Wearable return electrode for electrosurgical systems

Abstract

The present invention relates to a wearable electrosurgical return electrode comprising an outer liner, an inner liner, and an electrically conductive element disposed between the outer liner and the inner liner. The return electrode is formed as a flexible sheath and is configured to be worn on at least a portion of a body during use.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to and the benefit of U.S. Patent Application 62 / 910,183, filed October 3, 2019, and entitled “Wearable Return Electrode For Electrosurgical Systems,” the entire contents of which are incorporated herein by reference. BACKGROUND 1. TECHNICAL FIELD

[0004] The present disclosure relates generally to electrosurgical systems. In particular, the present disclosure relates to return electrodes. 2. BACKGROUND

[0006] In the field of electrosurgery, medical procedures are performed that cut tissue and / or cauterize leaking blood vessels by utilizing radio frequency (RF) electrical energy. As is known to those skilled in the medical arts, electrosurgery is widely used and offers many advantages, including the advantage of using a single surgical tool both for cutting and for coagulation. The radio frequency energy is generated by an RF energy source such as a wave generator or electrosurgical unit (ESU) and is transmitted to the patient's tissue through a hand-held electrode that is operated by the surgeon.

[0007] Monopolar electrosurgical generator systems have an active electrode applied by the surgeon to the patient at the site of the surgery to perform the surgery and a return path from the patient back to the ESU. The active electrode at the point of contact with the patient must be small in size to produce a high current density in order to produce the surgical effect of cutting or coagulating tissue. The return electrode, which carries the same current as the active electrode, has an effective surface area in contact with the patient that is large enough so that a low density current flows from the patient to the return electrode. An electrical return cable connected to the return electrode provides the conventional electrical return to the source of electrosurgical radio frequency energy.

[0008] Various types of return electrodes have been used since the advent of electrosurgery, including self-limiting return electrodes. Unlike typical adhesive pads and steel plate return electrodes, self-limiting return electrodes are relatively large, thereby eliminating the need for conductive gel that can irritate the patient's skin. Additionally, self-limiting return electrodes typically employ a variety of geometries and materials whose impedance characteristics cause the return electrode to self-limit the current density (and corresponding temperature rise) to a safe threshold if the area of contact between the patient and the electrode decreases below a level that would otherwise be expected. Moreover, self-limiting return electrodes are specifically designed to evenly distribute the current density across the entire area of contact between the patient and the return electrode in order to reduce the risk of patient burn.

[0009] Typical self-limiting return electrodes are typically made in a variety of sizes for use with patients of different body sizes. For example, a typical self-limiting return electrode for use with a smaller person (e.g., under 50 pounds) can be about 26 inches by 12 inches, while a typical self-limiting return electrode for use with a larger person can be about 46 inches by 20 inches.

[0010] As noted above, the electrical return cable connected to the return electrode provides electrical return to the electrosurgical radio frequency energy source. The more consistent and secure the contact between the patient and the return electrode, the more effective the return electrode is in safely drawing current from the patient's body and returning the current to the power source or its common ground.

[0011] Some return electrodes are comprised of a flat, layered structure that is placed on top of the operating table, which can result in inconsistent contact between the patient and the return electrode during use. For example, due to the contours of the human body, some areas of the body can not contact the return electrode when lying down. Additionally, any movement or change in position of the patient during use can cause the area of contact between the patient and the return electrode to change.

[0012] Furthermore, as noted above, some existing return electrodes vary in size to accommodate patients of different body sizes. A small return electrode can not be large enough to make proper contact with the patient, while a larger return electrode can be unnecessarily large and cumbersome for a smaller patient on a smaller operating table or bed.

[0013] Additionally, return electrodes comprised of layered pads can limit the available area of the patient's body that can be in contact with the return electrode. For example, a layered pad type return electrode can be limited to contacting only the back of a supine patient or only the front of a prone patient. However, a surgeon or other medical professional can desire the return electrode to contact the patient at certain specific locations on the body, depending on the type of procedure being performed and the part of the body on which the procedure is being performed.

[0014] Additionally, typical return electrodes include an electrically conductive element comprising an electrically conductive material adapted to transmit current from the patient's body to the return cable, as noted above. Typically, the same electrically conductive material used for the electrically conductive element in a return electrode is not transparent for use with certain medical imaging techniques. For example, surgical instruments such as scalpels, sponges, clamps, and other instruments can have RFID tags that medical personnel can use to identify during and after surgery using an antenna positioned beneath the patient. Doing so can ensure that no instruments are mistakenly left inside the patient's body before closing the surgical incision. However, a typical return electrode can be opaque to radio frequency signals and thus would mask the identification process of such instruments having RFID tags. The return electrode can also mask other imaging techniques used during surgery, such as x-ray imaging and CT scans.

[0015] Thus, there are many problems that can be solved in the field of return electrodes used in electrosurgical systems. SUMMARY

[0016] The present disclosure solves the aforementioned shortcomings by providing a wearable return electrode that can be fastened around the contours of a patient's body and conform to the contours of the patient's body during use to ensure accurate and sufficient contact to the patient during use. For example, in one embodiment of the present disclosure, the wearable return electrode includes a sheath having an outer pad. The return electrode also includes a conductive element disposed inside the outer pad. The conductive element and the outer pad are flexible such that the return electrode conforms to the contours of the patient when donned during use.

[0017] In one embodiment, the wearable return electrode includes an outer pad and a conductive element disposed inside the outer pad. The conductive element and the outer pad are flexible such that the return electrode can be worn on a portion of the body during use.

[0018] In one embodiment, the wearable return electrode includes an outer pad, an inner pad, and a conductive element disposed between the outer pad and the inner pad. The return electrode is formed as a flexible sheath and is configured to be worn on at least a portion of the body during use.

[0019] Additional features and advantages of the disclosed embodiments will be set forth in the description that follows, and in part will be apparent from the description, or can be learned by practice of the disclosure. These features and other features will be more fully apparent from the following description and appended claims, or can be learned by practice of the disclosure. BRIEF DESCRIPTION OF DRAWINGS

[0020] To further clarify the above and other advantages and features of the present disclosure, a more particular description will be rendered by reference to specific embodiments thereof, which are illustrated in the appended drawings. It is appreciated that these drawings depict only illustrated embodiments of the present disclosure and are therefore not to be considered limiting of its scope. The present disclosure will be described and explained with additional specificity and detail by the use of the accompanying drawings in which:

[0021] FIG. 1 An electrical schematic diagram illustrating an embodiment of an electrosurgical system according to the present disclosure is shown;

[0022] FIG. 2 An embodiment of an electrosurgical system according to the present disclosure is shown;

[0023] FIG. 3 An embodiment of a return electrode disposed on a surgical table according to the present disclosure is shown;

[0024] FIG. 4The following is shown in accordance with this disclosure: FIG. 3 A partial cross-sectional view of the return electrode is shown;

[0025] FIG. 5A An embodiment of a return electrode on an operating table according to an embodiment of the present disclosure is shown;

[0026] FIG. 5B Its exploded diagram is shown;

[0027] FIG. 6A An embodiment of a return electrode on an operating table according to an embodiment of the present disclosure is shown;

[0028] FIG. 6B Its exploded diagram is shown;

[0029] FIG. 6C As shown FIG. 6A The cross-sectional view of the return electrode is shown.

[0030] FIG. 6D Its exploded diagram is shown;

[0031] Figure 7A illustrates an embodiment of the return electrode according to this disclosure;

[0032] Figure 7B shows its exploded view;

[0033] FIG. 7C A cross-sectional view of the return electrode shown in Figure 7A is shown, taken along plane 7C as shown in Figure 7A;

[0034] FIG. 7D A cross-sectional view of the return electrode shown in Figure 7A is shown, taken along plane 7D as shown in Figure 7A;

[0035] FIG. 8A An embodiment of a return electrode fastened to a patient according to this disclosure is shown;

[0036] FIG. 8B An embodiment of the return electrode according to this disclosure is shown;

[0037] FIG. 8C An embodiment of a return electrode fastened to a patient according to this disclosure is shown;

[0038] FIG. 9 Various embodiments of a return electrode fastened to a patient according to this disclosure are shown;

[0039] FIG. 10A An embodiment of the return electrode according to this disclosure is shown;

[0040] FIG. 10B An embodiment of the return electrode according to this disclosure is shown;

[0041] FIG. 10C one cross-sectional view thereof is shown;

[0042] FIG. 10D another cross-sectional view thereof is shown;

[0043] FIG. 11A an embodiment of a return electrode according to the present disclosure is shown;

[0044] FIG. 11B a return electrode secured to a patient is shown; FIG. 11A a return electrode is shown; and

[0045] FIG. 12 an embodiment of a return electrode according to the present disclosure is shown. DETAILED DESCRIPTION

[0046] The present disclosure relates generally to electrosurgical systems. In particular, the present disclosure relates to return electrodes. Embodiments of return electrodes described herein are suitable for use with patients of various body sizes and can maintain consistent and secure contact with a patient during use. Furthermore, the return electrodes described herein are transparent to medical imaging techniques used during surgery.

[0047] FIGS. 1-4 and the corresponding discussion relates to the general structure and features of an electrosurgical return electrode that provides self-limiting characteristics and can be used with substantially any body size patient. Turning to the drawings, and more particularly to FIGS. 1-3 a general discussion of self-limiting return electrodes and their general principles of operation will be provided. Among other things, FIG. 1 a simplified electrical schematic of an electrosurgical system is depicted showing typical impedances contained in the surgical path of the flow of radiofrequency current as presented to an electrosurgical generator during a surgical procedure. Thus, a conventional radiofrequency power generator 100, such as but not limited to a constant power, voltage and / or current generator, or a variable power, voltage and / or current generator, will be seen.

[0048] Connected to the power generator 100 are conventional electrical conductors 102 and 104 that connect the generator 100 to the surgeon's instruments, represented by impedance zl, and to an electrosurgical return electrode, represented by impedance z3, respectively. Impedance z2 is provided to represent the impedance presented by the patient tissue located between the surgical site and the return electrode. Electrical conductors 102 and 104 represent one exemplary structure capable of performing the functions of a connection means for making electrical connection with the return electrode. However, those skilled in the art will appreciate that various other structures are suitable and capable of performing the desired functions.

[0049] While FIG. 1The diagrams are simplified and generally consider circuit elements in terms of a main resistance, including reactance provided by the surgical instrument, the patient's body, and the return electrode, to make clear and concise the principles of the present disclosure, but it should be understood that certain other parameters, such as distributed inductance and distributed capacitance, among others, are in fact encountered, and are considered to be relatively small for purposes of making clear the principles of the present disclosure, and are thus not considered in this regard in the present specification.

[0050] FIG. 2 The practical application of the electrical schematic shown in FIG. 1 is shown in the form of an electrosurgical system 101. In FIG. 2 , the patient 106 lies on the return electrode 108 during a procedure in which the hand-held surgical electrode 110 is in contact with the patient 106. The power generator 100 powers the surgical electrode 110 via the power cable 112. During use, current flows from the power generator 100 to the surgical electrode 110 and into the patient 106. The current flows through the patient 106, into the return electrode 108, and then back to the power generator 100 or its utility ground via the return cable 114.

[0051] Referring back to FIG. 1 , FIG. 2 The power cable 112 is similar to the conductor 102, and the return cable 114 is similar to the conductor 104. Additionally, as noted above, the surgical electrode 110 is represented by an impedance zl, and the return electrode 108 is represented by an impedance z3. The patient 106 is represented by an impedance z2. FIG. 1

[0052] Reference is now made to FIGS. 3-4 , which shows an embodiment of an electrosurgical return electrode 132 according to the present disclosure. In FIG. 3 , the electrosurgical return electrode 132 is shown in perspective on an operating table 130, with the electrosurgical return electrode 132 according to the present disclosure disposed on its upper surface, the edges of the table 130 are identified by reference numeral 134. The operating table 130 is shown as having conventional legs 136a-136d, which can be fitted with wheels or casters as shown.

[0053] The table 130 is one structure capable of performing the functions of a support device for supporting a patient during treatment. However, one skilled in the art will appreciate that various other configurations of support devices are possible and capable of performing the required functions. For example, the support device can include, but is not limited to, a chair, a board, a bed, a cart, and the like.

[0054] Although in FIG. 3 ​In the embodiment shown, the entire upper surface of the table 130 is shown covered with the return electrode 132, but it will be appreciated that total coverage is by no means necessary to practice the principles of the present disclosure. Thus, when used with a conventional electrosurgical generator, the return electrode need only present an effective working surface area sufficient to provide sufficient resistive, capacitive or inductive coupling at the RF frequencies typically employed so as not to interfere with the surgeon's ability to perform the procedure while avoiding unwanted tissue damage. It has been found that at conventional electrosurgical frequencies, this requires no more than an effective working surface area no greater than one-third of the projected outline of the torso for an adult patient lying on the table or a portion of the hips of a patient seated in a chair.

[0055] However, depending on the materials used, in certain geometries, and in the case of layers of surgical room draping placed over the electrode, the effective working surface area will vary. It is possible to successfully employ the principles of the present disclosure and, through routine experimentation, determine the effective working surface area of the return electrode in such situations. In certain conditions, the effective working surface can be as small as about seven square inches (or about 45 square centimeters).

[0056] The surface of the return electrode 132 is preferably smooth and uniform and includes a thin resistive layer and / or a thin dielectric layer. Alternatively, the surface of the return electrode 132 can include a capacitive layer and / or an inductive layer, depending on the particular operation of the return electrode 132. The properties of the desired dielectric of the present embodiment are sufficient to rival the properties of the selected rubbers, plastics and other related materials that can be satisfactorily used as materials for the return electrode.

[0057] As noted above, with such a return electrode, if the patient is positioned so that there is not sufficient return electrode in close enough proximity to the patient to result in the generally low impedance required, the result will be that the current from the electrosurgical generator is reduced to a level that makes it difficult for the surgeon to perform the procedure. Thus, in the present embodiment, the above-described feature will continue to occur despite the additional capacitance represented by the surgical gown being interpolated.

[0058] It will be observed that when the return electrode 132 is laid out on the table 130, the exposed or working upper surface of the electrode is again expandable so as to provide low impedance. While it is not necessary for the electrode to cover the entire surface of the table or the entire seat surface of a dental patient or other patient chair, it has been found that in certain situations it is desirable to provide a surface area greater than the projected area of a portion of the patient's hips or torso so that if the patient position shifts during the procedure, a sufficient portion of the patient will remain registered with the electrode surface so that the effective impedance will remain below the levels described above.

[0059] As FIGS. 3-4As shown, the return electrode 132 can be made of a conductive plastic, rubber, or other flexible material that, when employed in the electrode, will result in an effective DC resistance presented by each square centimeter of the working surface that is greater than about 8000 ohms or alternatively provide an overall impedance of greater than 4000 ohms x cm. Silicone, butyl rubber, or urethane have been found to be particularly attractive materials because they are flexible as well as easy to wash and sterilize. Alternatively, the body of the return electrode can be made of a flexible material that inherently has a relatively high resistance to provide the necessary electrical conductivity. One preferred example of the latter is a silicone rubber material in which there are impregnated conductive fibers such as carbon fibers or in which there has been distributed a substantial amount of other conductive substance such as carbon black, gold, silver, nickel, copper, steel, iron, stainless steel, brass, aluminum, or other conductor.

[0060] FIG. 3 The return electrode 132 is also shown to include a region 139. The region 139 of the return electrode 132 can be adapted to position a smaller sized patient thereon. For example, the region 139 can be sized to position an infant sized patient thereon. Further, as discussed in greater detail below, the return electrode 132, and particularly the region 139 thereof, can be configured to provide the self-limiting characteristics discussed herein for an infant sized patient positioned on the region 139.

[0061] Although not shown, the return electrode can also include additional regions that are configured to provide self-limiting characteristics for patients from different industry standard weight categories. As a non-limiting example, the region 139 can be configured to provide self-limiting characteristics for patients weighing less than 5 kg, a second region can be configured to provide self-limiting characteristics for patients weighing between 5 kg and 15 kg, and a third region can be configured to provide self-limiting characteristics for patients weighing more than 15 kg. In some embodiments, the regions for patients of different size can overlap one another, while in other embodiments, the regions do not overlap. Further, the regions can be concentrically formed with one another.

[0062] Regardless of the particular arrangement of the regions for patients of different size (e.g., non-overlapping, overlapping, concentric, etc.), the return electrode 132 can include one or more visual indicators to identify the regions for patients of different size. For example, the region 139 can include a visual indicator that identifies the region 139 as being suitable for patients weighing less than 5 kg. Similarly, a second region can include a visual indicator that identifies the second region as being suitable for patients weighing between 5 kg and 15 kg, and a third region can include a visual indicator that identifies the third region as being suitable for patients weighing more than 15 kg.

[0063] One or more visual indicators may include labels, outlines, pictures, or other markings printed or otherwise displayed on the outer surface of the return electrode 132. One or more visual indicators may also, or alternatively, be in the form of color coding. For example, each region of the return electrode 132 may have a different color. The color may be printed on the return electrode 132, or the color may be integrated into other components of the return electrode 132. For example, one or more components within region 139 may have a first color, while one or more components in other regions may have different colors, making these regions distinguishable from each other.

[0064] Now let's turn our attention to... FIG. 4 It shows along FIG. 3 A simplified partial cross-sectional view intercepted by line 4-4. (See figure.) FIG. 4 As shown, the return electrode 132 includes a conductive element 140 and pads 142, 144 on opposite sides of the conductive element 140. In at least one embodiment, the conductive element 140 is made of a conductive braided fabric material. The braided fabric material of the conductive element 140 is flexible and foldable. In at least one embodiment, the braided fabric material of the conductive element 140 includes conductive fibers embedded in non-conductive natural or synthetic braided fabric yarns. In at least one embodiment, the braided fabric material of the conductive element 140 includes conductive fibers woven together into the fabric material.

[0065] When used as a conductive element, such conductive fabric material will result in an effective DC resistance per square centimeter of the working surface of the return electrode 132 (the surface in contact with or adjacent to the patient), which is greater than about 8000 ohms, or alternatively provides an overall impedance greater than 4000 Ω × cm.

[0066] Various conductive fibers can be woven or incorporated into woven fabric materials to achieve the desired impedance. For example, conductive fibers such as carbon black, a certain amount of gold, silver, nickel, copper, steel, iron, stainless steel, brass, aluminum or other conductors, or other conductive metal fibers have been found to be particularly attractive materials for conductive element 140 because they are flexible and easy to wash, disinfect, and sterilize.

[0067] As described above, one or more conductive fibers may be woven together to form conductive element 140, or one or more conductive fibers may be embedded in or otherwise incorporated into other man-made or natural woven yarns to form conductive element 140. Such yarns may include, but are not limited to, cotton, silk, wool, nylon, polyester, acrylic, or other fabrics known in the art.

[0068] In at least one embodiment, the woven fabric material of the conductive element 140 is substantially transparent to one or more wavelengths of electromagnetic radiation, such as but not limited to microwave radiation, infrared (IR) radiation, ultraviolet (UV) radiation, X-ray radiation, radio frequency (RF), and the like. This allows the conductive element 140 and the return electrode 132 to be maintained in place during performance of certain medical procedures using a particular wavelength of electromagnetic radiation while other components of the return electrode 132 are transparent to the one or more wavelengths of electromagnetic radiation.

[0069] For example, in many surgeries, each surgical tool used during the surgery can include an RFID tag. After or during the surgery, emitted radio frequencies, in conjunction with an antenna placed behind the patient and an RF receiver placed on the opposite side of the patient, can be used to identify any surgical tools or other instruments that are still within the patient prior to performing a surgical wound closure. Typically, the antenna used by such systems is placed underneath a patient lying on an operating table. If a return electrode is needed to perform electrosurgical procedures, the return electrode is placed in direct contact with the patient and is therefore interposed between the antenna and the RF receiver. Typically, the conductive element within the return electrode is not transparent to RF signals such that such a process cannot be used during surgery.

[0070] However, the woven fabric material of the conductive element 140 of the present disclosure is transparent to such RF imaging systems and other medical imaging systems described above. For example, in at least one embodiment, the density of the conductive element 140 is low enough that RF signals can pass through the conductive element between an antenna and a receiver, but high enough to provide sufficient conductive properties needed to draw current through the patient's body and into the return cable 114. In one or more other embodiments, the yarn count and the yarn thickness of the conductive element 104, both of which contribute to the density of the conductive element 140, can be varied to achieve suitable transparency and conductive properties using the various fabric yarns and conductive fibers described above.

[0071] Still referring to FIG. 4On opposite sides of the conductive element 140 are pads 142, 144. As can be seen, the pad 142 has an outer surface 146 and an inner surface 148. The outer surface 146 is configured to be placed against the surface of the patient (thereby acting as a working surface for the return electrode 132), while the inner surface 148 is disposed alongside the conductive element 140. In some embodiments, the inner surface 148 is fastened to the conductive element 140 (such as with an adhesive) to prevent air bubbles or separation between the pad 142 and the conductive element 140. The pad 142 can include an outer cover layer and an inner cover layer that are formed individually and fastened together around their edges, or integrally formed. The outer and inner cover layers can define the outer and inner surfaces 146, 148. The outer and inner cover layers can be formed from a variety of materials such as urethane, polyurethane, polyethylene, polypropylene, polyolefin, polyvinyl chloride, PET, etc. The filler material 152 discussed below can be disposed between the outer and inner cover layers.

[0072] Similar to the pad 142, the pad 144 includes an outer surface 154 and an inner surface 156. The outer surface 154 is configured to be placed on a support surface (e.g., an operating table, a surgical chair, etc.), while the inner surface 156 is disposed alongside the conductive element 140. Like the outer and inner cover layers 146, 148, one or both of the outer and inner surfaces 154, 156 can be defined by a cover layer formed from a variety of materials such as urethane, polyurethane, polyethylene, polypropylene, polyolefin, polyvinyl chloride, PET, etc. Like the pad 142, the inner surface 156 can be fastened to the conductive element 140 (such as with an adhesive) to prevent air bubbles or separation between the pad 144 and the conductive element 140. However, in other embodiments, the edges of the pad 144 can be fastened to the edges of the pad 142 with the conductive element 140 disposed therebetween. Also, like the pad 142, the pad 144 can include a filler material.

[0073] The filler material used by the pads 142, 144 can provide certain pressure- reducing properties to the return electrode 132. More specifically, because the pads 142, 144 retain a defined volume of filler material, when an individual lies on the return electrode 132, the filler material distributes the downward force of the patient across the entire filler material, thereby reducing the point force applied to those locations where bony prominences of the patient's anatomy are located. However, as discussed elsewhere herein, the pads 142, 144 are relatively thin to ensure sufficient coupling between the patient and the conductive element 140. Thus, in some scenarios, such as during long surgical procedures, it can be desirable or necessary to use a separate pressure-reducing pad in combination with the return electrode 132 to prevent pressure sores from forming on the patient, or to increase the patient's comfort.

[0074] The filler material used for the pads 142, 144 can act as a dielectric layer to reduce the current flow through the pads 142, 144, respectively. Alternatively, the filler material can take the form of a conductive material to facilitate the transmission of current therethrough. Additionally, the filler material can provide a thermal mass for heat distribution during electrosurgery. As discussed above, IEC requirements mandate that the temperature rise of patient tissue during electrosurgery be kept below six degrees Celsius (6°C). The thermal mass provided by the filler material facilitates heat distribution throughout the patient's body and substantially eliminates the possibility of hot spots that can burn the patient. Thus, the substance used for the filler material can perform multiple functions during electrosurgery.

[0075] Generally, the filler material can take the form of one or more solids, liquids, gases, or combinations thereof, depending on the desired pressure reduction, dielectric, and / or conductive properties of the return electrode 132. For example, in one illustrative embodiment, the filler material is an elastomeric gel having a low durometer level, such as SORBOTHANE. In addition to SORBOTHANE, various other elastomeric gels can be used, such as, but not limited to, elastomeric gels based on polymer chemistry of urethane, silicone, hydrophilic elastomers or hydrogels, vinyl, vinyl alcohol, or other similar materials and techniques. Additionally, the filler material can take the form of water, saline, water-based materials, conductive oils, and the like. Further, the filler material can take the form of a solid but be a flexible foam type material.

[0076] The formation of the return electrode 132, the conductive elements 140, and the pads 142, 144 at least partially controls the transmission of current from the patient to the conductive elements 140. Thus, in one embodiment, the pads 142, 144 are insulative. In alternative configurations, the pads 142, 144 can be conductive and facilitate the transmission of current from the patient to the conductive elements 140. The various elements of the return electrode 132, i.e., the conductive elements 140 and the pads 142, 144, can provide one or more resistive, inductive, and / or capacitive components to the overall impedance of the return electrode. In this manner, the return electrode 132 is self-limiting while also providing at least some pressure reduction characteristics.

[0077] In addition to the material used to form the pads 142, 144, the thickness and arrangement of the pads 142, 144 and the conductive element 140 can also affect the transmission of current from the patient to the conductive element 140. As a non-limiting example, the distance between the outer surface 146 of the pad 142 and the conductive element 140 can affect the capacitive coupling between the conductive element 140 and a patient lying on the return electrode 132. Through this capacitive coupling, current used during an electrosurgical procedure is transferred from the patient to the return electrode 132. In view of the disclosure herein, one of ordinary skill in the art will appreciate that the capacitive coupling between the patient and the return electrode 132 can be directly related to the self-limiting characteristics of the return electrode 132. Thus, by varying the distance between the outer surface 146 and the conductive element 140, the capacitive coupling between the patient and the return electrode 132 can be adjusted. Thus, as shown, certain portions of the conductive element 140 can be positioned closer to the outer surface 146 than other portions of the conductive element 140. In other embodiments, the conductive element 140 can be spaced a uniform distance relative to the outer surface 146. FIG. 4

[0078] FIG. 5A The return electrode 132 on the surgical table 130 is shown. In at least one embodiment, the return electrode 132 includes an electrical connector 182 to provide a conventional electrical return to an electrosurgical radiofrequency energy source. As seen in the exploded view of FIG. 5B The conductive element 140 sandwiched between the pad 142 and the pad 144 includes a bus bar 158 extending along a side edge thereof, as seen in the exploded view. The bus bar 158 is in communication with the electrical connector 182. The conductive fibers of the woven fabric material of the conductive element 140 contact the bus bar 158 along the edge of the conductive element 140 to transmit current from the conductive element 140 to the bus bar 158. The bus bar 158 also serves to lower the electrical resistance of the conductive element 140 to form an electrical connection with the return cable 114.

[0079] In at least one embodiment, the bus bar 158 includes an elongated strip of conductive material disposed along an edge of the conductive element 140. In the embodiment shown, the bus bar 158 extends along a long edge of the conductive element 140. However, in one or more other embodiments, the bus bar 158 extends along a short edge of the conductive element 140. In any case, as described above, the bus bar 158 draws current from the conductive fibers or conductive yarns of the conductive material of the conductive element 140 into the electrical connector 182 for passage through the return cable 114. FIG. 5B

[0080] ​​The bus bar 158 can include any number or any combination of electrically conductive materials, including various metals such as gold, silver, nickel, copper, steel, iron, stainless steel, brass, aluminum, or other conductors such as carbon black. In at least one embodiment, the bus bar 158, along with the fabric material of the conductive element 140, is configured to be flexible. In this way, the bus bar 158, along with the rest of the conductive element 140, can be bent and folded to facilitate transport and storage. The flexibility of the bus bar 158 can also reduce the chance of breaking when bent during use. The flexibility of such a bus bar 158 can result from its material properties, including the thickness and other dimensions of the bus bar 158. Also, in at least one embodiment, the bus bar 158 is formed similar to a flexible woven fabric of the conductive element 140, including electrically conductive yarns or fibers that draw current from the electrically conductive yarns or fibers of the conductive element 140. In one or more other embodiments, the dimensions of the bus bar 158, including length, width, and thickness, can also differ from those of the conductive element 140. FIG. 5B

[0081] FIG. 6A Another embodiment of the return electrode 132 is shown. In the embodiment shown, the return electrode 132 does not include an exposed electrical connection, such as the electrical connector 182 shown. FIG. 6A FIG. 5A FIG. 6A In contrast, as shown in the embodiment of FIG. 2, the return electrode 132 does not include a conventional electrical connection, such as a hardwire connection or plug at any location on the return electrode 132. However, as shown in the exploded view of FIG. 3, similar to the embodiment of the conductive element 140 shown in FIG. 1, the conductive element 140 does include a bus bar 158. FIG. 6B FIG. 5B The embodiments of the return electrode 132 described herein are configured such that no external plug or hardwire electrical connection is needed, allowing medical personnel to arrange and position the return electrode 132 anywhere within the operating room, regardless of where an electrical outlet or other power source, such as the power generator 100, can be located.

[0082] For example, with a conventional return electrode having an exposed electrical connection with an external plug or other hardwire, an electrical outlet must be located within the operating room and in a convenient location relative to the power source, so that a power cord can be connected between the power source and the return electrode plug without impeding medical personnel or other medical systems during surgery. Thus, the external plug and other hardwire electrical connection limit the orientations available for setting up the return electrode on the surgical table for use with a patient. The available orientations for a return electrode having an external plug are also limited by the presence of other medical devices and systems connected to the patient that are positioned around the surgical table or used by the physician or nurse, which the power cord and power source must also accommodate.

[0083] For example, with a conventional return electrode having an exposed electrical connection with an external plug or other hardwire, an electrical outlet must be located within the operating room and in a convenient location relative to the power source, so that a power cord can be connected between the power source and the return electrode plug without impeding medical personnel or other medical systems during surgery. Thus, the external plug and other hardwire electrical connection limit the orientations available for setting up the return electrode on the surgical table for use with a patient. The available orientations for a return electrode having an external plug are also limited by the presence of other medical devices and systems connected to the patient that are positioned around the surgical table or used by the physician or nurse, which the power cord and power source must also accommodate. ​​​​

[0084] In addition to integrating return electrodes with external plugs into existing operating rooms with other devices and systems, other factors further complicate the integration and use of return electrodes with external plugs or other hard-wired connections. For example, medical personnel must take precautions to orient return electrodes with external plugs so that the plug does not come into contact with the patient during use, as contact could cause current to flow back into the patient's body, resulting in injury and reduced effectiveness of the surgical system. Furthermore, medical personnel must, for example, take precautions to minimize the chance of fluid entering the plug and disrupting the circuitry of the surgical system. All these factors make it difficult to ensure the safe and convenient use of return electrodes with external plugs.

[0085] Conversely, and advantageously, the return electrode 132 of this disclosure, which does not include an external electrical connector, eliminates the various problems posed by external electrical plugs and other exposed electrical connections by completely eliminating any external plugs. That is, as FIG. 6A As shown, the return electrode 132 does not include such an external plug. Instead, FIG. 6A The return electrode 132 can be oriented and positioned in any configuration within the operating room and below the patient without moving the position of the electrical connection between the conductive element 140 and the return cable 114.

[0086] To draw current from the busbar 158 of the conductive element 140 without exposed connectors, at least one embodiment of the electrosurgical system includes a capacitive electrical connection between the conductive element 140 of the return electrode 132 and the return cable 114. The capacitive connection can occur wherever the busbar 158 is located along the edge of the return electrode 132.

[0087] like FIG. 6B As seen in the exploded diagram, and as... FIG. 6A It is inferred that the conductive element 140 is sandwiched between pads 142 and 144. In at least one embodiment, the pads 142 and 144 of the return electrode 132 completely surround the conductive element 140, which is completely disposed within the return electrode 132, such that no part of the conductive element 140 (including the busbar 158) is exposed outside the return electrode 132 or accessible from the outside of the return electrode.

[0088] In such embodiments, the return electrode 132 includes a simplified geometry that lacks the hard-to-reach contours and recesses of exposed electrical plugs or other common electrical connections. This is advantageous when cleaning and / or sterilizing the return electrode 132 between two patient uses to reduce the risk of infection. For example, a typical return electrode includes electrical connections or plugs that communicate with the conductive heating element inside the return electrode. During sterilization with a wipe or other common sterilization technique, it is difficult for medical personnel to reach the interior contours and crevices of the electrical connections. As a result, bacteria can remain inside the connections. In contrast, the return electrode 132 of the present disclosure does not include such common connections. As a result, the return electrode 132 can be more easily wiped down and sterilized between uses, thereby reducing the risk of infection to a patient lying thereon.

[0089] Additionally, the material of the conductive element inside the return electrode 132 is not exposed in any way to be corroded, damaged, or otherwise compromised during shipping, movement, storage, and use. There are no electrical connections that can break or corrode. Moreover, the return electrode can be freely folded, rolled, or otherwise packaged and stored in any number of ways without the rigidity or bulk of electrical connections impeding or complicating the packaging or storage process.

[0090] To illustrate the construction of at least one embodiment of the return electrode 132, including the conductive element 140 and bus bar 158 disposed therein, FIG. 6C A simplified cross-sectional view taken along line 6C-6C of FIG. 6A is shown. FIG. 6D An exploded cross-sectional view of the return electrode 132 is shown. As FIG. 6C and FIG. 6D shown, the return electrode 132 includes the conductive element 140 and pads 142, 144 on opposite sides of the conductive element 140. The pads 142, 144 can be individually referred to as an upper pad 142 and a lower pad 144. However, as will be clear from the subsequent description and drawings, the pad 142 or 144 can be oriented above or below the conductive element 140 during use while maintaining the functionality of the return electrode 132. Indeed, at least one advantage of the return electrode 132 is that medical personnel can place the return electrode 132 on the surgical table 130 in any orientation without losing the functionality provided by the return electrode 132.

[0091] Disposed on opposite sides of the conductive element 140 are pads 142, 144. As can be seen, the pad 142 has an outer cover layer 160 and an inner cover layer 162 that define an interior chamber 164 therebetween. The outer cover layer 160 is configured to be placed against the surface of the patient (thereby serving as a working surface for the return electrode 132), while the inner cover layer 162 is disposed alongside the conductive element 140. In some embodiments, the inner cover layer 162 is fastened to the conductive element 140 (such as with an adhesive) to prevent air bubbles or separation between the pad 142 and the conductive element 140. The outer cover layer 160 and the inner cover layer 162 can be formed individually and fastened together around their edges, or can be formed integrally. The outer cover layer 160 and the inner cover layer 162 can be formed of various materials such as amino ester, polyurethane, polyethylene, polypropylene, polyolefin, polyvinyl chloride, PET, etc. A filler material 166, similar to that discussed elsewhere herein, can be disposed in the interior chamber 164.

[0092] Similar to the pad 142, the pad 144 includes an outer cover layer 168 and a filler material 170. The outer cover layer 168 is configured to be placed against the surface of the patient (thereby serving as a second working surface for the return electrode 132), while the filler material 170 is disposed alongside the conductive element 140. Like the outer cover layer 160 and the inner cover layer 162, the outer cover layer 168 can be formed of various materials such as amino ester, polyurethane, polyethylene, polypropylene, polyolefin, polyvinyl chloride, PET, etc.

[0093] Rather than having a second inner cover layer, the pad 144 can be formed during assembly of the return electrode 132. For example, during assembly of the return electrode 132, the chamber 164 in the pad 142 can be filled with the material 166 and hermetically closed so that the material 166 cannot escape from the chamber 164. The pad 142 can be disposed alongside and / or fastened to the first major surface of the conductive element 140. The edges of the outer cover layer 168 can then be fastened to the edges of the pad 142 so as to create a chamber between the conductive element 140 and the outer cover layer 168. The newly defined chamber can then be filled with the material 170 and hermetically closed so that the material 170 is retained therein.

[0094] It should be appreciated that the pads 142, 144 can be similar or identical to one another. For example, in addition to the outer cover layer 168 and the material 170, the pad 144 can also include an inner cover layer (similar to the inner cover layer 162) that cooperates with the outer cover layer 168 to define a chamber for containing the material 170. Further, the pad 144 can also be at least partially fastened to the conductive element 140. For example, in embodiments in which the pad 144 includes an inner cover layer, the inner cover layer can be fastened to the second major surface of the conductive element 140, such as with an adhesive.

[0095] Similarly, pad 142 can be similar to pad 144 in that it can be formed without the inner cover layer 162. In such embodiments, the outer layer 160 of pad 142 can be fastened to the outer layer 168 of pad 144. Additionally or alternatively, in at least one embodiment, each outer layer 160, 168 can be at least partially fastened to the conductive element 140 at its outer edge, and to the opposite outer layer 160, 168.

[0096] In all cases, it will be understood that the conductive element 140 of the return electrode 132 is completely surrounded by the surrounding pads 142, 144, such that the conductive element 140 is not exposed in any way, such as FIG. 6A and FIG. 6B The embodiment of the return electrode 132 is shown.

[0097] Although FIG. 6C It shows along FIG. 6A The image shows a cross-sectional view of the return electrode 132 taken by line 6C-6C. However, regardless of the orientation of line 6C-6C, whether it is arranged longitudinally, laterally, or diagonally on the return electrode 132, the cross-sectional view of the return electrode 132 will look similar. That is, the pads 142 and 144 extend beyond the outer edge of the conductive element 140 around the entire periphery of the return electrode 132, such that the conductive element is disposed within and completely surrounded by the pads 142 and 144.

[0098] In at least one embodiment, gaskets 142, 144 are welded, adhered, sealed, or otherwise formed together at the gasket joint 172 around the outer periphery of the conductive element 140. In at least one embodiment, gaskets 142, 144 are integrally formed together as a single piece. In any case, as described above, the conductive element 140 is completely surrounded and enclosed by gaskets 142, 144, such that no part of the conductive element 140 is exposed or extends beyond the gaskets 142, 144. Furthermore, as referenced above... FIG. 6A Specifically, no conductive plug or any other external conductive connector passes through the pad joint 172 at any point around the periphery of the return electrode 132 to make conductive electrical contact with the conductive element 140. Therefore, the conductive element 140 is completely isolated from the environment outside the pads 142 and 144.

[0099] The materials forming the return electrode 132, the conductive elements 140, and the pads 142, 144 control the transmission of current from the patient to the conductive elements 140. Thus, in at least one embodiment, the pads 142, 144 and the filler material 166, 170 are insulative, while in alternative configurations, the pads 142, 144 and / or the material 166, 170 can be conductive and aid in the transmission of current from the patient to the conductive elements 140. The various elements of the return electrode 132, i.e., the conductive elements 140 and the pads 142, 144, can provide one or more resistive, inductive, and / or capacitive inductive components for the overall impedance.

[0100] In addition to the materials used to form the pads 142, 144, the thickness of the pads 142, 144 can also affect the transmission of current from the patient to the conductive elements 140. As a non-limiting example, forming relatively thin pads 142, 144 can facilitate capacitive coupling between the conductive elements 140 and a patient lying on the return electrode 132. Through this capacitive coupling, current used during electrosurgery is transmitted from the patient to the return electrode 132. In view of the present disclosure, one of ordinary skill in the art will appreciate that the capacitive coupling between the patient and the return electrode 132 can be directly related to the self-limiting characteristics of the return electrode 132. Thus, making the pads 142, 144 relatively thin facilitates good electrical coupling between the patient and the return electrode 132 in order to achieve safe and effective electrosurgery for substantially any body size patient. Accordingly, the thickness of one or both of the pads 142, 144 can be within a predetermined range.

[0101] For example, in some embodiments, the approximate thickness of one or both of the pads 142, 144 is between about 0.02 inches and about 0.120 inches. In other embodiments, the approximate thickness of one or both of the pads 142, 144 is less than about 0.10 inches, about 0.09 inches, about 0.075 inches, about 0.06 inches, about 0.05 inches, about 0.03 inches, or about 0.02 inches. In some embodiments, the overall thickness of the return electrode 132 is about 0.135 inches or less.

[0102] Inclusion of substantially similar pads 142, 144 on opposite sides of the conductive element 140 provides a substantially symmetrical configuration for the return electrode 132. The symmetrical nature of the return electrode 132 provides two surfaces for the return electrode 132 to function as a working surface. More specifically, the major surfaces of the return electrode 132 defined by the outer cover layers 162, 168 can each function as a working surface. For example, the return electrode can be positioned such that the outer cover layer 162 is positioned toward the patient, and the return electrode 132 will exhibit the self-limiting characteristics discussed herein. Likewise, the return electrode 132 can be flipped over such that the outer cover layer 168 is positioned against the patient, and the return electrode 132 will exhibit the self-limiting characteristics discussed herein.

[0103] As discussed above with reference to FIG. 2 The electrical return cable 114 can be connected to the return electrode 132 to carry current back to the electrosurgical generator 100, thereby drawing current out of the patient via the return electrode 132. Accordingly, an electrosurgical system incorporating various embodiments of the return electrode 132, 174 described herein can employ one or more capacitive electrical connections that allow current to pass through at least the pads 142, 144 that surround the conductive element 140, or any other material that separates the conductive element 140 from the return cable 114.

[0104] In at least one embodiment, the capacitive connection between the return cable 114 and the conductive element 140 can include a conductive material that is removably fastened to the return electrode 132. Such removable connections can be implemented using magnetic connections, pressure-adhesive type connections, hook-and-loop connections, spring-loaded clips, or other removable devices to fasten the conductive material to the return electrode 132. In at least one embodiment, the capacitive connection can include a conductive material placed under the return electrode 132 such that the patient’s body weight will fasten the capacitive connection against the return electrode 132 between the return electrode 132 and the surgical table 130. Other capacitive connections are also contemplated herein that bring the conductive material in close enough proximity to the bus bar 158 such that current can be passed from the bus bar 158 to the conductive material that is electrically connected to the return cable 114.

[0105] The embodiments of return electrodes described thus far, including FIGS. 2-6D The embodiments shown, which are configured to be placed on a generally flat, layered pad on a surgical table during use. In such embodiments, as discussed above, contact between the patient and the return electrode 132 results from the patient’s body weight pushing the return electrode 132 down against the surgical table 130. Such contact can be unreliable and unpredictable due to potential movement and repositioning of the patient’s body during surgery as well as the curved profile of the patient’s body, which can impact the proper functioning of the return electrode 132 and, thus, the overall electrosurgical system.

[0106] To ensure a proper, consistent, and secure connection between the patient and the return electrode during surgery, regardless of the patient's body geometry and how their position or movement changes during the procedure, at least one embodiment of the return electrode 174 includes a wearable return electrode 174. Such an embodiment is shown in Figure 7A. Here, the return electrode 174 includes a flexible sheath-like structure configured to be placed on the patient's limb or other body part. The return electrode 174 is shown as a hollow cylindrical sheath in Figure 7A. However, the return electrode 174 is flexible so that it can conform to the contours of the patient's body while wearing the return electrode 174. As described below with reference to the following figures, the return electrode 174 can take many different forms, allowing the return electrode 174 to be worn by the patient on various body areas.

[0107] Figure 7B shows an exploded view of the return electrode 174 of Figure 7A, including pad 142, conductive element 140, and pad 144. Conductive element 140 includes busbar 158, and may be constructed from conductive fabric fibers and / or conductive yarns woven together as described above. Busbar 158 may also include various conductive materials and / or conductive fabrics as described above. Additionally, pads 142 and 144 may include the components described above. FIGS. 4-6D The materials, layers, and configurations described are as follows, relating to the other pads 142, 144 found. Additionally, pads 142, 144 and conductive element 140 can be combined as shown in FIG. 7A, such that conductive element 140 is completely surrounded by pads 142, 144 without any exposed electrical connections, as described above. Alternatively, at least one embodiment of the return electrode 174 may include an external electrical connector, similar to... FIG. 5A and FIG. 5B The electrical connector 182 is shown.

[0108] like FIG. 7C As seen in the cross-sectional view taken along line 7C-7C of Figure 7A, the conductive element 140 is sandwiched between pads 142 and 144. In this type of wearable configuration, pad 144 serves as an inner pad defining channel 176, and pad 142 serves as an outer pad. In at least one embodiment, the materials of pads 142, 144, and conductive element 140 are flexible and elastic to conform to the patient's contours when worn. (See below for further details.) FIG. 9 Figure 10 provides further details about patients wearing such return electrodes.

[0109] First, refer to FIG. 7DIn at least one embodiment of the return electrode 174, the return electrode 174 includes an electrically conductive element 140 sandwiched between an outer liner 142 and an inner liner 144. As previously described, the liners 142, 144 can be joined together at a liner junction 172 to secure the electrically conductive element 140 therebetween. The liners 142, 144 can be permanently secured together at the liner junction 172, or they can be removably secured together at the liner junction 172, such as by a pressure adhesive, hook-and-loop material, a zipper, snaps, or the like. Alternatively, in at least one embodiment, the liners 142, 144 can not be secured together at the liner junction 172. Rather, each layer of the return electrode 174, including the liners 142, 144 and the electrically conductive element 140, can be individually donned on a patient's limb or other body part.

[0110] Additionally, at least one embodiment of the return electrode 174 can not include all layers, including the liners 142, 144 and the electrically conductive element 140. For example, in at least one embodiment, the return electrode 174 can include only the electrically conductive element 140 and the outer liner 142. In such an embodiment, the return electrode 174 can include a flexible, fabric electrically conductive element 140 placed on / placed around a portion of a patient and an outer liner 142 placed on and around the electrically conductive element 140. In such an embodiment, the outer liner 142 can act as a compression layer that holds the electrically conductive element 140 to the patient. Additionally or alternatively, the return electrode 174 can include additional layers not shown in the figures. For example, embodiments of the return electrode 174 that include all layers, including the liners 142, 144 and the electrically conductive element 140, can also include an additional outer cover layer that extends beyond the return electrode 174 to secure the return electrode 174 to the patient.

[0111] Along these lines, FIG. 8A A return electrode 174 is shown secured to a patient lying on the surgical table 130. In the illustrated implementation of the return electrode 174, the return electrode 174 is secured around a lower leg portion of the patient. The return cable 114 extends from the return electrode 174. As described above, in at least one embodiment, the return electrode 174 is flexible and elastic such that the return electrode 174 conforms to the contours of the patient's body, in this case, the contours of the patient's lower leg. In such an embodiment, the return electrode 174 can be expanded to fit over the patient's leg or foot, and then the elasticity of the return electrode 174 or its individual layers, including the liners 142, 144 and the electrically conductive element 140, cinches the patient's leg to secure the return electrode 174 thereto via a friction fit. In this sense, the return electrode 174 is capable of being donned on a limb or other portion of a patient's body.

[0112] In such embodiments shown in FIG. 8, the bus bar 158 of the return electrode 174 remains in close contact with the patient along with the conductive element 140. To prevent the current (which flows through the patient's body during electrosurgery) from primarily and directly flowing into the bus bar 158 and burning the patient due to the current being concentrated only in the bus bar 158, the bus bar 158 can include one or more insulating features, rather than letting the current spread out and flow through the fabric portion of the conductive element 140. For example, as shown in FIG. 8B At least one embodiment of the conductive element 140 includes an insulating layer 178 that at least partially surrounds the bus bar 158.

[0113] In at least one embodiment, the insulating layer 178 can include a separate layer that surrounds the bus bar 158. Alternatively or additionally, the insulating layer 178 can include a coating that coats the bus bar 158. The insulating layer 178 prevents the current flowing through the patient's body from directly entering the bus bar 158. In at least one embodiment, a portion of the bus bar 158 can remain uninsulated to enable an electrical connection with the return cable 114. In embodiments where the conductive element 140 includes exposed electrical connectors, such as the electrical connectors 182 shown in FIG. 5A and FIG. 5B The bus bar 158 can be completely coated or covered with the insulating layer 178, and the electrical connectors can pierce the insulating layer 178 to make direct electrical contact with the bus bar 158.

[0114] Alternatively, in embodiments where the conductive element 140 does not include any exposed electrical connectors, such as the embodiment shown in FIG. 7D one or more portions of the bus bar 158 can remain exposed without the insulating layer 178, such as the exposed layer 180 shown in FIG. 8B In such embodiments, the exposed portions 180 can still be used to make capacitive connections with capacitive connectors secured to the outside of the return electrode 174. Such embodiments are shown in FIG. 8B and FIG. 8C The number, location, and size of the exposed portions 180 can vary from different embodiments.

[0115] Along these lines, FIG. 8CA cross-sectional view of the return electrode 174 secured to the patient's calf is shown. The capacitive connector 182 can include a clamp that positions a conductive portion 184 in close enough proximity to the bus bar 158 to create a capacitive electrical connection therebetween. In such embodiments, to achieve this connection, the bus bar 158 can not include an insulating layer 178 between the bus bar 158 and the conductive portion 184. The rest of the bus bar 158 can include the insulating layer 178, as shown, between the bus bar 158 and the upper side of the patient's leg, as well as around the portion of the bus bar 158 that is located below the leg, or in other words, not in the vicinity of the conductive portion 184 of the capacitive connector 182. Again, the insulating layer 178 protects the patient by preventing a dense current from flowing directly into the bus bar 158. Because the insulating layer 178 surrounds the bus bar 158, the current that flows through the patient's leg will first enter the conductive element 140 and spread out through the conductive element, and then travel to the bus bar 158 outside of the body.

[0116] Alternatively or additionally, the exposed portion 180 can extend below the bus bar 158 such that, at the exposed portion 180, no insulating layer 178 is positioned between the bus bar 158 and the patient's leg. In such embodiments, the lower arm 183 of the capacitive connector 182 can act as an insulator to prevent current from flowing directly from the patient's leg to the bus bar 158 at the exposed portion 178.

[0117] Further, the insulating layer 117 can be included within or as part of the portions of the padding 142, 144 that surround the conductive element 140 and the bus bar 158. In such embodiments, the insulating layer 178 can be integrated into the padding 142, 144 or portions thereof that surround the bus bar 158. Additionally, in at least one embodiment, the padding 142, 144 can be doped with an insulating material at the locations that surround the bus bar 158 as described above.

[0118] Because the conductive element 140 and the bus bar 158 can not be visible due to their being sandwiched between the padding 142, 144, the outer surface of the padding 142, 144 can include one or more visual indicators that indicate the location of the exposed portion of the bus bar 158. In this way, the visual indicators can show where to place the capacitive connector 182 on the return electrode 174 to form a capacitive connection between the bus bar 158 and the capacitive connector 182. The foregoing insulating layer 178 described with respect to the embodiment of the return electrode 174 shown in FIG. 7A- FIG. 8C The foregoing insulating layer 178 described with respect to the embodiment of the return electrode 174 shown in FIG. 7A-

[0119] FIG. 9Possible locations of the return electrodes 174a-174d on the patient's body are shown, including the thigh 174a, arm 174b, torso 174c, and calf and ankle 174d. It will be understood that the size and shape of the return electrodes 174 can vary depending on where the return electrodes 174 are placed on the patient's body. Additionally, in at least one embodiment, the return electrodes 174 can be closed at one end to form a sock or glove-type structure that can also be donned by the patient. Additionally or alternatively, as noted above, the return electrodes 174 can also include an additional outer cover, whether or not fabric, that extends beyond the return electrodes 174 to hold the return electrodes 174 on the patient's body. Such an outer cover can also be waterproof to prevent the return electrodes 174 from becoming wet during surgery. The material of such an outer cover can be similar to the materials described with reference to the pads 142, 144 described herein.

[0120] The configuration, size, shape, and placement of the return electrodes 174 can thus vary depending on the needs of a particular surgery. For example, if a surgery is being performed on a leg, it can be advantageous to don the return electrodes 174 on the patient's torso. Conversely, during a surgery on the patient's torso, it can be advantageous to place the return electrodes 174 on the patient's peripheral limbs so as not to impede the surgery.

[0121] Likewise, the extent to which the return electrodes 174 cover and contact the surface area of the patient can also vary in other embodiments. For example, in at least one embodiment, the return electrodes 174 can take the form of pants that cover the patient entirely from the waist down. Alternatively or additionally, the return electrodes 174 can take the form of a shirt that covers at least a portion of the patient's torso and arms. From the foregoing, it will be understood that in order to allow the patient to don the return electrodes 174 and to be in sufficient contact therewith to enable current to flow from the patient and into the conductive elements 140, the return electrodes 174 can take many forms, shapes, and configurations.

[0122] Attention will now be directed to FIGS. 10A-10C which show another embodiment of the conductive elements 140 disposed in the return electrodes 174. FIG. 10A The conductive elements 140 are shown with bus bars 158 that extend longitudinally along the conductive elements 140. In such a configuration, the bus bars 158 can also be insulated by the insulating layer 178 as described above with reference to other embodiments. In FIG. 10A In the embodiment shown, current entering the conductive elements 140 can flow through the conductive fibers / conductive yarns of the conductive elements 140 and to the bus bars 158 in any direction. Alternatively, as FIG. 10BAs shown, the conductive element 140 can include a longitudinally extending bus bar 158, and a gap between the bus bar 158 and an opposite edge 186 of the conductive element 140 on one side. In this embodiment, current entering the conductive element 140 from the conductive fabric can only flow into the bus bar 158 in one direction.

[0123] FIG. 10C And FIG. 10D As shown, the gap between the bus bar 158 and the opposite edge 186 of the conductive element 140 is filled by the opposing pads 142, 144 when the conductive element 140 is sandwiched between them during use. Alternatively, as shown, FIG. 10C the gap can be filled with an insulating material portion 188. The insulating material portion 188 can be formed with the conductive element 140, or inserted into the gap separately when the conductive element 140 is sandwiched between the pads 142, 144. FIG. 10D

[0124] In addition to the foregoing, one or more embodiments of the return electrode 174 can also include a strap or other fastening device to fasten the return electrode 174 to the patient's body or a portion of the patient's body. For example, FIG. 11A As shown, the return electrode 174 includes a fastening strap 178 that holds the return electrode 174 to the patient, as seen in FIG. 11B In such embodiments, the return electrode 174 can not extend completely around a limb or other portion of the patient's body. In at least one embodiment, the strap 178 is flexible and elastic such that the strap 178 fastens the return electrode 174 to the patient's leg or other portion. In at least one embodiment, the strap 178 is permanently fastened to the return electrode 174. In at least one embodiment, the strap 178 is removably fastened to it at one or both ends such that they can be removed. In at least one embodiment, the strap 178 includes an adjustable feature, such as a belt system with a buckle and belt holes, or other adjustable strap mechanism known in the art. In such embodiments, the strap 178 can be loosened to slip the return electrode 174 over a portion of the patient's body, and then tightened to fasten the return electrode 174 to the patient.

[0125] Alternatively or additionally, as FIG. 12 ​As shown, at least one embodiment of the return electrode 174 can include hook-and-loop portions 181 on opposite edges thereof. In such embodiments, the hook-and-loop portions 180 can be separated and the return electrode 174 positioned around a portion of the patient’s body. The hook-and-loop portions 180 can then be fastened together to secure the return electrode 174 around the patient. By varying the degree to which the hook-and-loop portions 180 of the return electrode 174 overlap one another, the snugness of the return electrode 174 can be adjusted.

[0126] It will be appreciated that many other fastening mechanisms known in the art can also be used in one or more other embodiments of the return electrode 174 to ensure that the return electrode 174 can be worn on at least a portion of a patient’s body as described herein. Such mechanisms can include, but are not limited to, pressure adhesives, snaps, zippers, clips, ribbons, and the like.

[0127] Additionally, the various embodiments and elements of the electrosurgical system described herein are not necessarily mutually exclusive of one another. Rather, the features described in each embodiment and / or some or all of the elements of the electrosurgical system described herein can be combined together with the features and / or elements of the other embodiments.

[0128] The application can also be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are therefore considered in all respects as illustrative and not restrictive. The scope of the application is indicated by the appended claims rather than the foregoing description. All changes that come within the meaning of equivalency of the claims are intended to be embraced therein.

Claims

1. A wearable electrosurgical return electrode comprising: a sheath having an outer liner and an inner liner; a conductive element disposed between the inner liner and the outer liner; wherein the inner liner, the outer liner, and the conductive element are flexible and elastic such that the return electrode conforms to a patient's contours when worn by the patient during use, wherein the return electrode further comprises a bus bar disposed along an edge of the conductive element, and wherein the wearable electrosurgical return electrode is free of any exposed electrical connectors in electrical contact with the conductive element.

2. The wearable electrosurgical return electrode of claim 1, wherein, the outer liner is elastic and is configured to expand to fit over at least a portion of the patient when worn; and to compress at least partially around the conductive element about the patient during use.

3. The wearable electrosurgical return electrode of claim 1, wherein, the conductive element comprises a conductive fabric material.

4. The wearable electrosurgical return electrode of claim 1, further comprising an insulating layer disposed at least partially around the bus bar.

5. The wearable electrosurgical return electrode of claim 1, wherein, the inner liner and the outer liner are formed together at a liner junction around an outer perimeter of the conductive element.

6. The wearable electrosurgical return electrode of claim 1, wherein, the inner liner and the outer liner are separately formed, separate layers.

7. The wearable electrosurgical return electrode of claim 1, wherein, the outer liner and the conductive element are separate layers of the return electrode such that each can be donned independently of the other.

8. The wearable electrosurgical return electrode of claim 7, wherein, the sheath is a compression layer configured to be donned over the conductive element to hold the conductive element to a patient during use.

9. A wearable electrosurgical return electrode comprising: an outer liner; a conductive element disposed inside the outer liner; wherein the conductive element and the outer liner are flexible such that the return electrode can be worn on a portion of a body during use, wherein the conductive element comprises a conductive, woven fabric material, and wherein the conductive element further comprises a bus bar disposed along an edge of the conductive element, and wherein the wearable electrosurgical return electrode is free of any exposed electrical connectors in electrical contact with the conductive element.

10. The wearable electrosurgical return electrode of claim 9, further comprising an inner liner disposed inside the conductive element such that the conductive element is sandwiched between the outer liner and the inner liner.

11. The wearable electrosurgical return electrode of claim 10, wherein, the conductive element, the inner liner, and the outer liner are elastic.

12. The wearable electrosurgical return electrode of claim 9, wherein, the bus bar comprises an insulating layer that prevents current from flowing directly from a body wearing the return electrode into the bus bar during use.

13. A wearable electrosurgical return electrode comprising: an outer liner; an inner liner; a conductive element disposed between the outer liner and the inner liner; wherein the return electrode is formed as a flexible sheath and is configured to be worn on at least a portion of a body during use, wherein the return electrode further comprises a bus bar disposed along an edge of the conductive element, and wherein the wearable electrosurgical return electrode is free of any exposed electrical connectors in electrical contact with the conductive element.

14. The wearable electrosurgical return electrode of claim 13, further comprising a strap connecting opposite edges of the return electrode, the strap configured to hold the return electrode at least partially around the at least a portion of the body during use.

15. The wearable electrosurgical return electrode of claim 13, further comprising hook and loop portions on opposite edges of the return electrode, the hook and loop portions configured to engage together to secure the return electrode to the at least a portion of the body during use.

16. The wearable electrosurgical return electrode of claim 13, wherein one end of the sheath is closed to form a sock-like structure, the sock-like structure configured to be pulled on by a patient during use.

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