Stabilizing connector devices for vascular access and methods of using the same

Abstract

To provide an improved device and method for connecting to and / or stabilizing a deployed vascular access device.SOLUTION: A stabilizing connector includes a connector portion and a stabilization portion. The connector portion is configured to couple to an access device. The connector portion defines at least one lumen that is configured to be placed in fluid communication with a lumen of the access device. The stabilization portion is coupled to the connector portion. The stabilization portion is configured to be placed in contact with a surface of a patient's skin to stabilize at least one of the stabilizing connector or the access device.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 592,684, filed on November 30, 2017, entitled "Stabilizing Connector Devices for Vascular Access and Methods of Using the Same", the disclosure of which is hereby incorporated by reference in its entirety.

[0002] This application also claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 631,208, filed on February 15, 2018, entitled "Stabilizing Connector Devices for Vascular Access and Methods of Using the Same", the disclosure of which is hereby incorporated by reference in its entirety.

Background Art

[0003] Embodiments described herein generally relate to medical devices, and more specifically, to devices and methods for connecting and / or stabilizing vascular access devices, such as intravenous catheters, and / or devices coupled thereto.

[0004] Many medical procedures and / or surgical interventions involve inserting an access device or fluid transfer device into a part of the body. For example, catheters and / or other lumen - defining devices can be inserted into and / or through a vascular structure to access a part of the body and / or to transfer fluid to and / or from a patient. In some examples, vascular access devices (VADs), such as peripheral intravenous catheters (PIVs), are designed and / or intended to be inserted into a patient (e.g., while the patient is in the hospital or during other medical procedures) and remain in the patient's body for an extended period of time.

[0005] A VAD typically includes a catheter formed from a soft biocompatible polymer that is partially disposed within the body and attached to a hub at its proximal end (e.g., the end outside the body), and can then provide an interface, a coupler, and / or ports for connecting suitable devices. After a VAD (e.g., a PIV catheter, etc.) is placed within a patient's vein (or artery), it is often desirable to stabilize and / or fix the VAD to the patient. For example, in some instances, movement of the VAD relative to the patient can result in undesirable bending, flexing, and / or twisting of the catheter. In other instances, movement of the VAD (e.g., along the longitudinal axis of the VAD) can pull a portion of the catheter out of the patient's body, and then expose that portion of the catheter to a non-sterile environment. Further, when the VAD is returned to its original position, a potentially contaminated portion of the VAD (e.g., the catheter) is inserted into the patient, thereby increasing the likelihood of infection.

[0006] Stabilization and / or fixation devices are often used to minimize movement of a placed VAD (e.g., a PIV catheter). However, some known stabilization and / or fixation devices are complex and / or time-consuming to use, while other devices may provide inadequate stabilization. Further, the shape and / or configuration of some known stabilization and / or fixation devices can negatively impact the flow rate through the VAD and / or a portion of the vein (or artery) in which the catheter is placed. Additionally, VADs are often used with intermediate devices or connectors such as extension sets. In such instances, adding a stabilization device increases the complexity and / or cost of the procedure that is required to be performed. Further, some of such stabilization devices are designed to be used with specific VADs and / or specific extension sets.

[0007] Accordingly, there is a need for improved devices and methods for connecting and / or stabilizing a placed vascular access device.

Summary of the Invention

[0008] In this specification, for example, devices and methods for stabilizing or otherwise using an implanted vascular access device, such as an intravenous or arterial catheter, will be described. In some embodiments, the device includes a connector portion and a stabilization portion integrally formed with at least a portion of the connector portion. The connector portion has a distal coupler and a proximal coupler, and defines a lumen extending between the distal coupler and the proximal coupler. The distal coupler is configured to be coupled to a hub of an access device at least partially inserted into a patient at a predetermined angle with respect to the patient's insertion site such that the lumen of the connector portion is disposed in fluid communication with the lumen defined by the access device. The stabilization portion is configured to contact the patient when the distal coupler is coupled to the hub of the access device and to stabilize at least one of the connector portion and the access device. When the stabilization portion is in contact with the patient, the connector portion is disposed at a substantially predetermined angle such that a common axis extends through at least a portion of the lumen defined by the connector portion and the lumen defined by the access device.

Brief Description of the Drawings

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Modes for Carrying Out the Invention

[0010] In some embodiments, the device includes a connector portion and a stabilization portion integrally formed with at least a portion of the connector portion. The connector portion has a distal coupler and a proximal coupler and defines a lumen extending between the distal coupler and the proximal coupler. The distal coupler is configured to be coupled to a hub of an access device at least partially inserted into a patient at a predetermined angle relative to the patient's insertion site such that the lumen of the connector portion is disposed in fluid communication with the lumen defined by the access device. The stabilization portion is configured to contact the patient when the distal coupler is coupled to the hub of the access device to stabilize at least one of the connector portion and the access device. When the stabilization portion is in contact with the patient, the connector portion is disposed at a substantially predetermined angle such that a common axis extends through at least a portion of the lumen defined by the connector portion and the lumen defined by the access device.

[0011] In some embodiments, the device includes a connector portion and a stabilization portion integrally formed with at least a portion of the connector portion. The connector portion has a distal coupler and a proximal coupler and defines a lumen extending between the distal coupler and the proximal coupler. The distal coupler is configured to be coupled to a hub of an access device at least partially inserted into a patient's vein such that the lumen of the connector portion is disposed in fluid communication with the lumen defined by the access device. The stabilization portion has a base surface. A portion of the base surface is configured to contact the patient when the distal coupler is coupled to the hub of the access device such that (1) the stabilization portion stabilizes at least one of the connector portion or the access device and (2) a common axis extends through at least a portion of the lumen defined by the connector portion and the lumen defined by the access device. The base surface forms a recess configured to align with the vein and be spaced from the patient when a portion of the base surface is in contact with the patient.

[0012] In some embodiments, the device includes a connector portion and a stabilization portion integrally formed with at least a portion of the connector portion. The connector portion has a distal coupler and a proximal coupler, and defines a lumen extending between the distal coupler and the proximal coupler. The distal coupler is configured to be coupled to a hub of an access device inserted at least partially into a patient such that the lumen of the connector portion is in fluid communication with the lumen defined by the access device. The stabilization portion has a base surface. A portion of the base surface is configured to contact the patient when the distal coupler is coupled to the hub of the access device, stabilizing at least one of the connector portion and the access device. The base surface forms a recess configured to be spaced from the patient when a portion of the base surface is in contact with the patient. The connector portion is arranged at a predetermined angle such that when the distal coupler is coupled to the hub of the access device and the base surface is in contact with the patient, a common axis extends through at least a portion of the lumen defined by the connector portion and the lumen defined by the access device. to the hub of an access device inserted at least partially into the patient.

[0013] In some embodiments, the stabilization connector includes a connector portion and a stabilization portion. The connector portion is configured to couple to an access device. The connector portion defines at least one lumen configured to be arranged in fluid communication with the lumen of the access device. The stabilization portion is coupled to the connector portion. The stabilization portion is configured to be arranged in contact with the surface of the patient's skin to stabilize at least one of the stabilization connector and the access device.

[0014] As used herein, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, the term "member" is intended to mean a single member or combination of members, the term "material" is intended to mean one or more materials or combinations thereof, and the term "device" is intended to mean a single device or combination of devices.

[0015] The devices and methods described herein are configured to stabilize devices and / or components of a device that are inserted directly or indirectly into a patient. Such devices are generally referred to herein as access devices. The devices and / or methods described herein can be used with any suitable access device that enables access to any part of a patient. The devices and methods are not intended to be limited to use with a particular access device, although specific examples of such devices are vascular access devices (VADs). Non-limiting examples of VADs include intravenous (IV) access devices such as peripheral intravenous catheters (PIVs), peripherally inserted central catheters (PICCs or PIC lines), midline catheters, extended dwell catheters (EDCs), etc. In other embodiments, the VAD can be an intra-arterial access device such as an arterial line. Although reference is made herein to use with a particular access device, it should be understood that such reference is presented by way of example and not limitation.

[0016] As used herein, the term "catheter" refers to an element configured to define a passageway, such as a cannula, tube, and / or other lumen-defining structure. In some examples, a catheter can be used to move a body fluid from a first location to a second location (e.g., a fluid passageway for moving the body fluid outside of the body). A cannula can be configured to receive a trocar, guidewire, and / or introducer and deliver the cannula into a volume within a patient's body, although the catheters and / or cannulas referred to herein need not include or receive a trocar, guidewire, and / or introducer and can be positioned and / or inserted into a patient's vasculature using, for example, any suitable method. Further, the reference to catheters herein is provided by way of example only and not limitation. Thus, describing a lumen-defining structure as a "catheter" is not intended to exclude the use of any other suitable lumen-defining structure, if desired.

[0017] As used herein, the term "extension set" generally refers to a device or connector coupled to the hub of a VAD, such as a peripheral intravenous catheter. The "extension set" can be of any suitable configuration. For example, in some embodiments, the extension set can be a single-port or multi-port connector. As a specific example, the extension set can be, and / or refer to, a "Y-shaped" dual-port extension. In other embodiments, the extension set can be, and / or refer to, a "T-shaped" dual-port extension set. In still other embodiments, the extension set can be, and / or refer to, a single-port extension set (i.e., an extension set that defines a single lumen therethrough). Generally, some known extension sets are configured to couple between the hub of a VAD and any suitable medical device, enabling one or more objects, devices, drugs, fluids, etc. to access a part of the patient's body (e.g., via the VAD). More specifically, in some examples, the extension set can be coupled to an indwelling access device (e.g., PIV, etc.) to facilitate the transfer and / or collection of one or more fluids. In some examples, the body fluid can be a body fluid including, but not limited to, blood, cerebrospinal fluid, urine, bile, lymphatic fluid, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, vitreous humor, air, etc., or any combination thereof.

[0018] As used herein, the terms "proximal" and "distal" refer to the directions approaching and moving away from, respectively, the user who positions the device in contact with the patient. Thus, for example, the end of the device that first touches the patient's body is the distal end, and the end on the opposite side of the device (e.g., the end of the device being operated by the user) is the proximal end of the device.

[0019] The embodiments described herein can be formed or constructed from one or more biocompatible materials. Examples of suitable biocompatible materials include metals, glasses, ceramics, or polymers. Examples of suitable metals include pharmaceutical grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or alloys thereof. The polymer material can be biodegradable or non-biodegradable. Examples of suitable biodegradable polymers include polylactide, polyglycolide, polylactide-co-glycolide (PLGA), polyanhydrides, polyorthoesters, polyether esters, polycaprolactone, polyester amides, poly(butyric acid), poly(valeric acid), polyurethanes, and / or blends and copolymers thereof. Examples of non-biodegradable polymers include nylon, polyester, polycarbonate, polyacrylate, ethylene vinyl acetate and other acyl-substituted cellulose acetate polymers, non-degradable polyurethanes, polystyrene, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulfonated polyolefin, polyethylene oxide, and / or blends and copolymers thereof.

[0020] Figure 1 shows a stabilization connector 100 according to the first embodiment. The stabilization connector 100 is configured to be placed in contact with the patient's skin at or near the insertion site of an indwelling or placed vascular access device (VAD) as described above. The stabilization connector 100 is configured to couple and / or otherwise engage with the VAD. When coupled to the VAD, the stabilization connector 100 can be secured to the patient's skin (e.g., via a medical tape, a transparent sterile barrier such as Tegaderm™, etc.), and then at least a portion of the VAD can be secured and / or stabilized with respect to the patient, as described in more detail herein.

[0021] The stabilization connector 100 can be of any suitable shape, size, and / or configuration. For example, as shown, the stabilization connector 100 (also referred to herein as the "connector") has a connector portion 110 and a stabilization portion 130. In some embodiments, the connector 100 can be configured as a combination of one or more stabilization devices and an extension set. Each of the connector portion 110 and / or the stabilization portion 130 can be arranged in any suitable manner that facilitates at least one of the functions of providing stabilization to one or more devices (e.g., a VAD, etc.) and / or one of the functions of providing an extension set for use with a VAD.

[0022] The connector portion 110 can have any suitable shape, size, and / or configuration. For example, in some embodiments, the connector portion 110 can be or can form a single port or dual port adapter or extension set configured to be used and / or coupled with, for example, an access device 15. As shown in FIG. 1, the connector portion 110 has a proximal coupler 115 and a distal coupler 120 and defines at least one lumen (not shown in FIG. 1) that extends through or otherwise is in fluid communication with the couplers 115 and 120. The proximal coupler 115 and / or the distal coupler 120 can be, for example, male or female luer locks, needleless connectors (NFCs), and / or any other suitable coupler or combination of couplers. As described in more detail herein, the proximal coupler 115 can be physically and fluidly coupled to any suitable medical device. The distal coupler 120 can be physically and fluidly coupled to an access device 15 such as, for example, a VAD, PIV, PICC line, arterial IV, etc., such that the lumen of the connector portion 110 is at least selectively in fluid communication with the access device 15 and / or a part of the body in which the access device 15 is at least partially disposed. In some embodiments, the lumen of the connector portion 110 can be substantially straight and / or can permit a substantially straight line of sight through it (e.g., at least between the proximal coupler 115 and the distal coupler 120).

[0023] Although not shown in FIG. 1, in some embodiments, the connector portion 110 can include one or more additional ports (e.g., one or more side ports, etc.). In some such examples, the port can define a lumen that is in fluid communication with a lumen that extends between the proximal connector 115 and the distal connector 120. In other words, the connector portion 110 and / or the port can include and / or define a first lumen and a second lumen. Thus, the port can provide access to the lumen that extends between the couplers 115 and 120, which in turn can provide access to the access device 15 coupled thereto via the distal coupler 120 and / or provide access to a body part in which the access device 15 is located. Further, the port can be coupled to a tubing or the like configured to establish fluid communication between the port and one or more devices, mechanisms, reservoirs, pumps, syringes, etc. coupled to an end portion of the tubing, as will be described in more detail herein with reference to certain embodiments.

[0024] The stabilization portion 130 is coupled to the connector portion 110 and configured to be placed in contact with a portion of the patient (e.g., the patient's skin) at or near the insertion site associated with the access device 15. The stabilization portion 130 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the stabilization portion 130 can be, and / or form, a base structure that is angled, tapered, flared, curved, rounded, etc. In some embodiments, the stabilization portion 130 can have a generally concave contour and / or shape. In some embodiments, the concave contour and / or shape can be at least partially based on the curvature and / or shape of a portion of the patient's anatomical structure. In some embodiments, forming the contour and / or shape of the stabilization portion 130 to be similar and / or at least partially based on, for example, the curvature and / or angle of the patient's IV insertion site can increase the surface area of the stabilization portion 130 that contacts the patient's skin, and in turn, as described in more detail herein, enhance the stability of the stabilization connector 100 and reduce the pressure associated with securing the stabilization connector 100 to the patient's skin. Further, in some embodiments, the base surface 131 of the stabilization portion 130 can include one or more contours, recesses, notches, cutouts, etc. (referred to herein as "recesses" 132) configured to reduce the amount of force applied to the patient's vein (e.g., the vein in which the access device 15 is disposed) by a portion of the stabilization portion 130, which, in other cases, could potentially result in at least partial occlusion and / or a decrease in flow rate of at least a portion of the vein.

[0025] In some embodiments, the base surface 131 of the stabilization portion 130 provides both stabilization and comfort It can be selectively formed from one or more materials (e.g., a relatively hard material and / or a relatively soft material) configured to provide a square. In some embodiments, the stabilization portion 130 can be configured to enhance stability at its given or desired portion (e.g., proximal portion, distal portion, one or more lateral portions, etc.). In some embodiments, the stabilization portion 130 can be reconfigurable, which can enable a user to selectively control the amount of stabilization provided by the stabilization portion 130. Further, in some such embodiments, the user can reconfigure (e.g., bend, flex, deform, conform, stretch, break, cut, add, etc.) one or more portions of the stabilization portion 130, e.g., to control the amount or pattern of stabilization, to conform at least a portion of the stabilization portion 130 to the contour of a particular patient, and to reduce or substantially prevent pressure points.

[0026] The stabilization portion 130 is configured to be placed in contact with a portion of the patient's skin at or near the insertion site (as described above). Further, the stabilization portion 130 and / or the stabilization connector 100 are generally configured to be secured to the patient's skin using any suitable securing means. For example, in some instances, the stabilization portion 130 can be taped to the patient's skin using medical tape or the like, or the base surface 131 can include an adhesive configured to secure the connector 100 to the patient and / or can be coated therewith. In other examples, the stabilization portion 130 can be secured to the patient's skin using, for example, a transparent sterile barrier such as Tegaderm™. In yet other embodiments, the stabilization portion 130 can be secured to the patient's skin using any suitable combination of securing methods (e.g., any combination of the methods described herein). In some embodiments, at least the size, shape, and / or configuration of the stabilization portion 130 can facilitate securing of the stabilization connector 100 to the patient's skin. For example, in some embodiments, the stabilization portion 130 can be configured such that at least a portion of a transparent sterile barrier (e.g., Tegaderm™) can wrap around the stabilization portion 130 and the stabilization portion 130 can be disposed inside or under the barrier. In some examples, by configuring the stabilization portion 130 to allow the barrier to surround the stabilization portion 130, for example, openings in the barrier that could otherwise introduce contamination points and the like can be reduced and / or substantially prevented.

[0027] Figures 2-7 show a stabilization connector 200 according to the second embodiment. The stabilization connector 200 is configured to be placed in contact with the patient's skin at or near the insertion site of a vascular access device (VAD) that has been placed or positioned as described above. The stabilization connector 200 is configured to couple and / or otherwise engage with the VAD. When coupled to the VAD, the stabilization connector 200 can be secured to the patient's skin (e.g., via a medical tape, a transparent sterile barrier such as Tegaderm™, etc.), and then at least a portion of the VAD can be secured and / or stabilized with respect to the patient, as described in further detail herein.

[0028] The stabilization connector 200 can be of any suitable shape, size, and / or configuration. For example, as shown, the stabilization connector 200 (also referred to herein as the "connector") has a connector portion 210 and a stabilization portion 230. In some embodiments, the connector 200 can be configured as a combination of one or more stabilization devices and an extension set. Each of the connector portion 210 and / or the stabilization portion 230 can be arranged in any suitable manner that facilitates at least one of the functions of providing stabilization to one or more devices (e.g., a VAD, etc.) and / or one of the functions of providing an extension set for use with the VAD.

[0029] The connector portion 210 has a proximal coupler 215 and a distal coupler 220, and at least one lumen 22 that extends through or otherwise provides fluid communication through the couplers 215 and 220 Define 5. The proximal coupler 215 and / or the distal coupler 220 can be, for example, male or female Luer locks, needleless connectors (NFCs), and / or any other suitable coupler or combination of couplers. As will be described in more detail herein, the proximal coupler 215 can be physically and fluidly coupled to any suitable medical device. The distal coupler 220 can be physically and fluidly coupled to, for example, a VAD, etc., such that the lumen 225 of the connector portion 210 is at least selectively in fluid communication with the VAD and / or a part of the body in which the VAD is at least partially disposed. In some embodiments, the lumen 225 of the connector portion 210 can be substantially straight and / or can allow a substantially straight line of sight through it (e.g., at least between the proximal coupler 215 and the distal coupler 220).

[0030] The stabilization portion 230 is coupled to the connector portion 210 and is configured to be disposed in contact with a portion of the patient (e.g., the patient's skin) at or near the insertion site associated with the VAD (or other similar device). The stabilization portion 230 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the stabilization portion 230 can be and / or form a base structure that is angled, tapered, flared, curved, rounded, etc. In some embodiments, the stabilization portion 230 can have a generally concave contour and / or shape. In some embodiments, the concave contour and / or shape can be at least partially based on the curvature and / or shape of a portion of the patient's anatomical structure. In some embodiments, forming the contour and / or shape of the stabilization portion 230 to be similar and / or at least partially based on, for example, the curvature and / or angle of the patient's IV insertion site can increase the surface area of the stabilization portion 230 that contacts the patient's skin, and in turn, as described in more detail herein, enhance the stability of the stabilization connector 200 and reduce the pressure associated with securing the stabilization connector 200 to the patient's skin. Further, in some embodiments, the base surface 231 of the stabilization portion 230 includes one or more contours, recesses, notches, cutouts, etc. (referred to herein as "recesses" 232 (e.g., see FIGS. 4 - 6)) that are configured to reduce the amount of force applied to the patient's vein (e.g., the vein in which the VAD is disposed) by a portion of the stabilization portion 230, which, in other cases, could potentially result in at least partial occlusion and / or a decrease in blood flow of at least a portion of the vein.

[0031] In some embodiments, the base surface 231 of the stabilization portion 230 can be selectively formed from one or more materials (e.g., a relatively hard material and / or a relatively soft material) configured to provide both stabilization and comfort. In some embodiments, the stabilization portion 230 can be configured to enhance stability at a given or desired portion (e.g., a proximal portion, a distal portion, one or more lateral portions, etc.). In some embodiments, the stabilization portion 230 can be reconfigurable, which can enable a user to selectively control the amount of stabilization provided by the stabilization portion 230. Further, in some such embodiments, the user can reconfigure (e.g., bend, flex, deform, conform, stretch, break, cut, add, etc.) one or more portions of the stabilization portion 230 in order to, for example, control the amount or pattern of stabilization, conform at least a portion of the stabilization portion 230 to the profile of a particular patient, reduce or substantially prevent pressure points, etc.

[0032] The stabilization portion 230 is configured to be disposed in contact with a portion of the patient's skin at or near the insertion site (as described above). Further, the stabilization portion 230 and / or the stabilization connector 200 are generally configured to be secured to the patient's skin using any suitable securing means. For example, in some instances, the stabilization portion 230 can be taped to the patient's skin using medical tape or the like, or the base surface 231 can include an adhesive configured to secure the connector 200 to the patient and / or can be coated therewith. In other instances, the stabilization portion 230 can be transparent, such as Tegaderm™, for example It can be fixed to the patient's skin using a sterile barrier. In further embodiments, the stabilization portion 230 can be fixed to the patient's skin using any suitable combination of fixation methods (e.g., any combination of the methods described herein). In some embodiments, at least the size, shape, and / or configuration of the stabilization portion 230 can facilitate the fixation of the stabilization connector 200 to the patient's skin. For example, in some embodiments, the stabilization portion 230 can be configured such that at least a portion of a transparent sterile barrier (e.g., Tegaderm (trademark)) can wrap around the stabilization portion 230 and the stabilization portion 230 can be disposed inside or under the barrier. In some examples, by configuring the stabilization portion 230 to allow the barrier to surround the stabilization portion 230, for example, it is possible to reduce and / or substantially prevent openings in the barrier that could otherwise result in contamination points and the like.

[0033] Connector 200 also includes port 250. Port 250 can be included in and / or be part of connector portion 210, stabilization portion 230, and / or combinations thereof. As shown, port 250 can define a lumen 255 in fluid communication with lumen 225. In other words, for example, as shown in FIG. 7, connector portion 210 and / or port 250 can include and / or define a first lumen (e.g., lumen 225) and a second lumen (e.g., lumen 255). Thus, port 250 can provide access to lumen 225, which in turn can provide access to a device (e.g., a VAD) coupled thereto via distal coupler 220 and / or to a portion of the body in which the VAD is at least partially disposed. As shown in FIGS. 2-7, port 250 is coupled to a tubing 252 in fluid communication with lumen 255 of port 250.

[0034] Although not shown in FIGS. 2-7, the end portion of the tubing 252 (e.g., the end portion opposite the port 250) can include and / or be coupled to a connector, port, coupler, luer lock, and / or any suitable flow control device or mechanism. In some embodiments, such a device can include one or more mechanisms, elements, members, devices, etc. configured to selectively control the flow of fluid through at least a portion of the tubing 252, as described in more detail herein.

[0035] In some embodiments, the connector 200 and / or any suitable portion thereof can include one or more mechanisms configured to manage and / or direct at least a portion of the tubing 252 extending from the port 250. Further, in some embodiments, the placement of the port 250 can be such that the connector 200 can form, for example, a Y-connector (see, e.g., FIGS. 2-7) or a T-connector. In the embodiments shown in FIGS. 2-7, the port 250 can be placed under, or at least partially under, the proximal coupler 215. In some embodiments, such placement of the port 250 along the centerline of the connector 200 under the proximal coupler 215 can enable the port 250 and / or the tubing 252 coupled thereto to be routed to either side of the connector 200. Further, such placement can reduce the profile and / or size of the connector 200 in at least one of the vertical or horizontal directions. In some embodiments, the port 250 and / or the tubing 252 coupled thereto can be, and / or can form, at least a portion of a fluid line that can be used to deliver fluid, remove fluid, flush fluid, etc. In other embodiments, the connector 200 can be a single-port connector that does not include the port 250.

[0036] As described herein, the connector 200 can include any suitable mechanism or combination of mechanisms and / or can be configured to perform any suitable function or combination of functions. By way of example, in some embodiments, the connector 20 0 can be a stable, comfortable, and smooth IV extension set configured for use with one or more VADs or other access devices. In some embodiments, the connector 200 can provide a stable and secure connection to a VAD (e.g., PIV, etc.) and / or any other device coupled to the connector 200. In some embodiments, the connector 200 can be configured as a dual-port access connector 200 comprising a port or lumen available for one or more objects (e.g., a blood sampling catheter or device) passing therethrough and a second port or lumen available for one or more fluids (independently or substantially simultaneously) passing therethrough. In some embodiments, the connector 200 can include one or more mechanisms and / or combinations thereof capable of, for example, providing and / or improving patient comfort, providing and / or improving blood flow through one or more veins under the connector 200, preventing accidental unlocking of a spin collar, luer lock, and / or coupler as a result of unwanted rotational movement, providing and / or improving the handleability and / or grip of one or more portions of the connector 200, reducing movement (e.g., reducing “piston movement”) transferred to the patient's insertion site or indwelling VAD in other ways, and providing and / or facilitating the use and / or connection to any suitable device (e.g., a fluid transfer device, a fluid collection device, an access device, etc.).

[0037] In some embodiments, the connector 200 can be included in and / or at least partially form a transfusion system for the delivery, collection, and / or transfer of fluids, drugs, blood or blood products, objects, devices, etc. For example, the connector 200 can enable the delivery and / or aspiration of fluids, substances, etc. via a VAD without additional needle sticks, venipunctures, etc. In some embodiments, the connector 200 can be configured for use with one or more fluid transfer devices for use as a direct blood sampling device to a vacuum tube, syringe, or blood culture holder (e.g., without using a needle).

[0038] For example, in some embodiments, the connector 200 can be coupled between a VAD that is at least partially disposed on a body part and a device configured to advance a catheter or other fluid conduit through the connector 200 and the VAD to enable aspiration of body fluid (e.g., blood) and / or enable delivery of fluid. For example, in some embodiments, the connector 200 is described in U.S. Patent Publication No. 2014 / 0364766, entitled "Systems and Methods for Phlebotomy Through a Peripheral IV Catheter," filed Aug. 26, 2014, U.S. Patent Publication No. 2017 / 0216564, entitled "Devices and Methods for Fluid Transfer Through a Placed Peripheral Intravenous Catheter," filed Feb. 3, 2016, and / or U.S. Patent No. 9,744,344, entitled "Devices and Methods for Catheter Placement Within a Vein," filed Jun. 30, 2016, and can be coupled to and / or otherwise used with VADs (e.g., PIVs, etc.) and medical devices such as those described therein, the disclosures of which are hereby incorporated by reference in their entirety.

[0039] Connector 200 can be formed from any suitable material or combination of materials such as those described herein, or from them. In some embodiments, for example, connector 200 can be formed biocompatibly (e.g., in compliance with the ISO 10993-1:2009 standard regarding cytotoxicity, acute systemic toxicity, subchronic toxicity, blood compatibility, etc.). The material and / or combination of materials can also be compatible with alcohol, lipids, chlorhexidine, chemotherapy, contrast agents, etc. In some embodiments, connector 200 can be formed from a material or combination of materials having a shelf life stability of 1 year, 2 years, 3 years, or more. Further, the material or combination of materials can be compatible with any suitable sterilization process (e.g., ethylene oxide (ETO), gamma ray sterilization, etc.) without substantial discoloration or other harmful effects. In some embodiments, for example, connector 200 can be sterile (or sterilizable) and non-pyrogenic, compatible with magnetic resonance imaging (MRI), and / or free of di(2-ethylhexyl) phthalate (DEHP) and / or latex. Further, connector 200 can comply with and / or exceed the standards, recommendations, and / or guidelines provided by the Food and Drug Administration ("FDA"). In some embodiments, for example, connector 200 can be sterile (or sterilizable) and non-pyrogenic, compatible with magnetic resonance imaging (MRI), and / or free of di(2-ethylhexyl) phthalate (DEHP) and / or latex. Further, connector 200 can comply with and / or exceed the standards, recommendations, and / or guidelines provided by the Food and Drug Administration ("FDA").

[0040] In some embodiments, the connector 200 may be configured to improve comfort, stabilization, and / or fixation, and / or provide a relatively low profile / footprint, while improving ease of use and / or enabling mass production (e.g., when compared to some known IV extension sets and / or stabilization devices). In some embodiments, the connector 200 may be configured to minimize skin pressure points such that the connector 200 can be comfortably worn for 1, 2, 3, 4, 5, or more days. The connector 200 and / or its stabilization portion 230 can be easily taped or secured with industry standard dressings, such as Tegaderm™. The connector 200 may have a relatively small size (e.g., height and area) and may be configured to reduce or limit overhang of the hand or other suitable insertion site. For example, in some embodiments, the connector 200 may have a length of about 1.48 inches (about 37.6 millimeters (mm)). In other embodiments, the connector 200 may have a length that is longer or shorter than 1.48 inches (about 37.6 mm).

[0041] In some embodiments, the inner surface defining the connector 200, the connector portion 210, and / or the lumen 225 can include and / or incorporate one or more internal alignment mechanisms configured to allow the passage of one or more objects, tubes, guidewires, catheters, and / or any other suitable devices and / or members. In some embodiments, the lumen 225 of the connector portion 210 can be substantially straight and / or can allow a substantially straight line of sight through it (e.g., between at least the proximal coupler 215 and the distal coupler 220). For example, in some embodiments, the substantially straight path and / or substantially straight portion of the inner surface defining the lumen 225 can define an aperture, path, or lumen having a diameter of, for example, about 1.4 mm, which can guide, direct, support, align, center, etc., one or more objects or devices (e.g., a catheter, etc.) through the connector 200. In other embodiments, the lumen or a portion of the lumen can define an aperture, path, or lumen having a diameter less than 1.4 mm or greater than 1.4 mm.

[0042] In some embodiments, the couplers 215 and / or 220 can be configured to be used with any suitable coupler, connector, and / or attachment means. For example, in some embodiments, the proximal coupler 215 and / or the distal coupler 220 can be a luer lock and / or any other suitable attachment means (e.g., a coupler and / or connector compatible with the ISO luer standard (male connector standard ISO594-1 and female connector standard 594-2)). More specifically, the connector 200 can be luer actuated to accommodate coupling to products and / or devices that use a luer connector (e.g., a VAD, a fluid collection or transfer device, a syringe, an access device, and / or any other suitable device). Further, in some embodiments, the couplers 215 and / or 220 can include and / or form and / or include an NFC valve, etc., and can include a needleless connector (NFC).

[0043] In some embodiments, coupler 215 and / or 220 can be arranged and / or configured to receive click-to-connect couplings (e.g., click-lock snap (trademark) connections), threaded couplings, luer connections, etc., and can be compatible with any suitable valve and and / or seal (e.g., a valve used with a luer lock). In some embodiments, coupler 215 and / or 220 can be a needleless or non-needle connector, can be a stand-alone connector, and / or can be replaceable. Coupler 215 and / or 220 can include, for example, a spin collar, etc., and / or, in other cases, can be configured to form a relatively simple, safe, and fluid-tight connection.

[0044] In some embodiments, the placement of the connector portion 210 and / or the couplers 215 and / or 220 can be configured to maintain a catheter, VAD, and / or any other suitable device at a desired angle A (referred to herein as the "desired angle" or "predetermined angle"), as shown in FIG. 7. For example, in some embodiments, angle A can be the desired or predetermined angle of entry into the body. In some embodiments, for example, angle A can be defined with respect to the lumen 225 (or the axis defined by or associated with the lumen 225) and extend through a reference plane that can be formed by the contact region or contact surface between the couplers 215 and 220 and the connector 200 and a portion of the patient, or be in fluid communication in some other way. That is, the connector portion 210 can be disposed at a substantially predetermined angle A such that when the stabilization portion 230 is in contact with the patient, the common axis extends through at least a portion of the lumen 225 defined by the connector portion 210 and the lumen defined by an access device (not shown). In some embodiments, angle A can include and / or be at least partially based on the insertion angle of at least a portion of the access device. In some examples, the stabilization portion 230 can be configured to dispose the connector portion 210 at a substantially predetermined angle A with respect to the insertion site when the distal coupler 220 is coupled to the hub of the access device and the base surface 231 of the stabilization portion 230 is in contact with the patient.

[0045] In some embodiments, couplers 215 and / or 220 can be configured to couple, for example, to a VAD such that their tapered portions can slide into a hub or the like to establish hemostasis, and can include a floating collar or the like so that the connector 200 remains coupled to the VAD during operation of one or more devices connected thereto. In some embodiments, couplers 215 and / or 220 can be configured to be compatible with any suitable known coupler or connector (e.g., those made by Smiths Medical, Inc. (“Smiths”), Becton, Dickinson, and Company (“BD”), B. Braun Medical, Inc. (“Braun”), ICU Medical, Inc. (“ICU Medical”), Terumo Medical Corporation (“Terumo”), etc.). Further, in some embodiments, couplers 215 and / or 220 can include a protective cap or the like removably coupled to couplers 215 and 220. Such a protective cap can be a slip fit or friction fit, or can be coupled via a threaded coupling.

[0046] In some embodiments, connector 200 can be configured to be used with at least a portion of connector 200 and / or to control the pressure or flow rate therethrough. For example, in some embodiments, connector 200 can include one or more mechanisms and / or can be configured to receive one or more mechanisms of different devices configured to increase the flow rate within a vein (e.g., a channel or support). In some embodiments, connector 200 can be configured to be prepared prior to use. In such embodiments, connector 200 can reduce the amount of priming volume and the amount of dead space within connector 200 (e.g., within a range between about 0.3 milliliters (ml) and about 1.0 ml). In some embodiments, connector 200 can include and / or be configured to allow for a neutral displacement flush or the like. It is possible. In some embodiments, the connector 200 enables a single-port flush and can clear the entire system or substantially the entire system in a double-port configuration (e.g., via port 250). In some embodiments, the connector 200 can be configured to be flushed with a fluid having a volume of, for example, about 1 ml, about 2 ml, about 3 ml, about 4 ml, about 5 ml, about 10 ml, about 20 ml or more. Further, the connector 200 can include one or more backflow prevention devices and / or valves (e.g., check valves, etc.).

[0047] In some embodiments, the connector 200 can be used with low-pressure devices such as, for example, syringes, vacuum containers, pumps, injectors, power injectors, etc. (e.g., configured to support a flow rate of up to 10 milliliters per second (ml / s) or more at a rating of up to 325 pounds per square inch ("psi") or more). In some embodiments, at least one of the couplers 215 and / or 220 can be a needleless connector port (also referred to herein as a "needleless connector" (NFC)) having a gravity flow rate equivalent or substantially equal to, for example, the gravity flow rate of a 16-gauge PIV (e.g., about 200 ml / min at 1 psi). In other embodiments, the connector 200 and / or at least one of the couplers 215 and / or 220 can have a gravity flow rate similar or substantially equal to, for example, the gravity flow rate of an 18-gauge PIV (e.g., 80 - 100 ml / min at 1 psi).

[0048] The connector 200 has been specifically described above with reference to FIGS. 2-7. However, in other embodiments, the stabilization connector can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the connector can be a substantially rigid device (e.g., formed of a substantially rigid material) having a size configured to reduce and / or limit weight, area, and / or footprint (e.g., the connector 200 shown in FIGS. 2-7). However, in other embodiments, the stabilization connector and / or at least a portion thereof can be formed from a substantially flexible material or a material having a relatively low durometer.

[0049] For example, FIGS. 8-15 show a stabilization connector 300 according to a third embodiment. As described above, the stabilization connector 300 is configured to be placed in contact with the patient's skin at or near the insertion site of the indwelling or placed vascular access device (VAD) as described above. The stabilization connector 300 is configured to couple and / or otherwise engage with the VAD. When coupled to the VAD, the stabilization connector 300 can be secured to the patient's skin and then, as will be described in more detail herein, secure and / or stabilize at least a portion of the VAD with respect to the patient. The stabilization connector 300 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the stabilization connector 300 and / or at least a portion thereof can be at least similar in form and / or function to the stabilization connectors 100 and / or 200 described above with reference to FIGS. 1 and 2-7, respectively. Accordingly, portions of the stabilization connector 300 may not be described in further detail herein.

[0050] As shown, the stabilization connector 300 (also referred to herein as the "connector") has a connector portion 310 and a stabilization portion 330. In some embodiments, the connector 300 can be configured as a combination of one or more stabilization devices and an extension set. Each of the connector portion 310 and / or the stabilization portion 330 can be arranged in any suitable manner that facilitates at least one of the functions of providing stabilization to one or more devices (e.g., VADs, etc.) and / or one of the functions of providing an extension set for use with a VAD.

[0051] The connector portion 310 has a proximal coupler 315 and a distal coupler 320 and defines at least one lumen 325 that extends through or otherwise is in fluid communication with the couplers 315 and 320. The proximal coupler 315 and / or the distal coupler 320 can be, for example, male or female luer locks and / or any other suitable couplers. As described in more detail herein, the proximal coupler 315 can be physically and fluidly coupled to any suitable medical device such as those described above. The distal coupler 320 can be physically and fluidly coupled to, for example, a VAD, etc. (not shown in FIGS. 8 - 15), such that the lumen 325 of the connector portion 310 is at least selectively in fluid communication with the VAD and / or a portion of the body in which the VAD is at least partially disposed. In some embodiments, the lumen 325 of the connector portion 310 can be substantially straight and / or can enable a substantially straight line of sight therethrough. In some embodiments, the inner surface of the connector portion 310 can be configured to provide alignment, guidance, centering, etc. to an object or device (e.g., a blood sampling catheter, etc.) advancing therethrough.

[0052] In the embodiments shown in FIGS. 8 - 15, the connector portion 310 includes a flexible region 312 formed and / or included between the proximal coupler 315 and the distal coupler 320. In some embodiments, the flexible region 312 may be configured to allow the connector portion 310 to bend, flex, curve, and / or otherwise reconfigure. In some examples, bending of the connector portion 310 and / or the flexible region 312 can, for example, enhance patient comfort. In other examples, bending of the connector portion 310 and / or the flexible region 312 can, for example, allow an object or device (e.g., a catheter) to advance through the lumen 325 of the connector portion 310 without substantially twisting, bending, and / or deforming, enabling greater access through the lumen 325 of the connector portion 310. In some embodiments, bending and / or flexing of the connector portion 310 and / or the flexible region 312 can allow the connector 300 to be manipulated such that a substantially straight passageway, opening, lumen (or a portion thereof), etc. can extend through the connector 300 and / or at least the lumen 325 of the connector portion 310. Further, in some embodiments, the connector 300 can be manipulated such that the lumen 325 of the connector portion 310 and / or one or more devices coupled to the connector portion 310 can be positioned at a desired angle B (see, e.g., FIG. 12). In some embodiments, the angle B can be the desired insertion angle into the body, as described above with reference to the connector 200.

[0053] The stabilization portion 330 is coupled to the connector portion 310. The stabilization portion 330 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the stabilization portion 330 can be and / or form a base structure that is angled, tapered, flared, curved, rounded, etc. In some embodiments, the stabilization portion 330 can have a base surface 331 that generally has a concave profile and / or shape. In some embodiments, the concave profile and / or shape of the base surface 331 can be at least partially based on the curvature and / or shape of a portion of the patient's anatomical structure. In some embodiments, forming the profile and / or shape of the base surface 331, for example, to be similar to and / or at least partially based on the curvature of the patient's IV insertion site, can increase the surface area of the stabilization portion 330 that contacts the patient's skin, and then, as described above, can enhance the stability of the stabilization connector 300 when secured to the patient's skin.

[0054] In some embodiments, the base surface 331 of the stabilization portion 330 can be selectively formed from one or more materials (e.g., a relatively hard material and / or a relatively soft material) configured to provide both stabilization and comfort. In some embodiments, the stabilization portion 330 can be configured to enhance stability at a given or desired portion (e.g., a proximal portion, a distal portion, one or more lateral portions, etc.). In some embodiments, the stabilization portion 330 can be reconfigurable, which can allow a user to selectively control the amount of stabilization provided by the stabilization portion 330. Further, in some such embodiments, the user can reconfigure (e.g., bend, flex, deform, conform, stretch, break, cut, add, etc.) one or more portions of the stabilization portion 330, for example, to control the amount or manner of stabilization, to conform at least a portion (e.g., the base surface 331) of the stabilization portion 330 to a particular patient's profile, to reduce or substantially prevent pressure points, etc.

[0055] The stabilization portion 330 is configured to be disposed in contact with a portion of the patient's skin at or near the insertion site (as described above). As described above with reference to the stabilization portions 130 and / or 230 of the connectors 100 and / or 200, respectively, the base surface 331 of the stabilization portion 330 includes and / or forms a recess, notch, cutout, contour, etc. (referred to herein as the "recess" 332). For example, as shown in FIGS. 13 and 14, the base surface 331 can form the recess 332 around and / or substantially along the centerline or longitudinal axis of the connector 300. As described above, the recess 332 is configured such that when the base surface 331 is in contact with the patient's skin, the recess 332 (or a portion of the base surface 331 defining the recess 332) is aligned with and / or disposed over the vein into which the VAD is inserted and disposed so as to be spaced from the patient's skin. In some examples, such an arrangement can reduce the forces that may otherwise be applied to the vein, which can result in pinching, clamping, crimping, and / or occlusion of at least a portion of the vein.

[0056] The stabilization portion 330 and / or the stabilization connector 300 are generally configured to be secured to the patient's skin using any suitable fixation means. For example, in some instances, the stabilization portion 330 can be taped to the patient's skin using medical tape or the like, or the base surface 331 can include and / or be coated with an adhesive configured to secure the connector 300 to the patient. In other instances, the stabilization portion 330 can be secured to the patient's skin using a transparent sterile barrier such as Tegaderm™, for example. In some embodiments, at least the size, shape, and / or configuration of the stabilization portion 330 can be configured to facilitate securing of the stabilization connector 300 to the patient's skin. For example, in some embodiments, the stabilization portion 330 can be configured such that at least a portion of a transparent sterile barrier (e.g., Tegaderm™) can wrap around the stabilization portion 330 and the stabilization portion 330 can be disposed within or beneath the barrier. In some instances, by configuring the stabilization portion 330 to allow the barrier to surround the stabilization portion 330, for example, openings in the barrier that could otherwise introduce contamination points and the like can be reduced and / or substantially prevented.

[0057] Connector 300 also includes port 350 (see, e.g., FIGS. 14 and 15). Port 350 can be included in and / or be part of connector portion 310, stabilization portion 330, and / or combinations thereof. As shown, port 350 can define a lumen 355 that is in fluid communication with lumen 325. In other words, for example, as shown in FIG. 15, connector portion 310 and / or port 350 can include and / or define a first lumen (e.g., lumen 325) and a second lumen (e.g., lumen 355). Thus, port 350 can provide access to lumen 325, which in turn can provide access to a device (e.g., a VAD) coupled to distal coupler 320 and / or to a portion of the body in which the VAD is at least partially disposed. As shown in FIGS. 8-15, port 350 is coupled to a tubing 352 that is in fluid communication with lumen 355 of port 350.

[0058] In some embodiments, connector 300 and / or any suitable portion thereof can include one or more mechanisms configured to manage and / or direct at least a portion of tubing 352 extending from port 350. Further, in some embodiments, of port 350 The configuration can be such that the connector 300 forms, for example, a Y-connector or a T-connector. In the embodiments shown in FIGS. 8-15, the port 350 can be disposed under, or at least partially under, the proximal coupler 315. In some embodiments, such an arrangement of the port 350 disposed along the centerline of the connector 300 under the proximal coupler 315 can enable the port 350 and / or the tubing 352 coupled thereto to be routed to either side of the connector 300. Further, such an arrangement can reduce the profile and / or size of the connector 300 in at least one of the vertical or horizontal directions. In some embodiments, the port 350 and / or the tubing 352 can be, and / or can form, at least a part of a fluid line that can be used to deliver fluid, remove fluid, flush fluid, etc. In other embodiments, the connector 300 can be a single-port connector that does not include the port 350.

[0059] As described above with reference to connector 100 and / or 200, connector 300 can include any suitable mechanism or combination of mechanisms and / or can be configured to perform any suitable function or combination of functions. As an example, in some embodiments, connector 300 can be a stable, comfortable, smooth IV extension set configured for use with one or more VADs or other access devices. In some embodiments, connector 300 can provide a stable and secure connection to a VAD (e.g., PIV, etc.) and anything coupled to connector 300. In some embodiments, connector 300 can be configured as a dual-port access connector 300 comprising a port or lumen available to one or more objects passing therethrough and a second port or lumen available to one or more fluids passing therethrough (independently or substantially simultaneously). In some embodiments, connector 300 can include any mechanism (or combination of mechanisms) and / or can be configured for use with any device (or combination of devices) described above with reference to connector 100 and / or 300. Accordingly, such mechanisms (or combinations of mechanisms) and / or such devices (or combinations of devices) are not described in further detail herein.

[0060] As described above, when the stabilization connector 300 is secured to the patient's skin (e.g., via a strip of medical tape), the stabilization connector 300 and / or the medical tape secures, stabilizes, and / or substantially fixes the IV catheter to the patient. That is, the placement of the stabilization connector 300 is such that by securing the stabilization connector 300 and the IV catheter to the patient's skin, movement of the IV catheter or at least a portion of the IV catheter with respect to the vein in which the IV catheter is at least partially disposed can be reduced and / or substantially prevented. Further, the placement of the recess 332 along the base surface 331 of the stabilization portion 330 is such that securing and / or adhering the stabilization connector 300 to the patient's skin does not apply force to the vein in which the IV catheter is disposed, thereby reducing and / or substantially eliminating complications and / or limitations that would otherwise result from such force.

[0061] Figures 16 - 19 show at least a portion of a stabilization connector 400 according to the fourth embodiment. The stabilization connector 400 (also referred to as "connector" 400) may be substantially similar in form and / or function to the connectors 100, 200, and / or 300 described in detail above. Accordingly, some portions of the connector 400 may not be described in further detail herein. In the embodiment shown in Figures 16 - 19, the connector 400 can be configured and / or arranged to facilitate, simplify, and / or enable in other ways the manufacture of the connector 400 as will be described in further detail herein.

[0062] As shown in Figure 16, the connector 400 includes a connector portion 410 and a stabilization portion 430. The connector portion 410 includes a proximal coupler 415, a distal coupler 420, and a port 450 It includes. The connector portion 410 can be substantially the same in form and / or function as the connector portions 110, 200, and / or 310 described in detail above. As shown in FIGS. 16, 18, and 19, the connector portion 410 is configured such that the proximal coupler 415 and the distal coupler 420 can be coupled (e.g., screwed, snapped, pressed, and / or fixed by other methods) to the connector portion 410. In some embodiments, the port 450 can similarly be coupled to the connector portion 410. In other embodiments, the port 450 can be integrally formed with the connector portion 410 (e.g., as in the embodiments shown in FIGS. 16-19). Thus, the connector portion 410 can be formed, for example, from three parts: the connector portion 410, the proximal coupler 415, and the distal coupler 420. In some embodiments, forming the connector portion 410 from three parts (e.g., the connector portion 410, the proximal coupler 415, and the distal coupler 420) can improve, facilitate, simplify, and / or reduce the costs associated with manufacturing. Further, the proximal coupler 415 and the distal coupler 420 are configured to be coupled and / or assembled to the connector portion 410 during one or more manufacturing processes.

[0063] As shown in FIGS. 17 and 18, the stabilization portion 430 includes a coupler 435 configured to couple the stabilization portion 430 to the connector portion 410. The stabilization portion 430 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the stabilization portion 430 can be substantially similar to the stabilization portions 130, 230, and / or 330 of the connectors 100, 200, and / or 300, respectively, at least in form and / or function. As shown in FIGS. 17-19, the stabilization portion 430 includes a base surface 431 configured to be disposed in contact with the patient's skin. As described above, the base surface 431 can have a contour that is at least partially based on the size and / or shape of the IV insertion site on the patient's skin. Further, the base surface 431 forms and / or defines a recess 432 configured to align with and / or be disposed over the patient's vein when the connector 400 is secured to the patient. As described in detail above with reference to the connectors 100, 200, and / or 300, the arrangement of the recess 432 can be configured to reduce, limit, and / or substantially eliminate the force applied to the vein into which at least a portion of the VAD is inserted.

[0064] In the embodiments shown in FIGS. 16-19, the stabilization portion 430 can be formed separately from the connector portion 410 and can be coupled to the connector portion 410 via the coupler 435 during one or more manufacturing processes. More specifically, as shown in FIG. 17, the coupler 435 can be a semi-ring, clamp, clip, and / or any other suitable fixing device configured to receive a portion of the connector portion 410 to couple the stabilization portion 430 thereto. Further, as shown in FIGS. 18 and 19, the stabilization portion 430 can be coupled to the connector portion 410 in an arrangement that does not obstruct or otherwise inhibit access to the port 450. During manufacturing, the stabilization portion 430 can be coupled to the connector portion 410 by inserting at least a portion of the connector portion 410 into the coupler 435 of the stabilization portion 430 and fixedly coupling the components, for example, via ultrasonic welding, friction welding, adhesives, etc.

[0065] As described above, in some embodiments, a connector (e.g., connector 400) can be formed from a plurality of components that are coupled and / or assembled to each other during manufacturing. In some embodiments, such an arrangement can reduce costs associated with, for example, complex molds and the like that might otherwise be involved.

[0066] The stabilization connector 400 has been specifically described above with reference to FIGS. 16 - 19. However, in other embodiments, the stabilization connector can be formed from a plurality of components having any suitable configuration, which are coupled and / or assembled to each other during manufacturing to form the assembled stabilization connector. For example, FIGS. 20 - 23 show at least a portion of a stabilization connector 500 according to a fifth embodiment. The stabilization connector 500 (also referred to as "connector" 500) can be substantially similar in form and / or function to the connectors 100, 200, 300, and / or 400 described in detail above. Accordingly, some portions of connector 500 may not be described in further detail herein. In the embodiments shown in FIGS. 20 - 23, connector 500 can be configured and / or arranged to facilitate, simplify, and / or enable in other ways the manufacture of connector 500 as will be described in further detail herein.

[0067] As shown in FIG. 20, the connector 500 includes a connector portion 510 and a stabilization portion 530. The connector portion 510 includes a proximal coupler 515, a distal coupler 520, and a port 550. The connector portion 510 may be at least substantially similar in form and / or function to the connector portions 110, 210, 310, and / or 410 described in detail above. More specifically, as shown in FIGS. 20, 22, and 23, the connector portion 510 is configured such that the proximal coupler 515 and the distal coupler 520 can be coupled (e.g., screwed, snapped, pressed, and / or fixed by other means) to the connector portion 510. In some embodiments, the port 550 can similarly be coupled to the connector portion 510. In other embodiments, the port 550 can be formed integrally with the connector portion 510 (e.g., as in the embodiments shown in FIGS. 20-23). Thus, the connector portion 510 can be formed from three components, i.e., the connector portion 510, the proximal coupler 515, and the distal coupler 520, as described in detail above with respect to, for example, the connector portion 410. In some embodiments, forming the connector portion 510 in three parts (e.g., the connector portion 510, the proximal coupler 515, and the distal coupler 520) can improve, facilitate, simplify, and / or reduce the costs associated with manufacturing.

[0068] As shown in FIGS. 20 and 21, the stabilization portion 530 includes a coupler 535 configured to couple the stabilization portion 530 to the connector portion 510. The stabilization portion 530 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the stabilization portion 530 can be substantially similar to the stabilization portions 130, 230, 330, and / or 430 of the connectors 100, 200, 300, and / or 400, respectively, at least in form and / or function. As shown, the stabilization portion 530 includes a base surface 531 configured to be disposed in contact with the patient's skin. As described above, the base surface 531 can have a contour that is at least partially based on the size and / or shape of the IV insertion site on the patient's skin. Further, the base surface 531 forms and / or defines a recess 532 configured to align with and / or be disposed over the patient's vein when the connector 500 is secured to the patient. As described in detail above with reference to connectors 100, 200, 300, and / or 400, the placement of the recess 532 can be configured to reduce, limit, and / or substantially eliminate the force applied to the vein into which at least a portion of the VAD is inserted.

[0069] As described above with reference to connector 400, the stabilization portion 530 of connector 500 can be formed separately from the connector portion 510 and can be coupled to the connector portion 510 via a coupler 535 or coupler portion during one or more manufacturing processes. The coupler 435 of the stabilization portion 430 was shown as forming a ring, clip, clamp, etc., but the coupler 535 of the stabilization portion 530 shown in FIGS. 20 - 23 can be configured to form a dovetail joint and / or any other suitable connection, fitting, and / or connection with the connector portion 510. Further, when the stabilization portion 530 is disposed and / or coupled adjacent to the connector portion 510 (i.e., during manufacturing), the two components can be fixedly coupled and / or assembled via, for example, ultrasonic welding, friction welding, adhesives, etc. Thus, as described above with reference to connector 400, forming the connector 500 from a plurality of components that are coupled and / or assembled together during manufacturing or forming the connector 500 from a plurality of components can facilitate, simplify, improve, and / or reduce the costs associated with manufacturing. By forming the connector 500, the costs associated with manufacturing can be facilitated, simplified, improved, and / or reduced.

[0070] Connectors 200, 300, 400, and / or 500 have each been described as having ports 250, 350, 450, and / or 550, respectively. However, in other embodiments, a connector need not include such ports or can include ports having any suitable configuration. For example, FIG. 24 is a side view of a known connector 10 (e.g., a dual port extension set) coupled to an intravenous catheter 15. As shown, connector 10 includes a connector portion 11 (or body), a proximal coupler 12, a distal coupler 13, and a side port 14. Connector portion 11 (or body) can be of any suitable shape, size, and / or configuration. Proximal coupler 12 and distal coupler 13 can be physical and / or fluid couplers or locks configured to couple to one or more devices. For example, couplers 12 and 13 can be, for example, luer connectors, luer lock connectors, etc. In some examples, distal coupler 13 can be coupled to, for example, IV catheter 15, while the proximal coupler can be coupled to any suitable device such as an infusion or transfusion device, a suction device, an intervention device, etc.

[0071] As shown in FIG. 24, side port 14 can be coupled to and / or can include a tubing that can be used to transfer fluid into or out of connector 10. The arrangement of some known connectors, such as connector 10, can be such that side port 14 extends substantially vertically from connector portion 11 (or body). In some examples, a medical procedure can include and / or can call for flushing the connector with a sterile fluid, such as saline, prior to injection of a drug or other fluid or prior to aspiration of a body fluid. However, as identified by region A in FIG. 24, such an arrangement can result in an amount of fluid or gas being trapped, confined, and / or otherwise not flushed within proximal coupler 12 (or a portion of connector portion 11 or body adjacent to proximal coupler 12). Thus, contaminants contained within the unflushed volume can potentially cause contamination of a body fluid sample, injection of contaminants into an undesired part of the body, and / or an undesired interaction between a subsequent volume of fluid, such as a body fluid, drug, etc., and the unflushed volume (e.g., fluid or gas). Further, some medical procedures and / or protocols can include flushing connector 10 using side port 14 and proximal coupler 12 to fully flush connector 10, which can, in some examples, result in an increase in time or effort when using connector 10.

[0072] In some embodiments, any of the devices described herein can include a side port, one or more internal mechanisms, and / or the like configured to completely flush the connector through the side port. For example, FIG. 25 is a side view of a connector 600 according to a sixth embodiment. The connector 600 can be substantially similar to any of the connectors described herein. In other embodiments, the connector can be substantially similar to a standard or known dual port connector or expansion set. In other words, the connector can be an integrated stabilization connector including a connector portion and a stabilization portion, or can be a connector without a stabilization base or the like. As shown in FIG. 25, the connector 600 includes a connector portion 610 (or body), a proximal coupler 615, a distal coupler 620, and a side port 650. The connector portion 610 (or body) can be of any suitable shape, size, and / or configuration. The proximal coupler 615 and the distal coupler 620 can be physical and / or fluid couplers or locks configured to couple to one or more devices. For example, the couplers 615 and 620 can be, for example, needleless or non-needle connectors, luer connectors, and the like. In some examples, the distal coupler 620 can be coupled to, for example, an IV catheter 15, while the proximal coupler 615 can be coupled to any suitable device such as an infusion or transfusion device, a suction device, an intervention device, and the like.

[0073] As shown in FIG. 25, side port 650 can be coupled to, and / or include, a pipe member 652 that can be used to transfer fluid into or out of connector 600. In this embodiment, side port 650 can be located proximate to the location of another standard or known side port (e.g., the location of side port 14 shown in FIG. 24), and can extend from connector portion 610 (or body) at an angle other than a substantially perpendicular angle. For example, in some instances, side port 650 can be angled such that, for example, the lumen of the port leads to proximal coupler 615. As shown in FIG. 25, in some instances, this arrangement of side port 650 can cause fluid (e.g., saline) to flow in a proximal direction toward proximal coupler 615 when the fluid is flowed through side port 650 into connector portion 610 (or body), and then can create a turbulent flow of the fluid at or near the proximal end portion of connector 600. As shown by region B in FIG. 25, in some instances, such an arrangement can result in a flush of the proximal end portion of connector 600 that is sufficient to remove or flush a certain amount of fluid or gas that might otherwise be trapped, confined, and / or not flushed in proximal coupler 615 (or a portion of connector portion 610 or body adjacent to proximal coupler 615). Thus, a connector is formed having a side port that is (1) angled toward the proximal coupler and / or (2) disposed adjacent to the proximal coupler or otherwise offset in the proximal direction, such that a complete or otherwise sufficient connector is obtained via the side port.

[0074] Although not shown in FIG. 25, in some embodiments, the connector portion 610 may have an inner surface that forms and / or defines one or more mechanisms configured to facilitate the flushing of the connector 600 through the side port 650. For example, in some embodiments, the inner surface or internal surface of the connector portion 610 may include, form, and / or define one or more mechanisms, walls, channels, ports, weirs, veins, flow paths, etc. configured to direct the flow of fluid from the side port 650, for example, to the proximal coupler 615. In some embodiments, the one or more mechanisms may result in a flow of fluid having a rotational or cyclonic motion. In some embodiments, the one or more mechanisms may be configured to increase the amount of turbulent flow associated with the flow of fluid. In yet other embodiments, the one or more mechanisms may be configured to facilitate the flushing of the entire connector portion 610 or substantially the entire connector portion 610 in any suitable manner.

[0075] FIGS. 26 - 31 illustrate a stabilization connector 700 according to a seventh embodiment. As described above, the stabilization connector 700 is configured to be placed in contact with the patient's skin at or near the insertion site of a vascular access device (VAD) placed or positioned as described above. The stabilization connector 700 is configured to couple to and / or otherwise engage with a VAD. When coupled to the VAD, the stabilization connector 700 can be secured to the patient's skin (e.g., via a medical tape, a transparent sterile barrier such as Tegaderm™, etc.) and then, as described in more detail herein, at least partially secure and / or stabilize the VAD with respect to the patient.

[0076] The stabilization connector 700 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the stabilization connector 700 and / or at least a portion thereof may be similar in at least form and / or function to any of the stabilization connectors 100, 200, 300, 400, 500, and / or 600 described above. Accordingly, portions of the stabilization connector 700 may not be described in further detail herein.

[0077] As shown in FIG. 26, the stabilization connector 700 (also referred to herein as the “connector”) has a connector portion 710 and a stabilization portion 730. In some embodiments, the connector 700 can be configured as a combination of one or more stabilization devices and an extension set. Each of the connector portion 710 and / or the stabilization portion 730 can be arranged in any suitable manner that facilitates at least one of the functions of providing stabilization to one or more devices (e.g., VAD, etc.) and / or one of the functions of providing an extension set for use with a VAD. The connector portion 710 has a proximal coupler 715 and a distal coupler 720 and defines at least one lumen 725 that extends through or otherwise is in fluid communication through the couplers 715 and 720. The proximal coupler 715 and / or the distal coupler 720 can be, for example, male or female luer locks and / or any other suitable coupler. The proximal coupler 715 can be physically and fluidly coupled to any suitable medical device such as those described above. The distal coupler 720 can be physically and fluidly coupled to, for example, a VAD, etc., such that the lumen 725 of the connector portion 710 is at least selectively in fluid communication with the VAD and / or a part of the body in which the VAD is at least partially disposed. In some embodiments, the lumen 725 of the connector portion 710 can be substantially straight and / or can allow a substantially straight line of sight therethrough. In some embodiments, as described above with reference to connectors 100, 200, 300, 400, 500, and / or 600, the inner surface of the connector portion 710 can be configured to provide alignment, guidance, centering, etc. to an object or device (e.g., a blood sampling catheter, etc.) advancing therethrough.

[0078]

[0079] ​In some embodiments, couplers 715 and / or 720 can be arranged and / or configured to receive click-to-connect couplings (e.g., click-lock snap (TM) connections), threaded couplings, luer connections, etc. In some embodiments, couplers 715 and / or 720 can include, for example, a spin collar, etc., and / or, in other cases, can be configured to form a relatively simple, secure, and fluid-tight connection. In some embodiments, couplers 715 and / or 720 can be needleless or non-needle connectors, stand-alone connectors, and / or replaceable connectors, and / or can be compatible with any suitable valve and / or seal (e.g., valves used in luer locks, NFC valves, split septa, etc.). For example, as shown in FIGS. 29-31, proximal coupler 715 can include a valve 711 configured to selectively control the flow of fluid through proximal coupler 715. In some embodiments, valve 711 can be, for example, an NFC valve, a split septum, a resealable valve or membrane, and / or any other suitable valve. As a specific example, proximal port 715 can be configured as a needleless connector, etc., and valve 711 can be, for example, an NFC valve (e.g., similar or the same as known needleless connectors and / or known NFC valves).

[0080] In some embodiments, the distal coupler 720 can be configured to couple, for example, to a VAD such that its tapered portion can slide into a hub or the like to establish hemostasis, and can include a floating collar or the like such that the connector portion 710 remains coupled to the VAD during operation of one or more devices connected thereto. In some embodiments, the couplers 715 and / or 720 can be configured to be compatible with any suitable known coupler or connector (e.g., those made by Smiths, BD, Braun, ICU Medical, Terumo, etc.). In some embodiments, the coupler 720 can be, or can include, for example, a floating male luer spin collar, a rotating male luer lock collar, or the like. Further, in some embodiments, the couplers 715 and / or 720 can include a protective cap or the like removably coupled to the couplers 715 and 720. Such a protective cap can be a slip fit or friction fit, or can be coupled via a threaded coupling.

[0081] The connector portion 710 also includes and / or defines a port 750. The port 750 can be included in and / or be part of the connector portion 710, the proximal coupler 715, the distal coupler 720, and / or combinations thereof. For example, in the embodiments shown in FIGS. 26 - 31, the port 750 is distal to the proximal coupler 715. However, in other embodiments, the connector portion can include and / or define a port formed by a structure or mechanism that forms the proximal coupler. In some examples, by positioning the port 750 at a desired location along the length of the connector portion 710 between the couplers 715 and 720, it can be possible to reduce the length of the connector portion 710 and / or facilitate flushing and / or fluid transfer through the port 750.

[0082] Port 750 can define a lumen 755 that is in fluid communication with lumen 725. In other words, connector portion 710 and / or port 750 can include and / or define a first lumen (e.g., lumen 725) and a second lumen (e.g., lumen 755). Thus, port 750 can provide access to lumen 725, which in turn can provide access to a device (e.g., a VAD) coupled to distal coupler 720 and / or to a portion of the body in which the VAD is at least partially disposed.

[0083] As shown in FIG. 26, port 750 is coupled to a tubing 752 that is in fluid communication with lumen 755 of port 750. In some embodiments, connector 700 and / or any suitable portion thereof can include one or more mechanisms configured to manage and / or direct at least a portion of tubing 752 extending from port 750. As shown, an end portion of tubing 752 (e.g., the end portion opposite port 750) can include and / or be coupled to an attachment device, coupler, connector, port, etc. For example, in the embodiments shown in FIGS. 26-31, tubing 752 can include a coupler 760 configured to couple to any suitable device such as a fluid source, fluid collection device, vacuum container, pump, syringe, and / or any other suitable device. Further, in some embodiments, connector 700 can include a clamp 770 coupled to tubing 752 and configured to selectively engage tubing 752 to constrict, crimp, clamp, and / or otherwise occlude the lumen defined by tubing 752 to limit and / or substantially prevent fluid flow therethrough. Clamp 770 is shown as being separate from coupler 760, but in other embodiments, at least a portion of clamp 770 can be incorporated into coupler 760, as will be described in further detail herein with respect to particular embodiments.

[0084] In some embodiments, the placement of port 750 can be such that connector portion 710 forms, for example, a Y-connector or a T-connector. More specifically, in the embodiments shown in FIGS. 26 - 31, port 750 can be placed substantially perpendicular to the lumen 725 of connector portion 710 and near or adjacent to proximal coupler 715. In some embodiments, the position of port 750 can be shifted along connector portion 710 in a desired manner to enable the use of a shorter proximal connector (e.g., proximal coupler 715). In some embodiments, port 750 and / or the tubing 752 coupled thereto can be at least a part of and / or can form a fluid line that can be used, for example, to deliver fluid, remove fluid, flush fluid, etc. In such embodiments, for example, an arrangement where port 750 is placed adjacent to proximal coupler 715 can enable flushing of proximal coupler 715, valve 711, and / or the space between valve 711 and the inner surface of connector portion 710 (e.g., defining at least a part of lumen 725). In other embodiments, connector portion 710 can be a single-port connector that does not include port 750 (and can be flushed, for example, through proximal port 715).

[0085] In some embodiments, the connector 700 can be configured for use with at least a portion of the connector portion 710 and / or its lumen 725, and / or can be configured to control the pressure or flow rate therethrough. In some embodiments, the connector portion 710 can include and / or receive one or more mechanisms, members, devices, etc. configured to control the flow of fluid through at least a portion of the connector portion 710 and / or the lumen 725. For example, in the embodiments shown in FIGS. 26-31, the connector portion 710, the distal coupler 720, and / or the proximal coupler 715 can include a fluid flow control device 713 (see, e.g., FIGS. 29 and 31). The fluid flow control device 713 can be implemented and / or operable to control the pressure or flow rate through at least a portion of the lumen 725. The fluid flow control device 713 can include, for example, one or more backflow prevention devices and / or valves (e.g., backflow prevention valves, check valves, split diaphragms, etc.), one or more pressure regulators, and / or any other suitable flow control device according to a particular embodiment. In some embodiments, the fluid flow control device 713 can be incorporated, integrated, and / or otherwise disposed internally or adjacent to, for example, the connector portion 710, the distal coupler 720, and / or the proximal coupler 715. More specifically, in some embodiments, as shown in FIG. 31, while the valve 711 is proximal to the port 750, the fluid flow control device 713 can be disposed at a position distal to the port 750.

[0086] In some embodiments, the connector portion 710 can be configured to be primed and / or flushed prior to use. In some embodiments, the connector portion 710 can include and / or be configured to enable neutral displacement flushing and the like. In some embodiments, the connector portion 710 can enable single-port flushing to clear the entire system and / or substantially the entire system in a double-port configuration (e.g., via port 750). In some embodiments, the connector portion 710 can be configured to be flushed with a fluid in an amount of, for example, about 1 ml, about 2 ml, about 3 ml, about 4 ml, about 5 ml, about 10 ml, about 20 ml or more.

[0087] In some embodiments, the connector portion 710 can be configured to define one or more fluid flow paths and / or can include one or more internal flushing mechanisms configured to control and / or direct the flow of fluid through at least a portion of the lumen 725 in other cases. In some such embodiments, the internal flushing mechanism can be any other suitable mechanism that can be configured to reduce the amount of the priming volume and the amount of dead space (e.g., in the range between about 0.3 ml and about 1.0 ml) within the mechanism, walls, channels, flow paths, protrusions, and / or the connector portion 710 and / or the lumen 725. In other embodiments, the connector portion 710 can include any suitable mechanism configured to facilitate and / or improve the priming and / or flushing of the connector portion 710, the proximal coupler 715, the NFC valve and / or any other suitable component, part, or region of the proximal coupler 715, the distal coupler 720, and / or the connector portion 710.

[0088] For example, in some embodiments, the NFC valve and / or any other suitable fluid flow control device can be sized and / or shaped to allow for complete or substantially complete flushing of, for example, the proximal coupler 715 and / or any other portion of the lumen 725. In some embodiments, the fluid flow control device (e.g., NFC valve, etc.) can include and / or define one or more mechanisms, channels, contours, openings, etc. configured to facilitate and / or enhance flushing of any portion of the lumen 725 defined by the proximal coupler 715 and / or the connector portion 710. For example, although not shown, in some embodiments, the NFC valve and / or any other suitable fluid flow control device can define an opening and / or aperture on the side of the NFC valve (or other suitable device) opposite the port 750. In such embodiments, when priming and / or flushing the connector portion 710 via the port 750, the position of the opening and / or aperture of the valve (or the like) can result in a fluid flow that circulates around at least a portion of the valve (or the like), which can then facilitate and / or enhance priming and / or flushing of at least a portion of the lumen 725. Further, after the fluid flow has circulated around at least a portion of the valve (or the like), the fluid can flow through the opening and / or aperture to flush the internal portion of the valve (or the like) and / or the remaining portion of the lumen 725 of the connector portion 710. Side may define an opening and / or aperture. In such embodiments, when priming and / or flushing the connector portion 710 via the port 750, the position of the opening and / or aperture of the valve (or the like) can result in a fluid flow that circulates around at least a portion of the valve (or the like), which can then facilitate and / or enhance priming and / or flushing of at least a portion of the lumen 725. Further, after the fluid flow has circulated around at least a portion of the valve (or the like), the fluid can flow through the opening and / or aperture to flush the internal portion of the valve (or the like) and / or the remaining portion of the lumen 725 of the connector portion 710.

[0089] The stabilization portion 730 is coupled to the connector portion 710 and is configured to be disposed in contact with a portion of the patient (e.g., the patient's skin) at or near the insertion site associated with the VAD (or other similar device). The stabilization portion 730 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the stabilization portion 730 can be, and / or can form, a base structure that is angled, tapered, flared, curved, rounded, etc. In some embodiments, the stabilization portion 730 can have a base surface 731 (or bottom surface) having a generally concave contour and / or shape. In some embodiments, the concave contour and / or shape of the base surface 731 can be at least partially based on the curvature and / or shape of a portion of the patient's anatomical structure. In some embodiments, forming the contour and / or shape of the base surface 731 to be similar to and / or at least partially based on, for example, the curvature and / or angle of the patient's IV insertion site can increase the surface area of the stabilization portion 730 (e.g., the base surface 731) that contacts the patient's skin, and then, as described in more detail herein, can enhance the stability of the stabilization connector 700 and reduce the pressure associated with the stabilization connector 700 when secured to the patient's skin.

[0090] In some embodiments, the base surface 731 of the stabilization portion 730 can be selectively formed from one or more materials (e.g., a relatively hard material and / or a relatively soft material) configured to provide both stabilization and comfort. In some embodiments, the stabilization portion 730 can be configured to enhance stability at a given or desired portion (e.g., a proximal portion, a distal portion, one or more lateral portions, etc.). In some embodiments, the stabilization portion 730 can be reconfigurable, which can allow a user to selectively control the amount of stabilization provided by the stabilization portion 730. Further, in some such embodiments, the user can reconfigure (e.g., bend, flex, deform, conform, stretch, break, cut, add, etc.) one or more portions of the stabilization portion 730, for example, to control the amount or manner of stabilization, to conform at least a portion of the stabilization portion 730 to the profile of a particular patient, to reduce or substantially prevent pressure points, etc.

[0091] The base surface 731 can include one or more contours, recesses, notches, cutouts, channels, etc. (referred to herein as “recesses” 732 (see, e.g., FIGS. 28 and 30)) configured to reduce the amount of force applied by the stabilization portion 730 to a patient's vein (e.g., the vein in which the VAD is disposed), which, in other cases, can potentially result in at least partial occlusion of and / or a reduction in the flow rate of at least a portion of the vein, as described in detail above with reference to connectors 100, 200, 300, and / or 400. The contour and / or shape of the base surface 731 can be based, at least in part, on, for example, the curvature and / or shape of a portion of the patient's anatomical structure. In some embodiments, at least one of the one or more recesses 732 can extend substantially between the proximal and distal ends of the base surface 731.

[0092] The stabilization portion 730 and / or the stabilization connector 700 are generally configured to be secured to a patient's skin using any suitable securing means. For example, in some instances, the stabilization The stabilization portion 730 can be taped to the patient's skin using a medical tape or the like, or the bottom surface can include an adhesive configured to secure the connector 700 to the patient and / or can be coated therewith. In other examples, the stabilization portion 730 can be secured to the patient's skin using a transparent sterile barrier such as Tegaderm™. In some embodiments, at least the size, shape, and / or configuration of the stabilization portion 730 can be configured to facilitate securing the stabilization connector 700 to the patient's skin. For example, in some embodiments, the stabilization portion 730 can be configured such that at least a portion of a transparent sterile barrier (e.g., Tegaderm™) can wrap around the stabilization portion 730 and the stabilization portion 730 can be disposed inside or under the barrier. In some examples, by configuring the stabilization portion 730 to allow the barrier to surround the stabilization portion 730, for example, it is possible to reduce and / or substantially prevent an opening in the barrier that could otherwise introduce contamination points and the like.

[0093] In some embodiments, the stabilizing portion 730 and / or the base surface 731 of the stabilizing portion 730 may be configured to allow and / or facilitate free movement of at least a portion of the coupler 720 with respect to various loading conditions (e.g., in the form of applied forces or pressures) that the stabilizing connector 700 may receive. For example, in the unloaded state of the stabilizing connector 700, the stabilizing portion 730 may be configured to allow and / or facilitate free movement of at least a portion of the distal coupler 720, such as when the distal coupler 720 is a floating male Luer spin collar or includes one. In some such embodiments, when the stabilizing connector 700 is in a loaded state (e.g., when a force or pressure is applied to the stabilizing portion 730 in a direction substantially perpendicular to the patient contact region of the base surface 731), the stabilizing portion 730 and / or the base surface 731 may be configured to support the coupler 720 (e.g., from below). Thus, such support of the coupler 720 can reduce, limit, and / or substantially prevent pressure from being transmitted to the patient. In the examples shown in FIGS. 26 - 31, the portion of the coupler 720 that can allow and / or facilitate such free movement can include, for example, a rotatable, swiveling, or otherwise angularly displaceable collar of a male Luer.

[0094] In some embodiments, the connector 700 can include one or more mechanisms and / or combinations thereof that can provide and / or improve the ease of handling and gripping of one or more portions of the connector 700, and / or that can facilitate the use and / or connection to any suitable device (e.g., a fluid transfer device, a fluid collection device, an access device, etc.). For example, as shown in FIGS. 26 - 31, the connector portion 710, the distal coupler 720, or the proximal coupler 715 can include a tapered portion to improve gripping and facilitate handling of one or more portions of the connector 700. As another example, the connector 700 can include a flat upper surface having a surface area increasing element such as a groove to facilitate secure attachment to a patient's skin (e.g., via a medical tape, a transparent sterile barrier such as Tegaderm™, etc.), thereby facilitating use with and / or connection to another device.

[0095] In some embodiments, the connector 700 can include a mark (not shown) to facilitate connection to any suitable device such as preventing the use of the connector 700 and / or user error (e.g., taping over the extension tubing or other inappropriate portion of the connector 700) with respect to a patient. For example, the mark can include markings or symbols indicating proper alignment of the connector 700 with respect to the treatment site of the patient, proper positioning of the connector 700 with respect to a tubing configured to couple to or be coupled to the connector (e.g., for fluid communication between the tubing 752 and the lumen 755 of the port 750), a proper taping zone for the connector 700, etc. In some embodiments, the connector 700 can include any mechanism (or combination of mechanisms), and / or can be configured to be used with any of the devices (or combinations of devices) described above with reference to connectors 100, 200, 300, 400, 500, and / or 600.

[0096] As described above with reference to connectors 100, 200, 300, 400, 500, and / or 600, connector 700 can include any suitable mechanism or combination of mechanisms and / or can be configured to perform any suitable function or combination of functions. As an example, in some embodiments, connector 700 can be a stable, comfortable, and smooth IV extension set configured for use with one or more VADs or other access devices. In some embodiments, connector 700 can provide a stable and secure connection to a VAD (e.g., PIV, etc.) and / or any other device coupled to connector 700. In some embodiments, connector 700 can be configured as a dual-port access connector 700 comprising a port or lumen available for one or more objects (e.g., a blood sampling catheter or device) passing therethrough and a second port or lumen available for one or more fluids (independently or substantially simultaneously) passing therethrough.

[0097] Connector 700 has been described above with particular reference to FIGS. 26 - 31, but in other embodiments, the stabilization connector can be of any suitable shape, size, and / or configuration and / or can be formed from a plurality of components having any suitable configuration, which are coupled and / or assembled to each other during manufacture to form the assembled stabilization connector. Thus, it is to be understood that the size, shape, and / or arrangement of the embodiments and / or their components can be adapted to a given application unless the context clearly states otherwise. For example, connector 700 has been described above with reference to FIGS. 26 - 31 as a dual-port stabilization connector having a proximal coupler 715, a distal coupler 720, and a port 750, but in other embodiments, the stabilization connector can be a single-port stabilization connector having a proximal coupler and a distal coupler but no additional ports (e.g., no side ports, etc.).

[0098] For example, FIGS. 32-35 show at least a part of the stabilization connector 800 according to the eighth embodiment. As described above, the stabilization connector 800 is configured to be placed in contact with the patient's skin at or near the insertion site of the indwelling or placed vascular access device (VAD) as described above. The stabilization connector 800 is configured to be coupled and / or otherwise engaged to the VAD. When coupled to the VAD, the stabilization connector 800 can be fixed to the patient's skin and then, as will be described in more detail herein, at least a part of the VAD can be fixed and / or stabilized with respect to the patient.

[0099] The stabilization connector 800 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the stabilization connector 800 and / or at least a part thereof can be similar in at least form and / or function to any of the stabilization connectors 100, 200, 300, 400, 500, 600, and / or 700 described above. Accordingly, parts of the stabilization connector 800 may not be described in further detail herein.

[0100] As shown in FIGS. 32-35, the stabilization connector 800 (also referred to herein as the "connector") has a connector portion 810 and a stabilization portion 830. In some embodiments, the connector 800 can be configured as a combination of one or more stabilization devices and an extension set. Each of the connector portion 810 and / or the stabilization portion 830 can be arranged in any suitable manner that facilitates at least one of the functions of providing stabilization to one or more devices (e.g., VAD, etc.) and / or one of the functions of providing an extension set for use with the VAD.

[0101] The connector portion 810 has a proximal coupler 815 and a distal coupler 820 and defines at least one lumen 825 that extends through or otherwise provides fluid communication between the couplers 815 and 820. The proximal coupler 815 and / or the distal coupler 820 can be, for example, male or female luer locks and / or any other suitable couplers. As will be described in more detail herein, the proximal coupler 815 can be physically and fluidly coupled to any suitable medical device such as those described above. The distal coupler 820 can be physically and fluidly coupled to, for example, a VAD, such that the lumen 825 of the connector portion 810 is at least selectively in fluid communication with the VAD and / or a part of the body in which the VAD is at least partially disposed. In some embodiments, the lumen 825 of the connector portion 810 can be substantially straight and / or can provide a substantially straight line of sight therethrough, as shown in FIG. 35. In some embodiments, the inner surface of the connector portion 810 can be configured to provide alignment, guidance, centering, etc. to an object or device (e.g., a blood sampling catheter, etc.) advancing therethrough. In some embodiments, the proximal coupler 815 and / or the distal coupler 820 can be substantially similar to the proximal coupler 715 and / or the distal coupler 720, respectively, described above with reference to the connector 700. Accordingly, similar parts and / or aspects of the proximal coupler 815 and / or the distal coupler 820 are not described in further detail herein.

[0102] As shown in FIG. 32, in some embodiments, the proximal coupler 815 is coupled to the tubing 852 such that the tubing 852 is in fluid communication with the lumen 825. In some embodiments, the connector 800 and / or any suitable portion thereof can include one or more mechanisms configured to manage and / or direct at least a portion of the tubing 852 extending from the proximal coupler 815. Although the tubing 752 was described above as being coupled to the port 750 and used to flush the connector portion 710 of the stabilization connector 700, in the embodiments shown in FIGS. 32 - 35, the tubing 852 is coupled to the proximal coupler 815. Thus, the user can flush the connector portion 810 via the tubing 852 and the proximal coupler 815.

[0103] As described above, the end portion of the tubing 852 (e.g., the end portion opposite the proximal coupler 815) can include and / or be coupled to an attachment device, coupler, connector, port, etc. For example, in the embodiments shown in FIGS. 32 - 35, the tubing 852 can include a coupler 860 configured to couple to any suitable device such as a fluid source, fluid collection device, vacuum vessel, pump, syringe, and / or any other suitable device. Further, in some embodiments, the connector 800 can include a clamp 870 coupled to the tubing 852 and configured to selectively engage the tubing 852 to constrict, crimp, clamp, and / or otherwise occlude the lumen defined by the tubing 852 to limit and / or substantially prevent the flow of fluid therethrough. Although the clamp 870 is shown as being separate from the coupler 860, in other embodiments, at least a portion of the clamp 870 can be incorporated into the coupler 860, as will be described in more detail herein with respect to specific embodiments.

[0104] As described above with reference to the connector 700, in the embodiments shown in FIGS. 32 - 35, the connector portion 810, the distal coupler 820, and / or the proximal coupler 815 can include a fluid flow control device 813 (see, e.g., FIGS. 34 and 35). The fluid flow control device 813 can be implemented and / or operable to control the pressure or flow rate through at least a portion of the lumen 825. The fluid flow control device 813 can include, for example, one or more backflow prevention devices and / or valves (e.g., backflow prevention valves, check valves, split diaphragms, etc.), one or more pressure regulators, and / or any other suitable flow control device according to a particular embodiment. In some embodiments, the fluid flow control device 813 can be incorporated into, integrated with, and / or otherwise disposed internally or adjacent to, for example, the connector portion 810, the distal coupler 820, and / or the proximal coupler 815. placed.

[0105] The stabilization portion 830 is coupled to and / or integrally formed with at least a portion of the connector portion 810. The stabilization portion 830 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the stabilization portion 830 can be the same as or substantially the same as the stabilization portion 730 described above. Accordingly, similar portions and / or aspects of the stabilization portion 830 are not described in further detail herein.

[0106] As shown in FIG. 32, the stabilization portion 730 can have a base surface 731 (or bottom surface) having a generally concave contour and / or shape. In some embodiments, the concave contour and / or shape of the base surface 731 can be at least partially based on the curvature and / or shape of a portion of the patient's anatomy, as described above with reference to the stabilization portion 630. Further, the base surface 731 of the stabilization portion 730 can include and / or define one or more contours, recesses, notches, cutouts, channels, etc. (referred to herein as "recesses" 732 (e.g., see FIG. 32)) configured to reduce the amount of force applied to a patient's vein (e.g., the vein in which the VAD is disposed) by the stabilization portion 730, as described in detail above.

[0107] The stabilization portion 830 is configured to be disposed in contact with a portion of the patient's skin at or near the insertion site (as described above). Further, the stabilization portion 830 and / or the stabilization connector 800 are generally configured to be secured to the patient's skin using any suitable securing means, such as those generally described above with reference to at least the stabilization portion 730. In some examples, securing the stabilization connector 800 to the patient's skin (e.g., via a strip of medical tape) secures, stabilizes, and / or substantially immobilizes the VAD (e.g., an IV catheter) relative to the patient. That is, the placement of the stabilization connector 800 is such that securing the stabilization connector 800 and the IV catheter to the patient's skin reduces and / or substantially prevents movement of the IV catheter or at least a portion of the IV catheter relative to the vein in which the IV catheter is at least partially disposed. Further, the placement of the recesses 832 along the base surface 831 is such that securing and / or adhering the stabilization connector 800 to the patient's skin does not apply force to the vein in which the IV catheter is disposed, thereby reducing and / or substantially eliminating impairments and / or restrictions that would otherwise result from such force.

[0108] As described above, any of the stabilization connectors 100, 200, 300, 400, 500, 600, 700, and / or 800 described herein can be coupled to, for example, a pipe or the like that can be used to transfer a fluid or the like to or from the stabilization connector. As described above with reference to stabilization connectors 700 and / or 800, in some embodiments, the pipe (e.g., pipe members 752 and / or 852) can have an end portion (opposite the end portion coupled to stabilization connectors 700 and / or 800, respectively) that includes a coupler, attachment device, connector, and / or any other suitable engagement mechanism (e.g., couplers 760 and / or 860, respectively). Further, the pipe 752 and / or 852 can include and / or be coupled to a clamp or other suitable device configured to selectively control the flow of fluid through the pipe 752 and / or 852 (e.g., clamps 770 and / or 870, respectively). Pipe 752 and 852, couplers 760 and 860, and clamps 770 and 870 are specifically described above with reference to FIGS. 26 and 32, respectively, although in other embodiments, the stabilization connector and / or any other suitable device can include and / or be coupled to a pipe having any suitable coupler, clamp, and / or combination thereof.

[0109] For example, FIGS. 36 and 37 depict at least one of couplers 960, respectively, according to the ninth embodiment It is a perspective view and a side view of the part. Any of the stabilization connectors 100, 200, 300, 400, 500, 600, 700, and / or 800 described in this specification can include a pipe material or the like (not shown), which in turn includes and / or is connected to the coupler 960. The coupler 960 can be configured to couple segments of one or more pipe materials (e.g., a pipe material set) and / or segments of one or more pipe materials to any suitable fluid source, fluid reservoir, fluid container, pump, syringe, and / or device. Further, in some examples, the coupler 960 can be physically and fluidly coupled to such a device or the like such that the lumen defined by the coupler 960 and the pipe material is in fluid communication with a stabilization connector (e.g., any of the connectors 100, 200, 300, 400, 500, 600, 700, and / or 800 described above) to which the pipe material is connected.

[0110] The coupler 960 can be of any suitable shape, size, and / or configuration. In some embodiments, the coupler 960 can be configured as a combination integrated or otherwise incorporated with one or more connectors or couplers (e.g., couplers 760 and / or 860), as well as one or more pipe clamps (e.g., clamps 770 and / or 870) of a stabilization device, an extension set, and / or any other suitable device as described in this specification. The coupler 960 can be arranged in any suitable manner to facilitate at least one of the functions of securing the connection between one or more pipe segments and one or more connectors and / or any other suitable device. In some embodiments, the coupler 960 can be an integrated coupling device and clamp device, for example, which can simplify manufacturing and / or assembly, thereby reducing operating costs. In some embodiments, the coupler 960 can be or include a male or female luer lock, a female luer with an integrated pipe clamp or pipe clamp mechanism, and / or any other suitable coupler or fluid coupling.

[0111] The coupler 960 has a connector coupling interface or engagement portion 961 (also referred to herein as the "engagement portion" 961) and a clamp portion 962. The engagement portion 961 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the engagement portion 961 can be, for example, a male or female luer lock and / or any other suitable coupler. In some examples, the engagement portion 961 can be physically and fluidly coupled to any suitable medical device, fluid source, fluid reservoir, pump, syringe, etc., such as any of those described herein. In some embodiments, the engagement portion 961 can be arranged and / or configured to receive a click-to-connect coupling (e.g., a click-lock snap (trademark) connection), a threaded coupling, a luer connection, etc. In some embodiments, the engagement portion 961 can include, for example, a spin collar, etc., and / or, in other cases, can be configured to form a relatively simple, secure, and fluid-tight connection. In some embodiments, the engagement portion 961 can be compatible with any suitable valve and / or seal (e.g., a valve used in a luer lock, an NFC valve, a split septum, a resealable valve or membrane, etc.) and / or can be a needleless or needle-free connector, a stand-alone connector, and / or an interchangeable connector. In some embodiments, the engagement portion 961 can be configured to be compatible with any suitable known coupler or connector (e.g., those made by Smiths, BD, Braun, ICU Medical, Terumo, etc.). Thus, the engagement portion 961 can be coupled to any suitable device, mechanism, member, etc., as described in more detail herein, and can then be arranged in fluid communication with the lumen of the tubing coupled to the clamp portion 962.

[0112] The clamp portion 962 can be of any suitable shape, size, and / or configuration. As shown in FIG. 36, the clamp portion 962 has an internal volume, recess, port, opening, etc. (referred to herein as the "opening" 96 It can be defined as (referred to as 4). More specifically, the pipe can be inserted into the clamp portion 962 and / or coupled in other ways such that the lumen of the pipe is disposed in fluid communication with the coupling portion 961. Thus, the coupler 960 can be configured to establish fluid communication between the pipe physically and fluidly coupled to the clamp portion 962 and the device, mechanism, member, etc. physically and fluidly coupled to the coupling portion 961.

[0113] In addition, the clamp portion 962 can be any suitable physical coupling or clamping device and / or mechanism, such as, for example, a clamp, clip, slit, wedge, pinching device or mechanism, semi-ring (e.g., double-sided open slide clamp, slide clamp with loop, double-sided closed slide clamp, pinch clamp with release lever, etc.), and / or any other suitable clamping mechanism, etc., and / or can include them. For example, in the embodiments shown in FIGS. 36 and 37, the clamp portion 962 defines a slot 963 along at least a portion of the length of the clamp portion 962 (e.g., substantially parallel to the longitudinal axis of at least the clamp portion 962).

[0114] The clamping portion 962 can be configured to selectively clamp, grip, deform, block, and / or otherwise occlude at least a portion of the pipe material and / or at least a portion of the lumen defined by the pipe material. For example, in some instances, a user can manipulate at least a portion of the pipe material coupled to the clamping portion 962 by inserting a portion of the pipe material into the slot 963. Although not shown in FIGS. 36 and 37, the slot 963 can be arranged such that the width of the slot 963 is less than at least the diameter of a portion of the pipe material. Thus, when the pipe material is inserted into the slot 963, the opposing surfaces of the clamping portion 962 that define the slot 963 can contact a portion of the pipe material and apply a force operable to bend, twist, grip, clamp, and / or otherwise deform a portion of the pipe material. In such instances, deformation of the pipe material, etc., can be such that the lumen of the pipe material is blocked, occluded, clamped, or pinched closed. Thus, the coupler 960 can be configured to function as a combination of a coupler (e.g., couplers 760 and / or 860) and a clamp (770 and / or 870).

[0115] FIGS. 38 and 39 are, respectively, a perspective view and a top view of at least a portion of a coupler 1060 according to the tenth embodiment. As described above, any of the stabilization connectors 100, 200, 300, 400, 500, 600, 700, and / or 800 can include a pipe material, etc. (not shown), which in turn can include and / or be coupled to the coupler 1060. The coupler 1060 can be configured to couple segments of one or more pipe materials (e.g., a pipe material set) and / or segments of one or more pipe materials to any suitable fluid source, fluid reservoir, fluid container, pump, syringe, and / or device. Further, in some instances, the coupler 1060 can be physically and fluidly coupled to such a device, etc., such that the lumen defined by the coupler 1060 and the pipe material is in fluid communication with a stabilization connector (e.g., any of the connectors 100, 200, 300, 400, 500, 600, 700, and / or 800 described above) to which the pipe material is connected.

[0116] The coupler 1060 can be of any suitable shape, size, and / or configuration. In some embodiments, the coupler 1060 can be configured as an integrated or other incorporated combination of one or more connectors and one or more tube clamps of a stabilization device or stabilization connector, an extension set, and / or any other suitable device, as described above with reference to coupler 960. In some embodiments, the coupler 1060 and / or at least a part or aspect thereof can be the same as and / or substantially the same as a part and / or aspect of the coupler 960 described above with reference to FIGS. 36 and 37. Accordingly, the similar parts and / or aspects of the coupler 1060 are not described in further detail herein.

[0117] As shown in FIGS. 38 and 39, the coupler 1060 has a connector coupling interface or engagement portion 1061 (also referred to herein as the "engagement portion" 1061) and a clamp portion 1062. The engagement portion 1061 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the engagement portion 1061 can be, for example, a male or female luer lock, and / or any other suitable coupler. In some examples, the engagement portion 1061 can be physically and fluidly coupled to any suitable medical device, fluid source, fluid reservoir, pump, syringe, etc., such as any of those described herein. In some embodiments, the engagement portion 1061 can be substantially the same as the engagement portion 961 of the coupler 960, at least in form and / or function, and thus is not described in further detail herein.

[0118] The clamp portion 1062 can be of any suitable shape, size, and / or configuration. As shown in FIG. 38, the clamp portion 1062 can define an internal volume, recess, port, opening, etc. (referred to herein as "opening" 1064) configured to receive at least an end portion (not shown) of a pipe or the like. More specifically, the pipe can be inserted into and / or otherwise coupled to the clamp portion 1062 such that the lumen of the pipe is disposed in fluid communication with the coupling portion 1061. Thus, the coupler 1060 can be configured to establish fluid communication between a pipe physically and fluidly coupled to the clamp portion 1062 and a device, mechanism, member, etc. physically and fluidly coupled to the coupling portion 1061.

[0119] Furthermore, the clamp portion 1062 can be and / or can include any suitable clamping mechanism and / or mechanisms such as those described above with reference to the coupler 960. For example, in the embodiments shown in FIGS. 38 and 39, the clamp portion 1062 defines a slot 1063 along at least a portion of the length of the clamp portion 1062 (e.g., substantially parallel to the longitudinal axis of at least the clamp portion 1062). As shown in FIG. 39, the slot 1063 includes a first portion 1065 and a second portion 1066. In some embodiments, the first portion 1065 of the slot 1063 can have a diameter, size, and / or area that is larger than the diameter, size, and / or area of the second portion 1066 of the slot 1063. Although the first portion 1065 and the second portion 1066 of the slot 1063 are specifically shown in FIG. 39, it should be understood that the slot 1063 and / or the clamp portion 1062 are shown by way of example only and not by way of limitation. In other embodiments, the clamp portion 1062 can have any suitable shape, size, and / or configuration and can define a slot that is functionally similar and / or substantially the same as the slot 1063.

[0120] As described above with reference to coupler 960, the clamp portion 1062 can be configured to selectively clamp, grip, deform, occlude, and / or otherwise block at least a portion of the tubing and / or at least a portion of the lumen defined by the tubing. For example, in some embodiments, the end portion of the tubing can be inserted into the opening 1064 and / or otherwise coupled to the clamp portion 1062. Although not shown in FIGS. 38 and 39, a portion of the tubing can extend out of the opening 1064 and through at least a portion of the slot 1063. In some examples, a user can manipulate at least a portion of the tubing by positioning and / or disposing a portion of the tubing in the first portion 1065 of the slot 1063 or the second portion 1066 of the slot 1063. As described above, in some embodiments, the first portion 1065 of the slot 1063 can have a larger diameter and / or size than the second portion 1066 of the slot, such that when a portion of the tubing is disposed within and / or extends through the first portion 1065 of the slot 1063, the portion of the tubing can be in a non-deformed or unclamped configuration where the lumen of the tubing is not substantially clamped, blocked, occluded, etc., thereby allowing fluid flow therethrough.

[0121] Conversely, in some examples, a user can position and / or dispose a portion of the tubing in the second portion 1066 of the slot 1063 to clamp, grip, close, block, and / or otherwise occlude the lumen of the tubing. For example, as described above with reference to coupler 960, the opposing surfaces of the clamp portion 1062 that define the second portion 1066 of the slot 1063 can contact a portion of the tubing such that the lumen of the tubing is occluded, blocked, clamped, or pinched closed, and can apply a force operable to bend, twist, grip, clamp, and / or otherwise deform a portion of the tubing. Thus, as described above with reference to coupler 960, the coupler 1060 can be configured to function as a combination of a coupler (e.g., couplers 760 and / or 860) and a clamp (770 and / or 870).

[0122] Figures 40 and 41 are a perspective view and a top view, respectively, of at least a portion of the coupler 1160 according to the eleventh embodiment. As described above, any of the stabilization connectors 100, 200, 300, 400, 500, 600, 700, and / or 800 can include a pipe or the like (not shown), which in turn includes and / or is coupled to the coupler 1160. The coupler 1160 can be configured to couple segments of one or more pipes (e.g., a pipe set) and / or segments of one or more pipes to any suitable fluid source, fluid reservoir, fluid container, pump, syringe, and / or device. Further, in some examples, the coupler 1160 can be physically and fluidly coupled to such a device or the like such that the lumen defined by the coupler 1160 and the pipe is in fluid communication with a stabilization connector (e.g., any of the connectors 100, 200, 300, 400, 500, 600, 700, and / or 800 described above) to which the pipe is connected.

[0123] The coupler 1160 can be of any suitable shape, size, and / or configuration. In some embodiments, the coupler 1160 can be configured as an integration or another incorporated combination of one or more connectors and one or more tube clamps of a stabilization device or stabilization connector, an extension set, and / or any other suitable device, as described above with reference to the coupler 1060. In some embodiments, the coupler 1160 and / or at least a portion or aspect thereof can be the same as and / or substantially the same as a portion and / or aspect of the coupler 1060 described above with reference to FIGS. 38 and 39. Accordingly, similar parts and / or aspects of the coupler 1160 are not described in further detail herein.

[0124] As shown in FIGS. 40 and 41, coupler 1160 has a connector coupling interface or engagement portion 1161 (also referred to herein as "coupling portion" 1161) and a clamp portion 1162. The coupling portion 1161 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the coupling portion 1161 can be, for example, a male or female luer lock, and / or any other suitable coupler. In some examples, the coupling portion 1161 can be physically and fluidly coupled to any suitable medical device, fluid source, fluid reservoir, pump, syringe, etc., such as any of those described herein. In some embodiments, the coupling portion 1161 can be substantially similar to the coupling portion 1061 of coupler 1060, at least in form and / or function, and thus will not be described in further detail herein.

[0125] The clamp portion 1162 can be of any suitable shape, size, and / or configuration. As shown in FIG. 40, the clamp portion 1162 can define an internal volume, recess, port, opening, etc. (referred to herein as "opening" 1164) configured to receive at least an end portion (not shown) of a tubing or the like, as described in detail above with reference to clamp portion 1062. Further, the clamp portion 1162 can be and / or include any suitable clamping mechanism and / or mechanism such as those described above with reference to couplers 960 and / or 1060. For example, in the embodiments shown in FIGS. 40 and 41, the clamp portion 1162 defines a slot 1163 having a first portion 1165 and a second portion 1166. In some embodiments, the first portion 1165 of the slot 1163 can have a diameter, size, and / or area that is larger than the diameter, size, and / or area of the second portion 1166 of the slot 1163, as described above with reference to slot 1063.

[0126] The clamping portion 1162 can be substantially similar to the clamping portion 1062 described above with reference to FIGS. 38 and 39. As shown, the clamping portion 1162 can include a substantially U-shaped member 1167 that differs from the clamping portion 1062 by including a first portion 1165 of a slot 1163 (see, e.g., FIG. 40) that extends through an end portion or a curved portion of the U-shaped member 1167, and a second portion 1166 of the slot 1163 (see, e.g., FIG. 41) that extends through each side (e.g., two opposing sides) of the U-shaped member 1167. Thus, as described above with reference to the clamping portion 1062, the clamping portion 1162 can be configured to allow a portion of the pipe material to extend through the first portion 1165 of the slot 1163 without substantially clamping or closing the lumen of the pipe material, and to clamp, pinch, deform, and / or otherwise block at least a portion of the lumen when a portion of the pipe material is disposed and / or positioned in the second portion 1166 of the slot 1163. Thus, as described above with reference to the couplers 960 and / or 1060, the coupler 1160 can be configured to function as a combination of a coupler (e.g., couplers 760 and / or 860) and a clamp (770 and / or 870).

[0127] Figures 42 to 44 show at least a part of the coupler 1260 according to the twelfth embodiment. As described above, any of the stabilization connectors 100, 200, 300, 400, 500, 600, 700, and / or 800 can include a pipe or the like (not shown), which in turn includes and / or is coupled to the coupler 1260. The coupler 1260 can be configured to couple segments of one or more pipes (e.g., a pipe set) and / or segments of one or more pipes to any suitable fluid source, fluid reservoir, fluid container, pump, syringe, and / or device. Further, in some examples, the coupler 1260 is physically and fluidly coupled to such a device or the like such that the lumen defined by the coupler 1260 and the pipe is in fluid communication with a stabilization connector (e.g., any of the connectors 100, 200, 300, 400, 500, 600, 700, and / or 800 described above) to which the pipe is connected by arranging the device.

[0128] The coupler 1260 can be of any suitable shape, size, and / or configuration. In some embodiments, the coupler 1260 can be configured as an integration or another incorporated combination of one or more connectors and one or more pipe clamps of a stabilization device or stabilization connector, an extension set, and / or any other suitable device, as described above with reference to the couplers 960, 1060, and / or 1160. In some embodiments, the coupler 1260 and / or at least a part or aspect thereof can be the same as and / or substantially the same as a part and / or aspect of the couplers 960, 1060, and / or 1160 described in detail above. Accordingly, similar parts and / or aspects of the coupler 1260 are not described in further detail herein.

[0129] As shown in FIGS. 42 - 44, the coupler 1260 has a connector coupling interface or engagement portion 1261 (also referred to herein as the "engagement portion" 1261) and a clamp portion 1262. The engagement portion 1261 can be of any suitable shape, size, and / or configuration. For example, in some embodiments, the engagement portion 1261 can be, for example, a male or female luer lock and / or any other suitable coupler. In some examples, the engagement portion 1261 can be physically and fluidly coupled to any suitable medical device, fluid source, fluid reservoir, pump, syringe, etc., such as any of those described herein. In some embodiments, the engagement portion 1261 can be substantially similar in at least form and / or function to the engagement portions 961, 1061, and / or 1161, and thus will not be described in further detail herein. It can be substantially similar to the engagement portions 961, 1061, and / or 1161 and thus is not described in further detail herein.

[0130] The clamp portion 1262 can be of any suitable shape, size, and / or configuration. As shown in FIG. 42, the clamp portion 1262 can define an internal volume, recess, port, opening, etc. (referred to herein as the "opening" 1264) configured to receive at least an end portion (not shown) of a tubing or the like. Further, the clamp portion 1262 can be any suitable clamping mechanism and / or mechanism, such as any of those described above with reference to the couplers 960, 1060, and / or 1160, and / or can include them. For example, in the embodiments shown in FIGS. 42 - 44, the clamp portion 1262 includes a clip 1268 and / or any other suitable member configured to transition between a first state and / or configuration and a second state and / or configuration.

[0131] As shown in FIG. 42, clip 1268 defines a slot 1263 or opening configured to receive a portion of the pipe. Slots 963, 1063, and / or 1163 were described above as being configured to selectively engage a portion of the pipe to at least partially clamp the portion of the pipe, but in the embodiments shown in FIGS. 42-44, slot 1263 (or opening) can have a size and / or diameter sufficient to receive a portion of the pipe without clamping or otherwise blocking the lumen defined by the pipe. Thus, slot 1263 can receive a portion of the pipe and act to guide, restrict, and / or at least partially limit movement of the pipe relative to clamp portion 1262.

[0132] Clip 1268 includes a set of protrusions extending from the inner surface of clip 1268 and configured to selectively engage at least a portion of a pipe (not shown) extending from opening 1264 to slot 1263. As shown in FIG. 43, clip 1268 can be arranged in a first state and / or configuration in which the space defined between protrusions 1269 is sufficient to receive a portion of the pipe without substantially clamping, bending, twisting, deforming, and / or otherwise engaging the pipe. Thus, when clip 1268 is in the first state and / or configuration, there is a possibility that the lumen of the pipe is open or otherwise unblocked as a result of a portion of the pipe not being clamped.

[0133] Conversely, as shown in FIG. 44, the user can engage the clip 1268 to reduce the space defined between the protrusions 1269. For example, in some instances, the user can apply a force to a portion of the clip 1268 such that the first side of the clip 1268 is moved or brought closer to the second side of the clip 1268, thereby reducing the space formed between the protrusions 1269. In some such instances, the transition of the clip 1268 from the first state and / or configuration to the second state and / or configuration can be such that the protrusion 1269 engages the opposite side of a portion of the pipe member, thereby being sufficient to clamp, pinch, deform, bend, twist, etc. the pipe member and then close, block, seal, or clamp the lumen of the pipe member. Further, as shown in FIGS. 43 and 44, the clamping portion 1262 can include a latch 1271 or the like configured to selectively engage a portion of the clip 1268 to maintain the clip 1268 in the second state and / or configuration until the user operates the clip 1268 in such a way that the clip 1268 can transition from the second state and / or configuration to the first state and / or configuration. Accordingly, as described above with reference to the couplers 960, 1060, and / or 1160, the coupler 1260 can be configured to function as a combination of a coupler (e.g., couplers 760 and / or 860) and a clamp (770 and / or 870).

[0134] Although various embodiments have been described above, they are presented by way of example only and not limitation It should be understood. If the above schematic diagrams and / or embodiments show specific components arranged in a specific orientation or position, the arrangement of the components may be changed. Although various embodiments have been described as having a specific combination of mechanisms and / or components, other embodiments having any combination of mechanisms and / or components from any of the above embodiments are possible. Although embodiments have been specifically shown and described, it will be understood that various changes in form and detail may be made.

[0135] The specific configuration of various components can also be changed. For example, the size and specific shape of various components can be different from the illustrated embodiments while still providing the functions described herein. More specifically, the size and shape of various components can be specifically selected for a desired or intended use, or to facilitate, simplify, and / or enable in other ways manufacturing and / or assembly. Thus, it should be understood that the size, shape, and / or arrangement of an embodiment and / or its components can be adapted to a given application unless the context clearly states otherwise.

[0136] Connectors 100, 200, 300, 400, 500, 600, 700, and / or 800 are described herein as dual port adapters, connectors, and / or extension sets, but in other embodiments, the stabilization connector can be a single port connector, dual port connector, triple port connector, or a connector with four or more ports. For example, in some embodiments, any of connectors 100, 200, 300, 400, 500, 600, 700, and / or 800 can include, for example, an additional port (e.g., port 250 or similar to any other port described herein) extending from the side of the connector or connector portion. In some embodiments, the additional port (i.e., the third port) can be configured in a T-shaped arrangement, Y-shaped arrangement, and / or any other suitable arrangement. In some embodiments, the third port can be arranged substantially perpendicular to the bottom or the second port. In other embodiments, the third port can be arranged at any suitable position along the connector portion. In such an arrangement, a user (e.g., a physician, doctor, surgeon, nurse, technician, etc.) can, for example, use the second port and the third port to transfer, for example, a plurality of fluids and / or the same fluid in a plurality of volumes to or from a patient, for example, without accessing and / or using a proximal coupler. In other embodiments, the ports of the connector can be coupled to a branch or branched tubing that fluidly communicates the tubing and ports with a plurality of fluid sources and / or reservoirs without including a plurality of ports on or along the connector portion.

[0137] Any of the devices described herein can be included in a closed system that can be pre-assembled with any suitable access device or the like. For example, in some embodiments, connectors 100, 200, 300, 400, 500, 600, 700, and / or 800 can be coupled to and / or include means for placing at least a portion of the VAD within the VAD and a desired portion of the patient. More specifically, in some embodiments, the VAD can be, for example, a peripherally inserted central catheter (PIV) that can be coupled to and / or integrally formed with a stabilization connector. In such embodiments, the stabilization connector can be pre-assembled with the PIV and / or a needle or trocar configured to initiate and / or facilitate placement of at least a portion of the PIV catheter into a desired or target vein of the patient. In some embodiments, such a stabilization connector can be configured to be separated from the needle or trocar after the venipuncture event. In other words, after a portion of the PIV catheter has been placed in the desired and / or target vein, the needle or trocar can be removed from the stabilization connector, leaving a portion of the PIV catheter in the vein. Further, after removing and / or separating the needle or trocar from the stabilization connector, the user can secure the stabilization connector to the patient as described in detail above. Once secured, the stabilization connector (e.g., connector 100, 20 0, 300, 400, 500, 600, 700, and / or 800) can be used in any suitable manner as described herein.

[0138] If the above methods and / or schematic diagrams show specific events and / or flow patterns that occur in a particular order, the order of the specific events and / or flow patterns can be changed. Further, specific events can be executed either simultaneously in a parallel process or sequentially, if possible.

Claims

1. A connector portion having a distal coupler and a proximal coupler, and defining a lumen extending between the distal coupler and the proximal coupler, wherein the distal coupler is configured to be coupled to a hub of an access device, at least a portion of which is inserted into a patient, at a predetermined angle with respect to an insertion site of the patient, and the lumen of the connector portion is arranged in fluid communication with a lumen defined by the access device when the distal coupler is coupled to the hub, a connector portion; A stabilization portion integrally formed with at least a portion of the connector portion, the stabilization portion being configured to contact the patient to stabilize at least one of the connector portion and the access device when the distal coupler is coupled to the hub of the access device, and the connector portion being arranged at substantially the predetermined angle such that a common axis extends through at least a portion of the lumen defined by the connector portion and the lumen defined by the access device when the stabilization portion is in contact with the patient, a stabilization portion; comprising an apparatus.

2. The apparatus according to claim 1, wherein the proximal coupler includes a fluid flow control device.

3. The apparatus according to claim 1, wherein the predetermined angle is an insertion angle of at least a portion of the access device.

4. The lumen of the connector portion is a first lumen, The connector portion defines a second lumen in fluid communication with the first lumen, The apparatus according to claim 1, wherein the second lumen is substantially perpendicular to the first lumen.

5. The lumen of the connector portion is a first lumen, The connector portion includes a port defining a second lumen in fluid communication with the first lumen, The apparatus according to claim 1, wherein the port is arranged at a position along the connector portion adjacent to the proximal coupler.

6. The access device includes an intravenous catheter, The apparatus according to claim 1, wherein the intravenous catheter is configured such that at least a portion thereof is disposed within a vein of a patient.

7. The access device includes an intravenous catheter, The intravenous catheter is configured such that at least a portion thereof is disposed within a vein of a patient, The stabilization portion has a base surface forming a recess, A portion of the base surface is configured to contact the patient's insertion site such that when the distal coupler is coupled to the hub of the access device, the recess is aligned with the vein and spaced from the patient's insertion site, the apparatus of claim 1.

8. Aligning the recess with the vein and spacing the recess from the insertion site reduces the amount of force applied to the vein, the apparatus of claim 7.

9. A connector portion having a distal coupler and a proximal coupler and defining a lumen extending between the distal coupler and the proximal coupler, the distal coupler being configured to be coupled to a hub of an access device at least a portion of which is inserted into a patient's vein, the lumen of the connector portion being disposed in fluid communication with the lumen defined by the access device when the distal coupler is coupled to the hub, a connector portion; A stabilization portion integrally formed with at least a portion of the connector portion, the stabilization portion having a base surface, a portion of the base surface being such that when the distal coupler is coupled to the hub of the access device, (1) the stabilization portion stabilizes at least one of the connector portion and the access device, and (2) a common axis extends through at least a portion of the lumen defined by the connector portion and the lumen defined by the access device, the base surface being configured to contact the patient, the base surface forming a recess configured to align with the vein and be spaced from the patient when the portion of the base surface is in contact with the patient, a stabilization portion.

10. The base surface has a proximal edge and a distal edge, The recess extends between the proximal edge and the distal edge, the apparatus of claim 9.

11. A portion of the access device is inserted into the vein at a predetermined angle relative to the patient's insertion site, The stabilization portion is configured to dispose the connector portion at substantially the predetermined angle relative to the insertion site when the distal coupler is coupled to the hub of the access device and the portion of the base surface is in contact with the patient, the apparatus of claim 9.

12. The access device includes an intravascular catheter, the apparatus of claim 9.

13. The device according to claim 9, wherein the proximal coupler is configured to be coupled to a fluid transfer device.

14. The proximal coupler includes a needleless connector (NFC) valve, The device according to claim 13, wherein the NFC valve is configured to transition from a closed configuration to an open configuration in response to the fluid transfer device being coupled to the proximal coupler.

15. A connector portion having a distal coupler and a proximal coupler, and defining a lumen extending between the distal coupler and the proximal coupler, wherein the distal coupler is configured to be coupled to a hub of an access device with at least a portion of the access device inserted into a patient such that the lumen of the connector portion is in fluid communication with the lumen defined by the access device, and A stabilization portion integrally formed with at least a portion of the connector portion, the stabilization portion having a base surface, a portion of the base surface being configured to contact the patient when the distal coupler is coupled to the hub of the access device to stabilize at least one of the connector portion and the access device, and the base surface forming a recess configured to be spaced apart from the patient when the portion of the base surface is in contact with the patient. The device, wherein the connector portion is disposed at a predetermined angle such that a common axis extends through at least a portion of the lumen defined by the connector portion and the lumen defined by the access device when the distal coupler is coupled to the hub of the access device and a portion of the base surface is in contact with the patient.

16. The access device is a peripheral intravenous catheter, The device according to claim 15, wherein the peripheral intravenous catheter is configured such that at least a portion thereof is disposed within a vein of the patient.

17. The device according to claim 16, wherein the recess is configured to be aligned with the vein and spaced apart from the patient to reduce the amount of force otherwise applied to the vein by the base surface when the portion of the base surface is in contact with the patient.

18. The lumen of the connector portion is a first lumen, The connector portion includes a port defining a second lumen in fluid communication with the first lumen. The device according to claim 15, wherein the port is disposed between the base surface of the stabilization portion and the proximal coupler.

19. The device according to claim 15, wherein the proximal coupler is configured to be coupled to a fluid transfer device.

20. The proximal coupler includes a needleless connector (NFC) valve, The device according to claim 19, wherein the NFC valve is configured to transition from a closed configuration to an open configuration in response to the fluid transfer device being coupled to the proximal coupler.

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