Disposable surgical safety scalpel

Cutlery – Sheathed – Sliding blade

Reexamination Certificate

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Details

C030S335000, C606S167000

Reexamination Certificate

active

06757977

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a disposable surgical safety scalpel. More particularly, the present invention relates to a disposable surgical safety scalpel with a retractable blade inside a hollow handle with a novel locking and unlocking arrangement that enables easy use and ensures safety in pre-use, use, and post-use conditions.
BACKGROUND OF THE INVENTION
Scalpels are widely used in surgery the world over. Surgical scalpels have sharp cutting edges on the blades, which makes them dangerous to use for the surgical team. The potential for accidents when for example the scalpel is being passed back and forth during an operation, is very high. Similarly during post-use, the disposal of the scalpel also poses a problem, in that the slightest negligence during handling in the postoperative time frame can also result in accidents unless extreme care is exercised.
In recent years, the spread of communicable diseases such as Hepatitis, AIDS and such other diseases makes it important to ensure that safety features are built into the surgical scalpel such that the potential for accidental harm be falling the handler or any person in the vicinity, inadvertently is minimized. A study by Dr. Jannie Jagger in April 1995 on the “Advances in exposure prevention” published by International Health Care Workers and Safety, Research and Resource Center, shows that 34% of scalpel wounds occur during the use of the scalpel in an operative procedure, while 39% occurs when the scalpel is passed from hand to hand during an operation, and the balance 27% when disposal of the scalpel is being effected.
Hepatitis—B, AIDS and other blood carried diseases all can be communicated during the operative stage. Since detection and treatment of the above diseases is not possible at the time that a scalpel used accidentally cuts or nicks a person, the normal presumption is that all the persons who are involved in an operative procedure are exposed to risk of infection. Additionally, to ensure that injury is not caused during the disposal stage of the scalpel, it must be ensured that the blade is suitably inaccessible and protected such that the disposal of the scalpel is made free of the potential for injury.
Several methods are provided in the art to ensure that the scalpel during all of pre-use, use and post-use conditions is safe and does not cause accidental harm to the handler.
In the art, surgical scalpels have been provided with a blade shield or guard in order to ensure that the safe packaging of the product and thus its sterility is maintained. But the solution does not take care of the problem in the use and post operative stage.
U.S. Pat. No. 2,735,176 discloses a surgical knife that is provided with a hollow handle which functions as a sheath for the blade that is extendable slidingly and retractable between a first cutting position and a second shielded position. Movement of the blade requires the surgeon to positively act to at least rearrange the handle in his/her hand. In some embodiments, it requires a two-handed actuation of the shield to ensure that the blade is properly sheathed before transfer to another person. Another disadvantage of the sheath system for surgical knives is that they require complex locking and retraction mechanisms. Such mechanisms often prove to be extremely fragile and expensive to incorporate resulting in an increase in cost of manufacture. The increased cost of manufacture of such scalpels renders the disposal factor not very attractive for the user. Similar to the scalpel disclosed in the above patent, U.S. Pat. Nos. 3,905,101 and 3,906,626 disclose sheaths wherein the handle carrying the blade is slideble from a first protective position to a second cutting position and vice versa. However, to initiate the sliding action, two-handed actuation is required rendering the instrument user unfriendly.
OBJECTS OF THE INVENTION
The main object of the present invention is to provide a disposable safety scalpel wherein the blade is protected from exposure during pre- and post-use conditions.
It is another object of the present invention to provide a disposable safety scalpel where bringing the cutting edge of the blade into the operational mode requires a specific actuation by the user.
It is another object of the present invention to provide a disposable safety scalpel with a retractable blade that is user friendly and with a firm locking arrangement to ensure safety in handling during operative stage.
It is another object of the present invention to provide a disposable safety scalpel where the potential for pre- and post-operative accidental injury to the user or to other persons in the vicinity are completely eliminated or substantially minimized.
It is a further object of the invention to provide a disposable safety scalpel with a permanent locking mechanism in the post use stage to ensure total or at least substantial safety in disposal of the scalpel post—use.
SUMMARY OF THE INVENTION
Accordingly, the present invention provides a disposable safety scalpel comprising a housing with a proximal open end to enable sliding in and out of the blade carrier to expose the cutting edge of the scalpel blade and a distal closed end, a blade carrier slideably provided in such housing, said blade carrier being provided with a scalpel blade fixedly located on one end thereof, the other end of the blade carrier being provided with a plurality of locking means to enable locking of the blade in three positions of pre-use, actual use and post use disposal stage, said blade carrier also being provided with a sliding means to enable movement of the blade carrier within the housing, the housing being provided with lock cooperating mechanisms at three positions thereon corresponding to pre-use, use and post-use disposal stages, said lock cooperating mechanisms cooperating with the respective locking means provided on said blade carrier during use.
In one embodiment of the invention, the blade carrier is provided with actuating means to enable positive movement of the blade carrier from a first pre-use stage to an actual use stage and finally to a post-use disposal stage.
In another embodiment of the invention, the first locking mechanism for the pre-use stage comprises of at least one lug provided on the blade carrier and cooperating with a depression provided on said housing to ensure pass locking.
In another embodiment of the invention, the second in-use locking mechanism comprises of at least a pair of matched arms extending in the longitudinal direction from the end of the blade carrier opposite the blade end and provided with lugs cooperating with a corresponding second pair of slots provided in the flange on said housing, said pair of slots being adapted to receive the lugs on said arms and retain them therein permanently till actual release by the user.
In a further embodiment of the invention, the second in-use locking mechanism is provided with an actuating means to enable release of the blade carrier from the use position to the pass position by natural action of retraction.
In a further embodiment of the invention, the third arm provided on the said blade carrier to ensure permanent locking of the blade by wedge locking it to the end piece in the post use disposal stage.
In another embodiment of the invention, the housing is provided with a groove running on one side thereon to enable sliding movement of the blade carrier thereon from a pass position to a in use position as required during operation, and to a third permanent locking position for the post-use disposal stage.
In another embodiment of the invention, the blade carrier is provided with a actuating means to enable movement of the blade carrier from the pass to in use stage and finally to a post-use disposal stage.
In a further embodiment of the invention, the actuating means provided on said blade carrier comprises a knob.
In another embodiment of the invention, the slots on the housing are adapted to receive the said second locking mechanism and the third locking mechanism are provided res

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