Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-03-10
2001-01-09
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S187000, C604S181000, C604S263000
Reexamination Certificate
active
06171283
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to syringes, and more particularly to an improved syringe guard for a unit dose ampule or syringe and including a shield for covering the needle thereof after medication is dispensed from the syringe.
BACKGROUND
Medication is often dispensed using a unit dose cartridge, such as an ampule or syringe, and a syringe holder or adapter. The cartridge is typically a barrel having a needle at one end and a piston at the other end. Alternatively, the cartridge may include a rubber stopper instead of a needle, or may include a plunger assembly attached to the piston. The syringe adapter is typically a hollow body adapted to hold the cartridge, including a plunger to engage and move the piston in the cartridge.
Because of the threat of communicable diseases, a number of syringes and adapters have been developed to prevent accidental needle sticks or inadvertent reuse of needle devices. Many of these devices, however, are not easy to use or are complicated to manufacture, resulting in less effective disposable syringe devices.
For example, U.S. Pat. No. 5,569,211 discloses a syringe that allows the needle of the syringe to be withdrawn into the barrel of the syringe after medication is dispensed from it. This device, however, is a specially designed substitute for a conventional syringe, and cannot be used to hold commercially available unit dose cartridges.
U.S. Pat. No. 5,522,812 discloses a complicated syringe shield device for holding a conventional ampule not having its own needle. The device has a number of complicated parts, including a cylindrical body, a double needle assembly, a cylindrical shield, a special collar piece allowing the shield to be drawn over the needle and locked, and a plunger assembly, resulting in a device that is potentially difficult and expensive to manufacture. The device also requires two hands to operate, one to hold the body, and one to rotate the shield into the locked position, causing inconvenience to the medical professional using the device.
Another consideration with unit dose cartridges is that they are often made from glass, particularly for holding certain vaccines or biotech drugs where concern about micro-organisms or other contaminants is most critical. Glass cartridges are very fragile and often break during transportation or use. Some existing adapters may not adequately protect the cartridge contained therein from such risks. Others provide greater protection for the cartridge, but may obstruct the professional's view of the cartridge when the device is being used, hampering monitoring of the medication being delivered.
Therefore, there is a need for an improved safety syringe which is inexpensive and simple to manufacture.
In addition, there is a need for a safety syringe adapter which provides improved protection for the cartridge therein, but allows effective observation of the cartridge and the medication being dispensed.
SUMMARY OF THE INVENTION
The present invention is directed to a guard or adapter for a medical cartridge, such as a unit dose ampule or syringe, that is used to inject medication or other drugs into a patient. Generally, the guard comprises two parts, namely a housing or body for receiving and holding the cartridge, and a protective case or shield slidably attached to the body. In addition, for a cartridge provided without its own plunger, an embodiment of the guard includes a plunger assembly that is attached to the body. The various parts are generally molded from a suitable plastic, preferably synthetic resinous polymers of butadiene and styrene or polycarbonate, having a clear or opaque finish, which may be colored, such as a latex color or a flesh tone.
The body generally comprises two elongate rails or similar structures defining a substantially rectangular shape, having a cavity therein adapted to receive a medical cartridge. The body has an open proximal end communicating with the cavity, a distal end with an opening through it, and possibly a collar molded to the distal end.
The protective case or shield is a tubular member adapted to slidably fit on the body, having open proximal and distal ends. One or more elongate windows are formed in the shield, allowing observation of the cartridge held within the body. One or more windows, preferably the same windows used for viewing the cartridge, also cooperate with a stop tab or tabs molded on the body, thereby limiting the relative sliding relationship of the shield and the body. In addition, the shield includes a set of detents, preferably comprising a pair of detent arms and protruding detents molded into the proximal end of the shield. The detents cooperate with one or more sets of detent pockets molded into the body to lock the shield in relation to the body.
The shield is generally provided pre-assembled on the body, preferably by inserting the body into the shield until the stop tabs on the body communicate with the elongate windows on the shield. The shield may then slide in relation to the body between a proximal or unguarded position and a distal or guarded position, defined by the length of the windows on the shield. The guard is generally provided with the shield in the proximal or unguarded position, wherein the stop tabs abut the distal edges of the windows. In the unguarded position, the detents on the shield preferably engage a set of proximal detent pockets on the body, holding the shield in relation to the body.
Generally, after the cartridge in the guard has been used to deliver its medication, the shield is moved distally until it reaches the guarded position. In the guarded position, the stop tabs on the body abut the proximal edges of the windows, preventing further distal movement. As the shield is moved, the detents on the shield leave the proximal detent pockets, preferably because of sloping edges on the proximal detent pockets, and slide along the body until they enter a set of distal detent pockets when the shield reaches the guarded position. The distal detent pockets preferably have blunt edges, which prevent the shield from being returned proximally, and thereby substantially lock the shield in the guarded position for disposal.
In a first preferred embodiment, the guard comprises only two parts, namely a body and a shield, which are pre-assembled in the unguarded position ready to receive a cartridge. In this embodiment, the body includes a finger grip molded onto its proximal end, preferably defining a “T” shape, having locking detents formed on the finger grip. A cartridge, preferably and typically a conventional unit dose syringe including a needle and needle cover on its distal end and a plunger on its proximal end, is inserted into the proximal end of the body until it is fully encapsulated within the cavity. Once fully inserted, the proximal end of the cartridge engages the locking detents on the finger grip, substantially permanently locking the cartridge into the guard. Once locked into the guard, the needle and its cover on the cartridge extend through the distal openings in the body and shield and beyond their distal ends.
After medication is dispensed, the shield is slid into the guarded position, generally using only one hand. During use, the index and middle fingers are generally placed on the finger grip adjacent the shield, while the thumb directs the plunger on the cartridge. To move the shield, the thumb and ring finger are moved to the finger grip to hold the body. The index and middle fingers hold the sides of the shield and move it distally, thereby sliding the shield until it is locked in the guarded position.
In a second preferred embodiment, the guard includes a plunger assembly, in addition to the body and shield. The plunger assembly generally comprises a plunger, preferably including a thumb ring or a “T” handle, and a finger grip section into which the plunger is pre-assembled. The finger grip section and the proximal end of the body include members for locking the finger grip section to the body. Preferably, the finger grip section has
Firth John R
Perez Anthony R
Hayes Michael J.
Kennedy Sharon
Lyon & Lyon LLP
Safety Syringes, Inc.
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