GB2609233A

GB2609233A - System for treating tissue with energy

Info

Publication number: GB2609233A
Application number: GB2110685.1A
Authority: GB
Inventors: Thomas Daniel
Original assignee: Gyrus Medical Ltd
Current assignee: Gyrus Medical Ltd
Priority date: 2021-07-26
Filing date: 2021-07-26
Publication date: 2023-02-01
Also published as: GB202110685D0

Abstract

A system for treating tissue has an energy generator 1 and a tissue treatment instrument 12 comprising an end effector for treating tissue using the energy. The system has a delay module to receive an activation signal. The delay module enforces a predetermined time delay between the indication that energy is required at the tissue treatment instrument, and the generator providing the energy. The delay allows the end effector of the instrument to be positioned prior to the energy delivery, and accidental energy activation can be reversed before treatment is applied. A visual or aural signal may be emitted during the delay period; the aural signal may be a countdown. The delay period may be between one and five seconds and may be pre-programmed by a user. The delay module may be located within the generator or within the instrument.

Description

SYSTEM FOR TREATING TISSUE WITH ENERGY

Technical Field

Embodiments of the present invention described herein relate to a system for treating tissue with energy, and in particular to a system for treating tissue with energy with a delay module.

Background to the Invention and Prior Art

Examples of systems for treating tissue with energy where embodiments of the present invention may be applied include electrosurgical systems and cosmetic systems. Examples of energy to effect tissue change include radio frequency (RF) energy, ultrasound energy and plasma (e.g. cold plasma, nitrogen plasma, argon plasma and hot plasma). Plasma may be produced by using a combination of RF energy and inert gases.

Some cosmetic systems use energy to effect tissue change, for example, plasma skin regeneration systems may use a combination of inert nitrogen gas and ultra-high frequency RF energy to produce nitrogen plasma. When the nitrogen plasma impacts the skin surface, energy is transferred from the plasma to the tissue, thereby treating the tissue.

Cold plasmas that can be generated at atmospheric pressure and at temperatures below 40°C have in the past couple of decades opened up a new frontier in plasma applications: biomedical applications. These plasma sources produce agents, such as reactive species zo (radicals and non-radicals), charged particles, photons, and electric fields, which have impactful biological effects, for example by reducing viral and bacteriological pathogens. Laroussi M, in "Cold Plasma in Medicine and Healthcare: The New Frontier in Low Temperature Plasma Applications", Frontiers in Physics, Vol 8, Article 74, 20 March 2020 reviews the field in detail, including how such low temperature plasmas are generated, and their applications.

Electrosurgical instruments provide advantages over traditional surgical instruments in that they can be used for coagulation and tissue sealing purposes. Surgical apparatus used to shave, cut, resect, abrade and/or remove tissue, bone and/or other bodily materials are known. Examples of electrosurgical instruments include monopolar or bipolar instruments, electrosurgical pencils, RF suction probes, electrosurgical forceps, RF shaver instruments, electrosurgical vessel sealers and argon plasma coagulators (APCs), amongst others.

During open surgeries, it can be necessary to cut and/or ligate large blood vessels and large tissue structures. One way of achieving this involves the use of electrosurgical instruments having mechanical clamping mechanisms for grasping human tissue, such as electrosurgical forceps or electrosurgical vessel sealers. Some electrosurgical vessel sealers can also be operated to cut the tissue after grasping and sealing. During electrosurgical vessel and tissue sealing, radio or microwave frequency energy is used to heat the tissue to a temperature sufficiently high to liquefy the collagen in the tissue so that it forms a fused mass thereby sealing the vessel before the vessel can then be safely cut whilst minimising blood loss. Electrosurgical forceps are used to clamp tissue or vessels before cutting and/or sealing the tissue by delivering a coagulation RF signal to one or more electrodes located at the end of the instrument.

Combination RF shaver electrosurgical instruments comprise an electrode and shaver component, allowing one instrument to be used for both cutting and coagulation. One such prior art arrangement is known from US 5,904,681, which describes a surgical instrument is including a mechanical cutting portion, such as a rotary blade or burr, and a radio frequency (RF) cutting and/or cauterizing portion comprising an electrosurgical instrument which operates in bipolar mode. A rotary burr works best to remove hard tissues, such as bone, while the bipolar electrosurgical instrument can be used to cut or ablate soft tissues and/or cauterize tissue, including blood vessels. Alternatively, the mechanical cutting portion may include a rotary blade, which may be used for removing soft tissues, with the electrodes of the electrosurgical system being used for cauterisation or coagulation.

Argon beam coagulators have been known for many years, and examples are given in US patents 4,040,426, 5,720,745, 6,039,736 and 6,197,026. The first example is an end-effect instrument, in which the ionised gas exits through the end of the instrument, while the latter two examples are directed at side-effect instruments, in which the ionised gas exits the instrument though an aperture in the side of the instrument. Such instruments are often referred to as argon plasma coagulator (ARC) instruments.

During minimally invasive surgeries or cosmetic procedures there are a number of devices (examples of which are outlined above) for treating tissue which will often be used on or in close proximity to critical tissue structures. Often, it can be difficult to maintain control of the end effector of the instrument when the user adjusts their hand grip, or footing to activate the energy properties of the instrument.

For example, when a surgeon is using an electrosurgical instrument to clamp a vessel during surgery, the surgeon does not want to move the jaws of the electrosurgical instrument as this could result in straining the clamped tissue or burning non-target tissue when sealing. Changing hand position to press an activation switch causes the tip of the instrument to move as the seal commences as the energy is delivered as soon as the button is pressed. This problem is particularly apparent on finer smaller electrode instruments.

Summary of the Disclosure

The present disclosure addresses the above problem by providing a system for treating tissue with energy including a delay module. The delay module receives an activation signal which indicates when a user desires energy properties of a tissue treatment instrument to be activated. Upon receipt of the activation signal, the delay module waits io a predetermined delay time before triggering the delivery of energy to the tissue treatment instrument. Embodiments of the present invention may be applied to any surgical instrument where an activation switch (which may be hand-operated or foot-operated) is used to cause a surgical instrument to act upon tissue to be treated.

Embodiments of the present invention provide a system for treating tissue with energy, the system comprising an energy generator and a tissue treatment instrument comprising an end effector for treating tissue using the energy. The system comprises a delay module arranged in use to receive an activation signal indicating that the energy generator should supply energy to the tissue treatment instrument and to control the energy generator to operate to supply energy to the tissue treatment instrument after a predetermined delay time has elapsed after receipt of the activation signal.

Several advantages are obtained from embodiments according to the above. Firstly, the inclusion of a delay into the system increases the accuracy of targeted tissue treatment by the end effector. Without the delay, movement by the user to trigger energy delivery may cause movement of the end effector away from the target tissue and towards non-target tissue. Without the inclusion of the delay, the energy would be delivered to the instrument effectively immediately, and the non-target tissue may be mistakenly treated. With the inclusion of the delay, the user has time to precisely position the end effector on/in the target tissue prior to the delivery of the energy. Secondly, the delay gives the user time to deactivate the energy if the switch was actuated in error, before the energy is delivered to the instrument.

In some embodiments, the delay module controls the energy generator to operate to supply energy to the tissue treatment instrument by sending an initiation signal to the energy generator after the predetermined delay time has elapsed after the receipt of the activation signal.

In some embodiments, the activation signal is sent to the delay module in response to a switch being actuated. This is one way that the user can activate the energy properties of the instrument.

In some embodiments, the switch is located within a handpiece of the instrument. This enables easy access for the user.

In some embodiments, the switch comprises a footswitch. This enables easy access for the user.

In some embodiments, there may be two switches, one on the handpiece and one in the form of a footswitch. The user would then have the choice of which switch to use. In some scenarios the switch on the handpiece may be more accessible, whilst in others, the footswitch may be more accessible.

In some embodiments, a visual signal is emitted once the activation signal has been received by the delay module. This informs the user of when the energy is about to be delivered and/or is being delivered, and provides feedback confirming that the user has triggered delivery of the energy. In some embodiments, the visual signal stops emitting once the predetermined delay time has elapsed. In some embodiments, the visual signal is a light, e.g. a flashing light.

In some embodiments, an aural signal is emitted once the activation signal has been received by the delay module. This informs the user of when the energy is about to be delivered and/or is being delivered, and provides feedback confirming that the user has triggered delivery of the energy. In some embodiments, the aural signal stops emitting once the predetermined delay time has elapsed. In some embodiments, the aural signal comprises a first tone during the predetermined delay time, and a second tone once the energy generator supplies energy to the tissue treatment instrument. In some embodiments, the aural signal is a countdown to the delivery of the energy to the instrument.

In some embodiments, the predetermined delay time is between one and five seconds. In some embodiments, the predetermined delay time is between one and two seconds.

In some embodiments, the predetermined delay time is pre-programmed by the user. The user may select how long the delay is prior to using the instrument for tissue treatment.

In some embodiments, the predetermined delay time is adjustable by the user. The user may adjust the length of the delay to their preference. This may be done prior to use of the instrument, or even during use. The delay may be adjusted using push buttons on the generator, push buttons on the handpiece of the instrument, or using a footswitch.

In some embodiments, the system is an electrosurgical system, the energy is radio frequency (RF) energy, the energy generator is an RF energy generator, and the tissue treatment instrument is an electrosurgical instrument.

In some embodiments, the end effector comprises an electrode assembly arranged to treat the tissue using RF energy.

In some embodiments, the RF energy comprises an RF cutting waveform, an RF coagulation waveform, or a blended RF signal comprising an RF cutting waveform and an RF coagulation waveform.

In other embodiments the system may be a plasma-based system, such as for example, an argon plasma coagulator system for the coagulation of tissue, or a cold plasma system for the disinfection of tissue. In addition, the system may also be used in combination mechanical and energy based systems, such as, for example in RF shaver instruments or in RF forceps type instruments which combine mechanical cutting blades with RF electrosurgical coagulation systems.

Brief Description of the Drawings

Embodiments of the invention will now be further described by way of example only and with reference to the accompanying drawings, wherein: Figure 1 is a schematic diagram of an example of a tissue treatment system -an electrosurgical system including an electrosurgical instrument; Figure 2 is a flow diagram illustrating embodiments of the present invention; Figure 3 is a flow diagram illustrating embodiments of the present invention; Figure 4 illustrates an embodiment of the present invention wherein an activation signal is received by the delay module, and then an initiation signal is sent by the delay module to the generator after a time delay.

Description of the Embodiments

Embodiments of the present invention provide a system for treating tissue with energy which incorporates a delay between indicating that a generator should supply energy to a tissue treatment instrument (this indication may be by means of a switch) and propagation of energy from a generator to an end effector of an instrument for treating tissue. This delay is a significant delay and may be between one and five seconds, one and three seconds, or one and two seconds. This delay is advantageous for several reasons.

Firstly, the physical movement required by the user to actuate a switch, for example, may cause movement at the end effector where the tissue treatment takes place. Without the delay, the end effector would treat tissue (or whatever else it was near to) almost immediately such that the movement at the end effector could result in treatment of the wrong tissue. This is especially important when using finer smaller electrode instruments and/or during particularly precise treatments. The incorporation of the delay means that io there is a short time interval between triggering the energy activation and the delivery of the energy which gives the user enough time to adjust the positioning of the end effector such that the correct tissue is treated. Therefore, embodiments of the present invention improve accuracy of tissue treatment instruments.

Secondly, the delay gives the user time to deactivate the energy if, for example, the switch was actuated by mistake and/or the user has changed their mind. Without the delay, the energy would be delivered almost immediately and there would be no time to reverse the decision. Therefore, embodiments of the present invention improve safety of tissue treatment instruments.

Thirdly, in some embodiments, the delay is accompanied by a signal to the user. This signal may be visual or aural. This signal provides feedback to the user to confirm they have triggered the energy activation. The visual signal may be a light, for example, a flashing light. The flashing light may have a frequency of between 1 and 10 Hz. The visual signal may be in the form of a numerical countdown on a display (e.g. 5, 4, 3, 2, 1, if the delay is 5 seconds long). The aural signal may be a tone which notifies the user that the switch has been actuated and therefore the energy is about to be delivered to the end effector. The aural signal may be a countdown (e.g. 5, 4, 3, 2, 1, if the delay is 5 seconds long). It will be evident to the skilled person that the countdowns may be adjusted if the delay is longer or shorter than the examples given. There may be a further aural signal (an activation tone) once the generator is outputting energy. The tone during the delay period notifying the user that the switch has been actuated may be different to the activation tone. For example, the difference between the two tones may be in the form of a different frequency of tone, or different pulsing patterns of the tone. The change in the tone will indicate the transition from delay to energy output.

Referring to the drawings, Figure 1 shows an example of a tissue treatment system in the form of an electrosurgical system including an electrosurgical generator 1 having an output socket 2 providing an RF output, via a connection cord 4, for an electrosurgical instrument 12. The instrument 12 includes a proximal handle portion, a hollow shaft extending in a distal direction away from the proximal handle portion, and a distal end effector assembly at the distal end of the shaft. The end effector assembly may comprise an electrode assembly, which is operably connected to RF electrical connections which pass through the hollow shaft and connect the electrode assembly to connections within the handpiece, which in turn connect to the generator 1 via the power connection cord 4, such that the RF output (or RF energy) is transmitted to the electrode assembly. The power connection cord 4 connects the instrument to the RF generator 1. The instrument 12 has irrigation and suction tubes 14 which are connected to an irrigation fluid and suction pump 10. The electrosurgical functions of the end effector (e.g. coagulation or ablation) are activated by a switch. Activation of the generator 1 may be performed from the instrument 12 via an activation switch in the form of a handswitch (not shown) on the instrument 12 or in the form of a footswitch unit 5 connected separately to the rear of the generator 1 by a footswitch connection cord 6. In the illustrated embodiment, the footswitch unit 5 has two footswitches 5a and 5b for selecting a coagulation mode or a cutting or vaporisation (ablation) mode of the generator 1 respectively. The generator front panel has push buttons 7a and 7b for respectively setting ablation (cutting) or coagulation power levels, which are indicated in a display 8. Push buttons 9 are provided as an alternative means for selection between the ablation (cutting) and coagulation modes. The RF output may comprise (a) an RF cutting waveform; (b) an RF coagulation waveform; or (c) a blended RF signal comprising an RF cutting waveform and an RF coagulation waveform.

However, the skilled person will appreciate that the delay module of the present invention may equally be applied to other systems for treating tissue with energy which fall outside the realm of electrosurgical systems, for example, cosmetic treatment systems as outlined

in the background section.

Figure 2 shows a flow diagram in accordance with embodiments of the present invention. At step 2.1, a user indicates the desire for energy delivery to the tissue treatment instrument. This indication sends an activation signal to a delay module. This delay module may be located within the tissue treatment instrument 12 or the generator 1. This indication may be in the form of an activation switch which may be situated on the electrosurgical instrument 12, for example, on the handpiece. The activation switch may be in the form of a footswitch 5. There may be more than one activation switch such that there is one positioned on the electrosurgical instrument, e.g. the handpiece, and one in the form of a footswitch 5. In such an arrangement, the user may choose which activation switch is more accessible to them at that moment.

After the desire for energy delivery is indicated by the user and the activation signal is received by the delay module, there is a time delay s.2.2. This time delay should be long enough to allow the user to precisely position the end effector of the tissue treatment instrument 12 prior to the activation of the energy. This time delay is predetermined, either by the manufacturer of the tissue treatment system, or the user. This time delay may be between 1 and 5 seconds, 1 and 4 seconds, 1 and 3 seconds, or 1 and 2 seconds. The length of the time delay may be pre-programmed by the user prior to the surgery. For example, the user may set the time delay to be 2 seconds. The length of the time delay be adjustable such that the user may adjust the time delay when using the tissue treatment instrument 12. The time delay may be adjusted using buttons on the handpiece and/or buttons on the generator 1.

During this time delay, there may be a signal to the user to inform them that they have triggered the energy activation and the energy is about to be delivered to the instrument 12. Such a signal may be a visual signal and/or an aural signal. The signal may be triggered by the receipt of the activation signal at the delay module. The signal may cease upon the delivery of the energy. Examples of a visual signal include a light, a flashing light, and/or a numerical countdown on a display. Such a display could be positioned on the instrument 12 and/or the generator 1. The flashing light may have a frequency of 1 Hz, 5 Hz, 10 Hz, or any frequency between 1 and 10 Hz. Examples of an aural signal include a notifying tone and/or a countdown. The aural signal may comprise a first tone during the predetermined delay time, and a second tone once the energy generator supplies energy to the tissue treatment instrument. The change in tone indicates the transition from the delay phase and the energy output phase. The first and second tone may differ by way of frequency and/or pulsation. Countdowns (whether visual or aural) may countdown the seconds until the propagation of the energy. For example, if the time delay was programmed to be 3 seconds, the countdown may be "3, 2, 1" at the appropriate times. These visual and aural signals improve the safety of tissue treatment systems as they warn the user that the energy is about to be activated so they can act accordingly, either by deactivating the energy or correctly positioning the end effector of the instrument 12 relative to the target tissue. The signal (whether visual or aural) may be pre-programmed by the user prior to the surgery, i.e. the user may choose whether to have (a) no signal; (b) a visual signal (and may choose its form, e.g. flashing light with a frequency of 3 Hz); or (c) an aural signal (and may choose its form, e.g. frequency, pulsation). These choices may be made using buttons on the handpiece and/or buttons on the generator 1.

After the time delay has passed, energy is delivered to the instrument s. 2.3 and tissue treatment can commence.

Figure 3 shows a flow diagram in accordance with embodiments of the present invention from the perspective of the delay module. The delay module receives an activation signal s. 3.1. This activation signal is sent in response to an indication that energy generator 1 should supply energy to the tissue treatment instrument 12. Upon receipt of the activation signal, the delay module waits for a predetermined delay time to elapse s. 3.2. Once the predetermined delay time has elapsed, the delay module controls the generator 1 to operate to supply energy to the tissue treatment instrument s. 3.3. Tissue can then be treated using the supplied energy s. 3.4. The activation signal may be sent to the delay module in response to a switch being actuated, for example, by the user.

io The delay module may control the generator 1 to operate to supply energy to the tissue treatment instrument 12 by sending an initiation signal to the generator 1. Figure 4 illustrates this example of the present invention wherein an activation signal is received by the delay module, and then an initiation signal is sent by the delay module to the generator 1 after a time delay, prompting the generator 1 to deliver energy to the instrument 12.

As explained previously, in embodiments of the invention the system can be any of a RE electrosurgical system, which may include mechanical cutting elements or which may use RF energy for both cutting or ablation of tissue, and coagulation of tissue, or other types of energy based treatment systems, such as an APC or other hot plasma system, or a cold plasma system, or an ultrasound energy system.

Various modifications whether by way of addition, deletion, or substitution of features may be made to above described embodiment to provide further embodiments, any and all of which are intended to be encompassed by the appended claims.

Claims

Claims 1. A system for treating tissue with energy, the system comprising: an energy generator; and a tissue treatment instrument comprising an end effector for treating tissue using the energy; the system comprising a delay module arranged in use to receive an activation signal indicating that the energy generator should supply energy to the tissue treatment instrument and to control the energy generator to operate to supply energy to the tissue treatment instrument after a predetermined delay time has elapsed after receipt of the io activation signal.
2. A system for treating tissue with energy according to claim 1, wherein the delay module controls the energy generator to operate to supply energy to the tissue treatment instrument by sending an initiation signal to the energy generator after the predetermined delay time has elapsed after the receipt of the activation signal.
3. A system for treating tissue with energy according to claim 1 or 2, wherein the activation signal is sent to the delay module in response to a switch being actuated.
4. A system for treating tissue with energy according to claim 3, wherein the switch is located within a handpiece of the tissue treatment instrument.
5. A system for treating tissue with energy according to claim 3, wherein the switch comprises a footswitch.
6. A system for treating tissue with energy according to any of the preceding claims, wherein a visual signal is emitted once the activation signal has been received by the delay module.
7. A system for treating tissue with energy according to claim 6, wherein the visual signal stops emitting once the predetermined delay time has elapsed.
8. A system for treating tissue with energy according to any of the preceding claims, wherein an aural signal is emitted once the activation signal has been received by the delay module. 1.1
9. A system for treating tissue with energy according to claim 8, wherein the aural signal stops emitting once the predetermined delay time has elapsed.
10. A system for treating tissue with energy according to claim 8, wherein the aural signal comprises a first tone during the predetermined delay time, and a second tone once the energy generator supplies energy to the tissue treatment instrument.
11. A system for treating tissue with energy according to claim 8 or 9, wherein the aural signal is a countdown to the energy generator supplying energy to the tissue io treatment instrument.
12. A system for treating tissue with energy according to any of the preceding claims, wherein the predetermined delay time is between one and five seconds.is
13. A system for treating tissue with energy according to any of claims 1-11, wherein the predetermined delay time is between one and two seconds.
14. A system for treating tissue with energy according to any of the preceding claims, wherein the predetermined delay time is pre-programmed by a user.
15. A system for treating tissue with energy according to any of the preceding claims, wherein the predetermined delay time is adjustable by a user.
16. A system for treating tissue with energy according to any of the preceding claims, wherein the system is an electrosurgical system, the energy is radio frequency (RF) energy, the energy generator is an RF energy generator, and the tissue treatment instrument is an electrosurgical instrument.
17. A system for treating tissue with energy according to claim 16, wherein the end effector comprises an electrode assembly arranged to treat the tissue using RF energy.
18. A system for treating tissue with energy according to any of the preceding claims, wherein the delay module is located within the generator or within the tissue treatment instrument.