WO2024170143A1 - Dispositif électrochirurgical - Google Patents
Dispositif électrochirurgical Download PDFInfo
- Publication number
- WO2024170143A1 WO2024170143A1 PCT/EP2024/000008 EP2024000008W WO2024170143A1 WO 2024170143 A1 WO2024170143 A1 WO 2024170143A1 EP 2024000008 W EP2024000008 W EP 2024000008W WO 2024170143 A1 WO2024170143 A1 WO 2024170143A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- probe
- handpiece
- electrosurgical instrument
- housing
- electrical
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1477—Needle-like probes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00053—Mechanical features of the instrument of device
- A61B2018/00172—Connectors and adapters therefor
- A61B2018/00178—Electrical connectors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00321—Head or parts thereof
- A61B2018/00327—Ear, nose or throat
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00577—Ablation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00589—Coagulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00601—Cutting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/1206—Generators therefor
- A61B2018/1226—Generators therefor powered by a battery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1405—Electrodes having a specific shape
- A61B2018/1425—Needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B2018/1495—Electrodes being detachable from a support structure
Definitions
- the invention relates to an electrosurgical instrument comprising a handpiece and a probe that comprises a bipolar or multipolar electrode configuration.
- Electrosurgical instruments having a probe that comprises a bipolar or multipolar electrode configuration are known in general and can be used in various ways.
- this patent will describe a new invention for a low cost, handheld and battery driven electrosurgical device for ENT doctors, offering several therapeutic solutions for CRS patients, designed to be used preferably in an office environment.
- Medical treatment modalities in Otolaryngology are manifold, varying from Surgical to Minimally Invasive treatment options using therapeutic devices to manage, remove, or reduce infected pathologic tissue for improving ventilation, mucosal drain and reducing discomfort.
- Chronic Rhino-Sinusitis is one of the most common chronic diseases worldwide.
- the prevalence of chronic rhinosinusitis in Europe is around 10.9% and about 14.9% in the US. This might be an overestimation because of overlap with other diseases, such as allergic rhinitis.
- This huge number of patients requesting for treatment is challenging each national health care system worldwide, requiring solutions for new low-cost therapy devices which can be used also in an office setting.
- nasal obstruction nose closed
- rhinorrhea runny nose
- Other symptoms are: loss of smell (anosmia), postnasal drip, headache (mostly localized frontally), urge to sneeze, sleep disorders, snoring, voice problems.
- the inflammation or allergies cause swelling of the mucous membrane, possibly polyp formation, which in turn causes a narrowing of the nasal passageway or ostia and thus a build-up of secretion in the paranasal sinuses.
- the nasal secretion can become secondary infected with bacteria.
- Viruses such as rhino, influenza and parainfluenza viruses as well as chlamydia pneumoniae and mycoplasmas are among the most common causes of acute rhinosinusitis.
- the clinical picture worsens when the ciliary transport stops due to damage to the epithelial layer which has to be considered when choosing the right therapy for conserving the ciliary epithelium.
- central structures in the nasal cavity which are often involved in the clinical pathologic image of CRS and nasal flow distortion, are the nasal turbinates, in particular the hyperplastic nasal turbinates (concha nasalis superior and concha nasalis inferior), which can obstruct nasal air flow, creating a lot of negative secondary side effects as already described above.
- Hyperplastic nasal turbinates can be treated very efficiently through minimally invasive, submucosal turbinate reduction, preserving the natural functionality of the ciliary epithelium.
- Another clinical problem related to CRS is rhinorrhea and post nasal dripping of the patient’s nose, which is caused by a hyperactive nerve root activity in the region of the turbinates head located in the deeper nose cavity (cavum nasi). This symptom can be successfully treated by a local nerve root denervation using precisely applied energy to deactivate the hyperactivity of the parasympathetic nervous root.
- Nasal polyps are also often related to CRS which require intervention and removal in order to restore nasal ventilation.
- All these energy and power grid supplied devices listed above consist usually out of two main components, a main power-unit and an instrument or probe as the energy application tool used by the doctor. Both components are usually connected by an energy transmitting cable, fiber or tubing.
- the major component is usually a 110V/220V power grid supplied energy generating, controlling and delivering device (“energy-box”), which is often heavy and bulky, which sits usually on a trolley, cart or table or is designed to be integrated into an OR video tower.
- This necessary hardware (“energy-box”) is usually sold as capital investment, ranging in price from a couple of thousand Dollars up to several hundred thousand Dollars.
- the other component of these energy therapy devices is the instrument or probe (the “application devices”), which will plug into the hardware box of said energy device and represents the consumable component of the medical device.
- Electrosurgery is a common form of a surgical energy device, using high frequency electric energy applied with handheld instruments and probes in a frequency range of 250KHz-2MHz with a voltage ⁇ 200V peak for tissue coagulation and voltage peaks »200V for tissue cutting and vaporization.
- Bipolar Electrosurgery is a method that can be used to perform i. turbinate reduction, in particular for submucosal turbinate reduction, ii. for local denervation of the parasympathetic nervous root, and/or ill. for hemostasis (tissue coagulation) during a surgical intervention such as polyp resection or tissue shrinkage for tissue remodeling.
- an electrosurgical instrument comprising a handpiece and a probe that is releasably connected to the handpiece.
- the probe has a linearshaped probe shaft extending along a longitudinal probe axis and comprising a bipolar or multipolar electrode configuration.
- the probe with the linear-shaped probe shaft is releasable connected to the housing via an electro-mechanical interface.
- the handpiece comprises a self-contained housing, that has a longitudinal axis and that is shaped as a handle.
- the housing contains electrical components of the electrosurgical instrument including electrical components for generating an RF output voltage to be fed to said electrode configuration of the probe.
- the electrical components contained in the handpiece preferably include rechargeable batteries and electronic circuitry including a miniaturized radiofrequency (“RF”) generator.
- RF radiofrequency
- the elongate probe shaft has a distal end that is needle-shaped.
- at least one, preferably two or more probe electrodes are arranged on the probe shaft.
- the probe electrodes are configured for supplying radio frequency electric current to tissue that is adjacent to the probe electrodes when the electrosurgical instrument is used.
- the probe shaft is provided with an ultrasound transducer, for instance a piezo transducer that can vibrate with an ultrasound frequency.
- Ultrasound vibration of the piezo transducer causes vibration of the tip of the probe and thus helps to prevent sticking of the probe to tissue to be treated.
- the piezo transducer preferably is arranged within the probe shaft close to the distal end of the probe.
- the piezo transducer is electrically connected to a control unit within the housing of the handpiece of the electrosurgical instrument.
- the electric connection between the ultrasound piezo transducer and the control unit comprises a releasable electrical connection at the electro-mechanical interface between the probe and the handpiece.
- the location of the ultrasound transducer and the frequency of the ultrasound transducer during operation preferably are adapted to cause a resonance of the probe shaft.
- the preferred arrangement of the ultrasound transducer may depend on the type of probe. If the probe shaft has a paddle-shape electrode tip, the ultrasound transducer preferably is arranged close to or at the tip of the probe shaft. If the electrode shaft is needle-shaped, i.e. has a needle shaped tip, the ultrasound transducer may be arranged in the probe shaft close to the probe electrodes arranged on the probe shaft. The envisaged effect is to create efficient vibration of the application area/tip to avoid adhesion/sticking of the heated tissue with the applicator due to thermal coagulation and sticking effects.
- the longitudinal probe axis is angled with respect to the housing's longitudinal axis with an angle between 10°- 80°, preferably 25°- 40° when the probe is attached to the housing.
- the probe and the housing are connected via an electro-mechanical interface that comprises electrical contact elements arranged at a distal end of the housing and that mate electrical contact elements on a base of the probe being arranged at a proximal end of the probe, wherein the electrical contacts arranged at a distal end of the housing preferably comprise at least one circular or ring-shaped electric contact element that preferably is flush with respect to a surface of the housing adjacent to the electric contact element.
- the circular or ring-shaped contact element allows connecting the probe in different rotation angles to the handpiece.
- the flush arrangement of the contact elements allows easy cleaning of the handpiece and thus facilitates reuse of the handpiece.
- the releasable electro-mechanical coupling comprises a lock mechanism that is configured to allow a mechanical connection between the handpiece and the probe in different rotation angles of the probe relative to the housing and selective fixation of the rotation angle.
- the direction of extension of the probe can be adapted to the intended use.
- the electrical components in the housing comprise a primary winding of an output transformer and the probe comprises a secondary winding of the output transformer.
- the secondary winding is arranged within a base of the probe.
- the base is arranged at the proximal end of the probe and comprises a mechanical coupling member that is configured to place the secondary winding close to the primary winding when the probe is mechanically connected to the housing via said mechanical coupling member.
- a set comprising a handpiece and at least two different probes.
- the probes may differ with respect to their mechanical and/or their electrical configuration.
- the probes may comprise different secondary windings that are configured to form an output transformer when being inductively coupled to a primary winding comprised in the handpiece.
- the electrical components in the housing comprise a rechargeable electrical energy store such as an accumulator or a capacitor having a capacity of between 30000 and 100000 Joules.
- a probe assembly for an electrosurgical instrument comprises an electro-mechanical interface with a mechanical coupling member that is adapted to establish a mechanical and an electrical connection to a handpiece of the electrosurgical instrument and an elongate cylindrical probe shaft, wherein the elongate cylindrical shaft is attached to the mechanical coupling member and the elongate cylindrical probe shaft and the mechanical coupling member are configured to provide for an angle of 25°- 40° between a longitudinal axis of the elongate cylindrical probe shaft and a longitudinal axis of the a handpiece when the probe assembly is attached to the handpiece.
- a system comprising an electrosurgical instrument and an external device.
- the external instrument is configured for providing a wireless data communication between the electrosurgical instrument and the external device and comprises an application providing a user interface for controlling the electro-surgical instrument via the external device.
- a method of using the electrosurgical instrument includes the steps of: placing the electrosurgical instrument next to the treatment site; connecting the base with the wireless battery charger and fully load the electrosurgical instrument; positioning a patient at a semi-upright position while seating on a chair, preferably at 30 degrees from horizontal; locally sedating the target area to be treated following a sedation scheme; once fully charged, removing the electrosurgical instrument from the wireless battery charger; choosing a sterile probe and removing the sterile application probe of choice from its sterile packaging; attaching and electrically connecting the chosen sterile probe to the distal end of the electrosurgical instrument; holding the handpiece of the electrosurgical instrument like a pen; inserting and positioning of the distal probe end region in the tissue to be treated; once the probe has been placed properly, activating the electrosurgical instrument by pressing the activation button until a signal tone indicates the end of the treatment; repositioning of the probe and repeating the procedure according to the treatment recommendations and requirements; slowly removing the probe from the treatment site
- the method preferably further comprises the initial steps of providing a handpiece of an electrosurgical instrument, said handpiece comprising a generator for generating radiofrequency electrical energy, and a probe that that can be releasably connected to the handpiece.
- the method preferably further comprises electrically and mechanically connecting the probe to the handpiece for establishing an electrical connection between electrodes on the probe with the generator in the handpiece and for enabling manipulation of the probe by means of the handpiece.
- the handpiece preferably is reusable while the probe preferably is a single use component.
- the method preferably further comprises releasing the probe form the handpiece and disposing of the probe after use.
- FIG. 1 is simplified block diagram of a surgical instrument and base station in accordance with the various embodiments disclosed herein.
- FIG. 2 is a perspective view of a surgical instrument and base station in accordance with the various embodiments disclosed herein.
- FIG. 3 is a perspective view of a surgical instrument and base station in accordance with the various embodiments disclosed herein.
- FIG. 4 is a perspective view of a surgical instrument and base station in accordance with the various embodiments disclosed herein.
- FIG. 5 is a front view of a surgical instrument and base station in accordance with the various embodiments disclosed herein.
- FIG. 6 is a front view of a surgical instrument and base station in accordance with the various embodiments disclosed herein.
- FIG. 7 is a side view of a surgical instrument and base station in accordance with the various embodiments disclosed herein.
- FIG. 8 is a perspective view of a surgical instrument and base station in accordance with the various embodiments disclosed herein.
- FIG. 9 is a perspective view of a surgical instrument and base station in accordance with the various embodiments disclosed herein.
- FIG. 10 is a perspective view of a surgical instrument and base station in accordance with the various embodiments disclosed herein.
- FIG. 11 is a perspective view of a probe in accordance with the various embodiments disclosed herein.
- FIG. 12 is a schematic view of a probe in accordance with the various embodiments disclosed herein.
- FIG. 13 is a schematic view of a probe in accordance with the various embodiments disclosed herein.
- FIG. 14 is depicts a surgical instrument and base station in accordance with the various embodiments disclosed herein, including various probe configurations.
- FIG. 15 schematically illustrates electrical components of a handpiece of an embodiment of the electrosurgical instrument.
- FIG. 16 schematically illustrates electrical components of a handpiece of an embodiment of the electrosurgical instrument providing inductive energy transfer from the handpiece to the probe.
- Fig. 17 schematically illustrates a probe with an ultrasound transducer arranged within the probe shaft.
- Fig. 18 schematically illustrates a system comprising an electrosurgical instrument and at least an external device that can wirelessly communicate with the electrosurgical instrument.
- FIG. 19 depicts a method of treatment in accordance with the various embodiments disclosed herein.
- FIG. 20 depicts a method of treatment in accordance with the various embodiments disclosed herein.
- the embodiments herein relate to a handheld and self-contained electrosurgical instrument comprising a linear-shaped probe which contains a bipolar or multipolar electrode configuration at its distal end and a handpiece comprising a self-contained housing.
- the linear-shaped probe is releasably connected to the housing via an electric and mechanical interface, i.e. an electro-mechanical interface.
- the housing can be shaped as a handle.
- the housing contains electrical components of the electrosurgical apparatus which can include rechargeable batteries and electronic circuitry including a miniaturized radiofrequency (“RF") generator.
- the electrical components generally include an RF generator and a power source.
- the power source preferably comprises a rechargeable energy store, such as one or more rechargeable batteries.
- a handheld and self-contained electrosurgical instrument can have a needle-shaped probe with embodiments of different distal electrode configurations and a self-contained housing, which can be shaped as a handle.
- the probe can be releasably connected to the housing and electrically connected to the electrical components in the housing via the electro-mechanical interface.
- the electro-mechanical interface may comprise a mechanically coupling member that is part of a base of the probe.
- the base of the probe is arranged at the proximal end of the probe.
- the base of the probe is connected to the elongate probe shaft.
- the probe when being connected at its proximal end to the housing of the handpiece, is angled with respect to a longitudinal axis of the housing with an angle between 10°- 80°, preferably 25°- 40° when attached to the housing.
- the probe can be a needle shaped probe with an elongate cylindrical probe shaft having a pointed tip.
- the probe can be a bipolar or a multipolar probe with at least two electrodes integrated in the shaft or arranged at the shaft.
- One embodiment of the probe has a flat or slightly bend electrode carrier at its distal end.
- the cylindrical shaft can have at least two or more distinct, electrically conducting surface areas that are electrodes of the probe and that are electrically connected to electrical contacts for electrically connecting the electrodes to the RF generator.
- the electrodes are ring electrodes that are axially spaced by an insulator.
- the ring electrodes and the at least one insulator can have the same outer diameter as the remainder of the elongate cylindrical shaft.
- the electrodes are helical electrodes wound around the elongate cylindrical shaft of the probe and being separated by a helical insulator.
- the length of the cylindrical shaft portion is between 4 cm and 12 cm.
- the diameter of the cylindrical shaft portion is between 0.8 mm and 3.2 mm.
- the electrodes are located and arranged on a flat or slightly bent paddle where the electrodes are spaced equidistantly parallel or in another embodiment helically by or on an insulator.
- the plane of the flat active electrode portion at the distal tip has a surface between 0.3 cm 2 and 3.5 cm 2 .
- the distal electrode paddle is angled relative to the axis of the instrument with an angle between 3°- 25°.
- Other embodiments have a flat interlocked electrode arrangement which are seated on an insulator carrier element.
- a sensor module is integrated in the active tip for process control.
- the probe can have various configurations.
- the elongate cylindrical shaft is angled with respect to the longitudinal axis of the housing. This and similar configurations can ensure that a surgeon's view is not blocked by the housing when using the surgical instrument.
- a mechanical coupling between the housing and the probe can be constructed to cause an angle between the shaft and the housing.
- the shaft of the probe may have a bend or curvature.
- the shaft can also be fixed to a probe's coupling structure at an angle.
- the distal active tip of the probe can be angled relatively to the shaft.
- Embodiments of the active distal tip of this invention can have the shape of a tapered needle or sharp trocar, other embodiments can have a shape of a flat or slightly bend paddle.
- the active electrode components are integrated into the distal tip of the probe creating a unified surface with the shaft and isolator sleeve, in other embodiments the electrode configurations sit on an insulator body. All electrode configurations have in common, that they are orientated in or on the shaft that the electric current can pass to the tissue perpendicular to the cylindrical shaft orientation.
- the active tip of the probe can have expandable tip portion for increasing the surface area of the electrodes after inserting into the tissue in order to vary the geometry of the thermal lesion.
- the shaft of the probe can be malleable to allow adjustments of the doctor for individual anatomies.
- the probe shaft is provided with a piezo transducer that can vibrate with an ultrasound frequency.
- Ultrasound vibration of the piezo transducer causes vibration of the tip of the probe and thus helps to prevent sticking of the probe to tissue to be treated.
- the piezo transducer preferably is arranged within the probe close to the distal end of the probe.
- the piezo transducer is electrically connected to a control unit within the housing of the handpiece of the electrosurgical instrument.
- the electric connection between the ultrasound piezo transducer and the control unit comprises a releasable electrical connection at the electro-mechanical interface between the probe and the handpiece.
- the handpiece The handpiece
- the handpiece has a longitudinal housing that has the shape of a handle.
- the housing may have at least one flat or nearly flat side face so a user can more easily maintain a certain rotation angle of the tip if the tip is angled with respect to the longitudinal axis of the instrument.
- a possible shape for the handpiece is an oval shape (instead of a completely round shape).
- the housing has a length between 7 cm and 20 cm.
- the housing has a maximum outer diameter between 1.5 cm and 4 cm.
- the housing has a volume between 12 cm 3 and 250 cm 3 , for instance between 50 cm 3 and 150 cm 3 .
- the housing can be sealed and thus fluid tight.
- the housing can be shaped as a handle for holding the electrosurgical instrument.
- the housing generally includes the electrical components needed for operating the electrosurgical instrument.
- the electrosurgical instrument can be used as a self-contained, autonomous, standalone instrument that is not teetered to a power supply, a generator or the like.
- the housing and the components therein, including the electrical components can in some embodiments have a mass between 18 g and 375 g for instance between 50 g and 200 g.
- the mass distribution achieved by the arrangement of the components in the housing and the housing itself is such that the center of mass is approximately in the middle of the length of the housing.
- the center of mass can be at the middle of the length of the housing or a distance from the middle that is within 30% the distance from the middle to either end of the housing.
- the shape of housing tapers towards the end with the probe.
- the housing can have a generally round cross section with recessed grip sections to enhance ergonomic handling.
- the housing may be configured to provide electrical and/or heat insulation.
- the housing may be electrically insulated from the internal electrical components and probe coupling.
- a releasable mechanical coupling between the probe and the housing can be provided. Any type of releasable mechanical coupling can be implemented.
- the releasable mechanical coupling is a bayonet type coupling.
- the releasable mechanical coupling is a press-fit coupling.
- the releasable mechanical coupling is a snap-in coupling providing an unlock button that can be pressed for releasing the mechanical connection between the housing and the probe.
- the releasable mechanical coupling allows rotation of the attached probe relative to the housing.
- the releasable mechanical coupling could have a lock mechanism when connect, allowing different rotation angles of the probe relative to the housing and selective fixation of the rotation angle.
- the releasable mechanical coupling between the housing and the probe may include electrical contact elements for electrically connecting the electrodes of the probe with the electrical components in the housing.
- the electrical contact elements are configured to establish an electrical connection between the probe and the electrical components in the housing when the probe is mechanically attached to the housing by way of the mechanical coupling.
- the electrical connection can be achieved by means of mating, electrically connecting contact elements.
- At least two electrical contact elements are provided with the housing and at least two mating contact elements are provided with the mechanical coupling of the probe. Accordingly, each electrical contact element of the probe contacts a respective electrical contact element of the housing when the probe is mechanically connected to the housing.
- the electrical contact elements are arranged in a concentric manner with respect to the longitudinal axis of the housing. For instance, one center electrical contact element can be arranged at the center of the housing's longitudinal axis and one or more second electrical contact elements can be arranged in a circular manner around the center electrical contact element.
- the electrical contact elements arranged in the mechanical coupling of the probe are positioned to contact the respective electrical contact elements of the housing.
- a center electrical contact element or concentric electrical contact elements allows the probe to be attached to the housing in any rotational angle. This can allow lateral orientating the elongated cylindrical shaft of the probe if the elongated cylindrical shaft of the probe is arranged at an angle with respect to the longitudinal axis of the housing. The angle between the longitudinal axis of the elongated cylindrical shaft and the longitudinal axis of the housing is defined by the mechanical coupling of the probe.
- concentric electric contact elements allows different rotational angles between the housing and the mechanical coupling of the probe.
- the connection between housing and probe can have three or more electrical contact elements to add and connect sensor elements (thermal sensors or optical sensors) between the active tip of the probe and electrical components contained in the housing.
- the electrical contact elements of the housing are flush with respect to the surface of the housing next to the electrical contact elements.
- Flush electrical contact elements can avoid gaps or bumps and facilitate easy cleaning.
- windings may be provided in the handpiece and the probe for inductively transferring the electrical energy to the probe.
- the electrodes of the probe are electrically connected to the at least one winding of the probe.
- the winding of the probe preferably is arranged close to the proximal end of the probe.
- the winding of the handpiece preferably is arranged close to the distal end of the handpiece. The mutual arrangement of the windings of the probe and of the handpiece is configured to minimize the gap between the windings of the probe and of the handpiece when the probe is attached to the handpiece.
- the windings of the probe preferably are secondary windings of an output transformer of the radio frequency generator of the electrosurgical instrument.
- the probe may further comprise electric filter elements that may comprise at least one capacitance.
- Providing a handpiece with a primary winding and a probe with a secondary winding of an output transformer allows providing different probes with different secondary windings that result in different output voltages of the electrosurgical instrument depending on the type of probe connected to the handpiece.
- the surgical instrument can include a control system that blocks the activation of the surgical instrument when no probe is connected to the housing.
- a control system can include electrical, and/or mechanical interlock. This can include a mechanism for determining whether the probe is connected to the housing, such as a switch that is actuated by the insertion or removal of the probe.
- the control system preferably is an integral part of the electrical components contained in the surgical instrument's housing that preferably is handle-shaped.
- a control unit of the electrosurgical device may implement a safety feature, for instance an activation lock that prevents activation of the electrosurgical instrument while charging, when no tip is connected and/or no wireless data communication connection is set up to a verified host or external device.
- a safety feature for instance an activation lock that prevents activation of the electrosurgical instrument while charging, when no tip is connected and/or no wireless data communication connection is set up to a verified host or external device.
- the electrical components in the housing include a power source, which can include at least one battery. Batteries used as an electrical power source can be rechargeable batteries. Batteries used in the device can have a capacity of more than 30,000 Joules. In some embodiments, the battery can have a battery voltage of 3.5 V or more and a capacity of 2,400 mAh or more. In some embodiments, the battery is configured to allow a short circuit current of more than 10 A.
- the rechargeable battery can be connected to charging electronics.
- the charging electronics can be configured for inductive charging and can include an inductive receiver coil and a battery charger circuit including an AC/DC converter and a voltage regulator.
- the electrical components in the housing can also include an intermediate voltage generating circuit, i.e. a DC-DC converter that is electrically connected to the electrical power source.
- the intermediate voltage generating circuit can include a boost converter for converting an input voltage (e.g., 3.7 V) to an output voltage (e.g., 36 V). In some embodiments, the input voltage is lower than the output voltage.
- the boost converter is configured to receive an input voltage of 3.7 V + 0.7 V and thus allows for an input voltage between 3 V and 4.4 V.
- the exact input voltage is not limited, and can include any voltage required by the other electrical components of the system, such as the battery or battery charger circuit.
- the intermediate voltage generating circuit can be designed for an input current of up to 10 A and an input power of up to 40 W.
- the intermediate voltage generating circuit can also be designed for input currents of over 10 A and/or input power of over 40 W.
- the intermediate voltage generating circuit has an efficiency of more than 90% and/or can deliver an output power of more than 36 W.
- the output current of the intermediate voltage generating circuit is greater than 1 A and the output voltage is 36 V ⁇ 10 V.
- the output voltage can also be greater or less than 36 V, and is not particularly limited.
- the electrical components in the housing can also include a RF generator with an RF- generating circuit (RF generating circuit) comprising a resonance converter.
- the RF-gen- erating circuit (RF generating circuit) is electrically connected to the intermediate voltage generating circuit.
- the resonance converter can be configured for an input voltage of 36 V + 10 V and an input current of more than 1 A.
- the input voltage can also be greater or less than 36 V.
- the input voltage of the resonance converter is generally the same as the output voltage of the boost converter, which is not limited to any particular voltage.
- the input power is greater than or equal to 36 W.
- the input power can also be less than 36 W.
- the efficiency of the resonance converter is 70% or greater.
- the resonance converter can be designed to provide an output power between 10 W and 25 W and an output voltage of up to 190 V.
- the output current of the resonance converter preferably is larger than 130 mA.
- the output frequency of the RF-generating circuit is between 300 kHz and 1 MHz and preferably between 300 kHz and 500 kHz.
- the electrical components in the housing can include an output filter.
- the output filter is arranged between the resonance converter and the electrical contact elements of the housing for electrically connecting the electrodes of the probe to the RF-generating circuit.
- the output filter can be a band pass filter.
- the output filter can be a band pass filter with a resonant frequency fo of ⁇ more than 200 kHz at an attenuation of equal or more than 3 dB.
- the electrical components in the housing can include a control unit.
- a control unit can be configured to control electronic circuitry in the housing, in particular the RF-generating circuit.
- the control unit does not comprise a micro controller.
- the control unit is electrically connected to the electrical power source.
- the control unit includes two power supply circuits.
- the control unit can be connected to a wireless interface for wireless data communication with an external device such as a smartphone.
- the electrical components in the housing can include sensors.
- the sensors can be part of the power supply circuit.
- the power supply circuit can include a temperature sensor (e.g., a thermocouple) and a current sensor (e.g., an ammeter).
- the surgical instrument can be configured to allow a charging time of less than 3 hours for a complete charge of the rechargeable battery.
- the operation time per patient can be less than 40 seconds, and in some embodiments less than 10 seconds.
- the surgical instrument can be configured to allow treatment of tissue having of a volume of less than 6 cm 3 per application.
- the device can be configured so that in less than 10 seconds an amount of energy of 200 Joules can be delivered to the tissue to be treated.
- This exemplary treatment corresponds to an averaged output power of approximately 20 W and can cause the tissue being treated to increase in temperature by about 8 K, for example from 37°C to 45°C, thus causing denaturation of the treated tissue.
- up to 100 treatments can be carried out with the surgical instrument on a single charge of a rechargeable battery.
- the electrical components in the housing can include control electronics for controlling the output power of the device.
- the control electronics can be part of the control unit mentioned above.
- a control interface for controlling the control electronics is provided.
- the electrosurgical device is configured for automatic probe detection.
- Automatic probe detection may include automatic detection of a probe being connected to the handpiece, i.e. automatic probe connection detection.
- Automatic probe detection may further comprise automatic detection of a probe type of a probe connected to the handpiece, i.e. automatic probe type detection.
- the latter embodiment is particularly useful if different probe types are provided. Providing different types of probes allows provision of specialized probes for different use case, for instance for different types of treatment.
- a probe type identifier can be a characteristic probe impedance, capacitance and/or inductance that can be detected by means of a sensing unit and the control unit.
- a probe identifier can also be a NFC chip or similar identifier and the handpiece may comprise an identifier reader, for instance an NFC (near field communication) reader.
- automatic probe type detection preferably includes sensing of the probe's inductance.
- the electrosurgical instrument is configured for an automatic operation mode setting.
- the automatic operation mode setting can for instance be implemented in an electrosurgical device that provides automatic probe type detection.
- the control unit can be configured to activate a particular operation mode in response to a detected probe type.
- Operation modes of the electrosurgical device may include a cutting mode and a coagulation mode as known in the art.
- Operation parameter values of these modes refer to the output voltage, the output voltage shape, for instance the pulse shape and the output voltage frequency.
- the electrosurgical instrument preferably is designed for providing different levels of output power in different operation modes.
- the different operation modes are preferably implemented in a single electrosurgical instrument so that the same electrosurgical instrument can be used for instance for coagulation or for cutting. Switching between the operation modes preferably automatically occurs depending on the type of probe attached to the handpiece.
- At least two different kinds of handpieces are provided that are distinguished by their shape or their color or both.
- One hand piece could be configured for high power surgery while the other sort of hand piece could be configured for low power surgery. Due to the different shapes and/or colors of the hand pieces, the user would not apply a wrong power setting in a certain procedure.
- the user interface
- the housing of the surgical instrument can include one or more user interface elements for indicating an operation status and for indicating charging and energy level status of the battery.
- the interface elements may include an acoustic transducer that can emit acoustic signals.
- only one continuous activation sound is played during activation of the surgical instrument.
- the frequency of the activation sound may vary with the tissue impedance.
- Interface elements can also include a charging indicator.
- a charging indicator can include an LED that can be lit during charging and switch off when the battery is fully charged.
- the surgical instrument can also provide an activation indicator and/or an operating mode indicator. These indicators can comprise an LED. For instance, a blue LED can be used to indicate that a coagulation output is active.
- the instrument does not include any on/off button and does not allow for switching between operation modes. Thus, the surgical instrument and its use can be kept very simple.
- the instrument can be configured to allow a coagulation of tissue to be treated. To activate coagulation treatment, a coagulation activation button can be provided.
- the only operation mode provided by the surgical instrument is a soft coagulation (cauterizing) operation mode. In an exemplary soft coagulation mode, the surgical instrument can put out an electric current at a voltage less than 190 V and having a continuous sinusoidal wave form.
- the user interface elements may be configured for providing a control interface for controlling the operation of the electrosurgical instrument, in particular for controlling the output power delivered via the electrodes of the probe of the electrosurgical instrument.
- the control unit may comprise a wireless interface that allows controlling of the control unit and thus the electrosurgical device via an external device, for instance a smartphone with an application for controlling the electrosurgical device.
- the application on the external device may provide further user interface elements in addition to user interface elements on the housing of the electrosurgical device's handpiece.
- no user interface elements are provided on the housing of the electrosurgical device's handpiece.
- the operation of the electrosurgical device during is solely controlled via an application on a smartphone that can be wirelessly connected to the electrosurgical device.
- Embodiments having at least one additional user interface elements such as buttons and/or touch sensitive surface elements on the housing of the electrosurgical device's handpiece are preferred.
- the user elements on the housing include a slider for adjusting the output power setting.
- the slider can have a mechanical sliding element that can be displaced along a path on the housing of the handpiece.
- the slider is implemented as a touch sensitive path on the housing of the handpiece.
- a touch sensitive path - i.e. a touch sensor slider - can be implemented by means of capacitive touch sensor elements arranged at the periphery of the housing of the electrosurgical instrument's handpiece.
- a graphics display preferably a color graphics display is arranged on the electrosurgical instrument's handpiece.
- the graphics display can be a touch sensitive display and as such may also implement a touch sensor slider for adjusting the electrosurgical instrument's output power or other settings.
- the control unit may comprise a memory for storing settings and/or for storing recorded values of operation parameters such as, for instance, activation time, sensed impedance values, time course of the output power and/or the delivered energy etc.
- the wireless connection to an external device can be a Bluetooth connection or a similar bidirectional wireless data communication connection.
- the wireless data communication connection allows transmission of control commands from the external device to the control unit within the housing of the electrosurgical device's handpiece.
- the wireless data communication connection further allows transmission of recorded parameter values of status information from the control unit within the housing of the electrosurgical device's handpiece to the external device.
- the surgical instrument 10 comprises a handpiece 12 with a housing 14 and a probe 16.
- the probe 16 comprises an elongate cylindrical shaft 18 and a base 20 with a mechanical coupling member 20 that includes at least two first electrical contact elements 22 and 24.
- the first electrical contact elements 22 and 24 on the probe are arranged concentrically, as depicted in FIG. 4.
- the probe 16 is a bipolar probe with two active electrodes 54.1 and 54.2 of similar or identical length and diameter.
- electrode 54.1 is a tip electrode
- electrode 54.2 is a ring electrode.
- the two active electrodes 54.1 and 54.2 are arranged at or near the distal end of the elongate cylindrical probe shaft 18.
- the elongate cylindrical shaft 18 and the base 20 are configured for forming a single unit, i.e. probe 16 that can be exchanged - i.e. attached to the handpiece and released from the handpiece - as whole.
- the housing 14 of the handpiece 12 is shaped to allow a mechanical connection between the housing 14 and the coupling member 20 of the probe 16.
- the housing 14 has at least two second electrical contact elements 26 and 28 Each of the second electrical contact elements 26 and 28 is arranged and configured to mate with and make electrical contact with a respective first contact element 22 or 24, respectively, when the probe 16 is mechanically coupled to the handpiece 12.
- the second electrical contact elements 26 and 28 of the headpiece 12 are arranged concentrically, as depicted in FIGS. 3 and 4.
- the handpiece can have a length between 12 cm and 18 cm, a volume between 150 ccm and 350 ccm, a diameter between 3.5 cm and 5cm, and a mass between 150 and 250 grams.
- a battery 30 is arranged that supplies an intermediate voltage generating circuit having a boost converter 32 with electrical energy.
- the boost converter 32 in turn supplies an RF-generating circuit comprising a resonance converter 34 with electrical energy.
- High frequency output voltage of the resonance converter 34 is fed through an output filter 36 to the electrical contact elements 26 and 28 arranged at the housing 14 of the handpiece 12 of the surgical instrument 10.
- a non-limiting, exemplary battery 30 can have the following specifications.
- the battery 30 can have a capacity of at least 30,000 Joules.
- the battery can have a battery voltage of 3.5 V.
- the battery can have a capacity of 2400 mAh.
- the battery 30 can be configured to have a short circuit current of at least 10 A.
- the boost converter 32 of the intermediate voltage generating circuit comprises a DC-DC converter that converts an input voltage as supplied by the battery 30 (e.g., 3.7 V) to a higher output voltage (e.g., 36 V).
- the boost converter can be configured for an input current of less than 11 A and an input power of less than 40 W.
- the boost converter 32 can have an efficiency of more than 90% and can provide an output Power up to 36 W with an output current up to 1 A.
- the output voltage of the boost converter 32 is 36 V +/- 10 V.
- a receiver coil 40 and a battery charging circuit 42 are provided.
- the receiver coil 40 is configured to receive electrical energy via an alternating electromagnetic field.
- the output of the receiver coil is fed to the battery charger circuit 42.
- the battery charger circuit comprises an AC-DC converter 44 and a voltage regulator 46.
- a wireless battery charger 60 comprising a mains power supply configured for an AC input from an external power supply.
- the mains power supply can receive electrical power at a voltage between 90 V and 250 V at a frequency between 50 Hz and 60Hz or such voltage and frequency as is typically provided by an electrical utility.
- the wireless battery charger 60 further comprises an inductive charger circuit 62 with a transmitter coil 64.
- the inductive charger circuit 62 with a transmitter coil 64 is configured to match the receiver coil 40 and battery charger circuit 42 of the surgical device 10.
- both, the wireless battery charger 60 and the proximal end of the handpiece 12 of the electrosurgical instrument 10 are provided with magnets 72 to ease up positioning and guarantee a tight connection.
- Figure 15 schematically illustrates a magnet 72 arranged at the proximal end of the handpiece 12.
- the resonance converter 34 of the RF -generating circuit can be specified as follows.
- the input voltage is 36 V +/- 10 V, the input current up to 1 A and thus the input power up to 36 W.
- the efficiency is better than 70%.
- the output power is between 10 W and 25 W, the output voltage up to 190 V, the output current up to 130 mA and the output frequency between 300 kHz and 1 MHz.
- the surgical instrument 10 is configured to be fully charged within less than 3 hours.
- the operation time per patient is less than 40 sec., for instance 4 times up to 10 sec.
- the volume of treated tissue per application is up to 6 cm 3 . This is achieved by delivering an energy of about 200 J within 10 sec., and thus a power of about 20 W, which results in a raise of temperature (dT) of about 8 k, i.e. from 37°C to 45°C, thus leading to denaturation of the treated tissue.
- dT temperature
- the user interface elements for Indicating operation status and charging/energy level status are as follows.
- a single on/off switch 50 is provided for starting and stopping energy delivery via the probe electrodes 54.1 and 54.2 (treatment electrodes).
- a continuous activation sound during activation is provided.
- an LED activation indicator 52 is provided that indicates an active coagulation output by way of a blue light, i.e. when the surgical instrument 10 is activated by' pressing the on/off button 50.
- the surgical instrument 10 can be configured to provide only a single operation mode, only one on/off button 50 and no switching between operation modes is needed. Only for activating a coagulation output, a blue coagulation activation button 50 is provided. The color of the coagulation activation button matches the color of the LED activation indicator 52.
- the electrosurgical instrument 10 is configured to provide a soft coagulation (cauterizing) of tissue with continuous sinus waveform of less than 190 V.
- Figures 11 to 14 illustrate various different shapes of electrodes on the probe 16. Since the probe 16 can be easily exchanged with other probes having a different electrode configuration, different treatments can be performed with particular suitable probes.
- Bipolar RFITT application for submucosal volume reduction of hyperplastic nasal turbinates.
- the electrosurgical instrument 10 can be configured as a bipolar radio-frequency induced thermotherapy (RFITT) applicator for submucosal volume reduction of hyperplastic nasal turbinates, safely and gently developing predictably sized lesions in 4-10 seconds.
- RFITT radio-frequency induced thermotherapy
- snoring treatment Bipolar RFITT application for submucosal coagulation in the soft palate to tighten the velum palatinum for the treatment of habitual snoring.
- the electrosurgical instrument 10 can be configured as a bipolar radio-frequency induced thermotherapy (RFITT) applicator for submucosal coagulation in the soft palate to tighten the velum palatinum for the treatment of habitual snoring.
- RFITT radio-frequency induced thermotherapy
- the handpiece of the electrosurgical device may comprise a control unit 66 connected to a memory 68 and interface elements.
- the interface elements may include a status indicator light 52 or a display 52' and input elements such as at least one button 50 or a slider 50' or both.
- a sensing unit 70 that is connected to the control unit and to sensors in the handpiece or in the probe may be provided.
- the sensing unit 70 can comprise sensors such as an ammeter a temperature sensor or other sensors for sensing values of operation parameters of the electrosurgical device 10. While being connected to the sensing unit 70 and thus functionally being part of the sensing unit 70, the sensors can be structural parts of the power supply circuit.
- the power supply circuit can include a temperature sensor (e.g., a thermocouple) and a current sensor (e.g., an ammeter).
- the control unit 66 is operatively connected to the memory 68 and a wireless data communication interface, for instance a Bluetooth interface. .
- the wireless data communication interface 74 in combination with the control unit 66 allows transmission of control commands from an external device 90 (see figure 17) to the control unit 66 within the housing 14 of the electrosurgical device's handpiece 12.
- the wireless data communication interface further allows transmission of recorded parameter values or status information from the control unit 66 within the housing of the electrosurgical device's handpiece 12 to the external device 90.
- windings in the handpiece and in the probe may be provided, see Figure 16.
- the windings serve for transferring electrical energy from the handpiece to the probe.
- the electrodes of the probe are electrically connected to the at least one winding 34.2 of the probe.
- the winding 34.2 of the probe preferably is arranged close to the proximal end of the probe 16, i.e. in the electro-mechanical interface of the probe 16.
- the winding 34.1 of the handpiece 12 is arranged close to the distal end of the handpiece 12.
- the mutual arrangement of the windings of the probe 16 and of the handpiece 12 is configured to minimize the gap between the windings of the probe and of the handpiece when the probe 16 is attached to the handpiece 12 to thus improve energy transfer between the handpiece and the probe.
- the windings of the probe are secondary windings 34.2 of an output transformer of the radio frequency generator of the electrosurgical instrument 10.
- the windings 34.2 of the probe are secondary windings 34.2 of an output transformer of the resonance converter 34.
- the probe may further comprise electric filter elements 36' that may comprise at least one capacitance.
- the probe shaft 18 may comprise an ultrasound transducer 80, for instance a piezo transducer; see figure 17.
- the ultrasound transducer 80 preferably is arranged close to the probe tip 76.
- the ultrasound transducer 80 for instance the piezo transducer, can vibrate with an ultrasound frequency.
- Ultrasound vibration of the piezo transducer 80 causes vibration of the tip 76 of the probe shaft 18 and thus helps to prevent sticking of the probe shaft 18 to tissue to be treated.
- the piezo transducer 80 preferably is arranged within the probe shaft 18 close to the distal end of the probe.
- the piezo transducer 80 is electrically connected to a control unit within the housing of the handpiece of the electrosurgical instrument via electrical conductors 82 and contacts 84 that are arranged in the probe base 20.
- the electric connection between the ultrasound piezo transducer and the control unit thus comprises a releasable electrical connection at the electro-mechanical interface between the probe 16 and the handpiece 12.
- the probe 16 schematically shown in figure 17 may comprise any electrode configuration disclosed herein.
- the probe shaft 19 may comprise electrodes 54,1 and 54.2 as shown in figures 9, 11 or 12. Further, the electrodes may be electrically connected to the radio frequency generator
- the electrosurgical instrument 10 preferably is part of a system 100 that further comprises at least an external device 90 that can wirelessly communicate with the electrosurgical instrument 10; see figure 18.
- the electrosurgical instrument 10 may comprise a wireless data communication interface 74 that is connected to control unit 66 and that provides for a bidirectional wireless data communication between the electrosurgical instrument 10 and the external device 90.
- the external device 90 may be configured to communicate with a remote server 92.
- the remote server 92 may serve for administrating a plurality of electrosurgical instruments 10 via respective external devices 90.
- the remote server 92 may also be connected to a data base 94 for collecting and evaluating data received from a plurality of electrosurgical instruments 10 via respective external devices 90.
- the external device 90 may for instance be a smartphone.
- an application may be installed that provides a user interface for controlling at least some functions of an electrosurgical instrument wirelessly connected to the external device 90.
- the user interface provided by the application on the external device 90 may complement a user interface provided on the handpiece 12 of the electrosurgical instrument 10.
- the handpiece 12 may only comprise a single button 50 and sample display 52’ without means for setting the output power of the electrosurgical device 10. Setting the output power and an operation mode may then be carried out by means of the user interface on the external device 90.
- the electrosurgical instrument 10 may comprise more sophisticated interface elements such as a slider 50’ for setting the electrosurgical instrument’s output power and a graphical display 52’.
- FIG. 19 depicts the probe of an electrosurgical instrument in accordance with the various embodiments herein treating a hyperplastic nasal turbinate.
- FIG. 19 also depicts a turbinate following a turbinate reduction procedure using the electrosurgical instruments disclosed herein.
- the electrosurgical instrument can be used in methods for treating (inter alia): hypertrophic turbinates (breathing problems) hyperactive root nerve (nasal dripping) nasal polyps (breathing problems) nasal valve collapse (breathing problems)
- the method of using an electrosurgical instrument consistent with the embodiments described herein includes the following steps, as depicted by Fig. 20:
- Step 0 place the electrosurgical instrument on a table next to the treatment site, connect the base with the general power supply (i.e. , plug it in to wall outlet) and fully load the electrosurgical instrument via integrated inductive charger plate.
- the general power supply i.e. , plug it in to wall outlet
- Step 1 seat patient in the treatment chair and bring them into a semi-upright position, preferably positioned at 30 degrees (with respect to horizontal, where 90 degrees would be fully upright).
- Step 2 locally sedate the turbinate (or target area to treat) following a sedation scheme.
- Step 3 remove the electrosurgical instrument from its base (charger plate) once fully or sufficiently loaded.
- the charge indicator can be checked to ensure the battery is fully or sufficiently charged for the operation.
- Step 4 remove sterile application probe of choice (e.g., “Type A, B or C,” one of a few types of probes available for use on the electrosurgical instrument, depending on the use case) from its sterile packaging
- Step 5 connect or clip-on the sterile probe to the distal end of the electrosurgical instrument which can produce a mechanical and auditory “click” which locks on the application probe.
- the electrosurgical instrument will automatically recognize type of probe which is attached and will choose pre-settings (power and time regime) automatically.
- Step 6 The electrosurgical instrument is held like a pen and with the probe attached. Due to the angle of between the linear shaped probe shaft and the handpiece of electrosurgical instrument, good visibility of the target area of the nasal cavity (cave nasi) is provided.
- Step 7 Insert and position carefully the distal probe end region in the tissue (e.g. nasal turbinate treatment) or apply probe with its distal end to the target area superficially (e.g. for nerve root deactivation or tissue remodeling).
- tissue e.g. nasal turbinate treatment
- probe with its distal end to the target area superficially (e.g. for nerve root deactivation or tissue remodeling).
- Step 8 Once probe has been placed properly, activate the electrosurgical instrument by pressing the activation button until a signal tone indicates the end of the treatment.
- Step 9 Reposition and repeat the procedure according to the treatment recommendations and requirements.
- Step 10 slowly remove the probe from the treatment site and nasal cavity.
- Step 11 release the probe according the instructions on the Instructions for Use (IFU) and dispose of the probe (e.g., in an infectious waste stream).
- IFU Instructions for Use
- Step 12 put the electrosurgical instrument back on to the charger plate for power reload and the next use.
- control unit memory sensing unit magnet wireless data communication interface probe tip ultrasound transducer, piezo transducer electrical conductors contacts for the ultrasound transducer external device server data base system
Landscapes
- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Otolaryngology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Plasma & Fusion (AREA)
- Physics & Mathematics (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
Abstract
Selon l'invention, un instrument électrochirurgical comprend une pièce à main et une sonde reliée amovible à la pièce à main. La sonde présente une forme linéaire s'étendant le long d'un axe de sonde longitudinal et comprenant une configuration d'électrode bipolaire ou multipolaire. La sonde de forme linéaire est reliée amovible au boîtier par l'intermédiaire d'une interface électromécanique. La pièce à main comprend un boîtier autonome, qui a un axe longitudinal et qui présente la forme d'une poignée. Le boîtier contient des composants électriques de l'instrument électrochirurgical comprenant des composants électriques pour générer une tension de sortie RF devant être acheminée à ladite configuration d'électrode de la sonde.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP24710630.5A EP4665255A1 (fr) | 2023-02-14 | 2024-02-12 | Dispositif électrochirurgical |
| CN202480025144.4A CN121057554A (zh) | 2023-02-14 | 2024-02-12 | 电外科手术装置 |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202363484819P | 2023-02-14 | 2023-02-14 | |
| US63/484,819 | 2023-02-14 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2024170143A1 true WO2024170143A1 (fr) | 2024-08-22 |
Family
ID=90364052
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/EP2024/000008 Ceased WO2024170143A1 (fr) | 2023-02-14 | 2024-02-12 | Dispositif électrochirurgical |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP4665255A1 (fr) |
| CN (1) | CN121057554A (fr) |
| WO (1) | WO2024170143A1 (fr) |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20140081256A1 (en) * | 2012-09-12 | 2014-03-20 | Electromedical Associates Llc | Portable electrosurgical instruments and method of using same |
| US20140207124A1 (en) * | 2013-01-23 | 2014-07-24 | Ethicon Endo-Surgery, Inc. | Surgical instrument with selectable integral or external power source |
| US20150112322A1 (en) * | 2012-06-12 | 2015-04-23 | Gyrus Medical Limited | Electrosurgical instrument and system |
| US20150305798A1 (en) * | 2014-04-29 | 2015-10-29 | Jon Garito | Portable electrosurgical instrument |
| US20170056100A1 (en) * | 2013-03-15 | 2017-03-02 | Alan G. Ellman | Electrosurgical Handpiece |
| WO2021245173A1 (fr) * | 2020-06-05 | 2021-12-09 | Creo Medical Limited | Appareil électrochirurgical |
-
2024
- 2024-02-12 CN CN202480025144.4A patent/CN121057554A/zh active Pending
- 2024-02-12 WO PCT/EP2024/000008 patent/WO2024170143A1/fr not_active Ceased
- 2024-02-12 EP EP24710630.5A patent/EP4665255A1/fr active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20150112322A1 (en) * | 2012-06-12 | 2015-04-23 | Gyrus Medical Limited | Electrosurgical instrument and system |
| US20140081256A1 (en) * | 2012-09-12 | 2014-03-20 | Electromedical Associates Llc | Portable electrosurgical instruments and method of using same |
| US20140207124A1 (en) * | 2013-01-23 | 2014-07-24 | Ethicon Endo-Surgery, Inc. | Surgical instrument with selectable integral or external power source |
| US20170056100A1 (en) * | 2013-03-15 | 2017-03-02 | Alan G. Ellman | Electrosurgical Handpiece |
| US20150305798A1 (en) * | 2014-04-29 | 2015-10-29 | Jon Garito | Portable electrosurgical instrument |
| WO2021245173A1 (fr) * | 2020-06-05 | 2021-12-09 | Creo Medical Limited | Appareil électrochirurgical |
Also Published As
| Publication number | Publication date |
|---|---|
| EP4665255A1 (fr) | 2025-12-24 |
| CN121057554A (zh) | 2025-12-02 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US8568400B2 (en) | Methods and apparatus for smart handset design in surgical instruments | |
| KR101929693B1 (ko) | 유도가열된 외과용 기구 | |
| JP5489397B2 (ja) | 電気外科用高周波エネルギー伝達媒体 | |
| CN1160024C (zh) | 一种电外科设备及一种电外科电极组件 | |
| CN106456235B (zh) | 用于处理肿瘤和增生细胞的处理方法和便携式外科设备 | |
| US20140081256A1 (en) | Portable electrosurgical instruments and method of using same | |
| CN106821491B (zh) | 消融电流测量 | |
| US20230397948A1 (en) | Instrument for endoscopic posterior nasal nerve ablation | |
| CN117503320A (zh) | 用于子宫消融的感应线圈组件和方法 | |
| CN103764057A (zh) | 电外科器械 | |
| US11534235B2 (en) | Needle instrument for posterior nasal neurectomy ablation | |
| WO2024170143A1 (fr) | Dispositif électrochirurgical | |
| US8486058B1 (en) | Minigenerator | |
| US9198712B1 (en) | Minigenerator | |
| BG67604B1 (bg) | Хибридна плазмена писалка | |
| WO2024131363A1 (fr) | Système d'ablation de cavité biologique, procédé d'ablation de cavité biologique et support de stockage | |
| CN119730803A (zh) | 多功能外科烧灼装置、系统及使用方法 | |
| Munro et al. | Energy-based surgical devices | |
| CN116035692A (zh) | 基于腱鞘囊肿的电极消融装置 | |
| JP2015104628A (ja) | トロッカー及び手術システム |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 24710630 Country of ref document: EP Kind code of ref document: A1 |
|
| WWE | Wipo information: entry into national phase |
Ref document number: 2024710630 Country of ref document: EP |
|
| NENP | Non-entry into the national phase |
Ref country code: DE |
|
| ENP | Entry into the national phase |
Ref document number: 2024710630 Country of ref document: EP Effective date: 20250915 |