Systems and methods for eliciting smooth muscle response during surgery

Abstract

A smooth muscle stimulation device is intended for use with any of a variety of electrosurgical units (ESUs) of the type used in tissue resection and other procedures that risk subjecting non-target tissue to damage. The smooth muscle stimulation device generally includes a housing having a stimulation circuit configured to generate a stimulation electrical signal that induces an observable response in a target anatomical structure when delivered to the target anatomical structure during a medical procedure. An input connector on the housing is detachably coupled to a power output of an ESU, and an output connector on the housing is detachably coupled to an electrosurgical tool. In response to a user input, a switch circuit within the housing selectively connects the power output of the ESU or the stimulation electrical signal of the stimulation circuit to the output connector.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application 63 / 046,294 (Agent No. 51010-706.101), filed June 30, 2020, the entire contents of which are incorporated herein by reference. Background Technology

[0003] 1. Technical Field This invention relates to electrical stimulation and novel systems and methods for delivering these signals to target tissues during surgery to help identify smooth muscle structures and determine their functions.

[0004] The field of surgery continues to evolve rapidly. Previously, the standard of care for many surgical procedures, including hysterectomies, colectomies, and even exploratory surgeries, was performed through long abdominal incisions. These “open surgery” procedures can be painful, require long recovery times, cause patient suffering, and produce adverse side effects such as poor wound healing and incisional hernias.

[0005] As an alternative to such open surgeries, various laparoscopic and other "minimally invasive" procedures have been developed. These procedures typically involve making a small incision of 5 to 10 mm and inserting a thin instrument into the body, while the operator views the surgical site via a "viewing instrument" (camera) also inserted through the abdominal wall. Such minimally invasive procedures reduce pain and shorten recovery time, and now dominate many traditional urological, obstetric, gynecological, and colorectal surgeries. Recently, the use of surgical robotics has further expanded the reach of these minimally invasive procedures.

[0006] Despite their numerous advantages, minimally invasive techniques have certain drawbacks that limit their practicality. For example, the use of small incisions restricts the surgeon's ability to actually access tissue, resulting in a loss of tactile feedback. In open surgery, surgeons are typically able to directly access the patient's tissues and feel structures of varying textures, thicknesses, shapes, and densities that are not readily apparent in other situations. Such tactile feedback often provides valuable information about the characteristics and location of structures such as blood vessels and other key anatomical features such as the ureter, enabling surgeons to avoid unintentionally damaging these otherwise invisible structures.

[0007] WO2015 / 123441 and WO2018 / 098468, which are co-inventories with this application, describe an electrostimulation unit with a dedicated electrode probe that delivers stimulation signals to tissue close to a target smooth muscle anatomy, such as the ureter, to induce an observable response, typically tissue contraction, in the target anatomy during medical procedures. By visually scanning or mapping the location of the response, surgeons can avoid these areas when performing procedures such as resections that might damage the ureter or other target smooth muscle anatomy.

[0008] While highly effective, this presents a challenge as it requires introducing another electrical stimulation unit with dedicated electrode probes into the already crowded surgical environment. Although the stimulation signals and circuitry of WO2015 / 123441 and WO2018 / 098468 can theoretically be incorporated into existing ESU designs, such a transition would take many years as the current large inventory of existing ESUs will be gradually replaced and upgraded over time.

[0009] Therefore, it is desirable to provide devices, systems, and methods that allow surgeons to employ the tissue identification procedures described in WO2015 / 123441 and WO2018 / 098468 while continuing to use existing commercially available ESUs and minimizing the need to introduce additional equipment into the surgical environment. In particular, it is desirable to eliminate the need for using separate electrosurgical probes to deliver stimulation signals and cutting / coagulation power to the tissue. It is also desirable to facilitate the switching between stimulation signals and cutting / coagulation energy when engaging tissue using the same electrosurgical tool. At least some of these objectives will be met by the inventions described and claimed below.

[0010] 2. List of background technologies WO2015 / 123441 and WO2018 / 098468 describe prior tissue stimulation systems and share common invention rights with this application. Other relevant patents and patent publications include US4535771; US5010895; US6292701; US7877152; US8954153; US2009 / 0247812; US2011 / 0301662; US2012 / 010326; and US2015 / 0005841. Summary of the Invention

[0011] A novel device and method for generating and delivering stimulation signals via existing surgical instruments during surgery, while allowing operators to switch between ESU outputs and the new system. In this way, surgeons can retain ESU functionality using their current instruments while enjoying additional tissue stimulation capabilities without changing instruments or disrupting 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 a housing having stimulation circuitry therein. The stimulation circuitry is configured to generate a stimulation electrical signal that induces an observable response in the target anatomical structure when delivered during a medical procedure. An input connector is disposed on the housing and configured to be detachably coupled to the power output of the ESU. An output connector is also disposed on the housing. The output connector is configured to be detachably coupled to an electrosurgical instrument of a type commonly used in minimally invasive or other electrosurgical procedures. A switching circuitry within the housing is configured to selectively connect either the power output of the ESU (bypassed from the ESU) or the stimulation electrical signal generated by the stimulation circuitry to the output connector in response to user input. In this way, the smooth muscle stimulation device of the present invention can be combined with conventional commercially available ESUs, thereby allowing the benefits of tissue stimulation and observation with minimal additional equipment and minimal disruption to the surgical environment.

[0013] In certain embodiments, the stimulation circuitry is configured to elicit a peristaltic response from the ureter when the electrodes on the electrosurgical tool are positioned near the patient's ureter during minimally invasive procedures, open surgery, or other procedures. Exemplary electrosurgical tools include grasping forceps, scissors, irrigators, dissecters, exciders, suction devices, etc., having electrodes or other conductive surfaces configured to couple to an output connector on a housing. This list is not intended to be exhaustive.

[0014] While the smooth muscle stimulation device of the present invention is generally a bipolar device, in other cases, the smooth muscle stimulation device may be configured to operate together with a monopolar electrosurgical instrument when the ESU is operated in monopolar mode together with the dispersion pad.

[0015] In a preferred embodiment, the stimulation circuit of the present invention may include a power supply configured to deliver undriven capacitor discharge and pulse control. Typically, the stimulation circuit will also include 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 housing, configured to control switching circuitry in response to user input via the interface. The user interface typically includes at least one selector that allows the user to selectively connect the power of the ESU or the stimulation electrical signal of the stimulation circuitry to an output connector to deliver a selected current signal to the electrosurgical instrument. In some examples, the selector may include a first button for selecting a stimulation mode and a second button for selecting an electrosurgical mode, wherein both buttons and the circuitry are typically locked so that they cannot be selected simultaneously. In other cases, the selector may be an easily locatable switch.

[0017] As briefly discussed above, the stimulation device of the present invention is intended for use with any of the various commercially available ESUs. Therefore, the stimulation device of the present invention will typically include multiple output plug adapters configured to provide a bridge or interface between the power input on the housing and the power output cable from the ESU. In some cases, the adapter may be incorporated into a connector cable, wherein one end of the cable is adapted to insert into the ESU, and the other end of the cable is adapted to insert into the stimulation device housing.

[0018] Similarly, the smooth muscle stimulation device of the present invention may also include multiple output plug adapters, wherein each output plug adapter is configured to provide a bridging electrical connection between the output connector on the housing of the stimulation device and the connection cable or wire of the electrosurgical tool. These adapters enable the stimulation device and housing to connect to a variety of commercially available electrosurgical tools, which may have different connector patterns and plugs.

[0019] As described above, while particularly useful in conjunction with an ESU, the smooth muscle stimulation device of the present invention typically includes an independent power supply and will also be used as a “standalone” device (independent of the ESU or other electrosurgical equipment) for stimulating target tissue for nerve identification and / or localization or other purposes. When used independently, a switching assembly will be enabled to deliver the stimulation electrical signal from the stimulation circuitry to the tool output, and optionally, the connection via the ESU input (typically empty) will be disabled.

[0020] In a second aspect, the present invention provides a smooth muscle stimulation system comprising a combination of the smooth muscle stimulation device as described above and an ESU including a power output. The ESU may be specifically designed to interface with the smooth muscle stimulation system of the present invention, but more commonly, commercially available ESUs are 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 with an ESU to selectively deliver electrical stimulation energy. The method includes providing a housing comprising 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 housing, while an electrosurgical tool is connected to an output connector on the housing. The output connector is selectively switched to receive current from (1) the power output of the ESU or (2) a stimulation electrical signal from a stimulation circuit in response to a user input, and to deliver the received current to the electrosurgical tool.

[0022] In certain cases, the method further includes energizing the electrostimulator to deliver a stimulation signal to the electrosurgical instrument, bringing the electrode surface of the electrosurgical instrument against the target tissue near the target smooth muscle anatomy, and observing the target tissue to detect contraction induced by the stimulation signal, indicating the presence of smooth muscle in or near the joined tissue. Once it is determined that a portion of the target tissue lacks smooth muscle or other target anatomy, the electrode surface of the electrosurgical instrument can be brought against the tissue surface for engagement based on the absence of tissue contraction. After engagement, the ESU can be energized to deliver power to the electrode-engaged tissue, typically electrosurgical power for cutting, coagulation, or other tissue modification results.

[0023] In an exemplary embodiment, selectively switching the output connector includes manually selecting a switch located outside the housing to control switching circuitry inside the housing. For example, switching may include selectively engaging a first selector button to activate an electrical stimulator to deliver a stimulation signal to tissue, or a second selector button to allow a switch to deliver bypass current from the ESU to an electrosurgical instrument. Alternatively, switching the output connector may include operating a two-position selector switch to select either a stimulation signal or power output from the ESU to deliver to the patient.

[0024] In specific cases, the method of the present invention can be used to treat target tissues selected from the ureter, bladder, stomach and esophagus, and intestine. In an exemplary embodiment, when an electrode on an electrosurgical instrument is positioned close to the patient's ureter, a stimulation output elicits a peristaltic response from the ureter. The method may include any of a variety of conventional and non-conventional electrosurgical procedures, including bipolar procedures, monopolar procedures, grasping, cutting, aspiration, tissue dissection, tissue resection, etc. Attached Figure Description

[0025] Figure 1A This is a perspective view of a smooth muscle stimulation device constructed according to the principles of the present invention, showing the front panel.

[0026] Figure 1B yes Figure 1A View of the rear panel of the smooth muscle stimulation device.

[0027] Figure 2 The diagram illustrates the interconnection with a conventional electrosurgical unit (ESU) and further connection via cables to conventional electrosurgical instruments and foot switches. Figure 1A and Figure 1B Smooth muscle stimulation device.

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

[0029] Figure 4This is a general schematic diagram of the components and circuits of a device constructed according to the principles of the present invention.

[0030] Figure 5 The illustration shows the muscle stimulation potential generated by the smooth muscle stimulation device of the present invention. Detailed Implementation

[0031] The smooth muscle stimulation device of the present invention is intended for use with any conventional or non-conventional electrosurgical unit (ESU) that delivers radiofrequency or other 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 known types to stimulate tissue contraction, thereby allowing the surgeon to visually identify smooth muscle targets that may be damaged by electrosurgery, such as the ureter.

[0032] The smooth muscle stimulation device of the present invention is configured to interconnect with an ESU to allow surgeons to use the combination as a single unit or assembly, thereby simplifying operation, 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 electrosurgical tools typically used with the ESU can be used as probes to deliver stimulation signals to target tissue, thus eliminating the need for dedicated probes.

[0033] In this way, surgeons have the option to select and switch between tissue stimulation signals and ES power output signals at any time during the procedure, and this switch does not require changing the electrosurgical tools being used. Surgeons do not need to change their tools or their field of vision, thus providing a seamless workflow experience to maintain a safe and efficient surgical environment.

[0034] The new device incorporates a repeater to redirect the signal from the new smooth muscle stimulation to the instrument's output, allowing electrosurgical signals from the electrosurgical generator in the operating room to pass through. For safety and precision, both the new device and the electrosurgical generator will be operated independently via their own foot pedals.

[0035] Now for reference Figure 1A and Figure 1B The smooth muscle stimulation device 10, constructed according to the principles of the present invention, includes a housing 12 having a front side 14 and a back side 16. The front side 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 side also includes an electrosurgical tool output socket 26 and a slot 28 configured to receive an activation card. The activation card authorizes the use of the system for a specific patient and / or a specific procedure. The electrosurgical tool output socket is typically configured to receive one or more adapters that allow insertion of various conventional electrosurgical tools for the procedures described below.

[0036] The rear panel 16 of housing 12 includes an electrosurgical unit (ESD) connector. The input connector will be configured to receive the output of a conventional ESU, which typically requires an adapter to mate with a proprietary ESU connector and bridge to the standard connector 26 on housing 12. The rear panel 16 of housing 12 also includes a foot switch connector 32 and a power cord connector 34. As described in more detail below, a foot switch 54 will be provided to allow the surgeon to turn the stimulation current from the smooth muscle stimulation device 10 on and off when the stimulation selector button 20 has been pressed. While a separate foot switch or pedal is typically provided for the ESU, in some cases it may be desirable to combine the foot switch functionality for both the stimulation device and the ESU into a single connector.

[0037] Now for reference Figure 2 The smooth muscle stimulation device 10 is shown as an assembly with a standard or conventional ESU 36. While the ESU will have many features that allow it to perform normally in electrosurgical procedures, those features relevant to the present invention include a power switch 38 and an ESU power output socket 40. Many other connectors 42 are generally located on the front of the ESU, while many displays and controls 44 are located on the top of the ESU.

[0038] To interconnect the smooth muscle stimulation device 10 and the ESU 36, one end of the cable 41 is inserted into the ESU power output socket, and the other end is inserted into the ESU input connector 30 on the back of the smooth muscle cell stimulation device, as shown below. Figure 1B As shown. Therefore, the normal power output of the ESU is directed to the housing 12, where it will be bypassed to the electrosurgical tool output connector 26 on the front side 14 of the stimulator device.

[0039] like Figure 2 The conventional electrosurgical tool 46, illustrated in the diagram, is connected to an output socket 26 via a cable 52 and a plug 52. (See reference...) Figure 3 and Figure 4 In more detail, the smooth muscle stimulation device 10 is configured to selectively deliver a muscle stimulation current or signal generated by the stimulator device or a power current generated by the ESU to the electrosurgical tool 46 for use in the method of the present invention.

[0040] Now for reference Figure 3 The smooth muscle stimulation device 10 internally 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 DC power to each of the controller CONT and the stimulation current generator STIM. The power supply PS is controlled by a switch 18 on the front of the housing 12.

[0041] The controller CONT receives input from both the stimulation selector button 20 and the ESU selector button 22 and provides output to the display 24. In this way, the controller CONT can control the function of the stimulator STIM and the switching function of the switch module 62. The switch module 62 is shown as a simple single-pole double-throw switch (SPDT), but is typically implemented using a power repeater to selectively direct the output of either the low-voltage stimulator STIM or the high-voltage, high-current ESU output to the electrosurgical tool output connector 26. In short, when the surgeon presses the stimulation selector button 20, the controller CONT causes the switch module 62 to connect the output of the stimulator STIM that will be directed to output 26. When the ESU selector button 22 is pressed, the ESU output entering through the ESU input connector 30 is delivered to the electrosurgical tool output socket 26. Therefore, the surgeon can simply select the type of current applied through the electrosurgical tool 46 by selecting the appropriate button on the front of the housing 12. Of course, other switches and means can be provided to achieve such switching, including other types of switches, verbal commands, etc.

[0042] Now for reference Figure 4 An alternative diagram of the circuitry for the smooth muscle stimulation device 10 is provided. As shown, a user interface is connected to a system controller, which in turn controls stimulator pulse control and bypass control. The stimulator pulse control and bypass control together operate a bypass repeater that, in one case, selectively delivers stimulation current from a generator power supply with a storage capacitor to the patient lead output. Alternatively, in another case, the output of the ESU input connector is delivered to the patient lead connector. The system is monitored by a connection quality monitor, which feeds information back to the system controller for the user, for example, to provide information enabling proper clinical use of the device.

[0043] like Figure 5 As shown, the smooth muscle stimulation device of the present invention generates electrical pulses specifically designed for smooth muscle stimulation. Smooth muscle, particularly the ureter, relies on proximal stimulation to trigger a contraction cascade manifested as visible peristalsis. The stimulation pulses of the present invention simulate the initial excitation signal that triggers the contraction cascade of smooth muscle. After signal delivery, the ureteral smooth muscle depolarizes and contracts in a physiological wave-like motion known as peristalsis. Through gap junctions, the action potential then spontaneously propagates from one cell to another, resulting in a propagating, visible contraction that naturally extends the entire length of the ureter.

[0044] The stimulation signal generated by the new device is a single, brief pulse that is non-continuous, has no intrinsic frequency, and is short in duration. It can trigger depolarization but is not long enough to prevent subsequent depolarization cascades from transforming into visible peristaltic smooth muscle structures in clinical and surgical settings. Figure 5The duration of the stimulus signal is important because the waveform decay cannot be prolonged, as this would interfere with the subsequent propagation of the action potential triggered by the stimulus signal.

[0045] In addition to generating this specific stimulus signal and delivering it to the surgical area and the patient during the procedure using existing surgical instruments, it is important to inform the surgeon whether the signal has been successfully delivered to the desired tissue and any possible errors (assembly or user).

[0046] The stimulation device of this invention may have a small speaker inside the housing. When the stimulation button is selected, the foot pedal is pressed, and the stimulation signal is delivered to the appropriate tissue, the speaker delivers a single tone. The connection quality monitoring control includes a built-in impedance monitoring system that detects the resistance of the tissue to which the stimulation signal is delivered. It is well known that internal tissues (on which manipulation will be performed during minimally invasive surgery) have a moderate resistance range of approximately 300 Ω. If the new device detects that the stimulation signal is delivered to a resistance far above (>1000 Ω) or far below (<10 Ω) this range, it will emit multiple short beeps and display a visual alarm on the LCD screen.

[0047] A resistance that is too high either means that neither tip of the surgical instrument is making contact with the target tissue (and therefore infinite Ω in an open circuit), or that they are contacting the wrong tissue, such as skin, which has extremely high resistance. A resistance that is too low may mean that the instrument tips are touching each other (effectively zero or a short circuit), or that there may be too much fluid on the tissue surface, preventing the desired signal from reaching the target tissue. Therefore, by monitoring the impedance between the bipolar leads on the electrosurgical device, any of these potential operational anomalies can be detected and optionally alerted.

[0048] To ensure a truly seamless workflow experience, it remains important that the new device allows surgeons to connect as many existing instruments as possible. Since many instruments on the market are disposable with specially designed plugs, a range of plug adapters can be provided with the system during installation. These adapters are designed to fundamentally ensure the instrument functions as intended, but can optionally deliver smooth muscle stimulation signals via its instrument tip / end effector when needed.

[0049] In most cases, adapters only require different configurations and male / female pin spacing, but in other cases, additional components are needed within the adapter housing. These include RFID signal extenders and camera systems that capture the QR code on the instrument plug and project it via a small screen on the adapter for the ESU to read.

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

Claims

1. A smooth muscle stimulation device for use with an electrosurgical unit (ESU), the smooth muscle stimulation device comprising: shell; The stimulation circuitry within the housing is configured to generate a stimulation electrical signal that, when delivered to a target anatomical structure during a medical procedure, induces an observable response in that target anatomical structure. The input connector on the housing is configured to be detachably coupled to the power output of the electrosurgical unit; The output connector on the housing is configured to be detachably coupled to an electrosurgical tool; and The switching circuit within the housing is configured to selectively connect the power output of the electrosurgical unit or the stimulation signal of the stimulation circuit to the output connector in response to user input. The stimulation circuit includes a power supply configured to deliver non-driven capacitor discharge and pulse control.

2. The smooth muscle stimulation device of claim 1, wherein the stimulation circuit is configured to elicit a peristaltic response from the ureter when an electrode on the electrosurgical instrument is positioned near the patient's ureter.

3. The smooth muscle stimulation device according to claim 1 or 2, wherein the electrosurgical tool is selected from grippers, scissors, irrigators, dissecters, exciders, and suction devices having a conductive surface configured to be coupled to the output connector on the housing.

4. The smooth muscle stimulation device according to claim 1 or 2, wherein the input connector and the output connector are bipolar.

5. The smooth muscle stimulation device of claim 1, wherein the stimulation circuit further comprises a controller configured to control the pulse output from the power source.

6. The smooth muscle stimulation device of claim 5, wherein the controller is further configured to control the switching circuit in response to a user interface on the housing.

7. The smooth muscle stimulation device of claim 6, wherein the user interface includes at least one selector to allow a user to selectively connect the power output of the electrosurgical unit or the stimulation electrical signal of the stimulation circuit to the output connector.

8. The smooth muscle stimulation device according to claim 7, wherein the at least one selector includes a first button for selecting a stimulation mode and a second button for selecting an electrosurgical mode.

9. The smooth muscle stimulation device according to any one of claims 1, 2, 5 to 8, further comprising a plurality of input plug adapters, wherein each input plug adapter is configured to provide a bridging electrical connection between the input connector on the housing and the power output of one of the plurality of electrosurgical units.

10. The smooth muscle stimulation device according to any one of claims 1, 2, 5 to 8, further comprising a plurality of output plug adapters, wherein each output plug adapter is configured to provide a bridging electrical connection between the output connector on the housing and one of a plurality of electrosurgical tools.

11. A smooth muscle stimulation system, comprising: Includes an electrosurgical unit (ESU) for power output; and The smooth muscle stimulation device according to any one of claims 1 to 10.

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