System and method to evoke smooth muscle response during surgery

Abstract

To provide a favorable system and method to evoke a smooth muscle response during surgery.SOLUTION: A smooth muscle stimulation device is intended for use with any one of a variety of electrosurgical units (ESUs) of the type used in tissue resection and other procedures that risk damage to non-target tissues. The smooth muscle stimulation devices typically include an enclosure with stimulation circuitry configured to generate a stimulatory electrical signal which when delivered to a target anatomy induces an observable response in the target anatomy during a medical procedure. An input connector on the enclosure detachably couples to a power output of the ESU, and an output connector on the enclosure detachably couples to an electrosurgical tool. Switching circuitry within the enclosure selectively connects either the power output of the ESU or the stimulatory electrical signal of the stimulation circuitry to the output connector in response to user input.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Application No. 63 / 046,294 (Attorney Docket No. 51010-706.101), filed June 30, 2020, the entire disclosure of which is incorporated herein by reference.

[0002] 1. FIELD OF THE INVENTION The present invention relates to electrical stimulation and to novel systems and methods for delivering these signals into target tissue during surgery to help identify smooth muscle structures and determine their functionality. [Background technology]

[0003] BACKGROUND OF THE INVENTION The field of surgery continues to advance at a rapid pace. Previously, the standard of care for many surgical procedures, including hysterectomies, colectomies, and even exploratory laparotomies, was performed with lengthy abdominal incisions. Such "open surgical" procedures are painful, require lengthy recovery times, patient discomfort, and can have undesirable side effects such as poor wound healing and incisional hernias.

[0004] As alternatives to such open surgery, various laparoscopic and other "minimally invasive" procedures have been developed, in which small incisions, typically 5-10 mm, are made and long, slender instruments are inserted into the body while the operator visualizes the surgical field through a "speculum" (camera), which is also inserted through the abdominal wall. Such minimally invasive procedures offer reduced pain and shorter recovery times and now dominate many routine urological, obstetric, gynecological, and colorectal surgeries. Recently, the use of surgical robots has further expanded the popularity of such minimally invasive procedures.

[0005] Despite its manifold advantages, minimally invasive surgery has certain drawbacks that have limited its practical use. For example, the use of small access incisions limits the surgeon's ability to actually touch tissue, resulting in a loss of tactile feedback. In open surgical procedures, surgeons often directly touch patient tissue and can palpate structures of different textures, thicknesses, shapes, and densities that would not otherwise be apparent. Such tactile feedback often provides useful information regarding the identification and location of structures such as blood vessels and other critical anatomical features such as the ureter, allowing surgeons to avoid inadvertent damage to these otherwise invisible structures.

[0006] WO2015 / 123441 and WO2018 / 098468, which share common inventorship with the present application, describe electrical stimulation units with dedicated electrode probes that deliver stimulation signals to tissue adjacent to a target smooth muscle anatomy, such as the ureter, to induce an observable response, typically tissue contraction within the target anatomy during a medical procedure. By visually scanning or mapping the locations where a response is observed, surgeons can avoid those areas when performing procedures, such as resections, that may damage the ureter or other target smooth muscle anatomy.

[0007] While highly effective, the need to introduce yet another electrical stimulation unit with a dedicated electrode probe into an already saturated surgical environment presents certain challenges. While it would theoretically be possible to incorporate the stimulation signals and circuitry of WO2015 / 123441 and WO2018 / 098468 into existing ESU designs, such a transition would likely take many years as the current large inventory of existing ESUs is gradually replaced with upgraded versions over time.

[0008] It would therefore be desirable to provide devices, systems, and methods that would enable surgeons to employ the tissue discrimination techniques of WO 2015 / 123441 and WO 2018 / 098468 while continuing to use existing commercially available ESUs and minimizing the need to introduce additional equipment into the surgical environment. In particular, it would be desirable to eliminate the need to employ separate electrosurgical probes to deliver both the stimulation signal and the cutting / coagulation force to the tissue. It would further be desirable to facilitate switching between the stimulation signal and the cutting / coagulation energy when using the same electrosurgical tool to engage tissue. At least some of these goals will be met by the present invention, as described and claimed below.

[0009] (2. List of Background Art) WO2015 / 123441 and WO2018 / 098468 describe previous tissue stimulation systems and share common inventorship with the present application. Other related patents and patent publications include US4535771, US5010895, US6292701, US7877152, US8954153, US2009 / 0247812, US2011 / 0301662, US2012 / 010326, and US2015 / 0005841. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] International Publication No. 2015 / 123441 [Patent Document 2] International Publication No. 2018 / 098468 Summary of the Invention [Means for solving the problem]

[0011] (Summary of the Invention) A novel device and method for generating and delivering stimulation signals through existing surgical instruments during surgery, while allowing the operator to switch between ESU output and a novel system, allowing surgeons to retain ESU capabilities using their current instruments while enjoying the added capability of tissue stimulation without having to change instruments and interrupt their workflow.

[0012] In a first aspect, the present invention provides a smooth muscle stimulation device suitable for use with an electrosurgical unit (ESU). The smooth muscle stimulation unit includes an enclosure having stimulation circuitry therein. The stimulation circuitry is configured to generate a stimulating electrical signal that, when delivered to a target anatomy during a medical procedure, elicits an observable response in the target anatomy. An input connector is disposed on the enclosure and configured to be removably coupled to a power output of the ESU. An output connector is also disposed on the enclosure. The output connector is configured to be removably coupled to an electrosurgical tool of a type typically employed in minimally invasive or other electrosurgical procedures. Switching circuitry within the enclosure is configured to selectively connect either the power output of the ESU (bypassed from the ESU) or the stimulating electrical signal generated by the stimulation circuitry to the output connector in response to a user input. In this manner, the smooth muscle stimulation device of the present invention can be combined with a conventional, commercially available ESU, allowing the benefits of tissue stimulation and observation to be made available with minimal additional equipment and disruption to the surgical environment.

[0013] In specific embodiments, the stimulation circuitry is configured to elicit a peristaltic response from a patient's ureter when electrodes on the electrosurgical tool are positioned adjacent to the ureter in minimally invasive, open surgery, or other procedures. Exemplary electrosurgical tools include grasping forceps, scissors, irrigators, dissectors, resecters, suction devices, and the like, having electrodes or other conductive surfaces configured to be coupled to output connectors on the enclosure. This list is not meant to be exhaustive.

[0014] The smooth muscle stimulation devices of the present invention are most often bipolar devices, but in other cases the smooth muscle stimulation devices may be configured to be operated with monopolar electrosurgical instruments when the ESU, together with the dispersive pad, is operated in monopolar mode.

[0015] In a preferred embodiment, the stimulation circuitry of the present invention may comprise a power supply configured to deliver undriven capacitive discharges with pulse control. Typically, the stimulation circuitry will further comprise a controller configured to control the pulse output from the power supply.

[0016] In most cases, the smooth muscle stimulation device of the present invention will include a user interface on the enclosure configured to control the switching circuitry in response to user input via the interface. The user interface will typically include at least one selector that allows the user to selectively connect either the ESU's power or the stimulation circuitry's stimulating electrical signal to the output connector to deliver the selected signal for electrical current to the electrosurgical tool. In some embodiments, the selector may include a first pushbutton for selecting the stimulation mode and a second pushbutton for selecting the electrosurgical mode, in which case the two buttons and circuitry are typically unlocked so that they cannot be selected simultaneously. In other cases, the selector may simply be a switch positioning device.

[0017] As briefly discussed above, stimulation devices of the present invention are intended to be utilized with any one of a variety of commercially available ESUs. Accordingly, stimulation devices of the present invention will often include multiple output plug adapters configured to provide a bridge or interface between the power input on the enclosure and the power output cable from the ESU. In some cases, the adapters may be incorporated into a connector cable, where one end of the cable is adapted to plug into the ESU and the other end of the cable is adapted to plug into the stimulation device enclosure.

[0018] Similarly, the smooth muscle stimulation device of the present invention may further comprise a plurality of output plug adapters, each configured to provide a bridging electrical connection between the output connector on the stimulation device enclosure and the connecting cable or cord of the electrosurgical tool. These adapters enable the stimulation device and enclosure to be connected to a wide variety of commercially available electrosurgical tools, which may have different connector patterns and plugs.

[0019] Although particularly useful in combination with an ESU, as explained above, the smooth muscle stimulation device of the present invention will typically include a standalone power supply and will also find use as a "standalone" device (independent of an ESU or other electrosurgical device) for stimulation of target tissue for nerve identification and / or localization or other purposes. When used independently, the switching component will be enabled to deliver the stimulation electrical signal of the stimulation circuitry to the tool output, and optionally, pass-through connections to the ESU input (which is typically empty) will be disabled.

[0020] In a second aspect, the present invention provides a smooth muscle stimulation system comprising a smooth muscle stimulation device as described above in combination with an ESU having a power output. The ESU may be specially designed to interface with the smooth muscle stimulation system of the present invention, but more often will be a commercially available ESU obtained separately from the stimulation system of the present invention.

[0021] In a third aspect, the present invention provides a method for assembling a smooth muscle stimulation system and an ESU to selectively output electrical stimulation energy and power. The method includes providing an enclosure including an electrical stimulator having a stimulation signal output and an ESU having a power output. The power output of the ESU is connected to an input connector on the enclosure, and an electrosurgical tool is connected to an output connector of the enclosure. The output connector is selectively switched in response to a user input to receive current from either (1) the power output of the ESU or (2) the stimulation electrical signal of the stimulation circuitry, and to deliver the received current to the electrosurgical tool.

[0022] In a specific example, the method further includes energizing an electrical stimulator to deliver a stimulation signal to the electrosurgical tool, engaging an electrode surface on the electrosurgical tool with target tissue proximate the target smooth muscle, and observing the target tissue to detect contractions induced by the stimulation signal, which indicate the presence of smooth muscle in or near the engaged tissue. Once a portion of the target tissue is determined to be free from the smooth muscle or other target anatomical structure, the electrode surface of the electrosurgical tool can be engaged with the tissue surface based on the absence of tissue contraction. After engagement, the ESU can be energized to deliver power to the tissue engaged by the electrode, typically electrosurgical power for cutting, coagulation, or other tissue-modifying results.

[0023] In an exemplary embodiment, selectively switching the output connector includes manually selecting a switch located on the exterior of the enclosure to control switching circuitry within the enclosure. For example, switching may include selectively engaging either a first selector button to energize the electrical stimulator to deliver the stimulation signal to tissue, or a second selector button to enable the switch to deliver bypass current from the ESU to the electrosurgical tool. Alternatively, switching the output connector may include operating a two-position selector switch to select either the stimulation signal or the power output from the ESU for delivery to the patient.

[0024] In specific instances, the methods of the present invention may be utilized to treat target tissue selected from the group consisting of the ureter, bladder, stomach, esophagus, intestine, and the like. In an exemplary embodiment, the stimulation output elicits a peristaltic response from a patient's ureter when electrodes on the electrosurgical tool are positioned adjacent to the ureter. The methods may include any one of a variety of conventional and non-conventional electrosurgical procedures, including bipolar procedures, monopolar procedures, grasping, cutting, suction, tissue dissection, tissue ablation, and the like. The present invention provides, for example, the following. (Item 1) 1. A smooth muscle stimulation device for use with an electrosurgical unit (ESU), comprising: An enclosure; stimulation circuitry within the enclosure configured to generate a stimulation electrical signal that, when delivered to a target anatomy during a medical procedure, elicits an observable response in the target anatomy; and an input connector on the enclosure configured to be removably coupled to a power output of the ESU; and an output connector on the enclosure configured to be removably coupled to an electrosurgical tool; and switching circuitry within the enclosure configured to selectively connect either the power output of the ESU or the electrical stimulation signal of the stimulation circuitry to the output connector in response to a user input; A smooth muscle stimulation device comprising: (Item 2) 2. The smooth muscle stimulation device of claim 1, wherein the stimulation circuitry is configured to elicit a peristaltic response from a patient's ureter when electrodes on the electrosurgical tool are positioned adjacent to the ureter. (Item 3) 3. The smooth muscle stimulation device of claim 1, wherein the electrosurgical tool is selected from the group consisting of a grasping forceps, scissors, irrigator, dissector, resector, and suction device having a conductive surface configured to be coupled to the output connector on the enclosure. instruments, and pulsed output from the power supply. Dissection instruments. (Item 4) 4. The smooth muscle stimulation device of any one of items 1-3, wherein the input connector and the output connector are bipolar. (Item 5) 5. The smooth muscle stimulation device of any one of claims 1-4, wherein the stimulation circuitry comprises a power supply configured to deliver non-driven capacitive discharge and pulse control. (Item 6) 6. The smooth muscle stimulation device of claim 5, wherein the stimulation circuitry further comprises a controller configured to control pulse output from the power supply. (Item 7) 7. The smooth muscle stimulation device of claim 6, wherein the controller is further configured to control the switching circuitry in response to a user interface on the enclosure. (Item 8) 8. The smooth muscle stimulation device of claim 7, wherein the user interface comprises at least one selector to allow a user to selectively connect either the power output of the ESU or the stimulation electrical signal of the stimulation circuitry to the output connector. (Item 9) 9. The smooth muscle stimulation device of claim 8, wherein the at least one selector comprises a first push button for selecting a stimulation mode and a second push button for selecting an electrosurgery mode. (Item 10) The smooth muscle stimulation device of any one of items 1-9, further comprising a plurality of input plug adapters, each input plug adapter configured to provide a bridge electrical connection between the input connector on the enclosure and the power output of one of the plurality of ESUs. (Item 11) 11. The smooth muscle stimulation device of any one of items 1-10, further comprising a plurality of output plug adapters, each output plug adapter configured to provide a bridge electrical connection between the output connector on the enclosure and one of a plurality of electrosurgical tools. (Item 12) an electrosurgical unit (ESU) having the power output; The smooth muscle stimulation device according to any one of items 1 to 11. A smooth muscle stimulation system comprising: (Item 13) 1. A method for assembling a smooth muscle stimulation system and an electrosurgical unit (ESU) and selectively outputting electrical stimulation energy and power, the method comprising: providing an enclosure containing an electrical stimulation device having a stimulation signal output; providing an electrosurgical unit (ESU) having a power output; connecting the power output of the ESU to an input connector of the enclosure; connecting an electrosurgical tool to an output connector of said enclosure; selectively switching, in response to a user input, the output connector to receive current from either (1) the power output of the ESU or (2) the stimulation electrical signal of the stimulation circuitry, and to deliver the received current to the electrosurgical tool; A method comprising: (Item 14) 14. The method of claim 13, further comprising energizing the electrical stimulator to deliver a stimulation signal to the electrosurgical tool, engaging an electrode surface on the electrosurgical tool against target tissue adjacent to a target smooth muscle anatomy, and observing the target tissue to detect contractions induced by the stimulation signal, which are indicative of the presence of the target smooth muscle anatomy in or near the engaged tissue. (Item 15) Item 15. The method of item 14, further comprising engaging the electrode against a tissue surface determined to be free of target smooth muscle based on the absence of tissue contraction, and energizing the ESU to deliver power to the tissue surface. (Item 16) 16. The method of any one of items 13-15, wherein selectively switching the output connectors includes manually selecting a switch position on the enclosure to control switching circuitry with the enclosure. (Item 17) Item 17. The method of item 16, wherein manually selecting includes selectively engaging a first selector button for the electrical stimulation device or a second selector button for the ESU. (Item 18) Item 17. The method of item 16, wherein manually selecting includes operating a selector switch having a first position that enables the electrical stimulator and a second position that enables the ESU. (Item 19) 19. The method of any one of items 13-18, wherein the target tissue is selected from the group consisting of the ureter, bladder, stomach, esophagus, and intestine. (Item 20) 20. The method of any one of items 13-19, wherein the stimulation signal output elicits a peristaltic response from the patient's ureter when an electrode on the electrosurgical tool is positioned adjacent to the ureter. (Item 21) 21. The method of any one of items 13-20, wherein the electrosurgical tool is selected from the group consisting of grasping forceps, scissors, suction irrigators, and dissection instruments. (Item 22) 22. The method of any one of items 13-21, wherein at least one of the stimulation signal output and the power output of the ESU is bipolar. (Item 23) 23. The method of any one of items 13-22, wherein the stimulation signal output and the power output of the ESU are both bipolar. (Item 24) 24. The method of any one of items 13-23, wherein the electrical stimulation device comprises a power supply configured to deliver non-driven capacitive discharge and pulse control. (Item 25) 25. The method of claim 24, wherein the electrical stimulation device further comprises a controller configured to control the pulse output from the power supply. (Item 26) 26. The method of claim 25, wherein the controller is further configured to control the switching circuitry in response to a user interface on the enclosure. (Item 27) 27. The method of any one of items 13-26, further comprising advancing the electrosurgical tool through a trocar, cannula, endoscope, or catheter into the target tissue. (Item 28) 27. The method of any one of items 14-26, wherein the target anatomy comprises a ureter, and further comprising visually observing the target tissue through a surgical opening and visualizing contraction of the tissue to determine a path of the ureter within the tissue. (Item 29) 29. The method of any one of items 14-28, further comprising monitoring the impedance of the stimulation signal output of the electrical stimulation device, wherein an impedance below a first threshold indicates a short circuit and an impedance above a second threshold indicates an open circuit. [Brief explanation of the drawings]

[0025] [Figure 1A] FIG. 1A is a perspective view of a smooth muscle stimulation device constructed in accordance with the principles of the present invention, showing the front panel.

[0026] [Figure 1B] FIG. 1B is a view of the back panel of the smooth muscle stimulation device of FIG. 1A.

[0027] [Figure 2] FIG. 2 illustrates the smooth muscle stimulation device of FIGS. 1A and 1B interconnected with a conventional electrosurgical unit (ESU) and further connected via a switch cable to a conventional electrosurgical instrument and foot switch.

[0028] [Figure 3] FIG. 3 is a schematic diagram of the components and circuitry within the smooth muscle stimulation device of FIGS. 1A and 1B.

[0029] [Figure 4] FIG. 4 is a generalized schematic diagram of the components and circuitry of a device constructed in accordance with the principles of the present invention.

[0030] [Figure 5] FIG. 5 illustrates the muscle stimulation potential generated by the smooth muscle stimulation device of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0031] Detailed Description of the Invention The smooth muscle stimulation device of the present invention is intended for use in conjunction with any conventional or non-conventional electrosurgical unit (ESU) that delivers radio frequency or other electrical current to a patient for therapeutic, diagnostic, or other purposes. The smooth muscle stimulation device will be configured to deliver pulse patterns and other waveforms of the type known to stimulate tissue contraction to allow the surgeon to visually identify smooth muscle targets, such as the ureter, that may be damaged by the electrosurgical procedure.

[0032] The smooth muscle stimulation device of the present invention is configured to interconnect with an ESU, allowing the surgeon to use the combination as a single unit or assembly, simplifying the procedure, saving space, and eliminating redundancy in the surgical environment. In particular, the smooth muscle stimulation device can be assembled with the ESU to have a single footprint, and the electrosurgical tool typically used with the ESU can be used as a probe to deliver stimulation signals to the target tissue, eliminating the need for a dedicated probe.

[0033] In this manner, the surgeon has the option to select and switch between the tissue stimulation signal and the ES power output signal at any point during the procedure, and this change does not require changing the electrosurgical tool in use. The surgeon does not need to change the tool or its field of view, thus providing a seamless workflow experience and maintaining a safe and efficient surgical environment.

[0034] The new device has a relay internally to change the output from the new smooth muscle stimulation signal back and forth to the instrument, allowing the electrosurgical signal to pass through from the electrosurgical generator in the operating room. Both the new device and the electrosurgical generator will be operated independently with their own foot pedals for both safety and precision.

[0035] 1A and 1B, a smooth muscle stimulation device 10 constructed in accordance with the principles of the present invention includes an enclosure 12 having a front surface 14 and a rear surface 16. The front surface has a user interface including a power switch 18, a stimulation selector button 20, an ESU selector button 22, and a display, typically an LED or LCD display. The front surface further includes an electrosurgical tool output receptacle 26 and a slot 28 configured to receive an activation card. The activation card would provide authorization to utilize the system for a particular patient and / or for a particular procedure. The electrosurgical tool output receptacle would typically be configured to receive one or more adapters that allow various conventional electrosurgical tools to be plugged in for use in the procedures described below.

[0036] The rear face 16 of the enclosure 12 includes an electrosurgical device (ESD) connector. This input connector is configured to receive the output of a conventional ESU and will often require the use of an adapter to interface with the proprietary ESU connector and bridge it to the standard connector 26 on the enclosure 12. The rear face 16 of the enclosure 12 also includes a footswitch connector 32 and a power cord connector 34. As described in further detail below, a footswitch 54 will be provided to allow the surgeon to turn the stimulation current on and off from the smooth muscle stimulation device 10 when the stimulation selector button 20 is pressed. Typically, a separate footswitch or pedal will be provided for the ESU, but in some cases it may be desirable to combine the footswitch functions for both the stimulation device and the ESU into a single connector.

[0037] 2, the smooth muscle stimulation device 10 is shown in assembly with a standard or conventional ESU 36. The ESU has several features that enable its normal performance in performing electrosurgery, but those features relevant to the present invention will include a power switch 38 and an ESU power output receptacle 40. Several other connectors 42 will typically be found on the front of the ESU, while several display and controls 44 will be found on the top of the ESU.

[0038] To interconnect the smooth muscle stimulation device 10 and the ESU 36, a cable 41 plugs at one end into the ESU power output receptacle and at the other end into the ESU input connector 30 on the rear face of the smooth muscle cell stimulation device, as shown in Figure 1B. The normal power output of the ESU is thus directed into the enclosure 12, where it will be bypassed to the electrosurgical tool output connector 26 on the front face 14 of the stimulation device.

[0039] A conventional electrosurgical tool 46, illustrated in Figure 2 as a tissue resector, is connected to the output receptacle 26 by a cable 52 and plug 52. As will be explained in further detail with respect to Figures 3 and 4, the smooth muscle stimulation device 10 is configured to selectively deliver either a muscle stimulation current or signal, generated by the stimulation device, or a power current, generated by the ESU, to the electrosurgical tool 46 for use in the methods of the present invention.

[0040] 3, the smooth muscle stimulation device 10 includes a power supply PS, a controller CONT, a stimulation current generator STIM, and a switch module 62. The power supply PS receives line current directly from the power cord connector 34 and delivers low voltage direct current to each of the controller CONT and the stimulation current generator STIM. The power supply PS is controlled by a power switch 18 on the front of the enclosure 12.

[0041] The controller CONT not only receives input from both the stimulus selector button 20 and the ESU selector button 22, but also provides output to the display 24. In this manner, the controller CONT not only controls the function of the stimulator STIM, but also the switching function of the switch module 62. The switching module 62 is shown as a simple single-pole, double-throw switch (SPDT), but would typically be implemented using a power relay to selectively direct either the low-voltage stimulator STIM output or the high-voltage, high-current ESU output to the electrosurgical tool output connector 26. In essence, when the surgeon presses the stimulus selector button 20, the controller CONT will cause the switching module 62 to connect the stimulator STIM output to be directed to the output 26. When the ESU selector button 22 is pressed, the ESU output coming in through the ESU input connector 30 is passed through to the electrosurgical tool output receptacle 26. The surgeon can therefore select the type of current to be applied through the electrosurgical tool 46 by simply selecting the appropriate button on the front of the enclosure 12. Of course, other switches and means may be provided for implementing such switching, including other types of switches, verbal commands, and the like.

[0042] Referring now to FIG. 4, an alternative illustration of the circuitry of the smooth muscle stimulation device 10 is provided. As shown, a user interface is connected to the system controller, which in turn controls the stimulator pulse controller and bypass controller. The stimulator pulse controller and bypass controller together operate a bypass relay that selectively delivers stimulation current from, in one case, the generator power supply with a reservoir capacitor to the patient lead output, or, in an alternative case, the output of the ESU input connector to the patient lead connector. The system is monitored by a connection quality monitor that feeds information back to the system controller to provide to the user, for example, to provide information enabling proper clinical use of the device.

[0043] As shown in Figure 5, the smooth muscle stimulation device of the present invention produces an electrical impulse specifically designed for smooth muscle stimulation. Smooth muscle, particularly the ureter, relies on proximal stimulation to trigger a contractile cascade that manifests as visible peristalsis. The stimulation impulse of the present invention mimics the initial excitatory signal that triggers the smooth muscle contractile cascade. In response to signal delivery, the smooth muscle of the ureter depolarizes and contracts in a physiological wave-like movement known as peristalsis. Through gap junctions, the action potential then naturally and automatically travels from one cell to another, resulting in a propagating visible contraction that naturally extends throughout the length of the ureter.

[0044] The stimulation signal generated by the novel device is non-sustained, has no inherent frequency, and is a single, brief impulse that is short in duration so as to trigger depolarization, but not so long as to prevent the subsequent depolarization cascade of smooth muscle structures that translates into visible peristalsis in clinical and surgical settings (Figure 5). The duration of the stimulation signal is important because the decay of the waveform cannot be so prolonged that it would interfere with the subsequent propagation of the action potential triggered by the stimulation signal.

[0045] In conjunction with generating and delivering this specific stimulation signal into the surgical field and into the patient during surgery through existing surgical instruments, it is important that the surgeon be aware of both the successful delivery of this signal into the desired tissue as well as any errors (assembly or user) that may occur.

[0046] The stimulation device of the present invention may have a small speaker within the enclosure that delivers a single tone when the stimulation button is selected, the foot pedal is pressed, and the stimulation signal is delivered into the appropriate tissue. The connection quality monitor controller includes a built-in impedance monitoring system that detects the resistance of the tissue the instrument is contacting and into which the stimulation signal is being delivered. Using common knowledge that tissue inside the body (such as would be operated on during minimally invasive surgery) has a medium range resistance of approximately 300 Ω, if the novel device senses that the stimulation signal is being delivered into a resistance well above (less than 1,000 Ω) or below (more than 10 Ω) this range, it will provide multiple short audible tones paired with a visual warning on the LCD screen.

[0047] Encountering too high a resistance would mean either that the surgical instrument tips were not touching the target tissue (hence, infinite Ω with an open circuit) or that they were touching the wrong tissue, such as skin, which has an extremely high resistance. Resistance that is too low could mean that the instrument tips were touching each other (effectively 0 Ω or a short circuit) or that the tissue surface had an excessive amount of fluid on it, resulting in the desired signal not reaching the target tissue. Therefore, by monitoring the impedance between the bipolar leads on an electrosurgical device, any of these potential operational anomalies can be detected and optionally flagged.

[0048] To ensure a truly seamless workflow experience, it remains important to ensure that new devices allow surgeons to connect as many of their existing instruments as possible to them. Because many instruments sold on the market are disposable after a single use, with specifically designed plugs, a series of plug adapters can be attached to the system during deployment. The design of the adapters is fundamentally to ensure that instruments are used as intended, but can also be selected to deliver smooth muscle stimulation signals through their instrument tips / end effectors when desired.

[0049] Most often the adapter simply needs to have a different configuration and spacing of the male / female pins, but in other cases additional components need to be present within the adapter housing. These include RFID signal extenders and camera systems that capture the QR code on the appliance plug and project it through a small screen on the adapter for the ESU to read.

[0050] While preferred embodiments of the present invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, modifications, and substitutions will now occur to those skilled in the art without departing from the invention. It is understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. The following claims define the scope of the invention, and it is intended that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

[Claim 1] The invention described in this specification.

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