Luer securement device
A Luer securement device comprising a flexible hood that is configured to attach to the surface of a patient, the flexible hood further having a Luer adapter for receiving a catheter inserter and/or a fluid line. The Luer securement device further includes a wedge seal that is positioned within the Luer adapter and is configured to receive a base portion of a catheter during a catheterization procedure. Once the base of the catheter is seated within the wedge seal, a proper insertion depth of the catheter into the patient is achieved.
1. A Luer securement device, comprising:
a flexible hood comprising a base and a sidewall, the base disposed at a distal end of the flexible hood, the base configured to attach to a surface of a patient, the sidewall extending from the base to a proximal lip portion, the proximal lip portion forming a proximal opening of the flexible hood;
an adapter comprising a distal portion, a proximal portion, and a lumen that extends through the distal and proximal portions, the distal portion including an exterior annular channel into which the proximal lip portion of the flexible hood inserts to secure the flexible hood to the adapter, the distal portion also including an interior annular channel formed within the lumen, the proximal portion being configured to couple a catheter inserter to the adapter;
a wedge seal positioned within the interior annular channel, the wedge seal forming an inner lumen within which a proximal base of a catheter is secured when the catheter inserter is employed to insert the catheter into the Luer securement device; and
a septum secured within the proximal portion of the adapter, the septum sealing a proximal opening of the adapter.
2. The device of claim 1 , wherein a distal surface of the base comprises an adhesive film.
3. The device of claim 1 , wherein a diameter of the inner lumen of the wedge seal is approximately the same as a diameter of a distal opening of the adapter.
4. The device of claim 1 , wherein the wedge seal is formed of a polymer configured to form a fluid seal with the base of the catheter.
5. The device of claim 1 , wherein the proximal portion of the adapter comprises external threads for coupling the catheter inserter to the adapter.
6. The device of claim 1 , wherein the septum further comprises a self-sealing slit.
7. The device of claim 1 , wherein the sidewall is angled relative to the base from about 30° to about 90°.
8. The device of claim 7 , wherein the sidewall is angled relative to the base at about 90°.
9. The device of claim 1 , wherein a diameter of the lumen is greater in the proximal portion of the adapter than in the distal portion of the adapter.
10. The device of claim 1 , wherein a portion of the septum extends out of the proximal opening of the adapter.
11. A method for manufacturing a Luer securement device, comprising:
providing a flexible hood comprising a base and a sidewall, the base disposed at a distal end of the flexible hood, the base configured to attach to a surface of a patient, the sidewall extending from the base to a proximal lip portion, the proximal lip portion forming a proximal opening of the flexible hood;
providing an adapter comprising a distal portion, a proximal portion, and a lumen that extends through the distal and proximal portions, the distal portion including an exterior annular channel into which the proximal lip portion of the flexible hood inserts to secure the flexible hood to the adapter, the distal portion also including an interior annular channel formed within the lumen, the proximal portion being configured to couple a catheter inserter to the adapter;
positioning a wedge seal within the interior annular channel, the wedge seal forming an inner lumen within which a proximal base of a catheter is secured when the catheter inserter is employed to insert the catheter into the Luer securement device; and
securing a septum within the proximal portion of the adapter, the septum sealing a proximal opening of the adapter.
12. The method of claim 11 , further comprising attaching an adhesive film to the base of the flexible hood, the adhesive film enclosing an interior environment of the flexible hood.
13. The method of claim 11 , wherein a diameter of the inner lumen of the wedge seal is approximately the same as a diameter of a distal opening of the adapter.
14. The method of claim 11 , wherein the wedge seal is formed of a polymer configured to form a fluid seal with the base of the catheter.
15. The method of claim 11 , wherein the proximal portion of the adapter comprises external threads for coupling the catheter inserter to the adapter.
16. The method of claim 11 , wherein the septum further comprises a self-sealing slit.
17. The method of claim 11 , further comprising a step of angling the base relative to the sidewall to an angle from about 30° to about 90°.
18. A Luer securement device, comprising:
a flexible hood comprising a base and a sidewall, the base disposed at a distal end of the flexible hood, the base configured to attach to a surface of a patient, the sidewall extending from the base to a proximal lip portion, the proximal lip portion forming a proximal opening of the flexible hood;
an adapter comprising a distal portion, a proximal portion, and a lumen that extends through the distal and proximal portions, the distal portion including an exterior annular channel into which the proximal lip portion of the flexible hood inserts to secure the flexible hood to the adapter, the distal portion also including an interior annular channel formed within the lumen, the proximal portion being configured to couple a catheter inserter to the adapter;
a wedge seal positioned within the interior annular channel, the wedge seal forming an inner lumen having a first diameter;
a septum secured within the proximal portion of the adapter, the septum sealing a proximal opening of the adapter; and
a catheter having a base with an outer diameter substantially equal to the first diameter such that, when the base of the catheter is positioned within the wedge seal, the wedge seal prevents leakage of fluid between the catheter and the wedge seal.
19. The Luer securement device of claim 18 , further comprising:
the catheter inserter, the catheter inserter having a distal portion configured to insert into the adapter and a coupling portion configured to couple to the proximal portion of the adapter, the distal portion having a length configured to position the base of the catheter within the wedge seal when the coupling portion is coupled to the proximal portion of the adapter.
20. The Luer securement device of claim 18 , further comprising:
an adhesive film that is secured to a distal surface of the base, the adhesive film covering a distal opening of the flexible hood.