Disposable surgical safety scalpel

Details Disposable surgical safety scalpel Disposable surgical safety scalpel

2002-01-08

2003-07-08

Milano, Michael J. (Department: 3731)

Surgery

Instruments

Cutting, puncturing or piercing

Reexamination Certificate

active

06589258

ABSTRACT:

The present invention relates to a disposable surgical safety scalpel for medical use, having a retractable blade.
A scalpel is a highly professional surgical instrument which has been perfected over the years to such an extent that it cannot be compared to a jack knife or a cutter.
In describing the prior art, reference can be made only from an historical viewpoint to some patents relating to knives described in the more or less recent past, whose characteristic was to have a blade that is positioned after use in a protective container.
This is the case, for example, of the following patents:
GB- 5487 (LAKE), which as far back as 1884 described a knife with an extractable blade;
U.S. Pat. No. 4,028,758 (O'CONNOR), which describes a combination of a utility knife and a staple remover;
U.K.-1511889 (STEABBEN), which describes a pocket cutter with a blade that retracts but not automatically;
U.S. Pat. No. 4,769,912 (DAVIS), which describes a knife with an acceleration sensor;
U.S. Pat. No. 4,858,320 (LEMAIRE), which describes a pocket knife with retractable blade;
DE-3735294 (TEIHS), U.S. Pat. No. 4,835,865 (KNOOP) and lastly BE.1.002.554 (VAN HOOYDONCK), which describe an industrial cutter with retractable blade.
As it is well known, the surgical scalpels existing on the market are of the disposable or reusable type, with a fixed or interchangeable blade, and do not normally have any protection, except for a blade protecting cap in the case of disposable scalpels, which cap is slipped off before use and could be replaced after use.
In fact the cap should never be replaced because this maneuver can cause unwelcome cuts, with the risk of transmission of diseases, including serious ones like AIDS and viral hepatitis.
The use of a barrier system, such as gloves with a steel mesh, which protect from cuts but not from stab wounds, is not well accepted because of the increased thickness and stiffness of the gloves, which leads to a loss of sensitivity.
The use of a different system, called “Magnetic Drape”, which consists of a sort of magnet cloth to be placed near the operating field and to which the surgical instruments adhere through the action of a magnet, avoids the stage of passing the instruments from hand to hand, thus eliminating some wounds, i.e. those that occur during exchange of instruments between operators.
This system is poorly received by surgeons because it is essential to look away from the operating field to grasp the instrument and also because it is of no use for non-metallic objects.
The majority of accidental scalpel stab wounds or cuts occurs not so much when the surgeon makes an incision in the patient's skin or tissue as when the scalpel is passed from hand to hand by the medical operators or during disposal.
A study published in the USA in April 1995 by Dr. Janine Jagger in “Advances in exposure prevention”, Volume 1 No. 3 published by “INTERNATIONAL HEALTH CARE WORKER SAFETY RESEARCH AND RESOURCE CENTER” showed that 34% of scalpel wounds occur during use of the instrument, whilst the remaining 39% and 27% , respectively, take place when the scalpel is passed from hand to hand by operators and during removal replacement-disposal of the blade.
From these data it emerges that, overall, scalpels with an exposed blade or an interchangeable blade are responsible for 66% of cut wounds that occur among medical operators before, during and after use of the instrument.
It is for this reason that all scalpels with an exposed blade, such as those currently on the market, must be considered dangerous, as well as those with an interchangeable blade, such as those forming the object of the following patents:
PCT-WO 90/11725 (DOLGIN), which describes a metal scalpel with a mobile guard, with no automatic return and requiring replacement of the blade;
U.S. Pat. No. 5,250,063 (ABIDIN), which describes a metal scalpel with a mobile guard and an interchangeable blade;
PCT-WO 94/13216 (WERNER), which describes a metal scalpel with a voluntarily and automatically retracting blade that is extremely dangerous in that, pressure exerted on the rear part causes an accidental forward movement of the blade, is difficult to construct and also has an interchangeable blade;
PCT-WO 95/15723 (GHARIBIAN), which describes a scalpel with a mobile guard and interchangeable blade without any locking system between the cap and the blade holder, making it difficult to use and dangerous;
PCT-WO 93/24064 (NEWMAN P. H.) and U.S. Pat. No. 5,403,337 (PLATTS) which describe a disposable scalpel with a blade that can be changed during the surgical procedure, without foreseeing any protection for used blades.
Changing of the blade is in fact the weak point of any instrument, even those considered safe, because handling necessarily leads to an increased risk of accidental wounds.
In the analysis of the prior art it can be seen that as time went on, inventors refined the idea of a safe scalpel to meet the need for protection required by surgeons.
Starting from mobile blade protection system without automatic return, such as, for example, those described in patents:
U.S. Pat. No. 3,905,101 (SHEPHERD), U.S. Pat. No. 3,906,626 (RIULI), U.S. Pat. No. 4,414,974 (DOTSON), EP-0 251 485 (GORDY), U.S. Pat. No. 4,735,202 (WILLIAMS), EP-0 612 506 (NEWMAN C. D.), whose main defects lie in the need to use both hands to set up or to protect the instrument and the necessity to remember to cover the blade each time it is passed from hand to hand, systems have been designed with a mobile blade guard that can be moved with only one hand, but still without automatic return of the cap, such as those described in patents:
PCT-WO 90/11725 (DOLGIN), U.S. Pat. No. 5,250,063 (ABIDIN), U.S. Pat. No. 5,417,704 (WONDERLEY), PCT-WO 95/15723 (GHARIBIAN), in which advancement and retraction of the protective cap is carried out with one hand and must be intentional on the part of the operator.
Again with regard to mobile guard, the following patents must be considered separately:
U.S. Pat. No. 5,330,492 (HAUGEN), which describes a scalpel with a guard that can be moved by means of a push-button, which when pressed causes the protective cap to retract, uncovering the blade, and when released unintentionally causes the opposite effect; this instrument must be grasped in a an unnatural way, does not offer guarantees of safety because the push-button protrudes excessively and in addition, because of its excessive height, does not allow a correct cutting angle on the skin surface;
U.S. Pat. No. 5,330,494 (VAN DER WESTHUIZEN), which describes a guard that can move transversely to the blade, constituting a danger not only for the operators, because pressure exerted-casually on the lower edge of the cap causes uncovering of the blade with a high risk of wounds, but also for patients, since the cutting force cannot be regulated.
More recently different systems have been proposed, such as, for example, that in U.S. Pat. No. 5,116,351 (FRASSETTI), which describes a mobile blade mechanism, with automatic return of the blade to the protected position and with the possibility of voluntary locking, but it is basically awkward, because it obliges the operator to work in an unnatural position, that is with the finger exerting a certain pressure on the upper edge of the blade and with the blade partly covered by the protection system;
and that of U.S. Pat. No. 5,207,696 (MATWIJCOW), which describes a scalpel with a retractable blade and mobile guard, but which seems too bulky and therefore awkward and has no automatic involuntary return of the blade to the covered position.
A further development in the design of these instruments has come about with a concept that foresees the possibility of extracting the blade from the handle. This is probably the idea that holds most advantages, because it offers interesting solutions to the problems described up to now, although each of the ideas proposed gives rise to some considerations as regards their practical operation.
A first proposal for a retractable blade is presented in:
EP-0 217 638 (DESATNICK)

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