Surgery – Diagnostic testing – Liquid collection
Reexamination Certificate
1999-08-27
2001-05-22
Jackson, Gary (Department: 3731)
Surgery
Diagnostic testing
Liquid collection
C604S314000, C604S316000, C606S203000
Reexamination Certificate
active
06234980
ABSTRACT:
The present invention relates generally to an improved treatment for inadvertent sharps
eedlestick injuries to healthcare workers and the like, and, more particularly, to an apparatus for restricting blood flow to the area of the sharps injury, an apparatus for mechanically applying a sub-atmospheric pressure directly to the site of the sharps injury, a mechanism for delivering an antimicrobial/antiviral agent(s) to the site, and a convenient time saving kit for containing all of these components.
BACKGROUND OF THE INVENTION
There are approximately 1 million sharps and/or needlestick related injuries reported in the United States annually. This equates to about two needlestick injuries every minute. However, it is also reported that about 50% of the injuries that occur go unreported. Taking the unreported injuries into consideration, there could be upwards of 2 million sharps and/or needlestick injuries per year in this country.
Sharps related injuries carry the potential of infecting the injured person with a host of diseases which include, for example, human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). According to a 1997 report from the Centers for Disease Control and Prevention, the risk of HIV seroconversion, after a needlestick or cut exposure to HIV-infected blood is 0.3%. This risk increases with: 1) an increase in the quantity of infected blood being introduced into the injured tissue, 2) a higher viral load in the source of the contaminated blood at the time of the exposure, 3) an increased depth of the wound, and 4) if no post exposure treatment was administered.
Hollow bore needles, for example, increase the risk of contracting a disease, due to a sharps and/or needlestick related injury, because such needles can both deliver relatively large amounts of infected blood and achieve a fairly deep percutaneous penetration. It is to be appreciated that patients who are in the laterstages of AIDS usually have a high HIV load in their blood. They also require significant medical treatment including vascular access via hollow bore needles. Some of these patients get dementia and become relatively uncooperative during the later stages of AIDS prior to death. This condition can further increase the potential risk of an inadvertent needlestick injury to a healthcare worker.
As of December 1996, the Centers for Disease Control and Prevention had reported 52 documented cases and 111 possible cases of occupationally acquired HIV among healthcare workers in this country. A majority of these cases, i.e. 87%, are directly related to a sharps injury.
While HIV is a serious concern, hepatitis has a higher transmission rate and can be just as deadly. Although HBV carries a risk of infection of about 30%, which is one hundred times greater than HIV, healthcare workers can and should get vaccinated against this disease. HCV is a different story because of the lack of an available vaccine. HCV carries a about 10% risk of infection. Almost everyone contracting HCV will become a chronic carrier and about two-thirds will go on to have elevated liver enzymes requiring expensive drug treatment. HCV is currently the leading cause for liver transplant which costs upward of $
500
,
000
.
Currently on the market, there are numerous devices that shield, contain, and/or facilitate removal of a needle to minimize the risk of a healthcare worker getting stuck, and possibly infected, by a contaminated sharps needle. Such prior art devices, however, have only penetrated about 15% of the total United States market. The reason for this is several fold: such devices increase the cost of using the needle, some devices may be somewhat more difficult to utilize, and healthcare worker indifference to the seriousness of the potential problem. The bottom line is that needlesticks are occurring at a rate of about 2 to 4 per minute each day.
State legislation, starting with the state of California, is putting teeth into current OSHA regulations. These new regulations are requiring the use of sharps protection devices. The use of such devices has been shown to reduce the incidence of injury by up to 85%. But such efforts have not completely eliminated all of the sharps injuries.
The current procedure for post needlestick injury is to immediately administer first aid. This is generally defined as expressing blood from the site of the sharps injury in an attempt to flush the wound with one's own blood as completely as possible. If the expressing procedure is successfully executed, this can substantially reduce the viral loading at the site and hence substantially reduce the chance of infection resulting from the needle stick. Following the expressing step, it is next suggested to wash the injured area with an antimicrobial soap. There are some data that indicate vigorously scrubbing of injured area with an antimicrobial/antiviral agent(s) is beneficial. Next, the healthcare employee needs to report the incident to the appropriate authorities and be examined by a physician. Finally, once all of the above steps are completed and a full medical assessment is made, a treatment program can then be developed for the injured individual. It is to be appreciated that the resulting treatment program possibly involves a multi-drug regiment to reduce the risk of infection.
It is to be appreciated that the fact that a needlestick injury has occurred is very stressful to the injured individual. As a result of this, self-administering first aid by the individual stuck with the needle, during this stressful time, may possibly not be properly or completely administered. Anything, procedure or system, that can minimize or eliminate the guess work out of the initial first aid treatment because of a needlestick injury can insure more consistent and effective handling of such sharps injuries.
SUMMARY OF THE INVENTION
Wherefore, it is an object of the present invention to overcome the aforementioned problems and drawbacks associated with the prior art methods.
In particular, the present invention relates to a system for initial treatment of a sharps or needlestick injury via the application of a sub-atmospheric pressure to the site of the sharps injury. The present invention provides a single patient a disposable and economical kit to provide swift, efficient, and effective needlestick injury first aid as well as the method of performing such first aid. In its most basic form, the invention is a mechanical device for generating negative pressure at the site of a wound. In a broader form of the invention, it is a medical kit for the initial treatment of a sharps needlestick injury that contains a mechanical device for generating negative pressure, a tourniquet for slowing the flow of blood of the injured individual to and from the site of the sharps injury, at least one antimicrobial/antiviral agent(s) for washing and/or scrubbing the wound, and at least one bandage(s) for covering the wound following initial treatment.
In a preferred embodiment of the invention, the device for mechanical generation and maintenance of sub-atmospheric pressure is achieved by a manual arrangement, not relying on an auxiliary power, utilizing a one-handed technique.
According to another embodiment, the mechanical generation of the sub-atmospheric pressure is achieved by using a conventional syringe with a thumb ring for activating the plunger or piston, so that the plunger or piston can be operated via movement of a single hand of a user. This motion generates a negative pressure at the tip of the syringe.
Other embodiments include the use of vacuum tubes typically used for sampling venous blood, portable and hospital line vacuum pumps, and suction cups.
A primary object of the present invention is to provide a procedural kit that contains all of the necessary components to administer swift initial treatment to a site of a sharps injury. This kit includes, but is not limited to the following; a tourniquet, a mechanical device (e.g. a syringe) for generating sub-atmospheric pressure, a surface interface between th
Davis & Bujold P.L.L.C.
Jackson Gary
Medcare Medical Group, Inc.
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