Special receptacle or package – For a tool – Body treatment
Reexamination Certificate
1995-12-22
2001-03-20
Fidei, David T. (Department: 3728)
Special receptacle or package
For a tool
Body treatment
C206S370000
Reexamination Certificate
active
06202843
ABSTRACT:
1. FIELD
The field of the invention is the safe disposal of medical needles used to withdraw body fluids, and more particularly the disposal of such needles and associated contaminated items.
2. STATE OF THE ART
Several manually and electrically powered devices have been proposed for the destruction of used syringe needles. Some destroy only the cannula (needle), shearing it off and depositing it into a receptacle for discard. Others also destruct the plastic hub of the needle and portions of the syringe barrel. See U.S. Pat. Nos. 3,469,750, 4,255,996, 3,851,555 and 4,275,628. All provide receptacles for the severed needles, hubs and other destroyed parts of the syringe. The contaminated syringe bodies must be separately placed in the disposal receptacles when these devices are used, although U.S. Pat. No. 3,469,750 refers to a device which crushes the entire syringe assembly. It is noted that this device is very heavy, stationary and not portable. The large force required is felt to be potentially dangerous.
Blood samples are now. generally taken not with syringes for subsequent transfer to a sample container such as a test tube, but directly into such a container. This container is evacuated, sealed by an elastic plug, and placed seal first into an elongate barrel sleeve open at one end and narrowed to a threaded nipple at the other. A double ended tubular sampling needle (cannula) is mounted on a central hub threaded to fit the nipple. The outside end of the cannula is inserted into a vein. The sealed end of the evacuated container is then pressed against the other, inside, end of the needle, puncturing the resilient plug and allowing the internal vacuum to draw the blood sample through the needle into the container. After the needle is withdrawn from the vein, the container is withdrawn from the needle, leaving the sample inside. The sleeve may be safely reused since it never contacts the blood or the body of the patient. However, there is presently no method of removing the needle from the barrel without excessive manipulation and attendant danger of injury and infection to the medical technician. Typically, a needle disposal receptacle is provided with a lid having an aperture shaped to engage the needle hub. See U.S. Pat. No. 4,375,849. The technician, who most often has one hand engaged with the patient's needle wound, must very carefully insert the needle into the narrow opening with the other. Then, he must grip, release and regrip the sleeve several times while rotating it to unscrew it from the needle hub, all with a single hand. It is difficult to perceive when the needle is completely disengaged, and the needle even then tends to hang up in the opening. Danger of injury from the contaminated needles is considerable.
U. S. Pat. Nos. 4,667,821 and 4,738,362 add needle gripping wrenches to the lids, but do not facilitate removal with only one hand. U.S. Pat. Nos. 4,807,344 and 4,862,573 disclose motorized devices permitting one-handed needle removal, but the devices tend to be overly expensive.
The difficulty of disposing of the used needle assembly without manual contact is increased substantially by the configuration of state of the art medical sample needle assemblies. The assemblies have a hub with a flange which is larger in diameter than both the threads and the wrenching or gripping area therebelow. Clearly, state of the art medical sampling needle assemblies with hubs so configured tend to become suspended from any removal tool, whether manually or otherwise powered, rather than falling freely therethrough into the disposal receptacle.
A great need remains for an economical needle removal system allowing facile, safe, one-handed needle removal and disposal.
BRIEF SUMMARY OF THE INVENTION
With the foregoing in mind, the present invention eliminates or substantially alleviates the shortcomings and disadvantages of the prior art by removing virtually all the manual manipulation now required to remove and dispose of double ended fluid sampling needles used with evacuated sample containers. The device comprises a rotating wheel adapted to engage the hubs of the needles, an electrical motor to provide torque to the wheel, either directly or through appropriate gears, and electrical switching and control means. Advantageously, these components are all mounted upon a base adapted to be secured to the mouth of a disposal receptacle for the used needles. After the specimen container is removed, the container sleeve is positioned in the device, the needle and hub being inserted through an aperture provided through the base. The hub is then unthreaded from the sleeve by the wheel, and then drops into the receptacle.
In the preferred embodiment, the rotating wheel is powered by a two phase unidirectional stepper motor, along with a pulse generating tinier circuit and motor controller (chip). The stepper type motor is preferred because it builds very quickly to full torque, and also because it stops promptly without appreciable coasting when electric power to it is interrupted. The needle engaging periphery of the wheel may be recessed in at least one location to provide clearance for inserting the needle for removal. A spring loaded, normally open, initiation switch is pressed by the vacuum container sleeve to start the motor. A cam operated cycle control switch assures that the motor is always stopped with the wheel in proper position for the next use. Parallel arrangement of the initiation and cycle control switches assures the continued operation as long as the former is held in depressed, closed position. Direct current batteries are provided in one embodiment. In another, a transformer/rectifier is used with an alternating current source. Batteries, is used, may be mounted upon the above mentioned plate. In this case, it is advantageous to employ rechargeable batteries and appropriate recharging circuitry. Since needle hubs commonly carry cruciform, gear-like knurls, the hub engaging wheel advantageously carries cogs on its circumference, although knurls or other high friction constructions may also be used.
In another preferred embodiment, a standard direct current motor is employed, again with batteries or a transformer/rectifier with AC source. Recharging circuitry is advantageous with this embodiment also.
It is therefore the principal objective of the invention to provide a device for the disposal of used medical cannulae without danger of injury or infection to the medical technician, nurse or doctor.
The herein claimed invention eliminates or substantially alleviates the shortcomings and disadvantages in state of the art medical sampling and needle removal devices, by providing a needle assembly which facilitates its removal from body fluid sampling assemblies without manual contact. The needle assembly comprises a cannula mounted within a hub having an uppermost portion threaded to engage the internally threaded nipple of the barrel sleeve. The threaded portion is integral with a lowermost portion, which is configured to be gripped on at least a portion of its surface for installation into and removal from the nipple. The hub is configured so that no point on the portion of its surface used for gripping is radially nearer to the cannula than is any other point thereabove on the surface of the hub. This is to assure that the needle, when unscrewed from the nipple, may fall freely into a used needle receptacle without hanging up on whatever removal tool may be employed. Preferably, the gripping surface is significantly more distant from the cannula than any other point on the hub, to provide ample clearance.
The invention further provides a cooperating lid for a needle disposal container, designed to grip the needle hub and to support the sleeve to provide facile one-landed rotation of the sampling assembly sleeve to unscrew the needle.
In accordance with other preferred embodiment of the invention, such a cooperating lid is adapted for use with state-of-the-art, unaltered conventional medical sampling needle assemblies.
It is therefore the principal obj
Kelson Lance P.
Kelson Ross J.
Fidei David T.
Mallinckrodt Robert R.
Mallinckrodt & Mallinckrodt
Rayve Brian R.
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