Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
1995-11-08
2003-05-06
Levy, Neil S. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C523S122000, C600S030000, C604S891100, C623S009000
Reexamination Certificate
active
06558686
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the use of a combination of antiseptics for coating or impregnating indwelling or implanted medical devices, to inhibit the growth of bacterial and fungal organisms. The invention also relates to a method of coating or impregnating the indwelling or implanted medical device with a combination of antiseptics.
2. Description of the Prior Art
Indwelling vascular catheters are becoming essential in the management of hospitalized patients. Implanted orthopedic devices are also becoming more prevalent, partly to meet the needs of a growing elderly population. The benefit derived from these catheters and orthopedic devices, as well as other types of medical implants is often offset by infectious complications. The most common organisms causing infectious complications of vascular catheters and orthopedic devices are
Staphylococcus epidermidis
and
Staphylococcus aureus
. In the case of vascular catheters, these two organisms account for almost 70-80% of all infectious organisms, with
Staphylococcus epidermidis
being the most common organism. Gram-negative bacilli cause about 15-20% of infected cases, and Candida species, a fungal agent, accounts for about 10-15% of vascular catheter infections.
Staphylococcus epidermidis
and
Staphylococcus aureus
also are responsible for about two-thirds of the cases of infection in orthopedic implants. Other gram-negative bacteria and fungal organisms (Candida) account for the remaining one-third of cases.
Another common hospital-acquired infection is urinary tract infection (UTI). The majority of cases of UTI are associated with the use of urinary catheters, including transurethral foley, suprapubic and nephrostomy catheters. These urinary catheters are inserted in a variety of populations, including the elderly, stroke victims, spinal cord-injured patients, post-operative patients and those with obstructive uropathy. Despite adherence to sterile guidelines for the insertion and maintenance of urinary catheters, catheter-associated UTI continues to pose a major problem. In the U.S. alone, about 1 million cases of hospital-acquired cases of UTI occur annually. For instance, it is estimated that almost one-quarter of hospitalized spinal cord-injured patients develop symptomatic UTI during their hospital course. Gram-negative bacilli account for almost 60-70%, enterococci for about 25% and Candida species for about 10% of cases of UTI.
Colonization of bacteria on the surfaces of the implant or other parts of the device can produce serious patient problems, including the need to remove and/or replace the implanted device and to vigorously treat secondary infective conditions. A considerable amount of attention and study has been directed toward preventing such colonization by the use of antimicrobial agents, such as antibiotics, bound to the surface of the materials employed in such devices. In such attempts the objective has been to produce a sufficient bacteriostatic or bactericidal action to prevent colonization.
Various methods have previously been employed to prevent infection of medical devices. One of the simplest methods would be to flush the surfaces of the device with an antibiotic solution. Generally, the flushing technique would require convenient access to the implantable device. For example, catheters are generally amenable to flushing with a solution of rifampin and minocycline or rifampin and novobiocin. For use in flushing solutions, the effective concentration of the antibiotic would range from about 1 to 10 mg/ml for minocycline, preferably about 2 mg/ml; 1 to 10 mg/ml for rifampin, preferably about 2 mg/ml; and 1 to 10 mg/ml for novobiocin, preferably about 2 mg/ml. The flushing solution would normally be composed of sterile water or sterile normal saline solutions.
A method of coating the devices would be to first apply or absorb to the surface of the medical device a layer of surfactant, such as tridodecylmethyl ammonium chloride (TDMAC) surfactant followed by an antibiotic coating layer. For example, a medical device having a polymeric surface, such as polyethylene, silastic elastomers, polytetrafluoroethylene or Dacron, can be soaked in a 5% by weight solution of TDMAC for 30 minutes at room temperature, air dried, and rinsed in water to remove excess TDMAC. Alternatively, TDMAC pre-coated central vascular catheters are commercially available. The device carrying the absorbed TDMAC surfactant coating can then be incubated in an antibiotic solution for up to one hour or so, allowed to dry, then washed in sterile water to remove unbound antibiotic and stored in a sterile package until ready for implantation. In general, the antibiotic solution is composed of a concentration of 0.01 mg/ml to 60 mg/ml of each antibiotic in an aqueous pH 7.4-7.6 buffered solution, sterile water, or methanol. According to one method, an antibiotic solution of 60 mg of minocycline and 30 mg of rifampin per ml of solution is applied to the TDMAC coated catheter.
A further method known to coat the surface of medical devices with antibiotics involves first coating the selected surfaces with benzalkonium chloride followed by ionic bonding of the antibiotic composition. See, e.g., Solomon, D. D. and Sherertz, R. J.,
J. Controlled Release
, 6:343-352 (1987) and U.S. Pat. No. 4,442,133.
Other methods of coating surfaces of medical devices with antibiotics are taught in U.S. Pat. No. 4,895,566 (a medical device substrate carrying a negatively charged group having a pK of less than 6 and a cationic antibiotic bound to the negatively charged group); U.S. Pat. No. 4,917686 (antibiotics are dissolved in a swelling agent which is absorbed into the matrix of the surface material of the medical device); U.S. Pat. No. 4,107,121 (constructing the medical device with ionogenic hydrogels, which thereafter absorb or ionically bind antibiotics); U.S. Pat. No. 5,013,306 (laminating an antibiotic to a polymeric surface layer of a medical device); and U.S. Pat. No. 4,952,419 (applying a film of silicone oil to the surface of an implant and then contacting the silicone film bearing surface with antibiotic powders).
These and many other methods of coating medical devices with antibiotics appear in numerous patents and medical journal articles. However, although antibiotic-coated medical devices, such as those coated with minocycline and rifampin, are very effective against Staphylococci, their efficacy against gram-negative bacteria and candida is limited. Moreover, there exists a potential concern of developing antibiotic resistance due to the use of antibiotics for coating devices.
Accordingly, there is a need for an antimicrobial coated medical device that will provide a broader range of antimicrobial activity. There is also a need for an antimicrobial coated medical device that will avoid the potential concern of developing antibiotic resistance.
SUMMARY OF THE INVENTION
An object of the present invention is the provision of an antiseptic coated medical device.
A further object of the invention is a practical, inexpensive, safe and effective method for coating or impregnating medical devices with a combination of antiseptics.
Another object of the invention is the application of a combination of antiseptics to a medical device to avoid developing antibiotic resistance.
Thus in accomplishing the foregoing objects, there is provided in accordance with one aspect of the present invention an implantable medical device comprising a medical device having one or more surfaces; and an antiseptic composition layer coating said one or more surfaces of the medical device, the antiseptic composition including a combination of antiseptics in an effective concentration to inhibit the growth of bacterial and fungal organisms. The medical device can be either a metallic or a non-metallic device.
In the non-metallic embodiment the antiseptic composition layer penetrates the surfaces thereof. The antiseptic composition, according to this embodiment, may preferably comprise a mixture of the combin
Baylor College of Medicine
Fulbright & Jaworski LLP
Levy Neil S.
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