Granted Patent B2

US 12,485,263 · App. 18/500,055 · Granted Dec 2, 2025

Inventors: Robert J. Ziebol (Shoreview, MN); Matthew David Beilke (Plymouth, MN)

Assignee: ICU Medical, Inc

A61M39/1011A61M5/178A61M2039/1033A61M2039/1083A61M2039/1088A61M2205/0205

Abstract

Claims (35)

1 . A male cap, comprising:

a male extension including a male tapered outer surface configured to mate with a female luer to create a fluid tight fit;

a distal tip at a distal end of the male cap, the distal tip having an outer diameter smaller than an outer diameter at a distal end of the male tapered outer surface;

a water-soluble antimicrobial composition disposed only on an outer surface of the distal tip; and

a fluid-soluble, slower-dissolving material covering the water-soluble antimicrobial composition;

wherein the fluid-soluble, slower-dissolving material is configured to slow a dissolution of the water-soluble antimicrobial composition of the male cap into the female luer by dissolving to expose the underlying water-soluble antimicrobial composition over a desired period of time.

2 . The male cap of claim 1 , wherein the fluid-soluble, slower-dissolving material is configured to dissolve in fluid to expose the water-soluble antimicrobial composition to the fluid in 1 minute or less.

3 . The male cap of claim 1 , wherein the fluid-soluble, slower-dissolving material is configured to dissolve over a few seconds.

4 . The male cap of claim 1 , wherein the fluid-soluble, slower-dissolving material is configured to dissolve in fluid to expose the water-soluble antimicrobial composition to the fluid in 10 minutes or less.

5 . The male cap of claim 1 , wherein the fluid-soluble, slower-dissolving material comprises at least one of biocompatible cellulose, dextrose, and sodium chloride.

6 . The male cap of claim 1 , wherein the fluid-soluble, slower-dissolving material comprises polyvinyl alcohol or a polyurethane hydrogel.

7 . The male cap of claim 1 , wherein the fluid-soluble, slower-dissolving material comprises microspheres.

8 . The male cap of claim 1 , wherein the male extension is configured to form a cavity between a female tapered surface and a recess surface when the male cap is mated with a female luer connector.

9 . The male cap of claim 8 , wherein the recess surface has a diameter less than 3.97 mm at a distance of 0.75 mm proximal to an end face.

10 . The male cap of claim 8 , further comprising a proximal trap comprising an annular cavity at least partially opening into the cavity formed between the female tapered surface and the recess surface.

11 . The male cap of claim 8 , wherein a first taper angle of the male tapered outer surface is equal to a second taper angle of the recess surface relative to a central longitudinal axis of the male cap.

12 . The male cap of claim 8 , wherein the male tapered outer surface further comprises a tapered surface distal edge proximal to an end face of the male cap.

13 . The male cap of claim 8 , wherein the water-soluble antimicrobial composition comprises chlorhexidine and wherein, after a portion of the chlorhexidine is dispersed within a lock solution fluid in the cavity, the dispersed antimicrobial composition retains a concentration of at least 200 micrograms per milliliter for a time period of at least 1 minute.

14 . The male cap of claim 1 , wherein the water-soluble antimicrobial composition comprises chlorhexidine.

15 . The male cap of claim 1 , wherein the distal tip is rigid.

16 . A male cap, comprising:

a male extension including a male tapered outer surface configured to mate with a female luer to create a fluid tight fit;

a distal surface distal to the male tapered outer surface, the distal surface having an outer diameter smaller than an outer diameter at a distal end of the male tapered outer surface;

a water-soluble dry antimicrobial composition disposed on the distal surface; and

a fluid-soluble, slower-dissolving material covering the water-soluble dry antimicrobial composition;

wherein the fluid-soluble, slower-dissolving material is configured to slow a dissolution of the water-soluble dry antimicrobial composition of the male cap into the female luer by dissolving to expose the underlying water-soluble antimicrobial composition over a desired period of time.

17 . The male cap of claim 16 , wherein the fluid-soluble, slower-dissolving material is configured to dissolve in fluid to expose the water-soluble dry antimicrobial composition to the fluid in 1 minute or less.

18 . The male cap of claim 16 , wherein the fluid-soluble, slower-dissolving material is configured to dissolve in fluid to expose the water-soluble dry antimicrobial composition to the fluid in 10 minutes or less.

19 . A male cap, comprising:

a male extension including a male tapered outer surface configured to mate with a female luer to create a fluid tight fit;

a distal tip at a distal end of the male cap, the distal tip having an outer diameter smaller than an outer diameter at a distal end of the male tapered outer surface;

a water-soluble antimicrobial composition on an outer surface of the distal tip; and

a fluid-soluble, slower-dissolving material covering the water-soluble antimicrobial composition;

wherein the fluid-soluble, slower-dissolving material is configured to slow a dissolution of the water-soluble antimicrobial composition of the male cap into the female luer by dissolving to expose the underlying water-soluble antimicrobial composition over a desired period of time.

20 . The male cap of claim 18 , wherein the water-soluble antimicrobial composition comprises chlorhexidine.

Assignments (1)

Continuity (10)

References Cited (400)

Cited By (3)

US 12,661,492 US 12,673,005 US 12,697,477