Surgery – Instruments – Electrical application
Reexamination Certificate
1999-01-21
2001-05-22
Leubecker, John P. (Department: 3739)
Surgery
Instruments
Electrical application
C606S028000, C606S030000, C606S042000, C606S049000
Reexamination Certificate
active
06235027
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a handheld, portable thermal-cauterizing forceps including an integrated thermal heating surface disposed at each tip.
There are many surgical cautery devices available for the surgeon to ablate and vaporize tissue. Hot knives and cutting coagulators have been used to make skin incisions. The cautery can also be used in surgery to aid in hemostasis or control bleeding by coagulating blood vessels. Employing various cautery modalities decreases the duration of some surgical procedures by providing the surgeon a rapid method of coagulation without the need for suture ligation of blood vessels encountered during dissection.
Typically, surgical cautery is accomplished by directing a heating process onto tissue. The heat may be generated by either a thermal or electro-surgical process. Most commonly, an electro-surgical process using a radio frequency (RF) is used. The RF units generate heat by using high frequency electrical current and the resistive nature of tissue to produce heat. This technique requires a bulky generator and heavy electrical components to operate. Typically, RF electrocautery units require a power lead cable to the electro-surgical hand instrument and a large surface area grounding pad. More often than not, radio frequency surgical units are bulky expensive units which require a cable connection. Employing RF cauterization in a surgical operation may add significant cost to the procedure because the grounding pad, cable and handpiece must all be either re-sterilized or replaced in the case of disposable use.
A less common method of generating heat for coagulation of tissue is by thermal cautery. Thermal cautery is achieved by electrical heating of a resistive-wire loop or resistive electronic part by applying an electrical voltage. The prior art describes many handheld disposable, hot-wire loop cautery instruments. These devices have severe limitations as to their scope of use in surgery. The heat generated by the handheld battery powered devices is very small with a low heat capacity. The available patented devices are effective for cauterization of only the smallest of blood vessels, such as, vessels in the sclera of the eye. These battery powered hot-wire cautery instruments are not effective for use in cauterization of larger blood vessels encountered in most surgical procedures. A technique employing the electrical over driving of a zener diodes to produce heat has also been described in several patents. This device is primarily for limited endoscopic applications.
SUMMARY OF THE INVENTION
In order to overcome the limitations and disadvantages of the prior art, the present invention provides, in an embodiment, a new and improved hand-held, high energy, portable thermal cautery forceps. More particularly, the new and improved surgical forceps instrument includes an enclosure which houses a battery and electronic control. Active ceramic heaters are provided on the two tips of the operative end of the forceps. In a second embodiment, the thermal forceps may alternatively be powered by an external power source.
The new thermo-cautery forceps device in accordance with an embodiment of the invention provides the surgeon with several significant improvements in the state of the art. A first benefit of the thermal-cautery forceps is that it is cordless and fully portable. In the first embodiment of the invention, no cables or external power supply is necessary. This keeps the operative field clear of wires and cables. The thermal cautery of this invention does not require any grounding pad or foot switches.
A second benefit is the very high heating capacity of the thermal elements of the device. Temperatures of over 1000° C. are easily obtainable. A preferred tip operating range is from 650° to 700° C. This heat capacity and temperature can easily cauterize medium and large blood vessels.
A third benefit provided by the new and improved thermal cautery forceps of the invention is its ability to heat to operating temperature in a very short time period, for example, within about one second. The preferred embodiment uses silicon nitride, ceramic heater elements. These new ceramic heaters exhibit rapid heating and cooling characteristics. Silicon nitride ceramic heaters have been used successfully in other fields outside surgery. To the inventor's knowledge, this is believed to be the first use within the field of surgical thermal coagulation.
In an alternative embodiment, less expensive alumina heaters and ceramic resistors or diodes may be employed in substitution for the silicon nitride ceramic heater elements to provide cost savings. However, such alternative types of heaters may be less preferred because longer times to obtain operating temperatures may be required.
In an embodiment, the preferred power source is a battery rendering the device completely portable. Four lithium metal 3 volt batteries can be utilized as well as dual 9 volt batteries, one for each tine. One preferred battery is TADIRAN® which provide 11.5 volts and are rechargeable. A 12 volt direct current power supply can be utilized as well with a connecting cord or cable.
A fourth advantage provided by the new and improved forceps is the placement of the thermal cautery heater elements at the ends of forceps tines. The unique position of the ceramic heater elements allows tissue and blood vessels to be easily grasped and directly coagulated in a controlled manner. The application of a closing or gripping pressure of the forceps against the tissue or vessel enhances the effectiveness of the coagulation.
A fifth benefit of the forceps device in accordance with the invention is to decrease the cost and enhance the availability of surgical cautery. The first embodiment of the thermal forceps allows for the device to be packaged as a sterile disposable instrument. The instrument can be used in emergency or field operations. The device may be used for hemostasis during outpatient surgical procedures in clinics and in surgery centers, as well as, at emergency scenes
Other objects and advantages provided by the present invention will become apparent from the following Detailed Description taken in conjunction with the Drawings, in which:
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