Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
1999-06-01
2001-02-13
Weddington, Kevin E. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
C514S152000, C514S024000, C514S025000, C514S029000, C514S200000, C514S601000
Reexamination Certificate
active
06187768
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to indwelling medical devices, for example, catheters. More particularly, the present invention relates to kits and methods for preparing these kits which can be used to flush these medical devices to maintain their patency.
BACKGROUND OF THE INVENTION
Indwelling medical devices, including intravascular catheters, are among the most commonly used medical devices. Such catheters are routinely placed into a patient s vascular system for many procedures and often are left in place for extended periods. Since an intravascular catheter is a direct path from the outside environment to the patients bloodstream, the catheter presents a substantial and continuous potential for introduction of microorganisms into the patient's bloodstream. Clinicians have developed many protocols related to placement, use, attachment and detachment of fluid handling devices and other procedures related to catheters. The goal of almost all of these procedures is to avoid introduction of a microorganism into the patient's bloodstream.
When a medicament is introduced into a patient through a catheter, the practitioner commonly follows the introduction with a flush solution that may include an anticoagulant such as heparin. The purpose of the flush solution is to move the medicament out of the catheter so that the entire dosage is delivered, and to leave a residual fill in the catheter so that the patient's blood does not back up in the catheter and possibly form a clot that would occlude the bore of the catheter. Thus, when the catheter is subsequently needed again, the properly flushed catheter is likely fully patent and ready for the next usage.
In 1988, Root, et al., published a study that reported on the effect of disodium ethylene diamine tetra acetic acid (EDTA), a compound well known for its chelating properties in vivo and widely used as an anticoagulant in vitro. The authors compared EDTA, heparin and vancomycin/heparin for effectiveness upon the growth of
S. epidermis
in vitro and its relation to infection prophylaxis of Hickman catheters in their report in
Antimicrob. Agents Chemother.,
32:1627-1631, (1988). Recently, Raad, et al., in U.S. Pat. No. 5,363,754, disclosed that pharmaceutical compositions of a mixture of minocycline and EDTA were useful in maintaining the patency of a catheter port. The compositions are useful in preventing adhesions of infectious organisms, such as
S. epidermidis
and
S. aureus.
More recently, Raad, et al. in U.S. Pat. No. 5,688,516, further disclosed that effective catheter flush solutions could he prepared with non-glycopeptide antimicrobial agents other than vancomycin and a second agent selected from the group consisting of (a) an anticoagulant, (b) an antithrombotic agent, and (c) a chelating agent. Raad, et al. teaches that since many antibiotic agents are not particularly stable at ambient conditions in aqueous solutions, the disclosed compositions are stable and effective for about one month when stored under refrigerated conditions. In addition, the solution should be brought to room temperature before administration to a patient. Alternatively, Raad, et al. teaches a kit including three compartments, the compartments containing the antimicrobial agent, the chelating, anticoagulant or antithrombotic agent and a diluent such as saline, Ringers solution or water so that the clinician could mix the components prior to administration to the patient, thereby avoiding the reported stability problems.
U.S. patent application Ser. No. 09/160,745, filed on Sep. 25, 1998 and entitled Catheter Flush Solution, discloses solutions useful for flushing intravascular catheters comprising a pharmacologically acceptable sodium salt, a pharmacologically acceptable calcium salt, a pharmacologically acceptable potassium salt, and about one milligram per milliliter of polyhexamethylene biguanide in an aqueous admixture. Examples of pharmacalogically acceptable salts disclosed therein include sodium chloride, calcium chloride and potassium chloride.
While the disclosures of Raad, et al. and U.S. application Ser. No. 09/160,745 teach a variety of antimicrobial agents combined with a variety of other compounds, such solutions typically have a short shelf-life once the components are mixed together, particularly solutions of minocycline and EDTA (hereinafter referred to as M-EDTA). A mixed solution of M-EDTA turns yellow when stored and has a shelf-life of less than seven days, and M-EDTA solutions must be used within three days of mixing.
One method of solving the problem with the short shelf-life of the mixed solutions is to provide assembled kits containing a vial of EDTA, a vial of minocycline, and a device for delivering the mixed solutions to a catheter, such as a syringe. Another method of addressing the problem is for the hospital pharmacy to prepare the solution upon request as required. However, both of these methods are expensive and cost prohibitive in practice. One particular problem associated with both of these methods is that there is typically excess solution that must be discarded.
There is an explicit need for a kit and a method for providing catheter flush solutions that have a long shelf life and are simple and inexpensive to use in the hospital setting. It would be useful to provide a kit containing a unit dose of the solution containing all of the components (e.g., an antimicrobial agent and an anticoagulant) which is ready to be mixed with a carrier solution and flushed through an indwelling medical device such as a catheter.
SUMMARY OF INVENTION
Accordingly, the present invention generally provides a kit and a method for preparing a kit for flushing a medical device, such as a catheter. The kit includes a container containing a dry mixture of a 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. As used herein, pharmacologically effective amount means that the solution is effective in the local area of the medical device. According to the present invention, the dry mixture has been mixed in a carrier solution and lyophilized. In another aspect of the invention, the kit may further include a second carrier solution for reconstituting the lyophilized unit dose.
According to one aspect of the invention, 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 calcium salt, and a pharmacologically acceptable potassium salt. In another aspect of the invention, 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. In still another aspect, the anticoagulant is selected from the group consisting of EDTA, heparin, and hirudin.
In a preferred embodiment, the antimicrobial agent is a tetracycline antibiotic, and more preferably, the antimicrobial agent is minocycline. Preferably, the kit contains a unit dose of a pharmacologically effective amount of minocycline and EDTA mixed in a carrier solution and lyophilized. More preferably, the kit includes 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.
Another aspect of the invention involves a method of preparing a solution, which can be used in a kit for flushing a catheter. The method involves mixing in a carrier solution an antimicrobial agent and a second agent selected from the group consisting of an anticoagulant, an
Felton Steven C.
Khan Mohammad A.
Welle Charles J.
Becton Dickinson and Company
Lee, Esq. Eric M.
Weddington Kevin E.
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