Patent Application
20230355298
The present disclosure relates generally to electrosurgery and electrosurgical systems and apparatuses, and more particularly, devices, systems and methods for calculating the amount of energy delivered to tissue during an electrosurgical treatment.
High frequency electrical energy has been widely used in surgery and is commonly referred to as electrosurgical energy. Tissue is cut and bodily fluids are coagulated using electrosurgical energy.
Electrosurgical instruments generally comprise “monopolar” devices or “bipolar” devices. Monopolar devices comprise an active electrode on the electrosurgical instrument with a return electrode attached to the patient. In monopolar electrosurgery, the electrosurgical energy flows through the active electrode on the instrument through the patient's body to the return electrode. Such monopolar devices are effective in surgical procedures where cutting and coagulation of tissue are required and where stray electrical currents do not pose a substantial risk to the patient.
Bipolar devices comprise an active electrode and a return electrode on the surgical instrument. In a bipolar electrosurgical device, electrosurgical energy flows through the active electrode to the tissue of a patient through a short distance through the tissue to the return electrode. The electrosurgical effects are substantially localized to a small area of tissue that is disposed between the two electrodes on the surgical instrument. Bipolar electrosurgical devices have been found to be useful with surgical procedures where stray electrical currents may pose a hazard to the patient or where other procedural concerns require close proximity of the active and return electrodes. Surgical operations involving bipolar electrosurgery often require methods and procedures that differ substantially from the methods and procedures involving monopolar electrosurgery.
Gas plasma is an ionized gas capable of conducting electrical energy. Plasmas are used in surgical devices to conduct electrosurgical energy to a patient. The plasma conducts the energy by providing a pathway of relatively low electrical resistance. The electrosurgical energy will follow through the plasma to cut, coagulate, desiccate, or fulgurate blood or tissue of the patient. There is no physical contact required between an electrode and the tissue treated.
Electrosurgical systems that do not incorporate a source of regulated gas can ionize the ambient air between the active electrode and the patient. The plasma that is thereby created will conduct the electrosurgical energy to the patient, although the plasma arc will typically appear more spatially dispersed compared with systems that have a regulated flow of ionizable gas.
The amount of energy delivered to patient tissue by the plasma outputted by the electrosurgical system, e.g., by an applicator or handpiece, is not the same as the amount of energy generated and outputted by the electrosurgical generator of the electrosurgical system. Some of the energy outputted by the electrosurgical generator is lost in producing a plasma beam in addition to other inefficiencies. Knowing the amount of energy delivered to patient tissue, and not just the amount of energy outputted by the electrosurgical generator of a system, is useful for producing the desired results in a given treatment. However, currently used electrosurgical systems do not provide a simple and efficient mean by which to accurately measure the energy delivered to patient tissue. Thus, a need exists for devices, systems, and methods that calculate the amount of energy delivered to patient tissue.
The present disclosure relates to devices, systems and methods for calculating the amount of energy delivered to tissue during an electrosurgical treatment.
According to one aspect of the present disclosure, an electrosurgical generator is provided including a power supply that supplies electrosurgical energy to an applicator via a radio frequency (RF) output stage; a memory that stores at least one energy quantification function that determines an amount of energy delivered to patient tissue by the applicator; and a controller that determines the amount of energy delivered to the patient tissue based on the energy quantification function and output power of the RF output stage.
In one aspect, the output power is determined based on a selected generator power setting.
In another aspect, the output power is determined based on sampling output voltage and current of the RF output stage.
In a further aspect, the electrosurgical generator further includes an input/output interface that receives an input for selecting the generator power setting.
In another aspect, the electrosurgical generator further includes an input/output interface that displays the amount of energy delivered to the patient tissue.
In one aspect, the amount of energy delivered to the patient tissue is displayed in Joules.
In a further aspect, the controller counts the energy delivered to the patient tissue based on the selected power setting and a duration of activation time of the applicator at the selected power setting.
In yet another aspect, the electrosurgical generator further includes at least one sensor coupled to an output of the RF output stage, the sensor configured to sample voltage and/or current of the RF output of stage and provide the sampled voltage and/or current to the controller.
In yet another aspect, the selected generator power setting is used to determine the energy delivered is based on the sampled voltage and/or current of the RF output stage.
In one aspect, the electrosurgical generator further incudes at least one sensor that measures impedance at the RF output stage and provides the measured impedance to the controller, the controller determines if the applicator is applying energy to the patient tissue based on the measured impedance and adds the delivered energy to the count only when the applicator is applying energy to the patient tissue.
In another aspect, the electrosurgical generator further includes an input/output interface that enables selection of an energy endpoint for a procedure, wherein the controller causes the power supply to stop supplying electrosurgical energy to the applicator when the count exceeds the energy endpoint.
In one aspect, the controller triggers a notification via the input/output interface when the count exceeds the energy endpoint.
In another aspect, the controller triggers a notification when the count exceeds the energy endpoint and transmits the notification to an external device via a communication module.
In still a further aspect, the memory stores a predetermined energy endpoint for each of a plurality of procedures.
In yet another aspect, the input/output interface enables selection of at least one of the plurality of procedures, wherein upon selection of at least one procedure, the controller retrieves a corresponding energy endpoint from the memory.
In a further aspect, the electrosurgical generator further includes a communication module that receives the predetermined energy endpoint for each of the plurality of procedures from an external device.
In another aspect, the at least one energy quantification function is selected based on a type of applicator.
In one aspect, the at least one energy quantification function is received from the applicator upon coupling the applicator to at least one receptacle.
In a further aspect, the electrosurgical generator further includes an input/output interface that enables storing in memory a total count of energy delivered to a first treatment area of a patient as an energy endpoint, wherein upon selection of a procedure for a contralateral treatment area of the patient, the controller retrieves a stored energy endpoint from the memory.
In one aspect, upon completion of a procedure to a first treatment area of a patient, the controller determines a total amount of energy delivered to the patient tissue and stores the determined total amount of energy in the memory as an energy endpoint for a procedure to a contralateral treatment area of the patient.
In another aspect, the electrosurgical generator further incudes an input/output interface that enables selection of a procedure for the contralateral treatment area, wherein upon selection of the procedure, the controller retrieves the stored energy endpoint from the memory.
According to one aspect of the present disclosure, the electrosurgical generator further includes a flow controller that provides at least one gas to the applicator, wherein the applicator generates plasma from the electrosurgical energy and the at least one gas, the plasma to be delivered to the patient tissue.
In one aspect, the controller counts the energy delivered to the patient tissue based on at least one of a type of the at least one gas, a flow rate of the at least one gas and/or a power setting of the electrosurgical setting.
In another aspect, the electrosurgical generator further includes an input/output interface that displays the counted amount of energy delivered to the patient tissue, wherein the counted amount of energy delivered to the patient tissue is displayed in Joules.
In a further aspect, the electrosurgical generator further includes an input/output interface that displays the amount of energy delivered to the patient tissue, wherein the amount of energy delivered to the patient tissue is displayed in Joules per second.
According to another aspect of the present disclosure, a method of performing a medical procedure is provided including applying, via an electrosurgical generator, electrosurgical energy to patient tissue; determining an amount of energy delivered to the patient tissue based on at least one energy quantification function and output power of the electrosurgical generator; comparing the determined amount of energy delivered to an energy endpoint; and stopping application of the electrosurgical energy when the determined amount of energy delivered meets or exceeds the energy endpoint.
In one aspect, the method further includes displaying the amount of energy delivered to patient tissue via an input/output interface of the electrosurgical generator.
In another aspect, the displayed amount of energy delivered is instantaneous energy being delivered in Joules/second.
In a further aspect, the displayed amount of energy delivered is an accumulated count of energy delivered in Joules.
In yet another aspect, the method further includes triggering a notification when the amount of energy delivered meets or exceeds the energy endpoint.
In one aspect, the method further includes storing in a memory a predetermined energy endpoint for each of a plurality of procedures.
In yet another aspect, the method further includes selecting of at least one procedure and retrieving a corresponding energy endpoint from the memory.
In a further aspect, the applying further includes: providing the electrosurgical energy to the patient tissue via an applicator coupled to the electrosurgical generator, providing at least one gas to the applicator, and generating plasma to be delivered to the patient tissue from the electrosurgical energy and the at least one gas.
In one aspect, the at least one energy quantification function is based on at least one of a type of applicator, a type of the at least one gas and/or a flow rate of the at least one gas.
In another aspect, the method further includes, wherein upon completion of a procedure to a first treatment area of a patient, determining a total amount of energy delivered to the patient tissue and storing the determined total amount of energy in a memory as the energy endpoint for a procedure to a contralateral treatment area of the patient.
In still another aspect, the method further includes selecting a procedure for the contralateral treatment area and retrieving the stored energy endpoint from the memory.
The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:
It should be understood that the drawings are for purposes of illustrating the concepts of the disclosure and are not necessarily the only possible configuration for illustrating the disclosure.
Preferred embodiments of the present disclosure will be described hereinbelow with reference to the accompanying drawings. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. In the drawings and in the description which follow, the term “proximal”, as is traditional, will refer to the end of the device, e.g., instrument, apparatus, applicator, handpiece, forceps, etc., which is closer to the user, while the term “distal” will refer to the end which is further from the user. Herein, the phrase “coupled” is defined to mean directly connected to or indirectly connected with through one or more intermediate components. Such intermediate components may include both hardware and software based components.
It will be appreciated by those skilled in the art that the block diagrams presented herein represent conceptual views of illustrative circuitry embodying the principles of the disclosure. Similarly, it will be appreciated that any flow charts, flow diagrams, state transition diagrams, pseudo-code, and the like represent various processes which may be substantially represented in computer readable media and so executed by a computer or processor, whether or not such computer or processor is explicitly shown.
The present disclosure relates to devices, systems and methods for calculating the amount of energy delivered to tissue during an electrosurgical treatment.
Referring to
Applicator 10 is configured to receive electrosurgical energy from ESU 50 via a cable 20. Applicator 10 is further configured to receive an inert gas from a gas source 70. In some embodiments, the inert gas is received from a gas supply 70 and provided from ESU 50 to applicator 10 via cable 20. It is to be appreciated that gas supply 70 may be internal to ESU 50 or external to ESU 50. In other embodiments, applicator 10 receives the inert gas directly from gas supply 70. Applicator 10 includes a handle housing 12 having a button 18 and a shaft 14 having a distal tip 16. When button 18 is pressed, electrosurgical energy is delivered to applicator 10 by ESU 50 and inert gas is delivered to applicator 10 by the gas source 70. The electrosurgical energy is used to energize an electrode disposed in shaft 14. When the inert gas is passed over the energized electrode, a plasma is generated and emitted from tip 16 to patient tissue, which allows for conduction of the radio frequency (RF) energy from the electrode to the patient in the form of a precise plasma beam. In one embodiment, helium is used as the inert gas because helium can be converted to a plasma with very little energy, however, other inert gases, such as argon, are considered within the scope of the present disclosure. Additionally, mixtures of inert gases may be utilized to generate a plasma. Exemplary applicators are shown and described in commonly-owned U.S. Pat. No. 9,060,765, the contents of which are incorporated by reference.
It is to be appreciated that, in some embodiments, applicator 10 may be configured to apply or deliver energy to patient tissue in ways or forms other than plasma. For example, applicator 10 may deliver RF energy to patient tissue via direct contact of the electrode to patient tissue. In some embodiments, the electrode may be retractable within shaft 14 to enable the electrode to be extended and used to directly contact patient tissue to deliver RF energy or retract to deliver RF energy via plasma. In other embodiments, the electrode may be configured as a probe or heating element (e.g., heated by applying current received from ESU 50 to the heating element) and heat energy may be applied directly to patient tissue by the heat element.
Referring to
Referring to
Flow controller 62 is configured for controlling the flow of gas received from supply 70 to the applicator 10. The flow controller 62 is coupled to the controller 51 and receives control signals from the controller 51 based on user input via I/O interface 56, selector switch or input 46 or based on an algorithm or software function stored in memory 60. Additionally, the flow controller 62 may include appropriate sensors to determine a type of gas being input to receptacles 40, 42. Furthermore, the flow controller 62 may use the inputted gases to create a mixture of gases to be provided to the applicator. Although in the embodiment shown in
Communication module 66 of ESU 50 is configured to communicate with other devices (e.g., client devices, servers, etc.) via a communication link (e.g., wired or wireless) to send and receive data and communications. Although in the embodiment shown in
In one embodiment, sensor 64 of ESU 50 is coupled to the output of RF output stage 54. Sensor 64 is configured to sample the voltage and/or current (or any other electrical properties) of the output of stage 54 and provide the sample voltage and/or current to controller 51. Controller 51 may use the information to determine one or more properties associated with the power provided by ESU 50 to applicator 10. In one embodiment, sensor 64 may include at least one voltage sensor for sensing output voltage and at least one current sensor for sensing output current. Optionally, sensor 64 may include at least one analog-to-digital converter for converting the sensed signal to a digital signal to be input to controller 51; or alternatively, at least one analog-to-digital converter may be provided on controller 51.
In one embodiment, controller 51 is configured to determine the amount of energy delivered, e.g., in Joules, to patient tissue by applicator 10 during a treatment. Controller 51 executes an energy quantification algorithm or function (e.g., stored in memory 60 of ESU 50) that enables the controller 51 of ESU 50 to determine the amount of energy delivered to patient tissue by applicator 10 over a period of time. The algorithm or function makes use of an equation or a look-up table for determining the energy delivered to the tissue. As will be described below, in one embodiment, the equation is based on the results of calorimeter testing.
It is to be appreciated that the functions of the ESU 50 shown in
Referring to
In step 102, a predetermined volume of fluid (e.g., saline) is placed in a calorimeter. In step 104, the calorimeter is used to measure the baseline temperature of the volume of fluid. In step 106, a first generator setting is selected, e.g., via touchscreen 21 or an appropriate level control 22, and applicator 10 is used to apply plasma energy (or other types of energy, e.g., RF energy via direct contact of the electrode to the volume of fluid, heat energy via direct contact of the electrode or heating element to the volume of fluid, etc.) to the volume of fluid for a predetermined period or length of time. It is to be appreciated that, so long as the distal tip 16 is held within a sufficient distance from the surface of the volume of fluid (or to patient tissue) to enable a plasma arc to occur between the distal tip 16 and the surface of the fluid (or to patient tissue), the tip 16 may be held at any distance within this sufficient distance without causing more heat to be delivered to the fluid (or to patient tissue). As such, once within the sufficient distance, tip 16 may be placed closer or further from a fluid surface or patient tissue without changing the amount of heat delivered. It is to be appreciated that the generator setting of ESU 50 represents an amount of power delivered by ESU 50 (e.g., from RF output stage 54) to applicator 10. In one embodiment, the power setting is expressed as a percentage of the max power deliverable by ESU 50 to applicator 10. For example, in one embodiment, the max output power deliverable from the ESU 50 to applicator 10 may be 40 Watts (W). Thus, setting the ESU 50 to a setting of 20% will result in an output of 20% of 40 W (i.e., 8 W).
In step 108, the calorimeter is used to measure the temperature of the volume of fluid after applying the plasma energy for the predetermined period of time. In step 110, the amount of energy that was delivered to the volume of fluid by applicator 10 is calculated by calculating the amount of energy needed to increase the temperature of the known volume of fluid from the baseline temperature measured in step 104 to the temperature measured in step 108 over the predetermined period of time. The data from steps 104-110 are recorded in an energy delivery chart or table (e.g., stored in a memory, such as memory 60). In one embodiment, the temperature measured in step 108 is inputted to the ESU 50, for example, via input/output section 21. The amount of energy needed to increase the temperature of the known volume of fluid from the baseline temperature measured in step 104 to the temperature measured in step 108 may then be calculated by an algorithm or function stored in memory 60 and executed by controller 51. In this manner, the energy delivery chart or table may be generated by the controller 51 and stored in memory 60 for later use.
In step 112, a new generator setting is selected via input/output section 21 or an appropriate level control 22 (e.g., in one embodiment incrementing the percentage of power delivered up by a predetermined increment amount), and steps 104-112 are performed until the maximum power setting for ESU 50 is reached. In this way, the energy delivery chart includes the amount of energy being delivered for the predetermined period of time over multiple different generator settings of ESU 50. In step 114, based on the data collected in steps 104-112, the energy delivery (or Joule counter equation) chart is generated and an equation, e.g., an energy quantification function, for calculating the amount of energy delivered to patient tissue by applicator 10 is determined based, at least in part, on the energy delivery chart, the details of which will be described in detail below in relation to
It is to be appreciated that method 100 may be used to determine an equation, e.g., an energy quantification function, for calculating the amount of energy delivered to patient tissue via any energy delivery means (e.g., RF energy delivery via a plasma arc between tip 16 and a fluid or patient tissue, RF energy delivery via direct contact of an electrode of applicator 10 and a fluid or patient tissue, heat energy deliver via direct contact of a heat element of applicator 10 and a fluid or patient tissue).
In one embodiment, the equation determined in step 114 is as follows:
Y=AX+B(Equation1)(for x>=10 and <=100) (1)
In the equation 1 above, Y is equal to the energy delivered to patient tissue by applicator 10 per second, X is the generator power setting (e.g., a percentage of the maximum power deliverable by ESU 50 to applicator 10), and A and B are constants determined based on the energy delivery chart constructed in step 114 of method 100. It is to be appreciated that constants A and B will vary depending on the electrical properties of ESU 50 and applicator 10. Thus, where ESU 50 is used with applicators 10 having different electrical properties, memory 60 of ESU 50 may store the different values of constants A and B that are associated to each different applicator 10 that can be used with ESU 50. Alternatively, a connector of each applicator may include a memory which stores the constants A and B and transfers the constants to controller 51 upon coupling the application to the ESU 50.
Exemplary results of the method of
E
S
=ΔT×H×D×V (2)
Where ΔT is the measured temperature change 304, H is the heat capacity of saline (J/kg K)=4150, D is the density of saline (kg/L)=1.0046 and V is the volume of saline (mL)=30. The calculated energy delivered to increase the saline temperature (ES) 306 is then used to calculate energy delivered to Patient Tissue per second 308 using the following formula:
E
p
=E
S/activation time (3)
Where the activation time is 40 seconds. The energy delivered to patient tissue EP 308 data is then plotted for each generator power setting 302 employed, as shown in
It is to be appreciated that other variables or factors may be considered when determining the energy quantification function or energy delivery chart of the present disclosure. In one embodiment, the method 300 may be performed using different types of inert gas and an energy quantification function may then be generated and stored for each type of gas. In another embodiment, the method 300 may be performed using different mixtures of gases and an energy quantification function may then be generated and stored for each mixture of gases. For example, a density of a mixture of gases may be determined based on the composition of the mixture and the density of each gas. The density of the mixture of gases may be then be employed to select the proper energy quantification function or energy delivery table. It is to be appreciated that the density of the gas mixture may be selected via input section 21, selector input 46 or may be determined automatically by the ESU 50, for example, flow controller 62 incorporating the proper sensors. In another embodiment, the method 300 may be performed using different flow rates for a predetermined gas and an energy quantification function may then be generated and stored for each flow rate of the predetermined gas. It is to be appreciated that a single variable or various combinations of variables may be used to generate and select an appropriate energy quantification function or energy delivery table. For example, upon selection of a type of gas and flow rate, the controller 51 may select a corresponding energy quantification function or energy delivery table. In another example, upon selection of a mixture of gases and flow rate, the controller 51 may select the corresponding energy quantification function or energy delivery table.
In one embodiment, controller or processor 51 of ESU 50 is configured to determine (e.g., based on user input received via interface 56 or automatically by communicating with a memory or processor of applicator 10) the type of applicator 10 coupled to ESU 50 and to use the appropriate constants A, B in equation 1. For example, in one embodiment, A=26.76 and B=−2.1561. In this example, if the generator setting is set to 50% of the max power, the applicator 10, while active and receiving power from ESU 50, will deliver 11.22 Joules per second to patient tissue as determined as follows:
Y=(26.76)*(0.50)−2.1561=11.22.
In one embodiment of the present disclosure, sensor 64 is configured to sample the output of RF output stage 54 for a voltage and current reading. The sampled voltage and/or current is provided to controller 51, where controller 51 is configured to determine the amount of power being outputted by the RF output stage 54 and provided to applicator based on the sampled voltage and current. The amount of power being provided to applicator 10 may be used by controller 51 to determine the current generator setting X in real time to increase the accuracy of the energy delivered to the patient calculations using the equation 1 described above. For example, the controller 51 may determine the amount of power being delivered to the applicator 10 based on actual voltage and current reading is different that the power setting that was input to the generator, i.e., the determined power is 55% while the inputted power setting is 50%. The controller 51 may use the determined power percentage to more accurately determine the energy delivered to patient tissue.
In another embodiment, the samplings from sensor 64 are used by controller 51 to calculate the amount of power delivered by applicator 10 to patient tissue. For example, the samplings (e.g., voltage and/or current) and any associated calculation and/or electrical properties (e.g., impedance) of the output of stage 54 may be mapped by controller 51 to various temperatures of a sample fluid (in the manner described above with respect to method 100) to determine energy delivered to the patient tissue based on the calculated power at the RF output stage 54. Thereafter, controller 51 is configured to sample the output of stage 54 during a procedure and, based on the saved mapping and the sampling of the output of stage 54, controller 51 is configured to determine the amount of energy being delivered to patent tissue by applicator 51 during the procedure. For example, a look-up table may be programmed into the generator based on the above following equation:
Y=AZ+B (4)
Where Y is equal to the energy delivered to patient tissue by applicator 10 per second, Z is the calculated output power, and A and B are constants determined based on the energy delivery chart constructed in step 114 of method 100. In this example, A=0.669 and B=−2.1561 (for x>=4 and <=40). The controller 51 samples the output stage 54 and determines the power output (Z). On the look-up table, the power output (Z) corresponds to the power being delivered to the patient (Y) based on the equation. Knowing Y(J/s) and the amount of activation time. The generator may determine the amount of energy delivered to the patient.
In one embodiment of the present disclosure, the equation 1 determined in step 114 and described above is stored in memory 60 of ESU 50 and executed by controller 51 during an electrosurgical procedure to determine the amount of energy applied to patient tissue. In this embodiment, the controller 51 uses at least two pieces of data to calculate or count the energy delivered to the patient tissue: (1) the generator power setting (i.e., X in equation 1); and (2) the length or duration of activation time at the power setting. Controller 51 is configured to continuously track the current power setting of ESU 50 (e.g., using data from sensor 64 and/or tracking the user selections received from I/O interface 56) and the activation time at the current power setting to determine or count the amount of energy delivered to patient tissue. It is to be appreciated that as applicator is turned on and off to apply plasma to tissue and discontinue the application of plasma to tissue and the power setting of ESU 50 is changed, controller 51 is continuously calculating or counting the amount of power delivered to patient tissue using equation 1, described above.
In one embodiment, controller 51 may be configured to determine if applicator 10 is actually applying energy to the patient tissue and not to the ambient air or another target that is not the patient tissue. In this embodiment, controller 51 uses the samplings from sensor 64, e.g., voltage and current readings or samples, to determine the impedance or change in impedance at the output of RF output stage 54. Based on the impedance or change in impedance, controller 51 is configured to determine if the energy outputted by applicator 10 is being applied to patient tissue. For example, controller 51 may determine that if the impedance is at or above a predetermined level or value, then the energy is being applied to patient tissue. As another example, controller 51 may determine that if the impedance has changed by a predetermined level or value, then the energy is being applied to patient tissue. In any case, controller 51 is configured to count the energy applied to the patient tissue using equation 1 only while controller 51 determines that the energy is being applied to patient tissue by applicator 10 and not to the ambient are or a target other than the patient tissue.
In one embodiment, the energy delivered to the patient tissue that is calculated by controller 51 is outputted for display in Joules by controller 51 to a display of ESU 50 via I/O interface 56, e.g., displayed on touchscreen 21. It is to be appreciated that the input/output section 21 may display instantaneous energy being delivered in Joules/second, the accumulated count of energy delivered in Joules or both simultaneously. I/O interface 56 is configured to receive user input (e.g., via one or more buttons 22, a touch screen 21, etc., of ESU 50) to enable a user to set an energy counter of controller 51 to zero and also to set an energy endpoint.
Referring to
In step 204, applicator 10 is used to apply plasma (or another type of) energy to patient tissue. In step 206, controller 51 is configured to monitor and calculate the amount of energy delivered to patient tissue by applicator 10, based on the selected generator power setting. In one embodiment, the accumulated amount of energy delivered to patient tissue is displayed via input/output section 21 and constantly updated throughout the procedure while the applicator 10 is activated. In another embodiment, the input/output section 21 may display the instantaneous energy being delivered in Joules/second, while also displaying the accumulated count of energy delivered in Joules. In step 206, the accumulated amount of energy delivered is compared to the energy endpoint and, if the energy endpoint is reached, controller 51 notifies the user (e.g., by triggering audible alarm 58, displaying the total amount of Joules delivered on input/output section 21, triggering a blinking indicator on the display of ESU 50, and/or sending a notification to another device or an external device via a communication module) that the energy endpoint has been reached, such that the user stops applying plasma to the patient tissue. In some embodiments, when controller 51 determines that the energy endpoint has been reached, controller 51 automatically causes power supply 52 to stop supplying power to applicator 10, such that additional plasma energy cannot be provided to the patient tissue.
It is to be appreciated that equation 1 described above and method 200 may be used in any type of procedure, electrosurgical or otherwise, where energy is delivered to patient tissue, e.g., via plasma, RF energy via direct contact of an electrode of applicator to patient tissue, and/or heat energy via direct contact of a heat element of applicator to patient tissue. Some procedures that equation 1 and method 200 may be used to calculate the energy delivered to patient tissue may include, but are not limited to, tissue tightening and wrinkle reduction procedures.
In one embodiment, the capability of controller 51 to determine the amount of energy that is delivered by applicator 10 to patient tissue is used to determine the optimal amount of applied energy needed to be applied for a given procedure performed on a given region of a body part. Furthermore, once the optimal energies are determined for various procedures, the energy for each procedure can be stored in memory 60 of ESU 50. Once the energies/procedures are stored, a user may select a stored procedure via I/O section 21 which transmits the selection to controller 51 via I/O interface 56, and controller 51 will retrieve the corresponding energy required for the selected procedure and perform the method 200 described above using the retrieved energy from memory 60 as the energy endpoint. In this way, each time a given procedure is performed, the optimal amount of energy is delivered to the patient tissue, thus ensuring consistent results. It is to be appreciated that the generator power setting for a selected procedure may be manually entered by an operator or, alternately, the generator power setting may be stored with the energy endpoint for a given procedure.
Referring to
As an example, a user may perform a tissue tightening procedure using applicator and ESU 50 to reduce skin laxity under each of the arms of a patient. To ensure uniform treatment of both arms of the patient, the user may observe the amount of energy delivered to the right arm of the patient that is calculated by controller 51 and document the energy delivered. Alternately, the controller 51 may store the amount of energy delivered in memory 60, where the amount of energy delivered may be associated with the type of procedure/treatment and/or the particular area of the patient and may further be stored as the energy setpoint for a contralateral area. Then, the user may set the documented or stored energy that was applied to the right arm as the energy endpoint via user input to I/O interface 56 before performing the tissue tightening procedure on the left arm. It is to be appreciated that the user may also select the energy endpoint that was stored for the contralateral area via the I/O interface 56. In this way, controller 51 will perform method 200 described above to ensure that the set energy endpoint is not exceeded and the same amount of energy that was applied to the right arm is applied to the left arm. The energy endpoint may be stored in memory 60 and used in future skin tightening procedures on arms.
As another example, a user may perform a dermal resurfacing procedure using applicator 10 and ESU 50 to reduce facial wrinkles. The user may document (via observing the calculations of controller 51) the amount of energy applied by applicator 10 to the right cheek during the resurfacing procedure. Alternately, the controller 51 may store the amount of energy delivered in memory 60, where the amount of energy delivered may be associated with the type of procedure/treatment and/or the particular area of the patient and may further be stored as the energy setpoint for a contralateral area, i.e., the left cheek. Then, the user may set the documented energy as the energy endpoint before performed the resurfacing procedure on the left cheek. It is to be appreciated that the user may also select the energy endpoint that was stored for the contralateral treatment area, i.e., the left cheek, via the I/O interface 56, e.g., touchscreen 21. When the skin resurfacing procedure is performed on the left cheek, controller 51 will perform method 200 described above to ensure that the set energy endpoint is not exceeded and the same amount of energy applied to the right cheek is applied to the left cheek. The energy endpoint may be stored in memory 60 and used in further skin resurfacing procedures.
As data from various procedures is gathered and stored in memory 60, memory 60 will include data for how much energy is needed to perform various procedures (e.g., skin tightening procedures) at various body regions. This data can be used by controller 51 to prevent over-treatment or under-treatment of a body region. For example, if it is determined that 10 J of energy must be applied to one region of the body (e.g., a quadrant of the abdomen), a user can select the region of the body via input to I/O interface 56, and the required energy (i.e., 10 J) will be retrieved from memory 60 and used by controller 51 as the energy set point to ensure no more than 10 J is delivered to patient tissue during the procedure.
It is to be appreciated that the data for performing various procedures may be gathered in several ways. In one embodiment, data is gathered by controller 51 and stored in memory 60 for each procedure performed using ESU 50 and applicator 10. The data accumulated or gathered by each ESU 50 may be extracted either manually (e.g., by a user connecting a device such as a universal serial bus (USB) or other type of device and extracting the data) or automatically (e.g., where controller 51 sends or pushes the data to an external device, such as a server via communication module 66) and provided to a server. Data for procedures may also be gathered and stored by the server via a data registry where users upload the data to the server. The data may be generated from the findings of a clinical trial or the data may be generated from procedures performed by physicians or other professionals at various facilities. In any case, the data on the server may be accessible for use by each ESU 50 via communication module 66 to be used in a procedure. The data on the server may be analyzed to determine an optimal data set that is smaller than the total data set on the server. The optimal data set may be stored in memory 60 and used by controller 51 to perform a procedure according to the data.
It is to be appreciated that the various features shown and described are interchangeable, that is a feature shown in one embodiment may be incorporated into another embodiment.
While the disclosure has been shown and described with reference to certain preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the disclosure as defined by the appended claims.
Furthermore, although the foregoing text sets forth a detailed description of numerous embodiments, it should be understood that the legal scope of the invention is defined by the words of the claims set forth at the end of this patent. The detailed description is to be construed as exemplary only and does not describe every possible embodiment, as describing every possible embodiment would be impractical, if not impossible. One could implement numerous alternate embodiments, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims.
It should also be understood that, unless a term is expressly defined in this patent using the sentence “As used herein, the term ‘______’ is hereby defined to mean . . . ” or a similar sentence, there is no intent to limit the meaning of that term, either expressly or by implication, beyond its plain or ordinary meaning, and such term should not be interpreted to be limited in scope based on any statement made in any section of this patent (other than the language of the claims). To the extent that any term recited in the claims at the end of this patent is referred to in this patent in a manner consistent with a single meaning, that is done for sake of clarity only so as to not confuse the reader, and it is not intended that such claim term be limited, by implication or otherwise, to that single meaning. Finally, unless a claim element is defined by reciting the word “means” and a function without the recital of any structure, it is not intended that the scope of any claim element be interpreted based on the application of 35 U.S.C. § 112, sixth paragraph.
This application claims priority to U.S. Provisional Patent Application Ser. No. 62/945,142, filed Dec. 7, 2019, entitled “DEVICES, SYSTEMS AND METHODS FOR CALCULATING THE AMOUNT OF ENERGY DELIVERED TO TISSUE DURING AN ELECTROSURGICAL TREATMENT”, the contents of which are hereby incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US20/63187 | 12/4/2020 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62945142 | Dec 2019 | US |
