Articulating ionizable gas coagulator

0001The present invention relates to an electrosurgical apparatus for coagulating tissue through an endoscopic tube, such as may be embodied by an articulating, gas-enhanced electrosurgical apparatus for coagulating tissue.

<u>Background of Related Art</u>

0002Over the last several decades, more and more surgeons are abandoning traditional open methods of gaining access to vital organs and body cavities in favor of endoscopes and endoscopic instruments which access organs through small puncture-like incisions. Endoscopic instruments are inserted into the patient through a cannula, or port, that has been made with a trocar. Typical sizes for cannulas range from three millimeters to twelve millimeters. Smaller cannulas are usually preferred, and this presents a design challenge to instrument manufacturers who must find ways to make surgical instruments that fit through the cannulas and operate in a safe and effective manner.

0003Endoscopic instruments for arresting blood loss and coagulating tissue are well known in the art. For example, several prior art instruments employ thermal coagulation (heated probes) to arrest bleeding. However, due to space limitations surgeons can have difficulty manipulating the instrument to coagulate, desiccate, fulgurate and/or cut tissue. Moreover, if the probe comes into close contact with the tissue, the probe may adhere to the eschar during probe removal possibly causing repeat bleeding. Other instruments direct high frequency electric current through the tissue to stop the bleeding. Again, eschar adherence may also be a problem with these instruments. In both types of instruments, the depth of the coagulation is difficult to control.

0004<patcit id="pcit0001" dnum="US5207675A"><text>U.S. Patent No. 5,207,675 to Canady</text></patcit> attempts to resolve certain of the above-noted problems with respect to the prior art by providing a tube-like coagulation instrument in which an ionizable gas is forced through the instrument and ionized by an electrode in the region between the distal end of the instrument and the bleeding tissue. The electrode, then, does not contact the tissue.

0005<patcit id="pcit0002" dnum="US5720745A"><text>U.S. Patent No. 5,720,745 to Farin et al</text></patcit>. discloses a coagulation instrument which extends through a working channel of an endoscope and includes an electrode for ionizing a stream of ionizable gas exiting the distal end of the instrument at a rate of less than about 1 liter/minute. As explained in detail in the Farin et al. specification, the purpose of discharging the gas at a very low flow rate is to effectively cloud the tissue area and create an ionizable gas "atmosphere" to gently coagulate the tissue.

0006Using these instruments to treat certain more tubular sites, e.g., the esophagus and/or colon, is often difficult, impractical and time consuming. For example, these longitudinally oriented instruments fire the ionised gas and the RF energy in an axial direction from their respective distal ends which, in the case of tubular tissue, would be parallel to the bleeding tissue. Thus, manipulating these instruments to focus the energy transversely or off-axis at the bleeding tissue may be very difficult.

0007Thus, a need exists for the development of a new and effective instrument for treating certain more tubular tissue.

<u>SUMMARY</u>

0008According to the present invention, there is provided an electrosurgical apparatus for coagulating tissue, the apparatus being insertable through an endoscopic tube, said apparatus comprising: an elongated flexible tube having a tube proximal end and a tube distal end and defining a longitudinal axis; a sleeve that is selectively extendable through the tube, the sleeve including a sleeve distal end and being movable from a first position in which the sleeve distal end is inserted into the tube, whereby it is disposed in a generally rectilinear fashion relative to the tube longitudinal axis, to a second position in which the sleeve distal end is extended distally of the tube and in which it is configured, in operation of the electrosurgical apparatus, to direct pressurized ionizable gas flowing through the sleeve at an angle with respect to the longitudinal axis; at least one electrode mounted proximal to the distal end of the sleeve for ionizing pressurized ionizable gas; a corona electrode disposed proximate the distal end of the sleeve; and a dielectric sleeve disposed between the at least one electrode and the corona electrode, wherein the sleeve is configured and arranged through the tube so that the angle of the distal end of the sleeve relative to the longitudinal axis progressively changes as the distance that the distal end of the sleeve extends from the tube changes, and wherein the sleeve is a hollow shape memory alloy sleeve having a generally curved-tube austenite configuration and displaying stress-induced martensite behavior, the hollow sleeve being at least partially restrained in a deformed stress-induced martensite configuration by the tube when extending therethrough, and wherein extension of a portion of a hollow sleeve from the distal end of the tube unstrains the extended portion from the deformed austenite configuration to a generally curved-tube configuration such that the extended unstrained portion can direct pressurized ionisable gas flowing through the tube at an angle with respect to the longitudinal axis.

<u>BRIEF DESCRIPTION OF THE DRAWINGS</u>

0009To tenable a better understanding of the present invention, and to show how the same may be carried into effect, reference will now be made, by way of example only, to the accompanying drawings, in which: <ul id="ul0001" list-style="none" compact="compact"><li><figref idref="f0001">Fig. 1</figref> is a front, perspective view of an electrosurgical instrument shown extending through a working channel of a flexible endoscope;</li><li><figref idref="f0002">Fig. 2a</figref> is an enlarged, side sectional view of one embodiment of the present disclosure showing a hollow shape memory sleeve in retracted position within a catheter;</li><li><figref idref="f0002">Fig. 2b</figref> is an enlarged view of the hollow shape memory sleeve shown in austenite configuration;</li><li><figref idref="f0003">Fig. 3</figref> is an enlarged, side sectional view of the shape memory sleeve of <figref idref="f0002">Figs. 2a and 2b</figref> shown extending and articulating from the catheter to direct ionized gas at the tissue;</li><li><figref idref="f0003">Fig. 4</figref> is an enlarged, side sectional view of disclosed embodiment not forming part of the present invention, showing a pull wire/return electrode affixed at the distal end of a flexible catheter;</li><li><figref idref="f0004">Fig. 5</figref> is an enlarged, side sectional view of the embodiment of <figref idref="f0003">Fig. 4</figref> showing the wire being drawn to articulate the flexible catheter and direct ionized gas at the tissue;</li><li><figref idref="f0004">Fig. 6</figref> is an enlarged, side sectional view of another embodiment of an electrosurgical instrument not forming part of the present invention, showing a ring corona electrode and a dielectric sleeve seated within a flexible catheter and a pull wire/return electrode affixed at the distal end of the flexible catheter;</li><li><figref idref="f0004">Fig. 7</figref> is a cross sectional view of the <figref idref="f0004">Fig. 6</figref> embodiment taken along line 7-7; and</li><li><figref idref="f0005">Fig. 8</figref> is an enlarged, side sectional view of the embodiment of <figref idref="f0004">Fig. 6</figref> showing the pull wire/return electrode being drawn to articulate the flexible catheter and direct ionized gas at the tissue.</li></ul>

<u>DETAILED DESCRIPTON</u>

0010The present disclosure relates to an electrosurgical apparatus for coagulating tissue which includes an elongated flexible tube having a proximal end, a distal end a source for supplying pressurized ionisable gas to the proximal end of the tube. The apparatus in one embodiment includes a hollow sleeve made from a shape memory alloy, e.g., Nitinol and/or Tinel, which has a generally curved austenite state and displays stress-induced martensite behaviour at normal body temperatures. The hollow sleeve is restrained in a deformed stress-induced martensite configuration within the tube wherein partial extension of a portion of the hollow sleeve from the tube transforms the portion from the deformed configuration to its generally curved austenite configuration such that the portion directs the gas transversely at the tissue. The surgical apparatus also includes at least one active electrode and a source of high frequency electrical energy for ionizing the gas prior to the gas exiting the portion of the sleeve.

0011Preferably, the angle at which the gas is directed at the tissue is directly related to the distance the portion of the sleeve extends from the tube.

0012One disclosed electrosurgical apparatus include a wire connected to the distal end of the tube. The wire is movable from a first generally relaxed position wherein the tube is disposed in generally rectilinear parallel fashion relative to the tissue to a second retracted position wherein the distal end of the tube flexes at an angle to direct the gas towards the tissue.

0013Another disclosed embodiment of an electrosurgical apparatus according to the present invention includes a corona electrode disposed proximate the distal end of the tube for inducing ignition of the plasma prior to emission. Preferably, a wire is connected to the corona electrode and electrically connects the corona electrode to a source of electrosurgical energy. A dielectric material is preferably disposed between the corona electrode and the active electrode to prevent arcing between electrodes.

0014Referring now to <figref idref="f0001">Fig. 1</figref>, an articulating tissue coagulator generally identified by reference numeral 10 is shown extending through a working channel of an endoscope 12. Preferably, the coagulator 10 can be employed with a variety of different endoscopes such as those manufactured by Olympus, Pentax and Fujinon.

0015As such, only the basic operating features of the endoscope 12 which work in combination with the apparatus of the present disclosure need to be described herein. For example, endoscope 12 includes a handpiece 26 having a proximal end 27 and a distal end 29. In the drawings and in the description which follows, the term "proximal", as is traditional, will refer to the end of the apparatus which is closer to the user, while the term "distal" will refer to the end which is further from the user.

0016preferably, the proximal end of the coagulator 10 is mechanically coupled to a supply 18 of pressurized ionizable gas, e.g., inert gas, by way of hose 20 and electrically coupled to an electrosurgical generator 22 by way of cable 24 to supply a source of electrosurgical energy, e.g., high frequency coagulation current. It is envisioned that the electrosurgical generator 22 selectively controls the amount of electrosurgical energy transmitted to an electrode during a surgical procedure. Il is also envisioned that the supply of pressurized ionizable gas selectively controls the rate of flow of gas. A pressure regulator, designated by reference numeral 21, is preferably provided to regulate the fluid pressure.

0017As shown in <figref idref="f0001">Fig. 1</figref>, a long, flexible tubular member 13 having one or more of working channels 14 located therein is mechanically coupled to the distal end 29 of the handpiece 26. Preferably, at least one of the working channels 14 is sufficiently dimensioned to receive the coagulator 10 of the present disclosure. Other working channels 14 can be utilized to receive other surgical instruments and accessories such as graspers and biopsy forceps.

0018Turning now to <figref idref="f0001">Figs. 1</figref>, <figref idref="f0002">2a</figref>, <figref idref="f0002">2b</figref> and <figref idref="f0003">3</figref>, one specific embodiment of the coagulator 10 is shown therein and includes an elongated, generally flexible catheter or tube 30 having a proximal end 32 which extends through a working channel 14 of the endoscope 12 and a distal end 34 which projects outwardly from the distal end 15 of tube 13. Ionizable gas 28, e.g., argon, is supplied to the proximal end 32 of the coagulator 10 by a gas conduit (not shown) located inside tube 13. Preferably, gas 28 is supplied from source 18 to the coagulator 10 at a selectable, predetermined flow rate and flows generally within the tube 30 in the direction of the arrow towards the distal end 34 of tube 30. Advantageously, the flow rate of the gas 28 is selectively adjustable and can easily be regulated depending upon a particular purpose or a particular surgical condition.

0019Electrode 48 produces an RF electric field, which ionizes the gas 28 in the region between the electrode and the tissue 50. Electrode 48 is connected by way of an electrical conduit (not shown) disposed within tubes 30 and 13 which is ultimately connected to electrosurgical generator 22. Preferably, the electrode 48 is ring or pin-type and is spaced from the distal end 34 such that the electrode 48 cannot come into contact with the tissue 50 during the surgical procedure. A return electrode or pad 17 is positioned on the patient and is electrically coupled to the electrosurgical generator 22 to provide a return path for the electrosurgical current.

0020Preferably, a stream of gas plasma 46 conducts the current to the tissue 50 while effectively scattering blood away from the treatment site allowing the tissue 50 to readily coagulate and arrest bleeding. A gas plasma 46 is an ionized gas that is used in surgical procedures to conduct electrosurgical energy to a patient without electrode contact by providing a pathway of low electrical resistance. The electrosurgical energy will follow this path and can therefore be used to coagulate, desiccate, or fulgurate blood or tissue 50 of the patient. One of the advantages of this procedure is that no physical contact is required between an electrode 48 and the tissue 50 being treated. One advantage of having a directed flow of gas 28 is that the plasma arc can be accurately focused and directed by the flow.

0021As best seen in <figref idref="f0002">Figs. 2a, 2b</figref> and <figref idref="f0003">3</figref>, one approach according to the invention for manipulating and/or directing the plasma/ionized gas 46 emitting from the distal end 34 of the tube 30 is to implant a hollow sleeve 40 having shape memory characteristics within the distal end 34 of the tube 30. As the sleeve 40 is extended from the distal end 34 of the tube 30, the sleeve 40 flexes and directs the ionized gas 46 towards the tissue 50.

0022More particularly, shape memory alloys (SMAs) are a family of alloys having anthropomorphic qualities of memory and trainability and are particularly well suited for use with medical instruments. SMAs have been applied to such items as for control systems, steerable catheters and clamps. One of the most common SMAs is Nitinol which can retain shape memories for two different physical and changes shape as a function of temperature. Recently, other have been developed based on copper, zinc and aluminum and have similar shape memory retaining features.

0023SMAs undergo a crystalline phase transition upon applied temperature and/or stress variations. A particularly useful attribute of SMAs is that after it is deformed by temperature/stress, it can completely recover its original shape on being returned to the original temperature. The ability of an alloy to possess shape memory is a result of the fact that the alloy undergoes a reversible transformation from an autstenite state to a martensite state with a change in temperature (or stress-induced condition). This transformation is referred to as a thermoelastic martensite transformation.

0024Under normal conditions, the thermoelastic martensite transformation occurs over a temperature range which varies with the composition of the alloy, itself, and the type of thermal-mechanical processing by which it was manufactured. In other words, the temperature at which a shape is "memorized" by an SMA is a function of the temperature at which the martensite and austenite crystals form in that particular alloy. For example, Nitinol alloys can be fabricated so that the shape memory effect will occur over a wide range of temperatures, e.g., -270° to +100° Celsius.

0025Many SMAs are also known to display stress-induced martensite (SIM) which occurs when the alloy is deformed from its original austenite state to a martensite state by subjecting the alloy to a stress condition. For example and with respect to <figref idref="f0002">Figs. 2a, 2b</figref> and <figref idref="f0003">3</figref> of the present disclosure, hollow sleeve 40 is generally bent or L-shaped when disposed in its original or austenite state (see <figref idref="f0002">Fig. 2b</figref>). When sleeve 40 is inserted into the tube 30, sleeve 40 is deformed, i.e., straightened, into a stress-induced martensite state enabling the user more easily to insert the tube 30 through the endoscope and to navigate the tube 30 through tight body cavities and passageways to access damaged tissue 50.

0026As seen best in <figref idref="f0003">Fig. 3</figref>, after insertion of the tube 30 into the body cavity/passageway, the user can easily direct the ionized gas 46 flowing through the tube 30 transversely (off-axis) at the tissue 50 by extending the sleeve 40 distally which causes the extended portion of the sleeve 40 to revert back to its original/austenite state (it is assumed that the temperature of use of the alloy allows spontaneous reversion when stress is removed). The user can also control the angle s_x of the ionized gas 46 being directed at the tissue 50 by controlling the distance "X" that the sleeve 40 extends from the tube 30. Preferably, angle s_x and distance "X" are directly related, i.e., as distance "X" increases angle s_x increases.

0027It is envisioned that by empowering the user to articulate, i.e., bend, the distal end 41 of the sleeve at various angles s_x will enable the operator to more effectively coagulate bleeding tissue 50 with more longitudinal-type lesions, i.e., tissue lesions which run parallel to the axial direction of endoscope 12, and without causing collateral tissue damage. It is also envisioned that by adjusting the angle s_x of the distal end 41 of the sleeve 40, the angle with respect to the tissue surface or longitudinal axis of the tube at which the ionized gas 46 impinges can be selectively controlled.

0028<figref idref="f0003">Figs. 4</figref> and <figref idref="f0004">5</figref> show an example of an articulating coagulator 110 not forming part of the claimed invention, but useful for understanding thereof, which includes an elongated tube 130 having a proximal end 132 and a distal end 134. Preferably, tube 130 is flexible at or proximate the distal end 134 of tube 130. Ionizable gas 28 is supplied to the proximal end 132 of the coagulator 110 at a selectable, predetermined flow rate and flows generally within the tube 130 in the direction of the arrow towards the distal end 134 of tube 130. Advantageously, the flow rate of the gas 28 is selectively adjustable and can easily be regulated depending upon a particular purpose or a particular surgical condition. Much in the same manner as described with respect to <figref idref="f0002">Figs. 2a, 2b</figref> and <figref idref="f0003">3</figref>, electrode 48 discharges an electrosurgical current which ionizes gas 28 prior to gas 28 emission.

0029Coagulator 110 also includes a pull wire 160 which is connected at one end proximate the distal end 134 of tube 130 such that retraction of wire 160 flexes tube 130. Preferably, wire 160 is disposed within the proximal end 132 of tube 130 and exits a port 136 disposed within tube 130 to attach to tube 130 at a point proximate distal end 134. Wire 160 is movable from a first generally relaxed position wherein tube 30 is disposed in a generally rectilinear fashion relative to tissue 50 (see <figref idref="f0003">Fig. 4</figref>) to a second retracted or tensed position wherein the distal end 134 of tube 130 flexes towards tissue 50 (see <figref idref="f0004">Fig. 5</figref>). The user can easily direct the ionized gas 46 flowing through the tube 130 transversely at tissue 50 by controlling the tensile force applied to wire 160 which, in turn, flexes the distal end 134 of tube 130 to a desired angle s_x. Empowering the user to articulate, i.e., flex, the distal end 134 of the tube 130 at various angles s_x will enable the operator to more effectively target bleeding tissue 50 without causing collateral tissue damage.

0030In some cases it may be preferable to utilize wire 160 as a return electrode and couple wire 160 to electrosurgical generator 22. In this case, the portion of wire 160 disposed within tube 130 is preferably insulated to avoid unintentional ignition and ionization of gas 28.

0031<figref idref="f0004 f0005">Figs. 6-8</figref> show another embodiment useful for understanding, but not forming part of, the claimed invention, which includes an articulating coagulator 210 having an elongated tube 230 with proximal and distal ends 232 and 234, respectively. Preferably, tube 230 is flexible at or proximate the distal end 234. Coagulator 210 contains many of the same components and features of the <figref idref="f0003">Figs. 4</figref> and <figref idref="f0004">5</figref> embodiment with the exception that a "corona ring" electrode is located at the distal end 234 of tube 230 and is used to initiate ionization of gas 28.

0032A "corona" is a type of discharge which forms around an active electrode and can be used to increase the reliability of plasma ignition. Coronas are low current discharges and consume very little power and, therefore, do not affect the overall power delivered to the tissue. Coronas typically occur in highly non-uniform electric fields which are commonly generated between electrodes of greatly differing sizes.

0033A corona electrode is typically located proximate the active electrode 48 and is electrically connected to the return potential of the electrosurgical generator 22. For example and with respect to the <figref idref="f0004">Fig. 6</figref> embodiment, a ring corona electrode 275 is disposed at the distal end 234 of tube 230 in co-axial alignment with the active electrode 48.

0034As seen best in <figref idref="f0004">Fig. 7</figref>, a dielectric or insulating sleeve 270 is disposed between the corona electrode 275 and active electrode 48 to prevent arcing between electrodes 275 and 48. Preferably, dielectric sleeve 270 is made from a ceramic material or other high temperature resistant material.

0035When the electrosurgical generator 22 is activated, a non-uniform electric field is generated between corona electrode 275 and active electrode 48 and a corona forms around active electrode 48 which aids in igniting gas 28 to produce gas plasma 46.

0036As mentioned above, coagulator 210 also includes a wire 260 which is connected at one end proximate the distal end 234 of tube 230 such that retraction of the wire 260 flexes tube 230. Preferably, wire 260 is also connected to corona electrode 275 and performs a dual function: 1) to electrically connect corona electrode 275 to electrosurgical generator 22; and 2) to empower the user with the ability to selectively articulate the distal end 234 of tube 230 at varying angles s_x to effectively coagulate bleeding tissue 50 in a manner similar to the manner described with respect to the <figref idref="f0003">Fig. 4</figref> embodiment.

0037More particularly and as best seen in <figref idref="f0005">Fig. 8</figref>, the user can easily direct gas plasma 46 exiting tube 230 transversely at tissue 50 by controlling the tensile force applied to wire 260 which, in turn, articulates distal end 234 to a desired angle s_x and enables the user to more effectively coagulate or arrest bleeding tissue 50 without causing collateral tissue damage.

0038From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that not only can the coagulator 10, 110 and 210 of the present disclosure be used to arrest bleeding tissue, but the disclosed coagulator may readily be modified to be employed for desiccating the surface tissue, eradicating cysts, forming eschars on tumors or thermically marking tissue. Those skilled in the art will also appreciate that certain modifications can also be made to the coagulator 10 without departing from the scope of the appended claims.

0039In some embodiments falling within the scope of the claimed invention, it is preferable to use various combinations of the component parts shown with respect to each of the embodiments described herein. For example, it is possible to combine a SMA (or a stress-induced martensite) sleeve with a wire to articulate the distal end of the tube. Another case, in accordance with the invention, uses a ring-like corona return electrode with a SMA to induce plasma ignition.

0040In some cases it may be preferable to employ an electrode control mechanism to allow a user to selectively adjust the amount of current flowing through the electrodes during surgical conditions. Moreover, even though it may be preferable to use argon as the ionisable gas for promulgating coagulation of the tissue, in some cases it may be preferable to use another ionisable gas to effect the same or different result.

0041There have been described and illustrated herein several embodiments of the coagulator for arresting bleeding and performing other surgical procedures. While particular embodiments have been described, the above description should not be construed as limiting, but merely as explanation by way of specific embodiments. Those skilled in the art will envision modifications within the scope of the claims appended hereto.