Non-tethered catheter storage system

Abstract

A catheter containment system configured to hold a proximal portion of a catheter placement system (100) within a sterile field, relieving the clinician from holding the proximal portion and preventing the proximal portion from falling outside the sterile field. Additionally, the proximal portion can be secured out of the insertion site to provide a clear view. The embodiment includes a body (210) having a channel (214) configured to releasably engage an extension leg (162) or guidewire, and a securing mechanism (220) for securing the body to a portion of a drape or similar in the sterile field. Exemplary securing mechanisms can include clips, clasps, pins, magnetic elements, adhesives, twist ties, zip ties, snap fasteners, hook and loop attachments, mechanical gripping devices, or adhesive pads. The system can further include a securing tab that can be adhered to a drape to provide a securing point.

Description

[Background technology]

[0001] Central venous catheters (CVCs) are typically introduced into a patient's body by the Seldinger technique and advanced within the patient's vasculature. The Seldinger technique involves many steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, CVCs, etc.). Although the Seldinger technique is effective, many of the steps are time consuming and the handling of numerous medical devices is cumbersome, both of which can cause trauma to the patient and increase the risk of infection. Due to the large number of medical devices that need to be replaced during the Seldinger technique, the potential for contamination through contact is relatively high. Thus, advanced catheter placement systems have been developed to reduce the number of steps and medical devices involved in placing a catheter such as a CVC in a patient's body.

[0002] An exemplary advanced catheter placement system can include, for example, a rapidly insertable central catheter (RICC) placement system, which includes a distally disposed single lumen access section having a first diameter, a proximally disposed multi-lumen catheter section having a second diameter larger than the first diameter, and a tapered extension section disposed therebetween and extending between the first and second diameters.

[0003] Whether using the traditional Seldinger technique or the RICC placement system, clinicians are often required to stabilize the proximal portions of the catheter placement system (e.g., hub, extension legs, guidewire, etc.) while placing the distal tip of the catheter within the vasculature. This prevents these proximal portions of the catheter placement system from becoming tangled or falling outside the sterile field. However, holding these proximal portions may reduce the clinician's dexterity, cause tangling, or complicate the procedure. Furthermore, these proximal portions run the risk of falling outside the sterile field, contaminating the device, or causing the clinician to abort the placement procedure. Therefore, what is needed is a catheter containment system that allows the clinician to secure the proximal portions of the catheter placement system during placement without reducing the clinician's dexterity and mitigating the proximal portions from falling outside the sterile field. The embodiments disclosed herein are directed to addressing at least the above. Summary of the Invention

[0004] Disclosed herein is a catheter containment system for retaining a portion of the catheter placement system within a sterile field, the containment device including a body defining a channel extending longitudinally along a first axis, the channel configured to retain a portion of the catheter placement system, the body having an opening extending longitudinally and configured to allow entry or exit along a second axis extending at an angle to the first axis of the channel, and a fixation mechanism coupled to the body and configured to releasably engage a portion of the sterile field adjacent an insertion site.

[0005] In some embodiments, the portion of the catheter placement system includes one of a catheter body, a catheter hub, an extension leg, a luer lock, or a guidewire. In some embodiments, the body includes a first channel configured to hold the first extension leg and a second channel configured to hold the second extension leg.

[0006] In some embodiments, the body includes a first channel configured to hold the first extension leg and the second extension leg. In some embodiments, the catheter placement system includes a RICC catheter placement system for placing a rapid insertion central venous catheter.

[0007] In some embodiments, the body is rotatably, hingedly, or pivotally coupled to the securing mechanism. In some embodiments, the fastening mechanism includes one of a spring clip, a butterfly clip, a beret clip, an alligator clip, a clothes peg, a safety pin, or a suction cup.

[0008] In some embodiments, the catheter storage system further includes an anchor having a foot plate and a tab extending at an angle relative to the foot plate, the foot plate including an adhesive layer, and the tab configured to be engaged by the securing mechanism.

[0009] In some embodiments, the securing mechanism includes a first clip member hingedly coupled to a second clip member, the first clip member including a first gripping mechanism configured to engage a second gripping mechanism of the second clip member to secure the containment device to a portion of the sterile field.

[0010] In some embodiments, the locking mechanism further includes a biasing member configured to bias the locking mechanism to the closed position, the biasing member including one of a spring, a compression spring, a leaf spring, an O-ring, a rubber grommet, or a magnetic element.

[0011] In some embodiments, the catheter containment system further includes a base coupled to both the body and the fixation mechanism, the fixation mechanism including a first coupling portion disposed on the base and a second coupling portion disposed over a portion of the sterile field.

[0012] In some embodiments, the fastening mechanism includes one of a hook and loop fastener, a snap fastener, a magnetic element, or an adhesive. In some embodiments, the securing mechanism comprises a tie selected from the group consisting of a string, a cord, a wire, a twist tie, or a zip tie.

[0013] In some embodiments, the fixation mechanism includes a hook slidably engaged with the sleeve, the hook having an arm having a finger plate disposed at a first end of the arm and a J-hook disposed at a second end of the arm opposite the finger plate, and configured to receive a portion of the sterile field between the J-hook and the sleeve.

[0014] In some embodiments, the securing mechanism includes a sleeve and two or more hooks slidably engaged to the sleeve, each of the two or more hooks being slidable between a retracted position, an open position, and a closed position.

[0015] Also disclosed herein is a catheter placement and containment system for placing a catheter within a patient's vasculature, the catheter placement and containment system including a catheter placement device having a needle, a catheter including an extension leg, and a guidewire, a sterile drape configured to define a sterile field around an insertion site, and a catheter containment system having a body defining a channel and configured to engage a portion of the catheter placement device, and a securing mechanism coupled to the body and configured to secure the catheter containment system to the sterile drape.

[0016] In some embodiments, the fastening mechanism includes one of a spring clip, a butterfly clip, a beret clip, an alligator clip, a clothes peg, a safety pin, or a suction cup. In some embodiments, the system further includes an anchor having a foot plate and a tab extending at an angle relative to the foot plate, the foot plate including an adhesive layer, and the tab configured to be engaged by the fastening mechanism.

[0017] In some embodiments, the system further includes a base coupled to both the body and the securing mechanism, the securing mechanism including a first coupling portion disposed on the base and a second coupling portion disposed on the sterile drape.

[0018] In some embodiments, the fastening mechanism includes one of a hook and loop fastener, a snap fastener, a magnetic element, or an adhesive. Also disclosed is a method of placing a catheter, the method including providing a catheter placement system including a needle, a catheter, and a guidewire, releasably engaging a portion of the catheter placement system with a catheter containing device, securing the catheter containing device to a portion of a sterile field, and placing the catheter into the vasculature through an insertion site within the sterile field.

[0019] In some embodiments, the method further includes adhering a portion of the catheter placement system to a top surface of the catheter containing device, the catheter containing device including a flexible pad coupled to a portion of the sterile field.

[0020] In some embodiments, the catheter containment device comprises one of a spring clip, a butterfly clip, a beret clip, an alligator clip, a clothes peg, a safety pin, a suction cup, a string, a cord, a wire, a twist tie, or a zip tie.

[0021] Also disclosed is a catheter containment device for holding a portion of a catheter placement system, the catheter containment device including a body extending along a longitudinal axis and defining a channel configured to permanently hold a portion of the catheter placement system, and a handle coupled to the body and configured to releasably engage a portion of the sterile field adjacent an insertion site.

[0022] In some embodiments, a portion of the catheter placement system includes a proximal end of a guidewire that is permanently affixed to the body. In some embodiments, a portion of the catheter placement system includes a proximal portion of a guidewire slidably engaged with the body.

[0023] A more particular description of the present disclosure will be made by reference to specific embodiments that are illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and should not be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0024] [Figure 1A] FIG. 1 is a perspective view illustrating a catheter placement system in an unfolded configuration according to an embodiment disclosed herein. [Figure 1B] FIG. 1 is a top view of a catheter placement system in a folded configuration ready for use, according to an embodiment disclosed herein. [Diagram 2] FIG. 1B is a side view illustrating the catheter placement system of FIG. 1A in an unfolded configuration according to an embodiment disclosed herein. [Figure 3A] 3 is an enlarged detail view of a distal portion of the catheter of FIG. 2 according to an embodiment disclosed herein. [Figure 3B] 3B is a cross-sectional view of the catheter of FIG. 3A according to an embodiment disclosed herein. [Figure 3C] 3B is a cross-sectional view of the catheter of FIG. 3A according to an embodiment disclosed herein. [Figure 4A] FIG. 1 is a perspective view of a spring clip catheter containment system according to an embodiment disclosed herein. [Figure 4B] FIG. 4B illustrates the catheter containment system of FIG. 4A in an exemplary environment of use, according to an embodiment disclosed herein. [Figure 4C] FIG. 4B is an enlarged detail view of the catheter containment system of FIG. 4A according to an embodiment disclosed herein. [Diagram 5]FIG. 2 illustrates a proximal portion of an exemplary catheter placement system, according to an embodiment disclosed herein. [Figure 6A] FIG. 1 is a perspective view of a catheter containment system according to an embodiment disclosed herein. [Figure 6B] FIG. 1 is a perspective view of a catheter containment system according to an embodiment disclosed herein. [Figure 6C] FIG. 1 is a perspective view of a catheter containment system according to an embodiment disclosed herein. [Figure 6D] 1A-1C illustrate an exemplary method of use of a catheter containment system according to embodiments disclosed herein. [Figure 7A] FIG. 1 is a perspective view illustrating an anchor of a catheter containment system according to an embodiment disclosed herein. [Figure 7B] 1 is a perspective view of an anchor in a first configuration according to an embodiment disclosed herein. FIG. [Figure 7C] 1 is a perspective view of an anchor in a second configuration according to an embodiment disclosed herein. FIG. [Figure 7D] FIG. 1 illustrates a catheter containment system including an anchor in an exemplary environment of use, according to an embodiment disclosed herein. [Figure 8A] FIG. 1 illustrates a catheter containment system according to an embodiment disclosed herein. [Figure 8B] FIG. 1 illustrates a catheter containment system according to an embodiment disclosed herein. [Figure 8C] FIG. 1 is an enlarged detail view showing a catheter containment system including a releasable coupling according to an embodiment disclosed herein. [Figure 8D] FIG. 1 is an enlarged detail view showing a catheter containment system including a tie according to an embodiment disclosed herein. [Figure 8E] FIG. 1 illustrates a proximal portion of a catheter placement system including a catheter containment system coupled thereto, according to an embodiment disclosed herein. [Figure 9A] FIG. 1 is a perspective view of a catheter containment system according to an embodiment disclosed herein. [Figure 9B] 1 is a cross-sectional view illustrating a catheter containment system according to an embodiment disclosed herein. [Figure 9C] 1A-1C illustrate an exemplary method of use for a catheter containment system according to embodiments disclosed herein. [Figure 9D] 1A-1C illustrate an exemplary method of use for a catheter containment system according to embodiments disclosed herein. [Figure 9E] 1A-1C illustrate an exemplary method of use for a catheter containment system according to embodiments disclosed herein. [Figure 10A] 1A-1C illustrate an exemplary method of use for a catheter containment system according to embodiments disclosed herein. [Figure 10B] 1A-1C illustrate an exemplary method of use of a catheter containment system according to embodiments disclosed herein. [Figure 10C] 1A-1C illustrate an exemplary method of use of a catheter containment system according to embodiments disclosed herein. [Figure 11] FIG. 1 illustrates a proximal portion of a catheter placement system including a catheter containment system coupled thereto, according to an embodiment disclosed herein. [Figure 12A] FIG. 1 illustrates a catheter containment system in an exemplary environment of use, according to an embodiment disclosed herein. [Figure 12B] FIG. 12B is a side view of the catheter containment system of FIG. 12A according to an embodiment disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0026] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "upper", "lower", "front", "rear", etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "said" also include plural references unless the context clearly dictates otherwise.

[0027] In the above description, the terms "or" and "and / or" as used herein shall be construed as meaning inclusive or any one or any combination. As an example, "A, B or C" or "A, B and / or C" means "any of the following: A only, B only, C only, A and B, A and C, B and C, and A, B and C." Exceptions to this definition occur only when combinations of elements, components, features, steps, or acts are in some way inherently mutually exclusive.

[0028] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a needle includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, but the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless otherwise suggested by context, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0029] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, the "distal end" of a needle includes the end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Although a distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0030] In describing the embodiment, as shown in FIG. 1A, a longitudinal axis extends substantially parallel to the axial length of the catheter. A lateral axis extends perpendicular to the longitudinal axis, and a transverse axis extends perpendicular to both the longitudinal and lateral axes. A horizontal plane may be defined by the lateral and longitudinal axes. A vertical plane extends perpendicular to the horizontal plane.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. 1A-1B illustrate an exemplary catheter placement system 100, generally including a needle 120, a guidewire 130, a blood flush system 140, a catheter 150, and a needle housing 170. FIG. 1A illustrates the system 100 in a non-folded configuration for ease of illustration. FIG. 1B illustrates a top view of the system 100 in a folded configuration ready for use. In one embodiment, the catheter placement system 100 may be a Rapidly Insertable Central Catheter (RICC) placement system 100 configured to place a RICC 150. However, it will be understood that other catheter placement systems configured to place other types of catheters are also contemplated. Exemplary catheters 150 also include peripheral intravenous (PIV) catheters, peripherally inserted central catheters (PICCs), central venous catheters (CVCs), midline catheters, dialysis catheters, single lumen catheters, multi-lumen catheters, and the like.

[0032] In one embodiment, the catheter 150 generally includes a catheter body 152 supported at a proximal end by a catheter hub (hub) 160. The hub 160 includes one or more extension legs 162 extending proximally from the hub 160 and includes a fluid coupling device, such as a luer lock 164, disposed at a proximal end of one of the one or more extension legs 162. The luer lock 164 is configured to couple the extension leg with a medical fluid line, a syringe, or the like. Each of the one or more extension legs 162 can be in fluid communication with a lumen of the catheter 152. For example, a first extension leg 162A is in fluid communication with the proximal lumen 114A, a second extension leg 162B is in fluid communication with the middle lumen 114B, and a third extension leg 162C is in fluid communication with the distal lumen 114C. The catheter body 152 includes a distally disposed access section 154, a proximally disposed catheter section 156, and an extension section 158 disposed therebetween. The access section 154 defines a single lumen and has a first outer diameter, and the catheter section 156 defines two or more lumens and has a second diameter greater than the first diameter. The extension section 158 disposed between the access section 154 and the catheter section 156 defines a tapered outer profile that extends from the first diameter of the access section 154 to the second diameter of the catheter section 156. The guidewire 130 can extend through the lumen of the catheter 150 from the proximal end of the extension leg 162 to the distal tip of the access section 154.

[0033] 2 shows further details of an exemplary catheter 150 of the system 100. In one embodiment, different sections of the catheter 150 are required to perform different functions and therefore are required to exhibit different mechanical properties. For example, the access section 154 and the expansion section 158 can be provided with stiffer mechanical properties or a harder durometer material relative to the catheter section 156. Thus, the access section 154 and the expansion section 158 can withstand greater axial forces without kinking or collapsing as the sections are forced distally to form and expand the insertion site 50. The catheter section 156 can be formed of a softer durometer material or a more flexible material to facilitate passing the catheter section 156 through tortuous vascular pathways.

[0034] 3A-3C show further details of a distal portion of catheter 150, including access section 154, catheter section 156, and extension section 158. In one embodiment, catheter section 156 includes proximal lumen 114A terminating at proximal lumen opening 116A and intermediate lumen 114B terminating at intermediate lumen opening 116B. In one embodiment, each of proximal lumen aperture 116A and intermediate lumen aperture 116B extends through a sidewall of catheter section 156. In one embodiment, each of proximal lumen aperture 116A and intermediate lumen aperture 116B is disposed proximal to extension section 158. In one embodiment, proximal lumen aperture 116A may be disposed proximal to intermediate lumen aperture 116B. In one embodiment, the proximal lumen aperture 116A and the intermediate lumen aperture 116B may be positioned equidistant from the distal tip of the catheter 150.

[0035] FIG 3B shows a cross-sectional view of the catheter body 152 at point "A" in FIG 3A. As shown, the access section 154 defines a single lumen and a relatively smaller outer diameter. In one embodiment, a proximal portion of the access section 154 may be received within a distal portion of the extension section 158. The distal lumen 114C of the catheter 150 may extend to the distal tip 118 of the catheter 150 and communicate with the distal lumen opening 116C. FIG 3C shows a cross-sectional view of the catheter section 156 at point "B" in FIG 3A, showing the proximal lumen 114A, the intermediate lumen 114B, and the distal lumen 114C.

[0036] Further details and embodiments of such catheter deployment systems 100 can be found in, for example, U.S. Pat. No. 11,517,719, U.S. Pat. No. 10,376,675, U.S. Patent Application Publication No. 2019 / 0255294, U.S. Patent Application Publication No. 2021 / 0069471, U.S. Patent Application Publication No. 2021 / 0113809, U.S. Patent Application Publication No. 2021 / 0113810, U.S. Patent Application Publication No. 2021 / 0121667, U.S. Patent Application Publication No. 2021 / 0121661, U.S. Patent Application Publication No. 2021 / 0121662, U.S. Patent Application Publication No. 2021 / 0121663, U.S. Patent Application Publication No. 2021 / 0121664, U.S. Patent Application Publication No. 2021 / 0121665, U.S. Patent Application Publication No. 2021 / 0121666, U.S. Patent Application Publication No. 2021 / 0121667, U.S. Patent Application Publication No. 2021 / 0121668, U.S. Patent Application Publication No. 2021 / 0121669, U.S. Patent Application Publication No. 2021 / 0121670, U.S. Patent Application Publication No. 2021 / 0121671, U.S. Patent Application Publication No. 2021 / 0121672, U.S. Patent Application Publication No. 2021 / 0121673, U.S. Patent Application Publication No. 2021 / 0121674, U.S. Patent Application Publication No. 202 No. 1 / 0228843, U.S. Patent Application Publication No. 2021 / 0283381, U.S. Patent Application Publication No. 2021 / 0322729, U.S. Patent Application Publication No. 2021 / 0361915, U.S. Patent Application Publication No. 2021 / 0330941, U.S. Patent Application Publication No. 2021 / 0330942, U.S. Patent Application Publication No. 2021 / 0402149, U.S. Patent Application Publication No. 2022 / 0001138, U.S. Patent Application Publication No. 2021 / 0402142, U.S. Patent Application Publication No. 2022 / 0032013 , U.S. Patent Application Publication No. 2021 / 0402153, U.S. Patent Application Publication No. 2021 / 0379336, U.S. Patent Application Publication No. 2021 / 0283368, U.S. Patent Application Publication No. 2022 / 0062528, U.S. Patent Application Publication No. 2022 / 0032014, U.S. Patent Application Publication No. 2022 / 0126064, U.S. Patent Application Publication No. 2022 / 0193378, U.S. Patent Application Publication No. 2022 / 0176081, U.S. Patent Application Publication No. 2022 / 0193376 ...93378, U.S. Patent Application Publication No. 2022 / 0193376, U.S. Patent Application Publication No. 2022 / 0193378, U.S. Patent Application Publication No. 2022 / 0193376, U.S. Patent Application Publication No. 2022 / 0193378, U.S. Patent Application Publication No. 2022 / 0193376, U.S. Patent Application Publication No. 2022 / 0193376, U.S. Patent Application Publication No. 2022 / 0193376, U.S. Patent Application Publication No. 2022 / 0193376, U.S US Patent Application Publication No. 2022 / 0193377, US Patent Application Publication No. 2022 / 0152368, US Patent Application Publication No. 2022 / 0176082, US Patent Application Publication No. 2022 / 0193379, US Patent Application Publication No. 2022 / 0296862, US Patent Application Publication No. 2022 / 0323723, US Patent Application Publication No. 2022 / 0370762, US Patent Application Publication No. 2022 / 0362524, US Patent Application Publication No. 2023 / 0043989, US Patent Application Publication No. 2023 / 0041261,No. 2023 / 0039733 and U.S. Patent Application Publication No. 2023 / 0042898, which are incorporated herein by reference in their entireties.

[0037] FIG 4A illustrates a spring clip catheter containment device (device) 200. FIG 4B illustrates the spring clip catheter containment device 200 in an exemplary environment of use. FIG 4C illustrates an enlarged detail of the catheter containment device 200 of FIG 4A. The device 200 generally includes a body 210 defining one or more channels 214 and a fixation mechanism, such as a spring clip (clip) 220, coupled to the body 210. The body 210 is configured to hold a portion of the catheter placement system 100, such as a portion of the catheter body 152, the hub 160, one or more extension legs 162, the luer lock 164, the guidewire 130, a combination thereof, or the like.

[0038] 5 illustrates some exemplary portions of the catheter placement system 100 that may be held by the device 200. However, it should be understood that this is in no way intended to be limiting. Advantageously, securing one or more portions of the catheter placement system 100 together, such as one or more extension legs 162, may improve the speed of placement and keep the portions of the catheter placement system 100 organized, reducing entanglement of the portions. Additionally, the device 200 coupled with the proximal portion of the system 100 reduces the portions from falling outside the sterile field, preventing contamination thereof, as discussed in more detail herein.

[0039] In one embodiment, one or more of the proximal portions of the catheter placement system 100, e.g., the extension leg 162, the guidewire 130, etc., can be releasably held by the body 210, as described in more detail herein. In one embodiment, one or more of the proximal portions of the catheter placement system 100 can be permanently and / or slidably engaged with the device 200, e.g., the body 210 or one of the securing mechanisms 220, to prevent the system 100 from disengaging from the device 200 and accidentally falling outside the sterile field. In one embodiment, one or more of the proximal portions of the catheter placement system 100 can be permanently affixed to the device 200, e.g., the body 210 or one of the securing mechanisms 220. For example, the proximal end of the guidewire 130 can be integrally formed with the body 210 or permanently coupled to the body 210. Advantageously, this not only prevents the guidewire 130 from falling outside the sterile field, but also can prevent the guidewire 130 from being pulled through the catheter placement system 100 and into the vasculature.

[0040] In one embodiment, the securing mechanism, i.e., spring clip 220, is configured to releasably secure the device 200 to a portion of the sterile field 80 surrounding the insertion site 50. Exemplary portions of the sterile field 80 include, but are not limited to, the patient's clothing, the patient's surgical gown, sleeves, dressing gowns, adhesive dressings, medical devices attached to the patient such as anchor pads, the clinician's clothing, surgical gowns, scrubs, sleeves, gloves, bed linens, surgical drapes, surgical table drapes, combinations thereof, and the like. In one embodiment, one or both of the body 210 and the spring clip 220 can be formed from a substantially rigid or elastic material such as a plastic, polymer, metal, alloy, composite material, and the like. In one embodiment, the securing mechanism 220 can include a butterfly clip 220A, a beret clip 220B, an alligator clip 220C, a clothes peg 220D, a safety pin, a suction cup, and can be coupled to the body 210 as described herein. An exemplary securing mechanism 220 is shown in FIG. 11. In this manner, the securing mechanism 220 can be configured to secure the device 200 to various portions of the sterile field 80 depending on the shape, size, and material of the sterile field to be secured. Advantageously, as shown in FIG 6D, the device 200 can hold a proximal portion of the catheter placement system 100 away from the insertion site 50, providing improved visibility, simplified presentation, and increased control.

[0041] 4A , in one embodiment, the spring clip 220 includes a first clip member 222A hingedly coupled to a second clip member 222B by a hinge 224. Each of the first clip member 222A and the second clip member 222B extends along an axis 60 between a first end and a second end opposite the first end. The first end of the clip member 222 includes a handle 226. The second end of the clip member 222 opposite the first end includes a gripping feature 228. The hinge 224 may be disposed between the first end and the second end of the clip member 222 and is configured to allow the first clip member 222A to pivot relative to the second clip member 222B between an open position and a closed position.

[0042] In the open position, the first gripping feature 228A disposed on the first clip member 222A is disposed in a spaced apart relationship relative to the second gripping feature 228B, as shown in FIG. 4B. In the closed position, the first gripping feature 228A disposed on the first clip member 222A is disposed adjacent to or in contact with the second gripping feature 228B, as shown in FIG. 4A. In one embodiment, the gripping feature 228 may include interlocking teeth, a lip, a flange, or may include a second material different from the first material of the device 200, having a relatively high coefficient of friction, such as silicone rubber, an elastomer, an adhesive, etc. In this manner, the gripping feature 228 increases friction between the spring clip 220 and a portion of the sterile field 80 disposed between the gripping features 228.

[0043] The spring clip device 200 further includes a biasing member 230 configured to bias the spring clip 220 toward the closed position. Exemplary biasing members 230 include, but are not limited to, springs configured to resiliently deform, compression springs, leaf springs, O-rings, rubber grommets, or similar devices formed from plastics, polymers, elastomers, metals, alloys, nitinol, composites, etc. As shown, the biasing member 230 is a compression spring and is disposed between the hinge 224 and the handle 226 to bias the device 200 toward the closed position.

[0044] In one embodiment, for example as shown in FIG. 6A, the biasing member 230 can be a magnetic element and can be disposed along the clip member axis 60 between the hinge 224 and the gripping feature 228 and configured to bias the device 200 toward the closed position. The device 200 can include a first magnetic element disposed on the first clip member 222A and a second magnetic element disposed on the second clip member 222B and configured to attract the first magnetic element toward the second magnetic element. In one embodiment, the magnetic element biasing member 230 can be disposed between the hinge 224 and the handle 226 and configured to bias the device 200 toward the closed position. The device 200 can include a first magnetic element disposed on the first clip member 222A and a second magnetic element disposed on the second clip member 222B and configured to repel the first magnetic element from the second magnetic element. As used herein, a magnetic element may include a permanent magnet, an electromagnet, a magnetized ferrous material, or a ferrous material.

[0045] FIG. 4C shows further details of the device 200. In one embodiment, the body 210 can be coupled to one of the first clip member 222A or the second clip member 222B. In one embodiment, the body 210 can include one or more channels 214 formed therein and extending longitudinally along the first axis 70. The channels 214 can be configured to releasably retain a portion of the catheter placement system 100. For example, as shown in FIG. 4C, the body 210 includes a first channel 214A configured to receive the first extension leg 162A, a second channel 214B configured to receive the second extension leg 162B, and a third channel 214C configured to receive the third extension leg 162C. However, this is not intended to be limiting, and other portions of the catheter placement system 100, such as the luer lock 164, the hub 160, the extension leg 162, the guidewire 130, etc., may be received by and releasably retained within each of the first channel 214A, the second channel 214B, or the third channel 214C.

[0046] In one embodiment, a portion of the catheter placement system 100 is permanently affixed to the body 210 or permanently retained within the channel 214 of the body 210. For example, the body 210 may not have an opening 216, but instead include a channel 214 that completely surrounds the extension leg 162, guidewire 130, etc. In this manner, the body 210 may be slidably engaged with a portion of the catheter placement system 100, but may not be removed therefrom. Note that the guidewire 130 may include a plug 132 permanently affixed to its proximal end, and similarly, the extension leg 162 may include a luer lock 164, etc. attached to its proximal end. In this manner, the plug 132 or luer lock 164 may abut the body 210 to prevent the guidewire 130 or extension leg 162 from slidably disengaging from the body 210 along the axis of the channel 214.

[0047] In one embodiment, the proximal end of guidewire 130 and / or plug 132 may be permanently affixed to device 200. For example, plug 132 may be hingedly, pivotally, or rotatably coupled to body 210 or fixation mechanism 220. Alternatively, plug 132 or the proximal portion of guidewire 130 may be attached to or integrally formed with device 200, for example, by adhesive, bonding, welding, ultrasonic welding, etc.

[0048] Advantageously, permanently affixing the proximal portion of the catheter placement system 100 to the device 200 prevents the catheter placement system 100 from accidentally disengaging from the device 200 and falling outside of the sterile field. Additionally, the device 200 acts as a plug 132 to prevent the guidewire 130 from being accidentally pulled through the catheter lumen and into the vasculature, for example.

[0049] In one embodiment, the channel 214 includes an opening 216 that extends axially with the channel 214 and is configured to allow a portion of the catheter 150 to enter or exit the channel 214. In one embodiment, the width (w1) of the opening 216 can be smaller than the diameter (d1) of the portion of the catheter 150 that is retained by the channel 214. In this manner, one or both of the extension leg 162 and the channel opening 216 must elastically deform slightly to receive the extension leg 162 within the channel 214. Furthermore, the opening 216 can abut the extension leg 162 to retain the extension leg 162 within the channel 214. In this manner, the channel 214 can retain the extension leg 162 in a snap-fit ​​engagement. In one embodiment, the width of the channel 214 can be equal to or smaller than the outer diameter of the portion of the catheter 150 and can engage the portion of the catheter 150 in an interference, press-fit, or snap-fit ​​engagement to releasably retain the portion of the catheter 150 therein.

[0050] In an exemplary method of use, a clinician can couple the device 200 to a portion of the catheter placement system 100. For example, the first extension leg 162A can be biased into the first channel 214A through the first opening 216A, the second extension leg 162B can be biased into the first channel 214B through the second opening 216B, and the third extension leg 162C can be biased into the third channel 214C through the third opening 216C. Advantageously, the device 200 can hold the extension legs 162, preventing them from falling outside the sterile field as well as preventing them from becoming entangled. As will be appreciated, other portions of the catheter placement system 100, such as a portion of the guidewire 130, the luer lock 164, the extension legs 162, the catheter hub 160, the catheter body 152, or combinations thereof, can also be held without limitation.

[0051] The clinician can then urge the first handle 226A of the first clip member 222A toward the second handle 226B of the second clip member 222B to overcome the force of the biasing member 230 and pivot the first gripping feature 228A away from the second gripping feature 228B to transition the device 200 to the open position (FIG. 4B). The clinician can then pinch a portion of the sterile field 80 (FIG. 6D) and then place that portion of the sterile field 80 between the first and second gripping features 228A, 228B, and release the handle 226 to allow the biasing member 230 to bias the device 200 toward the closed position (FIG. 4A), securing the device 200 and a portion of the catheter placement system 100 coupled to the device 200 within the sterile field 80.

[0052] As shown in FIGS. 4A-4C, the axis 70 of the channel 214 may be aligned perpendicular to the axis 60 of the clip member 222. However, it should be understood that the axis 70 of the channel 214 may be aligned parallel or at an angle to the axis 60 of the clip member 222. For example, as shown in FIG. 6A, the axis 70 of the channel 214 may be aligned parallel to the axis of the clip member 222. In one embodiment, the body 210 may be rotatably coupled to the securing mechanism 220 to allow the axis 70 of the channel 214 to rotate or pivot relative to the axis 60 of the securing mechanism 220. In one embodiment, the body 210 may be releasably coupled to the spring clip 220 using an interference fit, a press fit, a snap fit engagement, a latching mechanism, an adhesive, a frangible bridge, a hook and loop attachment, combinations thereof, or the like.

[0053] 5 illustrates a proximal portion of the catheter placement system 100 and illustrates various structures of the catheter placement system 100 that may be retained by the channel 214. Exemplary structures of the system 100 may include a portion of the guidewire 130, a luer lock 164, an extension leg 162, a catheter hub 160, a catheter body 152, combinations thereof, and the like.

[0054] In one embodiment, the shape of the clip member 222 may vary. As shown in FIG. 4A, the clip member 22 may define a substantially "T" shaped piece, with the gripping feature 228 having a width greater than the width of the handle 226. As shown in FIG. 6A, the clip member 222 may define a substantially circular or disk shape. As shown in FIG. 6B, the clip member 222 may define a substantially rectangular shape. It should be understood that clip members of other regular or irregular three-dimensional shapes, such as circular, oval, elliptical, polygonal, etc., are also contemplated within the scope of the present invention.

[0055] In one embodiment, the relative positions of the hinge 224, handle 226, gripping feature 228, and biasing member 230 may vary along the axis 60 of the clip member 222. For example, FIG. 6B illustrates one embodiment of the device 200 including a handle 226 disposed at a first end and a hinge 224 disposed at a second end. The gripping feature 228 may be disposed on an inner surface of the clip member 222 at a point between the first and second ends. In one embodiment, the biasing member 230 may be disposed at the second end, e.g., a spring may be incorporated into the mechanism of the hinge 224. These and other combinations of the hinge 224, handle 226, gripping feature 228, and biasing member 230 positioned on the clip member 222 are also contemplated to be within the scope of the present invention.

[0056] In one embodiment, as shown in FIG. 6C, the device 200 can include a "non-slip" pad 240 disposed on a surface of the device 200, such as a surface of the securing mechanism 220. In one embodiment, the non-slip pad 240 can include a material having a relatively high coefficient of friction, such as rubber, silicone rubber, a polymer, an elastomer, or the like. In one embodiment, the non-slip pad 240 can include a lightly tacky adhesive layer. Advantageously, the non-slip pad 240 allows the device 200, including a portion of the catheter placement system 100 coupled with the device 200, to be placed on a portion of the sterile field 80 (e.g., a drape, etc.) without the need to clip the device 200 to the drape 80, thereby mitigating the assembly of the device 200 and the catheter placement system 100 from slipping or falling outside the sterile field 80. The non-slip pad 240 can be repositioned multiple times while maintaining its non-slip function.

[0057] 6D illustrates an exemplary method for attaching the catheter containing device 200 to a portion of the sterile field 80, such as a drape, which may include the clinician manually pinching the drape 80 to bunch the material, thereby providing enough material for the catheter containing device 200 to grasp, as described herein.

[0058] In one embodiment, the catheter containment system 198 can include a catheter containment device 200 and can further include an anchoring device (anchor) 250. Figures 7A-7F show further details of an exemplary catheter 250. The anchor 250 can generally include a foot plate 252 and a tab 260.

[0059] The foot plate 252 can include an adhesive layer disposed on a first surface 254 of the foot plate 252, e.g., an underside of the foot plate 252, and is configured to attach the anchor 250 to a surface of the sterile field 80. The tab 260 can extend from the foot plate 252 at an angle relative to the foot plate 252 and can be configured to engage the clip 220. For example, the tab 260 can extend between the first gripping feature 228A and the second gripping feature 228B and can be secured therebetween when the device 200 is in the closed position. Advantageously, the anchor 250 can be coupled to the sterile field 80 and provide an easily accessible anchor point to selectively couple the device 200 to the anchor point. For example, a portion of the sterile field 80, such as a drape or gown that is pulled flat, may not be easily grasped by the clinician, especially when the clinician is wearing gloves. This can then make it difficult to place the portion of the sterile field 80 between the gripping features 228A, 228B when the device is in the open position.

[0060] 7A, the anchor 250 can include a first foot plate portion 252A coupled to a first tab portion 260A and a second tab portion 260B coupled to a second foot plate portion 252B. The first tab portion 260A can be coupled to the second tab portion 260B along a first edge 270 and can be folded along the first edge 270 such that a first side of the first tab portion 260A is disposed adjacent to a first side of the second tab portion 260B. In one embodiment, one or both of the first side of the first tab portion 260A and the first side of the second tab portion 260B can include an adhesive layer disposed thereon to attach the first side of the first tab portion 260A to the first side of the second tab portion 260B.

[0061] In one embodiment, the first foot plate portion 252A can be folded along the second edge 272 relative to the first tab portion 260A in a direction opposite the crease along the first edge 270. Similarly, the second foot plate portion 252B can be folded along the third edge 274 relative to the second tab portion 260B in a direction opposite the crease along the first edge 270. The second edge 272 and the third edge 274 can be disposed equidistant from the first edge 270. In this manner, the first surface 254A of the first foot plate portion 252A and the first surface 254B of the second foot plate portion 252A can be aligned along the first axis 64, and the tab 260 can be aligned along a second axis 66 that extends at an angle relative to the first axis 64.

[0062] 7B-7C illustrate one embodiment of the anchor 250. FIG. 7B illustrates the anchor 250 in a first configuration. FIG. 7C illustrates the anchor 250 in a second configuration. In one embodiment, the anchor 250 can include a foot plate 252 extending across a first plane, e.g., a horizontal plane, and can include an adhesive layer disposed on at least a portion of a first surface 254, e.g., a bottom surface. The anchor 250 can further include a cut line 262, such as a laser cut line, a perforation, a tear line, or the like. The cut line 262 can define a "U" shape, a "V" shape, or the like, extending between a first point 264 and a second point 266 to define a tab 260. The tab 260 can be coupled to the foot plate 252 along a fold line 274 extending along a straight line between the first point 264 and the second point 266.

[0063] In one embodiment, the tab 260 can further include a second fold line 278 disposed at a midpoint along the tab 260. In this manner, the tab 260 can be folded into a first tab portion 260A and a second tab portion 260B such that the second tab portion 260B can support the first tab portion 260A and extend along the second axis 66. One or both of the first fold line 276 and the second fold line 278 can include score lines, grooves, laser cut lines, perforations, etc. to facilitate folding therealong.

[0064] 7D illustrates the catheter containment system 198 in an exemplary environment of use. The device 200 is coupled to a proximal portion of the catheter placement system 100 and secured to an anchor 250. The anchor 250 is adhered to a drape within the sterile field 80 adjacent the insertion site 50. Advantageously, the catheter containment system 198 can secure the proximal portion of the catheter placement system 100 within the sterile field 80 without affecting the clinician's dexterity or obstructing the view of the insertion site 50 during vascular access and catheter placement.

[0065] 8A-8B show an embodiment of a catheter containment device 300 including a body 310 defining one or more channels 314 and coupled to a base 320. In an embodiment, the channel 314 can be configured to receive one or more portions of the catheter placement system 100, such as the extension leg 162, as described herein. In an embodiment, the body 310 can releasably retain, permanently retain, or be permanently coupled to a proximal portion of the catheter placement system 100, such as the extension leg 162, the guidewire 130, as described herein. In an embodiment, the body 310 and the base 320 can be integrally formed as a single monolithic piece. In an embodiment, the body 310 and the base 320 can be formed as separate structures and coupled using adhesives, bonding, welding, ultrasonic welding, or the like. In an embodiment, the body 310 and the base 320 can be formed of the same material or different materials providing different mechanical properties. In one embodiment, the body 310 and the base 320 may be rotatably, pivotally, or hingedly coupled.

[0066] In one embodiment, the base 320 can include one or more channels, latches, clips, pinions, etc. configured to releasably engage one or more support structures 330 in one or more of an interference fit, press fit, or snap fit engagement. The support structures 330 can include a footing, bracket, clamp, or similar structure configured to attach to one or more pieces of equipment in a sterile field, such as a table, trolley, bed, gurney, pole, IV bag hanger, clamp, etc. In one embodiment, one or more of the base 320 or support structures 330 can be pivotally or rotatably coupled to allow a clinician to position the body 310 and the channel 314 in an ergonomically convenient position.

[0067] In one embodiment, as shown in Figures 8B-8C, the base 320 can define a substantially flat surface. In one embodiment, a first surface, e.g., a lower surface, of the base 320 can include an adhesive layer configured to adhere the device 300 to a surface of the sterile field 80. In one embodiment, the first surface, e.g., a lower surface, of the base 320 can include a second material having a relatively high coefficient of friction. Exemplary materials can include rubber, silicone rubber, polymers, elastomers, etc., and can provide a "non-slip" surface that engages a portion of the sterile field 80.

[0068] In one embodiment, a first surface of the base 320, e.g., the underside, can include a first coupling portion 340. The surface of the sterile field 80 can include a second coupling portion 342 configured to releasably engage the first coupling portion 340. It is noted that the body 310 can be coupled to the second surface of the base 320. In one embodiment, the second surface of the base 320 can be opposite the first surface. It is understood that the body 310 can be coupled to any surface of the base 320 without limitation.

[0069] In one embodiment, the first coupling portion 340 may be integrally formed with the base 320. In one embodiment, the first coupling portion 340 may be formed as a separate structure and coupled to the base 320 using adhesives, bonding, welding, ultrasonic welding, etc. In one embodiment, the second coupling portion 342 may be integrally formed with the sterile field 80. In one embodiment, the second coupling portion 342 may be formed as a separate structure and coupled to the sterile field 90 using adhesives, bonding, welding, ultrasonic welding, etc.

[0070] In one embodiment, the first coupling 340 and the second coupling 342 can be a hook and loop system or a VELCRO® system. For example, the first coupling 340 can be a hook system configured to releasably engage with a loop system integrally formed or adhered to a surface of the sterile field 80. As will be appreciated, the second coupling 342 can also be a hook system configured to releasably engage with a loop system integrally formed or adhered to a surface of the base 320.

[0071] In one embodiment, the first coupling portion 340 and the second coupling portion 342 can be snap fastener systems. For example, the first coupling portion 340 can be a male snap fastener system configured to releasably engage with a female snap fastener system of the second coupling portion 342 integrally formed with or coupled to a surface of the sterile field 80. As will be appreciated, the second coupling portion 342 can also be a male snap fastener system configured to releasably engage with a female snap fastener system integrally formed with or bonded to a surface of the base 320.

[0072] In one embodiment, one or both of the first coupling 340 and the second coupling 342 can be magnetic elements configured to releasably engage the base 320 with the sterile field 80. As used herein, a magnetic element can include a permanent magnet, an electromagnet, a magnetized ferrous material, or a ferrous material. In one embodiment, the second coupling 342 of the magnetic element can be located outside of the sterile field. In one embodiment, the second coupling 342 of the magnetic element can hold a portion of the sterile field 80 between the first magnetic coupling 340 and the second magnetic coupling 342 to secure the catheter containing device 300 to the portion of the sterile field 80.

[0073] In one embodiment, one or both of the first coupling portion 340 and the second coupling portion 342 can be a permanent or temporary adhesive configured to couple the base 320 to the sterile field 80. In one embodiment, the first coupling portion 340 can directly engage a proximal portion of the catheter placement system 100 and can engage a second coupling portion 342 that is coupled to the sterile field 80 to directly secure the proximal portion of the catheter placement system 100 thereto.

[0074] 8D, the base can include a tie 350 coupled thereto and configured to tie the base 320 to a portion of the sterile field 80, such as a bar, a pole, an IV bag hanger, a bed, a gurney, a portion of a drape, a sleeve, a glove, etc. In one embodiment, the tie 350 can be a woven or non-woven synthetic or organic material such as string, cord, wire, twist tie, zip tie, etc., and can be formed from plastics, polymers, metals, alloys, composites, cotton, nylon, combinations thereof, and the like.

[0075] In one embodiment, as shown in FIG. 8E, the tie 350 can be coupled directly to a proximal portion of the catheter placement system 100 and can couple the proximal portion of the catheter placement system 100 to a portion of the sterile field 80 as described herein.

[0076] 9A-9B illustrate one embodiment of a gripping catheter containment device ("gripping device") 400. The gripping device 400 may generally include a hook 420 slidably engaged with a sleeve 430 between an open position and a closed position. The hook 420 may cooperate with the sleeve 430 to releasably hold one of a portion of the catheter placement system 100 or a portion of the sterile field 80. In one embodiment, when the gripping device 400 is configured to releasably hold a portion of the sterile field 80, the gripping device 400 may further include a body 410. The body 410 may be coupled to the gripping device 400, e.g., the hook 420, the sleeve 430, etc. The body 410 may include one or more channels 414 disposed therein. The channels 414 may be configured to engage a portion of the catheter placement system 100, such as the extension leg 162, the luer lock 164, the hub 160, etc., as described herein. In one embodiment, the channel 414 can releasably hold a proximal portion of the catheter placement system 100, e.g., the extension leg 162, the guidewire 130, etc., as described herein. In one embodiment, the proximal portion of the catheter placement system 100, e.g., the guidewire 130, the plug 132, etc., can be permanently coupled to the device 400, as described herein.

[0077] The hook 420 can include an arm 422 extending along an axis from a first finger plate 424 disposed at a first end to a J hook 426 disposed at a second end. The J hook 426 can extend from a tip of the arm 422 at the second end toward the first end to a tip 428 of the J hook 426, i.e., to a point between the first end and the second end. In one embodiment, the sleeve 430 can include a second finger plate 432 disposed at the first end and a sleeve body 434 extending from the second finger plate 432 toward the second end. The sleeve 430 can define an axially extending lumen 436. A portion of the hook 420 can be slidably engaged with the sleeve lumen 436 and can transition between an open configuration and a closed configuration. The gripping device 400 can further include a biasing member 440 configured to bias the gripping device 400 toward a closed position. In one embodiment, the biasing member 440 can be a compression spring, a leaf spring, a rubber O-ring, or a similar resiliently deformable device, as described herein. In one embodiment, the lateral width (w2) between the radially outermost point of the J-hook 246 and the radially outermost point of the arm 422 can be substantially equal to the inner diameter of the sleeve lumen 436.

[0078] 9C-9E illustrate an exemplary method of use of the gripping device 400 described herein. As shown in FIG. 9C, a clinician can compress the first finger plate 424 of the hook 420 and the second finger plate 432 of the sleeve 430 toward one another to overcome the force of the biasing member 440 and transition the gripping device 400 from a closed position to an open position. In the closed position, as shown in FIG. 9C, the tip 428 of the J hook 426 can be disposed within the lumen of the sleeve body 434. In the open position, as shown in FIG. 9D, the tip 428 of the J hook 426 can be disposed past the tip 438 of the sleeve body 434 to provide an opening 402 therebetween.

[0079] In one embodiment, a proximal portion of the catheter placement system 100, such as one or more extension legs 162, can be placed through the opening 402 and can be received between the J hook 426 and the arm 422. Advantageously, securing the one or more extension legs 162 together increases the speed of placement while preventing contamination. In one embodiment, a portion of the sterile field 80 can be placed through the opening 402 and can be received between the J hook 426 and the arm 422. As shown in FIG. 9E, the clinician can then release one or both of the first finger plate 424 and the second finger plate 432 to allow the biasing member 440 to transition the gripping device 400 from the open position to the closed position and retain the proximal portion of the catheter placement system 100 or a portion of the sterile field 80 within the hook 420.

[0080] In one embodiment, with a portion of the catheter placement system 100 received by the hook 420, the gripping device 400 can be secured to a portion of the sterile field 80 by temporary or permanent adhesives, spring clips 220, anchors 250, base 320, support structure 330, first and second couplings 340 and 342, ties 350, combinations thereof, etc. In one embodiment, the gripping device 400 can be integrally formed with a portion of the sterile field 80, for example, a portion of a drape or gown worn by either the clinician or the patient.

[0081] In an exemplary method of use, the gripping device 400 can include a body 410 having one or more channels 414. A clinician can push a proximal portion of the catheter placement system 100 into the channel 414 to hold it therein, as described herein. The body 410 can be coupled to the gripping device 400, for example, to one of the hooks 420 or the sleeve 430. The gripping device 400 can be transitioned from a closed position to an open position by biasing the first finger plate 424 and the second finger plate 432 toward each other, as described herein. A portion of the sterile field 80 can then be placed through the opening 402 and between the J hook 426 and the arm 422. The clinician can then release one or both of the first finger plate 424 and the second finger plate 432 to allow the biasing member 440 to transition the gripping device 400 from the open position to the closed position and hold a portion of the sterile field 80 within the hook 420. The gripping device 400 can then hold the proximal portion of the catheter placement system 100 within the sterile field 80.

[0082] In one embodiment, as shown in FIGS. 10A-10C, the gripping device 400 can include two or more arms 422. As shown, the gripping device 400 can include three arms 422, namely, a first arm 422A, a second arm 422B, and a third arm 422C. However, a greater or lesser number of arms 422 is also contemplated. In one embodiment, the arms 422 can be formed from a resilient, rigid, or elastically deformable material, such as a plastic, polymer, metal, alloy, composite material, or the like. In one embodiment, one or more of the first arm 422A, the second arm 422B, and the third arm 422C can include a J hook 426, for example, a first J hook 426A, a second J hook 426B, and a third J hook 426C disposed at a distal tip of the first arm 422A, the second arm 422B, and the third arm 422C, respectively.

[0083] In one embodiment, the arm 422 can be slidable relative to the sleeve 430 between a retracted position ( FIG. 10A ), an open position ( FIG. 10B ), and a closed position ( FIG. 10C ). In the open position, the arm 422 can be disposed in an extended position relative to the sleeve 430, as shown in FIG. 10B . In the closed position, the arm 422 can be disposed in a relatively retracted position as compared to the open position, as shown in FIG. 10C . In the retracted position, the arm 422 can be retracted into the sleeve 430, as shown in FIG. 10A . In one embodiment, a distal portion of the arm 422 can be curved radially outward from the central axis 68 and can be elastically deformed to a relatively less curved or relatively straight shape when the arm 422 is retracted into the sleeve 430.

[0084] In an exemplary method of use, a gripping device 400 is provided that includes two or more arms 422, as described herein. As shown in Fig. 10A, in a resting state, a biasing member 440 can bias the arms 422 to a retracted position in which the arms 422 can be disposed within the sleeve lumen 436 and can be elastically deformed to a relatively less curved or substantially straight shape.

[0085] The clinician can then transition the gripping device 400 from the retracted position to the open position (FIG. 10B). The clinician can urge the first finger plate 424 and the second finger plate 432 toward each other to overcome the force of the biasing member 440 and advance the tip of the arm 422 to extend past the tip 438 of the sleeve. In one embodiment, the arm 422 in the open position can grip a portion of the catheter placement system 100, such as the extension leg 162. In one embodiment, the arm 422 in the open position can grip a portion of the sterile field 80.

[0086] The clinician can then release one or both of the first finger plate 424 and the second finger plate 432 to allow the biasing member 440 to transition the arms to a closed position (FIG. 10C), in which the arms 422 extend from the sleeve lumen 436 but are in a relatively more retracted position compared to the open position (FIG. 10B). In this manner, the arms 422 can close around the proximal portion of the catheter placement system 100 or the sterile field 80.

[0087] In one embodiment, as shown in FIG. 11 , the catheter containment device 500 may include a fixation mechanism, such as one or more of a spring clip 220, a butterfly clip 220A, a beret clip 220B, an alligator clip 220C, or a clothespin 220D, as described herein, configured to engage both a proximal portion of the catheter placement system 100 and a portion of the sterile field 80 between the first gripping mechanism 228A and the second gripping mechanism 228B to secure the proximal portion of the catheter placement system 100 within the sterile field 80.

[0088] As shown in FIGS. 12A-12B, in one embodiment, the catheter containing device 600 can include a pad 610 including a material having a high coefficient of friction and bonded to a portion of the sterile field 80. The pad 610 can include a first surface that engages a surface of the sterile field 80 and a second surface 614 opposite the first surface that includes a high coefficient of friction material. In one embodiment, the pad 610 can be formed from a rigid or elastic material. In one embodiment, the pad 610 can be formed from a flexible, malleable, or elastically deformable material. In one embodiment, the pad 610 can be formed from a first material having rigid or elastic mechanical properties and can include a second material disposed thereon, the second material exhibiting a more pliable, more flexible mechanical property compared to the first material. The second material can exhibit a higher coefficient of friction than the first material. In one embodiment, one or both of the first material and the second material can include a plastic, a polymer, an elastomer, a rubber, a silicone rubber, a metal, an alloy, a composite material, and the like. The second surface 614 may include a material having a high coefficient of friction, such as silicone rubber, rubber, latex, etc. In one embodiment, the second surface 614 of the pad 610 may include a coating having a high coefficient of friction. In one embodiment, the second surface 614 of the pad 610 may include a relatively light tacky or temporary adhesive coating.

[0089] In one embodiment, the pad 610 may include indicators, such as different colors, opaque surfaces, symbols, or alphanumeric symbols, combinations thereof, to indicate the location of the catheter receiving pad 610 within the sterile field 80. In one embodiment, the pad 610 may be integrally formed with the sterile field 80, such as integrally formed with a drape or surgical gown. In one embodiment, the pad 610 may be releasably coupled to the sterile field 80 using snap fasteners, hook and loop attachments, adhesives, etc., disposed on a first surface. In one embodiment, the pad 610 may be coupled to the sterile field 80 using a permanent adhesive.

[0090] In an exemplary method of use, a pad 610 can be prepared as described herein. A first surface of the pad 610 can engage a surface of the sterile field 80. A clinician can place a proximal portion of the catheter placement system 100 on a second surface 614 of the pad 610. A high coefficient of friction or adhesive on the second surface can hold the proximal portion of the catheter placement system 100 on the second surface and prevent the proximal portion of the catheter placement system 100 from falling outside of the sterile field 80.

[0091] Although some specific embodiments have been disclosed herein, and those specific embodiments have been disclosed in some detail, those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may become apparent to those skilled in the art, and are likewise encompassed in the broader aspects. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. 1. A catheter containment system for maintaining a portion of a catheter placement system within a sterile field, comprising: an anchor including an adhesive layer on a first surface of the anchor and having a U-shaped cut line defining a tab and a foot plate, the tab being coupled to the foot plate along a first fold line folded in a first direction, the tab including a second fold line folded in a second direction opposite the first direction, the foot plate being configured to adhere to a portion of the sterile field adjacent an insertion site; A containing device, a body defining a channel extending longitudinally along a first axis, the channel configured to hold a portion of the catheter placement system, the body having an opening extending longitudinally and configured to allow entry or exit along a second axis extending at an angle relative to the first axis of the channel; a locking mechanism coupled to the body and configured to releasably engage a portion of the sterile field adjacent an insertion site; a containing device including A catheter containment system comprising:

2. The catheter containment system of claim 1 , wherein the portion of the catheter placement system includes one of a catheter body, a catheter hub, an extension leg, a luer lock, or a guidewire.

3. The catheter housing system of claim 2 , wherein the body includes a first channel configured to hold a first extension leg and a second channel configured to hold a second extension leg.

4. The catheter housing system of claim 2 , wherein the body includes a first channel configured to hold a first extension leg and a second extension leg.

5. 5. The catheter storage system of claim 1, wherein the catheter placement system comprises a rapid insertion central venous catheter (RICC) placement system.

6. The catheter storage system of claim 1 , wherein the body is rotatably, hingedly, or pivotally coupled to the fixation mechanism.

7. 5. The catheter containment system of claim 1, wherein the securing mechanism comprises one of a spring clip, a butterfly clip, a beret clip, an alligator clip, a clothespin, a safety pin, or a suction cup.

8. 5. The catheter storage system of claim 1, wherein the tab folded along the second fold defines a first tab portion and a second tab portion, the second tab portion supporting the first tab portion along an axis extending at an angle relative to the foot plate.

9. 5. The catheter storage system of claim 1, wherein the securing mechanism includes a first clip member hingedly connected to a second clip member, the first clip member including a first gripping mechanism configured to engage a second gripping mechanism of the second clip member to secure the storage device in a portion of the sterile field.

10. 5. The catheter storage system of claim 1, wherein the locking mechanism further comprises a biasing member configured to bias the locking mechanism to a closed position, the biasing member comprising one of a spring, a compression spring, a leaf spring, an O-ring, a rubber grommet, or a magnetic element.

11. The catheter containment system of claim 1 , wherein the securing mechanism comprises a tie selected from the group consisting of a string, a cord, a wire, a twist tie, or a zip tie.

12. 2. The catheter containment system of claim 1, wherein the fixation mechanism includes a hook slidably engaged with a sleeve, the hook having an arm having a finger plate disposed at a first end of the arm and a J-hook disposed at a second end of the arm opposite the finger plate, the J-hook configured to receive a portion of the sterile field between the J-hook and the sleeve.

13. 2. The catheter storage system of claim 1, wherein the securing mechanism includes a sleeve and two or more hooks slidably engaged with the sleeve, each of the two or more hooks being slidable between a retracted position, an open position, and a closed position.

14. 1. A catheter placement and containment system for placing a catheter within the vasculature of a patient, comprising: A catheter placement device, comprising: Needles and a catheter including an extension leg; Guidewire and a catheter placement device including: a sterile drape configured to define a sterile field around the insertion site; 1. A catheter containment system comprising: an anchor including an adhesive layer on a first surface of the anchor and having a U-shaped cut line defining a tab and a foot plate, the tab being coupled to the foot plate along a first fold line folded in a first direction, the tab including a second fold line folded in a second direction opposite the first direction, the foot plate being configured to adhere to a portion of the sterile drape adjacent the insertion site; 1. A catheter containing device comprising: a body defining a channel and configured to engage a portion of the catheter placement device; a securing mechanism coupled to the body and configured to secure the catheter housing system to the sterile drape; a catheter-containing device comprising: a catheter containment system including: A catheter placement and containment system comprising:

15. 15. The system of claim 14, wherein the securing mechanism comprises one of a spring clip, a butterfly clip, a beret clip, an alligator clip, a clothespin, a safety pin, or a suction cup.

16. 16. The system of claim 14 or 15, further comprising an anchor having a foot plate and a tab extending at an angle relative to the foot plate, the foot plate including an adhesive layer, the tab configured to be engaged by the securing mechanism.

17. 1. A catheter containment device for holding a portion of a catheter placement system, comprising: a body defining a channel extending along a longitudinal axis, the channel configured to permanently retain the portion of the catheter placement system; a handle coupled to the body and configured to releasably engage a portion of the sterile field adjacent the insertion site; A catheter containment device comprising:

18. 18. The catheter containment device of claim 17, wherein the portion of the catheter placement system includes a proximal end of a guidewire permanently affixed to the body.

19. 18. The catheter containment device of claim 17, wherein the portion of the catheter placement system includes a proximal portion of a guidewire slidably engaged with the body.

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