Abstract:
An electrosurgical electrode configured for use in a breast plastic surgical procedure comprises an elongated forceps that is operated as a unipolar electrode. The electrosurgical electrode is provided with internal channels that can provide suction or fluids at the surgical site when a source of suction or fluid is connected to the electrode. It is provided with uniquely configured cutting edges at its distal end for cutting tissue while simultaneously coagulating any bleeding that occurs. It can cleanly and precisely cut tissue and coagulate bleeding vessels at the same time.

Description:
This invention relates to electrosurgery, and in particular to an electrode especially configured for surgery on the breast of a patient. 
     BACKGROUND OF THE INVENTION 
     Electrosurgery is a common procedure for dentists, doctors, and veterinarians. Electrosurgical handpieces are commercially available that will accommodate a wide variety of electrodes shapes and sizes, such as needles, blades, scalpels, balls and wire loops. Also, multi-function electrodes are available. A suction coagulator is described in U.S. Pat. No. 5,196,007, whose contents are herein incorporated by reference. This is an instrument that can be connected to a source of electrosurgical energy and that provides the handpiece in the form of a hollow tube with an exposed tip. By connecting a suction source to the hollow tube end, blood and other liquids as well as vapors and odors at the operative field can be drawn out while simultaneously bleeding capillaries can be coagulated electrosurgically. 
     The importance of using suction to capture smoke and plume generated during an electrosurgical procedure is also well known in the art. Such procedures involving tissue excision invariably result in the generation of smoke and odors. This causes several problems. Firstly, the smoke interferes with the vision of the surgeon. Secondly, the smoke can be inhaled by the patient or the surgeon. Thirdly, the odors are offensive. See, for example, U.S. Pat. No. 6,001,077, which describes a plume evacuation system employing a novel wand—the fitting used to capture the plume and which is attached to the suction apparatus—whose contents are herein incorporated by reference. 
     Reconstructive plastic surgery on the breast of a patient, especially breast implants, is a common surgical procedure. See for example the discussion and techniques described in RECONSTRUCTIVE PLASTIC SURGERY, 2 nd  ed., Vol. 7, Pgs. 3689–3704, publ. By W.B. Saunders Company. One of the more important steps in performing a successful breast implant is creating the pocket for the implant. Traditionally, the pocket is created using a sharp instrument (scalpel or scissors) to cut and dissect the tissue. The main problem of creating the pocket with a sharp instrument is the bleeding which obscures the surgical site and can reduce the surgeon&#39;s accuracy. Bleeding is messy and time consuming to control but if time is not taken to control the bleeding, accuracy is compromised. 
     Another traditional method used to create the pocket is blunt dissection. Blunt dissection however can tear rather than precisely and cleanly cut the tissue. Tearing and separating tissue with blunt dissection is a blind method and while it is fast it is very traumatic and causes an abundance of bleeding. 
     While the two traditional methods are easy and fast to learn, the sharp or blunt dissection techniques cause more bleeding and more tissue injury, can tear tissue, and often result in a longer recovery time. 
     SUMMARY OF THE INVENTION 
     An object of the invention is an electrosurgical electrode for performing breast surgery causing fewer problems than known procedures. 
     A further object of the invention is an electrosurgical electrode that ensures that the active end from which suction is active is located close to the operative field. 
     Another object of the invention is a unipolar electrosurgical electrode configured to carefully dissect and coagulate breast tissue in a breast plastic surgical procedure. 
     Still a further object of the invention is a suction device integrated with an electrosurgical electrode specifically adapted for use in breast implantology. 
     In accordance with an important aspect of the present invention, an electrosurgical electrode configured for use in a breast plastic surgical procedure comprises an elongated forceps that is operated as a unipolar electrode. 
     In accordance with another aspect of the present invention, the electrosurgical electrode is provided with internal channels that can provide suction or fluids at the surgical site when a source of suction or fluid is connected to the electrode. 
     In accordance with still another aspect of the present invention, the electrosurgical electrode is provided with uniquely configured cutting edges at its distal end for cutting tissue while simultaneously coagulating any bleeding that occurs. 
     The unipolar electrosurgical forceps of the invention cleanly and precisely cuts tissue and coagulates bleeding vessels at the same time. It becomes possible to produce a very precise pocket in a relatively short time (less than 20–30 min). The result in a procedure for forming a pocket in the breast is a dry pocket, which means more accuracy and better vision for the surgeon. A shorter recovery time is possible for many augmentation patients. Even in sub-muscular pocket dissection, it is possible for the majority of the patients to return to normal life in less than two-three days. 
     The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its use, reference should be had to the accompanying drawings and descriptive matter in which there are illustrated and described the preferred embodiments of the invention, like reference numerals or letters signifying the same or similar components. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       In the drawings: 
         FIG. 1  is a perspective view of one form of electrosurgical electrode according to the invention shown electrically connected to electrosurgical apparatus and suction and fluid sources; 
         FIG. 2  is a top view of the electrosurgical electrode of  FIG. 1 ; 
         FIG. 3  is a perspective view of part of the front end of the electrosurgical electrode of  FIG. 2 ; 
         FIGS. 4A ,  4 B, and  4 C cross-sectional views of the electrosurgical electrode of  FIG. 2  along the lines  4 — 4 . 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     U.S. Pat. No. 6,001,077 shows a typical surgical smoke plume evacuation system with a hand-held wand connected via filters and a vacuum hose to a vacuum blower, referred to herein as the suction generator. 
     The invention described in the present application provides an electrode configuration that is stand alone, meaning that it incorporates the handpiece and is not attached to a standard handpiece as is more common in this art. 
       FIG. 1  is a perspective view and  FIG. 2  is a top view of a unipolar electrosurgical electrode  10  according to the invention. It is made of any electrically-conductive material preferably metal, e.g., stainless steel. It is completely coated with electrically-insulating material, except for the distal working end (explained below), and thus is configured to be handled by the surgeon, with the surgeon holding both arms  12 ,  14  of the forceps configuration in the palm of his hand. The two arms  12 ,  14  are attached at the proximal end to a common support  16  and are each configured so that they are biased outwardly, like ordinary forceps, so that when the surgeon release his or her pressure on the forceps&#39; arms, they automatically assume the rest position shown in  FIG. 2 . The common metal support  16  is in turn connected to an electrical cable  18  connected at its opposite end to a connector (not shown) for plugging into a standard electrosurgical apparatus  20  supplying electrosurgical currents to the electrode  10 . In this embodiment, the surgeon would use the standard foot pedal for activating and inactivating the apparatus  20 . While not shown, it is possible to add to the forceps the kind of fingerswitches commonly found on electrosurgical handpieces to operate the apparatus  20 . 
     The electrosurgical apparatus  20  preferably is a high frequency (RF) radiosurgical energy source, which operates in the range of about 3.8–4.0 MHz. Studies have shown that the 3.8–4.0 MHz frequency range is the preferred RF energy to incise and coagulate tissue because tissue thermal necrosis is minimal and, when interfaced with the electrosurgical electrode of the invention, provides excellent cutting and hemostasis for virtually all procedures. An example of suitable electrosurgical apparatus is the Model SURGITRON Dual-Frequency electrosurgical unit manufactured by and available from Ellman International, Inc. of Hewlett, N.Y. 
     Mounted along the inside of each of the forceps&#39; arms  12 ,  14  are conduits in the form of narrow tubes  22 ,  24 . The distal ends of the tubes  22 ,  24  are open  26 . In addition, one of the tubes  22  has an additional opening  28  at the side near the end opening  26 . Each of the tubes  22 ,  24  extend along the inside of their respective arm, pass through a an opening at the proximal arm end and terminate in fittings  30 ,  32  for receiving flexible tubes (not shown) which under normal operation would be respectively connected to a source of suction and fluid. The suction withdraws smoke at the surgical site and the fluid can be used by the surgeon for irrigating the surgical site, as illustrated by the arrows in  FIG. 1 . Fittings  34  are mounted on the common support  16  and are used to support the suction/fluid tubes, respectively.  FIG. 3  is an enlarged view of the tube  22  on arm  12  showing the openings  26 ,  28 . 
     At the distal end of each arm is located the working end  36  of the electrode  10 . The working end comprises in this embodiment a short bare metal end that has a triangular configuration with triangle vertices  40  facing inward (and vertices  42  facing downward in the  FIG. 2  view) to form on each forceps end a sharp cutter  38  with a flat top  43 . The cutters  38  may have the same configuration.  FIG. 4A  is a cross-section at the working end and shows the triangular shape  38 . When the forceps&#39; arms are brought together, the vertices  40  on opposite corners abut. Thus, cutting can take place by bringing the forceps arms together using the inner vertices  40  to cut tissue between the forceps&#39; ends, or cutting can take place by bringing together the forceps arms, and moving the forceps as a unit sideways, using the outer vertices  39  opposite to that of the vertices  40 , or downward using the vertices  42  at the bottom. This gives the surgeon complete freedom as to how he or she can use the electrode during a procedure. The triangles are sharp enough to allow cutting or blunt dissection without electrosurgical currents, but in most situations electrosurgical currents will be applied at the same time as cutting to enhance the cutting and achieve hemostasis. 
     An important feature is the dimensions of the unipolar forceps of the invention. Preferably, it comes as a family in two different lengths for different breast procedures each with different sized working ends. Preferably, the overall length measured from the working end tip to the fittings  34  for one member of the family of electrodes is about 230 mm, and for the other member is about 210 mm. The former is mainly for inframammary approaches and the latter for periareolar approaches. While having both suction/fluid tubings are preferred, it is also possible to omit the fluid tubing for the shorter version for the periareolar approach. The working ends  36  also preferably come in three sizes illustrated at  FIGS. 4A ,  4 B, and  4 C. The smallest preferably has a transverse dimension  44  of about 1.8 mm and a height  46  of about 1.36 mm. The next largest preferably has a transverse dimension  44  also of about 1.8 mm but a larger height  46  of about 1.8 mm. The largest preferably has a transverse dimension  44  of about 3 mm and a height  46  of about 2.26 mm. The different sized forceps and working ends are useful for surgical procedures on different sized breasts and for different procedures. 
     In all cases, the complete forceps is completely insulated except for the small bare working end, which is bare from the line  48  to the tip. 
     In use of the forceps of the invention, with a suction source attached to the tubing  30 , when the suction generator is activated, the reduced pressure is conveyed down the hollow tubing  22 , and escapes via the ports  26  and  28  at the exit of the tubing  22 , which it will be noted is always located very close to the point of origin of the smoke plume, which is where the working electrode end  36  excises the tissue when the electrosurgical apparatus is activated. This allows smoke and airborne contaminants to be captured close to their point of origin, and avoids the need of an additional staff member to hold a separate plume capture device near the excision site. The close proximity of the capture ports  26 ,  28  to the plume origin also allows the use of lower reduced pressure and thus lower noise levels. Similarly, when a fluid source is connected to the fitting  32  and activated, irrigating fluid such as saline solution will exit from the port  26  again close to the excision site. 
     As a result of the relatively simple construction, manufacture is quite simple and low cost, which is important for disposable hospital and office environments. 
     When RF energy is supplied, it will flow to the sharp vertices of the working end. The RF energy focuses on the sharp corners of the forceps&#39; tip. The RF energy flowing through the sharp edge of the working end allows for dissection and excision of all degrees of breast tissue types, while at the same time effectively coagulating any bleeders that may result. 
     The RF forceps of the invention enables the surgeon to use one instrument to provide the necessary surgical features of cutting, coagulation and suction, with or without suction or fluids, with RF energy being applied during part or all of the time that the dissection procedure is carried out, with RF energy and blunt dissection, or with blunt dissection, or with suction alone without RF energy being applied. The surgeon would be otherwise required to utilize several different surgical instruments to accomplish what the RF forceps probe alone can accomplish. The changing of instruments during the surgical intervention prolongs the surgery, blood loss and anesthetic time for the patient. 
     By interfacing the RF breast probe with the ultra-high 3.8–4.0 MHz Radiosurgery apparatus, a number of surgical and clinical advantages, namely: better operative results, due to the high frequency radiosurgery device&#39;s ability to significantly reduce tissue necrosis; minimal scarring; reduced surgical pain and post-operative pain; and controlled bleeding and post-operative bleeding. 
     Precise 3.8–4.0 MHz high frequency/low temperature dissection, using the special monopolar plume suction forceps to cut and coagulate bleeding vessels under direct vision can produce a very precise pocket in short time (less than 20–30 min.). The radiofrequency method dramatically reduces the risk of complications (bleeding, infection, asymmetry, etc). Additionally typically there is less pain and a shorter recovery period. 
     Other variations in the shape of the electrosurgical electrode working end while retaining its benefits and advantages will be evident to those skilled in the art. 
     While the invention has been described in connection with preferred embodiments, it will be understood that modifications thereof within the principles outlined above will be evident to those skilled in the art and thus the invention is not limited to the preferred embodiments but is intended to encompass such modifications.