1. Technical Field
The present disclosure relates generally to body fluid testing devices and methods, and more particularly, to a body fluid testing device and method that incorporates a post-operative test strip of material and a media-dispensing apparatus.
2. Background of the Art
Infection is a serious complication of implantable and insertable medical devices. The most common microorganisms causing these complications are Staphylococcus epidermidis and Staphylococcus aureus, which account for about two-thirds of cases of contamination or infection. Other gram-positive bacteria, gram-negative bacteria, viruses, and fungal microorganisms such as Candida, account for the remaining one-third of cases. Management of infected medical devices is very expensive and in most instances requires the removal of the infected device from the patient. Replacement medical devices must then be inserted or implanted in place of the contaminated medical device, which may require taking an X-ray to ensure proper insertion or implantation of the medical device. Accordingly, removal and replacement of medical devices is costly to hospitals and patients.
In patients with indwelling medical devices who develop fever, the possibility of device-related infection is considered. To accurately determine if the medical device is the source of infection, the medical device is typically removed and cultured to observe whether microbial activity is present on the medical device. Accordingly, even if the medical device turns out not to be the source of infection, it has already been removed, and a new medical device must be put in place of the suspect medical device. It has been reported that as much as 85% of indwelling central venous catheters that have been removed in suspicion of catheter-related infection yield sterile cultures. Thus, in as much as 85% of the time that medical devices are removed from patients, the medical devices themselves are not causing the fever, and the removal of them, in hindsight, was not necessary.
It has been observed that in the majority of cases where microbial contamination or infection of vascular catheters have been detected, the primary cause was dermal microbial colonization at the insertion or implantation site. The dermal microbial colonization migrated along the medical devices to colonize the medical devices at the interface between the medical device and the insertion or implantation site. This finding suggests that a prominent location to detect potentially pathogenic microbes would be at the medical device insertion or implantation site, and in some cases, on the external surface of the medical devices.
Infections are also attributed to leaks after suturing or stapling tissue, e.g., intestinal tissue. Intestinal contents have high concentrations of bacteria, which, if leaked into the abdomen, may lead to an inflammation or an infection. With current technology, it is difficult to detect the infection at an early stage when it is easiest to treat.
The acquisition and testing of body fluids is useful for many purposes and continues to grow in importance for use in medical diagnosis and treatment, and in other diverse applications. In the medical field, it is desirable for operators to be able to perform such tests routinely, quickly and reproducibly. Testing can be performed on various body fluids, and for certain applications is particularly related to the testing of blood and/or interstitial fluid. Such fluids can be tested for a variety of characteristics of the fluid, or analytes contained in the fluid, to identify a medical condition, determine therapeutic responses, assess the progress of treatment, and the like.
Various methods and apparatus for testing body fluids have been developed. These include inserting a syringe into a vein to withdraw a blood sample, making an incision in a patient's skin and collecting the blood in a container, and creating an incision and having patients urge fluid to the incision site by applying pressure to the area surrounding the incision. Sampling devices may be used to analyze the sample for a variety of properties or components. Such devices include, for example, systems in which a tube or test strip is either located adjacent the incision site prior to forming the incision, or is moved to the incision site shortly after the incision has been formed. The test strips in these systems include structure which react with the fluid to allow the sample to be analyzed. Such structure could allow for optical, electrochemical, and/or magnetic ways for analyzing the sampled fluid. One example of a testing device using a test media tape is disclosed in International Publication No. WO 2004/0005629 A1, the entire contents of which are incorporated by reference herein.
USPTO Backgrounds
USPTO Backgrounds