US-12623057-B2 - Securement assembly and method for central venous access devices and surgical drains

Abstract

A securement assembly for supporting and stabilizing a vascular access device, such as a tunneled central venous access devices (CVAD) or a surgical drain, is provided herein. The securement assembly may comprise a base and a lid. The base may include a central post about/around which the external portion of the access device or surgical drain may be wrapped. The lid may extend from the base and may be configured to cover the external portion of the access device or surgical drain (when installed). In various embodiments, the base and the lid collectively define an annular chamber around the central post of the base.

Inventors

• Steven Moulton
• Christopher Seighman
• Joshua Eng-Morris
• Bryan Norman
• Gabriel Chapel
• Tyler Mironuck

Assignees

• THE REGENTS OF THE UNIVESITY OF COLORADO, A BODY CORPORATE

Dates

Publication Date

20260512

Application Date

20210226

Claims (20)

1. 1 . A securement assembly for an access device or surgical drain (“access device”), the securement assembly comprising: a base comprising a central post, wherein an external portion of the access device is configured to be wrapped around the central post; and a resiliently flexible and flippable lid extending from the base and configured to cover the external portion of the access device, the lid comprising radially outward edges to allow the wrapped access device underneath the lid.
2. 2 . The securement assembly of claim 1 , wherein the base and the lid collectively define an annular chamber around the central post of the base.
3. 3 . The securement assembly of claim 2 , wherein at least one of the base and the lid comprises a rim that forms an outer sidewall of the annular chamber.
4. 4 . The securement assembly of claim 3 , wherein the rim defines one or more crenels thatfacilitate insertion of the external portion of the access device into the annular chamber.
5. 5 . The securement assembly of claim 1 , further comprising an adhesive layer coupled to the base.
6. 6 . The securement assembly of claim 1 , further comprising a clip extending from at least one of the base and the lid, wherein the clip is configured to detachably retain a port or reservoir of the external portion of the access device.
7. 7 . The securement assembly of claim 6 , wherein the clip is a first clip, wherein the securement assembly further comprises a second clip extending from at least one of the base and the lid, wherein the second clip is also configured to detachably retain another port or reservoir of the external portion of the access device.
8. 8 . The securement assembly of claim 6 , wherein the clip comprises a finger tab protruding from an upper surface of the clip.
9. 9 . The securement assembly of claim 6 , wherein the clip extends from the base and bends around more than 180 degrees such that a terminating end of the clip is facing back toward the lid.
10. 10 . The securement assembly of claim 9 , wherein the clip extends from the base and bends around about 235 degrees.
11. 11 . The securement assembly of claim 1 , wherein the lid comprises a post receptacle configured to receive the central post of the base.
12. 12 . The securement assembly of claim 11 , wherein the central post and the post receptacle have a D-shaped cross-section.
13. 13 . The securement assembly of claim 11 , wherein the central post comprises a protrusion and a recess is defined in a wall of the post receptacle, wherein the recess is configured to receive the protrusion to couple the lid to the base.
14. 14 . The securement assembly of claim 13 , wherein a radially inward surface of the wall of the post receptacle comprises a channel for receiving the protrusion during inserting of the central post into the post receptacle.
15. 15 . The securement assembly of claim 13 , wherein the protrusion comprises an upper surface that is slanted and a lower surface that is perpendicular to the central post.
16. 16 . A securement assembly for an access device or surgical drain (“access device”), the securement assembly comprising: a base comprising a central post, wherein an external portion of the access device is configured to be wrapped around the central post; a lid extending from the base and configured to cover the external portion of the access device, the lid comprising radially outward edges to allow the wrapped access device underneath the lid; and a clip extending from the base; wherein the base and the lid collectively define an annular chamber around the central post of the base; and wherein the clip is configured to detachably retain at least one of a port and a catheter of the external portion of the access device.
17. 17 . The securement assembly of claim 16 , wherein the lid comprises a post receptacle configured to receive the central post of the base.
18. 18 . The securement assembly of claim 17 , wherein the central post and the post receptacle have a D-shaped cross-section.
19. 19 . The securement assembly of claim 17 , wherein the central post comprises a protrusion and a recess is defined in a wall of the post receptacle, wherein the recess is configured to receive the protrusion to couple the lid to the base.
20. 20 . The securement assembly of claim 19 , wherein the protrusion comprises an upper surface that is slanted and a lower surface that is perpendicular to the central post.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a national stage application of PCT/US2021/019984, filed on Feb. 26, 2021, entitled “SECUREMENT ASSEMBLY AND METHOD FOR TUNNELED CENTRAL VENOUS ACCESS DEVICES AND SURGICAL DRAINS”, which claims priority to U.S. Provisional Patent Application Ser. No. 62/982,481, filed on Feb. 27, 2020, the entire contents of which are incorporated herein by reference in their entirety. FIELD The present disclosure relates to tunneled central venous access devices and/or surgical drains, and more particularly to a securement assembly for venous access devices and/or surgical drains. BACKGROUND Central venous access devices (CVADs) facilitate the delivery of fluids and medications to and/or from a patient. For example, CVADs may be used for the administration of parenteral nutrition, blood products, chemotherapeutics, a wide variety of medications, and other intravenous fluids to patients. Certain types of CVADs, such as an external tunneled CVADs, are ‘tunneled’ under the skin and into the bloodstream. They are commonly directed into a subclavian or jugular vein to the junction of the superior vena cava and right atrium of the heart, leaving an external port available for venous access. Pediatric patients, for example, may heavily rely on CVADs throughout a treatment process or their entire life. Unfortunately, conventional CVAD dressing and securement methods and assemblies have various shortcomings. Conventional CVAD securement methods do not provide sufficient protection and/or retention for the CVAD. For example, current methods do not adequately protect patients from bloodstream infections, nor do they safeguard from inadvertent dislodgement, catheter thrombosis or occlusion, catheter fracture, or skin erosion at the exit site. Dislodgement may require removal and/or replacement of the CVAD. Further, conventional CVAD dressing and securement assemblies are generally uncomfortable, especially for younger patients with smaller torsos and more sensitive skin. Although there are various methods for securing catheters, these conventional devices are used specifically for peripherally inserted central-line catheters (PICC) and do not work with external tunneled CVADs. In addition, these conventional solutions focus mainly on the exit site and redundant catheter; they do not address securement of the external port. Further, conventional solutions are often changed every few days (or more frequently if they become soiled), and nurses or other practitioners may frequently check the exit site to look for signs of infection or accidental dislodgement. Importantly, the external lines and/or external port of CVADs are often not properly secured, and thus are left dangling out of the patient where they may get caught on surrounding objects, thereby increasing the chances of dislodgement and/or increasing the discomfort for the patient. The use of surgical drains is commonplace in many types of surgical procedures and every surgeon is familiar with Jackson-Pratt (JP) and Blake drains. These drains are used throughout the body in a wide variety of surgical procedures to evacuate fluid from a body cavity, or post-surgical fluid that may be produced by a wound. The portion of a Jackson-Pratt drain that is placed inside a body cavity or in a closed space wound is composed of a flat, rectangular silicone or Silastic drain with multiple perforations and internal ridges. The rectangular, internal portion is fused to a soft silicone or Silastic tube, which exists through the skin and is attached to a reservoir that provides intermittent or, more commonly, continuous suction. The design of the Blake drain is that of a cylindrical silicone or Silastic catheter with a solid crossed-shaped center and four open fluted channels to prevent plugging of or at the draining perforations. There is an even transition between the internal, perforated cylindrical portion to the nonperforated portion, which exits through a hole in the skin. Jackson-Pratt and Blake drains are composed of a soft silicone, Silastic or similar material. They are designed to provide constant drainage and not collapse when under suction. They are sutured to the skin at the skin exit site, which is typically covered with a sterile, clear plastic adhesive dressing. The clear plastic dressing is usually changed every few days (or more frequently if soiled), and nurses or other practitioners may frequently check the exit site for signs of drainage and/or infection, or dislodgement of the drain. Similar to external tunneled CVADS, the external tubing of JP and Blake drains and their associated drainage reservoir may not be properly secured. They may be left dangling out of the patient where they can get caught on surrounding objects, thereby increasing the chances of dislodgement and/or increasing the discomfort for the patient. SUMMARY In various embodiments, the present disclosure provides a securement assembly for an access