 100 are engaged. The user then, while stillapplying the compressive force, applies a twisting, or rotary, force to one or both of the first and second hub-clave tools 100, such that a rotary torque is applied to one or both of the hub 2 and clave 1, respectively, of the hubclave joint. In some embodiments, the first or second hub-clave tool 100 may be held substantially stationary, in which case the user applies the rotary force to the other of the first or second hub-clave tools 100, such that only one of the hub 2 and clave 1 is rotated with respect to the other. In instances in which a rotary force is applied, through the first and second hub-clave tools 100, to both the hub 2 and the clave 1 of the hub-clave joint, the direction of rotation of the rotary force applied to the first hub-clave tool 100 is opposite the direction of rotation of the rotary force applied to the second hub-clave tool 100. During disengagement of a clave 1 and hub 2 in a seized hub-clave joint, the direction of rotation is always in the direction of threaded disengagement (e.g., “unthreading” or “unscrewing”) of the clave 1 from the hub 2. During engagement of a clave 1 and hub 2, the direction of rotation is always in the direction of threaded engagement (e.g., “threading” or “screwing”) of the clave 1 onto the hub 2 or of the hub 2 into the clave 1.

[0087] Once the clave 1 and hub 2 of the hub-clave joint have been loosened by the torque applied by the first and / or second hub-clave tools 100, the hub-clave tools 100 may continue to be used to fully threadably disengage the clave 1 from the hub 2 or, in some instances, the first and / or second hub-clave tools 100 may be removed or disengaged from the respective hub 2 and clave 1 after the clave 1 and hub 2 have been unscrewed from each other to a degree sufficient for the clave 1 and hub 2 of the hub-clave joint to no longer be seized together, in which case the firstand / or second hub-clave tools 100 may be removed and the clave 1 and / or the hub 2 may, for the remainder of the unscrewing procedure, be unscrewed from each other manually by the user. Given the comparatively smaller diameter of the hub 2 relative to the clave 1, it may be advantageous for the first hub-clave tool 100 to remain, during the remainder of the unscrewing procedure, engaged with the hub 2 and for the user to unscrew the clave 1 from the hub 2 manually after the clave 1 is no longer rotationally seized to the hub 2.

[0088] FIG. 8 shows another example embodiment of a hub-clave tool, generally designated 104, that can be used for grasping a portion (e.g., a clave 1 or a hub 2) of a hub-clave joint for loosening a clave 1 and hub 2 of such a hub-clave joint that are seized together. The hub-clave tool 104 shown in FIG. 8 has a generally “scissors” style design and has a body 110 that has a monolithic or unitary construction. The body 110 of the hub-clave tool 104 comprises a handle region, generally designated 120, an extension region, generally designated 118, and a grip region, generally designated 130. The grip region 130 has a generally annular, or circular, profile over at least 180° (e.g., in the manner of a semicircular profile) when the hub-clave tool 104 is viewed from the side.

[0089] The grip region 130 comprises one or more grip areas 132, which are substantially similar, at least in terms of function, to the grip areas of the hub-clave tools 100-103. The hub-clave tool 104 has, on an entire inner surface of the at least partially circular profile thereof, or at least portions thereof, a grip liner 134 which is made from a softer and more compressible than the material from which the body 110 is formed. The body 110, forexample, can be made of a plastic material (e.g., polyvinylchloride, or PVC) and the grip liner 134 can be made, for example, from medical-grade silicone. In some embodiments, the body 110 can be formed from plastic, metal, and / or a composite material.

[0090] The grip region 130 is connected to the extension region 118, which comprises two arms 112, each of which is connected between one end of the portion of the profile of the grip region 130 and one of the two handles 122 of the handle region 120. The arms 112 of the body 110 are generally longitudinally-extending elements that are separated from each other (e.g., parallel to each other), when the hub-clave tool 104 is not in use. The handles 122 are attached to the arms 112 and each handle 122 has a hole into which one or more fingers of the user of the hub-clave tool 104 can be inserted for exerting a force on the handles 122 towards each other. This force causes the diameter of the grip area 132 to decrease as the handles 122 of the handle region 120 and the arms 112 in the extension region 118 move toward each other (e.g., in a pivoting manner, such that the arms 112 are no longer parallel to each other), this decrease in the diameter of the grip area 132 causing the grip liner 134 to grasp a circumferential outer surface of the clave 1 or hub 2 that is inserted within, or otherwise positioned within, the grip area 132.

[0091] The grip liner 134 has, in all embodiments, a coefficient of friction sufficient to allow the rotary force imparted on the hub-clave tool 104 (e.g., through the handles 122) by the user to be transmitted to the circumferential outer surface of the hub 2 or clave 1, which is inserted within the grip area 132, by the grip liner 134.

[0092] The hub-clave tool 104 comprises an open end, generally designated 116, between the handles 122, within the handle region 120. This open end 116 is connected to a continuous channel formed between the handles 122 and also the arms 112 in the extension region 118, this continuous channel thereby allowing a hub 2 or clave 1, or a transfusion / catheter line attached thereto, to pass through the open end 116, along the channel, and into the grip area 132, such that the hub 2 or clave 1 can be positioned within the grip area 132. Thus, during use of the hub-clave tool 104, a hub 2 or clave 1 is inserted within the grip area 132, a compressive force is exerted by a user on the handles 122, this compressive force pushing the handles 122 towards each other in the direction of closing the open end 116 to deform (e.g., elastically), squeeze and / or move the grip area 132 of the hub-clave tool 100, such that an inner diameter of the grip liner 134 decreases as the handles 122 are moved towards each other. This decrease of the inner diameter of the grip liner 134 exerts a radially compressive force against the outer circumferential surface of the hub 2 or clave 1 positioned within the grip area 132. While the grip liner 134 is compressed against the hub 2 or clave 1, the user exerts a rotary force, from the handles 122, in a direction of unthreading (e.g., “unscrewing”) the clave 1 from the hub 2 or the hub 2 from the clave 1 (i.e. , unscrewing a clave 1 from a hub 2 when the clave 1 is in the grip area 132 and unscrewing a hub 2 from a clave 1 when the hub 2 is in the grip area 132).

[0093] The hub-clave tool 104 shown in FIG. 8 is designed to only be used on a hub 2 or a clave 1, but not both, depending on the inner diameter of the grip liner 134 when the grip area 132 is in the undeformed state. Thus,for engaging with a hub 2 having an outer diameter of about 7 mm, the hubclave tool 104 may be designed such that the grip liner 134 has an inner diameter of about 8 mm (e.g., + / - 1 mm, + / - 0.5 mm, etc.). Similarly, for engaging with a clave 1 having an outer diameter of about 14 mm, the hubclave tool 104 may be designed such that the grip liner 134 has an inner diameter of about 15 mm (e.g., + / - 1 mm, + / - 0.5 mm, etc.).

[0094] Like elements, structures, features, etc. between different embodiments of the hub-clave tools 100-103, 105-109 described anywhere herein are not described with respect to the hub-clave tool 104 shown in FIG. 8; rather, in order to fully understand the features of the hub-clave tool 104, reference should be made to the descriptions and / or illustrations of such like elements, structures, features, etc. in relation to the other hubclave tools 100-103, 105-109, described and / or shown elsewhere herein as having such like elements, structures, features, etc. that are shown for the hub-clave tool 104 in FIG. 8.

[0095] FIGS. 9-12B show various views and aspects of another example embodiment of a hub-clave tool, generally designated 105. Hub-clave tool 105 is substantially identical in form and function to the hub-clave tool 104, with the exception that the hub-clave tool 105 has an hub grip insert 140 pivotably attached thereto by an insert hinge, generally designated 150. The hub grip insert 140 allows the hub-clave tool 105 to be selectively operable with generally annularly-shaped objects having different diameters from each other, such as the clave 1 and the hub 2. With the exception of the hub grip insert 140 and the insert hinge 150, by which the hub grip insert 140 is pivotably attached to the grip region 130 of the body 110 of the hub-clavetool 105, the hub-clave tool 105 shown in FIGS. 9-12B is substantially identical in terms of structure, functionality, and method of use to the hubclave tool 104 shown in FIG. 8.

[0096] The hub-clave tool 105 shown in FIGS. 9-12B has a hub grip insert 140 that is pivotably attached, via an insert hinge 150, to the grip region 130 of the hub-clave tool 105. The hub grip insert 140 is pivotable, with respect to the body 110, between a disengaged position, shown in FIGS. 10, 11 , and 12A, and an engaged position, shown in FIGS. 9 and 12B. In the engaged position, the hub grip insert 140 is located radially within the grip liner 134 of the grip area 132. Thus, the outer diameter of the insert grip area 142 is the same as, or less than, the inner diameter of the grip liner 134 of the grip area 132. The hub grip insert 140 comprises, on an inner surface of the insert grip area 142, a grip liner 144. The grip liner 144 is substantially similar to the grip liner 134, described elsewhere herein. The grip liner 144 is thus more compressible (e.g., softer) and / or having a higher coefficient of friction than the material from which the hub grip insert 140 and / or the body 110 of the hub-clave tool 105 is made. In the disengaged position, the hub grip insert 140 is pivoted to a position so that no portion of the hub grip insert 140 is positioned radially within the grip area 132.

[0097] In this example embodiment, the hub 2 has an outer diameter of about 7 mm, such that the insert grip area 142 for the hub 2 advantageously has an undeformed inner diameter, between opposing inner surfaces of the grip liner 144, of about 8 mm (e.g., + / - 1 mm, + / - 0.5 mm, etc.), and the clave 1 has an outer diameter of about 14 mm, such that the grip area 132 for the clave 1 advantageously has an undeformed inner diameter, betweenopposing inner surfaces of the grip liner 134, of about 15 mm (e.g., + / - 1 mm, + / - 0.5 mm, etc.).

[0098] For gripping a clave 1, the hub grip insert 140 is pivoted into the disengaged position (see FIGS. 10, 11 , and 12A), in which the hub grip insert 140 is not within the grip area 130, and the clave 1 is positioned within the grip region 130, in such a position that the grip liner 134 can be radially compressed against the outer surface of the clave 1 for exerting a rotary force, or torque, on the clave 1 to loosen such a clave 1 when the clave 1 is seized to a hub 2 in a seized hub-clave joint.

[0099] For gripping a hub 2, the hub grip insert 140 is pivoted into an engaged position (see FIGS. 9 and 12B), in which the hub grip insert 140 is positioned radially within the grip area 132, in a position in which an outer surface of the hub grip insert 140 can be radially compressed by the grip liner 134, and the hub 2 is inserted into the insert grip area 142, in such a position that the grip liner 144 can be radially compressed against the outer surface of the hub 2 for exerting a rotary force, or torque, on the hub 2 to loosen such a hub 2 when the hub 2 is seized to a clave 1 in a seized hubclave joint. Thus, the grip liner 134 of the grip area 132 compresses against the outer surface of the hub grip insert 140, which in turn compresses against, via the inner surface of the grip liner 144, the outer surface of the hub 2.

[0100] The hub grip insert 140 comprises, in some embodiments, a bracket 146 on one or both distal ends thereof, the term “distal” here being used to mean the portion of the hub grip insert 140 that is furthest away from the insert hinge 150. The bracket 146 is used to engage with the arms 112of the body 110 in the extension region 118 to prevent over-rotation of the hub grip insert 14- with respect to the body 110 of the hub-clave tool 105 when the hub grip insert 140 is being pivoted into the engaged position. In some embodiments, the insert hinge 150 allows at least 90° of rotation relative to the hub grip insert 140 and the body 110 when moving between the disengaged position and the engaged position. Advantageously, the insert hinge 150 allows about 180° (e.g., + / - 20°, + / - 15°, + / - 10°, or + / -5°) of rotation of the hub grip insert 140 relative to the body 110 when the hub grip insert 140 is moving between the disengaged position and the engaged position. In some embodiments, the insert hinge 150 allows greater than 180° (e.g., at much as 270°) of rotation of the hub grip insert 140 relative to the body 110 when moving between the disengaged position and the engaged position.

[0101] The hub-clave tool 105 shown in FIGS. 9-12B is designed to be selectively used on either a hub 2 or a clave 1, based on whether the hub grip insert 140 is in the engaged position or the disengaged position. While the hub-clave tool 105 can be used on both the hub 2 and the clave 1, the hub-clave tool 105 cannot be used for simultaneously engaging with both a hub 2 and a clave 1. Thus, for engaging with a hub 2 having an outer diameter of about 7 mm, the hub-clave tool 105 may be designed to have an undeformed inner diameter between the grip liner 144 of about 8 mm (e.g., + / - 1 mm, + / - 0.5 mm, etc.). Similarly, for engaging with a clave 1 having an outer diameter of about 14 mm, the hub-clave tool 105 may be designed to have an undeformed inner diameter between the grip liner 134 of about 15 mm (e.g., + / - 1 mm, + / - 0.5 mm, etc.).

[0102] Like elements, structures, features, etc. between different embodiments of the hub-clave tools 100-104, 106-109 described anywhere herein are not described with respect to the hub-clave tool 105 shown in FIGS. 9-12; rather, in order to fully understand the features of the hub-clave tool 105, reference should be made to the descriptions and / or illustrations of such like elements, structures, features, etc. in relation to the other hubclave tools 100-104, 106-109, described and / or shown elsewhere herein as having such like elements, structures, features, etc. that are shown for the hub-clave tool 105 in FIGS. 9-12.

[0103] FIGS. 13, 14A, and 14B show various views and aspects of another example embodiment of a hub-clave tool, generally designated 106. The method of operation of this hub-clave tool 106 is similar to the method of operation of the hub-clave tools 100-105, 107-109 disclosed elsewhere herein, in particular with respect to the example embodiments of the hubclave tools 100-103 shown in FIGS. 3-7.

[0104] The hub-clave tool 106 according to this example embodiment comprises a body 110, which has two arms 112 that are attached to each other at a hinge structure, generally designated 114, of the hub-clave tool 106, such that the arms 112 can pivot relative to each other about the hinge structure 114 to change a distance between the arms 112 at the distal end of these arms 112, which defines the open end, generally designated 116, of the hub-clave tool 106. The arms 112 are generally longitudinally-extending structures that extend away from the hinge structure 114. The arms 112 have, formed therein at positions along the length thereof, at least one grip area 232, 242. Preferably, the hub-clave tool 106 has at least two grip areas232, 242, as shown in FIGS. 13, 14A, and 14B. Each of the grip areas 232, 242 is defined by a recessed area, having a profile that is generally in the form of an arc segment (e.g., less than or equal to 180° of a circular profile.) The recessed areas that form the respective grip areas 232, 242 may have a non-semicircular profile (e.g., for using the hub-clave tool 106 to engage with, or loosen, structures with a non-circular cross-sectional profile). The two recessed areas that define the first grip area 232 are formed at a same position (e.g., defined as a distance from the hinge structure 114) along the length of the arms 112 of the body 110. The two recessed areas that define the second grip area 242 are formed at a same position (e.g., defined as a distance from the hinge structure 114) along the length of the arms 112 of the body 110.

[0105] Each of the recessed areas that define the first grip area 232 has, attached to an inner surface thereof, a grip liner 234. Each of the recessed areas that define the second grip area 242 has, attached to an inner surface thereof, a grip liner 244. The grip liners 234, 244 are made from a material that is more compressible (e.g., softer) and / or has a higher coefficient of friction than the material from which the arms 112 of the body 110 are made. A non-limiting example of the material from which the grip liners 234, 244 can be made is medical-grade silicone. A non-limiting example of the material from which the body 110 can be made includes polyvinylchloride (PVC).

[0106] The two grip areas 232, 242 of the hub-clave tool 106 have different inner diameters between the respective grip liners 234, 244 thereof. Thus, for engaging with a clave 1 having an outer diameter of about 14 mm,the hub-clave tool 106 may be designed such that the first grip area 232 has an inner diameter, between the grip liners 244 thereof, of about 15 mm (e.g., + / - 1 mm, + / - 0.5 mm, etc.). For engaging with a hub 2 having an outer diameter of about 7 mm, the hub-clave tool 106 may be designed such that the second grip area 242 has an inner diameter between the grip liners 244 thereof of about 8 mm (e.g., + / - 1 mm, + / - 0.5 mm, etc.). In the example embodiment shown, the second grip area 242 is closest to the hinge structure 114 and the first grip area 232 is closest to the open end 116. In some embodiments, the first grip area 232 may be closest to the hinge structure 114 and the second grip area 242 may be closest to the open end 116. Just as discussed with respect to the example embodiments of the hubclave tools 100-103, shown in FIGS. 3-7, the grip areas 232, 242 of the hubclave tool 106 shown in FIGS. 13, 14A, and 14B may be arranged such that the inner diameters thereof are in ascending order, descending order, or in any suitable pattern, including a random, non-ordered distribution.

[0107] Like elements, structures, features, etc. between different embodiments of the hub-clave tools 100-105, 107-109 described anywhere herein are not described with respect to the hub-clave tool 106 shown in FIGS. 13, 14A, and 14B; rather, in order to fully understand the features of the hub-clave tool 106, reference should be made to the descriptions and / or illustrations of such like elements, structures, features, etc. in relation to the other hub-clave tools 100-105, 107-109, described and / or shown elsewhere herein as having such like elements, structures, features, etc. that are shown for the hub-clave tool 106 in FIGS. 13, 14A, and 14B.

[0108] A method of use of the hub-clave tool 106 comprises providing the hub-clave tool 106 shown in FIGS. 13, 14A, and 14B, inserting a hub 2 of a seized hub-clave joint into the second grip area 242 or a clave 1 of a seized hub-clave joint into the first grip area 232, applying a compressive force to the arms 112 of the body 110 to pivot the arms 112 together about the hinge structure 114, such that the grip liner 244 of the second grip area 242 is compressed against the outer surface of the hub 2 or the grip liner 234 of the first grip area 232 is compressed against the outer surface of the clave 1, and applying a rotary force, or torque, to the body 110 of the hub-clave tool 106, which causes a rotation of the hub 2 or clave 1, as the case may be (i.e. , whichever of which the hub-clave tool 106 is engaged with), relative to the clave 1 or hub 2 for loosening a seized hub-clave joint.

[0109] In some embodiments, the method comprises using two of the hub-clave tools 106 shown in FIGS. 13, 14A, and 14B, a clave 1 of a seized hub-clave joint being engaged within the first grip area 232 of the first hubclave tool 106, as shown in FIG. 14A, and a hub 2 of the same seized hubclave joint being engaged within the second grip area 242 of the second hub-clave tool 106, as shown in FIG. 14B. The user grasps both of the first and second hub-clave tools 106, applying a compressive force between the arms 112 of the body 110 of both of the first and second hub-clave tools 106, to apply a compressive force to the clave 1 and hub 2, respectively, of the hub-clave joint with which the first and second hub-clave tools 106 are engaged. The user then, while still applying the compressive force to the arms 112 of the body 110, applies a twisting, or rotary, force to one or both of the first and second hub-clave tools 106, such that a rotary torque isapplied to one or both of the clave 1 and hub 2, respectively, of the hubclave joint. In some embodiments, the first or second hub-clave tool 106 may be held substantially stationary and the user applies the rotary force to the other of the first or second hub-clave tools 106, such that only one of the hub 2 and clave 1 is rotated with respect to the other. In instances in which a rotary force is applied, through the first and second hub-clave tools 106, to both the hub 2 and the clave 1 of the hub-clave joint, the direction of rotation of the rotary force applied to the first hub-clave tool 106 is opposite the direction of rotation of the rotary force applied to the second hub-clave tool 106. During disengagement of a clave 1 and hub 2 in a seized hub-clave joint, the direction of rotation is always in the direction of threaded disengagement (e.g., “unthreading” or “unscrewing”) of the clave 1 from the hub 2. During engagement of a clave 1 and hub 2, the direction of rotation is always in the direction of threaded engagement (e.g., “threading” or “screwing”) of the clave 1 onto the hub 2 or of the hub 2 into the clave 1.

[0110] FIGS. 15-17 show various views and aspects of another example embodiment of a hub-clave tool, generally designated 107, which is substantially identical to the hub-clave tool 106, shown in FIGS. 13, 14A, and 14B, in structure, functionality, and methods of operation, with the exception being that the hub-clave tool 107 shown in FIGS. 15-17 comprises a lock, generally designated 210, and clamping ridges 220 for substantially stopping a flow of a fluid through a tube. The clamping ridges 220 comprise ridges that are substantially coplanar with each other and are each provided on one of the respective arms 112 of the body 110, at a position along the length of such arms 112 to be defined between the first and second grip areas 232,242. The clamping ridges 220 are aligned such that, when the compressive force is applied between the arms 112 of the body 110 to pivot the arms 112 towards each other about the hinge structure 114 of the body 110, the clamping ridges 220 can directly contact each other unless a tube or catheter, through which a flow of a fluid therethrough is to be stopped, is positioned between the clamping ridges 220, in which case the clamping ridges 220 directly contact the tube or catheter and collapse the inner walls thereof to stop a flow of a fluid through the tube or catheter.

[0111] In order to allow for the hub-clave tool 107 to be released while still preventing fluid flow through the tube or catheter deformed between the clamping ridges 220, the hub-clave tool 107 also comprises a lock 210, which holds the clamping ridges 220 against each other until the lock 210 is released (e.g., manually). The lock 210 comprises two locking tabs 212, each locking tab 212 being attached to a different one of the arms 112 of the body 110 of the hub-clave tool 106. The locking tabs 212 extend towards each other from the inner surfaces of the arms 112 of the body 110 and are provided at a same distance from the hinge structure 114 as each other on both of the arms 112 of the body 110. Each of the locking tabs 212 comprises locking teeth 214, such that the locking tabs 212 have a generally serrated surface. The serrated surface of the first locking tab 212 faces the serrated surface of the second locking tab 212. The locking teeth 214 of both of the locking tabs 214 have a substantially identical construction (e.g., tooth shape, depth, pitch) to each other, such that the locking teeth 214 of the first locking tab 212 can interlock with, and resist disengagement from, the locking teeth 214 of the second locking tab 212.

[0112] The locking tabs 212 of the lock 210 are advantageously easily manually disengaged from each other by moving the arms 112 of the body 110 of the hub-clave tool 107 in the direction of the respective disengagement direction 216, shown in FIG. 17. Thus, the clamping ridges 220 allow for the hub-clave tool 107 of FIGS. 15-17 to be used instead of an occluding clamp in at least some instances.

[0113] Like elements, structures, features, etc. between different embodiments of the hub-clave tools 100-106, 108, and 109 described anywhere herein are not described with respect to the hub-clave tool 107 shown in FIGS. 15-17; rather, in order to fully understand the features of the hub-clave tool 107, reference should be made to the descriptions and / or illustrations of such like elements, structures, features, etc. in relation to the other hub-clave tools 100-106, 108, and 109, described and / or shown elsewhere herein as having such like elements, structures, features, etc. that are shown for the hub-clave tool 107 in FIGS. 15-17.

[0114] A method of use of the hub-clave tool 107 comprises providing the hub-clave tool 107 shown in FIGS. 15-17, inserting a hub 2 of a seized hubclave joint into the second grip area 242 or a clave 1 of a seized hub-clave joint into the first grip area 232, applying a compressive force to the arms 112 of the body 110 to pivot the arms 112 together about the hinge structure 114, such that the grip liners 234 of the first grip area 232 are compressed against the outer surface of the clave 1 or the grip liners 244 of the second grip area 242 are compressed against the outer surface of the hub 2, and applying a rotary force, or torque, to the body 110 of the hub-clave tool 107, which causes a rotation of the hub 2 or clave 1, as the case may be (i.e.,whichever of which the hub-clave tool 107 is engaged with), relative to the clave 1 or hub 2 for loosening a seized hub-clave joint.

[0115] In some embodiments, the method comprises using two of the hub-clave tools 107 shown in FIGS. 15-17, a clave 1 of a seized hub-clave joint being engaged within the first grip area 232 of the first hub-clave tool 107 and a hub 2 of the same seized hub-clave joint being engaged within the second grip area 242 of the second hub-clave tool 107. The user can grasp both of the first and second hub-clave tools 107, applying a compressive force between the arms 112 of the body 110 of both of the first and second hub-clave tools 107, to apply a compressive force to the clave 1 and hub 2, respectively, of the hub-clave joint with which the first and second hub-clave tools 107 are engaged. The user then, while still applying the compressive force to the arms 112 of the body 110, applies a twisting, or rotary, force to one or both of the first and second hub-clave tools 107, such that a rotary torque is applied to one or both of the clave 1 and hub 2, respectively, of the hub-clave joint. In some embodiments, the first or second hub-clave tool 107 may be held substantially stationary, and the user applies the rotary force to the other of the first or second hub-clave tools 107, such that only one of the hub 2 and clave 1 is rotated with respect to the other. In instances in which a rotary force is applied, through the first and second hubclave tools 107, to both the hub 2 and the clave 1 of the hub-clave joint, the direction of rotation of the rotary force applied to the first hub-clave tool 107 is opposite the direction of rotation of the rotary force applied to the second hub-clave tool 107. During disengagement of a clave 1 and hub 2 in a seized hub-clave joint, the direction of rotation is always in the direction of threadeddisengagement (e.g., “unthreading” or “unscrewing”) of the clave 1 from the hub 2. During engagement of a clave 1 and hub 2, the direction of rotation is always in the direction of threaded engagement (e.g., “threading” or “screwing”) of the clave 1 onto the hub 2 or of the hub 2 into the clave 1.

[0116] In some embodiments, the method comprises using a third hubclave tool 107 to stop a flow of fluid through a transfusion tube or catheter, the method comprising positioning the transfusion tube or catheter between the clamping ridges 220 of the third hub-clave tool 107, applying a compressive force between the arms 112 of the third hub-clave tool 107 to compressively deform the transfusion tube or catheter between the clamping ridges 220 and stop a flow of a fluid through the transfusion tube or catheter. In some embodiments, the method comprises using the lock 210 to lock the third hub-clave tool 107 in the clamped position, such that the fluid flow through the transfusion tube or catheter is prevented even in the absence of the user applying the compressive force between the arms 112 of the third hub-clave tool 107. In some embodiments, the method comprises moving the arms 112 in a disengagement direction to allow a fluid flow through the transfusion tube or catheter to resume.

[0117] FIGS. 18 and 19 show various aspects and features of another example embodiment of a hub-clave tool, generally designated 108. The hub-clave tool 108 is substantially identical to the hub-clave tool 107 in terms of structure, functionality, and method of use, with the exception that, unlike in the hub-clave tool 107, the clamping ridges 220 of the hub-clave tool 108 are not provided between the first and second grip areas 232, 242. Instead, in the hub-clave tool 108, the clamping ridges 220 are formed at a positionbetween the second grip area 242 and the lock 210. The function of the lock 210, the clamping ridges 220, and the first and second grip areas 232, 242 are otherwise substantially identical to the function of the same structures of the hub-clave lock 107.

[0118] Like elements, structures, features, etc. between different embodiments of the hub-clave tools 100-107, 109 described anywhere herein are not described with respect to the hub-clave tool 108 shown in FIGS. 18 and 19; rather, in order to fully understand the features of the hubclave tool 108, reference should be made to the descriptions and / or illustrations of such like elements, structures, features, etc. in relation to the other hub-clave tools 100-107, 109, described and / or shown elsewhere herein as having such like elements, structures, features, etc. that are shown for the hub-clave tool 108 in FIGS. 18 and 19.

[0119] FIGS. 20 and 21 show various aspects and features of another example embodiment of a hub-clave tool, generally designated 109. The hub-clave tool 109 is substantially identical to the hub-clave tool 106 in terms of structure, functionality, and method of use, with the exception that, unlike in the hub-clave tool 106, the hub-clave tool 109 comprises a gripping area, generally designated 111, and a tubing crimper, generally designated 250. The purpose of the tubing crimper 250 in the hub-clave tool 109 is substantially similar to that of the clamping ridges 220 of the hub-clave tools 107, 108

[0120] The tubing crimper 250 is formed in the hinge structure 114 of the body 110 of the hub-clave tool 109 and comprises two tapering fin-like structures 252 that are substantially coplanar with each other and definetherebetween a crimping slot, generally designated 254, which narrows (e.g., progressively) in the direction towards the hinge structure 114. The tubing crimper 250 is configured for substantially stopping a flow of a fluid through a tube or catheter that is inserted within the crimping slot 254. When the tube or catheter is inserted into the crimping slot 254, the outer surface of the walls of the tube or catheter contact the fin-like structures 252. At this initial point of contact between the walls of the tube or catheter and the fin-like structures 252, the walls of the tube or catheter are substantially undeformed by the tubing crimper 250. As the tube or catheter is inserted progressively further into the crimping slot 254, the fin-like structures 252 progressively squeeze together and deform the walls of the tube or catheter as a function of the insertion distance of the tube or catheter into the crimping slot 254. When the tube or catheter is inserted into the crimping slot 254 to be in the narrowest part thereof (e.g., adjacent to the hinge structure 114), the walls of the tube or catheter are fully collapsed (i.e. , the inner surfaces of the walls of the tube or catheter are touching each other) and, thus, a flow of a fluid through the tube or catheter is stopped while the tube or catheter is inserted a sufficient distance within the crimping slot 254 to fully collapse the walls of the tube or catheter.

[0121] The gripping area 111 is formed on both of the arms 112 of the body 110, at a position along the length of the body 110 to be over one or both of the first and second grip areas 232, 242. The gripping area 111 comprises a textured surface on the outer surface of the arms 112 that aid the user in gripping and squeezing the arms 112 together. In the example embodiment shown, the gripping area 111 is a series of ribbed or knurledelements that form a roughened outer surface of the arms 112. The gripping area 111 can optionally be formed in a recessed portion of the outer surface of the arms 112 of the body 110.

[0122] Like elements, structures, features, etc. between different embodiments of the hub-clave tools 100-108 described anywhere herein are not described with respect to the hub-clave tool 109 shown in FIGS. 20 and 21 ; rather, in order to fully understand the features of the hub-clave tool 109, reference should be made to the descriptions and / or illustrations of such like elements, structures, features, etc. in relation to the other hub-clave tools 100-108, described and / or shown elsewhere herein as having such like elements, structures, features, etc. that are shown for the hub-clave tool 109 in FIGS. 20 and 21.

[0123] FIGS. 22 and 23 show the hub-clave tool 109 with a hub 1, which have 2 wing-like tabbed structures extending from opposite directions of the hub 1, inserted within the second grip area 242 (see, e.g., FIGS. 20 and 21 ). Thus, the hub-clave tool 109 is configured for use with a hub 2 with such wing-like tabbed structures.

[0124] FIG. 24 shows another example of a hub-clave tool, generally designated 109-1. The hub-clave tool 109-1 is substantially identical to the hub-clave tool 109, however, the tubing crimper 250 is omitted and a retention feature, generally designated 300, is provided, formed in and / or extending from an exterior surface of the body 110 at the hinge structure 114. The retention feature 300 is in the form of a hook or similar structure, such that the hub-clave tool 109-1 can be easily attached to, for example, abadge or other credential holder worn by the user of the hub-clave tool 109- 1

[0125] FIG. 25 shows another example of a hub-clave tool, generally designated 109-2. The hub-clave tool 109-2 is substantially identical to the hub-clave tool 109, however, the tubing crimper 250 is omitted and a retention feature, generally designated 300, is provided, formed in and / or extending from an exterior surface of the body 110 at the hinge structure 114. The retention feature 300 is in the form of a pocket 302 or similar structure, with a triangularly-shaped retainer 304 captive within the pocket 302, such that the hub-clave tool 109-2 can be easily attached to, for example, a badge or other credential holder worn by the user of the hubclave tool 109-2.

[0126] Like elements, structures, features, etc. between different embodiments of the hub-clave tools 100-109 described anywhere herein are not described with respect to the hub-clave tool 109-1 shown in FIG. 24; rather, in order to fully understand the features of the hub-clave tool 109-1, reference should be made to the descriptions and / or illustrations of such like elements, structures, features, etc. in relation to the other hub-clave tools 100-109, described and / or shown elsewhere herein as having such like elements, structures, features, etc. that are shown for the hub-clave tool 109-1 in FIG. 24.

[0127] The hub-clave tools 100-109, 109-1, 109-2 disclosed herein can be used for connection and / or disconnection of a hub 2 and clave 1.

[0128] The hub-clave tools 100-109, 109-1, 109-2 disclosed herein can be used for loosening or tightening any secure screw / twist lock / threaded connection.

[0129] The hub-clave tools 100-109, 109-1, 109-2 disclosed herein can have a body 110 that is formed from plastic, metal, and / or a composite material. Any physically non-deformative or minimally deformative material can be used to form the body 110. It is advantageous for the material from which the body 110 is formed is a lightweight material.

[0130] The hub-clave tools 100-109, 109-1, 109-2 disclosed herein can have a body 110 that is made from a single material, such as, for example, a suitable plastic material capable of gripping and exerting a torque on a clave 1 and / or a hub 2 for loosening or connecting a clave 1 and hub 2 to form a hub-clave joint.

[0131] Any of the hub-clave tools 100-109, 109-1, 109-2 can be coated in (e.g., by being dipped in) a silicone material to aid in the user securely gripping and using the hub-clave tool 100-109, 109-1, 109-2. The silicone can cover, partially or entirely, any of the hub-clave tools 100-109, 109-1, 109-2

[0132] While the present disclosure refers to certain embodiments, numerous modifications, alterations, and changes to the described embodiments are possible without departing from the sphere and scope of the present disclosure, as defined in the appended claim(s). Accordingly, it is intended that the present disclosure not be limited to the described embodiments, but that it has the full scope defined by the language of the following claims, and equivalents thereof. The discussion of any embodimentis meant only to be explanatory and is not intended to suggest that the scope of the disclosure, including the claims, is limited to these embodiments. In other words, while illustrative embodiments of the disclosure have been described in detail herein, it is to be understood that the inventive concepts may be otherwise variously embodied and employed, and that the appended claims are intended to be construed to include such variations, except as limited by the prior art.

[0133] The foregoing discussion has been presented for purposes of illustration and description and is not intended to limit the disclosure to the form or forms disclosed herein. For example, various features of the disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of the certain aspects, embodiments, or configurations of the disclosure may be combined in alternate aspects, embodiments, or configurations. Moreover, the following claims are hereby incorporated into this description by this reference, with each claim standing on its own as a separate embodiment of the present disclosure.

[0134] As used herein, an element or step recited in the singular and proceeded with the word “a” or “an” should be understood as not excluding plural elements or steps, unless such exclusion is explicitly recited. Furthermore, references to “one embodiment” of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features.

[0135] The phrases “at least one”, “one or more”, and “and / or”, as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. The terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, and counterclockwise) are only used for identification purposes to aid the reader’s understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of this disclosure. Connection references (e.g., engaged, attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative to movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. All rotational references describe relative movement between the various elements. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to connote importance or priority but are used to distinguish one feature from another. The drawings are for purposes of illustration only and the dimensions, positions, order and relative to sizes reflected in the drawings attached hereto may vary.

Claims

CLAIMS1 . A tool for loosening a clave and a hub that are attached to each other in a seized hub-clave joint and / or for connecting the clave and the hub to form a hub-clave joint, the tool comprising: a body; and one or more grip areas disposed at different positions along the body; wherein each grip area of the one or more grip areas comprises a grip liner; wherein at least a portion or more of the body is deformable or movable when the clave or the hub is positioned within a corresponding grip area of the one or more grip areas; wherein the grip liner is configured such that, when at least a portion or all of the body is deformed, squeezed and / or moved, an inner diameter, defined by a distance between opposing points on an inner surface of the grip liner for each of the one or more grip areas, of the one or more grip areas is decreased; wherein, as a result of the inner diameter of the corresponding grip area decreasing, the inner surface of the grip liner of the corresponding grip area directly contacts and is compressed against the clave or the hub positioned within the corresponding grip area, such that a user can rotate the tool about an axis defined by the corresponding grip area to exert a torque on the clave or the hub positioned in the corresponding grip area for loosening the seized hub-clave joint.

2. The tool according to claim 1 , wherein:the body comprises two arms that are attached, at a respective proximal end thereof, to a hinge, such that the two arms are pivotable about the hinge relative to each other; the body has an open end between a respective distal end of the two arms, by which the clave or the hub is positioned within the corresponding grip area; the hinge defines the body as having a closed end, opposite the open end; the one or more grip areas is a plurality of grip areas; and all of the plurality of grip areas are spaced apart from each other along a length of the body.

3. The tool according to claim 2, wherein: a first grip area of the plurality of grip areas is formed at least partially within the hinge, such that the hinge extends circumferentially around the first grip area; and optionally, all of the plurality of grip areas, other than the first grip area, are defined by recesses formed into the two arms, each of the recesses being in a shape of an arc segment.

4. The tool according to any of claims 1 and 2, wherein all of the plurality of grip areas are defined by recesses formed into the two arms, each of the recesses being in a shape of an arc segment.

5. The tool according to any of claims 1-4, comprising:a clamping ridge formed on each of the first and second arms, the clamping ridge on the first arm being coplanar with, and at a same distance from the hinge as, the clamping ridge on the second arm; the clamping ridge on the first arm and the clamping ridge on the second arm are configured, when the first arm and the second arm are pressed together by a sufficiently strong force, to deform a tube or lumen positioned between the clamping ridge of the first arm and the clamping ridge of the second arm to stop a flow of a fluid through the tube or lumen; and a lock configured to, when the first arm and the second arm have been pressed together by a force that causes the clamping ridge of the first arm and the clamping ridge of the second arm to stop the flow of the fluid through the tube or lumen, resist a separation movement of the first and second arms away from each other, such that the flow of the fluid through the tube or lumen remains stopped until the first and / or second arms are moved in a disengagement direction to disengage the lock.

6. The tool according to claim 1 , wherein: the body comprises a handle region, an extension region, and a grip region; the one or more grip areas comprises an outer grip area in the grip region; the handle region comprises a first handle and a second handle, by which a user is configured to manipulate the tool; the extension region comprises a first arm and a second arm;the first arm is connected between the grip region, at a first end of the outer grip area, and the handle region, at the first handle; the second arm is connected between the grip region, at a second end of the outer grip area, and the handle region, at the second handle; the first and second handles are spaced apart from each other to define an open end of the tool; when the tool is in an undeformed state, the first arm and the second arm are spaced apart from each other to form a channel, the channel extending continuously from the open end into the outer grip area; the outer grip area has a C-shaped profile; and when the user squeezes the first and second handles together, the inner diameter of the outer grip area decreases.

7. The tool according to claim 6, comprising a hub grip insert that is pivotably attached to the body at an insert hinge, the hub grip insert being pivotable between an engagement position, in which the hub grip insert is positioned radially within the outer grip area, such that the hub grip insert defines an inner grip area therein, and a nonengagement position, in which the hub grip insert is positioned to that no portion of the hub grip insert is within the outer grip area, wherein: the hub grip insert is smaller than and has a same profile shape as the outer grip area, such that the inner grip area of the hub grip insert is, when in the engagement position, concentrically located within the outer grip area;the hub grip insert comprises, on an inner surface of the inner grip area, a grip liner that comprises a same material as the grip liner of the one or more grip areas; the inner diameter of the inner grip area is substantially similar to the outer diameter of the hub when the tool is in an undeformed state; and the inner diameter of the outer grip area is substantially similar to the outer diameter of the clave when the tool is in the undeformed state.

8. The tool according to any of claims 1-7, wherein the plurality of grip areas comprises: at least one grip area that has an inner diameter that is substantially similar to an outer diameter of the clave; and at least one further grip area that has an inner diameter that is substantially similar to an outer diameter of the hub.

9. The tool according to any of claims 1-8, wherein each of the grip liners comprises silicone.

10. The tool according to any of claims 1-9, wherein each of the grip liners comprises a substantially smooth surface or a substantially ribbed surface.

11. The tool according to any of claims 1-10, comprising, formed in the body, a clamp that is configured to stop a flow of a fluid through a tube or catheter attached to the clave and / or the hub.

12. The tool according to any of claims 1-11 , wherein the body comprises, on an outer surface thereof, a gripping portion that aids the user to grasp and manipulate the tool during use.

13. A method of loosening a clave and a hub that are attached to each other in a seized hub-clave joint and / or for connecting the clave and the hub to form a hub-clave joint, the method comprising: providing one or more tools comprising: a body; and one or more grip areas disposed at different positions along the body; wherein each grip area of the one or more grip areas comprises a grip liner; inserting the clave or the hub within a corresponding grip area of the one or more grip areas of the one or more tools; deforming, squeezing and / or moving at least some of the body of the at least one tool to grasp the clave or the hub; wherein the grip liner is configured such that, when the body is deformed, squeezed and / or moved, an inner diameter, defined by a distance between opposing points on an inner surface of the grip liner for each of the one or more grip areas, of the one or more grip areas is decreased; and wherein, as a result of the inner diameter of the corresponding grip area decreasing, the inner surface of the grip liner of the corresponding griparea directly contacts and is compressed against the clave or the hub positioned within the corresponding grip area; the method comprising: rotating the tool about an axis defined by the corresponding grip area to exert a torque on the clave or the hub positioned in the corresponding grip area for loosening the seized hub-clave joint.

14. The method according to claim 13, wherein: the body comprises two arms that are attached, at a respective proximal end thereof, to a hinge, such that the two arms are pivotable about the hinge relative to each other; the body has an open end between a respective distal end of the two arms, by which the clave or the hub is positioned within the corresponding grip area; the hinge defines the body as having a closed end, opposite the open end; the one or more grip areas is a plurality of grip areas; and all of the plurality of grip areas are spaced apart from each other along a length of the body.

15. The method according to claim 14, wherein: a first grip area of the plurality of grip areas is formed at least partially within the hinge, such that the hinge extends circumferentially around the first grip area; andoptionally, all of the plurality of grip areas, other than the first grip area, are defined by recesses formed into the two arms, each of the recesses being in a shape of an arc segment.

16. The method according to any of claims 13 and 14, wherein all of the plurality of grip areas are defined by recesses formed into the two arms, each of the recesses being in a shape of an arc segment.

17. The method according to any of claims 13-16, wherein: at least one of the one or more tools comprises a clamping ridge formed on each of the first and second arms, the clamping ridge on the first arm being coplanar with, and at a same distance from the hinge as, the clamping ridge on the second arm; the clamping ridge on the first arm and the clamping ridge on the second arm are configured, when the first arm and the second arm are pressed together by a sufficiently strong force, to deform a tube or lumen positioned between the clamping ridge of the first arm and the clamping ridge of the second arm to stop a flow of a fluid through the tube or lumen; and at least one of the one or more tools comprises a lock configured to, when the first arm and the second arm have been pressed together by a force that causes the clamping ridge of the first arm and the clamping ridge of the second arm to stop the flow of the fluid through the tube or lumen, resist a separation movement of the first and second arms away from each other, such that the flow of the fluid through the tube or lumen remainsstopped until the first and / or second arms are moved in a disengagement direction to disengage the lock.

18. The method according to claim 13, wherein: the body comprises a handle region, an extension region, and a grip region; the one or more grip areas comprises an outer grip area in the grip region; the handle region comprises a first handle and a second handle, by which a user is configured to manipulate the tool; the extension region comprises a first arm and a second arm; the first arm is connected between the grip region, at a first end of the outer grip area, and the handle region, at the first handle; the second arm is connected between the grip region, at a second end of the outer grip area, and the handle region, at the second handle; the first and second handles are spaced apart from each other to define an open end of the tool; when the tool is in an undeformed state, the first arm and the second arm are spaced apart from each other to form a channel, the channel extending continuously from the open end into the outer grip area; the outer grip area has a C-shaped profile; and when the first and second handles are moved or squeezed together, the inner diameter of the outer grip area decreases.

19. The method according to claim 18, wherein:at least one of the one or more tools comprises a hub grip insert that is pivotably attached to the body at an insert hinge, the hub grip insert being pivotable between an engagement position, in which the hub grip insert is positioned radially within the outer grip area, such that the hub grip insert defines an inner grip area therein, and a nonengagement position, in which the hub grip insert is positioned to that no portion of the hub grip insert is within the outer grip area, wherein: the hub grip insert is smaller than and has a same profile shape as the outer grip area, such that the inner grip area of the hub grip insert is, when in the engagement position, concentrically located within the outer grip area; the hub grip insert comprises, on an inner surface of the inner grip area, a grip liner that comprises a same material as the grip liner of the one or more grip areas; the inner diameter of the inner grip area is substantially similar to the outer diameter of the hub when the tool is in an undeformed state; and the inner diameter of the outer grip area is substantially similar to the outer diameter of the clave when the tool is in the undeformed state.

20. The method according to any of claims 13-19, wherein the plurality of grip areas comprises: at least one grip area that has an inner diameter that is substantially similar to an outer diameter of the clave; and at least one further grip area that has an inner diameter that is substantially similar to an outer diameter of the hub.

21. The method according to any of claims 13-20, wherein each of the grip liners comprises silicone.

22. The method according to any of claims 13-21 , wherein each of the grip liners comprises a substantially smooth surface or a substantially ribbed surface.

23. The method according to any of claims 13-21 , wherein providing the one or more tools comprises providing at least a first tool and a second tool, the method comprising: inserting the clave within a corresponding grip area of the one or more grip areas of the first tool; inserting the hub within a corresponding grip area of the one or more grip areas of the second tool; deforming, squeezing and / or moving at least some of the body of the first tool to grasp the clave; deforming, squeezing and / or moving at least some of the body of the second tool to grasp the hub; rotating the first tool relative to the second tool to loosen the seized hub-clave joint.

24. The method according to any of claims 13-23, wherein the body comprises a clamp that can stop a flow of a fluid through a tube or catheter attached to the clave and / or the hub.

25. The tool according to any of claims 13-24, wherein the body comprises, on an outer surface thereof, a gripping portion that aids the user to grasp and manipulate the tool during use.

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