Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
2001-03-21
2003-10-07
Izaguirre, Ismael (Department: 3731)
Surgery
Instruments
Cutting, puncturing or piercing
C030S162000, C030S339000
Reexamination Certificate
active
06629985
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a surgical scalpel which has a retractable guard to reduce the incidence of sharps injury.
The invention will be described with reference to a surgical scalpel but it should be appreciated that the invention can be construed broadly enough to cover any other type of cutting implement which requires safe handling procedures.
BACKGROUND ART
Surgical scalpels or surgical knives which are in commercial use have a handle and a disposable blade. The blade can be detached from the handle and disposed of by deposit in a special container which can thereafter be handled with reduced hazard of sharps injury.
A sharps injury means any cutting or penetrating object that can be reasonably anticipated to penetrate the skin or other part of the body to result in an exposure incident which includes occupational exposure to blood and other potentially infectious materials. Clearly, this covers scalpels and other types of surgical knives.
The commercially available scalpels which have a disposable blade generally have reusable handles. The handle can be sterilised by autoclaving and reused, and these handles are usually formed from metal. The surgical blade comes packaged in a protective foil. The foil is carefully opened to expose the blade. The blade is then held between thumb and finger and carefully attached to an extending projection of finger on the handle. Upon completion of the surgical procedure, the blade is either manually detached from the handle and placed in a sharps bin, or the handle with the blade is inserted into a container which breaks off the blade.
It can be seen that attachment of the blade to the handle is a hazardous procedure and can easily result in a sharps injury. If the blade is manually detached, this can also result in a sharps injury which is even more hazardous as the blade may be contaminated.
During surgical use, the scalpels can accidentally cut the surgeon's fingers, or the fingers of nurses and other support persons in the operating theatre. As well, operating personnel can be accidentally cut when the scalpel is passed between personnel.
To partially mitigate against accidental sharps injuries in handling the scalpel, it is known to provide a retractable blade guard. The blade guard is attached to the handle, and can be manually pushed between an extended blade guarding position, and a retracted blade exposed position. Thus, blade guards attached to scalpel handles are known.
These blade guards have some disadvantages. Firstly, by being part of the handle, the handle must be thoroughly cleaned from any blood and tissue after use, if the handle is to be reused. The blade guard can catch and contain tissue, congealed blood, and the like in the various nooks and cavities in the blade guard and it is extremely difficult to ensure that the blade guard is absolutely spotlessly clean to allow the handle with the attached blade guard to be reused. To allow the handle to be reused many times, the blade guard must be fairly robust and this can result in the guard being of fairly complex manufacture, quite bulky, and quite expensive.
A second disadvantage with this arrangement is that the blade guard cannot protect against initial attachment of the sterile blade to the handle. That is, the blade guard must be fully retracted to expose the projection or finger on the handle to which the blade is attached. The blade must be attached in the usual manner which is to initially remove it from its protective foil and then physically attach it to the handle. Thus, existing blade guards do not reduce or eliminate sharps injuries which can result in initial attachment of the blade. As well, these guards do not protect against removal of the blade from the handle.
OBJECT OF THE INVENTION
The present invention is directed to an assembly which contains a blade attached to a blade guard. The assembly can be packaged within a sterile foil (similar to conventional blades). The assembly can be removed from the foil and can be safely handled with little risk of the blade cutting the person, and the assembly can be attached to a scalpel handle with the blade guard in place. When the assembly is attached to the scalpel handle, the blade guard can then be retracted fully or partially to expose the blade. When the surgical procedure is finished, the blade guard can be pushed back over the blade and the blade and blade guard can be removed from the handle for safe disposal. In this arrangement, the handle itself does not keep the blade guard as the guard is disposed with the blade after use.
With this arrangement, there is reduced likelihood of sharps injuries in attachment of a blade to the handle. As well, the handle does not keep the guard which means that the handle can be more easily cleaned and sterilised for reuse. The guard can stay with the blade when the blade is removed which reduces the incidence of sharps injury when removing the blade from the handle.
It is an object of the invention to provide a scalpel blade assembly, and a scalpel which may at least partially overcome the abovementioned disadvantages or provide the public with a useful or commercial choice.
In one form, the invention resides in a safety scalpel blade assembly comprising a scalpel blade, a guard which extends at least about the cutting edge of the blade, and releasable attachment means to releasably attach the blade to the guard, the attachment means being operable between a locking position where the blade is held relative to the guard such that the cutting edge is protected by the guard, and a free position where the blade can slide out of the guard.
In a more particularised form, the invention comprises a safety scalpel blade assembly which is able to be attached to a handle of the type which has a blade carrier in the form of a finger, the assembly comprising a scalpel blade which can be of conventional manufacture and which has a slot which allows the blade to be attached to the blade carrier on the handle, and a guard which extends at least about the cutting edge of the blade, the guard having attachment means which locks the blade to the guard as the assembly is being attached to the handle thereby preventing the blade from cutting a person, but which releases the blade from the guard when the blade is attached to the blade carrier on the handle.
In another form, the invention resides in a scalpel comprising a scalpel blade assembly and a handle, the scalpel blade assembly having:
a scalpel blade, a guard which extends at least about the cutting edge of the blade, and releasable attachment means to releasably attach the blade to the guard, the attachment means being operable between a locking position where the blade is held relative to the guard such that the cutting edge is protected by the guard, and a free position where the blade can slide out of the guard,
the handle having:
a portion which is releasably lockable to the blade, the handle further having guide means which engages with the guard when the handle is attached to the blade to allow the guard to slide along the guide means on the handle between a retracted position where at least a portion of the cutting edge of the blade is exposed, and an extended position where the cutting edge of the blade is protected,
the scalpel further having means to move the attachment means to its free position when the handle is attached to the blade.
The scalpel blade assembly has the scalpel blade initially attached to a blade guard. The assembly can be packed in a sterile foil and the foil can be opened to safely remove the blade and the blade guard. The assembly can then be attached to a scalpel handle and thereafter the guard can be retracted to expose the scalpel blade.
The scalpel blade can be of various types depending on the surgical procedure to be carried out. It is usual for the blade to be elongate and to have a forward cutting edge. The blade body is provided with an elongate slot extending therethrough and the slot allows the blade to be attached to a projection or finger on the handle.
Hoffmann, Wasson & Gitler, PC
Izaguirre Ismael
Occupational & Medical Innovations PTY LTD
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