Patent Application
20070055226
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.
An electrosurgical handpiece for blades is described in U.S. Pat. No. 4,754,754, whose contents are herein incorporated by reference. This is an instrument that can be connected to a source of electrosurgical currents and that provides a slitted collet for receiving the shank of a standard disposable scalpel blade. The instrument can be used in many surgical procedures in which a conventional scalpel is employed, mainly for general cutting procedures. It has the advantage of providing electrosurgical currents at the sharp edge of the scalpel which assist in cutting tissue while at the same time providing a coagulation effect. Other known electrode shapes include a curet, as described in our U.S. Pat. No. 5,913,864, whose contents are herein incorporated by reference. This is a circular band with one sharpened edge for use in an electrosurgical dermatological curretage procedure. Another shape is the well-known ball electrode which is a spherical ball on the end of an electrode shank which is used for coagulation. Still another shape is a flat round disc with a tapered edge useful for vaporizing lesions and tumor tissue, as described in our issued U.S. Pat. No. 6,610,057, whose contents are herein incorporated by reference. See also our U.S. Pat. No. 6,673,072 relating to an electrode with a projecting point.
While these various shaped electrodes are suitable for their intended purposes, occasions arise from time-to-time when the electrode during use may tend to stick to the cut or coagulated tissue, which can prove undesirable. Similarly, during use, the electrode may overheat, which can lead to undesirable tissue damage.
Another problem may arise when the electrode is used to slice a thin tissue specimen for biopsy purposes. In this application, the physician performs histological studies by examining the specimen surface under a microscope, for example, searching for potentially tumor-forming cells. It is desirable that the surface represent as closely as possible the underlying tissue, meaning the surface cells at the severed surface should exhibit as little alteration and damage as possible. For example, an ordinary cold steel scalpel used to slice off a specimen typically forms at the severed surface damage extending to a certain depth. Using a typical electrosurgically-activated electrode, such as a scalpel or needle, loop or blade of tungsten or steel provides an improvement in that the damage extends to a lesser depth.
An object of the invention is an improved electrosurgical electrode capable of performing cutting or coagulation with an active edge or point.
Another object of the invention is an electrosurgical electrode that may tend to stick to tissue less than other known electrodes.
Still another object of the invention is an electrosurgical electrode capable of cutting through tissue and causing less alteration and damage to the cut tissue surfaces.
According to one aspect of the invention, an electrosurgical electrode comprises mainly an outer surface of a silver-alloy. Preferably, the silver alloy covers a core metal having a higher melting point than that of the silver.
It has been suggested in the past to use noble metals as electrode materials because of their reduced electrical resistance that therefore allows the use of lower electrosurgical currents which in turn means that less heat is developed at the incision. It has also been suggested that an electrosurgical electrode should have an outer surface of a noble metal because the noble metal is bio-compatible with tissue and also reduces the tendency for the electrode to stick to the tissue. Thus the prior art has suggested the use of pure silver or gold and silver coated core metals such as copper, brass, or stainless steel. See for example, US 2004/0236203 A1 which describes a special silver alloy capable of generating far infra-red radiation. We have tried to make and use such prior art electrodes but have not been fully satisfied with the results, for various reasons.
The principal feature of our invention is an electrosurgical electrode with a core mainly of a refractory, reasonably ductile metal and clad with a silver alloy with a small percentage of other constituents. Preferably the core is molybdenum. Preferably the cladding is about 93-98% by weight silver with about 1.5-4% by weight of germanium and 1-2% by weight of indium. A preferred composition is a cladding of 97% silver with 2% germanium and 1% indium, on a molybdenum core. A small percentage of copper may also be present in the core or cladding.
“Cladding” as used herein is defined to mean a process that embeds a coating material into the core. It is not an ordinary coating, such as that obtained by plating or electro-plating or by vapor-depositing a coating material onto the core. The cladding process is much more intense and actually causes the cladding material and core material to interdiffuse and alloy at their interface over a significant depth. This produces an extremely strong bond between the cladding material and the core. This is critical to the invention. The reason is that, for a typical needle or loop electrode, the smaller the diameter of the needle or of the loop, the less likely that the damage at the incision will be deep. Preferably, the needle electrode of the invention employing the silver-alloy clad core metal has an overall diameter between about 0.004 and 0.025 inches, preferably, between about 0.006 and 0.020 inches (6-20 mils, where 0.001 inch=1 mil) with a pointed end. Manufacturing such a shaped electrode, which also applies to loop electrodes, typically requires that a coated core wire or rod be drawn down from a starting diameter of say about 450 mils to the final size desired. The drawing process could have a tendency to cause damage to the coating such as by chipping or cracking or stripping off ordinary coatings. We have found that the cladding process that is preferred, in contrast, produces such a strong bond between the coating and the core that the larger diameter needle is easily drawn, as explained below, down to the required very fine size without causing damage to the outside silver-alloy coating.
For making fine needles or wire for use as a loop, it is difficult to start with a thin enough clad wire such that only a single drawing step suffices to produce the desired fine needle or wire. On the other hand, if one starts with a thicker clad wire, then it is difficult if not impossible for a single drawing step to produce the desired fine needle or wire. Hence, several successive drawing steps are required. But, each drawing step even with ductile metals typically work-hardens the clad wire making it difficult to carry out a succeeding drawing step on the resultant work-hardened wire. Hence, it is preferred that each drawing step be followed by an annealing step which allows the drawn wire to regain its ductile properties in order to ease the next drawing step until the desired fine needle or wire is obtained. Thus, in the preferred cladding process, the starting relatively thick clad wire or rod is drawn through a first die which reduces the diameter by say 10-20%, annealed to restore the molybdenum ductility, drawn through a second die which reduces the diameter by another 10-20%, again annealed to restore the molybdenum ductility, and so on until the resultant wire has reached the preferred small diameter desired.
The thickness of the cladding is typically about 5-15% of the overall needle diameter. The mainly high melting point molybdenum core provides a stiff electrode body. The silver-alloy cladding provides the low resistance wanted to reduce heating of the tissue during use. We have also found that the silver-alloy cladding is bio-compatible with the tissue and no undesirable side-effects arise from contact between the silver-alloy and tissue.
While it is preferred that the silver-alloy cladding be thin, preferably about 1 mil thick, forming a sharpened point at the end for a needle electrode may have a tendency to remove the cladding at the tapered end. In such cases, it is preferred that a thicker cladding be used, such as 2-3 mils. In accordance with another feature of the invention, where a needle electrode with a very sharp pointed end is desired, then it is preferred that the entire electrode be composed of the silver alloy, i.e., with about 1.5-4% by weight of germanium and 1-2% by weight of indium, remainder silver. In this case, it is preferred that the starting stock be a straight silver alloy rod with a diameter of about 30-40 mils, preferably about 35 mils. Then it is possible to grind the working end down to a sharp point while retaining sufficient strength in the supporting rod for use as a needle electrode.
The same silver-alloy clad molybdenum core material can also be used to make blade, scalpel, and curet shaped electrodes, but the process has not yet been adequately refined for the manufacture of the typical ball-shaped electrode. In the latter case, it is preferred that the silver-alloy composition alone be used, without the molybdenum core, but the electrode preferably is specially shaped to enhance its performance. Preferably, the active part of the ball is not spherical, but has a truncated conical shape, with the narrower or distal end at the active tip. Preferably, this specially-shaped electrode is connected at its proximal end to a brass rod to serve as the electrode shank. Proximal and distal are taken with respect to the shank end of the electrode which is held by the electrosurgical handpiece.
We have found that best results are obtained when the electrosurgical electrode in accordance with the invention is used with an electrosurgical instrument capable of generating radio-frequency electrosurgical currents in the 2-4 MHz range. Examination of the severed surfaces of tissue cut with the loop electrode of the invention connected to an electrosurgical instrument generating 4 MHz cutting electrosurgical currents has a damaged tissue depth less than one-half of that cut with a cold scalpel, and at least 20% less than that cut with the same needle but using electrosurgical currents at KHz frequencies. Electrosurgical instruments capable of generating radio frequency cutting currents in the MHz range are available from Ellman International, Inc. of Oceanside, N.Y. See also our U.S. Pat. Nos. 5,954,686 and 6,238,388 relating to MHz frequency electrosurgical units.
The cladding processes that are preferably used to provide the tightly-bonded alloy coating in accordance with the invention may be briefly described in the following example.
A foil of silver-alloy that was approximately 0.010″ thick and 3″×3″ square was wrapped and then bonded by prolonged heating at an elevated temperature below the melting or softening point of the silver alloy around a molybdenum rod that was around ⅜ths of an inch in diameter. The resultant clad rod was drawn through a series of drawing dies each with a smaller aperture gradually reducing the diameter of the clad rod. Preferably, at the end of each drawing step, the wire was put into a furnace and heated at an elevated temperature to anneal and soften the material up from the resultant cold working it received during the drawing reduction process. These steps are repeated until the wire is at the desired size. The end result is a wire with a core of molybdenum and an outer clad layer of the silver-alloy. The cross-section would look similar to a pencil.
For a 9 mil electrode, the layer of the silver alloy is about 0.001″ thick on about a 7 mil core. For a 20 mil needle electrode, alloy again was 0.001″ thick and the core about 18 mils in diameter. For grinding the end to a fine point, a thicker alloy layer should be used.
As for the ball electrodes, these are prepared by turning from a solid rod stock of the silver-alloy alone. No cladding is necessary here for strength. The shaped ball is then assembled to a brass tube to serve as the shank. Small diameter ball shapes can have an overall diameter of about 5.0 mm. With the preferred geometry having the narrow cone end preferably has a diameter of about 1.0 mm at the narrow end.
For the silver-alloy clad core metal, the cladding process described ensures that sufficient mutual diffusion occurs such that the cladding interface is essentially embedded in the core metal. This produces the tightness of bonding required for the wire to withstand the subsequent drawing down process without cracking or chipping. Since the final needle product during use does not undergo any significant physical wear and tear, being used only as an electrosurgical electrode where the pressure against the tissue as applied by the surgeon is usually light, wearing of the coating is minimal and thus thin coatings are adequate for the purpose.
While an ultra-fine needle or a fine loop mainly of molybdenum clad with the silver-alloy is preferred as it produces the most benefits in terms of reducing tissue damage at the incision and reducing generated heat, especially for preparing biopsy specimens, the invention can also be used with, for example, blade electrodes or scalpel electrodes or ball or loop electrodes, and can also be used with forceps electrodes. This applies to both unipolar and bipolar electrodes. In the case of the forceps, the reduced heat generated by the electrosurgical currents will reduce the tendency of the forceps tips to stick to tissue.
Studies have been made comparing the surface alteration of the tissue when an incision (removal of a slice) is made by a tungsten loop electrode and a loop electrode in accordance with the invention comprising a core of molybdenum clad with an alloy of 97% silver with 2% germanium and 1% indium. The studies all used an electrosurgical instrument supplied by the Ellman company and all used the 4 MHz instrument setting. The specimens were Facial Nevus shavings (5 micron slice) separately made with a tungsten loop and the silver alloy loop of the invention. Of the six biopsy specimens taken, the measurements of the three specimens taken with the tungsten loop indicated a depth of thermal damage as high as 30 microns, whereas the measurements of the comparable three specimens taken with the silver alloy loop of the invention indicated a depth of thermal damage in micrometers no greater than 10 microns. Also, the silver alloy specimens were cut using the fully filtered waveform at the 12 watt setting, resulting in less heating. So it is clear that the silver alloy electrode of the invention offers on average less surface damage and thus inevitably less pain and suffering and faster healing at the biopsy site. In general, all three of the typical waveforms are usable with advantage, including the fully filtered, fully rectified and partially rectified, to do excisions, incisions, and coagulation. There will usually be a preferred power setting and waveform for the various procedures, to avoid arcing and undue tissue damage. With the silver alloy of the invention, we have found that typically, a power setting and waveform can be chosen by the surgeon that well matches the use of the silver alloy electrode and minimizes heating and undue damage to the tissue. While the 4 MHz frequency is preferred, advantageous results will be obtained with lower frequencies also.
The foregoing clearly demonstrates the superiority of the electrode in accordance with the invention for this application, and it can reasonably be forecast from these studies and others that an improvement will result in most electrosurgical procedures, because less tissue damage where the incision is made usually results in less pain and trauma for the patient and accelerates the healing process.
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.
In the drawings:
In the variation illustrated in
As described above, another preferred embodiment of the invention is a silver alloy needle electrode with a sharpened end, in this case without the molybdenum core. The electrode can have a straight shank but is preferably of a larger diameter than when the silver alloy is a cladding on a molybdenum core.
The preferred ball shape is illustrated in
It is clear that the invention is not limited to these illustrative embodiments and includes within its scope other shapes and styles of known electrodes, both unipolar and bipolar, especially those with sharpened points or edges or narrow edges such as a loop.
The electrosurgical apparatus 20 preferably is an ultra high frequency (RF) radiosurgical energy source, which operates in the range of about 2-4 MHz, preferably 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 especially for removal of cancerous tissue and also for cutting specimens for biopsy studies. An example of suitable electrosurgical apparatus is the Model SURGITRON Dual-Frequency electrosurgical unit manufactured by and available from Ellman International, Inc. of Oceanside, N.Y.
What is not shown in the drawings are the presence of electrically-insulating coatings on the conductive parts of the electrode that support the active end and that are not involved in the surgical procedure for preventing inadvertent burns to the patient.
In the operation of the embodiments of the invention, activation of the electrosurgical unit 20 causes the flow of electrosurgical currents from the electrode working end when applied against or close to the tissue to be destroyed. With the electrodes of
The electrodes of the invention can be made in a sterile disposable single use design but it is not limited to single use. It can also be made in reusable autoclaveable material.
Other variations in the shape of the electrosurgical electrode working end will provide the same or similar benefits and advantages as 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.
