Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-06-20
2002-07-02
Hayes, Michael J. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S195000, C604S198000, C604S222000, C604S240000
Reexamination Certificate
active
06413236
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to safety syringes, and more specifically to a safety syringe apparatus and method for injecting fluid from a syringe and subsequently automatically and immediately retracting a hollow needle permanently and protectively within the syringe body after a single use.
BACKGROUND OF THE INVENTION
In recent years, the public has become increasingly aware of the health hazards associated with needle reuse and accidental needle prickings. This is true, especially among drug addicts, drug users (e.g., diabetics), medical personnel and healthcare providers. More than twenty blood-borne pathogens can be transmitted by the reuse of needles or accidental needle prickings, just a few of which include human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B, hepatitis C, syphilis, malaria, tuberculosis, and herpes.
The problem of spreading blood-borne pathogens through the reuse of needles is significant among drug addicts unwilling or unable to pay for sterile needles. The United States government, having recognized and acknowledged this problem, has attempted to control the reuse of syringe needles among drug addicts by establishing needle exchange programs where drug addicts can obtain free sterile needles in exchange for their contaminated needles. Despite this effort, at least 36% of HIV/AIDS cases and more than 50% of hepatitis B and hepatitis C cases in the United States can be linked to the sharing of needles among drug addicts. With approximately one million people with HIV/AIDS, more than 1.25 million hepatitis B carriers and more than 3.5 million hepatitis C carriers in the United States, the need to curb the practice of sharing needles is great. With more than 1.3 million injection drug users in the United States, the need for syringes having an integral, unremovable and unoverridable safety feature that limits the syringe to only a single use is overwhelming. (tri-ject.net/stats.html).
In addition, the spreading of blood-borne pathogens through the reuse of contaminated needles by drug addicts, drug users, medical personnel and healthcare providers in other countries throughout the world is becoming increasingly prominent. For example, approximately 30% of reported HIV/AIDS cases in Brazil, Chile, Uruguay, Paraguay and Argentina are directly related to the sharing of contaminated needles among drug addicts. Nearly 74% of injection drug addicts in Spain are HIV infected. Approximately 70% of the HIV cases reported in China are directly linked to the sharing of contaminated needles. In eastern European countries, 80% of injection drug addicts admit to sharing contaminated needles. Approximately 43% of the HIV/AIDS cases reported in Poland and Yugoslavia are linked to the sharing of contaminated needles among drug addicts. Furthermore, It is estimated that approximately 22 million people worldwide are living with HIV or AIDS. Unfortunately, in many countries, especially third world countries, sterile syringes are simply unavailable due to economic reasons. (www.vanishpoint.com
eedlestick.html).
Although approximately one million accidental needle prickings are reported by healthcare workers annually, at least three million accidental needle prickings occur each year that subsequently go unreported. Various studies estimate that out of all the needle pricking injuries that occur to nurses, approximately 40% to 53% go unreported. Various studies also estimate that out of all the needle pricking injuries that occur to laboratory technicians, approximately 92% go unreported. Various studies further estimate that out of all the needle pricking injuries that occur to physicians, approximately 70% to 95% go unreported. (www.osha-slc.gov/SLTC
eedlestick/saferneedle devices/saferneedledevices.html).
In 1997, the Centers for Disease Control and Prevention (CDC) sponsored a study which found that approximately 76% of needle pricking injuries could be avoided by using safety needles. As a result, needle legislation has now been introduced in approximately twenty-five states and in the District of Columbia. In fact, such safety needle legislation has already been signed into law in a number of states including California, Texas, Tennessee, New Jersey and Maryland. In addition, the Occupational Safety and Health Administration (OSHA) has promulgated a Blood-borne Pathogens Standard requiring employers to evaluate the effectiveness of existing controls designed to minimize or eliminate employee occupational exposure and to review the feasibility of instituting more advanced controls. Furthermore, the Food and Drug Administration (FDA), in an effort to protect health care workers, has set forth guidelines suggesting specific features that a safety syringe should possess. These include a safety feature that is not only simple and self evident to operate, thus requiring little or no additional training to use effectively, but also a safety feature that is an integral part of the apparatus. In other words, the guidelines suggest that the safety feature itself be unremovable and utilization of the safety feature be unavoidable. (www.osha-slc.gov/SLTC
eedle stick/saferneedledevices/saferneedledevices.html; www.seiu.org).
As a result of the foregoing state legislation and agency guidelines, a great amount of time, effort and money has been invested by syringe manufacturers in developing syringes with safety needle designs. Presently, there are at least 250 types of safety syringes. However, the safety syringes that currently exist have been criticized for generally being too expensive to manufacture and having a safety feature that is not an integral part of the safety syringe. Another criticism includes safety syringes that are not economically feasible because operation of the safety feature is not self evident and therefore additional training is required to use the apparatus effectively. Additionally, the safety feature of at least one safety syringe is simply ineffective at preventing the transmission of blood-borne pathogens due to “reflux” blood contamination.
Of the current safety syringes, safety syringes using a spring mechanism are the most common for automatically retracting a hollow needle after injecting a fluid. However, these safety syringes are typically more expensive because of the required incorporation of additional materials for manufacture. Standard or conventional hypodermic needle syringes typically cost from five to seven cents each. On the other hand, the median increase in cost for a safety syringe is approximately thirty cents or more. At first glance, this minimal cost increase does not seem significant. However, after considering the thousands, if not millions, of needles used each year, the resultant increase in annual cost for utilizing the more expensive safety syringe is unfortunately excessive.
Another type of safety syringe is a syringe using a protective shield that slides and locks over the needle to protectively encase the piercing tip. However, the protective shield is not an integral part of the safety syringe. Because the protective shield slides manually over the needle, this safety feature may be overridden by a person who inadvertently or purposely fails to slide the shield over the needle thereby exposing a contaminated and potentially infectious piercing tip. Additionally, the protective shield requires two hands to slide the shield over the needle to encase the syringe needle. As a result, a person's hands may slip while sliding the shield and subsequently be pricked with the exposed and contaminated piercing tip.
Another type of safety syringe is a needleless jet injector that shoots a pinpoint jet of fluid through the skin at extremely high velocities. However, this safety syringe is not economically feasible because operation is not self evident and, therefore, costly time consuming training is required to use the apparatus effectively. Additionally, the needleless jet injector has been linked to causing hepatitis B infections resulting from “reflux” bloo
Dougherty & Clements LLP
Hayes Michael J.
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