IP Library Granted Patent US 12,246,137
Granted Patent B2
US 12,246,137 · App. 18/356,331 · Granted Mar 11, 2025

Catheter lock solution comprising sodium citrate and benzyl alcohol

Inventor: Stephen R. Ash (Lafayette, IN)
Assignee: HEMOCLEANSE TECHNOLOGIES LLC
A61M25/0017A61L2/18A61L29/16A61L2101/36A61M2025/0019
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Quick Facts
Patent No.
US 12,246,137
App. No.
18/356,331
Granted
Mar 11, 2025
Kind
B2
Abstract

This disclosure generally relates to catheters, methods of enhancing the patency of an intravascular catheter and compositions, methods, devices and kits relating to the infusion of a catheter lock solution into an indwelling catheter. Disclosed compositions, methods, devices and kits aid in diminishing the effects of microbial infection in catheters and occlusion of the catheters. A representative lock solution includes about 10% sodium citrate and about 1.5% benzyl alcohol. The solution has a density approximating the density of blood for retention of the solution in a catheter during the lock period.

Claims (25)

1. An aqueous antimicrobial solution comprising a synergistic amount of about 6 to about 11% by weight citrate and about 1.0 to about 2.0 percent by weight benzyl alcohol dispersed or dissolved therein.

2. The solution of claim 1 , wherein the concentration of citrate in the solution is from about 6 to about 10.5% by weight.

3. The solution of claim 1 , wherein the citrate is trisodium citrate dihydrate.

4. The solution of claim 1 , wherein the pH of the solution is from about 5 to about 7.5.

5. The solution of claim 1 , wherein the pH of the solution is from about 6 to about 7.

6. The solution of claim 1 , wherein the relative density of the solution is from about 1.030 to about 1.060 g/ml.

7. The solution of claim 1 , wherein the solution further comprises a viscosifying agent.

8. The solution of claim 7 , wherein the viscosifying agent comprises dextran, polyethylene glycol, glycerin, polygeline, a non-metabolizable sugar, or a combination thereof.

9. The solution of claim 1 , wherein the citrate has a concentration of from about 6 to about 10.5% by weight and the concentration of benzyl alcohol is from about 1.0 to about 1.7% by weight.

10. A catheter lock solution to prevent clotting of central venous catheters and to kill bacteria contaminating the interior lumen of the catheters comprising the antimicrobial composition of claim 1 .

11. The solution of claim 10 , in which the pH is adjusted to a range of about 6.0 to about 6.5 by addition of citric acid or other form of acid.

12. A method to prevent clotting of central venous catheters and to kill bacteria contaminating the interior lumen of the catheters using the catheter lock solution of claim 10 .

13. A method of inhibiting infection in an indwelling catheter defining at least one lumen therethrough, the method comprising infusing an aqueous catheter lock solution into a lumen of the catheter, the solution comprising about 5 to about 11% by weight citrate and about 0.5 to about 2.0 percent by weight benzyl alcohol.

14. The method of claim 13 wherein the catheter is an intravascular catheter or a body cavity catheter.

15. The method of claim 13 wherein the lumen of the catheter has an internal volume and the method comprises infusing an amount of the lock solution that is from about 80% to about 120% of the internal volume of the lumen.

16. The method according to claim 13 wherein the concentration of citrate in the solution is at least as high as the calcium concentration in a patient's blood.

17. The method according to claim 13 wherein the concentration of citrate in the solution is from about 6 to about 10.5% by weight.

18. The method according to claim 13 wherein the citrate is trisodium citrate dihydrate.

19. The method of according to claim 13 wherein the pH of the solution is from about 5 to about 7.5.

20. The method according to claim 13 wherein the pH of the solution is from about 6 to about 7.

21. The method according to claim 13 wherein the relative density of the solution is from about 1.030 to about 1.060 g/ml.

22. The method according to claim 13 wherein the solution further comprises a viscosifying agent.

23. The method according to claim 22 wherein the viscosifying agent comprises dextran, polyethylene glycol, glycerin, polygeline, a non-metabolizable sugar, or a combination thereof.

24. The method according to claim 13 , wherein the catheter is in a patient.

25. The method according to claim 24 , wherein the catheter is surgically implanted.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 21, 2023
From: ASH, STEPHEN R.
To: ASH ACCESS TECHNOLOGY, INC.
Reel/Frame 064336/0761 →
CHANGE OF NAME Recorded Jul 21, 2023
From: ASH ACCESS TECHNOLOGY, INC.
To: HEMOCLEANSE TECHNOLOGIES LLC
Reel/Frame 064336/0859 →
Continuity (3)
Continuation 16766326
Provisional Application 62590536 · Nov 25, 2017
Related Publication 20230364380A1 · Nov 16, 2023
References Cited (15)
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Shenep et al., Efficacy of Intravascular Catheter Lock Solutions Containing Preservatives in the Prevention of Microbial Colonization, J. Hosp Infect., 2011, 12 pages, vol. 79, Memphis, TN. [cited by applicant]
International Search Report, International Searching Authority, International Patent Application No. PCT/US18/62240, Jan. 24, 2019, 2 pages. [cited by applicant]
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