Granted Patent B2

US 12,201,760 · App. 17/843,908 · Granted Jan 21, 2025

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

Assignee: ICU Medical, Inc

A61M1/285A61M39/162A61L2300/404A61M2039/1083A61M2039/1088

Abstract

Claims (56)

1. A method for delivering an antimicrobial composition to a medical device, the method comprising:

inserting a male connector into a female connector having a female tapered surface, the male connector comprising:

a male tapered surface configured to engage the female tapered surface to form a substantially fluid-tight seal, the male tapered surface extending distally to a male tapered surface distal edge;

a distal tip extending distally from the male tapered surface distal edge, the distal tip comprising a distal end face;

an annular recess in the distal tip, the annular recess having a recess surface;

a water-soluble antimicrobial composition positioned on the recess surface; and

a fluid flow channel through the male connector;

wherein:

a radius of the distal tip along the annular recess surface is smaller than a radius of the male tapered surface at the male tapered surface distal edge;

the recess surface is proximal to the distal end face; and

a width of the recess surface in a radial direction at every point along the recess surface is smaller than a radius of the fluid flow channel through the male connector; and

forming a cavity between the recess surface and the female tapered surface by inserting the male connector into the female connector, whereby a fluid at least partially fills the cavity, and wherein at least a portion of the antimicrobial composition is dispersed within the fluid in the cavity.

2. The method of claim 1 , wherein the fluid flow channel is completely open for fluid transfer along an entire length thereof.

3. The method of claim 1 , wherein the male tapered surface distal edge is at a distalmost end of the male tapered surface.

4. The method of claim 1 , wherein the male tapered surface distal edge is proximal to the cavity formed between the female tapered surface and the recess surface.

5. The method of claim 1 , wherein the male connector is a distal end portion of the peritoneal dialysis transfer set.

6. The method of claim 1 , wherein the antimicrobial composition comprises chlorhexidine.

7. The method of claim 6 , wherein a portion of the antimicrobial composition dissolves into the fluid and forms a chlorhexidine precipitate on a portion of the female tapered surface.

8. The method of claim 6 , wherein after a portion of the antimicrobial composition is dispersed within the fluid in the cavity, the dispersed antimicrobial composition retains a concentration in the cavity of at least 200 micrograms per milliliter for a time period of at least 1 minute.

9. The method of claim 1 , wherein the cavity defines a volume within a range of 1 microliter to 25 microliters.

10. The method of claim 1 , wherein a plurality of angled surfaces extend outwardly away from the recess surface and wherein at least a portion of the antimicrobial composition is located on the plurality of angled surfaces.

11. The method of claim 1 , wherein a taper angle of the male tapered surface is equal to a taper angle of the recess surface relative to a central longitudinal axis.

12. The method of claim 1 , 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.

13. A method for delivering an antimicrobial composition to a medical device, the method comprising:

inserting a male connector comprising a male protrusion having a tapered surface into a female connector having a female tapered surface such that the tapered surface of the male protrusion engages the female tapered surface to form a fluid-tight seal, the male protrusion comprising:

a distal edge on the male tapered surface, the male tapered surface having a cross-sectional width;

a distal end face;

an unobstructed axially extending opening through an entire length of the male connector;

a recess having a recess surface that extends distally from the distal edge of the male tapered surface to the distal end face, the recess surface comprising a cross-sectional width that is smaller than the cross-sectional width of the distal edge of the male tapered surface; and

a water-soluble antimicrobial composition positioned on the recess surface; wherein:

a width of the recess in a radial direction is smaller than a radius of the fluid flow channel through the male connector; and

upon insertion of the male connector into the female connector, an annular cavity is formed between, and at least partly defined by, the recess surface and the female tapered surface of the female connector;

the annular cavity comprises a proximal end coincident with the distal edge of the tapered surface and a distal end coincident with the distal end face, a volume between the proximal end and the distal end, a depth measured radially, and a length measured axially;

the length of the annular cavity is at least twice the depth of the annular cavity; and

a fluid at least partially fills the annular cavity and at least a portion of the antimicrobial composition is dispersed within the fluid in the annular cavity when the male protrusion is advanced into the female connector.

14. The method of claim 13 , wherein the width of the recess in a radial direction is less than half of the radius of the fluid flow channel through the male connector.

15. The method of claim 13 , wherein the recess surface is formed in the male protrusion.

16. A device for delivering an antimicrobial composition to a medical device, the device comprising:

a medical tube; and

a male connector secured to the medical tube, the male connector comprising:

a male tapered surface configured to engage a female tapered surface of a female connector to form a substantially fluid-tight seal, the male tapered surface extending distally to a male tapered surface distal edge;

a distal tip extending distally from the male tapered surface distal edge, the distal tip comprising a distal end face;

an annular recess in the distal tip, the annular recess having a recess surface;

a water-soluble antimicrobial composition positioned on the recess surface; and

a fluid flow channel through the male connector;

wherein:

a radius of the distal tip along the annular recess surface is smaller than a radius of the male tapered surface at the male tapered surface distal edge;

the recess surface is proximal to the distal end face;

a width of the recess surface in a radial direction at every point along the recess surface is smaller than a radius of the fluid flow channel through the male connector; and

the male connector is configured to form a cavity between the recess surface and the female tapered surface to cause a fluid to at least partially fill the cavity and to cause at least a portion of the antimicrobial composition to be dispersed within the fluid in the cavity upon insertion of the male connector into the female connector.

17. The device of claim 16 , wherein the male connector comprises a plurality of angled surfaces that extend outwardly away from the recess surface and wherein at least a portion of the antimicrobial composition is located on the plurality of angled surfaces.

18. The device of claim 16 , further comprising a proximal trap comprising an annular cavity proximal to the distal end face of the distal tip.

19. The device of claim 16 , further comprising a fluid-soluble, time-release material covering the antimicrobial composition.

20. The device of claim 19 , wherein the time-release material is configured to dissolve in fluid to expose the antimicrobial composition to the fluid in a time interval of between 1 second and 60 seconds.

21. The device of claim 19 , wherein the time-release material is configured to dissolve in fluid to expose the antimicrobial composition to the fluid in a time interval of between 1 minute and 10 minutes.

22. The device of claim 16 , wherein the recess surface has a width greater than 0.5 mm.

Assignments (3)

Continuity (7)

References Cited (400)

Cited By (7)

US 12,485,263 US 12,485,264 US 12,539,409 US 12,594,410 US 12,661,492 US 12,673,005 US 12,697,477