Intravenous Catheter Device Having a Guidewire for Actively Repositioning a Catheter Tip

An intravenous catheter device may include a guidewire for actively repositioning the catheter tip. A guidewire assembly may be configured to enable a clinician to actively reposition the catheter tip by moving proximal ends of segments of the guidewire. By repositioning the catheter tip, the guidewire assembly may facilitate the collection of a blood sample or the injection of a fluid through the catheter even in instances when the catheter tip has become occluded.

BACKGROUND OF THE INVENTION

Intravenous (IV) catheter devices are commonly used for a variety of infusion therapies. For example, an IV catheter device may be used for infusing fluids, such as normal saline solution, various medicaments, and total parenteral nutrition, into a patient. IV catheter devices may also be used for withdrawing blood from the patient.

A common type of IV catheter device includes a catheter that is “over-the-needle.” As its name implies, the catheter that is over-the-needle may be mounted over a needle having a sharp distal tip. The catheter and the needle may be assembled so that the distal tip of the needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from skin of the patient. The catheter and the needle are generally inserted at a shallow angle through the skin into the vasculature of the patient. Once the catheter is positioned within the vasculature, it may become occluded such as when a thrombus forms around the catheter's distal opening or the distal opening is positioned against a vessel wall.

When IV catheter devices are not properly maintained within the patient's vasculature, they are likely to become occluded. Once an IV catheter device is occluded, it may no longer be possible to use the IV catheter device to infuse fluids or withdraw blood. In such cases, the IV catheter device may be replaced. Yet, replacing an IV catheter device is burdensome for the patient and increases costs. To address such issues, some devices have been developed that may be inserted through the indwelling catheter of the IV catheter device to remove the occlusion. For example, some devices employ rigid tubing that may be inserted through the catheter and distally beyond the catheter's distal opening. With the rigid tubing inserted in this manner, such devices may obtain a blood sample through the rigid tubing even if the catheter had become occluded. In other words, the rigid tubing is employed to physically pass through any occlusion that may have formed in or around the catheter's distal opening and forms a separate fluid pathway from the catheter for collecting the blood sample. When used in this manner, the rigid tubing may become occluded as the tubing is advanced through the occlusion or thrombus.

SUMMARY OF THE INVENTION

The present disclosure relates generally to an intravenous catheter device having a guidewire for actively repositioning the catheter tip. A guidewire assembly may be configured to enable a clinician to actively reposition the catheter tip by moving proximal ends of segments of the guidewire. By repositioning the catheter tip, the guidewire assembly may facilitate the collection of a blood sample or the injection of a fluid through the catheter even in instances when the catheter tip has become occluded.

In some embodiments, a guidewire assembly may include a guidewire housing, a guidewire actuator configured to slide within the guidewire housing and a guidewire having a first segment and a second segment. The guidewire actuator may be coupled to a proximal end of the first segment and to a proximal end of the second segment such that the guidewire slides when the guidewire actuator is slid within the guidewire housing. The guidewire actuator may further be configured to cause relative movement between the proximal end of the first segment and the proximal end of the second segment to thereby cause a distal end of the guidewire to reposition.

In some embodiments, a single wire may form the first segment and the second segment or multiple wires may form the first segment and the second segment. In some embodiments, the guidewire actuator may include a first tab that is coupled to the proximal end of the first segment. The first tab may move relative to a main body of the guidewire actuator to cause the relative movement between the proximal end of the first segment and the proximal end of the second segment. In some embodiments, the first tab may move relative to the main body by sliding along the main body. In some embodiments, the guidewire actuator may also include a second tab that is coupled to the proximal end of the second segment. The second tab may move relative to the main body of the guidewire actuator to cause the relative movement between the proximal end of the first segment and the proximal end of the second segment. In some embodiments, the first tab and the second tab may move relative to the main body by sliding along the main body.

In some embodiments, the guidewire actuator may include a main body and the proximal end of the first segment and the proximal end of the second segment may be coupled to the main body. The main body may rotate to cause the relative movement between the proximal end of the first segment and the proximal end of the second segment. In some embodiments, the first segment and the second segment may wrap around the main body in opposite directions.

In some embodiments, the guidewire may include a ring that maintains a spacing between the first and second segments. In some embodiments, the guidewire may include a bend that is spaced from the distal end. In some embodiments, the guidewire may include a dome-shaped distal end.

In some embodiments, the first segment may be a core wire and the second segment may be a coil that extends around the core wire. In some embodiments, a proximal end of the first segment may be coupled to a tab of the guidewire actuator, and the guidewire actuator may further include a spring that biases the tab in a proximal direction.

In some embodiments, an intravenous catheter device may include a catheter adapter from which a catheter extends and a guidewire assembly that is coupled to the catheter adapter. The guidewire assembly may include a guidewire housing, a guidewire actuator configured to slide within the guidewire housing and a guidewire having a first segment and a second segment. The guidewire actuator may be coupled to a proximal end of the first segment and to a proximal end of the second segment such that the guidewire slides when the guidewire actuator is slid within the guidewire housing to thereby enable a distal end of the guidewire to be positioned at or near a distal end of the catheter. The guidewire actuator may further be configured to cause relative movement between the proximal end of the first segment and the proximal end of the second segment to thereby cause a distal end of the guidewire to reposition to thereby reposition the distal end of the catheter. In some embodiments, the guidewire actuator may rotate relative to the guidewire housing and the rotation may also cause the distal end of the catheter to reposition. In some embodiments, the guidewire assembly may form a fluid pathway for collecting a blood sample through the catheter.

In some embodiments, the guidewire actuator may include a first tab that is coupled to the proximal end of the first segment. The first tab may move relative to a main body of the guidewire actuator to cause the relative movement between the proximal end of the first segment and the proximal end of the second segment.

In some embodiments, the guidewire actuator may include a second tab that is coupled to the proximal end of the second segment. The second tab may move relative to the main body of the guidewire actuator to cause the relative movement between the proximal end of the first segment and the proximal end of the second segment.

In some embodiments, the guidewire actuator may include a main body and the proximal end of the first segment and the proximal end of the second segment may be coupled to the main body. The main body may rotate to cause the relative movement between the proximal end of the first segment and the proximal end of the second segment.

In some embodiments, a method for repositioning a distal end of an intravenous catheter may include advancing a guidewire to a distal end of a catheter while the catheter is positioned intravenously. The guidewire may include a first segment and second segment. In some embodiments, the method may also include, while a distal end of the guidewire is positioned at or near the distal end of the catheter, moving a proximal end of the first segment relative to a proximal end of the second segment to thereby cause the distal end of the guidewire to reposition. The repositioning of the distal end of the guidewire may cause the distal end of the catheter to also reposition. In some embodiments, moving the proximal end of the first segment relative to the proximal end of the second segment may include moving the proximal end of the first segment distally or proximally, moving the proximal end of the second segment distally or proximally, moving both the proximal end of the first segment and the proximal end of the second segment in opposing proximal and distal directions or rotating the proximal end of the first segment and the proximal end of the second segment around an axis.

It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense.

DETAILED DESCRIPTION OF INVENTION

An IV catheter device that may be employed in some embodiments may include a catheter adapter from which a catheter distally extends and one or more ports or connectors for attaching other devices to the catheter adapter. Such devices may be attached to the catheter adapter before, during or after insertion of the catheter into a patient's vasculature and may include a needle assembly, a blood collection set, an infusion assembly, any embodiment of a guidewire assembly described herein, etc. In some embodiments, a guidewire assembly may be integrated into an IV catheter device as opposed to being selectively connected to the IV catheter device. Accordingly, embodiments of the present disclosure should not be limited to any particular configuration of an IV catheter device or to the specific examples of IV catheter devices used herein.

FIG.1provides an example of an IV catheter device100that is configured in accordance with some embodiments of the present disclosure. IV catheter device100includes a catheter adapter110from which a catheter111extends distally. Although not illustrated, a needle assembly may oftentimes be secured to catheter adapter110and may be employed to insert catheter111into a patient's vasculature and subsequently detached from catheter adapter110. IV catheter device100also includes an adapter114that is connected to a side port110aof catheter adapter110.

IV catheter device100also includes a guidewire assembly200having a guidewire housing210which may house a guidewire230at least when guidewire230is not extended through catheter111. A connector220may be formed at a distal end of guidewire housing210and may function to connect guidewire assembly200to IV catheter device100(e.g., via a port114aof adapter114as illustrated inFIG.1). In other embodiments, however, guidewire housing210may be integrated into adapter114or another component of catheter adapter110. In other words, how a guidewire assembly is connected to a catheter adapter is not essential to embodiments of the present disclosure.

Guidewire assembly200may also include a guidewire actuator240that extends out from guidewire housing210and slides along a channel211formed in guidewire housing210. Guidewire actuator240allows a clinician to move guidewire230relative to catheter111by sliding guidewire actuator240along the length of guidewire housing210within channel211. As described in detail below, a guidewire assembly configured in accordance with embodiments of the present disclosure may include a guidewire that may be actively repositioned via a guidewire actuator to thereby reposition the tip of a catheter through which the guidewire extends. In some embodiments, such as the embodiments represented inFIG.1, guidewire actuator240may include a main body241and one or more tabs242by which guidewire230may be actively repositioned.FIG.1illustrates guidewire actuator240in its distal-most position and therefore the distal end of guidewire230is positioned at, near or beyond the distal opening of catheter111.

IV catheter device100also includes extension tubing115that is coupled at one end to a port114bof adapter114and includes an adapter116at the opposing end. A blood collection set300may be coupled to or integrated with adapter116. A clamp115amay be positioned around extension tubing115to selectively block the flow of fluid through the extension tubing. In contrast to what is illustrated inFIG.1, in some embodiments, extension tubing115and blood collection set300may be coupled to the proximal end of guidewire assembly200to thereby allow a blood sample to be collected via guidewire assembly200or to allow a fluid to be injected via guidewire assembly200.

A guidewire assembly configured in accordance with embodiments of the present disclosure may be used to move the catheter tip to thereby remove an occlusion that may have formed around the distal opening of the catheter and/or to reposition the catheter tip such as when its distal opening may be occluded by a vessel wall or other vasculature structure. For example, after inserting catheter111into the patient's vasculature but prior to advancing and/or repositioning guidewire230in catheter111, a thrombus could form around or proximate to catheter111's opening and prevent blood or fluid from flowing through catheter111. In such a case, guidewire actuator240could be moved into the distal-most position to advance guidewire230near, to or beyond the distal tip of catheter111(if not already in this distal position). Tab(s)242could then be manipulated to move guidewire230and thereby move catheter111to remove any occlusion or blockage that may be present and/or to reposition catheter111's opening away from the thrombus or other source of occlusion (e.g., the vein wall, valve, blood clot, etc.).

FIGS.2A and2Bare cross-sectional views of an example implementation of guidewire assembly200. As illustrated, guidewire assembly200may include guidewire housing210along which one or more channels211extend to enable guidewire actuator240to be slid distally and proximally along guidewire housing210. In the depicted implementation, guidewire actuator240includes a main body241that is configured to house a first tab242aand a second tab242bin a slidable arrangement. Guidewire230may include a first segment231and a second segment232having distal ends that are connected together to form distal end233of guidewire230. A proximal end231aof first segment231may be coupled to first tab242aand a proximal end232aof second segment232may be coupled to second tab242b.Accordingly, as first tab242aand second tab242bmove relative to one another, first segment231and second segment232will also move relative to one another. More particularly, because the distal ends of first segment231and second segment232are fixed at distal end233, relative movement between proximal ends231aand232awill cause distal end233to reposition. With distal end233positioned in, at or near the distal opening of catheter111, the repositioning of distal end233will move catheter111. In some embodiments, guidewire230may extend through a fluid seal214that is positioned within guidewire housing240.

FIGS.3A-3Cillustrate how guidewire actuator240may be manipulated to reposition distal end233and thereby reposition the tip of catheter111. InFIG.3A, first tab242aand second tab242bare positioned in alignment. Therefore, assuming first and second segments231and232have substantially the same length, guidewire230may be substantially straight. In contrast, inFIG.3B, first tab242ais moved to the right and second tab242bis moved to the left. As a result, first segment231is moved to the right relative to second segment232thereby causing guidewire230to curve upwardly at distal end233. Similarly, inFIG.3C, first tab242ais moved to the left and second tab242bis moved to the right. As a result, first segment231is moved to the left relative to second segment232thereby causing guidewire230to curve downwardly at distal end233. The degree of this curvature may be dependent on the degree to which first and second tabs242aand242bare moved relative to one another. Notably, this active repositioning of distal end233may be caused by moving only one of first tab242aor second242b(i.e., a clinician may reposition the tip of catheter111by causing relative movement between first tab242aand second tab242b). Also, in some embodiments, guidewire actuator240may be configured to rotate to cause this curvature to occur along different planes (e.g., to the right or left).

FIG.2Cillustrates a variation of guidewire assembly200illustrated inFIGS.2A and2B. In this variation, guidewire actuator240includes a single tab242to which proximal end231aof first segment231is coupled. Proximal end232aof second segment232is fixed to main body241. Accordingly,FIG.2Crepresents embodiments where the proximal end of only one of first and second segments231and232moves to cause distal end233to reposition.

In some embodiments, first segment231and second segment232may be part of the same wire. For example, distal end233may be a bend in a single wire. In other embodiments, first segment231and second segment232may be different wires that are joined together at distal end233or at another location. The wire or wires from which guidewire230is formed could be made from a variety of materials including, for example, stainless steel, nickel titanium alloys or polymers such as nylon, polytetrafluoroethylene (PTFE) and polyetherimide. In some embodiments, the wire or wires may be formed of a core material with a coating such as a metal core with a polymeric coating. In some embodiments, first and second segments231and232may be substantially straight. In some embodiments, first and second segments231and232could include a bend towards distal end233. In some embodiments, first segment231could be a core wire while second segment232could be a coil that wraps around first segment231. In some embodiments, distal end233could be in the form of or include a dome shape. Accordingly, guidewire230may take a variety of forms and include a variety of features in embodiments of the present disclosure.

FIGS.4A-4Dprovide another example of a guidewire assembly200that is configured in accordance with one or more embodiments. In this example, guidewire actuator240includes a main body241that has a round shape and a tab242that may be used to rotate main body241. First and second segments231and232extend around main body241in opposite directions with proximal ends231aand232abeing fixed to main body241. Accordingly, when main body241is rotated, first and second segments231and232will move in opposite directions thereby causing distal end233to reposition.FIG.3Dillustrates that, in addition to this rotation, guidewire assembly240may slide within channel211to position distal end233near, at or beyond the tip of catheter111.

FIGS.5A-5Eeach provide an example of how guidewire230could be configured in one or more embodiments. InFIG.5A, first segment231and second segment232are formed from a single wire that is bent at distal end233. InFIG.5B, first segment231and second segment232are also formed of a single wire that is bent at distal end233but guidewire230also includes a ring500(or other coupling element). Ring500may be secured to second segment232and may also wrap around first segment231. For example, a weld500aor other bonding technique could be employed to secure ring500at a fixed point of second segment232. Ring500may function to retain the proximity of first segment231to second segment232when distal end233is repositioned. For example, if first segment231is pulled to the right relative to second segment232, ring500may function to create a pivot point at which the distal portions of first and second segments231and232may pivot upwardly. In contrast, without ring500, first segment231may tend to arch away from second segment232thereby minimizing the movement of distal end233.

FIG.5Cprovides an example where a bend501is formed in first and second segments231and232towards distal end233. Bend501may be formed independent of the manipulation of guidewire actuator240. In other words, guidewire233may form bend501as a default orientation.FIG.5Dprovides an example where a dome502or other rounded shape is formed at distal end233. Dome502may minimize the potential of harm to the vasculature when guidewire230is extended from catheter111.FIG.5Eprovides an example where first segment231and second segment232are formed of two separate wires that are joined together. In the depicted example, a weld503or other coupling technique or structure is formed at distal end233. However, multiple wires could be joined together at any other location to form guidewire230. The examples provided inFIGS.5A-5Eshould not be viewed as mutually exclusive.

FIGS.6A and6Billustrate another example configuration of guidewire assembly200on IV catheter device100. In this example configuration, guidewire actuator240includes first tab242aand second tab242band are slidably coupled to opposing sides of main body241. Additionally, main body241(or at least first and second tabs242aand242b) are configured to rotate relative to guidewire housing210. For example, inFIG.6B, guidewire actuator240has been rotated 90 degrees relative to its position inFIG.6Aand this rotation has caused guidewire230to reposition the tip of catheter111even without any sliding movement of first and second tabs242aand242b.

FIGS.6A and6Balso represent embodiments where guidewire assembly200is coupled to an inline port110bof catheter adapter110. A septum610may be positioned within inline port110b,and, in such cases, guidewire230may pass through septum610.

FIGS.7A-7Dillustrate another example configuration of guidewire assembly200in isolation. In comparison toFIG.1, guidewire assembly200in these figures includes extension tubing700that extends from the proximal end of guidewire housing210. Although not illustrated, blood collection set300or another fluid capture or fluid injection set could be coupled to extension tubing700to thereby allow a blood sample to be collected or fluid to be injected via guidewire assembly200. In other words, guidewire housing210may form a fluid pathway.FIGS.7A-7Dalso illustrate how guidewire230may be manipulated by sliding guidewire actuator240along guidewire housing210, sliding tab242relative to main body241and rotating guidewire actuator240relative to guidewire housing210.

FIGS.8A and8Billustrate another example configuration of guidewire assembly200. In this example configuration, first segment231is in the form of a core wire and second segment232is in the form of a coil that extends around the core wire. Proximal end231aof first segment231may be secured to tab242while proximal end232aof second segment232may be fixed to main body241. In such embodiments, guidewire actuator240may include a spring800that biases tab242into a proximal position relative to main body241. In some embodiments, guidewire230could be configured to be substantially straight when tab242is in this proximal position. In contrast, when tab242is slid distally, guidewire230may be repositioned as illustrated inFIG.8B. Alternatively, guidewire230could be in a curved position when tab242is in the proximal position and could be straightened when tab242is moved into the distal position. In any case, the distal movement of tab242relative to main housing241may cause distal end233of guidewire230to reposition. Spring800may cause tab242to return to the proximal position absent an external force. It is noted that a guidewire formed by a core wire and a coil could be used in any of the guidewire assemblies described herein and need not be limited to the embodiment illustrated inFIGS.8A and8B. In particular, a guidewire formed by a core wire and a coil need not be used with spring800.

In a variation of the embodiments represented inFIGS.8A and8B, spring800could be removed and proximal end232aof second segment232could extend to tab242. In other words, the coil that second segment232forms could be coupled to and therefore move with tab242. In such embodiments, main body241could be configured to apply a compressive force against second segment232(or otherwise retain it) at the point where second segment232passes through main body241to thereby cause the portion of second segment232contained within main body241to compress when tab242is moved distally. The compression of this portion of second segment232will cause tab242to spring back proximally once the distal force is no longer applied to tab242. Accordingly, in such embodiments, the portion of second segment232contained within main body241functions in a manner similar to spring800. In these embodiments, the repositioning of guidewire230can occur in substantially the same manner as represented inFIGS.8A and8Bgiven that main body241will anchor second segment232in place while first segment231moves distally.

In another similar variation, proximal end232aof second segment232could also extend to tab242and main body241could also be configured to apply a compressive force against second segment232(or otherwise retain it) at the point where second segment232passes through main body241. However, in contrast to the previously described variation, tab242can be configured to slide proximally to reposition guidewire230. In other words, a proximal force can be applied to tab242to pull distal end233of guidewire230proximally. Due to the compressive force on second segment232, the portion of second segment232that is positioned between tab242and the point where the compressive force is applied will stretch when tab242is slid proximally. Then when the proximal force is no longer applied to tab242, this portion of second segment232will return to its un-stretched position. In short, in these variations, an intermediary point of the coil-shaped second segment232can be held in place as first segment231is moved distally or proximally to thereby cause distal end233to move off axis.

FIGS.9A and9Beach illustrate another example configuration of guidewire assembly200. In each of these examples, guidewire assembly200is integrated into catheter adapter110. In other words, a portion of catheter adapter110is used in place of guidewire housing210. InFIG.9A, first tab242aand second tab242bare integrated into inline port110bbut otherwise function similarly as described above. InFIG.9B, first tab242aand second tab242bare integrated into side port110abut otherwise function similarly as described above. Accordingly, embodiments of the present disclosure encompass guidewire assemblies that are separate and detachable from the catheter adapter, separate but not detachable from the catheter adapter, integrated with the catheter adapter, etc.

In summary, a guidewire assembly configured in accordance with embodiments of the present disclosure may include a two segment guidewire having a distal end that may be moved off axis by relative movement between the proximal ends of the two segments. The movement of the distal end of the guidewire enables the tip of a catheter to be actively repositioned while it is positioned intravenously. The repositioning may be performed to remove an occlusion from the opening of the catheter, to move the opening of the catheter way from the vascular wall or other obstruction or to otherwise facilitate blood collection or fluid injection through the catheter. Notably, a guidewire assembly in accordance with embodiments of the present disclosure facilitate this repositioning of the catheter tip without moving or adjusting the catheter adapter or altering the insertion depth of the catheter itself. In short, embodiments of the present disclosure provide a clinician with targeted control over the position of the catheter's tip.