Special receptacle or package – For a tool – Body treatment
Reexamination Certificate
1999-04-14
2002-11-05
Yu, Mickey (Department: 3728)
Special receptacle or package
For a tool
Body treatment
C206S370000, C206S438000, C220S908300
Reexamination Certificate
active
06474472
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention pertains to safe disposal of medical sharps devices which exist in a safe and an unsafe state.
2. Background of the Art
Hospitals, doctors offices and laboratories are faced with the prospect of safely handling and disposing of needle-bearing and blade-bearing medical devices which are contaminated with blood or body fluids containing infectious agents. Medical facilities typically dispose of such medical devices in what are called “sharps” containers or boxes. These are typically hard sided plastic boxes with an opening in the top through which used medical devices are deposited after use. The sides must be puncture proof and are well known in the art. Standard sharps containers must meet regulations to make sure needles do not inadvertently become exposed to pose a danger to housekeeping staff and disposal personnel.
Because of the extreme hazard posed by used medical devices of this kind, the disposal process requires removal of the sharps containers from the hospital rooms and transport to an incinerator where the entire container and contents are incinerated. Since many of these containers cost approximately $4 to $12 at the present time, there is a significant cost associated with incineration as well as the creation of unnecessary air pollution hazards.
Because of the rise and prevalence of incurable infectious viral diseases, there has been a development of single use retractable medical devices including syringes, catheter introducers, intravenous needles and blood collection tube holders. Devices such as these have a needle, and a retraction activation structure which may vary somewhat between devices. In the better syringes, this involves merely a continuation of the pushing motion, for example, as fluid is injected to complete the activation of the retraction mechanism. In the case of catheter introducers there may be wing like arms that are squeezed to release a retractable needle into the housing. There are also devices having a safety shield that is pulled out over the needle to make it safe and devices where the needle is pulled back into the body of the device to make it safe. This latter type of device may also have a breaking part which is removed after the needle is safely within the body of the device.
There would be a significant cost savings and reduction in waste if it were possible to confidently bag used retracted medical devices for disposal in the manner of soft medical waste. Soft medical waste is normally bagged in red plastic bags similar in nature to a common plastic trash bag, which costs far less than $1.00 per bag. Heretofore, using flexible plastic bags instead of hard sided sharps containers has not been considered practical even for retractable needle devices because of the possibility that some unretracted medical devices might inadvertently be placed into the bag.
SUMMARY OF THE INVENTION
The invention provides an apparatus for removing the final small degree of uncertainty that may remain when the medical devices having a safe needle position, usually retractable medical devices, are being used exclusively. Disposal by bagging is now possible instead of incineration of a whole sharps container. It is far more economical and environmentally friendly to incinerate bagged medical needle devices than to dispose of needle bearing devices by incineration of relatively expensive sharps containers, as is done now.
A special access member is provided for use with disposal containers for sharps in a health clinic, doctor's office, hospital or laboratory. The access member is adapted for use with a disposal container for sharps and an impervious collapsible bag, preferably a plastic bag, is positioned to receive and collect medical devices in their safe condition. The access member has a conforming opening therein which conforms to the profile of a medical device in its safe condition. The walls of the conforming opening follow the exterior configuration of the medical device which has a protected needle. The access member is used in combination with the disposal bag for collecting medical devices in the safe condition of the needle which pass through the conforming opening. The invention deals with needle bearing medical devices which have a safe condition and an unsafe condition. The unsafe condition is the condition of the device in which the needle is exposed for use. In some devices which have a triggering mechanism, the unsafe condition might be called the “armed” condition which exists prior to activating the triggering mechanism to retract the needle into a housing or barrel. The safe condition is when the needle is “protected” so that is cannot inadvertently or otherwise cause a “needle stick”. The safe condition may result from triggering the device to retract the needle. In some devices a separate needle assembly is physically attached to a movable member and pulled into the housing or barrel. The movable member may then have an extending portion which is broken off to prevent reuse. Other medical devices have a shield which slides with respect to the body of the device. After the needle is used, the slide is pulled out to cover the needle which remains in place. When the needle is covered so that it cannot penetrate a person's skin, the device is in the safe condition. When the needle is exposed for use, the device is in the unsafe condition. This is the context in which the safe or unsafe condition of a medical device should be understood with respect to the invention. The medical device may be referred to as “unsafe” or “safe” to indicate respectively that the needle is exposed for use or protected (covered) by means of some safety device that is provided with the medical device to convert the medical device to a safe condition of the needle.
The invention takes advantage of the fact that needle bearing medical devices in their unsafe condition with the needle exposed have a different profile than the same medical device has in its safe condition. Most of the examples herein deal with “self-retracting” syringes wherein an action by the user at the completion of use of the device triggers retraction of the needle, thus altering the geometry of the exterior of the device from that of its previous unsafe condition. Because the needle is no longer extended when converted to the safe condition, the profile is smaller. Other devices are contemplated by the invention where the profile is different by being larger in some places and smaller elsewhere. Such an example is the Safety Shield® device sold by Becton Dickenson. It has a fixed needle with a cylindrical shield which is pulled out over the needle. This action puts it in a safe condition while changing the geometry and thus the profile. In this case, the device may be lengthened because the sliding shield must be longer than the needle.
The access member is supported upon a sharps container or a plastic container which holds a removable preferably plastic bag. The access member may rest on the upper surface, may clip on, may be hinged to a container, may overlap the outer edges or may sit on an internal ledge in the open upper end of a sharps container. The access member may have a configuration which removably locks onto the upper edge of the container over an intervening layer of the bag material. In an alternate embodiment, the flexible disposable bag is secured to the access member so that the access member and collapsible bag can be handled together as a unit and can be conveniently collapsed for shipping and storage. In this alternate embodiment, the access member is disposed of with the bag.
The access member may have a single conforming opening or a plurality of conforming openings depending upon the usage of retractable devices in a particular facility. Powerful physiological satisfactions and a physical reminder is provided to the person using the devices. They are conditioned to insert the appropriate device in the appropriate conforming opening which matches its shape. The invention serves an imp
Locke Liddell & Sapp LLP
Mohandesi Jila
Retractable Technologies Inc.
Ross Monty L.
Yu Mickey
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