Devices for catheter securement

Abstract

The present application is directed to a secondary catheter securement device (100). The secondary catheter securement device includes a pad (110) configured to be secured to a patient's skin and a clamping mechanism (130) pivotably coupled to the adhesive pad (110) and configured to grasp and hold a catheter therein without the risk of mechanical kinking. Pivoting of the clamping mechanism (130) allows the catheter to be lifted a sufficient distance relative to the patient's skin to allow cleaning thereof.

Description

DEVICES FOR CATHETER SECUREMENT AND RELATED METHODSRelated Application(s)

[0001] The present application claims priority from and the benefit of Indian Provisional Patent Application No. 202341061291, filed September 12, 2023, and Indian Provisional Patent Application No. 202441028018, filed April 4, 2024, the disclosures of which are hereby incorporated herein by reference in their entirety.Field

[0002] The present invention relates to medical devices, and in particular, devices for catheter securement.Background

[0003] Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Catheters are manufactured for specific applications, such as cardiovascular, urological, gastrointestinal, neurovascular and ophthalmic procedures. In most uses, a catheter is a thin, flexible tube (soft catheter) though catheters are available in varying levels of stiffness depending on the application. Catheters can be inserted into a body cavity, duct, vessel, brain, skin or adipose tissue. Functionally, they allow drainage, administration of fluids or gases, access by surgical instruments, and also perform a wide variety of other tasks depending on the type of catheter.

[0004] Referring to FIGS. 1-4E, when a catheter 12 is left in place in a patient long-term, often a securement technique is employed to secure the catheter 12 in its location. This is particularly true for central venous catheters (CVCs and PICCs), which are often inserted into the superior vena cava via the patient's neck and upper arm, respectively. Solutions to secure the catheter 12 include sutures 11 (see, e.g., FIG. 1) and adhesive-based catheter securement devices 20 (an exemplary catheter securement device is the STATLOCK™ device, available from BD, see, e.g., FIG. 3). With either of these techniques, typically a dressing 25 associated with the insertion site IS of the catheter 12 requires changing. As can be seen in FIGS. 2A-2C, cleaning around acatheter 12 that is secured by sutures 11 results in incomplete (and therefore inadequate) cleaning (e.g., an area A of the patient's skin S below the catheter hub 14 that has not been cleaned), which in turn can increase the risk of central line-associated bloodstream infection (CLABSI).

[0005] When the catheter 12 is secured with a securement device 20, typically the securement device 20 is changed at the same time as the dressing 25. During changing of the dressing 25, replacement of the securement device 20 and cleaning around the insertion site IS (e.g., with a disinfecting applicator 30), the caretaker should avoid undue movement of the catheter 12 (for example, tip migration or dislodgement of the catheter 12, which may result in the catheter 12 shifting sufficiently that the catheter 12 is no longer correctly positioned within the vein or other structure into which it is inserted). This is particularly important for certain catheters such as CVCs and PICCs.

[0006] Different techniques for changing the dressing 25 around the catheter are currently used, In one technique, caretakers may attempt to use a gloved finger F to hold the catheter 12 in place (see, e.g., FIG. 4A); however, this may require a second caretaker to clean the site while the first caretaker maintains the catheter 12 in position with one hand while removing the securement device 20 with the other hand. Also, this technique is not aligned with Aseptic Non-Touch Technique (ANTT) protocol. Alternatively, a rolled-up dressing 25 may be used to temporarily hold the catheter 12 as the securement device 20 is replaced (see, e.g., FIG. 4B). However, the use of the rolled-up dressing 25 for securement may present inconsistency (e.g., how much dressing to roll-up to secure catheter at / near insertion site). As a third technique, a secondary securement component, such as an adhesive strip 15, may be used to temporarily hold the catheter 12 in position during removal and replacement of the securement device 20 (see, e.g., FIGS. 4C-4E). This technique requires that the caretaker have the knowledge to do this and the adherence to protocol to use the adhesive strip 15. Experience has shown that this protocol is often ignored. Also, removal of the adhesive strip 15 may be difficult and / or may cause movement to the catheter 12, and in some instances the adhesive strip 15 leaves a residue on the catheter lumen after removal that can attract contaminants.

[0007] It may be desirable to provide techniques for improving adherence to protocols in terms of use of secondary securement device during dressing change of adhesive-based primary securement device (STATLOCK™)-secured catheters, which may in turn improve patient outcomes.Summary

[0008] A first aspect of the present invention is directed to a catheter securement device. The catheter securement device includes a pad configured to be secured to a patient's skin and a clamping mechanism pivotably coupled to the pad. The clamping mechanism is configured to grasp and hold a catheter therein while pivoting of the clamping mechanism allows the catheter to be lifted from extension lines during site cleaning (without increasing the risk of catheter movement at / near insertion site) a sufficient distance relative to the patient's skin to allow for cleaning thereof.

[0009] Another aspect of the present invention is directed to a catheter securement device. The catheter securement device includes a pad configured to be secured to a patient's skin, a base coupled to the pad, and a cantilevered member pivotably coupled to the base at one end. The cantilevered member includes a latching mechanism at an opposing end to the base. The latching mechanism is configured to grasp and hold a catheter therein while pivoting the cantilevered member allows the catheter to be lifted a sufficient distance above the patient's skin to allow for cleaning thereof.

[0010] Another aspect of the present invention is directed to a catheter securement device. The catheter securement device includes a pad configured to be secured to a patient's skin, a base coupled to the pad, and a pair of arm members pivotably coupled to the base. Each arm member has a recessed end that together define a first aperture configured to receive a catheter therethrough. One of the arm members further has a second aperture extending into the respective recessed end. The catheter securement device further includes a securing mechanism configured to be received through the second aperture to secure the catheter within the first aperture. When secured within the first aperture by the securing mechanism, the pair of arm members is configured to lift the catheter a sufficient distance above the patient's skin to allow for cleaning thereof.

[0011] Another aspect of the present invention is directed to a catheter securement device. The catheter securement device includes a pad configured to be secured to a patient's skin, a base coupled to the pad, the base having an arcuate recess, and an extended arm member. The extended arm member includes a slider at one end configured to travel along a guided path within the arcuate recess of the base and a latching mechanism at an opposing end, the latching mechanism configured to grasp and hold a catheter therein such that the catheter is held a sufficient distance above the patient's skin to allow for cleaning thereof.

[0012] Another aspect of the present invention is directed to a catheter securement assembly. The catheter securement assembly includes a disinfectant applicator and a catheter securement device. The catheter securement device has a main body and a clamp coupled to and extending outwardly from the main body. The clamp is configured to receive and hold one or more catheter extension lines therein. An end of the disinfectant applicator is received by the main body of the catheter securement device to secure the catheter securement device to the disinfectant applicator, and the catheter securement device is configured to hold the one or more catheter extension lines a sufficient distance above the patient's skin to allow for cleaning thereof.

[0013] It is noted that aspects of the invention described with respect to one embodiment, may be incorporated in a different embodiment although not specifically described relative thereto. That is, all embodiments and / or features of any embodiment can be combined in any way and / or combination. Applicant reserves the right to change any originally filed claim and / or file any new claim, accordingly, including the right to be able to amend any originally filed claim to depend from and / or incorporate any feature of any other claim or claims although not originally claimed in that manner. These and other objects and / or aspects of the present invention are explained in detail in the specification set forth below. Further features, advantages and details of the present invention will be appreciated by those of ordinary skill in the art from a reading of the figures and the detailed description of the preferred embodiments that follow, such description being merely illustrative of the present invention.Brief Description of the Drawings

[0014] FIG. 1 illustrates using sutures to secure a central venous catheter line on a patient.

[0015] FIGS. 2A-2C illustrate inadequate site-cleaning when sutures are used to secure a central venous catheter line as shown in FIG. 1.

[0016] FIG. 3 illustrates a known primary catheter securement device.

[0017] FIGS. 4A-4E illustrate current techniques used by caretakers to temporarily secure a catheter during a dressing change.

[0018] FIG. 5A is a rear perspective view of a secondary catheter securement device according to embodiments of the present invention.

[0019] FIG. 5B is a front perspective view of the secondary catheter securement device of FIG. 5A

[0020] FIGS. 6A-6G schematically illustrate exemplary steps for changing the dressing for a catheter using the secondary catheter securement device of FIG. 5A according to embodiments of the present invention.

[0021] FIG. 7A is a top perspective view of an alternative configuration for the secondary catheter securement device of FIG. 5A according to embodiments of the present invention.

[0022] FIG. 7B is an exploded view of the secondary catheter securement device of FIG. 7A.

[0023] FIG. 7C illustrates the secondary catheter securement device of FIG. 7A in use according to embodiments of the present invention.

[0024] FIG. 8 is a perspective view of another alternative configuration for the secondary catheter securement device of FIG. 5A according to embodiments of the present invention.

[0025] FIGS. 9A-9B are perspective views of another alternative configuration for the secondary catheter securement derive of FIG. 5A according to embodiments of the present invention.

[0026] FIGS. 10A-10B are perspective views of another alternative configuration for the secondary catheter securement device of FIG. 5A according to embodiments of the present invention.

[0027] FIG. 10C illustrates the secondary catheter securement device prototype of FIG. 10B in use according to embodiments of the present invention.

[0028] FIG. 10D illustrates an alternative configuration for secondary catheter securement device of FIG. 10A according to embodiments of the present invention in which the adhesive pad is positioned farther than the insertion site than for the device of FIGS. 10A-10C.

[0029] FIGS. 11A-11B are perspective and partially transparent views of an alternative clamping mechanism for a secondary catheter securement device according to embodiments of the present invention.

[0030] FIG. 12A is a perspective view of another secondary catheter securement device according to embodiments of the present invention.

[0031] FIG. 12B is an enlarged view of the head / catheter holding mechanism of the secondary catheter securement device of FIG. 12A.

[0032] FIGS. 13A-13C are partial cross-sectional views of the secondary catheter securement device of FIG. 12A illustrating an exemplary locking feature for the hinged joint.

[0033] FIGS. 14A-14F schematically illustrate exemplary steps for changing the dressing for a catheter using the secondary catheter securement device of FIG. 12A according to embodiments of the present invention.

[0034] FIG. 15A illustrates another configuration of secondary catheter securement device positioned on the neck of a patient according to embodiments of the present invention.

[0035] FIG. 15B is an enlarged view of the secondary catheter securement device of FIG. 15A.

[0036] FIG. 15C is another enlarged view of the secondary catheter securement device of FIG. 15A

[0037] FIG. 15D is an exploded view of the secondary catheter securement device of FIG. 15A.

[0038] FIGS. 16A-16L schematically illustrate exemplary steps for changing the dressing for a catheter using the secondary catheter securement device of FIG. 15A according to embodiments of the present invention.

[0039] FIGS. 17A-17B illustrate operation of a clamping mechanism for the secondary catheter securement device of FIG. 15A. FIG. 17A shows the clamping mechanism in an unlatched position and FIG. 17B shows the clamping mechanism in a latched position.

[0040] FIGS. 18A-18B illustrate operation of an alternative clamping mechanism for the secondary catheter securement device of FIG. 15A. FIG. 18A shows the alternative clamping mechanism in an unlatched position and FIG. 18B shows the alternative clamping mechanism in a latched position.

[0041] FIG. 19A is a perspective view of another secondary catheter securement device according to embodiments of the present invention.

[0042] FIG. 19B is an exploded view of the secondary catheter securement device of FIG. 19A.

[0043] FIG. 19C illustrates the secondary catheter securement device of FIG. 19A holding a catheter lumen according to embodiments of the present invention.

[0044] FIG. 20A is an exploded view of another secondary catheter securement device according to embodiments of the present invention.

[0045] FIG. 20B is a perspective view of the secondary catheter securement device of FIG. 20A

[0046] FIG. 20C shows the secondary catheter securement device of FIG. 20B secured to a catheter.

[0047] FIGS. 21A-21L schematically illustrate exemplary steps for changing the dressing for a catheter using the secondary catheter securement device of FIG. 20A according to embodiments of the present invention.

[0048] FIGS. 22A-22H illustrate another secondary catheter securement device and schematically illustrate exemplary steps for changing the dressing for a catheter using the secondary catheter securement device according to embodiments of the present invention.

[0049] FIGS. 23A-23G illustrate another secondary catheter securement device and schematically illustrate exemplary steps for changing the dressing for a catheter using the secondary catheter securement device according to embodiments of the present invention.

[0050] FIGS. 24A-24H illustrate another secondary catheter securement device and schematically illustrate exemplary steps for changing the dressing for a catheter using the secondary catheter securement device according to embodiments of the present invention.Detailed Description

[0051] The present invention now is described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

[0052] In the figures, certain layers, components, or features may be exaggerated for clarity, and broken lines illustrate optional features or operations unless specified otherwise. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

[0053] It will be understood that, although the terms first, second, etc. may be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or section from another region, layer, or section. Thus, a first element, component, region, layer, or section discussed below couldbe termed a second element, component, region, layer or section without departing from the teachings of the present invention. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.

[0054] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the specification and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Well-known functions or constructions may not be described in detail for brevity and / or clarity.

[0055] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising", when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0056] As used herein, phrases such as "between X and Y" and "between about X and Y" should be interpreted to include X and Y. As used herein, phrases such as "between about X and Y" mean "between about X and about Y." As used herein, phrases such as "from about X to Y" mean "from about X to about Y. "

[0057] It will be understood that when an element is referred to as being "on", "attached" to, "connected" to, "coupled" with, "contacting", etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, "directly on", "directly attached" to, "directly connected" to, "directly coupled" with or "directly contacting" another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0058] Spatially relative terms, such as "under", "below", "lower", "over", "upper", "lateral", "left", "right" and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the descriptors of relative spatial relationships used herein interpreted accordingly.

[0059] Embodiments of the present invention are directed to catheter securement solutions that helps minimize catheter migration and dislodgement during the dressing change of the catheter, while also not elevating other clinical burden, for example, microbial growth, patient pain, and significant workflow impact. Embodiments of the present invention provide secondary catheter securement devices that are configured to hold a catheter or catheter hub near the insertion site of the catheter in a patient's skin using a cantilever-based mechanism. The secondary catheter devices allow for 360° site cleaning without increasing the risk of catheter movement during dressing change of the catheter, such as long-dwelling intravascular (IV) catheters, for example, a peripherally inserted central catheter (PICC) line and a central venous catheter (CVC) line. Embodiments of the present invention will now be described in further detail below with reference to FIG. 5A through FIG. 24H.

[0060] Referring to FIG. 5A and FIG. 5B, a catheter securement device 100i (also referred to herein as "secondary catheter securement device", "secondary securement device" or "securement device") according to embodiments of the present invention is illustrated. As shown in FIGS. 5A- 5B, in some embodiments, the secondary securement device 100i comprises a pad 110i and a clamping mechanism 130i. The pad 110i is configured to be secured to a patient's skin. In some embodiments, the pad 110i may be an adhesive pad. In some embodiments, a main body 120i of the clamping mechanism 130i is coupled to the pad 110i via a pair of hinged joints 115i (i.e., a bistable hinged joint). In some embodiments, the pad 110i has a recess Illi which allows secondary securement device 100i to be adhered to the patient's skin S adjacent to an insertion site IS of the catheter 12 (also referred to herein as "main catheter" or "catheter lumen") (see, e.g., FIG. 6C). As described in further detail below, the hinged joints 115i are configured such that the secondarysecurement device 100i may raise the catheter 12 (and catheter hub 14) a sufficient distance D relative to the patient's skin S to allow 360° site cleaning near the catheter insertion site IS (see, e.g., FIG. 6D) and lower the catheter 12 after cleaning has been performed.

[0061] In some embodiments, the pad 110i of the secondary catheter securement device 100i may comprise a pair of arms 112i extend upwardly therefrom. In some embodiments, each arm 112i may comprise an aperture 112ai configured to receive a respective protrusion 122ai extending outwardly from the main body 120i of the clamping mechanism 130i to form the hinged joints 115i. In some embodiments, the hinged joints 115i may provide a step-wise locking function (see, e.g., locking feature 1234, 123s shown in FIGS. 9A-9B and FIGS. 10A-10B) which allows the secondary securement device 100i to hold the catheter 12 (and catheter hub 14) above the patient's skin S (i.e., distance D) to allow for site cleaning (see, e.g., FIG. 6D).

[0062] Still referring to FIGS. 5A-5B, in some embodiments, the clamping mechanism 130i of the secondary catheter securement device 100i may comprise a pair of wing members 132i that are coupled together to form a latching mechanism 134i. The latching mechanism 134i is sized and configured to accommodate most commercially available sizes (i.e., diameters) of catheter 12. As shown in FIG. 5B, in some embodiments, an inner wall of the latching mechanism 134i may comprise a grip feature 135i to help firmly hold an outer diameter surface of the catheter 12 within the latching mechanism 134i without increasing the risk of compressing the catheter 12 to hinder fluid flow / mechanical kinking. The grip feature 135i may also help to avoid any forward or backward movement (i.e., pistoning) of the catheter 12 at the insertion site IS (especially when the catheter hub 14 is not secured by a primary securement device 20 during dressing change and / or when the catheter hub 14 is being manipulated for site cleaning by a caretaker). In some embodiments, an outer surface of each wing member 132i may comprise one or more grip features 136i to help provide better user interaction with the secondary securement device 100i.

[0063] FIGS. 6A-6G schematically illustrate exemplary steps for changing a dressing (e.g., a first dressing 25a and / or a second dressing 25b) for a catheter 12 using the secondary catheter securement device 100i according to embodiments of the present invention.

[0064] FIG. 6A shows a catheter hub 14 secured by a primary securement device 20 which is adhered to the patient's skin S. One or more catheter extension lines 12a, 12b is coupled to and extends from one end of the catheter hub 14 and a main catheter 12 is coupled to and extends from an opposing end of the catheter hub 14. The catheter 12 is inserted into the patient (e.g., a vein ofthe patient) at an insertion site IS. A first dressing 25a (e. ., an antimicrobial hemostatic IV dressing) is applied over the catheter insertion site IS. A second (transparent) dressing 25b is applied to cover the insertion site IS, the first dressing 25a, the catheter 12, the primary securement device 20, the catheter hub 14, and at least a portion of the catheter extension lines 12a, 12b.

[0065] As shown in FIG. 6B, during dressing change, the first and second dressings 25a, 25b are removed such that the site may be cleaned around the insertion site IS. However, it may be difficult to clean the area of skin S below the catheter 12 and the primary securement device 20.

[0066] As shown in FIG. 6C, the secondary catheter securement device 100i of the present invention is secured adjacent to the catheter insertion site IS such that the insertion site IS (and catheter 12 extending therefrom) reside within the recess Illi of the pad 110i. The clamping mechanism 130i of the device 100i is lowered (pivoted downwardly via the bi-stable hinged joints 115i) toward the catheter 12. The caretaker forces (squeezes) the wing members 132i of the clamping mechanism 130i together which allows the latching mechanism 134i to sufficiently open to receive the outer diameter of the catheter 12, and releases the wing members 134i to grasp the catheter 12 therein. After the catheter 12 is firmly held within the latching mechanism 134i, the catheter hub 14 may be released from the primary securement device 20, and the old primary securement device 20 is removed from the patient's skin S.

[0067] According to embodiments the present invention, the secondary catheter securement device 100i of the present invention allows the catheter 12 (and catheter hub 14) to be lifted a sufficient distance D relative to the patient's skin S to allow 360° cleaning (e.g., with a disinfecting applicator 30) around the catheter insertion site IS, as well as the skin S underneath the catheter 12 and catheter hub 14 (previously not accessible because of the primary securement device 20). As shown in FIG. 6D, to lift the catheter 12 and catheter hub 14, the clamping mechanism 130i of the secondary securement device 100i is pivoted upwardly via the hinged joints 115i. In some embodiments, the hinged joints 115i may be configured to lock the clamping mechanism 130i of securement device 100i in a lifted position, thereby allowing the caretaker to have both hands available to clean the site.

[0068] As shown in FIG. 6E, after cleaning of the site has been performed, the clamping mechanism 130i is lowered (pivoted downwardly) via the hinged joints 115i, and the catheter hub 14 is secured in a new primary securement device 20. Once the catheter hub 14 is secured in the primary securement device 20, the secondary securement device 100i may be removed fromthe patient's skin. Next, as shown in FIG. 6F, the site that was initially covered by the pad 110i of the secondary catheter securement device 100i is cleaned (e.g., with the disinfecting applicator 30). Finally, as shown in FIG. 6G, new first and / or second dressings 25a, 25b are applied over the site.

[0069] Referring now to FIGS. 7A-7C, an alternative configuration for a secondary catheter securement device IOO2 is illustrated. Properties and / or features of the secondary securement device IOO2 may be as described above in reference to the secondary catheter securement device 100i shown in FIGS. 5A-5B and FIGS. 6A-6G and duplicate discussion thereof may be omitted herein for the purposes of discussing FIGS. 7A-7C.

[0070] As shown in FIGS. 7A-7B, the secondary catheter securement device IOO2 is similar to the secondary catheter securement device 100i described herein in that the secondary securement device IOO2 comprises a pad IIO2 and a clamping mechanism 1302, and that a main body 1202 of the clamping mechanism 1302 is coupled to the pad IIO2 via a pair of hinged joints 1152 (bi-stable hinged joint). In some embodiments, the pad IIO2 may be an adhesive pad. The catheter securement device IOO2 differs from the secondary catheter securement device 100i in the configuration (i.e., shape) of the wing members 1322 of the clamping mechanism 1302.

[0071] As shown in FIGS. 5A-5B, the wing members 132i of the clamping mechanism 130i of the secondary securement device 100i described above have a generally triangular shape with rounded corners. As shown in FIGS. 7A-7B, the wing members 1322 of the clamping mechanism 1302 of the secondary securement device IOO2 have a generally rectangular shape with rounded corners. In addition, in some embodiments, the pad IIO2 of the secondary securement device IOO2 may have a smaller recess III2 than the recess Illi of the pad 110i of the secondary securement device 100i described above.

[0072] As shown in FIG. 7C, the secondary catheter securement device IOO2 functions in a similar manner as the secondary securement device 100i described herein in which the clamping mechanism 1302 of the device IOO2 is lowered (pivoted downwardly) via the hinged joint 1152 toward the catheter 12 and the wing members 1322 are forced (squeezed) together which allows the latching mechanism 134' to sufficiently open to grasp the outer diameter of the catheter 12 without increasing the risk of compressing the catheter 12 to hinder fluid flow / mechanical kinking. The steps for changing a dressing for the catheter 12 using the secondary catheter securement device IOO2 are the same as those described above (see, e.g., FIGS. 6A-6G).

[0073] Another configuration for a secondary catheter securement device IOO3 according to embodiments of the present invention is illustrated in FIG. 8. As shown in FIG. 8, in some embodiments, the secondary catheter securement device IOO3 may have the pad IIO3 and clamping mechanism 1303 integrally formed as a single component. In some embodiments, the pad IIO3 of the secondary securement device IOO3 may have an extension member IH3 to which the clamping mechanism 1303 may be coupled. In some embodiments, a transition section or small main body HO3 may reside between the clamping mechanism 1303 and the extension member IH3.

[0074] Similar to the secondary catheter securement devices 100i, IOO2 described above, the clamping mechanism 130s of the secondary catheter securement device IOO3 comprises a pair of wing members 132s that are coupled together to form a latching mechanism 134s which is sized and configured to accommodate most commercially available sizes (i.e., diameters) of catheter 12. In some embodiments, each wing member 132s may comprise one or more grip features 1363 to help provide better user interaction. The secondary catheter securement device IOO3 differs from the secondary catheter securement devices 100i, IOO2 described above in that the secondary securement device lOOsdoes not include a pair of hinged joints 115i, 1152.

[0075] In addition, as shown in FIG. 8, the clamping mechanism 1303 is oriented differently than the clamping mechanism 130i, 1302 of secondary securement devices 100i, IOO2 to allow the latching mechanism 1343 of the secondary securement device IOO3 to grasp the catheter 12 without increasing the risk of compressing the catheter 12 to hinder fluid flow / mechanical kinking. As shown in FIGS. 5A-5B and FIGS. 7A-7B, the clamping mechanisms 130i, 1302 of secondary securement devices 100i, IOO2 extend along a plane that is generally perpendicular to the respective pads 110i, IIO2 when pivoted to grasp the catheter 12. In contrast, as shown in FIG. 8, the clamping mechanism 1303 of the device IOO3 extends along a plane that is generally parallel with the pad IIO3 to grasp the catheter 12.

[0076] Additional configurations for secondary catheter securement devices IOO4, IOO5 according to embodiments of the present invention are further illustrated in FIGS. 9A-9B and FIGS. 10A-10D and discussed below. Properties and / or features of the secondary catheter securement device IOO4, IOO5 may be as described above in reference to the secondary catheter securement devices 100i, IOO2 shown in FIGS. 5A-5B and FIGS. 7A-7B and duplicate discussion thereof may be omitted herein for the purposes of discussing FIGS. 9A-9B and FIGS. 10A-10D.

[0077] It is noted that while a pad of the secondary securement device IOO4 is not shown in FIGS. 9A-9B, the secondary securement device 1004may comprise the same or similar pad 110i, IIO2 (e.g., adhesive pad) as secondary securement devices 100i, IOO2 described herein, as well as the pad IIO5 for the secondary catheter securement device IOO5 shown in FIG. 10C. The secondary catheter securement devices IOO4, IOO5 differ from the secondary catheter securement devices 100i, IOO2 described herein in the configuration of the clamping mechanisms 1304, 130s, and in particular, the shapes of the respective wing members 1324, 132s.

[0078] For example, as shown in FIGS. 9A-9B, the end of each wing member 1324 of the clamping mechanism 1304 for the secondary securement device IOO4 has a slightly wider (i.e., more obtuse) triangular shape compared to the triangular shape of the wing members 132i of the secondary securement device 100i. As shown in FIGS. 10A-10D, the end of each wing member 132s of the clamping mechanism 130g for the secondary securement device IOO5 has an arcuate (generally circular) shape.

[0079] In addition, as discussed above, and as shown in FIGS. 9A-9B and FIGS. 10A-10B, in some embodiments, the protrusions 1224, 122s that form the hinged joints 1154, 115s with the respective arms extending upwardly from the pads (e.g., as shown in FIGS. 5A-5B) may comprise a locking feature 1234, 123g. In some embodiments, the locking features 1234, 123g may be configured to perform a step-wise locking function to secure the respective clamping mechanisms 1304, 130g (and catheter 12) in a raised or lifted position (i.e., a distance D above the patient's skin).

[0080] FIG. 10C illustrates the secondary catheter securement device 100g positioned adjacent to the catheter insertion site IS and ready to grasp the catheter 12 according to embodiments of the present invention. Similar to the secondary catheter securement device 100i described herein, in some embodiments, as shown in FIG. 10C, the pad 110g of the secondary securement device 100g may include a recess Illg which allows the secondary securement device 100g to be positioned in close proximity to the insertion site IS of the catheter 12. For example, in some embodiments, the secondary securement device 100g may be positioned such that the insertion site IS of the catheter 12 resides within the recess Illg of the pad 110g.

[0081] Referring to FIG. 10D, in some embodiments, the secondary catheter securement device 100g may further comprise a pair of extension arms 125g. As shown in FIG. 10D, the extension arms 125g may be configured to position the pad 110g a distance D2 from the insertionsite IS of the catheter 12, thereby avoiding adhesive residue near the insertion site IS. In some embodiments, a first pair of hinged joints 115s is formed where one end of each extension arm 125s is coupled to the pad IIO5 and a second pair of hinged joints 115s is formed where the opposing end of each extension arm 125s is coupled to the main body 120s of the secondary securement device IOO5.

[0082] Referring to FIGS. 11A-11B, an alternative clamping mechanism 130e is illustrated that may be incorporated into one or more of the secondary catheter securement devices IOO1-IOO5 described herein. As shown in FIGS. 11A-11B, the clamping mechanism 130e may comprise a pair of wing members 132s that together define a latching mechanism 134s at an end of the clamping mechanism 130e. In some embodiments, a biasing member 133e (c. ., a torsion spring) resides between the pair of wing members 1326. In some embodiments, the biasing member 1336 is configured to move the latching mechanism 134e into an open position to receive a catheter 12 (z.e., when the opposing ends of the wing members 132e are forced together) and configured to move the latching mechanism 1346 into a closed position to grasp the catheter 12 (z.e., when the opposing ends of the wing members 132e are released). The wing members 132e are configured to grasp the catheter without increasing the risk of compressing the catheter 12 to hinder fluid flow / mechanical kinking. As shown in FIG. 11B, in some embodiments, the latching mechanism 134e may comprise one or more grip features 135e to help firmly hold an outer diameter surface of the catheter 12 within the latching mechanism 1346

[0083] Another secondary catheter securement device 200 according to embodiments of the present invention is illustrated in FIGS. 12A-12B and FIGS. 13A-13C. As described in further detail below, in some embodiments, the secondary securement device 200 is configured to grasp and hold the catheter hub 14 a sufficient distance D above the patient's skin S (see, e.g., FIG. 14D), thereby allowing 360° cleaning around the catheter insertion site IS, as well as the skin S underneath the catheter 12 and catheter hub 14.

[0084] As shown in FIGS. 12A-12B, in some embodiments, the secondary catheter securement device 200 includes a pad 210, a base 220, and a cantilevered member 230 coupled to the base 220. The pad 210 is configured to be secured to a patient's skin. In some embodiments, the pad 210 may be an adhesive pad. In some embodiments, a hinged joint 225 is formed at an end of the cantilevered member 230 that is coupled to the base 220. As shown in FIG. 12B, in some embodiments, at an opposing end of the hinged joint 225, the cantilevered member 230 comprisesa latching mechanism 232. The latching mechanism 232 is configured to grasp and hold a catheter 12 or a catheter hub 14 without increasing the risk of compressing the catheter 12 to hinder fluid flow / mechanical kinking. For example, in some embodiments, the latching mechanism 232 may comprise a recess 234 configured to receive a section of the catheter 12 or catheter hub 14. In some embodiments, the recess 234 may comprise one or more grip features 235 to further hold the section of the catheter 12 or catheter hub 14 within the recess 234. In some embodiments, the latching mechanism 232 may be configured to deflect such that the section of the catheter 12 or catheter hub 14 may be received within the recess 234 (e.g., a snap-fit feature that forms an interference fit therewith).

[0085] FIGS. 13A-13C are cross-sectional views of the base 220 of the secondary catheter securement device 200 illustrating an exemplary locking feature 231 that may be incorporated into the hinged joint 225 of the device 200, according to some embodiments of the present invention. In some embodiments, the base 220 of the secondary securement device 200 may comprise an internal recess 222. As shown in FIGS. 13A-13C, in some embodiments, as the cantilevered member 230 is raised (pivoted upwardly about the hinged joint 225), a portion 233 of the locking feature 231 may be configured to be received within the internal recess 222 of the base 220 (FIG. 13C). When the portion 233 is received within the internal recess 222, the cantilevered member 230 is locked in a raised position (see also, e.g., FIG. 14D).

[0086] FIGS. 14A-14F schematically illustrate exemplary steps for changing a dressing 25 (e.g., a transparent dressing 25b) for a catheter 12 using the secondary securement device 200 according to embodiments of the present invention. FIG. 14A shows a catheter hub 14 secured to a patient's skin S by a primary securement 20. A main catheter 12 is coupled to and extends from one end of the catheter hub 14 and inserted into the patient (e.g., a vein) at an insertion site IS. A transparent dressing 25b covers the insertion site IS, the catheter 12, the primary securement 20 and the catheter hub 14. FIG. 14B shows the dressing 25b removed.

[0087] FIG. 14C shows the secondary catheter securement device 200 affixed to the patient's skin S via the pad 210 and the cantilevered member 230 pivoted downwardly (about the hinged joint 225) such that the latching mechanism 232 engages (grasps) the catheter hub 14. As shown in FIG. 14C, in some embodiments, the pad 210 is positioned proximate to the catheter insertion site IS. Once the latching mechanism 232 has a firm hold of the catheter hub 14 (i.e., a segment of the catheter hub 14 is received by and secured within the recess 234 of the latchingmechanism 232), as shown in FIG. 14D, the cantilevered member 230 may be lifted (pivoted upwardly about the hinged joint 225) to raise the catheter hub 14 (and catheter 12) a sufficient distance D above the patient's skin S (or until the portion 233 of the locking feature 231 is received within the internal recess 222 of the base 220) to allow for site cleaning. After the cantilevered member 230 is locked in the raised / lifted position (FIG. 14D), the site around the catheter insertion site IS, as well as the skin S underneath the catheter 12 and catheter hub 14, may be cleaned (e.g., with a disinfecting applicator or swab).

[0088] After the site has been cleaned, as shown in FIG. 14E, a new primary securement device 20 is adhered to the skin S, and the cantilevered member 230 is pivoted downwardly (about the hinged joint 225) to lower the catheter hub 14 (and catheter 12) toward the new primary securement device 20. After the catheter hub 14 is secured to the new primary securement device 20, the secondary catheter securement device 200 may be removed, and a new transparent dressing 25b may be applied over the insertion site IS, the catheter 12, the catheter hub 14, and the primary securement 20 (FIG. 14F).

[0089] Referring now to FIGS. 15A-15D and FIGS. 16A-16L, another secondary catheter securement device 300 according to embodiments of the present invention is illustrated. Properties and / or features of the secondary catheter securement device 300 may be as described above in reference to the secondary catheter securement devices 1001-6 described herein and duplicate discussion thereof may be omitted herein for the purposes of discussing FIGS. 15A-15D and FIGS. 16A-16L

[0090] FIG. 15A illustrates the secondary catheter securement device 300 positioned on the neck N of a patient. FIG. 15B is an enlarged view of the secondary securement device 300 shown in FIG. 15A. As shown in FIG. 15B, according to embodiments of the present invention, and similar to other secondary catheter securement devices described herein, the secondary catheter securement device 300 may be positioned adjacent to the insertion site IS of the catheter 12 such that the insertion site IS resides between the device 300 and the primary securement device 20 (which, as described herein, is configured to hold / secure the catheter hub 14 while the catheter 12 is inserted into a patient).

[0091] FIG. 15C is an enlarged view of the secondary catheter securement device 300 of the present invention and FIG. 15D is an exploded view of the secondary securement device 300. As shown in FIGS. 15C-15D, in some embodiments, the secondary securement device 300 comprisesa pad 310, a base 320, a pair of arm members 324, 326, and a securing or clamping mechanism 330. The pad 310 is configured to secure the device 300 to the patient's skin S. In some embodiments, the pad 310 may be an adhesive pad. Similar to the pads 110i, IIO2 of other secondary securement devices 100i, IOO2 described herein, the pad 310 of the device 300 may comprise a recess 311 which allows the secondary securement device 300 to be positioned closer to the insertion site IS of the catheter 12 (see, e.g., FIG. 15C). In some embodiments, the base 322 of the device 300 may be coupled to or integral with the pad 310.

[0092] In some embodiments, the base 320 and arm members 324, 326 comprise corresponding securing features 322a, 322b. In some embodiments, when each arm member 324, 326 is secured to the base 320, the corresponding securing features 322a, 322b are configured engage with each other to form respective hinged joints 315. For example, in some embodiments, the base 320 may comprise a pair of recesses or apertures 322a and each arm member 324, 326 may comprise a protrusion 322b configured to be received by a respective recess / aperture 322a in the base 320, thereby allowing the arm members 324, 326 to pivotably move relative to the base 320. In some embodiments, the recesses / apertures 322a may reside on the arm members 324, 326 and corresponding protrusions 322b may reside on the base 320.

[0093] As shown in FIG. 15D, in some embodiments, each arm member 324, 326 comprises a respective recess 324r, 326r that when positioned together define an aperture 328 configured to receive a catheter 12 (see, e.g., FIG. 15C). In some embodiments, the inner surfaces of the recesses 324r, 326 may comprise an elastomeric compressible material. The elastomeric compressible material may help to prevent squeezing and / or kinking of the catheter lumen 12 when received by the recesses 324r, 326r (i.e., within the aperture 328). In addition, in some embodiments, an aperture 327 extends through one of the arm members 324 and into the recess 324r. As shown in FIG. 15C, and described in further detail below, the aperture 327 is sized and configured to receive the securing mechanism 330 (e.g., a rod) therethrough such that the securing mechanism 330 can secure the catheter 12 within the device 300.

[0094] FIGS. 16A-16L schematically illustrate exemplary steps for changing a dressing 25 for a catheter 12 using the secondary catheter securement device 300 according to embodiments of the present invention. FIG. 16A shows a catheter hub 14 adhered to a patient's skin S by a primary securement device 20. One or more catheter extension lines 12a, 12b are coupled to and extend from one end of the catheter hub 14 and the main catheter 12 is coupled to and extends from theopposing end of the catheter hub 14. The catheter 12 is inserted into the patient (e.g., a vein) at insertion site IS. A first dressing 25a (e.g., an antimicrobial hemostatic IV dressing) is applied over the catheter insertion site IS. A second, transparent dressing 25b is applied and covers the insertion site IS, the first dressing 25a, the catheter 12, the primary securement device 20, the catheter hub 14, and at least a portion of the catheter extension lines 12a, 12b. As shown in FIGS. 16B-16C, during dressing change, the first and second dressings 25a, 25b are removed such that the site may be cleaned (e.g., via a disinfecting applicator 30) around the insertion site IS, except for the skin S below the catheter 12 and the primary securement 20.

[0095] As shown in FIGS. 16D-16E, the secondary catheter securement device 300 is positioned adjacent to the insertion site IS. In some embodiments, the secondary securement device 300 is positioned such that the insertion site IS resides within the recess 311 of the pad 310 of the device 300. As shown in FIG. 16D, the secondary catheter securement device 300 is positioned on an opposing side of the insertion side IS as the catheter hub 14 and primary securement device 20 with the hinged axis aligned with the catheter insertion site IS. As shown in FIG. 16E, the arm members 324, 326 of the secondary securement device 300 are then lowered (pivoted downwardly via the hinged joint 315) toward the catheter 12. The catheter 12 is positioned between the recesses 324r, 326r of the arm members 324, 326. The securing mechanism 330 (e.g., a rod) is inserted into the aperture 327 extending through one of the arm members 324 until the securing mechanism 330 contacts an outer diameter of the catheter 12 residing within the aperture 328 and forces the catheter 12 against an inner surface of the recess 324r of the other arm member 324, thereby securing the catheter 12 in position within the aperture 328 and to the secondary securement device 300 (see also, e.g., FIGS. 17A-17B and FIGS. 18A-18B).

[0096] As shown in FIG. 16F, after the catheter 12 is firmly held by the securing mechanism 330 of the secondary securement device 300, the catheter hub 14 is released from the old primary securement device 20, and the old primary securement 20 is removed. The catheter 12 may then be raised (pivoted upwardly via the bi-stable hinged joints 315 of the device 300). As shown in FIG. 16G, the catheter 12 may be raised using the securing mechanism 330 (i.e., without the caretaker touching the catheter 12 and / or catheter hub 14). As shown in FIG. 16H, similar to other secondary catheter securement devices 1001-6 described herein, the secondary catheter securement device 300 of the present invention allows the catheter 12 and catheter hub 14 to be lifted a sufficient distance D relative to the patient's skin S to allow 360° cleaning (e.g., with a disinfectingapplicator 30) around the catheter insertion site IS, as well as the skin S underneath the catheter 12 and catheter hub 14. In some embodiments, the hinged joints 315 may be configured to lock the secondary securement device 300 (and catheter 12) in a lifted position, thereby allowing the caretaker the ability to use both hands to clean around the catheter insertion site IS.

[0097] As shown in FIG. 161, after cleaning has been performed, the catheter 12 is lowered (pivoted downwardly via the hinged joints 315 of the device 300) and the catheter hub 14 is secured in a new primary securement device 20. Once the catheter hub 14 is secured, the securing mechanism 330 may be released (e.g., removed from the aperture 327) and the secondary catheter securement device 300 may be removed (FIG. 16J). The site initial covered by the pad 310 of the secondary securement device 300 may then be cleaned (e.g., with the disinfecting applicator 30). Finally, as shown in FIGS. 16K-16L, new first and second dressings 25a, 25b are applied over the site.

[0098] FIGS. 17A-17B illustrate the operation of the securing mechanism 330 for the secondary catheter securement device 300 described herein. FIG. 17A shows the securing mechanism 330 in an unlatched position. As shown in FIG. 17A, in some embodiments, the securing mechanism 330 extends through the aperture 327 in one of the arm members 326. In some embodiments, the securing mechanism 330 and the arm member 326 form a sliding joint within the aperture 327. FIG. 17B shows the securing mechanism 330 in a latched position. As shown in FIG. 17B, as described above, the securing mechanism 330 contacts the outer diameter of the catheter 12 residing within the aperture 328 (formed by recesses 324r, 326r) and pushes the catheter 12 against an inner surface of the recess 324r of the other arm member 324, thereby securing the catheter 12 within the aperture 328 of the securement device 300. In some embodiments, the securing mechanism 330 may comprise a locking and / or anti-rotation feature 329 to further secure the catheter 12 within the aperture 328 of the secondary securement device 300.

[0099] FIGS. 18A-18B illustrate the operation of an alternative securing mechanism 330' that may be incorporated into the secondary catheter securement device 300 described herein. FIG. 18A shows the securing mechanism 330' in an unlatched position. As shown in FIG. 18A, in some embodiments, the securing mechanism 330' may be configured to be driven by a rack and pinion mechanism 329'. FIG. 18B shows the securing mechanism 330' in a latched position. The rack and pinion mechanism 329' is configured to traverse the securing mechanism 330' within theaperture 327 of the arm member 326. Similar to the securing mechanism 330, the securing mechanism 330' is configured to apply a force F that pushes the catheter 12 against the inner surface of the recess 324r of the other arm member 324, thereby securing the catheter 12 within the aperture 328 of the secondary securement device 300. In some embodiments, the securing mechanisms 330, 330' may be used to secure the catheter 12 within the device 300 for short term securement (e.g., dressing changes) and long-term securement (e.g., dwell-time).

[0100] Referring now to FIGS. 19A-19C, another secondary catheter securement device 400 according to embodiments of the present invention is illustrated. Properties and / or features of the secondary catheter securement device 400 may be as described above in reference to the secondary catheter securement device 200 as shown in FIGS. 12A-12B and duplicate discussion thereof may be omitted herein for the purposes of discussing FIGS. 19A-19C.

[0101] As described in further detail below, in some embodiments, the secondary catheter securement device 400 is configured to grasp and raise the catheter 12 a sufficient distance D above the patient's skin S (see, e.g., FIG. 19C), thereby allowing 360° cleaning around the catheter insertion site IS, as well as the skin S underneath the catheter 12 and catheter hub 14. In some embodiments, as shown in FIGS. 19A-19B, the secondary securement device 400 includes a pad 410, a base 420 and an extended arm member 430 coupled to the base 420. The pad 410 is configured to be secured to a patient's skin. For example, in some embodiments, the pad 410 is an adhesive pad.

[0102] In some embodiments, the base 420 has an arcuate recess 422 extending therein. As shown in FIG. 19A, the extended arm member 430 comprises a slider 432 that is configured to be received and held within the arcuate recess 422 in the base 420. As described further below, the slider 432 is configured to travel along a guided path within the recess 422 of the base 420. In some embodiments, at an opposing end of the slider 432, the extended arm member 430 comprises a latching mechanism 434. The latching mechanism 434 is configured to grasp and hold a catheter 12 or catheter hub 14 therein. For example, in some embodiments, the latching mechanism 434 may comprise a recess 436 configured to receive a section of the catheter 12 or catheter hub 14 and form an interference fit therewith to hold the catheter 12 or catheter hub 14 within the latching mechanism 434 without increasing the risk of compressing the catheter 12 to hinder fluid flow / mechanical kinking.

[0103] As shown in FIG. 19C, the secondary catheter securement device 400 is secured to the patient's skin adjacent to the catheter insertion site IS (e.g., via adhesion of an adhesive pad 410 or with microneedles). The slider 432 (at one end of the extended arm member 430) is secured within the recess 422 of the base 420 and the latching mechanism 434 (at the opposing end of the extended arm member 430) grasps the catheter 12. In some embodiments, the arcuate shape of the base 420 (and guided path of the recess 422) positions the secondary securement device 400 on the patient such that a constant radial distance R from the insertion site IS of the catheter 12 is maintained with the device 400, thereby ensuring that migration in and out of the insertion site IS by the catheter 12 does not occur as the catheter 12 is moved during site cleaning and dressing change.

[0104] Referring now to FIGS. 20A-20C and FIGS. 21A-21L, another secondary catheter securement device 500 according to embodiments of the present invention is illustrated. Properties and / or features of the secondary catheter securement device 500 may be as described above in reference to the other secondary catheter securement devices described herein and duplicate discussion thereof may be omitted herein for the purposes of discussing FIGS. 20A-21L.

[0105] As shown in FIGS. 20A-20C, in some embodiments, the secondary catheter securement device 500 may be configured to be used as an add-on feature to an existing disinfecting applicator 30 (e.g., BD Chloraprep™). As shown in FIGS. 20B-20C, in some embodiments, the device 500 may be configured be secured to an end 30e of the applicator 30 and latch onto the one or more catheter extension lines 12a, 12b coupled to and extending from one end of the catheter hub 14, thereby leveraging an existing disinfecting applicator 30 to support the catheter extension lines 12a, 12b during dressing change. Adhesive tape or bands 40 may be used to hold an applicator sponge 32 of the applicator 30 over the insertion site IS to help reduce the risk of movement by the catheter 12 during cleaning (see, e.g., FIG. 20C).

[0106] In some embodiments, the secondary securement device 500 comprises an annular main body 512 configured to receive an end of the applicator 30 therethrough (see, e.g., FIG. 20B). A clamp 514 extends outwardly from the main body 512. In some embodiments, the device 500 may be formed from a polymeric material which allows the clamp 514 to deflect open to receive and hold the catheter extension lines 12a, 12b therein. As shown in FIG. 20C, and described in further detail below, the secondary securement device 500 allows the catheter extension lines 12a, 12b(and catheter hub 14) to be held a sufficient distance D above the patient's skin S to allow for 360° site cleaning during dressing change.

[0107] FIGS. 21A-21L schematically illustrate exemplary steps for changing a dressing 25 for a catheter 12 using the secondary securement device 500 according to embodiments of the present invention. FIG. 21A shows the catheter hub 14 secured by the primary securement device 20. One or more catheter extension lines 12a, 12b are coupled to and extend from one end of the catheter hub 14 and the main catheter 12 extends from an opposing end of the catheter hub 14. The catheter 12 is inserted into the patient (e.g., a vein) at insertion site IS. A first dressing 25a (e.g., an antimicrobial hemostatic IV dressing) is applied over the insertion site IS of the catheter 12. A second, transparent dressing 25b is applied and covers the insertion site IS, the first dressing 25a, the catheter 12, the primary securement 20, the catheter hub 14, and at least a portion of the catheter extension lines 12a, 12b. As shown in FIGS. 21B-21C, during dressing change, the first and second dressings 25a, 25b are removed such that the site may be cleaned around the insertion site IS, except for the skin S below the catheter 12 and the primary securement device 20.

[0108] As shown in FIGS. 21D, the sponge 32 of the disinfecting applicator 30 is secured over the insertion site IS with adhesive tape or bands 40. Next, as shown in FIG. 21E, the catheter extension lines 12a, 12b are secured by the clamp 514 of the secondary securement device 500 (which promotes ANTT practice, i.e., the caretaker touches the device 500 without having to touch the extension lines 12a, 12b). After the catheter extension lines 12a, 12b are secured to the applicator 30 (via the device 500), the catheter hub 14 may be released from the primary securement device 20, and the main body 512 of the secondary securement device 500 is slid onto an end 30e of the applicator 30 (FIG. 21F).

[0109] As shown in FIG. 21G, when the catheter 12 is secured at the insertion site IS and catheter extension lines 12a, 12b are held by the secondary securement device 500, the old primary securement device 20 may be removed. As shown in FIG. 21H, similar to other secondary catheter securement devices described herein, the secondary catheter securement device 500 allows the catheter 12, catheter hub 14, and catheter extension lines 12a, 12b to be lifted a sufficient distance D relative to the patient's skin S to allow 360° cleaning of the skin S underneath the catheter 12 and catheter hub 14 (e.g., with another disinfecting applicator 35 such as a disinfectant swab).

[0110] As shown in FIG. 211, after cleaning has been performed, the catheter hub 14 is secured in a new primary securement device 20. Once the catheter hub 14 is secured in the primary securement device 20, the adhesive tape 40 and applicator 30 are removed from the catheter insertion site IS (FIG. 21J) and the site may be cleaned (e.g., with the disinfecting applicator 30) (FIG. 21K). Finally, as shown in FIG. 21L, new first and second dressings 25a, 25b are applied over the site.

[0111] Referring now to FIGS. 22A-22H, another secondary catheter securement device 600 and exemplary steps for changing a dressing 25 for a catheter 12 using the secondary securement device 600 according to embodiments of the present invention are illustrated. Properties and / or features of the secondary catheter securement device 600 may be as described above in reference to the secondary catheter securement device 500 described herein and duplicate discussion thereof may be omitted herein for the purposes of discussing FIGS. 22A-22H.

[0112] As shown in FIGS. 22A-22H, and similar to secondary securement device 500 described herein, the secondary securement device 600 may be configured to be used as an add-on feature to an existing disinfecting applicator 30 e.g., BD Chloraprep™). In some embodiments, the secondary securement device 600 is configured be secured to the applicator 30 and clamp onto the catheter extension lines 12a, 12b coupled to and extending from the catheter hub 14, thereby leveraging an existing disinfecting applicator 30 to support the catheter extension lines 12a, 12b during dressing change. Adhesive tape or bands 40 may be used to hold the applicator sponge 32 of the applicator 30 over the insertion site IS to help reduce the risk of movement by the catheter 12 during cleaning (see, e.g., FIGS. 22B-22G).

[0113] In some embodiments, the secondary catheter securement device 600 has a concave main body 610 (see, e.g., FIGS. 22C-22D). In some embodiments, the concave main body 610 is sized and configured to receive an outer diameter of the applicator 30. In some embodiments, one end of the main body 610 of the secondary securement device 600 is pivotably coupled to a lower end of applicator 30 via a hinge 615 (see, e.g., FIG. 22C). The opposing end of the secondary securement device 600 comprises a clamp 620. Similar to the clamp 514 of device 500, the clamp 620 of securement device 600 may be configured to deflect to receive and hold the catheter extension lines 12a, 12b therein without increasing the risk of compressing the catheter extension lines 12a, 12b to hinder fluid flow / mechanical kinking. In some embodiments, the secondary securement device 600 further comprises a securing mechanism 630 opposing the clamp 620. Thesecuring mechanism 630 is configured to releasably secure the device 600 to the applicator 30. Different securing mechanisms 630 may be used to releasably secure the device 600 to the applicator 30. For example, in some embodiments, the securing mechanism 630 may comprise a snap-fit feature configured to engage and / or form an interference fit with the outer diameter of the applicator 30. In other embodiments, the securing mechanism 630 may comprise a protrusion or like feature that is configured to be received by a corresponding recess or aperture in the applicator 30.

[0114] As shown in FIG. 22A, the catheter hub 14 is secured to the primary securement device 20. One or more catheter extension lines 12a, 12b are coupled to and extend from one end of the catheter hub 14 and the main catheter 12 is coupled to and extends from an opposing end of the catheter hub 14. The catheter 12 is inserted into the patient (e.g., a vein) at insertion site IS. In FIG. 22A, as previously described herein, the first and second dressings 25a, 25b have already been removed such that the site may be cleaned around the insertion site IS, except for the skin S below the catheter 12 and the primary securement device 20, and the sponge 32 of the disinfecting application 30 has been placed over the insertion site IS.

[0115] As shown in FIGS. 22B, the sponge 32 of the applicator 30 is secured over the insertion site IS with adhesive tape or bands 40. Next, as shown in FIG. 21C, the securing mechanism 630 of the device 600 is released from the applicator 30 and the main body 610 of the secondary catheter securement device 600 is pivoted downwardly (lowered) via the hinge 615 toward the catheter extension lines 12a, 12b. The catheter extension line 12a, 12b are secured within the clamp 620 of the secondary securement device 600 without increasing the risk of compressing the catheter extension lines 12a, 12b to hinder fluid flow / mechanical kinking. This helps to promote ANTT practice, i.e., the caretaker only touches the secondary securement device 600 without having to touch the catheter extension lines 12a, 12b. As shown in FIG. 22D, after the catheter extension lines 12a, 12b are secured within the clamp 620 of the secondary securement device 600, the catheter hub 14 may be released from the old primary securement device 20, and the main body 610 of the secondary securement device 600 is pivoted upwardly (raised) via the hinge 615 toward the applicator 30. A length of the applicator 30 is received by the concave main boy 610 of the device 600 and, in some embodiments, the securing mechanism 630 secures an end of the device 600 to the applicator 30 (FIG. 22E).

[0116] As shown in FIG. 22F, when the catheter 12 is secured near the insertion site IS and the catheter hub 14 and catheter extension lines 12a, 12b are held by the clamp 620 of secondary securement device 600 (and against the applicator 30), the primary securement device 20 is removed. Similar to other catheter securement devices described herein, the secondary securement device 600 allows the catheter 12, catheter hub 14, and catheter extension lines 12a, 12b to be lifted a sufficient distance D relative to the patient's skin S to allow 360° cleaning (e.g., with another disinfecting applicator 35) of the skin S underneath the catheter 12 and catheter hub 14.

[0117] As shown in FIG. 22G, after cleaning has been performed, the securing mechanism 630 of the secondary securement device 600 is released from the applicator 30 and the main body 610 of the device 600 is pivoted downwardly (lowered) via the hinge 615 and the catheter hub 14 is secured in a new primary securement device 20. Once the catheter hub 14 is secured, the adhesive tape 40 and applicator 30 are removed from the insertion site IS and the site around the insertion site IS of the catheter 12 may be cleaned (e.g., with the disinfecting applicator 30) (FIG. 22H). Finally, as previously described, new first and second dressings 25a, 25b are applied over the site.

[0118] Referring now to FIGS. 23A-23G, another secondary catheter securement device 700 and exemplary steps for changing a dressing 25 for a catheter 12 using the secondary securement device 700 according to embodiments of the present invention are illustrated. Properties and / or features of the secondary securement device 700 may be as described above in reference to the secondary securement device 500 described herein and duplicate discussion thereof may be omitted herein for the purposes of discussing FIGS. 23A-23G.

[0119] As shown in FIGS. 23A-23G, and similar to secondary catheter securement devices 500, 600 described herein, the secondary catheter securement device 700 may be configured to be used as an add-on feature to an existing disinfecting applicator 30. In some embodiments, the secondary securement device 700 is configured be secured to the applicator 30 and clamp onto the catheter extension lines 12a, 12b extending from the catheter hub 14, thereby leveraging an existing disinfecting applicator 30 to support the catheter extension lines 12a, 12b during dressing change. Adhesive tape or bands 40 may be used to hold the applicator sponge 32 of the applicator 30 over the insertion site IS to help reduce the risk of movement by the catheter 12 during cleaning.

[0120] In some embodiments, similar to the secondary securement device 500 described herein, the secondary securement device 700 may comprise an annular main body 710 configured to receive an end of the applicator 30 therethrough. A clamp 720 extends outwardly from the mainbody 710. In some embodiments, the secondary securement device 700 may be formed from a polymeric material which allows the clamp 720 to deflect to receive and hold the catheter extension lines 12a, 12b therein. As shown in FIG. 23C, and described in further detail below, the secondary securement device 700 allows the catheter extension lines 12a, 12b (and catheter hub 14) to be held a sufficient distance D above the patient's skin S to allow for 360° site cleaning during dressing

[0121] In some embodiments, the secondary securement device 700 may differ from the secondary securement device 500 in the location that the device 700 is positioned on the applicator 30 (i.e., other than at the end of the applicator 30, as described above). For example, as shown in FIG. 23A, in some embodiments, the main body 710 of the secondary securement device 700 may be configured to be held along the length of the applicator 30 between a pair of annular rings 31 (or within a recess). In some embodiments, the annular rings 31 may be configured to prevent the secondary securement device 700 from sliding or moving along the length of the applicator 30.

[0122] As shown in FIG. 23A, the catheter hub 14 is secured by the primary securement device 20. One or more catheter extension lines 12a, 12b are coupled to and extend from one end of the catheter hub 14 and the main catheter 12 is coupled to and extends from an opposing end of the catheter hub 14. The catheter 12 is inserted into the patient (e.g., a vein) at insertion site IS. In FIG. 23A, as previously described herein, the first and second dressings 25a, 25b have already been removed such that the site may be cleaned around the insertion site IS, except for the skin S below the catheter 12 and the primary securement 20, and the sponge 32 of the disinfecting application 30 has been placed over the insertion site IS.

[0123] As shown in FIGS. 23B, the sponge 32 of the applicator 30 is secured over the insertion site IS with adhesive tape or bands 40. Next, as shown in FIG. 23C, the catheter hub 14 is released from the primary securement device 20, and the catheter hub 14 and catheter extension lines 12a, 12b are lifted toward the applicator 30. As shown in FIG. 23D, the main body 710 of the secondary securement device 700 is rotated relative to the applicator 30 to engage the clamp 720 with the catheter extension lines 12a, 12b.

[0124] As shown in FIG. 23E, with the catheter 12 secured near the insertion site IS and the catheter hub 14 and catheter extension lines 12a, 12b held by the clamp 720 of secondary securement device 700, the old primary securement device 20 is removed. Similar to othersecurement devices described herein, the secondary securement device 700 allows the catheter 12, catheter hub 14, and catheter extension lines 12a, 12b to be lifted a sufficient distance D relative to the patient's skin S to allow 360° cleaning (e.g., with another disinfecting applicator 35 such as a disinfectant swab) of the skin S underneath the catheter 12 and catheter hub 14.

[0125] As shown in FIG. 23F, after cleaning has been performed, the catheter extension lines 12a, 12b are released from the clamp 720 of the secondary securement device 700 and the catheter hub 14 is secured in a new primary securement device 20. Once the catheter hub 14 is secured, the adhesive tape 40 and applicator 30 are removed from the insertion site IS and the site around the insertion site IS of the catheter 12 may be cleaned (e.g., with the disinfecting applicator 30) (FIG. 23G). Finally, as previously described, new first and second dressings 25a, 25b are placed over the site.

[0126] Referring now to FIGS. 24A-24H, another secondary catheter securement device 800 and exemplary steps for changing a dressing 25 for a catheter 12 using the secondary securement device 800 according to embodiments of the present invention are illustrated. Properties and / or features of the secondary catheter securement device 800 may be as described above in reference to the secondary catheter securement device 500 described herein and duplicate discussion thereof may be omitted herein for the purposes of discussing FIGS. 24A-24H.

[0127] As shown in FIGS. 24A-24H, and similar to secondary securement devices 500, 600, 700 described herein, the secondary securement device 800 may be configured to be used as an add-on feature to an existing disinfecting applicator 30. In some embodiments, the secondary securement device 800 is configured be secured to the applicator 30 and clamp onto the catheter extension lines 12a, 12b extending from the catheter hub 14, thereby leveraging an existing disinfecting applicator 30 to support the catheter extension lines 12a, 12b during dressing change. Adhesive tape or bands 40 may be used to hold the applicator sponge 32 of the applicator 30 over the insertion site IS to help reduce the risk of movement by the catheter 12 during cleaning.

[0128] In some embodiments, the secondary catheter securement device 800 comprises a main body 810 having a recess or cavity 812 configured to receive an end of the applicator 30 (see, e.g., FIG. 24D). The secondary securement device 800 further comprises clamping mechanism 820 coupled to the main body 810. In some embodiments, the clamping mechanism 820 comprises one or more recesses 822. Each recess 822 is sized and configured to receive and hold (e.g., form an interference fit with) a respective catheter extension line 12a, 12b. In some embodiments, thesecondary securement device 800 may be formed from a polymeric material which allows the recesses 822 to deflect open to receive and hold the catheter extension lines 12a, 12b therein. As shown in FIG. 24E, and described in further detail below, the secondary securement device 800 allows the catheter extension lines 12a, 12b (and catheter hub 14) to be held a sufficient distance D above the patient's skin S to allow for 360° site cleaning during dressing change.

[0129] As shown in FIG. 24A, the catheter hub 14 is secured by the primary securement device 20. One or more catheter extension lines 12a, 12b are coupled to and extend from one end of the catheter hub 14 and the main catheter 12 is coupled to and extends from an opposing end of the catheter hub 14. The catheter 12 is inserted into the patient (e.g., a vein) at insertion site IS. In FIG. 24A, as previously described herein, the first and second dressings 25a, 25b have already been removed such that the site may be cleaned around the insertion site IS, except for the skin S below the catheter 12 and the primary securement 20, and the sponge 32 of the disinfecting application 30 has been placed over the insertion site IS.

[0130] As shown in FIGS. 24B, the sponge 32 of the applicator 30 is secured over the insertion site IS with adhesive tape or bands 40. Next, as shown in FIGS. 24C-24D, the catheter hub 14 is released from the old primary securement device 20, and the catheter hub 14 and catheter extension lines 12a, 12b are lifted toward the applicator 30. Each catheter extension line 12a, 12b is received by, and secured within, the securing mechanism 820 (e.g., each extension line 12a, 12b is secured within a respective recess 822) of the secondary securement device 800.

[0131] As shown in FIG. 24E, with the catheter 12 secured near the insertion site IS and the catheter hub 14 and catheter extension lines 12a, 12b held by the secondary securement device 800, the old primary securement device 20 is removed. Similar to other secondary catheter securement devices described herein, the secondary catheter securement device 800 allows the catheter 12, catheter hub 14, and catheter extension lines 12a, 12b to be lifted a sufficient distance D relative to the patient's skin S to allow 360° cleaning (e.g., with another disinfecting applicator 35 such as a disinfectant swab) of the skin S underneath the catheter 12 and catheter hub 14.

[0132] As shown in FIG. 24F, after cleaning has been performed, the catheter extension lines 12a, 12b are released from the securing mechanism 820 of the device 800 and the catheter hub 14 is secured in a new primary securement device 20. Once the catheter hub 14 is secured, the adhesive tape 40 and applicator 30 are removed from the insertion site IS and the site around theinsertion site IS of the catheter 12 may be cleaned (e.g., with the disinfecting applicator 30) (FIG. 24G). Finally, as shown in FIG. 24H, new first and second dressings 25a, 25b are placed over the site.

[0133] The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. The invention is defined by the following claims, with equivalents of the claims to be included therein.

Claims

What is claimed is:

1. A catheter securement device, comprising: a pad configured to be secured to a patient's skin; and a clamping mechanism pivotably coupled to the pad and configured to grasp and hold a catheter without increasing the risk of compressing the catheter to hinder fluid flow / mechanical kinking therein, wherein pivoting of the clamping mechanism allows the catheter to be lifted a sufficient distance relative to the patient's skin to allow for cleaning thereof.

2. The catheter securement device of Claim 1, wherein the pad is an adhesive pad.

3. The catheter securement device of Claim 1, wherein the pad comprises a recess, and wherein an insertion site of the catheter is positioned within the recess when the pad is secured to the patient's skin.

4. The catheter securement device of Claim 1, wherein the pad comprises a pair of arms extending upwardly therefrom, each arm configured to engage a section of the clamping member to from a hinged joint.

5. The catheter securement device of Claim 1, wherein the clamping mechanism comprises a pair of wing members that are coupled together to form a latching mechanism, the latching mechanism sized and configured to grasp and hold different sizes of catheters therein.

6. The catheter securement device of Claim 5, wherein an inner wall of the latching mechanism comprises a grip feature.

7. The catheter securement device of Claim 5, wherein an outer surface of each wing member comprises one or more grip features.

8. The catheter securement device of Claim 1, wherein the pad and the clamping mechanism are integrally formed as a single component.

9. The catheter securement device of Claim 1, wherein the pad comprises an extension member, and the clamping mechanism is coupled to the extension member.

10. The catheter securement device of Claim 1, wherein, when positioned to grasp the catheter, the clamping mechanism extends along a plane that is generally perpendicular to the pad.

11. The catheter securement device of Claim 9, wherein, when positioned to grasp the catheter, the clamping mechanism extends along a plane that is generally parallel to the pad.

12. The catheter securement device of Claim 4, wherein the hinged joint comprises a locking feature configured to secure the clamping mechanism at the distance above the patient's skin.

13. The catheter securement device of Claim 5, wherein the clamping mechanism comprises a biasing member residing between the pair of wing members.

14. A catheter securement device, comprising: a pad configured to be secured to a patient's skin; a base coupled to the pad; and a cantilevered member pivotably coupled to the base at one end and comprising a latching mechanism at an opposing end, the latching mechanism configured to grasp and hold a catheter therein, wherein pivoting of the cantilevered member allows the catheter to be lifted a sufficient distance above the patient's skin to allow for cleaning thereof.

15. The catheter securement device of Claim 14, wherein the pad is an adhesive pad.

16. The catheter securement device of Claim 14, wherein the latching mechanism comprises a recess configured to receive the section of the catheter and form an interference fit therewith.

17. The catheter securement device of Claim 14, wherein the cantilevered member comprises a first locking feature and the base comprises a second locking feature, and wherein the cantilevered member is configured to be held in a lifted position when the first locking feature engages with the second locking feature.

18. The catheter securement device of Claim 17, wherein the second locking feature is an internal recess and the first locking feature is configured to be received by the internal recess.

19. A catheter securement device, comprising: a pad configured to be secured to a patient's skin; a base coupled to the pad; a pair of arm members pivotably coupled to the base, each arm member comprises a recessed end that together define a first aperture configured to receive a catheter therethrough, wherein one of the arm members comprises a second aperture extending into the respective recessed end; and a securing mechanism configured to be received through the second aperture to secure the catheter within the first aperture, wherein, when the catheter is secured within the first aperture by the securing mechanism, the pair of arm members is configured to lift the catheter a sufficient distance above the patient's skin to allow for cleaning thereof.

20. The catheter securement device of Claim 19, wherein the pad is an adhesive pad.

21. The catheter securement device of Claim 19, wherein the pad comprises a recess, and wherein an insertion site of the catheter is positioned within the recess when the pad is secured to the patient's skin.

22. The catheter securement device of Claim 19, wherein the base is integrally formed with the pad.

23. The catheter securement device of Claim 19, wherein the base and each arm member comprise corresponding securing features that are configured to engage with each other to form respective hinged joints to allow pivotable movement of the arm members relative to the base.

24. The catheter securement device of Claim 19, wherein an inner surface of each recessed end of the arm members comprise an elastomeric compressible material.

25. The catheter securement device of Claim 19, wherein the securing mechanism and one of the arm members forms a sliding joint with the second aperture.

26. The catheter securement device of Claim 19, wherein the securing mechanism is a rod comprising an anti-rotation feature.

27. The catheter securement device of Claim 19, wherein the securing mechanism comprises a rack and pinion mechanism configured to traverse the clamping mechanism within the second aperture.

28. A catheter securement device, comprising: a pad configured to be secured to a patient's skin; a base coupled to the pad, the base comprising an arcuate recess; and an extended arm member, the extended arm member comprising a slider at one end configured to travel along a guided path within the arcuate recess of the base and a latching mechanism at an opposing end, wherein the latching mechanism is configured to grasp and hold a catheter therein such that the catheter can be held a sufficient distance above the patient's skin to allow for cleaning thereof.

29. The catheter securement device of Claim 28, wherein the pad is an adhesive pad.

30. The catheter securement device of Claim 28, wherein the latching mechanism comprises a recess configured to receive a section of the catheter and form an interference fit therewith.

31. The catheter securement device of Claim 28, wherein the arcuate recess positions the secondary catheter securement device on the patient's skin such that a constant radial distance from an insertion site of the catheter is maintained with the secondary catheter securement device.

32. A catheter securement assembly, the assembly comprising: a disinfectant applicator; a catheter securement device, the device comprising: a main body; and a clamp coupled to and extending outwardly from the main body, the clamp configured to receive and hold one or more catheter extension lines therein, wherein an end of the disinfectant applicator is received by the main body of the catheter securement device to secure the catheter securement device to the disinfectant applicator, and wherein the catheter securement device is configured to hold the one or more catheter extension lines a sufficient distance above the patient's skin to allow for cleaning thereof.

33. The catheter securement assembly of Claim 32, wherein the catheter securement device has an annular main body, the annular main body configured to receive the end of the disinfectant applicator therethrough.

34. The catheter securement assembly of Claim 33, wherein the catheter securement device is positioned along a length of the disinfectant applicator and configured to rotate about the disinfectant applicator to engage the one or more catheter extension lines.

35. The catheter securement assembly of Claim 32, wherein the catheter securement device is formed of a polymeric material which allows the clamp to deflect open to receive and hold the one or more catheter extension lines therein.

36. The catheter securement assembly of Claim 32, wherein the catheter securement device has a concave main body sized and configured to receive an outer diameter of the disinfectant applicator, wherein the clamp resides at one end of the main body and the opposing end of the main body is pivotably coupled to a lower end of the disinfectant applicator.

37. The catheter securement assembly of Claim 32, wherein the clamp comprises a plurality of recesses, each recess configured to receive and hold a respective catheter extension line.

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