Surgery is an important procedure of modern medicine system. Several incisions and cuts need to be made in the body during the course of a surgery. As surgery involves cutting of body parts, there is very little margin for error during a surgical procedure. Thus it is necessary that the instruments used for surgery have a high degree of accuracy and reliability. There are several surgical instruments that are used for making incisions and cuts during surgery. A scalpel is one such surgical instrument.
A scalpel comprises a handle with a blade attached at one end. It is used by surgeons to make incisions during a surgical procedure. The surgeon holds the scalpel with the handle while making the incisions with the blade. Therefore, the surgeon requires a good grip of the handle to ensure precise incision. Conventional scalpels have handles that do not provide a good grip to the surgeon especially when the surgeon has gloves on his hand.
During a typical surgical procedure several nurses and assistants assist a surgeon by providing him the surgical instruments that the surgeon needs. The transfer of instruments from the assistant to the surgeon should be in an efficient manner as time is a critical factor in surgery. Also, the transfer of a scalpel from the assistant to the surgeon should be such that the surgeon can grip the scalpel without moving his eyes from the surgery. In case the blade of the scalpel is exposed during the transfer of the scalpel, it may result in cuts on the surgeon's hand. Apart from causing pain to the surgeon and breaking his concentration, these seemingly innocuous cuts are very dangerous from the point of view of the surgeon as well as the patient. These cuts may result in the exchange of blood or body fluid between the surgeon and the patients that may lead to transfer of infections from one to the other. The exchange of body fluid may lead to infections as dangerous as Human Immuno Deficiency Virus (HIV) that leads to Acquired Immuno Deficiency Syndrome (AIDS). It may also lead to other fatal infections such as Hepatitis B Virus (HBV). Therefore, there is a lot of danger attached with the use of a scalpel with an exposed blade.
There are some scalpels that have been designed to prevent the occurrence of such “mishaps” and provide a more hygienic operating condition. These scalpel designs have a guard over the blade. The assistant covers the blade with the guard while transferring it to the surgeon. The surgeon removes the guard to expose the blade and then moves the guard to cover the blade again when transferring it back to the assistant.
However, these guarded systems have not been very effective and have a number of drawbacks.
Firstly, many of the guarded scalpels need the use of both hands for moving the guard to cover and uncover the blade. This is not very convenient for the surgeon; the surgeon would prefer to move the guard using just one hand.
Secondly, some of the scalpels allow the blade to be retracted into a slot constructed in the handle. In these scalpels the blade is not fixed; it is moved from the exposed to the retracted position and back. This leads to lesser reliability of the blade as the blade is not fixed and it may move while an incision is being made. This movement of the blade is not desirable during surgery. In an extreme case, the blade may retract during a surgery and may cause irreparable damage.
Third, in most of the scalpels the guard is made of opaque material. Therefore, the blade is not visible when covered by the guard.
The concern for transfer of infections like HIV and HBV during surgery has led to the development of disposable surgical instruments. These instruments are used on just a single patient for one surgery and then disposed off. This ensures better hygiene and protection for the patient and hospital staff during surgery.
There are several existing designs of disposable scalpels. These scalpels are manufactured with “plastic” handles and “metallic” blades unlike conventional scalpels, which are made completely of stainless steel. This makes these disposable scalpels more cost effective.
However, these scalpels have not been able to completely avoid the reuse of the scalpels. There are cases when surgical instruments have been reused by mistake. For example, an operating assistant may, by mistake, use the scalpel (for operating a patient) that has already been used (on another patient). This typically happens in the case when there are no visual indicia to tell that the scalpel has been used before. This greatly increases the risk of transfer of infections.
Another drawback associated with such scalpels is that the guard may sometimes retract at the time of disposal thereby exposing the blade. This may lead to injury to the person handling the disposed scalpels and inadvertently, transfer the existing blood or other contaminated material that is on the disposed scalpels.
Therefore, there is a need for a disposable scalpel that can provide the surgeon with a good grip of the scalpel during surgery. There is also a need for a scalpel with a guard that can prevent any accidental cuts during transfer of the scalpel from the assistant to the surgeon. The guard should be such that the surgeon can conveniently operate it, by using just one hand. The guard should also not retract at the time of disposal of the scalpel. Further, there is a need for visual indicia that tells the assistant or the surgeons that the scalpel has been used and it should be disposed of.