Patent Application
20230364389
Provided herein are devices and systems for use in vascular access, and, in particular, stabilization devices and vascular access systems including such devices.
During dwell, a peripheral intravenous catheter (PIVC) may become occluded with thrombus or fibrin, preventing the ability to draw blood through the PIVC. Line draw devices are meant to pass through the catheter and open up a fluid path for blood draw. One challenge with these devices is successfully navigating through the s-shaped profile the catheter takes as it enters the vein. The catheter tubing may kink slightly at the bends of the s-curve (
During insertion of a PIVC into a patient, the angle at which the catheter is inserted is typically around 30°, depending on a number of factors including the patient's vasculature, vein depth, and clinician technique. Once the catheter has been successfully inserted into the vein, the catheter adapter will be secured to the patient using adhesive tape or dressings. When securing the catheter adapter, the dressing is placed over the catheter adapter and the surrounding skin such that the catheter adapter lies roughly parallel to the skin. Because the catheter was inserted at a steeper angle relative to the skin, the tubing exiting the catheter adapter must transition from the plane of the adapter down into the vein, thus potentially kinking or deforming the tubing enough that a line draw device would be unable to pass through.
Proper securement of a PIVC is a critical step to ensure the success of line draw devices. Accordingly, there is a need in the art for a stabilization and securement device and dressing system to provide improved overall blood draw success, line draw device advancement reliability, and reduced risk of catheter complications resulting from additional access and use of the PIVC for blood collection.
Provided herein is an integrated dressing for use with a catheter assembly, including a base defining a perimeter, the base comprising a bottom surface configured to contact skin of a patient, a cover portion attached to the base and configured to cover a site of a catheter insertion, and a stabilizing clip, attached to the base or the cover portion, and configured to releasably couple to a catheter adapter.
Also provided herein is a stabilized catheter set, including a catheter assembly including a catheter adapter, having a distal end, a proximal end, a lumen arranged between and in fluid communication with the distal end and the proximal end, and a catheter arranged at the distal end of the catheter adapter and in fluid communication with the lumen, and an integrated dressing, including a base defining a perimeter, the base comprising a bottom surface configured to contact skin of a patient, a cover portion attached to the base and configured to cover a site of a catheter insertion, and a stabilizing clip, attached to the base or the cover portion, and configured to releasably couple to a catheter adapter.
Also provided herein is a method of securing a catheter at a site of insertion, including the steps of providing a catheter assembly including a catheter adapter, having a distal end, a proximal end, a lumen arranged between and in fluid communication with the distal end and the proximal end, and a catheter arranged at the distal end of the catheter adapter and in fluid communication with the lumen, inserting the catheter into a patient, providing an integrated dressing including a base defining a perimeter, the base comprising a bottom surface configured to contact skin of a patient, a cover portion attached to the base and configured to cover a site of a catheter insertion, and a stabilizing clip, attached to the base or the cover portion, and configured to releasably couple to the catheter adapter, coupling the stabilizing clip to the catheter adapter, and securing the base to the skin of the patient.
The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.
For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
It should be understood that any numerical range recited herein is intended to include all values and sub-ranges subsumed therein. For example, a range of “1 to 10” is intended to include all sub-ranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, that is, having a minimum value equal to or greater than 1 and a maximum value of equal to or less than 10.
Provided herein is a stabilization device for a catheter assembly. Stabilization devices as described herein may be used to provide a secure site of attachment of a catheter adapter to a site of a venipuncture, and may provide an optimal angle of entry of a catheter into the vasculature of a patient, reducing or eliminating kinking of medical devices that are passed through the catheter into the patient.
Referring now to
In some non-limiting embodiments or aspects, the catheter assembly 10 may include a catheter 22 extending from the distal end 14. In some embodiments, the first catheter 22 may include a peripheral intravenous catheter, a midline catheter, or a peripherally-inserted central catheter. Catheter 22 may be formed of any suitable material and may be of any useful length, as known to those of skill in the art. In some non-limiting embodiments or aspects, the catheter assembly 10 may include a first fluid conduit 24 extending from the port 18. First fluid conduit 24 may be formed of any suitable material known to those of skill in the art, and may have a distal end 26 and a proximal end 28, and first fluid conduit 24 may be coupled, at distal end 26 thereof, to port 18. In some non-limiting embodiments or aspects, a connector 30 may be coupled to a proximal end 28 of first fluid conduit 24. Connector 30 may be a t-connector (e.g., one side port arranged at a 90 degree angle relative to a longitudinal axis of connector 30), a y-connector (e.g., one side port arranged at a 25, a 60, or a 75 degree angle relative to a longitudinal axis of connector 30), or any other type of connector known in the art, and may include a second lumen therethrough, having any number of branches suitable for the type of connector.
In some non-limiting embodiments or aspects, catheter assembly 10 may include an extension set (integrated into or removably coupleable to catheter adapter 12, connector 30, and/or needless access connector 32) including a second fluid conduit, such as second fluid conduit 34. Extension sets 34 are known to those of skill in the art and are commercially available from, for example, Becton, Dickinson and Company under the tradename NEUTRACLEAR. In some non-limiting embodiments or aspects, second fluid conduit 34 may include a luer connection 36 at an end thereof. In some non-limiting embodiments or aspects, the extension set may include a clamp 40, to allow for occlusion of second fluid conduit 34. Clamp 40 and second fluid conduit 34 may be formed of any suitable materials known to those of skill in the art. In non-limiting embodiments, second lumen (e.g., within connector 30) has an inner diameter that is substantially equivalent to an inner diameter of first fluid conduit 24 and/or second fluid conduit 34.
Catheter assembly 10 may include a needleless access connector 32 and/or a second fluid conduit 34. Needleless access connectors 32 are known to those of skill in the art and are commercially available from, for example, Becton, Dickinson and Company under the tradenames MAXPLUS, MAXZERO, Q-SYTE, and SMARTSITE.
Turning to
With continuing reference to
Integrated dressing further may further include stabilizing clip 130, which is configured to couple, optionally reversibly, to one or more portions of a catheter adapter, such as catheter adapted 12. In some non-limiting embodiments, stabilizing clip 130 couples to distal end 14 of catheter adapter 12. In some non-limiting embodiments, stabilizing clip 130 couples to catheter adapter 12 by snap fit, press fit, friction fit, or other connection known to those of skill in the art. In some non-limiting embodiments or aspects, stabilizing clip is formed of a plastic, elastomeric material, or other resilient material. In some non-limiting embodiments, stabilizing clip 130 is biased towards a position that secures one or more parts of catheter adapter 12 therein when coupled thereto, e.g., one or more portions of stabilizer clip 130 must be moved away from one another to allow for a part of catheter adapter 12 to couple to stabilizer clip 130. In some non-limiting embodiments, stabilizer clip 130 is coupled to base 110, for example by one or more arms 115. One or more arms 115 may be formed as part of base 110, and/or may be formed of the same material as base 110.
Stabilizing clip 130 may be configured to hold catheter adapter 12 at a certain angle, or within a certain range of angles, relative to the skin of the patient. Stabilizing clip thus may be angled relative to base 110, such that catheter adapter 12 is arranged at an angle of between about 3 degrees and about 10 degrees (all values and subranges therebetween inclusive), optionally between about 6 degrees and about 10 degrees, optionally about 6 degrees, relative to skin of a patient onto which integrated dressing 100 is applied. Stabilizer clip 130 may include one or more features to maintain an optimal “s” curve of catheter 12 (e.g.,
Turning to
Although the present disclosure has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments or aspects, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.
The present application claims priority to U.S. Provisional Application Ser. No. 63/342,356 entitled “Dressing with Integrated Securement System for Catheter” filed May 16, 2022, the entire disclosure of which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63342356 | May 2022 | US |
