Stabilization devices for vascular access and methods of using the same

A stabilization device configured to stabilize an access device when a distal end portion of the access device is inserted through a target location of a patient. The stabilization device includes a coupling surface, a proximal surface, and a base surface. The coupling surface is configured to be placed in contact with an adapter coupled to a proximal end portion of the access device. The proximal surface forms at least one angle and is configured to facilitate securement of the stabilization device to the target location. The base surface forms a contoured portion configured to be placed in contact with the target location and a recessed portion configured to be spaced apart from the target location. The stabilization device is configured to be secured to the target location such that the adapter is retained in a fixed position relative to the coupling surface and the access device is stabilized.

BACKGROUND

The embodiments described herein relate generally to medical devices and, more particularly, to devices and methods for stabilizing vascular access devices such as intravenous catheters and/or extension sets.

Many medical procedures and/or surgical interventions include inserting an access device or fluid transfer device into a portion of the body. For example, catheters and/or other lumen-defining devices can be inserted into and/or through vascular structures to access portions of the body or to transfer fluids from or to a patient. In some instances, vascular access devices (VADs) such as, for example, peripheral intravenous catheters (PIVs), are inserted into patients (e.g., when a patient is hospitalized or during other medical procedures) and are designed and/or intended to remain within the patient for an extended period.

VADs typically include a catheter formed from a soft bio-reactive polymer that is partially disposed in the body and that is attached, at a proximal end (e.g., the end outside of the body) to a hub, which in turn, can provide an interface for attaching any suitable device. After placing the VAD (e.g., a PIV catheter or the like) within a vein (or artery) of the patient, it is often desirable to stabilize and/or secure the VAD relative to the patient. For example, in some instances, movement of the VAD relative to the patient can result in undesirable bending, flexing, and/or kinking of the catheter. In other instances, movement of the VAD (e.g., along a longitudinal axis of the VAD) can withdraw a portion of the catheter from the patient's body, which in turn, can expose that portion of the catheter to an unsterile environment. Moreover, moving the VAD back to its original position can disposed the potentially contaminated portion of the VAD catheter in the patient, thereby increasing the chances of infection.

Stabilizing and/or securing devices are often used in an effort to minimize movement of a placed or indwelling VAD (e.g., PIV catheter). Some known stabilizing and/or securing devices, however, are complicated and/or time consuming to use, while others may provide inadequate stabilization. In addition, the shape and/or configuration of some known stabilizing and/or securing devices can negatively impact a flow rate through a portion the VAD and/or the vein (or artery) in which the catheter is disposed.

Thus, a need exists for improved devices and methods for stabilizing placed vascular access devices.

SUMMARY

Devices and methods for stabilizing placed or indwelling vascular access devices such as, for example, intravenous or arterial catheters are described herein. In some embodiments, an apparatus includes a stabilization device configured to stabilize an access device when a distal end portion of the access device is inserted through a target location of a patient and at least partially disposed within a portion of the patient. The stabilization device can include a coupling surface, a proximal surface, and a base surface. The coupling surface is configured to be placed in contact with an adapter coupled to a proximal end portion of the access device. The proximal surface forms at least one angle and is configured to facilitate securement of the stabilization device to the target location of the patient. The base surface forms a contoured portion configured to be placed in contact with the target location and a recessed portion configured to be spaced apart from the target location when the contoured portion is in contact with the target location. The stabilization device is configured to be secured to the target location of the patient such that (1) the adapter is retained in a fixed position relative to the coupling surface and (2) the access device is stabilized relative to the target location.

DETAILED DESCRIPTION

In some embodiments, an apparatus includes a stabilization device configured to stabilize an access device when a distal end portion of the access device is inserted through a target location of a patient and at least partially disposed within a portion of the patient. The stabilization device can include a coupling surface, a proximal surface, and a base surface. The coupling surface is configured to be placed in contact with an adapter coupled to a proximal end portion of the access device. The proximal surface forms at least one angle and is configured to facilitate securement of the stabilization device to the target location of the patient. The base surface forms a contoured portion configured to be placed in contact with the target location and a recessed portion configured to be spaced apart from the target location when the contoured portion is in contact with the target location. The stabilization device is configured to be secured to the target location of the patient such that (1) the adapter is retained in a fixed position relative to the coupling surface and (2) the access device is stabilized relative to the target location.

In some embodiments, an apparatus includes a stabilization device configured to stabilize a vascular access device at least partially disposed within a vein of a patient. The stabilization device includes a base surface and a coupling surface. The base surface forms a contoured portion configured to be placed in contact with a target location of the patient and a recessed portion configured to be at least partially aligned with and spaced apart from the vein of the patient when the contoured portion is in contact with the target location. The coupling surface is configured to be placed in contact with an adapter coupled to a proximal end portion of the vascular access device. The coupling surface includes a first portion and a second portion. The first portion includes at least one protrusion configured to selectively engage the adapter such that (1) a portion of the adapter is aligned with and configured to be placed in contact with the second portion of the coupling surface when the first portion of the coupling surface is in contact with a distal end portion of the adapter, and (2) the portion of the adapter is misaligned with and spaced apart from the second portion of the coupling surface when the first portion of the coupling surface is in contact with a proximal end portion of the adapter.

In some embodiments, a method of stabilizing a vascular access device at least partially disposed within a vein of a patient includes coupling a stabilization device to the vascular access device at least partially disposed in the vein of the patient. The stabilization device is positioned on a target location of the patient such that a recessed portion formed by a base surface of the stabilization device is aligned with the vein. A first strip of medical tape is applied to a proximal surface of the stabilization device such that each of a first end portion and a second end portion of the first strip of medical tape are in contact with the target location of the patient and are distal to a medial portion of the medical tape. The medial portion of the first strip of medical tape is at least partially in contact with the proximal surface of the stabilization device and at least partially in contact with the target location of the patient. A second strip of medical tape is applied to a portion of the stabilization device distal to the proximal surface such that the second strip of medical tape partially overlaps at least the first end portion and the second end portion of the first strip of medical tape.

In some embodiments, a stabilization device has a proximal end portion and a distal end portion and is configured to be secured to the skin of a patient. The proximal end portion includes a proximal surface forming at least one angle configured to facilitate securement of the stabilization device to the skin of the patient. A base surface of the stabilization device forms a contour that is configured to be placed in contact with the skin of a patient, and defines a recess along the contour configured to be spaced apart from the skin of the patient. The stabilization device is configured to couple to at least one of a hub of a placed vascular access device or an adapter coupled to the placed vascular access device to stabilize the placed vascular access device when the stabilization device is secured to the skin of the patient.

As used herein, the terms “about” and “approximately” can be used interchangeably and generally mean plus or minus 10% of the value stated. For example, about 0.5 would include 0.45 and 0.55, about 10 would include 9 to 11, about 1000 would include 900 to 1100.

Similarly, the term “substantially” when used in connection with a geometric construction and/or geometric relationship is intended to convey that the structure and/or relationship so defined is nominally the recited structure and/or relationship. As one example, a first portion of a stabilization device that is described as being “substantially perpendicular” to a second portion of the stabilization device is intended to convey that, although a perpendicular relationship (e.g., being arranged, disposed at, and/or otherwise forming a 90° angle or orientation) is desirable, some variance or non-perpendicularity can occur in a “substantially perpendicular” relationship. As another example, two geometric constructs that are described as being substantially aligned is intended to convey that, although alignment of the geometric constructs is desirable, some variance or misalignment can occur. In some instances, variances such as those described above can result from, for example, manufacturing tolerances, or other practical considerations. Thus, a geometric construction modified by the term “substantially” includes such geometric properties within a tolerance of plus or minus 5% of the stated geometric construction. For example, a “substantially perpendicular” relationship is a relationship between two geometric constructs that is within plus or minus 5% of being perpendicular.

As used herein, the term “set” can refer to multiple features or a singular feature with multiple parts. For example, when referring to a set of protrusions, the set of protrusions can be considered as one protrusion with multiple portions, or the set of protrusions can be considered as multiple, distinct protrusions. Thus, a monolithically constructed item can include a set of protrusions. Such a “set” may include multiple portions and/or components that are either continuous or discontinuous from each other. Moreover, a “set” can also be formed from multiple components that are produced separately and are later joined together (e.g., via a weld, an adhesive, or any suitable method).

The devices and methods described herein are configured to stabilize devices and/or components of devices that are directly or indirectly inserted in a patient. Such devices are generally referred to herein as vascular access devices (VADs). Non-limiting examples of a VAD can include intravenous (IV) access devices such as peripheral intravenous catheters (PIV), peripheral intravenous central catheters (PICCs or PIC lines), midline catheters, extended dwell catheters (EDCs), etc. In other embodiments, a VAD can be an intra-arterial access device such as an arterial line, and/or the like. While reference to use with specific access devices is made herein, it should be understood that such reference is presented by way of example and not limitation.

As used herein, the term “catheter” describes an element configured to define a passageway such as a cannula, a tube, or other lumen-defining structure. In some instances, a catheter can be used for moving a bodily fluid from a first location to a second location (e.g., a fluid passageway to move a bodily fluid out of the body). While cannulas can be configured to receive a trocar, a guide wire, or an introducer to deliver the cannula to a volume inside the body of a patient, the catheters and/or cannulas referred to herein need not include or receive a trocar, guide wire, or introducer and can be positioned and/or inserted into, for example, the vasculature of a patient using any suitable method.

As used in this specification, the term “extension set” generally refers to a device or adapter that is coupled to a hub of a VAD such as a peripheral IV catheter or the like. The “extension sets” can be any suitable configuration. For example, in some embodiments, an extension set can be a single port or a multi-port adapter. As a specific example, an extension set can be and/or can refer to a “Y-shaped” dual port extension. In other embodiments, an extension set can be and/or can refer to a “T-shaped” dual port extension set.

In general, some known extension sets are configured to couple between a hub of a VAD and/or any suitable medical device and can allow one or more objects, devices, medicaments, fluids, etc. to access a portion of the body of a patient (e.g., via the VAD). More particularly, in some instances, an extension set can be coupled to an indwelling access device (e.g., a PIV or the like) and can facilitate the transfer and/or collection of one of more fluids. In some instances, the fluid can be a bodily fluid including, but not limited to, blood, cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, vitreous, air, and the like, or any combination thereof.

In some embodiments, any of the extension sets described herein can be a commercially available extension set. That is to say, in some embodiments, and of the stabilization devices described herein can be configured for use with a commercially available extension set. In other embodiments, any of the stabilization devices described herein can be configured for use with a custom extension set and/or an extension set configured for specific use with the stabilizer devices described herein. Accordingly, it should be understood, that the term “extension set” is provided by way of example only and not limitation.

As used in this specification, the words “proximal” and “distal” refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient. Thus, for example, the end of a device first touching the body of the patient would be the distal end, while the opposite end of the device (e.g., the end of the device being manipulated by the user) would be the proximal end of the device. Moreover, the terms “proximal” and “distal” when referring to a position of a construct or the like can be used to describe, for example, a relative position the construct so described. For example, a first portion of a device can be said to be in a distal position relative to second portion of the device when the position of the first portion of the device is further from the user of the device than the position of the second portion of the device.

FIGS. 1 and 2are schematic illustrations of a stabilization device100according to an embodiment. The stabilization device100is configured to be placed in contact with the skin of a patient at or near an insertion site of an indwelling or placed vascular access device (VAD) such as those described above. The stabilization device100is configured to couple to and/or otherwise engage the VAD and/or a device coupled to the VAD. Once coupled to the VAD and/or the device coupled to the VAD, the stabilization device100can be secured to the skin of the patient, which in turn, secures and/or stabilizes at least a portion of the VAD relative to the patient, as described in further detail herein.

The stabilization device100can be any suitable shape, size, and/or configuration. As shown inFIGS. 1 and 2, the stabilization device100has a proximal end portion102and a distal end portion106, and has a base surface108and a coupling surface112. The proximal end portion102has a proximal surface104that has a predetermined and/or desired shape. For example, in some embodiments, the proximal surface104can be angled, tapered, flared, curved, rounded, and/or the like. As described in further detail herein, the arrangement and/or shape of the proximal surface104can facilitate the coupling or securing of the stabilization device100to the skin of the patient (e.g., via medical tape or the like).

The base surface108can be any suitable shape and/or configuration. For example, the base surface108can have a contour and/or shape that is generally concave. In some embodiments, the concave contour and/or shape can be based at least in part on a curvature and/or shape of a portion of the patient's anatomy. For example, in some embodiments, the base surface108can have a contour and/or shape that is based at least in part on a general contour and/or curvature of a patient's hand or forearm (or other suitable IV insertion site). In some embodiments, forming the contour and/or shape of the base surface108to be similar to and/or at least partially based on the curvature of an IV insertion site of the patient can, for example, increase a surface area of the base surface108that is in contact with the skin of the patient, which in turn, can increase the stability of the stabilization device100when secured to the skin of the patient, as described in further detail herein.

As shown inFIG. 1, the base surface108defines a recess110(e.g., a notch, indentation, cutout, etc.) that extends along the base surface108in the direction of a longitudinal axis of the stabilization device100. In other words, the recess110extends along the base surface108in a proximal-distal direction. In some embodiments, the recess110extends along the base surface108through the proximal end portion102and through the distal end portion106(e.g., along the length L of the base surface108(FIG. 2)). In some embodiments, when the base surface108of the stabilization device100is placed in contact with the skin of the patient, the recess110can be spaced apart from the skin of the patient (e.g., not in contact with the skin of the patient). In other embodiments, the base surface108including the recess110can be in contact with the skin of the patient.

The stabilization device100is configured to be placed in a position along the skin of the patient such that the recess110is aligned with and/or otherwise disposed over a vein of the patient. In some instances, the stabilization device100can be placed on the skin of the patient at or near an insertion site (also referred to as a “target location”) of, for example, an IV catheter. More specifically, the stabilization device100is configured to be positioned on the skin of the patient such that the recess110is disposed over the vein in which the VAD (e.g., the indwelling IV catheter, arterial catheter, or the like) is disposed. In some instances, such an arrangement can reduce an amount of force exerted by the base surface108on the vein, which might otherwise result in a reduced flow rate through at least a portion of the vein. For example, in embodiments in which the recess110is spaced apart from the skin of the patient, the stabilization device100does not (or substantially does not) exert a force on the vein in which the VAD is disposed. In other embodiments (e.g., when the recess110is in contact with the skin of the patient), a force exerted on by the recess110on the vein in which the VAD is disposed can be less than a force exerted by other portions of the base surface108(e.g., non-recess portions) on or near an area of the patient surrounding the vein.

The coupling surface112of the stabilization device100can be any suitable shape, size, and/or configuration. In some embodiments, the coupling surface112can form a contour or shape that is at least partially based on a shape of a vascular access device (VAD)150(or a hub thereof) and/or a device coupled to a VAD (e.g., an extension set or the like). In some embodiments, the coupling surface112can be configured to contact and/or engage an outer surface of the VAD150to form and/or define a friction fit therebetween. That is to say, the coupling surface112can have a size and/or shape that is slightly undersized relative to the VAD150to form a friction fit, press fit, interference fit, etc. when the VAD150is in contact with the coupling surface112.

In some embodiments, the shape and/or contour of the coupling surface112can be configured to dispose the VAD150at a predetermined, predefined, and/or otherwise desired angle relative to the skin of the patient at or near the insertion site of the VAD150. For example, in some embodiments, the coupling surface112can be angled such that a height of the coupling surface112at or near the proximal end portion102is greater than a height of the coupling surface112at or near the distal end portion106. In some embodiments, the coupling surface112of the stabilization device100can be arranged to secure the VAD150at any suitable angle based at least in part on an angle of insertion of, for example, the VAD150or a catheter thereof. For example, in some embodiments, the coupling surface112can be configured to dispose the VAD150at an angle that can minimize a risk or likelihood of the VAD150(e.g., a catheter of the VAD150) becoming kinked.

As described above, the stabilization device100can be used to secure, for example, a device coupled to a vascular access device. By way of example, in some embodiments, the stabilization device100can be configured to couple to and/or secure an IV extension set, which in turn is coupled to an indwelling or placed intravenous catheter. Although not shown inFIGS. 1 and 2, in such embodiments, the coupling surface112can have a shape and/or contour that is configured and/or suitable for use with a dual port extension set such as a Y-shaped extension set, T-shaped extension set, and/or the like. For example, in some embodiments, the coupling surface112can have a side channel or the like configured to receive one of the ports of such an extension set (e.g., a side port of a T-shaped extension set). In some embodiments, the side channel or the like can be configured to extend substantially perpendicularly relative to the coupling surface112and/or the other portions of the coupling surface112.

As described above, the stabilization device100is configured to secure and/or stabilize the VAD150to, for example, the skin of a patient. For example, in some instances, an IV catheter (e.g., the VAD150) can be inserted into the hand of a patient such that (1) a portion of the IV catheter is disposed within a vein and (2) a hub of the IV catheter is disposed outside of the patient. In some instances, an extension set (e.g., a T-adapter, Y-adapter, and/or the like) can be coupled to the hub of the IV catheter. With the extension set coupled to the IV hub, a user (e.g., a doctor, nurse, technician, physician, surgeon, and/or other medical professional) can manipulate the stabilization device100by placing a portion of the extension set (e.g., represented inFIGS. 1 and 2as the VAD150) in contact with the coupling surface112of the stabilization device100. As described above, the coupling surface112can be configured to form a friction fit and/or the like with the portion of the extension set to couple the extension set to the stabilization device100. Although the extension set is described above as being coupled to the IV hub prior to being coupled to the stabilization device100, in other embodiments, the stabilization device100can be placed in a desired position and/or the extension set can be coupled to the stabilization device100prior to coupling the extension set to the IV hub.

Once the stabilization device100is coupled to the extension set, the stabilization device100can be positioned on the skin of the patient (e.g., at or near the insertion site). In this example, the IV catheter is inserted into the hand of the patient and thus, the stabilization device100is position relative to the hand of the patient. Thus, the base surface108of the stabilization device100can be placed in contact with the skin of the patient at or near the insertion site (e.g., the site at which the VAD150or IV catheter enters the patient). In some instances, the stabilization device100can be adjusted and/or positioned such that the recess110is aligned with and/or otherwise disposed about or over the vein in which the IV catheter is disposed, as described above.

Having coupled the stabilization device100to the extension set and having placed the stabilization device100in the desired position at or near the insertion site, the user can secure the stabilization device100to the patient. In some embodiments, the user can secure the stabilization device100via medical tape or the like. For example, a user can remove a strip of medical tape from a roll of medical tape (e.g., a first strip of medical tape) and can apply the strip of medical tape to the proximal surface104of the stabilization device100(not shown inFIGS. 1 and 2) such that a first portion of the medical tape is adhered to the proximal surface104and a second portion of the medical tape is adhered to the skin of the patient. In some instances, the user can substantially center the medical tape relative to the proximal surface104. As described above, the proximal surface104can have a shape, size, and/or configuration that facilitates the securement of the stabilization device100. For example, in some embodiments, the proximal surface104can be angled and/or can have a relatively curved contour or the like such that when the user applies the medical tape to the proximal surface104, the tape curves, bends, conforms, and/or otherwise forms a shape and/or follows a path that is at least partially based on the shape of the proximal surface104. As described in further detail herein, in some embodiments, the arrangement of the proximal surface104can be such that end portions of the tape are adhered to the skin of the patient and positioned distal to the proximal surface104.

In some instances, the user can remove a second strip of medical tape (not shown inFIGS. 1 and 2) from the roll of medical tape and can apply the second strip of medical tape transversely across a portion of the stabilization device100and the VAD150. In some instances, the user can apply the second strip of medical tape such that a first end portion of the medical tape is adhered to a portion of the patient's skin on a first side of the stabilization device100; a second end portion of the medical tape is adhered to a portion of the patient's skin on a second side of the stabilization device100substantially opposite the first side of the stabilization device100; and a medial portion (e.g., between the first end portion and the second end portion) is adhered to at least one of the stabilization device100or the VAD150. Moreover, the first end portion of the second strip of medical tape can at least partially overlap a first end portion of the first strip of medical tape and the second end portion of the second strip of medical tape can at least partially overlap a second end portion of the first strip of medical tape.

Although the first strip of medical tape and the second strip of tape are described as being applied in a specific order, it should be understood that the strips of medical tape can be applied to the stabilization device100and the VAD150in any suitable order. For example, in some instances, the user can apply the second strip of medical tape transversely across the portion of the stabilization device100and the VAD150(as described above) and then can apply the first strip of medical tape to the proximal surface104of the stabilization device100(as described above). Thus, in such instances, a portion of the first strip of medical tape overlaps a portion of the second strip of medical tape.

Securing the stabilization device100to the skin of the patient (e.g., via the medical tape) results in the stabilization device100and/or the medical tape securing, stabilizing, and/or substantially immobilizing the VAD150relative to the patient. That is to say, the arrangement of the stabilization device100is such that securing the stabilization device100and the VAD150to the skin of the patient can reduce and/or substantially prevent movement of the VAD150or at least an IV catheter thereof relative to the vein in which the IV catheter is at least partially disposed, as described in further detail herein with respect to a specific embodiment. Moreover, the arrangement of the recess110along the base surface108can reduce and/or can substantially eliminate a force otherwise exerted on the vein in which the VAD150(e.g., IV catheter or the like) is disposed.

FIGS. 3-9illustrate a stabilization device200according to an embodiment. As described above with reference to the stabilization device100, the stabilization device200is configured to be placed in contact with the skin of a patient at or near an insertion site of an indwelling or placed vascular access device (VAD). The stabilization device200is configured to couple to and/or otherwise engage the VAD and/or a device coupled to the VAD (e.g., an extension set). Once coupled to the VAD and/or the device coupled to the VAD, the stabilization device200can be secured to the skin of the patient, which in turn, secures and/or stabilizes at least a portion of the VAD relative to the patient, as described in further detail herein.

The stabilization device200can be any suitable shape, size, and/or configuration. For example, in some embodiments, the stabilization device200can have a size and/or shape that is based at least in part on a size and/or shape of the VAD to be stabilized. In some embodiments, the size and/or shape of the stabilization device200can facilitate ease of use, for example, by simplifying a process of securing the stabilization device200to the skin of a patient. In some embodiments, the size and/or shape of the stabilization device200can increase ergonomics, grip, and/or the like. For example, in some embodiments, the stabilization device200and/or a portion thereof can allow a user maintain a secure grip on the stabilization device200as the user couples (or decouples) one or more devices to a VAD, an extension set, and/or any other suitable device being stabilized. In some instances, maintaining a secure grip during such a coupling or decoupling process can limit a force exerted on the stabilization device200that may otherwise be sufficient to move the stabilization device200relative to a target location on the patient (e.g., an IV catheter insertion site). In other words, the size and/or shape of the stabilization device200can allow it to stabilize, secure, and/or substantially immobilize a VAD coupled thereto as the user couples or decouples a device (e.g., a fluid transfer device or the like) to the VAD.

As shown inFIGS. 3-6, the stabilization device200has a proximal end portion202and a distal end portion206, and has a base surface208and a coupling surface212. In general, the coupling surface212is configured to receive, retain, and/or otherwise couple to an extension set260such as, for example, a T-adapter or T-connector, which in turn is coupled to an indwelling or placed VAD. In this embodiment, the indwelling or placed VAD can be, for example, an IV catheter250(see e.g.,FIGS. 7-9). The base surface208is configured to be placed in contact with the skin of a patient in a predetermined and/or desired manner at or near an insertion site of the IV catheter250or the like (also referred to herein as a “target location”). Once the stabilization device200is coupled to the extension set260and the base surface208is in contact with the skin of the patient at or near the insertion site, the stabilization device200(and the extension set260) can be secured to the skin of the patient (see e.g.,FIGS. 7 and 8) to secure and/or stabilize at least a portion of the IV catheter250relative to the patient and/or the vein in which the IV catheter250is disposed, as described in further detail herein.

The proximal end portion202has a proximal surface204that has a predetermined and/or desired shape. For example, the proximal surface204can be angled, tapered, flared, curved, rounded, and/or the like. In the embodiment shown inFIGS. 3-9, the proximal surface204can have a rounded, curved, parabolic, and/or substantially bell-shaped perimeter. Moreover, the proximal end portion202and/or the proximal surface204can include a set of extensions205(e.g., feet, tabs, pads, protrusions, etc.) that extend transversely away from a center of the stabilization device200. As described in further detail herein, the arrangement and/or shape of the proximal surface204and/or the extensions205can facilitate the coupling or securing of the stabilization device200to the skin of the patient (e.g., via medical tape or the like).

The base surface208can be any suitable shape and/or configuration. For example, as shown inFIGS. 4 and 5, the base surface208can have a contour and/or shape that is generally concave. In some embodiments, the concave contour and/or shape can be based at least in part on a curvature and/or shape of a portion of the patient's anatomy. For example, in some embodiments, the base surface208can have a contour and/or shape that is based at least in part on a general contour and/or curvature of a patient's hand or forearm (or other suitable insertion site and/or target location). In some embodiments, forming the contour and/or shape of the base surface208to be similar to and/or at least partially based on the curvature of target location of the patient can, for example, increase a surface area of the base surface208that is in contact with the skin of the patient, which in turn, can increase the stability of the stabilization device200when secured to the skin of the patient, as described in further detail herein.

As shown inFIGS. 4 and 5, the base surface208defines a recess210(e.g., a notch, indentation, cutout, etc.) that extends along the base surface208in the direction of a longitudinal centerline of the stabilization device200. In other words, the recess210extends along the base surface208in a proximal-distal direction. In some embodiments, the recess210extends along the base surface208through the proximal end portion202and through the distal end portion206, as described above with reference to the stabilization device100shown inFIG. 2. In some embodiments, the recess210can have and/or can form a curved cross-sectional shape with a constant or a variable radius of curvature. For example, in some embodiments, the recess210can have and/or can form a parabolic cross-sectional shape. In other embodiments, the recess210can have and/or can form any suitable cross-sectional shape such as, for example, a V-shape, a U-shape, a W-shape, and/or any other suitable cross-sectional shape. In some embodiments, the size and/or shape of the recess210can be substantially constant along a length of the stabilization device200. In other embodiments, the size and/or shape of the recess210can vary along the length of the stabilization device200. For example, in some embodiments, the recess210can be tapered, decreasing in size and/or shape from a first size at the proximal end portion202to a second size at the distal end portion206(or vice versa).

The stabilization device200is configured to be placed in a position along the skin of the patient such that the recess210is aligned with and/or otherwise disposed over the vein in which the IV catheter250is disposed. In some embodiments, when the base surface208of the stabilization device200is placed in contact with the skin of the patient, the recess210can be spaced apart from the skin of the patient (e.g., not in contact with the skin of the patient). In other embodiments, the base surface208including the recess210can be in contact with a portion of the skin of the patient. In some embodiments, the recess210can have a height (or depth) and a width that are each larger than a diameter of the vein in which the IV catheter250is to be disposed. In other words, a size and/or shape of the recess210can be based at least in part on a size and/or shape of a vein over which the stabilization device200is disposed. For example, in some embodiments, the recess210can have a height or depth that is approximately 0.5 millimeters (mm) to approximately 3.0 mm and a width that is approximately 5.0 mm to approximately 40.0 mm. As one example, a recess210can have a height or depth that is approximately 2.0 mm and a width that is approximately 20 mm.

While the recess210is particularly shown in, for example,FIGS. 4 and 5, in some embodiments, the recess210can have any suitable size and/or shape. In some embodiments, the size and/or shape of the recess210can account for variations in vein size, shape, and/or path. For example, in some instances, a vein in which the IV catheter250is disposed can have one or more branch vessels coupled thereto, can extend in a non-linear or curved path, can extend at an angle, and/or otherwise can vary in size, shape, and/or arrangement between patients. As such, the recess210can have a width that is sufficiently large to allow the recess210to be disposed over a vein that can vary in size, shape, and/or arrangement. In some embodiments, for example, the recess210can have a width that is slightly smaller than a width of the base surface208. In such embodiments, a relatively thin portion of the base surface208can be disposed on opposite sides of the recess210. In other embodiments, the base surface208can include two parallel or substantially parallel protrusions, bumps, ridges, rails, etc. that that collectively define a space therebetween. In such embodiments, the portion of the base surface208disposed between the two protrusions or the like can form and/or can function similar to the recess210.

In some embodiments, forming and/or defining the recess210to be larger (e.g., in height and/or width) than the vein in which the IV catheter250is disposed can, for example, reduce an amount of force that would otherwise be exerted by the base surface208on the vein. In some instances, such a force exerted by the base surface208on the vein may be sufficient to reduce a flow of blood within the vein. In some specific instances, such a reduction in flow may negatively impact the ability to withdraw blood from the vein and/or may impede the delivery of fluids into the vein. Accordingly, forming the recess210in the base surface208is such that the stabilization device200does not (or substantially does not) exert a force on the vein in which the IV catheter250is disposed, thereby allowing the stabilization device200to secure and stabilize the IV catheter250without substantially impeding a flow of fluid through the vein.

While the recess210is described above as being configured to reduce and/or substantially remove a force exerted on the vein in which the IV catheter250is disposed, in some embodiments, the recess210can allow for movement and/or reconfiguration of a portion of the patient while continuing to provide stabilization to or for the IV catheter250. For example, in some embodiments, an IV catheter (e.g., the IV catheter250) can be inserted into a patient's cephalic or basilic vein and a stabilization device200(e.g., the stabilization device200) can be secured to the patient's antecubital fossa region. In some instances, bending of the patient's arm (e.g., at the elbow) can result in a change in tension, stress, and/or strain of the skin both in a circumferential direction and an axial direction along the patient's arm. In some instances, such a change in tension or the like can result in a bunching or bulging of skin at or near the antecubital fossa region. In some instances, such a bunching or bulging of skin can result in undesired lifting or movement of a stabilization device relative to an IV insertion site, which in turn, can result in undesired movement, bending, kinking, etc. of the IV catheter disposed in the vein.

In some embodiments, however, the arrangement of the recess210of the stabilization device200can allow at least a portion of the skin to bunch or bulge in a space defined by the recess210, thereby at least partially filling the void of the recess210and reducing and/or substantially preventing undesired lifting or movement of the stabilization device200. In other words, in some instances, the arrangement of the stabilization device200can be such that the stabilization device200stabilizes, secures, and/or substantially immobilizes the IV catheter250despite at least some movement of the patient. Moreover, in some embodiments, the recess210can extend along the width of the stabilization device200such that only the edges of the base surface208and/or only protrusions extending from the base surface208are in contact with the skin. In such embodiments, this arrangement can allow the skin to shift and stretch axially underneath and to either side of the stabilization device200as shear forces are applied by movement of the skin, thereby reducing the amount of force that can otherwise result in lateral movement of the stabilization device200relative to the insertion site and/or target location.

The coupling surface212of the stabilization device200can be any suitable shape, size, and/or configuration. In the embodiment shown inFIGS. 3-9, the coupling surface212can form a contour or shape that is at least partially based on a shape of the extension set260. In some embodiments, the coupling surface212can be configured to contact and/or engage an outer surface of the extension set260to form and/or define a friction fit therebetween. That is to say, the coupling surface212can have a size and/or shape that is slightly undersized relative to the extension set260to form a friction fit, press fit, interference fit, etc. when the extension set260is in contact with the coupling surface212.

In the embodiment shown inFIGS. 3-9, the coupling surface212can be configured to receive and/or couple to a T-shaped adapter or connector (e.g., the extension set260). For example, the coupling surface212includes a distal notch214and one or more side channels216. The distal notch214formed by and/or along the coupling surface212can be configured to accommodate a distal locking mechanism262(e.g., a Luer Lok®) of the extension set260. For example, in some embodiments, the extension set260(e.g., the T-adapter) can include a rotatable lock at a distal end portion thereof that is configured to physically and fluidically couple the extension set260to the IV catheter250. Accordingly, the distal notch214can provide sufficient space for a user to grasp and rotate the rotatable lock to couple or decouple the distal locking mechanism262of the extension set260to or from the IV catheter250. Moreover, the extension set260can couple to the coupling surface212such that a proximal locking mechanism261of the extension set260is proximal to the proximal surface204of the stabilization device200, as shown inFIG. 7. In some embodiments, such an arrangement can facilitate the coupling or decoupling of one or more devices (e.g., a fluid transfer device, syringe, fluid reservoir, etc.) to or from the proximal locking mechanism261of the extension set260.

The one or more side channels216of the stabilization device200can be any suitable shape, size, and/or configuration. In the embodiment shown inFIGS. 3-9, the stabilization device200includes two side channels216, with one side channel216on opposite sides of the stabilization device200and extending in a perpendicular and/or transverse direction relative to, for example, a longitudinal centerline C of the stabilization device200(see e.g.,FIG. 6). At least one of the side channels216is configured to receive a side port263of the extension set260(see e.g.,FIG. 7). For example, in the embodiment shown inFIGS. 3-9, the extension set260is a dual port extension set having a “T” configuration in which the side port263is substantially perpendicular to a longitudinal axis A defined between the proximal locking mechanism261and the distal locking mechanism262(see e.g.,FIG. 7). Accordingly, when the extension set260is coupled to the coupling surface212, the longitudinal centerline C of the stabilization device200and the longitudinal axis A defined by the extension set260are aligned and/or substantially coaxial and the side port263of the extension set260can be placed in contact with, disposed in, and/or extend through the side channel216on a left side of the stabilization device200or on a right side of the stabilization device200.

In some embodiments, the arrangement of the coupling surface212and the extension set260can be such that the extension set260is placed in contact with the coupling surface212and rotated into a position in which the side port263is disposed in one of the side channels216. In some embodiments, a portion of the coupling surface212that forms and/or defines the side channels212can form a snap or press fit with at least a portion of the side port263of the extension set260. Moreover, in use, the side port263of the extension set260is typically coupled to a flexible tubing265(see e.g.,FIG. 7) or the like and, as such, the side channels216can be configured to allow the coupling of the flexible tubing265to the side port263of the extension set260without resulting in undue bending or kinking of the flexible tubing265.

In some embodiments, the shape and/or contour of the coupling surface212can be configured to place and/or maintain a VAD (e.g., the IV catheter250) at a predetermined, predefined, and/or otherwise desired angle relative to the skin of the patient at or near the insertion site of the IV catheter250(or target location). For example, in some embodiments, the coupling surface212can be angled such that a height of the coupling surface212at or near the proximal end portion202is greater than a height of the coupling surface212at or near the distal end portion206. In some embodiments, the coupling surface212can be configured to receive, couple to, and/or secure the IV catheter250at an angle between, for example, about 3° and about 15° relative to the skin of the patient at the insertion site. Specifically, in some embodiments, the coupling surface212can be configured to receive, couple to, and/or secure the IV catheter250at an angle of about 10°, about 8°, about 6°, or less. In some embodiments, the coupling surface212of the stabilization device200can be arranged to secure the IV catheter250at any suitable angle based at least in part on an angle of insertion of, for example, the IV catheter. For example, in some embodiments, the coupling surface212can be configured to place and/or maintain the IV catheter250at an angle that can minimize a risk or likelihood of the IV catheter250becoming kinked (e.g., at the IV catheter insertion site or skin entry).

In some embodiments, the stabilization device200can be configured to secure the IV catheter250at an angle that is based at least in part on an IV insertion site. For example, in some embodiments, a stabilization device can be configured to secure an IV catheter at a first angle when the IV catheter is inserted into, for example, the antecubital fossa and a second angle, different from the first angle, when the IV catheter is inserted into, for example, the hand. In such embodiments, the stabilization device200can include an indicator and/or can have a color or the like configured provide an indication to a user associated with the intended use or intended insertion site.

As shown inFIGS. 7-9, the stabilization device200is configured to secure and/or stabilize the IV catheter250relative to, for example, a target location of a patient. For example, in some instances, the IV catheter250can be inserted into the hand of a patient (e.g., at or along a target location) such that (1) a portion of the IV catheter250is disposed within a vein (insertion of the IV catheter250is not shown inFIGS. 7-9) and (2) a hub of the IV catheter250is disposed outside of the patient. In some instances, the extension set260(e.g., the T-adapter) can be physically and fluidically coupled to the hub of the IV catheter250.

With the extension set260coupled to the IV hub, a user (e.g., a doctor, nurse, technician, physician, surgeon, and/or other medical professional) can manipulate the stabilization device200by placing a portion of the extension set260in contact with the coupling surface212of the stabilization device200. As described above, the coupling surface212can be configured to form a friction fit and/or the like with the portion of the extension set260to couple the extension set260to the stabilization device200. As shown, for example, inFIG. 7, the extension set260can be coupled to the coupling surface212of the stabilization device200such that the distal locking mechanism262or the like of the extension set260is at least partially disposed in and/or otherwise aligned with the distal notch214. As described above, such an arrangement can allow the user to engage the distal locking mechanism262to couple the extension set260to or decouple the extension set260from the IV catheter250. In addition, the side port263of the extension set260is positioned within one of the side channels216(see e.g.,FIG. 7) such that the flexible tubing265coupled to the side port263can extend out of the side channel216. Accordingly, the side port263of the extension set260can be used to deliver fluid to or withdraw fluid from the vein in which the IV catheter250is disposed. Furthermore, the proximal port or locking mechanism261of the extension set260can be disposed in a proximal position relative to the proximal surface204when the extension set260is coupled to the coupling surface212. In this manner, any suitable device can couple to the proximal port or locking mechanism261to deliver fluids to, withdraw fluids from, and/or otherwise gain access to the vein in which the IV catheter250is disposed.

Once the stabilization device200is coupled to the extension set260, the stabilization device200can be positioned on the skin of the patient (e.g., at or near the insertion site or target location). In this example, the IV catheter250is inserted into the hand of the patient and thus, the stabilization device200is positioned relative to the hand of the patient. Thus, the base surface208of the stabilization device200can be placed in contact with the skin of the patient at or near the insertion site of the IV catheter250and/or otherwise at or near a target location of the patient. As described above, the stabilization device200can be adjusted and/or positioned such that the recess210is aligned with and/or otherwise disposed about or over the vein in which the IV catheter250is disposed. In this manner, securing the stabilization device200to the skin of the patient does not result in the base surface208exerting a force on the vein that may otherwise be sufficient to occlude and/or restrict flow through the vein.

Having coupled the stabilization device200to the extension set260and having placed the stabilization device200in the desired position at or near the insertion site (e.g., such that the recess210is aligned with or disposed over the vein in which the IV catheter250is disposed), the user can secure the stabilization device200to the patient. In some embodiments, the user can secure the stabilization device200via medical tape or the like, as shown, for example, inFIGS. 8 and 9. More particularly, in some instances, a user can remove a first strip of medical tape232from a roll of medical tape and can apply the first strip of medical tape232to the proximal surface204of the stabilization device200such that a first portion of the medical tape is adhered to the proximal surface204and a second portion of the medical tape is adhered to the skin of the patient. For example, in some instances, the user can place the first strip of the medical tape232such that a first portion of the width of the first strip232overlays and/or is adhered to the proximal surface204of the stabilization device200while a second portion of the width of the first strip232overlays and/or is adhered to the skin of the patient, as shown inFIGS. 8 and 9.

As described above, the proximal surface204can have a shape, size, and/or configuration that facilitates the securement of the stabilization device200. For example, in some embodiments, the proximal surface204can be angled and/or can have a relatively curved contour or the like such that when the user applies the first strip of medical tape232to the proximal surface204, the tape curves bends, conforms, and/or otherwise forms a shape and/or follows a path that is at least partially based on the shape of the proximal surface204. As shown inFIGS. 8 and 9, the shape and/or configuration of the proximal surface204is such that a portion of the first strip of medical tape overlays and/or is adhered to the extensions205. Moreover, the arrangement of the proximal surface204and/or the extensions205is such that the first strip of medical tape232curves and/or bends such that end portions of the first strip232are adhered to the skin of the patient and positioned distal to, for example, a medial or middle portion of the first strip232, as indicated by the arrows AA inFIGS. 8 and 9.

After securing the first strip of medical tape232, the user can remove a second strip of medical tape234from the roll of medical tape and can apply the second strip of medical tape234transversely across a portion of the stabilization device200and the IV catheter250, as indicated by the arrows BB inFIGS. 8 and 9. As shown, the user can apply the second strip of medical tape234such that a first end portion of the second strip of medical tape234is adhered to a portion of the patient's skin on a first side of the stabilization device200; a second end portion of the second strip of medical tape234is adhered to a portion of the patient's skin on a second side of the stabilization device200substantially opposite the first side of the stabilization device200; and a medial or middle portion (e.g., between the first end portion and the second end portion) is adhered to at least one of the stabilization device200or the IV catheter250. Moreover, the first end portion of the second strip of medical tape234can at least partially overlap a first end portion of the first strip of medical tape232and the second end portion of the second strip of medical tape234can at least partially overlap a second end portion of the first strip of medical tape232, as shown inFIGS. 8 and 9. In some embodiments, positioning a portion of the second strip of medical tape234over a portion of the first strip of medical tape232can enhance the adhesion of at least one of the first strip232or the second strip234. In other words, positioning a portion of the second strip of medical tape234over a portion of the first strip of medical tape232can reduce a likelihood of the portion of the first strip of medical tape232from working loose, decoupling, and/or otherwise breaking the adhesive bond.

As described above, securing the stabilization device200to the skin of the patient (e.g., via the strips of medical tape232and234) results in the stabilization device200and/or the medical tape securing, stabilizing, and/or substantially immobilizing the IV catheter250relative to the patient. That is to say, the arrangement of the stabilization device200is such that securing the stabilization device200and the IV catheter250to the skin of the patient can reduce and/or substantially prevent movement of the IV catheter250or at least an IV catheter thereof relative to the vein in which the IV catheter is at least partially disposed, as described in further detail herein with respect to a specific embodiment. Moreover, the arrangement of the recess210along the base surface208is such that securing and/or adhering the stabilization device200to the skin of the patient does not exert a force on the vein in which the IV catheter250is disposed, thereby reducing and/or substantially eliminating any obstruction and/or restriction otherwise resulting from such a force.

While the stabilization device200is described above with reference toFIGS. 7-9as being secured to the skin of a patient via, for example, two strips of medical tape, it should be understood that the stabilization device200can be secured to the skin of the patient in any suitable manner. For example, although not shown, in some embodiments, the stabilization device200can be secured to the skin via a transparent dressing or the like such as, for example, Tegaderm™ and/or the like. In such instances, the transparent dressing can include an adhesive or the like disposed around the perimeter of the dressing or along one or more edges of the dressing. In some embodiments, the transparent dressing can be sized and/or shaped for use with the stabilization device200. For example, the transparent dressing can have a size or shape that allows the dressing to cover at least the IV insertion site while allowing access to, for example, a proximal port of the extension set260or the IV catheter250(e.g., similar to the medical tape shown inFIGS. 8 and 9). In some instances, multiple methods of securing the stabilization device200to the skin can be used such as, for example, a combination of transparent dressing and medical tape, and/or any other suitable method of securement (such as an adhesive or the like).

FIGS. 10-15illustrate a stabilization device300according to an embodiment. As described above with reference to the stabilization devices100and/or200, the stabilization device300is configured to be placed in contact with the skin of a patient at or near an insertion site of an indwelling or placed vascular access device (VAD). The stabilization device300is configured to couple to and/or otherwise engage the VAD and/or a device or adapter coupled to the VAD (e.g., an extension set). Once coupled to the VAD and/or the device or adapter coupled to the VAD, the stabilization device300can be secured to the skin of the patient, which in turn, secures and/or stabilizes at least a portion of the VAD relative to the patient, as described in further detail herein.

The stabilization device300can be any suitable shape, size, and/or configuration. For example, in some embodiments, the stabilization device300can have a size and/or shape that is based at least in part on a size and/or shape of the VAD to be stabilized. In some embodiments, the size and/or shape of the stabilization device300can facilitate ease of use, for example, by simplifying a process of securing the stabilization device300to the VAD, the device or adapter coupled to the VAD, and/or the skin of a patient. In some embodiments, the size and/or shape of the stabilization device300can increase ergonomics, grip, and/or the like. For example, in some embodiments, the stabilization device300and/or a portion thereof can allow a user maintain a secure grip on the stabilization device300as the user couples (or decouples) one or more devices to a VAD, an extension set, and/or any other suitable device being stabilized, as described above with reference to the stabilization device200. In some embodiments, aspects and/or portions of the stabilization device300can be substantially similar to corresponding aspects and/or portions of the stabilization device200. Accordingly, such aspects and/or portions of the stabilization device300are not described in further detail herein.

As shown inFIGS. 10-13, the stabilization device300has a proximal end portion302and a distal end portion306, and has a base surface308and a coupling surface312. In general, the coupling surface312is configured to receive, retain, and/or otherwise couple to an extension set360such as, for example, a T-adapter or T-connector, which in turn is coupled to an indwelling or placed VAD, as described above with reference to the coupling surface212of the stabilization device200. In this embodiment, the indwelling or placed VAD can be, for example, an IV catheter350(see e.g.,FIGS. 14 and 15). The base surface308is configured to be placed in contact with the skin of a patient in a predetermined and/or desired manner at or near an insertion site of the IV catheter350or the like (also referred to herein as a “target location”). Once the stabilization device300is coupled to the extension set360and the base surface308is in contact with the skin of the patient at or near the insertion site, the stabilization device300(and the extension set360) can be secured to the skin of the patient to secure and/or stabilize at least a portion of the IV catheter350relative to the patient and/or the vein in which the IV catheter350is disposed, as described above with reference to the stabilization device200.

The proximal end portion302has a proximal surface304that has a predetermined and/or desired shape. For example, the proximal surface304can be angled, tapered, flared, curved, rounded, and/or the like (see e.g.,FIGS. 10-12). In some embodiments, the proximal surface304can have a rounded, curved, parabolic, and/or substantially bell-shaped perimeter (see e.g.,FIG. 13). Moreover, the proximal end portion302and/or the proximal surface304can include a set of extensions305(e.g., feet, tabs, pads, protrusions, etc.) that extend transversely away from a center of the stabilization device300. In some embodiments, the arrangement and/or shape of the proximal surface304and/or the extensions305can facilitate the coupling or securing of the stabilization device300to the skin of the patient (e.g., via medical tape or the like), as described in detail above with reference to the stabilization device200.

The base surface308can be any suitable shape and/or configuration. For example, as shown inFIGS. 12 and 13, the base surface308can have a contour and/or shape that is generally concave. In some embodiments, the concave contour and/or shape can be based at least in part on a curvature and/or shape of a portion of the patient's anatomy. For example, in some embodiments, the base surface308can have a contour and/or shape that is based at least in part on a general contour and/or curvature of a target location and/or IV insertion site of a patient. For example, as described above with reference to the base surface208of the stabilization device200, in some embodiments, the contour and/or curvature can be based on a shape and/or curve of a patient's hand or forearm (or other suitable insertion site and/or target location).

As shown inFIG. 13, the base surface308defines a recess310(e.g., a notch, indentation, cutout, etc.) that extends along the base surface308in the direction of a longitudinal centerline of the stabilization device300. In other words, the recess310extends along the base surface308in a proximal-distal direction. In some embodiments, the recess310extends along the base surface308through the proximal end portion302and through the distal end portion306, as described above with reference to the stabilization devices100and/or200. In some embodiments, the base surface308and the recess310can be similar to and/or substantially the same as the base surface208and the recess210, respectively, of the stabilization device200. Accordingly, the size, shape, configuration, and/or form of the base surface308and/or the recess310are not described in further detail herein.

As described above with reference to the stabilization device200, the stabilization device300is configured to be placed in a position at or on a target location (e.g., along the skin of the patient at or near an IV insertion site) such that the recess310is aligned with and/or otherwise disposed over the vein in which the IV catheter350is disposed. In some embodiments, when the base surface308of the stabilization device300is placed in contact with the skin of the patient, the recess310can be spaced apart from the skin of the patient (e.g., not in contact with the skin of the patient). In some embodiments, the recess310can have a height (or depth) and a width that are each larger than a diameter of the vein in which the IV catheter350is to be disposed. In other words, a size and/or shape of the recess310can be based at least in part on a size and/or shape of a vein over which the stabilization device300is disposed. As such, the recess310can have a height and/or width that is sufficiently large to allow the recess310to be disposed over and/or above or about a vein that can vary in size, shape, and/or arrangement. Moreover, forming and/or defining the recess310to be larger (e.g., in height and/or width) than the vein in which the IV catheter350is disposed can, for example, reduce an amount of force that would otherwise be exerted by the base surface308on the vein and/or can allow for movement and/or reconfiguration of a portion of the patient while continuing to provide stabilization to or for the IV catheter350, as described in detail above with reference to the stabilization device200.

The coupling surface312of the stabilization device300can be any suitable shape, size, and/or configuration. In the embodiment shown inFIGS. 10-15, the coupling surface312can form a contour or shape that is at least partially based on a shape of the extension set360. In some embodiments, the coupling surface312can be configured to contact and/or engage an outer surface of the extension set360to form and/or define a friction fit therebetween. That is to say, at least a portion of the coupling surface312can have a size and/or shape that is slightly undersized relative to a corresponding portion of the extension set360to form a friction fit, press fit, interference fit, etc. when the extension set360is in contact with the coupling surface312.

In some embodiments, the coupling surface312can be configured to receive and/or couple to a T-shaped adapter or connector (e.g., the extension set360), which in turn is coupled to a VAD (e.g., the IV catheter350). As such, the stabilization device300can be configured to stabilize, support, and/or secure the VAD or IV catheter350when the coupling surface312is placed in contact with the T-shaped adapter, connector, and/or extension set360. In some embodiments, the shape and/or contour of the coupling surface312can be configured to place and/or maintain a VAD (e.g., the IV catheter350) at a predetermined, predefined, and/or otherwise desired angle relative to the skin of the patient at or near the insertion site of the IV catheter350(or target location). For example, in some embodiments, the coupling surface312can be angled such that a height of the coupling surface312at or near the proximal end portion302is greater than a height of the coupling surface312at or near the distal end portion306. In some embodiments, the coupling surface312can be configured to receive, couple to, and/or secure the IV catheter350at an angle between, for example, about 3° and about 15° relative to the skin of the patient at or near the insertion site. In some embodiments, the coupling surface312of the stabilization device300can be arranged to secure the IV catheter350at any suitable angle based at least in part on an angle of insertion of, for example, the IV catheter350and/or the insertion site of the patient, as described in detail above with reference to the stabilization device200.

As shown, for example, inFIG. 12, the coupling surface312includes a distal notch314, one or more side channels316, and one or more protrusions318. The distal notch314formed by and/or along the coupling surface312can be configured to accommodate a distal locking mechanism362(e.g., a Luer Lok®) of the extension set360. For example, in some embodiments, the extension set360(e.g., the T-adapter) can include a rotatable lock at a distal end portion thereof that is configured to physically and fluidically couple the extension set360to the IV catheter350. Accordingly, the distal notch314can provide sufficient space for a user to grasp and rotate the rotatable lock to couple or decouple the distal locking mechanism362of the extension set360to or from the IV catheter350, as described above with reference to the coupling surface212of the stabilizing device200.

The one or more side channels316of the stabilization device300can be any suitable shape, size, and/or configuration. In the embodiment shown inFIGS. 10-15, the stabilization device300includes two side channels316, with one side channel316on opposite sides of the stabilization device300and extending in a perpendicular and/or transverse direction relative to, for example, a longitudinal centerline C of the stabilization device300(see e.g.,FIG. 12). At least one of the side channels316is configured to receive a side port363of the extension set360. For example, as shown inFIGS. 14 and 15, the extension set360can be a dual port extension set having a “T” configuration in which the side port363is substantially perpendicular to a longitudinal axis A defined between the proximal locking mechanism361and the distal locking mechanism362(see e.g.,FIG. 15). Accordingly, when the extension set360is coupled to the coupling surface312, the longitudinal centerline C of the stabilization device300and the longitudinal axis A defined by the extension set360are aligned and/or substantially coaxial and the side port363of the extension set360can be placed in contact with, disposed in, and/or extend through the side channel316on a left side of the stabilization device300or on a right side of the stabilization device300.

In some embodiments, the arrangement of the coupling surface312and the extension set360can be such that the extension set360is placed in contact with the coupling surface312and rotated into a position in which the side port363is disposed in one of the side channels316. In some embodiments, a portion of the coupling surface312that forms and/or defines the side channels312can form a snap or press fit with at least a portion of the side port363of the extension set360. Moreover, in use, the side port363of the extension set360is typically coupled to a flexible tubing365(see e.g.,FIGS. 14 and 15) or the like and, as such, the side channels316can be configured to allow the coupling of the flexible tubing365to the side port363of the extension set360without resulting in undue bending or kinking of the flexible tubing365.

In some embodiments, the one or more protrusions318of the coupling surface312can be arranged and/or configured to ensure the stabilization device300is in a desired orientation and/or is facing a desired direction when the coupling surface312is placed in contact with the extension set360. For example, as shown inFIG. 12, the coupling surface312can include a set of protrusions318that extend from a portion of the coupling surface312that is distal to the side channels316. The set of protrusions318can be any suitable configuration and/or arrangement. For example, while the coupling surface312is shown as including a set of three protrusions318, in other embodiments, the coupling surface312can include any number of protrusions318(e.g., one protrusion, two protrusions, four protrusions, five protrusions, or more). In some embodiments, the protrusions318can be substantially uniform or can have one or more different heights, widths, lengths, etc.

In some embodiments, the protrusions318can be configured to selectively engage a portion of the extension set360such that the coupling surface312is placed in a desired position and/or orientation relative to the extension set360. For example, in some embodiments, the arrangement of the protrusions318can be such that when the distal end portion306of the stabilization device300is aligned with or placed in contact with the distal locking mechanism362, the side port363of the extension set360is aligned with the side channels316. More specifically, when the coupling surface312is placed in contact with the extension set360such that a portion of the distal locking mechanism362is disposed in and/or aligned with the distal notch314defined by the coupling surface312, the side port363of the extension set360is aligned with and capable of being disposed in one of the side channels316, as shown inFIGS. 14 and 15. In other words, when the distal end portion306of the stabilization device300and the distal locking mechanism362are placed in the same orientation (e.g., when the stabilization device300and the extension set360are facing the same direction), the side port363of the extension set360can be positioned in one of the side channels316. Said yet another way, when the distal locking mechanism362is disposed in and/or aligned with the distal notch314defined by the coupling surface312, a position of the side port363along the longitudinal axis A of the extension set360is substantially aligned with a position of the side channels316along the longitudinal centerline C of the stabilization device300, thereby allowing the side port363to be disposed in one of the side channels316.

As described above, the arrangement of the protrusions318can allow and/or can be configured to allow the coupling surface312to be placed in contact with and/or coupled to the extension set360when the stabilization device300is in a desired orientation relative to the extension set. Conversely, the arrangement of the protrusions318can be such that if the stabilization device300is placed in an undesired orientation relative to the extension set360, the contact between the coupling surface312and the extension set360can be limited and/or a coupling therebetween can be limited and/or prevented. For example, in instances in which the distal end portion306of the stabilization device300and the distal locking mechanism362are not aligned the protrusions318can selectively engage a portion of the extension set360, which in turn, results in the side port363of the extension set360being misaligned relative to the side channels316.

In some embodiments, the misalignment between the side port363and the side channels316can limit and/or substantially prevent the coupling surface312from being placed in contact with and/or being coupled to the extension set360, which can provide an indication to a user that the stabilization device300is in an undesirable orientation relative to the extension set360(and/or vice versa). For example, in some instances, the protrusions318can selectively engage a portion of the extension set360to misalign the side port363relative to the side channels316when the stabilization device300and the extension set360are placed in opposite directions and/or orientations. More particularly, the protrusions318can selectively engage a portion of the extension set360to misalign the side port363relative to the side channels316when the coupling surface312of the stabilization device300is at least partially placed in contact with the extension set360such that the proximal locking mechanism361of the extension set360is aligned with and/or at least partially disposed in the distal notch314defined by the coupling surface312. Said another way, when the proximal locking mechanism361of the extension set360is disposed in and/or aligned with the distal notch314defined by the coupling surface312, a position of the side port363along the longitudinal axis A of the extension set360is misaligned relative to a position of the side channels316along the longitudinal centerline C of the stabilization device300, which in turn, can limit and/or substantially prevent the side port363from being disposed in one of the side channels316. Put simply, in some embodiments, the protrusions318can limit and/or substantially prevent the stabilization device300from being placed in a desired contact with or coupled to the extension set360while the stabilization device300is in a backwards orientation relative to the extension set360.

As described above with reference to the stabilization device200, the stabilization device300is configured to secure and/or stabilize the IV catheter350relative to, for example, a target location of a patient. For example, in some instances, the IV catheter350can be inserted into the hand of a patient (e.g., at or along a target location) such that (1) a portion of the IV catheter350is disposed within a vein and (2) a hub of the IV catheter350is disposed outside of the patient. In some instances, the extension set360(e.g., the T-adapter) can be physically and fluidically coupled to the hub of the IV catheter350.

With the extension set360coupled to the IV hub, a user (e.g., a doctor, nurse, technician, physician, surgeon, and/or other medical professional) can manipulate the stabilization device300by placing a portion of the extension set360in contact with the coupling surface312of the stabilization device300. As described above, the coupling surface312can be configured to form a friction fit and/or the like with the portion of the extension set360to couple the extension set360to the stabilization device300. Moreover, the arrangement of the protrusions318can be configured to selectively engage the extension set360such that a user can visually inspect whether the stabilization device300and the extension set360are placed in a desired orientation relative each other, as described in detail above. Accordingly, the stabilization device300can be placed in contact with and/or coupled to the extension set360as described in detail above and shown in, for example,FIGS. 14 and 15.

Once the stabilization device300is coupled to the extension set360, the stabilization device300can be positioned on the skin of the patient (e.g., at or near the insertion site or target location). In this example, the IV catheter350is inserted into the hand of the patient and thus, the stabilization device300is positioned relative to the hand of the patient. Thus, the base surface308of the stabilization device300can be placed in contact with the skin of the patient at or near the insertion site of the IV catheter350and/or otherwise at or near a target location of the patient. As described above, the stabilization device300can be adjusted and/or positioned such that the recess310is aligned with and/or otherwise disposed about or over the vein in which the IV catheter350is disposed. In this manner, securing the stabilization device300to the skin of the patient does not result in the base surface308exerting a force on the vein that may otherwise be sufficient to occlude and/or restrict flow through the vein.

Having coupled the stabilization device300to the extension set360and having placed the stabilization device300in the desired position at or near the insertion site (e.g., such that the recess310is aligned with or disposed over the vein in which the IV catheter350is disposed), the user can secure the stabilization device300to the patient. For example, although not shown inFIGS. 14 and 15, in some instances, the user can secure the stabilization device300to the target location of the patient via medical tape or the like. More particularly, in some instances, a user can secure the stabilization device300to the target location of the patient using two strips of medical tape as described in detail above with reference to the stabilization device200andFIGS. 8 and 9. While the stabilization device300is described as being secured to the target location of the patient via, for example, two strips of medical tape, it should be understood that the stabilization device300can be secured to the target location of the patient (e.g., skin of the patient at or near an IV insertion site) in any suitable manner such as those described above with reference to the stabilization device200. Accordingly, the process of securing the stabilization device300to the target location of the patient is not described in further detail herein.

As described above, securing the stabilization device300to the skin of the patient (e.g., via the strips of medical tape332and334) results in the stabilization device300and/or the medical tape securing, stabilizing, and/or substantially immobilizing the IV catheter350relative to the patient. That is to say, the arrangement of the stabilization device300is such that securing the stabilization device300and the IV catheter350to the skin of the patient can reduce and/or substantially prevent movement of the IV catheter350or at least an IV catheter thereof relative to the vein in which the IV catheter is at least partially disposed, as described in further detail herein with respect to a specific embodiment. Moreover, the arrangement of the recess310along the base surface308is such that securing and/or adhering the stabilization device300to the skin of the patient does not exert a force on the vein in which the IV catheter350is disposed, thereby reducing and/or substantially eliminating any obstruction and/or restriction otherwise resulting from such a force.

FIG. 16is a flowchart illustrating a method10of using a stabilization device according to an embodiment. The stabilization device can be any suitable shape, size, and/or configuration. For example, in some embodiments, the stabilization device can be substantially similar to the stabilization devices100,200, and/or300described above. Accordingly, the stabilization device can be used to secure and/or stabilize a vascular access device (VAD) at least partially disposed in a patient. As described above, the VAD can be any suitable device or set of devices. For example, in some embodiments, the VAD can be an IV catheter. In other embodiments, the VAD can be an adapter or connector (e.g., an extension set) coupled to an indwelling or placed IV catheter.

As shown inFIG. 16, the method10includes coupling the stabilization device to the VAD at least partially disposed in a vein of a patient, at11. As described above with reference to the stabilization devices200and/or300, the stabilization device can include a coupling surface (e.g., the coupling surfaces212and/or312) configured to receive and/or couple to a portion of the VAD. For example, in some embodiments, the VAD can include and/or can be an IV catheter that is coupled to an IV extension set or the like. As described above with reference to the stabilization devices200and/or300, the extensions set can be a dual port extension set or adapter having, for example, a T-configuration or the like. In such embodiments, the coupling of the stabilization device to the VAD can include placing the extension set in contact with the coupling surface of the stabilization device such that a side port or the like of the extension set is aligned with and/or in contact with a side channel included in and/or formed by the coupling surface (see e.g.,FIGS. 7, 14, and/or15).

In some embodiments, the coupling surface can include one or more features, protrusions, members, etc. configured to selectively engage a portion of the VAD or adapter if, for example, the stabilization device, VAD, and/or adapter are in an undesirable orientation or the like, as described above with reference to the coupling surface312. For example, in some embodiments, the coupling of the stabilization device to the VAD includes coupling the stabilization device to an extension set, aligning a longitudinal axis of the extension set with a longitudinal centerline of the stabilization device (e.g., such that the longitudinal axis and the longitudinal centerline are co-axial, parallel, and/or otherwise extending in a substantially similar direction), and placing the extension set in contact with the coupling surface of the stabilization device. As described above, when the stabilization device and/or the extension set are in a desired orientation and/or are otherwise facing in the same direction, the side port of the extension set can be aligned with and placed in contact with a side channel of the coupling surface. If, however, the stabilization and/or the extension set are not in a desired orientation and/or are otherwise facing in opposite directions, the features, protrusions, members, etc. of the coupling surface can engage a portion of the extension set, which in turn, can result in the side port of the extension set being misaligned relative to the side channel and thereby, substantially prevented from being placed in contact therewith (as described in detail above with reference to the stabilization device300). In other embodiments, the coupling surface of the stabilization device need not include such a feature or the like.

After coupling the stabilization device to the VAD, the stabilization device is positioned on the skin of the patient (e.g., at a target location) such that a recessed portion formed by a base surface of the stabilization device is aligned with the vein, at12. As described above with reference to the stabilization devices100,200, and/or300, the recessed portion can be configured to reduce and/or substantially prevent the base surface from exerting an undesired force on the vein of the patient when the stabilization device is secured to the skin of the patient. Accordingly, the position of the stabilization device relative to the target location and/or an IV insertion site can be adjusted until the recessed portion is aligned with and/or disposed above or about the vein.

With the stabilization device in the desired position, a first strip of medical tape is applied to a proximal surface of the stabilization device such that each of a first end portion and a second end portion of the first strip of medical tape are in contact with the target location of the patient and are distal to a medial portion of the first strip of medical tape, at13. As described above with reference to the stabilization device200, the first strip of medical tape can be applied to the stabilization device such that a portion of the first strip overlays and/or is adhered to at least a portion of the proximal surface of the stabilization device. In some embodiments, the proximal surface of the stabilization device can have a size and/or shape that is configured to result in a bending or bowing of the first strip of medical tape when it is applied to the proximal surface (e.g., as described above with reference toFIGS. 8 and 9). The bending and/or bowing of the first strip of medical tape, in turn, results in each of the first end portion and the second end portion of the medical tape being secured to the target location of the patient (e.g., to the skin of the patient at or near the IV insertion site) in a distal position relative to the proximal surface of the stabilization device. Moreover, the medial portion of the first strip of medical tape (e.g., a middle portion) is at least partially in contact with the proximal surface of the stabilization device and at least partially in contact with the skin of the patient at or near the target location (see e.g.,FIGS. 8 and 9).

The method10includes applying a second strip of medical tape to a portion of the stabilization device such that the second strip of medical tape partially overlaps at least the first end portion and the second end portion of the first strip of medical tape, at14. For example, as described above with reference toFIGS. 8 and 9, the second strip of medical tape can be applied transversely to the portion of the stabilization device such that a first end portion of the second strip of medical tape is adhered to the skin of the patient and at least partially overlaps the first end portion of the first strip of medical tape; a second end portion of the second strip of medical tape is adhered to the skin of the patient and at least partially overlaps the second end portion of the first strip of medical tape; and a medial or middle portion of the second strip of medical tape is adhered to the portion of the stabilization device and/or to the extension set. Moreover, the portion of the stabilization device is distal to the proximal surface to which the first strip of medical tape is adhered. In some embodiments, positioning a portion of the second strip of medical tape over a portion of the first strip of medical tape can enhance the adhesion of at least one of the first strip or the second strip. In other words, positioning a portion of the second strip of medical tape over a portion of the first strip of medical tape can reduce a likelihood of the portion of the first strip of medical tape from working loose, decoupling, and/or otherwise breaking the adhesive bond.

In some embodiments, the arrangement of the first strip of medical tape and the second strip of medical tape can be such that a proximal locking mechanism of the extension set extends between and/or through a space, gap, and/or separation defined between, for example, the medial portion of the first strip of medical tape and the medial portion of the second strip of medical tape (see e.g.,FIGS. 8 and 9). In other words, neither the first strip nor the second strip of medical tape obstructs the proximal locking mechanism of the extension set. Accordingly, any suitable device or the like can be coupled to the proximal locking mechanism of the extension set when the stabilization device is secured to the target location of the patient.

As described above, securing the stabilization device to the skin of the patient at, on, or near the target location (e.g., via the strips of medical tape) results in the stabilization device securing, stabilizing, and/or substantially immobilizing the IV catheter relative to the target location of the patient. That is to say, the arrangement of the stabilization device is such that securing the stabilization device and the IV catheter to the skin of the patient can reduce and/or substantially prevent movement of the IV catheter or at least an IV catheter thereof relative to the vein in which the IV catheter is at least partially disposed, as described in further detail herein with respect to a specific embodiment. Moreover, the arrangement of the recessed portion along the base surface is such that securing and/or adhering the stabilization device to the skin of the patient does not exert a force on the vein in which the IV catheter is disposed, thereby reducing and/or substantially eliminating any obstruction and/or restriction otherwise resulting from such a force.

While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where schematics and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components may be modified. Although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having a combination of any features and/or components from any of embodiments as discussed above. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made.

In some embodiments, the specific configurations of the various components can also be varied. For example, the size and specific shape of the various components can be different from the embodiments shown, while still providing the functions as described herein. More specifically, the size and shape of the various components can be specifically selected for a desired rate and/or volume of bodily fluid flow into a fluid reservoir. Likewise, the size and/or shape of the various components can be specifically selected for a desired or intended usage.

Where methods and/or schematics described above indicate certain events and/or flow patterns occurring in certain order, the ordering of certain events and/or flow patterns may be modified. Additionally certain events may be performed concurrently in parallel processes when possible, as well as performed sequentially.