This invention relates to electrosurgical devices, and more particularly to improved electrosurgical devices having selectively insulated portions for use in procedures such as resection, incision, ablation, and/or coagulation.
There are many medical procedures in which tissue is removed for diagnostic or therapeutic reasons. For example, transurethral resection of the prostate (TURP) is performed to treat benign or cancerous prostatic hyperplasia, which blocks the urethra. Transurethral resection may also be performed in the bladder (TURB). In a transurethral resection procedure, a resection electrode is inserted into the urethra of a patient through a resectoscope. An electric current applied through the electrode heats the prostate tissue sufficiently to break inter-cellular bonds, thereby cutting or resecting the tissue. Extensive bleeding can occur as a result of resection, and the bleeding can obstruct the physician's view and/or lead to dangerous blood loss levels. Coagulation of the resected tissue can minimize bleeding.
Prior to and during the resection and coagulation procedures, a fluid inserted through the resectoscope irrigates the treatment region. Irrigation displaces urine in the urethra and distends the urethra to create a working space. During the resection procedure, irrigation displaces removed tissue and blood. Examples of suitable irrigation fluids include distilled water (i.e., deionized water), glycine, sorbitol, and saline. An advantage of using saline over the other irrigation fluids is that saline prevents side effects known as TURP syndrome. TURP syndrome occurs in 2-3% of patients undergoing prostate resection. TURP syndrome is caused by rapid absorption of electrolyte free fluid, which may lead to mental confusion, nausea, visual disturbance, cardiac arrhthmias, or central nervous system dysfunction. Complication from TUR syndrome can lead to death. A disadvantage of using saline, however, is that the electrolytic nature of the saline results in an increased conductivity through the irrigant. It is often difficult to generate a plasma field, necessary to resect tissue, at the tip of an electrode because current applied to the electrode quickly diffuses toward the saline, instead of traveling directly into the tissue. Moreover, an RF generator in communication with the electrode will sense that a short circuit is present at the electrode tip, because saline provides a low initial impedance across the output leads. Therefore, the output voltage starts low and then builds up as the RF generator learns that an impedance exists at the tip. The impedance builds up as the electrode is heated, causing the fluid in contact with the electrode to vaporize. The result is then an increase in the impedance of the system. The RF generator responds by increasing the amount of power delivered. This continues in the manufacturer's specified working impedance range. Above this range, the RF generator delivers decreasing amounts of power.
Existing electrosurgical devices tend to be inefficient when used with an electrolytic fluid such as saline. As a result, resection performed with existing devices is either inadequately carried out, or a greater amount of energy must be applied to the electrode to perform resection, which raises other concerns. Adjacent healthy tissues may be damaged during the resection procedure when a large amount of energy is applied.
An object of the invention is to provide an electrosurgical device which overcomes these problems by being able to focus energy emission towards the tissue, reducing energy loss to the resected chips or the fluid delivered to the tissue site, while avoiding the need for higher power levels to achieve such an effect. Another object of the invention is to provide an electrosurgical device which provides an increase in current density at the electrode, and an electrode that is capable of generating plasma fields in a tissue being irrigated with fluid, such as, for example, a non-osmotic fluid (e.g., saline, glycine, sorbitol), without being embedded within tissue. Lower power levels can be used with the electrosurgical devices of the present invention in performing resection procedures, since diffusion of energy at the distal tip of the resecting electrode has been reduced.
The present invention features an electrosurgical device comprising an elongated body including a proximal end and distal end and defining a longitudinal axis, at least one arm coupled to the distal end of the elongated body, and an electrode coupled to at least one arm. The electrode includes an upper surface and a lower surface. The lower surface is substantially convex and defines a radius of curvature relative to an axis substantially perpendicular to the longitudinal axis.
In one embodiment the upper surface of the electrode is smaller than the lower surface of the electrode. In another embodiment the upper surface of the electrode is substantially concave. Alternatively, the upper surface of the electrode can be substantially flat.
In another embodiment, the upper surface of the electrode includes an insulative coating. An example of an insulative coating is a ceramic coating. Ceramic coatings can comprise materials such as alumina, zirconia, and combinations such as alumina and titanic The preferable thickness of the ceramic coating is from about 0.0002 inches to about 0.03 inches. In still another embodiment, the lower surface of the electrode comprises a ceramic base material and a metallic coating disposed over the ceramic base material.
In another aspect, the invention comprises a method of manufacturing an electrosurgical device. According to the method, an electrode coupled to an elongated body is provided and a ceramic coating is sprayed over an upper surface of the electrode. The electrode comprises a conductive member. The electrode includes an upper surface and a lower surface. The lower surface is substantially convex with a radius of curvature relative to an axis substantially perpendicular to a longitudinal axis of the elongated body. In one embodiment, a bond coating is placed on the conductive member prior to spraying. The preferable thickness of the ceramic coating is from about 0.0002 inches to about 0.03 inches.
In another embodiment, the ceramic coating is applied by thermal spraying. Thermal spraying can also be performed using a high velocity fuel spraying method. In yet another embodiment, the upper surface of the electrode is roughened prior to thermal spraying. One method of roughening the upper surface is by sand blasting it. In still another embodiment, thermal spraying of the upper surface can also be accomplished with alumina coating or alumina and titania coating. In a further embodiment, the ceramic coating is applied by plasma spraying.
The foregoing and other objects, features, and advantages of the invention will become apparent from the following, more particular description of the preferred embodiments of the invention.
This invention is described with particularity in the appended claims. The above and further advantages of this invention may be better understood by referring to the following description taken in conjunction with the accompanying drawings.
a is a perspective view of an electrosurgical device having a broad loop electrode.
b is an enlarged perspective view of a distal portion of the electrosurgical device of
a is a side view of an electrosurgical device having a standard loop electrode.
b is a perspective view of an electrosurgical device having a horizontal loop electrode.
a is a perspective view of an electrosurgical device having a crescent shape electrode.
b is a side view of another electrosurgical device having a crescent shape electrode.
c is a side view of another electrosurgical device having a crescent shape electrode.
a is a side view of an electrosurgical device having a grooved roller electrode.
b is a side view of another electrosurgical device having a grooved roller electrode.
a is a perspective view of another electrosurgical device having a broad loop electrode.
b is an enlarged perspective view of a distal portion of the electrosurgical device of
a is a perspective view of an electrosurgical device having a cylindrical roller electrode.
b is a perspective view of an electrosurgical device having a spherical roller electrode.
a is a perspective view of another electrosurgical device having a broad loop electrode.
b is an enlarged perspective view from a proximal side of a distal portion of the electrosurgical device of
a is a cross-sectional view of a dual ion beam deposition chamber for depositing an insulative coating on an electrode.
b is a cross-sectional view of a high velocity oxygen fuel thermal spray chamber.
c is a cross-sectional view of a plasma thermal spray chamber.
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In another embodiment, the conductive regions 318 can comprise a plurality of pin holes created by the process of vapor deposition of the insulative coating 320 on the electrode, described above. The electrosurgical device can further include a sheath for carrying the elongated body 312 and for delivering an electrolytic non-osmotic fluid such as saline, to a treatment path. In this embodiment, energy applied to the electrode 316 remains focused at the conductive regions 318 when used in conjunction with an electrolytic fluid.
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In each of the embodiments, the electrosurgical device can be efficiently used with a non-osmotic fluid, such as, for example, saline, glycine or sorbitol. Moreover, the electrosurgical device of the present invention can be used in saline, an electrolytic, non-osmotic fluid without a considerable loss of energy to the tissue undergoing treatment or the fluid. Additionally, the present invention avoids the use of high currents to deliver energy to the treatment site, as energy is effectively focused in the conductive section or sections of the electrode. The result is higher current density, which promotes the generation of a plasma field. In addition, electrodes other than those provided as examples herein can include an insulative coating to expose only a working portion of the electrodes.
In the embodiments of the present invention, a portion of the conductive material of an electrode is covered with an insulative coating to minimize exposure of the conductive member to an environment such as the irrigation fluid, and only a working portion of the electrode is exposed to the environment. The insulative coating disposed on an electrode comprises a material capable of remaining adhered to a conductive material forming the electrode upon application of a voltage of up to about 1000 volts to 2000 volts and upon generation of a plasma field near the electrode. It is to be appreciated that finding the appropriate insulator for the coating is not a trivial matter as most insulators can disintegrate upon generation of plasma fields. A preferred insulator used in the present embodiment has superior electrical resistivity, dielectric strength, and hardness, in addition to having good adhesion to the conductive material forming the electrode. The thickness of the insulative coating covering a non-working portion of an electrode can range from 0.0005 inches to 0.030 inches. An insulative coating that is too thick can create residual stress in the coating, causing the coating to crack and be removed from the electrode. An insulative coating that is too thin may be insufficient to insulate the non-working portion of the electrode. Surface roughness of the insulative coating is less than 50 rms. In a preferred embodiment, the surface roughness is less than 32 root mean square.
In one embodiment, the insulative coating is a diamond-like carbon (DLC) coating sold under the trademark Diamonex® by Diamonex, a unit of Monsanto Company (Allentown, Pa.). DLC is an amorphous diamond material which resembles properties of a naturally occurring diamond. DLC has a hardness in the range from 1000 to 5000 kg/mm2, an electrical resistivity in the range from 104 to 1012 ohms-cm, a dielectric constant of approximately 100 volts (rms) at mains frequency and good adhesion to a substrate.
In one embodiment, DLC is vapor deposited onto the electrode. In other embodiments, the DLC can be deposited by ion beam deposition, RF plasma deposition and by the process of polycrystalline growth. As will be further described, vapor deposition is a microfabrication technology well known to those skilled in the electronics fabrication art. Ion beam deposition technique is described in U.S. Pat. No. 5,508,368, which is incorporated herein by reference. In another embodiment, DLC is deposited using a hot filament chemical vapor deposition technique. The DLC coating is deposited on a working portion of the electrode then removed by etching or other removal processes, such as grinding and EDM (Electrical Discharge Machining) while the DLC coating on the non-working portion remains. In another embodiment, a working portion of the electrode is masked. while DLC is vapor deposited on the electrode, such that DLC coating is prevented from depositing on the working portion of the electrode.
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In another embodiment, synthetic polycrystalline diamond can be used as insulative coating. Polycrystalline diamond has a thermal conductivity greater than 1000 W/m° K, an electrical resistivity of greater than 1011 ohm-cm, a thermal expansion of about 2×10−6/° C. between 25° C. and 200° C., a dielectric constant of about 5.7, a dielectric strength of about 300+V/μm, and a shear strength of about 108 N/m2.
In still another embodiment, a ceramic coating can be used to cover a non-working portion of the electrode. A ceramic coating is relatively inexpensive, durable, and does not wear over time. Examples of suitable ceramic coatings include alumina, zirconia, and a combination of alumina and titania. The alumina titania combination is particularly useful as the alumina is a good insulator having a high dielectric strength and titania provides toughness to the mixture. The preferred combination includes 87% alumina and 13% titania. The ceramic coating can be placed on the electrode using any one of several methods. In one detailed embodiment, metal disposed over the electrode may be anodized to form a metal oxide layer on the electrode. To grow an alumina layer, for example, aluminum is first disposed on the electrode and the aluminum is allowed to oxidize to form the alumina. The process of anodizing metal to form an oxide is well known to those in the art.
In another detailed embodiment, a ceramic coating is sprayed onto the electrode. Ceramic coating can be sprayed on the electrode using thermal spray. Thermal spraying provides several advantages. Thermal spraying improves adhesion of the ceramic coating to the electrode during use. Ceramic coating placed on a cold electrode tends to crack while the electrode is heated during electrosurgery, due to a difference in the coefficient of expansion between the metal and the ceramic material. Thermal spraying improves adhesion between the electrode and the ceramic coating during use of the electrode, because the ceramic coating is placed over the electrode, while the electrode is expanded under heat. Therefore, when the electrode is heated again during use, the ceramic coating is less likely to crack. Thermal spraying also allows one to control the thickness of the ceramic coating. A coating thickness can range from 0.0005 inches to 0.030 inches.
Examples of suitable thermal spraying techniques include high velocity oxygen fuel (HVOF) spraying, shown in
In a preferred embodiment, the electrode is pre-treated to enhance bonding with the ceramic coating and the ceramic coating is thermal sprayed onto the electrode. The electrode can be pre-treated in a number of ways. In one detailed embodiment, the electrode surface is roughened to create better mechanical bonding between the electrode and the coating. For example, the electrode surface can be sand blasted to create the rough surface. Alternatively, metal can be sprayed onto the electrode surface to create the rough surface. In another detailed embodiment, a bond coating is sprayed on the electrode prior to coating the electrode. The bonding coating, for example, may comprise nickel chromium super alloy.
In still another embodiment, the electrodes described in
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Although a resection procedure using the resecting electrode of the present invention has been described with reference to
It is to be appreciated that the use of an insulative coating such as a DLC coating or a ceramic coating can have other applications. For example, biopsy forceps can be selectively coated with an insulative coating to prevent the biopsy sample from being damaged. The inner surfaces of the biopsy forcep that comes in contact with the removed biopsy sample can be coated with the insulative coating, while the outer surfaces of the forceps used to remove the sample can remain conductive.
Those skilled in the art will be able to make numerous uses and modifications of and departures from the embodiments described herein without departing from the invention. Consequently, other embodiments are within the following claims.
This is a continuation-in-part of U.S. patent application Ser. No. 08/940,665 filed Sep. 30, 1997, the entirety of which is incorporated herein by reference.
Number | Date | Country | |
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Parent | 10292162 | Nov 2002 | US |
Child | 12027859 | US | |
Parent | 09359335 | Jul 1999 | US |
Child | 10292162 | US |
Number | Date | Country | |
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Parent | 08940665 | Sep 1997 | US |
Child | 09359335 | US |