Kit for flushing medical devices and method of preparation

• US 6,187,768 B1
• Filed: 06/01/1999
• Issued: 02/13/2001
• Est. Priority Date: 06/01/1999
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Felton, Steven C., Welle, Charles J., Khan, Mohammad A.
• Primary Examiner(s): Weddington, Kevin E.
• Application Number:
  US09/323,984
• Time in Patent Office: 623 Days
• Field of Search: 514/199, 514/152, 514/24, 514/25, 514/29, 514/200, 514/601
• US Class Current: 514/199
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30

Abstract

A kit and for flushing a medical device a method of preparing the kit is disclosed. The kit includes a container containing a mixed solution a unit dose of a pharmacologically effective amount of an antimicrobial agent and a second agent. The mixed solution has been mixed in a carrier solution and lyophilized. The second agent is an anticoagulant, an antithrombotic agent or a chelating agent. The kit and method are useful for maintaining the patency of indwelling medical devices such as catheters and for preventing infections caused by bacterial growth in catheters.

Claims

1. A kit for flushing a medical device comprising:

a dry lyophilized unit dose of a pharmacologically effective amount of an antimicrobial agent and a second agent selected from the group consisting of an anticoagulant, an antithrombotic agent and a chelating agent.

2. The kit of claim 1, further comprising a second carrier solution for reconstituting the lyophilized unit dose.

3. The kit of claim 1, wherein the antimicrobial agent is selected from the group consisting of aminoglycoside, amphothericin B, ampicillin, carbenicillin, cefazolin, cephalosporin, chloramphenicol, clindamycin, erythromycin, gentamicin, griseofulvin, kanamycin, methicillin, nafcillin, novobiocin, penicillin, polymyxin, rifampin, streptomycin, sulfamethoxazole, sulfonamide, tetracycline, trimethoprim, a pharmacologically acceptable sodium salt, a pharmacologically acceptable calcium salt, and a pharmacologically acceptable potassium salt.

4. The kit of claim 3, wherein the chelating agent is selected from the group consisting of EGTA, diethylenetriamine penta acetic acid, DMSA, deferoxamine, dimercaprol, zinc citrate, a combination of bismuth and citrate, penicillamine, succimer and etidronate.

5. The kit of claim 1, wherein the anticoagulant is selected from the group consisting of EDTA, heparin, and hirudin.

6. The kit of claim 1, wherein the antimicrobial agent is a tetracycline antibiotic.

7. The kit of claim 1, wherein the antimicrobial agent is minocycline.

8. A kit for flushing a medical device comprising a lyophilized unit dose of a pharmacologically effective amount of minocycline and EDTA mixed in a carrier solution.

9. The kit of claim 8, wherein the unit dose contains at least about 9 mg of minocycline and at least about 90 mg of EDTA.

10. The kit of claim 8, further comprising a preselected amount of a second carrier solution such that when the second carrier solution is mixed with the lyophilized unit dose, the concentration of minocycline is 3 mg/ml and the concentration of EDTA is 30 mg/ml.

11. A kit for flushing a catheter comprising:

a lyophilized unit dose of mixture of at least about 9 mg of minocycline and at least about 90 mg of EDTA that has been mixed in a carrier solution;

a second carrier solution for reconstituting the lyophilized unit dose;

a container for mixing the second carrier solution and the lyophilized unit dose; and

means for introducing the mixture of the lyophilized unit dose and the second carrier solution into the catheter.

12. A method of preparing a solution for flushing a catheter comprising:

lyophilizing a mixture of a pharmacologically effective amount of minocycline and EDTA in a carrier solution;

storing the lyophilized mixture in a container; and

reconstituting the lyophilized mixture in a liquid.

13. The method of claim 12, wherein the reconstituted solution contains at least about 3 mg/ml of minocycline and at least about 30 mg/ml EDTA.

14. A method for preparing a lyophilized solution for flushing a medical device comprising:

mixing in a carrier solution an antimicrobial agent and a second agent selected from the group consisting of an anticoagulant, an antithrombotic agent and a chelating agent; and

lyophilizing the mixture to provide a unit dose of the mixture which can be reconstituted in a second carrier solution.

15. The method of claim 14, wherein the antimicrobial agent is selected from the group consisting of aminoglycoside, amphothericin B, ampicillin, carbenicillin, cefazolin, cephalosporin, chloramphenicol, clindamycin, erythromycin, gentamicin, griseofulvin, kanamycin, methicillin, nafcillin, novobiocin, penicillin, polymyxin, rifampin, streptomycin, sulfamethoxazole, fulfonamide, tetracycline, trimethoprim, a pharmacologically acceptable sodium salt, a pharmacologically acceptable calcium salt, and a pharmacologically acceptable potassium salt.

16. The method of claim 15, wherein the chelating agent is selected from the group consisting of EGTA, diethylenetriamine penta acetic acid, DMSA, deferoxamine, dimercaprol, zinc citrate, a combination of bismuth and citrate, penicillamine, succimer and Etidronate.

17. The method of claim 16, wherein the anticoagulant is selected from the group consisting of EDTA, heparin, and hirudin.

18. The method of claim 16, wherein the antimicrobial agent is a tetracycline antibiotic.