Peripheral intravenous catheter with flow diverting features - Patents.com

Abstract

To maximize the amount of flushing that occurs within the interior of a catheter adapter.SOLUTION: PIVCs with extension sets can include one or more flow diverting features for maximizing the amount of flushing that occurs within the interior of a catheter adapter. These flow diverting features can therefore minimize the amount of residual blood, medicament, or other fluid that may exist within the catheter adapter after the PIVC has been flushed via the extension set. The flow diverting features may be in the form of structural modifications to the side port of the extension set, separate components that are contained within the side port or catheter adapter, integrated components within the side port or catheter adapter, other features or some combination of any of these features.SELECTED DRAWING: Figure 3A

Description

[Technical field]

[0001] The present invention relates to a peripheral intravenous catheter having flow diverting features. [Background technology]

[0002] A peripheral intravenous catheter (PIVC) is an intravenous device designed to be placed into a peripheral vein. PIVCs can often be configured as "closed" or "integrated" IV devices, which refers to the fact that the device is configured to prevent blood from escaping the device during catheter insertion. Typically, such PIVCs are designed with an integrated extension set to accomplish this.

[0003] FIG. 1 provides an example of a typical PIVC 100 that includes an integrated extension set. The PIVC 100 includes a catheter adapter 101 having a distal end from which a catheter 102 extends and a proximal end with a septum 103 positioned therein. Although not shown, the PIVC 100 initially includes an insertion needle that extends from the proximal end of the catheter adapter 101 through the septum 103 and out the distal end of the catheter 102. The septum 103 functions to seal the interior of the catheter adapter 101 after the insertion needle (or any other inserted device) is withdrawn. The extension set of the PIVC 100 is formed by a side port 104 that is fluidly coupled to the interior of the catheter adapter 101, an extension tube 105, and an adapter 106. Fluid injected into the extension tube 105 via the adapter 106 flows into the interior of the catheter adapter 101 via the side port 104 and eventually into the patient via the catheter 102. In this manner, fluids such as medications can be administered to a patient without requiring direct access to the interior of the catheter adapter 101.

[0004] While the PIVC is being inserted into a patient's vein, it may be necessary to flush the PIVC. For example, during insertion of the catheter 102, blood may flow proximally through the catheter 102 and into the interior of the catheter adapter 101. It is usually desirable to flush the blood from the catheter adapter 101 to prevent the growth of bacteria or other pathogens. On the other hand, when medication is administered through the extension set, some of the medication is likely to remain within the catheter adapter 101. Again, it is usually desirable to flush any residual medication from the catheter adapter 101 into the patient. This flushing is usually accomplished by injecting saline into the catheter adapter 101 through the extension set.

[0005] In existing PIVCs, it is difficult to completely flush the catheter adapter 101 by injecting saline through the extension set. For example, the angle of the side port 104 relative to the longitudinal axis of the catheter adapter 101 causes saline to flow into the catheter adapter 101 in a distal direction toward the catheter 102. To accommodate the septum 103, the interior of the catheter adapter 101 may elongate proximally relative to the opening of the side port 104. Although there is some deflection, the primary flow of saline is directly between the opening of the side port 104 and the catheter 102 as represented by the arrow in FIG. 1A. As a result, any residual blood, medication, or other fluids located in this "proximal elongated region" will likely not be properly flushed from the catheter adapter 101. Summary of the Invention

[0006] The present invention is generally directed to a PIVC with an extension set that includes one or more flow diverting features to maximize the amount of flushing that occurs within the interior of a catheter adapter. These flow diverting features can thus minimize the amount of residual blood, medication, or other fluids that may be present within the catheter adapter after the PIVC has been flushed through the extension set. The flow diverting features can be in the form of structural modifications to the side port of the extension set, separate components contained within the side port or catheter adapter, integrated components within the side port or catheter adapter, or other features.

[0007] In one embodiment, the invention is implemented as an IV access device including a catheter adapter having a sidewall forming proximal and distal ends and a lumen extending therebetween, a catheter extending from the distal end, a side port extending outwardly from the sidewall of the catheter adapter, the side port in fluid communication with the lumen of the catheter adapter, and a flow diverting feature configured to divert fluid flowing through the side port and into the lumen in a proximal direction. In some cases, the flow diverting feature can be in the form of at least one of a protrusion from a sidewall of the sidewall port, a diverting device centrally positioned within an opening of the side port thereby forming distal and proximal channels around the diverting device for fluid flowing from the side port into the lumen, a protrusion from a portion of the sidewall of the catheter adapter, the portion of the sidewall positioned opposite the side port, an insert, or a combination of such features.

[0008] In another embodiment, the invention is implemented as a peripheral intravenous catheter including a catheter adapter having a sidewall forming proximal and distal ends and a lumen extending therebetween, a catheter extending from the distal end, a side port extending outwardly from the sidewall of the catheter adapter, the side port being in fluid communication with the lumen of the catheter adapter, and a flow diverting feature configured to divert fluid flowing through the side port and into the lumen in a proximal direction. In some cases, the flow diverting feature can comprise one or more of a protrusion from a sidewall of the side port, a diverting device centrally positioned within an opening of the side port thereby forming distal and proximal channels around the diverting device for fluid flowing from the side port into the lumen, a protrusion from a portion of the sidewall of the catheter adapter, the portion of the sidewall positioned opposite the side port, or an insert positioned within the lumen or the side port.

[0009] In another embodiment, the invention is implemented as an IV access device including a catheter adapter having proximal and distal ends and a sidewall forming a lumen extending therebetween, a catheter extending from the distal end, a septum positioned within the lumen at the proximal end of the catheter adapter, a side port extending outwardly from the sidewall of the catheter adapter, the side port being in fluid communication with the lumen of the catheter adapter, and one or more flow diverting features comprising one or more of a protrusion from a sidewall of the side port, a diverting device centrally positioned within an opening of the side port thereby forming distal and proximal channels for fluid flowing from the side port into the lumen around the diverting device, a protrusion from a portion of the sidewall of the catheter adapter, the portion of the sidewall positioned opposite the side port, or an insert positioned within the lumen or within the side port.

[0010] These and other features and advantages of the present invention may be incorporated in particular embodiments of the invention and will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. It is not necessary for the present invention to incorporate every advantageous feature and every advantage described herein in every embodiment of the invention. [Brief description of the drawings]

[0011] So that it may be readily understood how the above-cited and other features and advantages of this invention are obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the accompanying drawings, which are merely exemplary embodiments of the invention and therefore should not be considered as limiting the scope of the invention.

[0012] [Figure 1] FIG. 1 shows a prior art PIVC including an extension set. [Figure 1A] FIG. 1A is a diagram illustrating how areas of reduced flushing can exist in a prior art PIVC. [Diagram 2] FIG. 2 illustrates a PIVC that includes flow turning features incorporated into the side ports of the extension set. [Figure 2A] FIG. 2A illustrates how the flow diverting features of FIG. 2 enhance flushing of the catheter adapter. [Figure 2B] FIG. 2B illustrates a curved embodiment of the flow diverting features of FIG. [Figure 2C] FIG. 2C illustrates how a flow diverting feature can be incorporated into the center of a side port. [Figure 3A] FIG. 3A illustrates a PIVC that includes a side port with a central axis that is offset relative to the central axis of the catheter adapter. [Figure 3B] FIG. 3B illustrates a PIVC that includes a side port with a central axis parallel to, but spaced apart from, the central axis of the catheter adapter. [Figure 4] FIG. 4 illustrates a PIVC that includes flow diverting features positioned on the side wall of the catheter adapter opposite the side port of the extension set. [Figure 5A] FIG. 5A illustrates a PIVC including a flow diverting insert positioned within a catheter adapter. [Figure 5B] FIG. 5B illustrates a PIVC that includes a flow diverting insert positioned in a side port. [Figure 6A] FIG. 6A illustrates a PIVC that includes a side port positioned near a septum housed within the proximal end of a catheter adapter. [Figure 6B] FIG. 6B is another view showing a PIVC including a side port positioned near a septum housed within the proximal end of a catheter adapter. [Figure 7] FIG. 7 illustrates a PIVC that includes a flow diverting insert positioned distal to a side port within a catheter adapter. [Figure 7A] FIG. 7A is a detailed perspective view of the flow diverting insert shown in FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] 2 shows a cross-sectional view of a PIVC 200 that may be configured to include one or more flow diverting features according to an embodiment of the present invention. Similar to the PIVC 100, the PIVC 200 includes a catheter adapter 201, a catheter 202 extending from a distal end of the catheter adapter 201, a septum 203 positioned within a proximal end of the catheter adapter 201, a side port 204 extending from a side wall of the catheter adapter 201 and providing a fluid passage into the interior of the catheter adapter 201, and an extension tube 205 coupled to the side port 204. The overall structure of the PIVC 200 is shown to be similar to the overall structure of the PIVC 100, but this need not be the case. The flow diverting features of the present invention may be incorporated into many different configurations / designs of a PIVC with an extension set.

[0014] In FIG. 2, the PIVC 200 is configured with a flow diverting feature in the form of a protrusion 210 from the sidewall of the side port 204. The protrusion 210 extends into the path of the fluid flowing from the extension set into the catheter adapter 201. Two main features of the protrusion 210 are provided in FIG. 2: (1) the angle of the face 210a of the protrusion 210 relative to the sidewall of the side port 204 and (2) the height of the protrusion 210. In the embodiment shown in FIG. 2, the angle of the face 210a is 85°, indicating that it is approximately perpendicular to the primary direction of fluid flowing into the catheter adapter 201. The height of the protrusion 201 as shown is 0.016 inches (0.4064 mm). This height is measured as the distance between the tip of face 210a and the point where the axis of the side wall of side port 204 intersects with the side wall of catheter adapter 201 (i.e., the point where the opening of side port 204 would begin if the side wall did not include protrusion 210). This height therefore defines how far protrusion 210 extends proximally along the axis of the side wall of catheter adapter 201 into the opening of side port 204.

[0015] The angle and / or height of the protrusions 210 can be varied to have different effects on the pressure of the flushing fluid to achieve different levels of flushing. For example, based on simulations, when the protrusions 210 have the angles and heights represented herein, a flushing efficiency of 57% can be obtained for the PIVC 100 with only a 0.2 psi pressure increase. Other variations that have been found to increase flushing efficiency include a 0.012 inch (0.3048 mm) height and an 85° angle, a 0.020 inch (0.508 mm) height and an 85° angle, and a 0.016 inch (0.4064 mm) height and a 60° angle. These variations are provided by way of example only and should not be construed as limiting the invention to any particular dimensions.

[0016] 2A generally illustrates how the protrusions 210 can increase the efficiency of flushing the PIVC 200. As represented by the arrows, fluid flowing through the side port 204 into the catheter adapter 201 is redirected by the protrusions 210 to create a vortex toward the proximal end of the catheter adapter 201. This vortex minimizes the amount of blood, medication, or other fluid that may remain at the proximal end of the catheter adapter 201 after flushing. As noted above, this can be accomplished with a relatively small increase in the pressure of the flushing fluid (i.e., only a small increase in force is required to flush the PIVC 200).

[0017] The protrusion 210 can be formed in any suitable manner. For example, the mold used to create the catheter adapter 201 and the side port 204 can be modified to form the protrusion 210. Alternatively, the protrusion 210 can be formed as a separate component that is coupled to the side port 204 in any suitable manner. If it is formed as a separate component, the protrusion 210 can be formed of a material designed to add antimicrobial benefit to the fluid contained within the catheter adapter 201, as described further below.

[0018] FIG. 2B illustrates an embodiment in which the protrusion 210 has a curved surface 210a. In some embodiments, configuring the surface 210a to be curved results in a reduction in the pressure of the flushing fluid, resulting in a slight increase in flushing efficiency. The curved surface 210a can be employed with any of the above-described variations of the protrusion 210, as well as any other suitable variations. Although not shown, in some embodiments, the surface 210a can be curved in a spiral shape. This spiral shape can be achieved by varying the height of the protrusion 210 along various cross sections. This variation in height can redirect the fluid at slightly different angles along the depth of the protrusion 210, thereby further imparting a spiral pattern to the resulting vortex.

[0019] FIG. 2C illustrates an embodiment in which a diverter 220 having the same general cross-sectional shape as the protrusion 210 is centrally positioned within the opening of the side port 204. Although not visible in FIG. 2C, the diverter 220 can extend between the upper and lower sidewalls of the side port 204, thereby forming fluid channels along the proximal and distal sides of the side port 204. Similar to the protrusion 210, the diverter 220 includes a surface 220a having a height and an angle. Both the height and angle of the diverter 220 can be similar to the variations discussed above with respect to the protrusion 210. Simulations have shown that the diverter 220 can further improve flushing efficiency over that obtained with the protrusion 210, despite increased flushing pressure.

[0020] Figures 3A and 3B each show an embodiment of a PIVC 300 that may have a similar overall structure to the PIVCs previously described. For example, PIVC 300 is shown as including a catheter adapter 301, a catheter 302, a septum (not shown), a side port 304, and an extension tube 305. Unlike the previous figures, Figures 3A and 3B are cross-sectional views taken perpendicular to the longitudinal axis of catheter adapter 301 and through side port 304.

[0021] In contrast to embodiment PIVC200, in which the longitudinal axis of side port 204 is assumed to be in the same plane as the longitudinal axis of catheter adapter 201, the longitudinal axis of side port 304 is offset relative to the plane of the longitudinal axis of catheter adapter 301 (FIG. 3A) or is parallel to but spaced from this plane (FIG. 3B).

[0022] 3A, the opening of the side port 304 is intersected by the plane of the central axis of the catheter adapter 301, and the central axis of the side port 304 is angled downward (or upward, depending on the orientation of the PIVC) relative to this plane (as represented by an angle between the two axes that is less than 180°). As a result, fluid flowing into the catheter adapter 301 via the side port 304 enters the catheter adapter 301 at an angle that deviates from the central axis, thereby forcing the flow to spiral or helically flow within the catheter adapter 301 to increase flushing efficiency.

[0023] A similar swirling or helical flow of flushing fluid can be achieved by configuring the side port 304 such that its central axis is substantially parallel to, but spaced apart from, the central axis of the catheter adapter 301 (by some non-trivial distance X), as shown in Figure 3B. In this way, the opening of the side port 304 is offset toward the bottom (or top, depending on the orientation of the PIVC) of the catheter adapter 301.

[0024] In any embodiment of the PIVC 300, the flow of flushing fluid as it exits the side port 304 is directed toward a portion of the side wall of the catheter adapter 301 that is below the central axis. The generally circular shape of the catheter adapter 301 then causes the flow to curve upward and spiral, thereby minimizing the amount of residual blood, medication, or other fluids after flushing. In some embodiments, the side port of the PIVC can be configured according to both FIGS. 3A and 3B (i.e., the side port can be angled away from this relative to the central axis of the catheter adapter 301).

[0025] 4 illustrates an embodiment of a PIVC 400 in which flow diverting features are formed along a sidewall of the catheter adapter opposite the side port. As shown, the PIVC 400 includes a catheter adapter 401, a catheter 402, a septum 403, a side port 404, and an extension tube 405, and thus has a similar overall structure to the PIVCs previously described. Additionally, the PIVC 400 includes a flow diverting feature in the form of a protrusion 410 from the sidewall of the catheter adapter 401. The protrusion 410 can be positioned opposite the side port 404 such that flow exiting the side port 404 impinges on the protrusion 410. The protrusion 410 can include a proximal facing surface 410a and a distal facing surface 410b. The surface 410a can divert the fluid in a proximal direction, thereby creating a vortex toward the proximal end of the catheter adapter 401.

[0026] 5A and 5B each show an embodiment of a PIVC 500 that includes a flow diverting feature in the form of an insert. The PIVC 500 includes a catheter adapter 501, a catheter 502, a septum 503, a side port 504, and an extension tube 505. As can be seen, the structure of the PIVC 500 itself can be the same as the PIVC 100, or any other PIVC that includes an extension set.

[0027] In Figure 5A, the PIVC 500 includes an insert 510a positioned within the catheter adapter 501 above the opening of the side port 504. The insert 510a can include a number of openings that form channels through the insert, including at least one channel that redirects the flow of flushing fluid in a proximal direction. Suitable inserts can be configured with many different shapes, sizes, and orientations of the openings to achieve this redirection.

[0028] In FIG. 5B, the PIVC 500 includes an insert 510b that can be positioned inside the side port 504 and extend partially into the catheter adapter 501. Similar to the insert 510a, the insert 510b can include a number of openings that form channels for redirecting the flow of flushing fluid in a proximal direction. The redirection of the flow in the proximal direction can create a vortex to increase flushing efficiency as described above.

[0029] Each of Figures 6A and 6B illustrates how the relative position of the side port along the longitudinal axis of the catheter adapter can be adjusted to further enhance flushing efficiency. Each of these figures illustrates a PIVC 600 having a catheter adapter 601, a catheter 602, a septum 603, a side port 604, and an extension tube 605. In Figure 6A, the side port 604 is positioned at a more proximal location near the septum 603. By positioning the side port 604 very close to the septum 603, the area of ​​the catheter adapter 601 proximal to the side port 604 is minimized. By minimizing this area, the vortex and / or proximal turning provided by the flow turning features described above can be more effective. In Figure 6B, the side port 604 is further illustrated as being oriented at a larger angle relative to the catheter adapter 601. In this case, the angle is acute, but approximately 90°. This near 90° angle reduces the amount that the flushing fluid needs to be redirected to increase flushing efficiency, especially if the side port 604 is also positioned near the septum 603 as shown in FIG.

[0030] Repositioning the side port 604 closer to the septum 603 and / or adjusting the angle of the side port 604 closer to 90° can be performed in conjunction with any of the flow redirecting features described above to enhance their effectiveness. For example, the PIVC 600 can also include protrusions 210 or 410 to form a vortex within the proximal end of the catheter adapter 601. This limited area of ​​the proximal end can result in a significant improvement in flushing efficiency over that possible with prior art PIVCs as a result of the formation of a vortex during flushing. The same can be said by including inserts 510a or 510b within the PIVC 600 or by further configuring the side port 604 according to FIG. 3A or 3B.

[0031] FIG. 7 illustrates a PIVC 700 having a catheter adapter 701, a catheter 702, a septum 703, a side port 704, and an extension tube 705. The PIVC 700 also includes a flow diverting feature in the form of an insert 710 positioned distal to the side port 704. As shown, the insert 701 can have a generally annular shape (see FIG. 7A) and can be configured to fit snugly (e.g., by a compression fit) within the side wall of the catheter adapter 701. The insert 710 can include a proximal face 710a that is outwardly oriented and extends proximally above the opening of the side port 704. The face 710a can thus function to divert the flow of flushing fluid in a proximal direction in a manner similar to the protrusion 210.

[0032] In some embodiments, the inserts 510 and 710 can be formed of a material that provides an antimicrobial benefit within the catheter adapter. For example, the inserts 510 or 710 can be formed of or coated with a material that elutes an antimicrobial agent, such as chlorhexidine. In some embodiments, the inserts can be formed primarily of a hygroscopic material that expands when wet to prevent slippage.

[0033] Although the various flow diverting features have been primarily described as being implemented separately on a PIVC, a combination of two or more of the described features may be employed on a single PIVC. Also, the described flow diverting features may be employed on any type or configuration of PIVC, including extension sets (i.e., on any PIVC having a side port used for flushing). Additionally, although the description has been limited to PIVCs, flow diverting features may be employed on any other IV access device that includes a side port.

[0034] The present invention may be embodied in other specific forms without departing from its structure, method, or other essential characteristics as broadly described and claimed herein. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are intended to be embraced within their scope.

Claims

1. 1. An intravenous access device comprising: a catheter adapter having proximal and distal ends and a sidewall defining a lumen extending therebetween; a catheter extending from the distal end; a side port extending outwardly from the sidewall of the catheter adapter and in fluid communication with the lumen of the catheter adapter; a first flow diverting feature configured to divert fluid flowing from the side port to the catheter adapter by offsetting a longitudinal axis of the side port relative to a plane of a longitudinal axis of the catheter adapter; a second flow diverting feature comprising a diverting device centrally positioned within the opening of the side port thereby forming distal and proximal channels around the diverting device for fluid flowing from the side port into the lumen; An intravenous access device comprising:

2. the longitudinal axis of the side port is offset relative to the plane of the longitudinal axis of the catheter adapter to form the first flow turning feature, whereby fluid flowing from the side port into the lumen is directed at an angle that deviates from the plane; or a longitudinal axis of the side port is substantially parallel to, but offset from, the plane of the longitudinal axis of the catheter adapter to form the first flow turning feature. The intravenous access device of claim 1 .

3. The intravenous access device of claim 2 , wherein the longitudinal axis of the side port is at an angle of less than 180 degrees relative to the plane of the longitudinal axis of the catheter adapter.

4. The intravenous access device of claim 2 , wherein the longitudinal axis of the side port is substantially parallel to but offset from the plane of the longitudinal axis of the catheter adapter.

5. 3. The intravenous access device of claim 2, further comprising: a third flow diverting feature configured to divert fluid flowing through the side port into the lumen in a proximal direction, the third flow diverting feature comprising a protrusion from a portion of the side wall of the catheter adapter, the portion of the side wall positioned opposite the side port such that the fluid impinges on the portion of the side wall, the protrusion including a proximally facing surface and a distally facing surface.

6. The intravenous access device of claim 1 , wherein the diverter extends between opposite sides of the side port.

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