IP Library Granted Patent US 12,420,317
Granted Patent B2
US 12,420,317 · App. 17/867,053 · Granted Sep 23, 2025

Methods and compositions for decontaminating PD catheters

Inventors: Garrick Lawrence Maenle (Arlington-Heights, IL); Robert Radford (Evanston, IL); Cristian Adolfo Menzel Bueno (Gurnee, IL); Mark Edward Pasmore (Grayslake, IL); Shawn Collin Oppegard (Fox River Grove, IL)
Assignees: Baxter International Inc.; Baxter Healthcare SA
B08B9/0321A61M1/285C11D1/37C11D3/2086C11D3/48A61M2025/0019B08B2209/032C11D1/143C11D1/146
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Quick Facts
Patent No.
US 12,420,317
App. No.
17/867,053
Granted
Sep 23, 2025
Kind
B2
Abstract

A method of performing peritoneal dialysis (PD), the method comprising: delivering a PD fluid to the peritoneal cavity of a patient through a PD catheter; dwelling the PD fluid within the peritoneal cavity; and while dwelling the PD fluid, removing a biofilm from the PD catheter wall using a biofilm removing solution. The biofilm removing solution comprises: sodium citrate dihydrate; citric acid anhydrous; sodium lauryl sulfate; and water. In another aspect, a method for decontaminating a peritoneal dialysis (PD) catheter and removing a biofilm from the PD catheter and a transfer set, the method comprising: providing a biofilm removing solution; transferring the biofilm removing solution into a syringe; connecting the syringe to a transfer set of the PD catheter; and filling the transfer set and the PD catheter with the biofilm removing solution.

Claims (42)

1. A method of performing peritoneal dialysis (PD), the method comprising: delivering a PD fluid to a peritoneal cavity of a patient through a PD catheter; dwelling the PD fluid within the peritoneal cavity; and while dwelling the PD fluid, removing a biofilm from a wall of the PD catheter using a biofilm removing solution, wherein the biofilm removing solution consists of: sodium citrate dihydrate in a concentration range of about 32.12 g/L to about 39.27 g/L; citric acid anhydrous in a concentration range of about 29.25 g/L to about 35.75 g/L; sodium lauryl sulfate in a concentration range of about 0.95 g/L to about 1.05 g/L; and water.

2. The method of claim 1 , wherein the biofilm removing solution has:

a pH value in the range of about 3.70 to about 4.10;

a total citrates in a concentration range of about 57.45 g/L to about 70.21 g/L; and

a specific gravity in range of about 1.025 to about 1.042.

3. A method of performing peritoneal dialysis (PD), the method comprising:

delivering a PD fluid to a peritoneal cavity of a patient through a PD catheter;

dwelling the PD fluid within the peritoneal cavity; and

while dwelling the PD fluid, removing a biofilm from a wall of the PD catheter using a biofilm removing solution,

wherein the biofilm removing solution consists of:

sodium citrate dihydrate in a concentration range of about 32.13 g/L to about 39.27 g/L;

citric acid anhydrous in a concentration range of about 29.25 g/L to about 35.75 g/L;

sodium lauryl sulfate in a concentration range of about 0.95 g/L to about 1.05 g/L; water; and

alkyl sulfonates in a concentration range of about 0.61 g/L to about 1.10 g/L.

4. A method of performing peritoneal dialysis (PD), the method comprising:

delivering a PD fluid to a peritoneal cavity of a patient through a PD catheter;

dwelling the PD fluid within the peritoneal cavity; and

while dwelling the PD fluid, removing a biofilm from a wall of the PD catheter using a biofilm removing solution,

wherein the biofilm removing solution consists of:

sodium citrate dihydrate in a concentration range of about 32.13 g/L to about 39.27 g/L;

citric acid anhydrous in a concentration range of about 29.25 g/L to about 35.75 g/L;

sodium lauryl sulfate in a concentration range of about 0.95 g/L to about 1.05 g/L; water; and

an antimicrobial ingredient, wherein the antimicrobial ingredient is selected from the group consisting of: an antibiotic, a bleach and silver sulfadiazine.

5. The method of claim 1 , wherein the PD fluid further includes an antibiotic for treating bacteria exposed by the removed biofilm.

6. The method of claim 1 , wherein the step of removing the biofilm from the wall of the PD catheter using the biofilm removing solution comprises:

transferring the biofilm removing solution into a syringe;

fluidly communicating the syringe with a transfer set located along the PD catheter; and

filling the transfer set and the PD catheter with the biofilm removing solution.

7. The method of claim 6 , wherein the step of removing the biofilm from the wall of the PD catheter using the biofilm removing solution further comprises:

closing a valve of the transfer set to keep the biofilm removing solution in the transfer set and the PD catheter for a first period of duration.

8. The method of claim 7 , wherein the first period of time is between about 1 hour and about 12 hours.

9. The method of claim 7 , wherein the first period of time is between about 1 hour and about 1.8 hours.

10. The method of claim 7 , wherein the first period of time is about 1.5 hours.

11. The method of claim 9 , wherein the step of removing a biofilm from the PD catheter wall using the biofilm removing solution further comprises removing the biofilm removing solution, the PD fluid and the biofilm.

12. The method of claim 11 , wherein the step of removing the biofilm removing solution, the PD fluid and the biofilm comprises:

replacing the syringe with appropriate fluid connection(s) to an effluent bag or other drain; and

opening the valve of the transfer set to drain the biofilm removing solution and the PD fluid into the effluent bag or other drain via gravity or pumping,

wherein the biofilm removing solution and the PD fluid comprise the biofilm removed from the transfer set and the PD catheter.

13. The method of claim 11 , wherein the biofilm is removed from a plurality of inner walls of the transfer set and the PD catheter and an outer wall of a portion of the PD catheter located within a patient's peritoneal cavity.

14. A method of performing peritoneal dialysis (PD), the method comprising: pumping or delivering a PD fluid including a biofilm removing solution to a peritoneal cavity of a patient through a PD catheter; dwelling the PD fluid including a biofilm removing solution within the peritoneal cavity; and while dwelling the PD fluid including a biofilm removing solution, removing a biofilm from a wall of the PD catheter via the a biofilm removing solution wherein the biofilm removing solution consists of: sodium citrate dihydrate in a concentration range of about 32.13 g/L to about 39.27 g/L; citric acid anhydrous in a concentration range of about 29.25 g/L to about 35.75 g/L; sodium lauryl sulfate in a concentration range of about 0.95 g/L to about 1.05 g/L; and water.

15. The method of claim 14 , wherein the PD fluid further includes an antibiotic for treating bacteria exposed by the removed biofilm.

16. A method of removing at least a portion of a biofilm present in a lumen of an indwelling peritoneal catheter while performing peritoneal dialysis therapy, the method comprising: delivering a dialysis fluid to a peritoneal cavity of a patient through the catheter; injecting a biofilm removing solution into the lumen of the catheter to occupy at least a portion of the lumen; dwelling the dialysis fluid within the peritoneal cavity; and removing at least a portion of the biofilm removing solution from the catheter by withdrawing at least a portion of the dialysis fluid from the peritoneal cavity into the catheter, wherein the biofilm removing solution consists of: sodium citrate dihydrate in a concentration range of about 32.13 g/L to about 39.27 g/L; citric acid anhydrous in a concentration range of about 29.25 g/L to about 35.75 g/L; sodium lauryl sulfate in a concentration range of about 0.95 g/L to about 1.05 g/L; and water.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 31, 2025
From: BAXTER HEALTHCARE SA
To: VANTIVE HEALTH GMBH
Reel/Frame 073433/0234 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 31, 2025
From: BAXTER INTERNATIONAL INC.
To: VANTIVE US HEALTHCARE LLC
Reel/Frame 074046/0877 →
SECURITY INTEREST Recorded Jan 31, 2025
From: VANTIVE US HEALTHCARE LLC; GAMBRO RENAL PRODUCTS, INC.
To: ARES CAPITAL CORPORATION
Reel/Frame 070076/0701 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 29, 2023
From: OPPEGARD, SHAWN COLLIN
To: BAXTER INTERNATIONAL INC.; BAXTER HEALTHCARE SA
Reel/Frame 064115/0451 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 1, 2022
From: MAENLE, GARRICK LAWRENCE; RADFORD, ROBERT; BUENO, CRISTIAN ADOLFO MENZEL; PASMORE, MARK EDWARD
To: BAXTER INTERNATIONAL INC.; BAXTER HEALTHCARE SA
Reel/Frame 060685/0447 →
Continuity (1)
Related Publication 20240017302A1 · Jan 18, 2024
References Cited (3)
US 20170157311A1 · Egley · 2017 [cited by examiner]
US 20180185410A1 · Holmgren · 2018 [cited by examiner]
US 20190336714A1 · Vazales · 2019 [cited by examiner]