Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
2001-03-29
2003-09-30
Calvert, John J. (Department: 3765)
Surgery
Instruments
Cutting, puncturing or piercing
C030S151000, C030S335000
Reexamination Certificate
active
06626925
ABSTRACT:
BACKGROUND OF THE INVENTION
The field of the invention is surgical cutting instruments. Conventional surgical instruments, e.g. surgical scalpels, provide a significant potential for harm to surgeons, nurses and other medical personnel in a health care facility. In the operating room, various surgical instruments are quickly passed by hand from person to person. The rapid handling of such instruments that have exposed sharp edges can lead to accidental cuts or puncture wounds. Surgical gloves may also be inadvertently punctured leading to loss of glove integrity further increasing the risk of infection to a surgeon, nurse or other medical personnel. Such accidental cuts or puncture wounds are especially problematic because of the advent of currently incurable and/or fatal diseases, such as Acquired Immunosuppressive Deficiency Syndrome (“AIDS”) and hepatitis C, which can be transmitted by the exchange of body fluids from an infected person to another person.
Previous attempts to guard against inadvertent cuts or punctures led to the development of various types of shielding mechanisms for blades used on a surgical scalpel. For example, some designs had retractable blades while others had retractable inner or outer shields. Although many different designs were developed, many of these designs had serious drawbacks. Some of the designs required two hands to operate or otherwise were difficult to operate or were easy to defeat.
SUMMARY OF THE INVENTION
It is therefore an object of this invention to provide a shielded surgical scalpel.
It is another object of this invention to provide a shielded surgical scalpel that requires only a single hand to operate and is simple to operate.
It is yet another object of this invention to provide a shielded surgical scalpel that is difficult to defeat.
The shielded surgical scalpel of this invention includes an elongate handle defining a longitudinal axis and having a proximal portion and a distal portion separated by a shoulder. A blade is fixedly attached to the distal portion of the elongate handle. A shield with a proximal end and a distal end is firmly mounted onto the elongate handle and is movable longitudinally along the distal portion of the elongate handle. The shield is movable between a distal position where the shield substantially prevents inadvertent access to the blade and a proximal position where the shield exposes the blade for use. The design of the elongate handle and the shield are such as to provide an intuitive indication to the clinician of the proper operation of the shielded surgical scalpel. In addition, arrows on the elongate handle provide a visual indication to the clinician of the direction the clinician must move the shield in order to shield or expose the blade. Furthermore, a lock indicator line on the distal portion of the elongate handle is aligned with the proximal end of the shield when the shield is locked in the distal position. This provides a visual indication to the clinician that the shield is properly locked and the blade is shielded.
The shield includes an upwardly biased cantilevered digital activation section having at least one inwardly directed boss disposed in a slot formed on the distal portion of the elongate handle. The slot extends generally longitudinally with a proximal upturned end and a distal upturned end. The upturned ends define the proximal most and distal most travel of the shield with respect to the elongate handle. The proximal and distal upturned ends on the elongate handle and the inwardly directed boss on the shield are configured such that they cooperate to tightly hold the shield in the distal or proximal position, as the case may be. The shield is releasable from both the distal position and the proximal position by the downward pressure on the upwardly biased cantilevered digital activation section of the shield, which moves the boss out of the proximal or distal upturned end into alignment with the longitudinal portion of the slot. Once released, the shield can be moved distally or proximally as the case may be to shield or expose the blade.
The shield also includes an inwardly directed lug that engages the surface of the distal portion of the elongate handle. This lug ensures that the shield fits snugly on the elongate handle and prevents undesirable lateral movement of the shield with respect to the elongate handle, especially when the shield is in the proximal position.
The shield and the elongate handle cooperate in such a way that the clinician's glove will not be pinched between the proximal end of the shield and the shoulder separating the proximal portion and the distal portion of the elongate handle when the shield is in the proximal position. The slot defines the length of travel of the shield with respect to the elongate handle. Preferably, the location of the slot and its length are chosen to ensure that there is a gap between the proximal end of the shield and the shoulder on the elongate handle when the shield is in the proximal position.
The shield is configured so that it will not interfere with the blade during use when the shield is in the proximal position. Specifically, the distal bottom edge of the shield is formed with a curve that corresponds to the shape of a standard blade so that a clinician can use the blade at a shallow angle with respect to the patient.
Finally, in order to facilitate the assembly of the shielded surgical scalpel of this invention, a pair of bumps is formed on the external surface of the shield with one bump being located on either side of the shield. These bumps allow the shield to ride on conveyor rails used in the manufacturing process that carry the shield from one station to another.
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patent: 5
Cohn Simon
Flowers Richard A.
Howell Glade H.
Hwang Charles G.
Newman Craig D.
Becton Dickinson and Company
Calvert John J.
Hoey Alissa L.
Murtha James J.
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