Handheld, untethered catheter storage system

Abstract

The catheter housing device (200) is configured to hold a proximal portion of a catheter placement system, such as a catheter (150), hub, extension leg (162), luer lock, or guidewire. The device engages the clinician's finger and allows the device and The catheter placement system includes a handle (220) configured to couple the proximal portion of the catheter placement system to the catheter insertion site and ... handle (220). This allows the clinician to hold the proximal portion within the sterile field without reducing dexterity or obstructing the clinician's view of the insertion site or the catheter placement system. Additionally, the device can allow the clinician to manipulate the proximal portion of the catheter system while mitigating

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 moving 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 may run the risk of moving 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 movement of these proximal portions 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 device for holding a portion of a catheter placement system, the catheter containment device including: a body defining a channel extending longitudinally along a first axis, the channel configured to hold a portion of the catheter placement system and having a longitudinally extending opening configured to allow entry or exit along a second axis extending at an angle to the first axis of the channel; and a handle coupled to the body and configured to be grasped by the fingers of a clinician.

[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 body includes a first channel extending along a first axis of the channel and a second channel extending along a third axis at an angle to the first axis of the channel.

[0007] In some embodiments, the inner diameter of the channel is equal to or slightly smaller than the outer diameter of the portion of the catheter placement system. In some embodiments, the width of the opening of the channel is less than the outer diameter of a portion of the catheter placement system.

[0008] In some embodiments, one or both of the body and the handle are formed from a substantially rigid or resilient material selected from the group consisting of a plastic, a polymer, a metal, an alloy, or a composite.

[0009] In some embodiments, one or both of the body and handle are formed from a flexible, malleable, or elastically deformable material selected from the group consisting of plastics, polymers, elastomers, rubber, silicone rubber, metals, alloys, shape memory materials, superelastic materials, Nitinol, and composites.

[0010] In some embodiments, the handle is formed from a first material having substantially rigid or elastic material properties and including a second material having relatively softer or more flexible material properties disposed over the first material.

[0011] In some embodiments, the handle is a ring defining an aperture and configured to receive one or more fingers therethrough. In some embodiments, the handle is hingedly, rotatably or pivotally coupled to the body.

[0012] In some embodiments, the handle extends from the body at an angle relative to the first axis of the channel. In some embodiments, the catheter containing device further includes a first handle extending from the body in a first direction and a second handle extending from the body in a second direction opposite the first direction.

[0013] In some embodiments, the handle includes one of a plug or a crossbar located at an opposite end of the handle from the body. Also disclosed is a catheter containing device for holding a portion of a medical device, the catheter containing device including: a body defining a disk shape extending across a horizontal plane and defining a top surface and a bottom surface; and a device channel extending along an axis parallel to one of the top surface or the bottom surface and including an opening in communication with one of the top surface or the bottom surface, the device channel configured to receive a portion of the medical device within the device channel.

[0014] In some embodiments, the body further includes a biconcave cross-section having one of a first finger channel extending across the top surface and a second finger channel extending across the bottom surface, wherein one of the first finger channel or the second finger channel extends at an angle relative to the device channel.

[0015] In some embodiments, the device channel is configured to hold one of a catheter body, a catheter hub, an extension leg, a luer lock, or a guidewire.

[0016] In some embodiments, the body includes a first device channel configured to hold a first extension leg and a second device channel extending parallel to the first device channel and configured to hold a second extension leg.

[0017] In some embodiments, the first device channel is configured to hold a first extension leg and a second extension leg. In some embodiments, the inner diameter of the device channel is equal to or slightly smaller than the outer diameter of the portion of the medical device.

[0018] In some embodiments, the width of the opening of the device channel is less than the outer diameter of a portion of the medical device. In some embodiments, the body is formed from a substantially rigid or resilient material selected from the group consisting of a plastic, a polymer, a metal, an alloy, or a composite.

[0019] In some embodiments, the body is formed from a flexible, malleable, or elastically deformable material selected from the group consisting of plastic, polymer, elastomer, rubber, silicone rubber, metal, alloy, shape memory material, superelastic material, Nitinol, and composites.

[0020] In some embodiments, the body is formed from a first material having substantially rigid or elastic material properties and including a second material having relatively softer or more flexible material properties disposed over the first material.

[0021] Also disclosed is a method of placing a catheter, the method including providing a catheter placement system including a needle, a blood flush system, a catheter including a catheter body, a hub disposed at a proximal end of the catheter body, and an extension leg extending proximally from the hub, and a guidewire extending through a lumen of the catheter; securing a portion of the catheter or guidewire within a channel of a storage device; engaging the catheter storage device with a finger of a first hand to hold the catheter storage device and the portion of the catheter or guidewire secured by the catheter storage device; and manipulating the catheter placement system with the first hand to place the catheter within the vasculature.

[0022] In some embodiments, the portion of the catheter includes a proximal portion of the catheter body, a catheter hub, an extension leg, a luer lock, or a proximal portion of a guidewire. In some embodiments, the catheter containing device includes a body defining a channel and a handle configured to engage with the fingers of a first hand.

[0023] In some embodiments, the method further includes engaging a portion of the catheter or guidewire with the channel in one of an interference fit engagement, a press fit engagement, or a snap fit engagement.

[0024] In some embodiments, the handle is formed from a first material having substantially rigid or elastic material properties and including a second material having relatively softer or more flexible material properties disposed over the first material.

[0025] In some embodiments, the handle is a ring defining an aperture and configured to receive one or more fingers therethrough. In some embodiments, the engaging step further comprises compressing the first handle with a first finger and compressing the second handle with a fourth finger of a first hand.

[0026] In some embodiments, the engaging step further includes applying radially outward pressure with a first finger of the first hand against a first crossbar of the first handle and a fourth finger of the first hand against a second crossbar of the second handle.

[0027] In some embodiments, the engaging step further includes compressing one of the body, the handle, or a crossbar coupled to the handle between two or more fingers of a first hand.

[0028] Also disclosed is a catheter containment device for holding a portion of a catheter placement system, the catheter containment device including: a body defining a channel extending along a longitudinal axis, the channel configured to permanently hold the portion of the catheter placement system; and a handle coupled to the body and configured to be grasped by the fingers of a clinician.

[0029] In some embodiments, a portion of the catheter placement system includes a proximal end of a guidewire that is permanently fixed 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.

[0030] 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]

[0031] [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 plan view illustrating a catheter placement system in a folded configuration 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 illustrates a catheter containment system in an exemplary environment of use, according to an embodiment disclosed herein. [Figure 4B] FIG. 1 illustrates a catheter containment system in an exemplary environment of use, according to an embodiment disclosed herein. [Figure 4C] FIG. 4B is a side view of the catheter containment system of FIG. 4A according to an embodiment disclosed herein. [Figure 5A] FIG. 1 is a side view illustrating a catheter containment system according to an embodiment disclosed herein. [Figure 5B] FIG. 1 illustrates a catheter containment system in an exemplary environment of use, according to an embodiment disclosed herein. [Figure 5C] FIG. 1 is a perspective view of a catheter containment system according to an embodiment disclosed herein. [Figure 5D] FIG. 1 illustrates a catheter containment system in an exemplary environment of use, according to an embodiment disclosed herein. [Figure 5E] FIG. 1 illustrates a catheter containment system in an exemplary environment of use, according to an embodiment disclosed herein. [Figure 5F] FIG. 1 illustrates a catheter containment system in an exemplary environment of use, 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 7A] FIG. 1 is a perspective view of a catheter containment system according to an embodiment disclosed herein. [Figure 7B] FIG. 7B is a side view of the catheter storage system of FIG. 7A according to an embodiment disclosed herein. [Figure 7C] 7B illustrates the catheter containment system of FIG. 7A in an exemplary environment of use, according to an embodiment disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] 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.

[0033] 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.

[0034] In the above description, the terms "or" and "and / or" as used herein shall be construed as meaning inclusively 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.

[0035] 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.

[0036] 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.

[0037] In describing the embodiment, as shown in Figure 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 transverse and longitudinal axes. A vertical plane extends perpendicular to the horizontal plane.

[0038] 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 may 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.

[0039] 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 may include 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 162 with a medical fluid line, a syringe, or the like. Each of the one or more extension legs 162 may be in fluid communication with a lumen of the catheter 152. For example, the first extension leg 162A is in fluid communication with the proximal lumen 114A, the second extension leg 162B is in fluid communication with the middle lumen 114B, and the 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.

[0040] 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 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. 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.

[0041] 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.

[0042] 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 is received within a distal portion of the extension section 158. The distal lumen 114C of the catheter 150 can extend to the distal tip 118 of the catheter 150 and communicates 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.

[0043] 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.

[0044] 4A-4B show a catheter containment device (device) 200 coupled to an extension leg 162 of a catheter placement system 100 in an exemplary environment of use. FIG. 4C shows a side view of the catheter containment device 200 of FIG. 4A. The device 200 generally includes a body 210 configured to hold a portion of the catheter placement system 100, e.g., a portion of the catheter body 152, the hub 160, one or more extension legs 162, the luer lock 164, the guidewire 130, or a combination thereof. The device 200 further includes a handle 220 configured to be grasped by a clinician. In one embodiment, a portion of the catheter placement system 100 is permanently fixed to the device 200, e.g., one of the body 210 or the handle 220. For example, a proximal end of the guidewire 130 may be integrally formed or permanently coupled to the handle 220 and / or the body 210. Advantageously, this can also prevent the guidewire 130 from being pulled through the catheter placement system 100 and into the vasculature, as well as preventing the guidewire 130 from falling outside the sterile field.

[0045] In one embodiment, as shown in FIG. 4C, the handle 220 can include a ring 222 defining an aperture 224 and configured to receive a clinician's finger 80 therethrough. In one embodiment, the ring 222 can define a circular, oval, elliptical, or polygonal aperture 224. However, it will be understood that other regular or irregular closed curve shapes are also contemplated. In one embodiment, the aperture 224 can be configured to receive two or more fingers 80 therethrough. In one embodiment, the handle 220 can include two or more rings 222, each ring configured to receive one or more fingers 80 therethrough. In one embodiment, the ring 222 is formed from a substantially rigid or resilient material, such as a plastic, polymer, metal, alloy, composite, or the like. In one embodiment, the ring 222 may be formed from a flexible, malleable, or elastically deformable material, such as a plastic, polymer, elastomer, rubber, silicone rubber, metal, alloy, shape memory material, superelastic material, Nitinol, composite, or the like.

[0046] Advantageously, the clinician can elastically or plastically deform the handle 220 to fit over one or more fingers 80 and hold the device 200 in a preferred position on the finger and remain in place until repositioned. For example, as shown in FIG. 4B, the device 200 can be engaged with the small finger 80D and rotated so that the body 210 of the device 200 is positioned outward from the clinician's palm. The clinician can elastically or plastically deform the handle 220 to hold the device 200 in this position relative to the hand. In one embodiment, one or both of the handle 220 and the body 210 can be formed from an elastic material, a superelastic material, or a shape memory material such as Nitinol and can be configured to return to the original shape of the handle 220 once the clinician has completed the procedure. In one embodiment, the handle 220 and the body 210 are hingedly or rotatably coupled to allow the handle 220 to rotate or pivot relative to the body 210.

[0047] 4C, in one embodiment, the body 210 includes one or more channels 214 formed therein and extending along the longitudinal axis 70. The channels 214 are configured to releasably hold a portion of the catheter placement system 100, such as a portion of the catheter body 152, the hub 160, the extension leg 162, the luer lock 164, the guidewire 130, or combinations thereof. For example, as shown in FIGS. 4A-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 the body 210 may include one or more channels 214 configured to hold other portions of the catheter placement system 100. In one embodiment, one or both of the body 210 and the handle 220 are formed from a substantially rigid or resilient material such as a plastic, polymer, metal, alloy, composite, or the like.

[0048] In one embodiment, a portion of the catheter placement system 100, such as the extension leg 162, the guidewire 130, etc., may be permanently retained within the channel 214 of the body 210. For example, the body 210 may include a channel 214 that does not have an opening 216 and completely surrounds the extension leg 162, the guidewire 130, etc. Thus, the body 210 may be slidably engaged with, but not removed from, a portion of the catheter placement system 100. Advantageously, this prevents the catheter placement system 100 from accidentally disengaging from the device 200 and falling outside of the sterile field. Additionally, the device 200 may function to prevent the guidewire 130, for example, from being accidentally pulled through the catheter lumen and into the vasculature, reducing complications to the patient.

[0049] In one embodiment, the channel 214 includes a longitudinally extending opening 216 configured to allow a portion of the extension leg 162 to enter and / or exit from the channel 214. In one embodiment, the width (w1) of the opening 216 is less than a diameter (d1) of a portion of the catheter placement system 100 (e.g., the extension leg 162) that is retained by the channel 214. Thus, one or both of the opening 216 and the portion of the extension leg 162 may elastically deform slightly to allow the extension leg 162 to fit through the opening 216. Additionally, the opening 216 may abut the extension leg 162 to retain the extension leg 162 within the channel 214. In one embodiment, the width of the channel 214 may be equal to or less than an outer diameter of the extension leg 162 and may engage the extension leg 162 in an interference-fit, press-fit, or snap-fit ​​engagement to releasably retain the extension leg 162 therein.

[0050] In an exemplary method of use, a clinician can couple the device 200 to a portion of the catheter 150. For example, the first extension leg 162A is urged through the first opening 216A into the first channel 214A, the second extension leg 162B is urged through the second opening 216B into the first channel 214B, the third extension leg 162C is urged through the third opening 216C into the third channel 214C, or combinations thereof. Advantageously, the device 200 can hold the extension legs 162, preventing them from entangling and preventing them from falling outside the sterile field.

[0051] The clinician then places a finger 80, e.g., pinky finger 80D, through aperture 224 in handle 220 to hold device 200 and associated extension leg 162 close to the clinician's hand without compromising the clinician's dexterity. Advantageously, this provides the clinician with improved control of catheter placement system 100, e.g., catheter 150 and guidewire 130. The clinician then accesses the vasculature with needle 120 and access section 154, confirms correct vascular access using blood flush system 140, advances guidewire 130, removes needle 120, advances catheter 150 over guidewire 130, dilates the insertion site, places distal tip 118 of catheter 150 at the target location within the vasculature, and removes guidewire 130, all without dropping the proximal end of catheter placement system 100 risking contamination. Advantageously, device 200 keeps the proximal portion of the catheter placement system 100 away from the insertion site, providing improved visibility, simplified presentation, and greater control.

[0052] 5A-5F illustrate an embodiment of a catheter-containing device (device) 300. The device 300 generally includes a centrally located body 310 with a first handle 320A extending laterally from a first side of the body 310 and a second handle 320B extending laterally from a second side of the body 310 opposite the first side. Optionally, the first handle 320A and / or the second handle 320B include one or more rings 322 for placement of a finger 80 therethrough, as described in more detail herein. For example, FIG. 5A illustrates an embodiment of the device 300 having one or more rings 322, and FIG. 5B illustrates an embodiment of the device 300 without any rings 322. As will be appreciated, these embodiments are exemplary and are not intended to be limiting. The body 310 includes a first channel 314A extending along a central longitudinal axis 70 and configured to hold a portion of the catheter placement system 100, as described herein. As will be appreciated, the device 300 can include one or more first channels 314A, each extending along the longitudinal axis 70 and each configured to hold a portion of the catheter placement system 100. However, for ease of illustration, only a single longitudinal first channel 314A is shown. In one embodiment, the channel 314 can permanently hold a portion of the catheter placement system 100, as described herein, to prevent the device 300 from disengaging from the catheter placement system 100. As described herein, the device 300 can be slidably engaged with the catheter placement system 100 or can be permanently fixed thereto.

[0053] As shown in FIGS. 5A-5C, in one embodiment, the body 310 further includes a second channel 314B extending along an axis at an angle relative to the longitudinal axis 70. As shown, the second channel 314B may extend along a central transverse axis 72 perpendicular to the axis 70 of the first channel 314A. However, it will be understood that the second channel 314B may extend along an axis 72 extending at other angles relative to the first longitudinal axis 70. In one embodiment, the second channel 314B may be configured to hold a portion of the catheter placement system 100, as described herein. As will be appreciated, the device 300 may include one or more second channels 314B, each extending along a (transverse) axis 72 and each configured to hold a portion of the catheter placement system 100, as described herein. However, for ease of illustration, only a single transverse second channel 314B is shown. In one embodiment, one or both of the first channel 314A or the second channel 314B can include an opening that defines a first width (w1) that is less than an outer diameter (d1) of a portion of the catheter placement system 100 retained therein, as described herein.

[0054] In one embodiment, one or both of the first handle 320A and the second handle 320B can include a crossbar 326, e.g., the first handle 320A includes a first crossbar 326A and the second handle 320B includes a second crossbar 326B. The crossbar 326 extends at an angle to the axis of the handle 320, e.g., the crossbar 326 extends substantially perpendicular to the transverse axis of the handle 320. As shown, the crossbar 326 extends along a transverse axis, but it will be understood that other angles and axes are contemplated. The crossbar 326 can define a straight or curved shape and can be configured to be grasped by one or more fingers 80 of a clinician. In one embodiment, the crossbar 326 can extend symmetrically from the handle 320, as shown in FIG. 5C. In one embodiment, the crossbar 326 can extend asymmetrically from the handle 320, as shown in FIG. 5A. Advantageously, the handle 320 and / or the crossbar 326 are configured to be grasped by one or more fingers 80 to facilitate manipulation of the device 300 and the portion of the system 100 held therein.

[0055] In one embodiment, the handle 320 is formed from a substantially rigid or elastic material, such as a plastic, polymer, metal, alloy, composite, etc. In one embodiment, the handle 320 is formed from a flexible, malleable, or elastically deformable material, such as a plastic, polymer, elastomer, rubber, silicone rubber, metal, alloy, shape memory material, superelastic material, nitinol, composite, etc. In one embodiment, the handle 320 is formed from a first material and includes a second material disposed thereon. For example, the first material includes a substantially rigid material as described herein and includes a second material disposed thereon, such as a softer material, elastomer, rubber, silicone rubber, or a material exhibiting a relatively high coefficient of friction, to facilitate gripping the handle 320.

[0056] As shown in FIG. 5A, in one embodiment, the handle 320 can further include a ring 322 coupled thereto, defining an aperture 324 configured to receive one or more fingers 80 therethrough, as described herein. In one embodiment, the handle 320 includes one or more rings 322, each configured to receive a finger 80 therethrough. As shown in FIG. 5A, the rings 322 are coupled to the first handle 320A and the second handle 320B. However, the number, location, and position of the one or more rings 322 shown in FIG. 5A are exemplary and not intended to be limiting. The rings 322 can be formed of the same material as one or both of the handle 320 and the body 310. In one embodiment, the rings 322 are formed of a different material than one or both of the handle 320 and the body 310 and are coupled thereto using adhesives, bonding, welding, ultrasonic welding, or the like. Advantageously, the ring 322 facilitates grasping of the handle 320 and securing the device 300 in the clinician's hand, and reduces accidental disengagement of the device 300 from the clinician's hand.

[0057] In an exemplary method of use, a clinician can grasp the device 300 by one or more of the body 310, the first handle 320A, the second handle 320B, the crossbar 326, and the ring 322, or a combination thereof. In one embodiment, the clinician can place one or more fingers 80 through the ring 322 as described herein. In one embodiment, the clinician can grasp the device 300 by placing one or more fingers 80 between the first crossbar 326A and the second crossbar 326B. In one embodiment, the clinician can grasp the device 300 with the handle 320 extending across the dorsum of the fingers, i.e., the dorsum of the hand (FIG. 5B). In one embodiment, the clinician can grasp the device 300 by applying pressure laterally outward with the first finger 80A and the fourth finger 80D. In one embodiment, a portion of the first crossbar 326A can be grasped between the first and second fingers 80A and a portion of the second crossbar 326B can be grasped between the third and fourth fingers 80C and 80D, as shown in FIG. 5D. In one embodiment, the clinician can grasp the device 300 using the handle 320 that extends across the front of the fingers, i.e., the palmar side of the hand. In one embodiment, the clinician can grasp the device 300 by applying lateral inward pressure with the first and fourth fingers 80A and 80D. Advantageously, the handle 320, crossbar 326, and / or ring 322 allow the clinician to grasp the device 300 in a variety of ways without interfering with the dexterity of the hand used to grasp the device 300. The versatility of the device 300 allows the clinician to hold the proximal portion of the system 100 in a variety of positions that are convenient for the clinician.

[0058] In one embodiment, as shown in FIGS. 5E-5F, the clinician can grasp the device 300 by extending the handle 320 between two of the fingers 80A-80D, such as between the first finger 80A and the second finger 80B, or between the second finger 80B and the third finger 80C, or a combination thereof. In one embodiment, the crossbar 326 extends across one of the front side of the fingers (i.e., palmar side, FIG. 5E) or the dorsal side of the fingers (FIG. 5F). In one embodiment, the body 310 is positioned on one of the dorsal side of the fingers (i.e., palmar side, FIG. 5E). The clinician then uses one or both of the handle 320 and the crossbar 326 to move the device 300 while maintaining dexterity of the fingers 80 to facilitate manipulation of the device 300.

[0059] In one embodiment, a clinician can grasp the device 300 as described herein and place a portion of the catheter placement system 100 either in the first channel 314A to align a portion of the catheter placement system 100 with the longitudinal (first) axis 70, or in the second channel 314B to align a portion of the catheter placement system 100 with the transverse (second) axis 72, depending on which position is most ergonomically convenient.

[0060] In one embodiment, one or both of the first channel 314A and the second channel 314B are configured to receive and retain two or more portions of the catheter placement system 100 therein. For example, as shown in FIG. 5D, the second channel 314B retains a portion of the first extension leg 162A, the second extension leg 162B, and the third extension leg 162C. Advantageously, the device 300 allows the clinician to grasp the device 300 with a portion of the catheter placement system 100 secured within the device 300, allowing the clinician to maintain finger dexterity of the same hand. The device 300 allows the clinician to continue placement of the catheter 150 while mitigating the catheter 150 from falling outside the sterile field. Additionally, the device 300 prevents entanglement of one or more proximal portions of the system 100.

[0061] In one embodiment, as shown in Figures 6A-6B, the catheter containing device (device) 400 includes a body 410 and a single handle 420 extending therefrom. The handle 420 defines a circular or curvilinear cross-sectional shape. In one embodiment, the handle 420 includes a plug 428 (Figure 6A) or a crossbar 426 (Figure 6B) disposed at an end of the handle 420 opposite the body 410. The plug 428 or crossbar 426 may be configured to abut the fingers 80 and prevent the handle 420 from sliding therebetween. The body 410 includes one or both of a first channel 414A (Figure 6B) extending along a first (longitudinal) axis 70 and a second channel 414B (Figure 6A) extending along a second (transverse) axis 72. It will be understood, however, that body 410 may include one or more channels extending along other axes or at angles thereto and are contemplated as falling within the scope of the present invention. In one embodiment, channel 414 is configured to releasably retain a portion of catheter placement system 100, as described herein. In one embodiment, channel 414 may permanently retain, slidably retain, and / or be permanently fixed to a portion of catheter placement system 100, as described herein.

[0062] In an exemplary method of use, a clinician can grasp the device 400 by one or more of the body 410, the handle 420, the crossbar 426, and the plug 428. In one embodiment, one or more of the handle 420 and the crossbar 426 extend between two or more fingers 80. The body 410 can be aligned either on the dorsum of the hand or on the front (palmar) side of the hand. In one embodiment, one of the plug 428 or the crossbar 426 can abut the fingers 80 to prevent the handle 420 from slipping between the fingers 80. The clinician can then secure a portion of the catheter placement system 100 in one of the first channel 414A or the second channel 414B as described herein.

[0063] In one embodiment, as shown in Figures 7A-7C, a catheter housing device (device) 500 includes a body 510 extending across a horizontal plane and defining substantially a disk shape having a top surface 512, a bottom surface 518, and a circular perimeter. However, it will be understood that the device 500 may define other three-dimensional outer contour shapes, including a cube, an ellipse, a polygon, or any regular or irregular closed curve, convex or concave shape. The body 510 of the device 500 includes one or more channels 514 extending longitudinally along a first axis 70 and configured to hold one or more portions of the catheter placement system 100, as described herein. The channel 514 may include an opening 516 communicating between the channel 514 and one of the top surface 512 or the bottom surface 518. In one embodiment, the channel 514 can permanently retain, slidably retain, and / or be permanently fixed to a portion of the catheter placement system 100, as described herein.

[0064] 7B shows a side view of device 500. In one embodiment, one or both of top surface 512 and bottom surface 518 may define a concave profile. In one embodiment, body 510 may define a bi-concave profile or an "hourglass" profile, having a concave top surface 512 and a concave bottom surface 518 disposed opposite top surface 512. One or both of concave top surface 512 and concave bottom surface 518 may each define a shallow finger channel 524 extending along transverse axis 74. In use, finger channel 524 may align a clinician's finger 80 with an axis of device 200 extending at an angle, e.g., perpendicular, to axis 70 of channel 514.

[0065] In one embodiment, the device 500 can be formed from a substantially rigid or elastic material, such as a plastic, polymer, metal, alloy, composite, etc. In one embodiment, the device 500 can be formed from a flexible, malleable, or elastically deformable material, such as a plastic, polymer, elastomer, rubber, silicone rubber, metal, alloy, shape memory material, superelastic material, nitinol, composite, etc. In one embodiment, the device 500 can be formed from a first material and can include a second material disposed thereon. For example, the first material can include a substantially rigid material as described herein and a second material disposed thereon, such as a softer material, elastomer, rubber, silicone rubber, or a material exhibiting a relatively high coefficient of friction, thereby facilitating gripping the device 500 or securing a portion of the catheter placement system 100.

[0066] In use, as shown in FIG. 7C, a clinician can hold a portion of the catheter placement system 100 in the channel 514 of the device 500 in an interference fit engagement, press fit engagement, snap fit engagement, or the like, as described herein. The clinician can then grasp the device 500 between two fingers 80 along the transverse axis 74, for example, between the third finger 80C and the fourth finger 80D, and hold the device 500 and catheter 150 assembly therebetween. Advantageously, the channel 514 can provide a large surface area between the device 500 and a portion of the catheter placement system 100, improving retention of the catheter placement system 100 in a friction fit engagement. Additionally, the device 500 can provide a relatively large surface area for the clinician to grip the device 500, allowing the clinician to manipulate the device 500 and the catheter placement system 100 coupled thereto, while mitigating slipping or falling of a portion of the catheter placement system 100.

[0067] 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 device for holding a portion of a catheter placement system, comprising: a body defining a longitudinally extending channel along a first axis, the channel configured to retain the portion of the catheter placement system and having a longitudinally extending opening configured to allow entry or exit along a second axis extending at an angle relative to the first axis of the channel; a handle coupled to the body and configured to be grasped by the fingers of a clinician; A catheter containment device comprising:

2. The catheter containment device 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 containing device 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 device of claim 2 , wherein the body includes a first channel configured to hold a first extension leg and a second extension leg.

5. 10. The catheter containing device of claim 1, wherein the body includes a first channel extending along the first axis of the channel and a second channel extending along a third axis at an angle to the first axis of the channel.

6. The catheter containment device of claim 1 , wherein the inner diameter of the channel is equal to or slightly smaller than the outer diameter of the portion of the catheter placement system.

7. The catheter containment device of claim 1 , wherein the width of the opening of the channel is less than an outer diameter of the portion of the catheter placement system.

8. 8. The catheter containment device of claim 1, wherein one or both of the body and the handle are formed from a substantially rigid or resilient material selected from the group consisting of a plastic, a polymer, a metal, an alloy, or a composite.

9. 8. The catheter containment device of claim 1, wherein one or both of the body and the handle are formed from a flexible, malleable, or elastically deformable material selected from the group consisting of plastic, polymer, elastomer, rubber, silicone rubber, metal, alloy, shape memory material, superelastic material, nitinol, and composite.

10. 8. The catheter containment device of claim 1, wherein the handle is formed from a first material having substantially rigid or elastic material properties, the first material including a second material having relatively softer or more flexible material properties disposed over the first material.

11. 8. The catheter housing device of claim 1, wherein the handle is a ring defining an aperture and configured to receive one or more fingers therethrough.

12. The catheter housing device of claim 1 , wherein the handle is hingedly, rotatably or pivotally coupled to the body.

13. The catheter housing device of claim 1 , wherein the handle extends from the body at an angle relative to the first axis of the channel.

14. 8. The catheter housing device of claim 1, further comprising a first handle extending from the body in a first direction and a second handle extending from the body in a second direction opposite the first direction.

15. 8. The catheter housing device of claim 1, wherein the handle includes one of a plug or a crossbar located at an opposite end of the handle from the body.

16. 1. A catheter containment device for holding a portion of a medical device, comprising: a body defining a disk shape extending across a horizontal plane and defining a top surface and a bottom surface; a device channel extending along an axis parallel to one of the top surface or the bottom surface and including an opening in communication with the one of the top surface or the bottom surface, the device channel configured to receive the portion of the medical device within the device channel; A catheter containment device comprising:

17. 17. The catheter containing device of claim 16, wherein the body further includes a biconcave cross-section having one of a first finger channel extending across the top surface and a second finger channel extending across the bottom surface, wherein one of the first finger channel or the second finger channel extends at an angle relative to the device channel.

18. 17. The catheter housing device of claim 16, wherein the device channel is configured to hold one of a catheter body, a catheter hub, an extension leg, a luer lock, or a guidewire.

19. 17. The catheter housing device of claim 16, wherein the body includes a first device channel configured to hold a first extension leg and a second device channel extending parallel to the first device channel and configured to hold a second extension leg.

20. 19. The catheter housing device of any one of claims 16 to 18, wherein the device channel is configured to hold a first extension leg and a second extension leg.

21. 19. The catheter housing device of any one of claims 16 to 18, wherein the inner diameter of the device channel is equal to or slightly smaller than the outer diameter of the portion of the medical device.

22. 19. The catheter containing device of claim 16, wherein the width of the opening of the device channel is less than the outer diameter of a portion of the medical device.

23. 19. The catheter containment device of any one of claims 16 to 18, wherein the body is formed from a substantially rigid or resilient material selected from the group consisting of a plastic, a polymer, a metal, an alloy, or a composite.

24. 19. The catheter containment device of any one of claims 16 to 18, wherein the body is formed from a flexible, malleable, or elastically deformable material selected from the group consisting of plastic, polymer, elastomer, rubber, silicone rubber, metal, alloy, shape memory material, superelastic material, nitinol, and composite.

25. 19. The catheter containment device of any one of claims 16 to 18, wherein the body is formed from a first material having substantially rigid or elastic material properties and the first material includes a second material having relatively softer or more flexible material properties disposed over the first material.

26. 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 be grasped by the fingers of a clinician; A catheter containment device comprising:

27. 27. The catheter containment device of claim 26, wherein the portion of the catheter placement system includes a proximal end of a guidewire permanently secured to the body.

28. 27. The catheter containment device of claim 26, wherein the portion of the catheter placement system includes a proximal portion of a guidewire slidably engaged with the body.

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